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CN117920015A - Preparation system and control method for preparing nano preparation - Google Patents

Preparation system and control method for preparing nano preparation Download PDF

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Publication number
CN117920015A
CN117920015A CN202410316254.8A CN202410316254A CN117920015A CN 117920015 A CN117920015 A CN 117920015A CN 202410316254 A CN202410316254 A CN 202410316254A CN 117920015 A CN117920015 A CN 117920015A
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CN
China
Prior art keywords
preparation
switching valve
main controller
infusion pump
flow rate
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Granted
Application number
CN202410316254.8A
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Chinese (zh)
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CN117920015B (en
Inventor
崔志平
刘晓华
袁洲
吕丕平
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Shanghai Fudi Source Code Biotechnology Co ltd
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Shanghai Fudi Source Code Biotechnology Co ltd
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Priority to CN202410316254.8A priority Critical patent/CN117920015B/en
Publication of CN117920015A publication Critical patent/CN117920015A/en
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/30—Micromixers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/80—Mixing plants; Combinations of mixers
    • B01F33/81—Combinations of similar mixers, e.g. with rotary stirring devices in two or more receptacles
    • B01F33/811—Combinations of similar mixers, e.g. with rotary stirring devices in two or more receptacles in two or more consecutive, i.e. successive, mixing receptacles or being consecutively arranged
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/21—Measuring
    • B01F35/211—Measuring of the operational parameters
    • B01F35/2111—Flow rate
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/21—Measuring
    • B01F35/211—Measuring of the operational parameters
    • B01F35/2113—Pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/22—Control or regulation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/20—Measuring; Control or regulation
    • B01F35/22—Control or regulation
    • B01F35/221—Control or regulation of operational parameters, e.g. level of material in the mixer, temperature or pressure
    • B01F35/2214—Speed during the operation
    • B01F35/22141—Speed of feeding of at least one component to be mixed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J19/00—Chemical, physical or physico-chemical processes in general; Their relevant apparatus
    • B01J19/0006—Controlling or regulating processes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J19/00—Chemical, physical or physico-chemical processes in general; Their relevant apparatus
    • B01J19/0093—Microreactors, e.g. miniaturised or microfabricated reactors
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/22—Mixing of ingredients for pharmaceutical or medical compositions

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention relates to a preparation system and a control method for preparing a nano preparation, wherein the preparation system comprises a first preparation unit, a second preparation unit, a pre-preparation unit, a collection device and a control unit; the first preparation unit comprises a first infusion pump and a first preparation chip connected with the first infusion pump; the second preparation unit comprises a second infusion pump, a second preparation chip and an acquisition pipeline, wherein the second preparation chip is connected with the second infusion pump and is connected in series; the preparation unit comprises a first switching valve, a third infusion pump and a liquid discharge pipeline, and the first preparation chip can be respectively connected with the second preparation chip or the liquid discharge pipeline through the switching state of the first switching valve; the acquisition device comprises a first container, a second container and a driver; the control unit comprises a main controller, a flow rate sensor, a pressure sensor and a flow sensor. The invention has the advantages of convenient operation, good universality and practicality, not only reduces the preparation time and improves the preparation efficiency, but also ensures the product quality.

Description

Preparation system and control method for preparing nano preparation
Technical Field
The invention relates to a preparation system and a control method for preparing a nano preparation, which are applicable to the technical field of biological pharmacy.
Background
With the continuous and deep theoretical research of modern drug delivery systems, the development of polymer science is continuous, and the research varieties and dosage forms of drug systems are also changed day by day. Many emerging technologies are gradually applied in the field of pharmaceutical preparations, and nanotechnology is one of the more mature technologies, and has been widely applied to various fields and the pharmaceutical and sanitary industries, and particularly has a more prominent effect in the field of pharmaceutical preparations. In the prior art, a microfluidic technology is generally adopted for preparing nano-medicament, and the principle is that a plurality of auxiliary material solutions are conveyed to a microfluidic chip according to a specific proportion by a power device, so that the solutions are mixed in the chip and a series of microscopic reactions occur, so that the required nano-medicament is obtained.
At present, when nano medicaments are actually prepared, only one medicament can be prepared in a single preparation process due to the difference of prescriptions and technological parameters of different medicaments, and even if the auxiliary materials adopted by the two medicaments are the same, the plurality of medicaments cannot be continuously prepared in the single preparation because of the difference of proportion, concentration and the like of auxiliary material solutions. The preparation process needs to be divided into a plurality of preparation procedures, so that the time cost is increased, the preparation efficiency is reduced, and the influence of human factors on the preparation process is increased.
Disclosure of Invention
In order to solve the defects in the prior art, the invention provides a preparation system and a control method for preparing a nano preparation.
In one aspect, the invention provides a preparation system for preparing a nano preparation, which comprises a first preparation unit, a second preparation unit, a pre-preparation unit, a collecting device and a control unit, wherein the pre-preparation unit is respectively connected with the first preparation unit and the second preparation unit, the collecting device is used for collecting products, and the control unit is used for controlling the operation of the system.
The first preparation unit comprises at least two first infusion pumps and a first preparation chip, and the input ends of the first preparation chip are respectively connected with the at least two first infusion pumps; the second preparation unit comprises at least one second infusion pump, second preparation chips, and acquisition pipelines, wherein the number of the second preparation chips is the same as that of the second infusion pumps and the second preparation chips are connected in a one-to-one correspondence manner, the acquisition pipelines are used for outputting products, each second preparation chip is provided with a first input end, a second input end and an output end, the second preparation chips are connected with the corresponding second infusion pump through the first input end, when the second infusion pumps and the second preparation chips are arranged into a single one, the output ends of the second preparation chips are connected with the acquisition pipelines, when the second infusion pumps and the second preparation chips are all provided with a plurality of second preparation chips, the plurality of second preparation chips are sequentially connected in series, the output ends of the second preparation chips positioned at the upstream are connected with the second input ends of the second preparation chips positioned at the downstream, which are adjacent to the second preparation chips positioned at the most, and the output ends of the second preparation chips positioned at the downstream are connected with the acquisition pipelines. The preparation method has the advantages that the mixed preparation of two or more than two medicinal auxiliary materials is realized through the first preparation unit, the degree of freedom of a preparation system is increased through the second preparation unit, and the product which is primarily mixed through the first preparation unit can be mixed with other auxiliary material solutions in the second preparation unit again for preparation, so that auxiliary material solutions with proper types and concentrations can be added into the first infusion pump and the second infusion pump according to specific technological parameters during actual preparation, the first infusion pump and the second infusion pump which need to participate in preparation are freely combined, the universality and the practicability of the preparation system are improved, and prescription auxiliary materials corresponding to various nano-medicaments are conveniently added into the first infusion pumps and the second infusion pumps, so that implementation conditions are provided for continuously preparing various nano-medicaments in a single preparation process.
The preparation unit comprises a first switching valve, a third infusion pump and a liquid discharge pipeline, wherein the output end of the first preparation chip, the second input end of the second preparation chip positioned at the most upstream, the third infusion pump and the liquid discharge pipeline are all connected with the first switching valve, the first switching valve is at least provided with two working states, when the first switching valve is in the first working state, the output end of the first preparation chip is communicated with the second input end of the second preparation chip positioned at the most upstream through the first switching valve, and the third infusion pump is communicated with the liquid discharge pipeline through the first switching valve; when the first switching valve is in the second working state, the output end of the first preparation chip is communicated with the liquid discharge pipeline through the first switching valve, the third infusion pump is communicated with the second input end of the second preparation chip positioned at the most upstream through the first switching valve, and specifically, when the second preparation chip is arranged as one, the chip is the second preparation chip at the most upstream. In actual preparation, because the solution input by a plurality of first infusion pumps can be mixed and then output by the first preparation chip, the liquid flow rate output by the second infusion pump is generally higher than the liquid flow rate output by the first infusion pump, when the first preparation unit is connected with the second preparation unit, the air in the preparation system cannot be normally discharged when the preparation is started, the first preparation unit and the second preparation unit are freely communicated and disconnected through switching the first switching valve into the first working state and the second working state, the air in the first preparation unit can be discharged through a liquid discharge pipeline, the air in the second preparation unit can be discharged through a collecting pipeline under the driving of the second infusion pump and the third infusion pump, the problem that the air discharge is unsmooth due to the fact that the pump speeds of the first infusion pump and the second infusion pump are inconsistent is avoided, the scheme of increasing the degree of freedom of the preparation system through the second preparation unit is further realized, and the practicability and universality of the preparation system are improved.
The collecting device comprises at least one first container for collecting good products, at least one second container for collecting defective products, and a driver for controlling the positions of the first container and the second container so that one of the first container and the second container is communicated with the output end of the collecting pipeline. Specifically, the first container and the second container can be both arranged as test tubes, the driver can be arranged as a test tube turntable, and the driver controls any first container or second container to collect products output by the collecting pipeline, so that different medicaments prepared by a plurality of process sections in the preparation process are conveniently collected into the corresponding first containers, defective products and good products generated during prescription or process parameter replacement are conveniently collected respectively, the quality of the good products is prevented from being influenced, and the first preparation unit and the second preparation unit can be combined, so that implementation conditions are provided for continuously preparing various nano medicaments in a single preparation process.
The control unit comprises a main controller, a flow rate sensor, a pressure sensor and a flow sensor, wherein the flow rate sensor is arranged between the first infusion pump and the first preparation chip and between the second infusion pump and the second preparation chip and used for monitoring the flow rate of liquid, the pressure sensor is arranged in the acquisition pipeline and used for monitoring the pressure of the liquid, the flow sensor is arranged in the acquisition pipeline and used for monitoring the flow rate of the liquid, and the main controller is respectively in communication connection with the first infusion pump, the second infusion pump, the flow rate sensor, the pressure sensor, the flow sensor and the driver. The liquid flow rate and the pressure output by each infusion pump are monitored in real time through the flow rate sensor and the pressure sensor, so that the master controller can conveniently control the infusion pump to adjust the liquid flow rate in real time, the master controller can also start any infusion pump in a segmented mode, meanwhile, any first container or second container can be controlled in real time through the driver to collect prepared products, the preparation process is conveniently divided into a plurality of process sections, each process section can realize the preparation of a nano medicament, various prescriptions and nano medicaments with different process parameters can be continuously prepared in a single preparation process, the reconfiguration is not required to be stopped, the preparation efficiency is improved, adverse effects on products caused by human factors in the reconfiguration process are avoided, and the product quality is ensured.
Further, the second preparation unit further comprises a quantifying component arranged between the second infusion pump and the second preparation chip, the quantifying component comprises a quantifying ring and a second switching valve connected with the quantifying ring, the second switching valve has at least two working states, when the second switching valve is in the first working state, the second infusion pump is communicated with the input end of the quantifying ring through the second switching valve, and the output end of the quantifying ring is communicated with the first input end of the second preparation chip through the second switching valve; when the second switching valve is in the second working state, the second infusion pump is directly communicated with the first input end of the second preparation chip through the second switching valve. The quantitative component can improve the precision of inputting the medicinal auxiliary material solution and is convenient for preparing precious samples.
In another aspect, the present invention provides a control method for the above-described preparation system, comprising:
S1, setting preparation parameters in a main controller, and then starting preparation; the preparation parameters comprise the number N of process sections to be prepared, the total volume L n of products to be collected in each process section, the number M n of infusion pumps participating in preparation in each process section, and the preset flow rate range V nm±Xnm of the solution output by each infusion pump in each process section, wherein N is more than 0 and less than or equal to N and is an integer, M is more than 0 and less than or equal to M n and is an integer, and X nm is more than 0; specifically, each process section is a preparation process of a nano medicament, and the preparation process of a plurality of nano medicaments is set into a plurality of process sections, and the infusion pumps which are needed to participate in each process section and the output flow rate of each infusion pump are respectively set, so that the preparation of a plurality of nano medicaments is continuously and automatically carried out in a single preparation process. Where n represents the current nth process segment and m represents the mth infusion pump in the current process segment.
S2, the main controller controls the first switching valve to be in a second working state, controls the second container to be communicated with the acquisition pipeline through the driver, and then starts all infusion pumps participating in preparation; after t 0, the main controller closes all the infusion pumps and simultaneously controls the first switching valve to switch to a first working state; the first preparation unit and the second preparation unit are cut off through the first switching valve, so that air in the preparation system is conveniently discharged; specifically, the time t 0 may be set according to the length of the infusion line in the preparation system and the average flow rate of the infusion pump.
S3, the main controller starts the infusion pumps needed to participate in preparation in the current process section, and monitors the real-time flow velocity v n1、vn2···vnm of the solution output by each infusion pump through the corresponding flow velocity sensor.
S4, comparing the real-time flow rate with a preset flow rate range by the main controller:
If V n1 is in the range of V n1±Xn1, V n2 is in the range of V n2±Xn2 and V nm is in the range of V nm±Xnm, after time t 1, the main controller controls the second container to be separated from the collecting pipeline and the first container to be communicated with the collecting pipeline through the driver; specifically, the time t 1 can be set according to the length of the infusion pipeline of the preparation system and the flow rate of the liquid, when the flow rates of all the infusion pumps are in a preset flow rate range, the first container is communicated with the collection pipeline by delaying the time t 1, so that residual defective products in the pipeline are conveniently collected to the second container, and the quality of products collected by the first container is ensured;
If any one of the real-time flow rates v n1、vn2···vnm exceeds the corresponding preset flow rate range, the main controller controls the corresponding infusion pump to adjust the output liquid flow rate upwards or downwards, and reads the real-time flow rate of the output liquid of the infusion pump again after the time t 2: if the real-time flow rate is in the corresponding preset flow rate range, after t 1, the main controller controls the second container to be separated from the acquisition pipeline and the first container to be communicated with the acquisition pipeline through the driver; otherwise, the main controller turns off all infusion pumps and gives an alarm. Specifically, the time t 2 is in direct proportion to the absolute value of the difference between the preset flow rate range and the real-time flow rate, so that the main controller can monitor the regulation and control condition of the liquid flow rate according to the specific value of the real-time flow rate, if the liquid flow rate is still not regulated and controlled to be in a qualified range after the time t 2, faults such as damage of an infusion pump and blockage of a pipeline can exist in the preparation system, and in the state, the main controller controls the system to stop and give an alarm to remind an operator to check, so that cost waste caused by a large number of defective products is avoided.
S5, the main controller monitors the collected real-time volume l n of the current process section through a flow sensor, compares the real-time volume with the total volume of the product required to be collected by the current process section, and returns to the step S3 if l n＜Ln; if l n≥Ln, the main controller closes all the infusion pumps, controls the first container to be separated from the collecting pipeline and the second container to be communicated with the collecting pipeline through the driver, and records the number n of the actually prepared process sections. The real-time volume of the collected product is compared with the preset total volume required to be collected by the process section in real time, so that whether the preparation of the current process section is finished or not is judged, and the number of the process sections which are finished currently is convenient to judge.
S6, comparing the number of the actually prepared process sections with the number of the process sections to be prepared by the main controller, and if N is less than N, preparing the next process section by the main controller according to the method in the steps S3-S6; if N is more than or equal to N, the preparation is finished. And comparing the number of the currently completed process sections with the number of the process sections preset to be prepared to judge whether the preparation process is finished.
Further, in step S1, the preparation parameters further include a predetermined pressure value P n of the liquid in the preparation system in each process section; in step S3, the main controller simultaneously monitors the real-time pressure p n of the liquid in the preparation system by means of the pressure sensor.
Further, in step S4, the main controller compares the real-time pressure with the predetermined pressure value at the same time:
if V n1 is in the range of V n1±Xn1, V n2 is in the range of V n2±Xn2, V nm is in the range of V nm±Xnm, and p n≤Pn, after t 1, the main controller controls the first container to be connected with the collection pipeline through the driver;
If p n＞Pn is in range, the master controller shuts down all infusion pumps and issues an alarm. Through the comprehensive judgment of the flow rate and the pressure of the liquid, the control accuracy of the preparation process is improved, and the quality of the prepared product is further ensured.
Further, step S2 further includes, after time t 0, that the main controller controls the second switching valve to switch to the second working state, and controls the on-off between the dosing ring and the second infusion pump and between the dosing ring and the second preparation chip through the second switching valve, so that the dosing ring is conveniently connected to the system pipeline when needed, and the accuracy of the pharmaceutical excipients input by the infusion pump is improved.
Further, in step S4, the main controller compares the real-time flow rate with the predetermined flow rate range, and when V n1 is in the range of V n1±Xn1, V n2 is in the range of V n2±Xn2, and V nm is in the range of V nm±Xnm, the main controller controls the second switching valve to switch to the first working state, and reads the real-time flow rate of the liquid again:
If V n1 is in the range of V n1±Xn1, V n2 is in the range of V n2±Xn2 and V nm is in the range of V nm±Xnm, after time t 1, the main controller controls the second container to be separated from the collecting pipeline and the first container to be communicated with the collecting pipeline through the driver;
If any one of the real-time flow rates v n1、vn2···vnm exceeds the corresponding preset flow rate range, the main controller controls the corresponding infusion pump to adjust the output liquid flow rate upwards or downwards, and reads the real-time flow rate of the output liquid of the infusion pump again after the time t 2: if the real-time flow rate is in the corresponding preset flow rate range, after t 1, the main controller controls the second container to be separated from the acquisition pipeline and the first container to be communicated with the acquisition pipeline through the driver; otherwise, the main controller turns off all infusion pumps and gives an alarm. When the real-time flow rate accords with the preset flow rate range, the quantitative ring is connected, so that the waste of precious auxiliary materials can be reduced to the greatest extent, the preparation cost is saved, and when the quantitative ring is connected to the preparation system, the liquid flow rate can be changed to a certain extent, and the normal preparation is ensured by reading the liquid flow rate again.
Further, the number of the first containers is the same as the number N of the process sections to be prepared and corresponds to one, when the main controller controls the first containers to be communicated with the collecting pipeline through the driver, the communicated first containers are the first containers corresponding to the current process sections, and different nano-medicaments prepared in different process sections can be collected through different first containers conveniently.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
The preparation system and the control method for preparing the nano preparation are convenient to operate, good in universality and practicability, capable of continuously preparing various nano preparations with different prescriptions and processes without stopping in a single preparation process, free of manual operation or reconfiguration of medicinal auxiliary materials in the process, capable of greatly reducing preparation time, improving preparation efficiency, avoiding adverse effects caused by human factors on preparation, and guaranteeing product quality.
Drawings
Some specific embodiments of the invention will be described in detail hereinafter by way of example and not by way of limitation with reference to the accompanying drawings. The same reference numbers will be used throughout the drawings to refer to the same or like components or portions. It will be appreciated by those skilled in the art that the drawings are not necessarily drawn to scale. In the accompanying drawings:
FIG. 1 is a schematic diagram of the structure of one embodiment of the present invention;
FIG. 2 is a schematic diagram of the first switching valve in the second operating state and the second switching valve in the first operating state in the embodiment shown in FIG. 1;
FIG. 3 is a schematic view of the structure of the acquisition device in the embodiment shown in FIG. 1;
The reference numerals are explained as follows:
1. A first preparation unit; 11. a first infusion pump; 12. a first preparation chip; 2. a second preparation unit; 21. a second infusion pump; 22. a second chip is prepared; 23. collecting a pipeline; 24. a dosing assembly; 241. a dosing ring; 242. a second switching valve; 3. prefabricating a unit; 31. a first switching valve; 32. a third infusion pump; 33. a liquid discharge pipeline; 4. a collection device; 41. a first container; 42. a second container; 43. a driver; 51. a flow sensor; 52. a flow rate sensor; 53. a pressure sensor.
Detailed Description
The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the description of the present invention, it should be noted that the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In addition, the technical features of the different embodiments of the present invention described below may be combined with each other as long as they do not collide with each other.
Referring to fig. 1 to 3, in one aspect, a preparation system for preparing a nano-preparation is provided in this embodiment, which includes a first preparation unit 1, a second preparation unit 2, a pre-preparation unit 3 connected to the first preparation unit 1 and the second preparation unit 2, respectively, a collection device 4 for collecting a product, and a control unit for controlling the operation of the system, which are not shown in the drawings.
The first preparation unit 1 comprises at least two first infusion pumps 11, and a first preparation chip 12, the input ends of which are respectively connected with the at least two first infusion pumps 11. The second preparation unit 2 comprises at least one second infusion pump 21, second preparation chips 22 which are the same in number as the second infusion pumps 21 and are connected in a one-to-one correspondence manner, and a collection pipeline 23 for outputting products, wherein the second preparation chips 22 are provided with first input ends, second input ends and output ends, the second preparation chips 22 are connected with the corresponding second infusion pumps 21 through the first input ends, when the second infusion pumps 21 and the second preparation chips 22 are arranged into a single one, the output ends of the second preparation chips 22 are connected with the collection pipeline 23, when the second infusion pumps 21 and the second preparation chips 22 are arranged into a plurality of pieces, the plurality of second preparation chips 22 are sequentially connected in series, the output ends of the second preparation chips 22 positioned at the upstream are connected with the second input ends of the second preparation chips 22 positioned at the downstream adjacent to the second preparation chips, and the output ends of the second preparation chips 22 positioned at the downstream are connected with the collection pipeline 23. The first preparation unit 1 is used for realizing the mixed preparation of two or more than two medicinal auxiliary materials, the second preparation unit 2 is used for increasing the degree of freedom of a preparation system, and the product which is primarily mixed by the first preparation unit 1 can be mixed with other auxiliary material solutions in the second preparation unit 2 again for preparation, so that the medicinal auxiliary material solutions with proper types and concentrations can be respectively added into the first infusion pump 11 and the second infusion pump 21 according to specific technological parameters during actual preparation, and the first infusion pump 11 and the second infusion pump 21 which need to participate in preparation are freely combined, the universality and the practicability of the preparation system are improved, and prescription auxiliary materials corresponding to various nano medicaments are conveniently added into the plurality of first infusion pumps 11 and the second infusion pumps 21, so that implementation conditions are provided for continuously preparing the various nano medicaments in a single preparation process.
The pre-preparation unit 3 comprises a first switching valve 31, a third infusion pump 32 and a liquid discharge pipeline 33, wherein the output end of the first preparation chip 12, the second input end of the second preparation chip 22 positioned at the most upstream, the third infusion pump 32 and the liquid discharge pipeline 33 are all connected with the first switching valve 31, the first switching valve 31 has at least two working states, when the first switching valve 31 is in the first working state, the output end of the first preparation chip 12 is communicated with the second input end of the second preparation chip 22 positioned at the most upstream through the first switching valve 31, and the third infusion pump 32 is communicated with the liquid discharge pipeline 33 through the first switching valve 31; when the first switching valve 31 is in the second working state, the output end of the first preparation chip 12 is communicated with the drain pipeline 33 through the first switching valve 31, and the third infusion pump 32 is communicated with the second input end of the second preparation chip 22 positioned at the most upstream through the first switching valve 31, specifically, when the second preparation chip 22 is set as one, the chip is the second preparation chip 22 positioned at the most upstream. In actual preparation, since the solution input by the plurality of first infusion pumps 11 is mixed and then output by the first preparation chip 12, the liquid flow rate output by the second infusion pump 21 is generally higher than the liquid flow rate output by the first infusion pump 11, when the first preparation unit 1 is connected with the second preparation unit 2, the air in the preparation system cannot be normally discharged when the preparation is started, the first switching valve 31 is switched to the first working state or the second working state, the free connection and disconnection of the first preparation unit 1 and the second preparation unit 2 are realized, the air in the first preparation unit 1 can be discharged through the liquid discharge pipeline 33, the air in the second preparation unit 2 can be discharged through the collection pipeline 23 under the driving of the second infusion pump 21 and the third infusion pump 32, and the problem that the air is not discharged smoothly due to the inconsistent pump speeds of the first infusion pump 11 and the second infusion pump 21 is avoided, so that the scheme of increasing the preparation system degree of freedom through the second preparation unit 2 is realized, and the practicability and universality of the preparation system are improved.
The collecting device 4 comprises at least one first container 41 for collecting good products, at least one second container 42 for collecting bad products, a driver 43 for controlling the position of the first container 41 and the second container 42 such that one of them is in communication with the output of the collecting line 23. Specifically, the first container 41 and the second container 42 may be both set as test tubes, the driver 43 may be set as a test tube turntable, and the driver 43 controls any first container 41 or second container 42 to collect the product output by the collecting pipeline 23, so that not only is different medicaments prepared by a plurality of process sections in the preparation process conveniently collected in the corresponding first container 41, but also defective products and good products generated during replacement of prescriptions or process parameters are conveniently collected respectively, thereby avoiding influencing quality of the good products, and further, the first preparation unit 1 and the second preparation unit 2 can be combined to provide implementation conditions for continuously preparing a plurality of nano medicaments in a single preparation process.
The control unit includes a flow rate sensor 52, a pressure sensor 53, and a flow rate sensor 51, which are not shown in the drawing, and are respectively disposed between the first infusion pump 11 and the first preparation chip 12 and between the second infusion pump 21 and the second preparation chip 22, for monitoring the flow rate of the liquid, and disposed in the collection line 23, for monitoring the pressure of the liquid, and disposed in the collection line 23, for monitoring the flow rate of the liquid, and the main controller is respectively in communication connection with the first infusion pump 11, the second infusion pump 21, the flow rate sensor 52, the pressure sensor 53, the flow rate sensor 51, and the driver 43. The flow rate sensor 52 and the pressure sensor 53 are used for monitoring the liquid flow rate and the pressure output by each infusion pump in real time, so that the master controller can conveniently control the infusion pump to adjust the liquid flow rate in real time, and can also start any infusion pump in a segmented mode, meanwhile, the driver 43 can be used for controlling any first container 41 or second container 42 in real time to collect the prepared products, the preparation process is conveniently divided into a plurality of process segments, each process segment can be used for preparing a nano medicament, various prescriptions and nano medicaments with different process parameters can be continuously prepared in a single preparation process, the shutdown reconfiguration is not needed, the preparation efficiency is improved, adverse effects on products caused by human factors in the reconfiguration process are avoided, and the product quality is ensured.
In a more preferred embodiment, the second preparation unit 2 further comprises a dosing assembly 24 arranged between the second infusion pump 21 and the second preparation chip 22, the dosing assembly 24 comprising a dosing ring 241, a second switching valve 242 connected to the dosing ring 241, the second switching valve 242 having at least two operating states, the second infusion pump 21 being in communication with the input of the dosing ring 241 via the second switching valve 242, the output of the dosing ring 241 being in communication with the first input of the second preparation chip 22 via the second switching valve 242 when the second switching valve 242 is in its first operating state; when the second switching valve 242 is in its second operating state, the second infusion pump 21 communicates directly with the first input of the second preparation chip 22 via the second switching valve 242.
On the other hand, the embodiment also provides a control method for the preparation system, which comprises the following steps:
S1, setting preparation parameters in a main controller, and then starting preparation; the preparation parameters comprise the number N of process sections to be prepared, the total volume L n of products to be collected in each process section, the number M n of infusion pumps participating in preparation in each process section, and the preset flow rate range V nm±Xnm of the solution output by each infusion pump in each process section, wherein N is more than 0 and less than or equal to N and is an integer, M is more than 0 and less than or equal to M n and is an integer, and X nm is more than 0; specifically, each process section is a preparation process of a nano medicament, and the preparation process of a plurality of nano medicaments is set into a plurality of process sections, and the infusion pumps which are needed to participate in each process section and the output flow rate of each infusion pump are respectively set, so that the preparation of a plurality of nano medicaments is continuously and automatically carried out in a single preparation process. Where n represents the current nth process segment and m represents the mth infusion pump in the current process segment.
S2, the main controller controls the first switching valve 31 to be in a second working state, controls the second container 42 to be communicated with the collection pipeline 23 through the driver 43, and then starts all infusion pumps participating in preparation; after time t 0, the main controller closes all the infusion pumps and simultaneously controls the first switching valve 31 to switch to the first working state; the first preparation unit 1 and the second preparation unit 2 are cut off through the first switching valve 31, so that air in the preparation system is conveniently discharged; specifically, the time t 0 may be set according to the length of the infusion line in the preparation system and the average flow rate of the infusion pump.
S3, the main controller starts the infusion pumps needed to participate in preparation in the current process section, and monitors the real-time flow velocity v n1、vn2···vnm of the solution output by each infusion pump through the corresponding flow velocity sensor 52.
S4, comparing the real-time flow rate with a preset flow rate range by the main controller:
If V n1 is in the range of V n1±Xn1, and V n2 is in the range of V n2±Xn2 and V nm is in the range of V nm±Xnm, after time t 1, the main controller controls the second container 42 to be disconnected from the collection line 23 and the first container 41 to be connected to the collection line 23 through the driver 43; specifically, the time t 1 can be set according to the length of the infusion pipeline of the preparation system and the flow rate of the liquid, when the flow rates of all the infusion pumps are in the preset flow rate range, the first container 41 is connected with the collection pipeline 23 by delaying the time t 1, so that defective products can be prevented from being collected by the first container 41, the residual defective products in the pipeline are ensured to be collected to the second container 42, and the quality of products collected by the first container 41 is ensured;
If any one of the real-time flow rates v n1、vn2···vnm exceeds the corresponding preset flow rate range, the main controller controls the corresponding infusion pump to adjust the output liquid flow rate upwards or downwards, and reads the real-time flow rate of the output liquid of the infusion pump again after the time t 2: if the real-time flow rate is within the corresponding preset flow rate range, after t 1, the main controller controls the second container 42 to be separated from the collection pipeline 23 and the first container 41 to be communicated with the collection pipeline 23 through the driver 43; otherwise, the main controller closes all the infusion pumps and sends out an alarm; specifically, the time t 2 is in direct proportion to the absolute value of the difference between the preset flow rate range and the real-time flow rate, so that the main controller can monitor the regulation and control condition of the liquid flow rate according to the specific value of the real-time flow rate, if the liquid flow rate is still not regulated and controlled to be in a qualified range after the time t 2, faults such as damage of an infusion pump and blockage of a pipeline can exist in the preparation system, and in the state, the main controller controls the system to stop and give an alarm to remind an operator to check, so that cost waste caused by a large number of defective products is avoided.
S5, the main controller monitors the real-time volume l n collected by the current process section through the flow sensor 51, compares the real-time volume with the total volume of the product required to be collected by the current process section, and returns to the step S3 if l n＜Ln; if l n≥Ln, the main controller turns off all the infusion pumps, controls the first container 41 to be separated from the collection pipeline 23 and the second container 42 to be communicated with the collection pipeline 23 through the driver 43, and records the number n of actually prepared process sections; the real-time volume of the collected product is compared with the preset total volume required to be collected by the process section in real time, so that whether the preparation of the current process section is finished or not is judged, and the number of the process sections which are finished currently is convenient to judge.
S6, comparing the number of the actually prepared process sections with the number of the process sections to be prepared by the main controller, and if N is less than N, preparing the next process section by the main controller according to the method in the steps S3-S6; if N is more than or equal to N, the preparation is finished. And comparing the number of the currently completed process sections with the number of the process sections preset to be prepared to judge whether the preparation process is finished.
In a more preferred embodiment, in step S1, the production parameters further comprise a predetermined pressure value P n of the liquid in the production system in each process section; in step S3, the main controller simultaneously monitors the real-time pressure p n of the liquid in the preparation system through the pressure sensor 53;
In step S4, the main controller compares the real-time pressure with a predetermined pressure value at the same time:
If V n1 is in the range of V n1±Xn1, V n2 is in the range of V n2±Xn2, V nm is in the range of V nm±Xnm, and p n≤Pn, after t 1, the main controller controls the first container 41 to be connected with the collection pipeline 23 through the driver 43;
if the range of p n＞Pn is within the range, the main controller turns off all infusion pumps and gives an alarm;
Through the comprehensive judgment of the flow rate and the pressure of the liquid, the control accuracy of the preparation process is improved, and the quality of the prepared product is further ensured.
In a more preferred embodiment, step S2 further includes, after time t 0, controlling the second switching valve 242 by the main controller to switch to the second working state, and controlling the on-off between the dosing ring 241 and the second infusion pump 21 and between the dosing ring 241 and the second preparation chip 22 by the second switching valve 242, so that the dosing ring 241 is connected to the system pipeline when needed, so as to improve the accuracy of the pharmaceutical excipients input by the infusion pump.
In a more preferred embodiment, in step S4, the main controller compares the real-time flow rate with the predetermined flow rate range, and when V n1 is in the range of V n1±Xn1, V n2 is in the range of V n2±Xn2, and V nm is in the range of V nm±Xnm, the main controller controls the second switching valve 242 to switch to the first operating state, and reads the real-time flow rate of the liquid again:
If V n1 is in the range of V n1±Xn1, and V n2 is in the range of V n2±Xn2 and V nm is in the range of V nm±Xnm, after time t 1, the main controller controls the second container 42 to be disconnected from the collection line 23 and the first container 41 to be connected to the collection line 23 through the driver 43;
If any one of the real-time flow rates v n1、vn2···vnm exceeds the corresponding preset flow rate range, the main controller controls the corresponding infusion pump to adjust the output liquid flow rate upwards or downwards, and reads the real-time flow rate of the output liquid of the infusion pump again after the time t 2: if the real-time flow rate is within the corresponding preset flow rate range, after t 1, the main controller controls the second container 42 to be separated from the collection pipeline 23 and the first container 41 to be communicated with the collection pipeline 23 through the driver 43; otherwise, the main controller turns off all infusion pumps and gives an alarm. When the real-time flow rate accords with the preset flow rate range, the quantitative ring 241 is connected, so that the waste of precious auxiliary materials can be reduced to the greatest extent, the preparation cost is saved, and when the quantitative ring 241 is connected to the preparation system, the liquid flow rate can be changed to a certain extent, and the normal preparation is ensured by reading the liquid flow rate again.
In a more preferred embodiment, the number of first containers 41 is the same as the number of process segments N to be prepared and corresponds one to one, and when the master controller controls the first containers 41 to be connected to the collection line 23 through the driver 43, the connected first containers 41 are the first containers 41 corresponding to the current process segments, so that different nano-medicaments prepared in different process segments can be collected through different first containers 41.
Due to the application of the technical scheme, compared with the prior art, the invention has the following advantages:
The preparation system and the control method for preparing the nano preparation are convenient to operate, good in universality and practicability, capable of continuously preparing various nano preparations with different prescriptions and processes without stopping in a single preparation process, free of manual operation or reconfiguration of medicinal auxiliary materials in the process, capable of greatly reducing preparation time, improving preparation efficiency, avoiding adverse effects caused by human factors on preparation, and guaranteeing product quality.
The above embodiments are only for illustrating the technical concept and features of the present invention, and are intended to enable those skilled in the art to understand the present invention and to implement the same, but are not intended to limit the scope of the present invention, and all equivalent changes or modifications made according to the spirit of the present invention should be included in the scope of the present invention.

Claims (5)

1. A preparation system for preparing a nano-formulation, characterized by: the device comprises a first preparation unit (1), a second preparation unit (2), a pre-preparation unit (3) respectively connected with the first preparation unit (1) and the second preparation unit (2), a collection device (4) for collecting products and a control unit for controlling the operation of a system;
The first preparation unit (1) comprises at least two first infusion pumps (11) and a first preparation chip (12) with input ends respectively connected with the at least two first infusion pumps (11);
The second preparation unit (2) comprises at least one second infusion pump (21), second preparation chips (22) which are the same in number as the second infusion pumps (21) and are connected in a one-to-one correspondence manner, and acquisition pipelines (23) for outputting products, wherein the second preparation chips (22) are provided with first input ends, second input ends and output ends, the second preparation chips (22) are connected with the corresponding second infusion pumps (21) through the first input ends, when the second infusion pumps (21) and the second preparation chips (22) are arranged into a single one, the output ends of the second preparation chips (22) are connected with the acquisition pipelines (23), when the second infusion pumps (21) and the second preparation chips (22) are arranged into a plurality of one-to-one correspondence manner, the output ends of the second preparation chips (22) positioned at the upstream are sequentially connected with the second input ends of the second preparation chips (22) positioned at the downstream adjacent to the second input ends of the second preparation chips (22), and the second preparation chips (22) positioned at the downstream end are connected with the second acquisition pipelines (23);
The preparation unit (3) comprises a first switching valve (31), a third infusion pump (32) and a liquid discharge pipeline (33), wherein the output end of the first preparation chip (12), the second input end of the second preparation chip (22) which is positioned at the most upstream, the third infusion pump (32) and the liquid discharge pipeline (33) are all connected with the first switching valve (31), the first switching valve (31) has at least two working states, when the first switching valve is in the first working state, the output end of the first preparation chip (12) is communicated with the second input end of the second preparation chip (22) which is positioned at the most upstream through the first switching valve (31), and the third infusion pump (32) is communicated with the liquid discharge pipeline (33) through the first switching valve (31); when the first switching valve (31) is in a second working state, the output end of the first preparation chip (12) is communicated with the liquid discharge pipeline (33) through the first switching valve (31), and the third liquid conveying pump (32) is communicated with the second input end of the second preparation chip (22) positioned at the most upstream through the first switching valve (31);
The collecting device (4) comprises at least one first container (41) for collecting good products, at least one second container (42) for collecting bad products, and a driver (43) for controlling the positions of the first container (41) and the second container (42) so that one of the first container and the second container is communicated with the output end of the collecting pipeline (23);
the control unit comprises a main controller, a flow rate sensor (52) which is arranged between the first infusion pump (11) and the first preparation chip (12) and between the second infusion pump (21) and the second preparation chip (22) and used for monitoring the flow rate of liquid, a pressure sensor (53) which is arranged in the acquisition pipeline (23) and used for monitoring the pressure of the liquid, and a flow rate sensor (51) which is arranged in the acquisition pipeline (23) and used for monitoring the flow rate of the liquid, wherein the main controller is respectively connected with the first infusion pump (11), the second infusion pump (21), the flow rate sensor (52), the pressure sensor (53), the flow rate sensor (51) and the driver (43) in a communication mode.
2. The preparation system for preparing a nano-formulation according to claim 1, wherein: the second preparation unit (2) further comprises a dosing assembly (24) arranged between the second infusion pump (21) and the second preparation chip (22), the dosing assembly (24) comprises a dosing ring (241) and a second switching valve (242) connected with the dosing ring (241), the second switching valve (242) has at least two working states, when the second switching valve (242) is in a first working state, the second infusion pump (21) is communicated with the input end of the dosing ring (241) through the second switching valve (242), and the output end of the dosing ring (241) is communicated with the first input end of the second preparation chip (22) through the second switching valve (242); when the second switching valve (242) is in the second working state, the second infusion pump (21) is directly communicated with the first input end of the second preparation chip (22) through the second switching valve (242).
3. A control method for the preparation system for preparing a nano-formulation according to any one of claims 1 to 2, characterized by comprising:
S1, setting preparation parameters in the main controller, and then starting preparation; the preparation parameters comprise the number N of process sections to be prepared, the total volume L n of products to be collected in each process section, the number M n of infusion pumps participating in preparation in each process section, and the preset flow rate range V nm±Xnm of the solution output by each infusion pump in each process section, wherein N is more than 0 and less than or equal to N and is an integer, M is more than 0 and less than or equal to M n and is an integer, and X nm is more than 0;
S2, the main controller controls the first switching valve (31) to be in a second working state, controls the second container (42) to be communicated with the collection pipeline (23) through the driver (43), and then starts all infusion pumps participating in preparation; after time t 0, the main controller closes all infusion pumps and simultaneously controls the first switching valve (31) to switch to a first working state;
S3, the main controller starts infusion pumps which are needed to participate in preparation in the current process section, and monitors the real-time flow velocity v n1、vn2···vnm of the solution output by each infusion pump through the corresponding flow velocity sensor (52);
s4, comparing the real-time flow rate with a preset flow rate range by the main controller:
If V n1 is in the range of V n1±Xn1, and V n2 is in the range of V n2±Xn2 and V nm is in the range of V nm±Xnm, after time t 1, the master controller controls the second container (42) to be disconnected from the collection line (23) and the first container (41) to be connected to the collection line (23) through the driver (43);
If any one of the real-time flow rates v n1、vn2···vnm exceeds the corresponding preset flow rate range, the main controller controls the corresponding infusion pump to adjust the output liquid flow rate upwards or downwards, and reads the real-time flow rate of the output liquid of the infusion pump again after the time t 2: if the real-time flow rate is in the corresponding preset flow rate range, after t 1, the main controller controls the second container (42) to be separated from the collection pipeline (23) through the driver (43) and the first container (41) to be communicated with the collection pipeline (23); otherwise, the main controller closes all infusion pumps and sends out an alarm;
S5, the main controller monitors the real-time volume l n collected by the current process section through the flow sensor (51), compares the real-time volume with the total volume of the product required to be collected by the current process section, and returns to the step S3 if l n＜Ln; if l n≥Ln, the main controller closes all infusion pumps, controls the first container (41) to be separated from the collecting pipeline (23) and the second container (42) to be communicated with the collecting pipeline (23) through the driver (43), and records the number n of actually prepared process sections at the same time;
s6, comparing the number of the actually prepared process sections with the number of the process sections to be prepared by the main controller, and if N is smaller than N, preparing the next process section by the main controller according to the method in the steps S3-S6; if N is more than or equal to N, ending the preparation;
The number of the first containers (41) is the same as the number N of the process sections to be prepared and corresponds to one by one, and when the main controller controls the first containers (41) to be communicated with the collecting pipeline (23) through the driver (43), the communicated first containers (41) are the first containers (41) corresponding to the current process sections.
4. A control method according to claim 3, wherein in step S1, the preparation parameters further comprise a predetermined pressure value P n of the liquid in the preparation system in each process section; in step S3, the main controller simultaneously monitors the real-time pressure p n of the liquid in the preparation system through the pressure sensor (53).
5. The control method according to claim 4, wherein in step S4, the main controller compares the real-time pressure with a predetermined pressure value at the same time:
If V n1 is in the range of V n1±Xn1, V n2 is in the range of V n2±Xn2, V nm is in the range of V nm±Xnm, and p n≤Pn, after time t 1, the main controller controls the first container (41) to be connected with the collection line (23) through the driver (43);
If p n＞Pn is in range, the master controller turns off all infusion pumps and issues an alarm.
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CN218688899U (en) * 2022-11-09 2023-03-24 山东微井化工科技有限公司 Cosmetics serialization is compound device
CN220345633U (en) * 2023-07-07 2024-01-16 苏州星核迪赛生物技术有限公司 Preparation device for nano preparation

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