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CN115501229A - A Chinese medicinal composition for treating new coronary pneumonia and its preparation method - Google Patents

A Chinese medicinal composition for treating new coronary pneumonia and its preparation method Download PDF

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CN115501229A
CN115501229A CN202211089915.5A CN202211089915A CN115501229A CN 115501229 A CN115501229 A CN 115501229A CN 202211089915 A CN202211089915 A CN 202211089915A CN 115501229 A CN115501229 A CN 115501229A
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component
additive
preparation
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彭俊清
张家艾
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China Pharmaceutical University
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China Pharmaceutical University
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/4025—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil not condensed and containing further heterocyclic rings, e.g. cromakalim
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/427—Thiazoles not condensed and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
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  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Virology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Physiology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention provides an oral preparation for treating neocoronary pneumonia, which comprises the following components in parts by mass: 100-200 parts of component A and 30-70 parts of component B, wherein the component A and the component B are different or the same protease inhibitor. The component A is as follows: a covalent inhibitor that can bind directly to the cysteine-catalytic residue of a protease (Cys 145). The component B is as follows: an inhibitor of aspartic protease. The compound preparation with the effective components of the nelmavir tablets and the ritonavir tablets can be produced without adjusting the production line of the existing oral dosage form on a large scale.

Description

Oral preparation for treating neocoronary pneumonia and preparation method thereof
Technical Field
The disclosure relates to the technical field of medicines, in particular to an oral preparation for treating neocoronary pneumonia and a preparation method thereof.
Background
The novel coronavirus pneumonia (Corona Virus Disease 2019, COVID-19) is called new coronavirus pneumonia for short, and the world health organization is named as '2019 coronavirus Disease', and means pneumonia caused by 2019 novel coronavirus infection.
Aiming at the disease, the currently common medicine is a combined medicine packaged by combining the nemadefovir dipivoxil tablets and the ritonavir tablets, wherein the nemadefovir dipivoxil tablets and the ritonavir tablets are required to be packaged separately. This results in: 1. when the combined medicine is prepared, special requirements are required on a packaging machine, the existing production line needs to be modified, and the production cost is obviously improved. 2. When a patient takes the medicine, the two tablets are separately packaged, so that the patient easily takes more or neglects to take one of the medicines, and inconvenience is brought to non-patients.
Disclosure of Invention
In order to overcome the defects of the prior art, the invention aims to provide an oral medicament which can combine the main effective ingredients in the nemadevir tablets and the ritonavir tablets in the same dosage form.
In order to achieve the above purpose, the present disclosure adopts the following technical solutions:
an oral preparation for treating neocoronary pneumonia comprises the following components in parts by mass: 100-200 parts of component A and 30-70 parts of component B, wherein the component A and the component B are different or the same protease inhibitor.
The present disclosure illustratively provides a component a that is: a covalent inhibitor that can bind directly to the cysteine-catalytic residue of a protease (Cys 145).
The present disclosure illustratively provides a component B, which is: an inhibitor of aspartic protease.
The present disclosure illustratively provides a component a, which is: a compound of formula (I), formula (I) is:
Figure BDA0003836600410000021
the present disclosure illustratively provides a component a that is: a compound which adds, replaces and reduces partial groups on the basis of the structural formula (I).
The present disclosure illustratively provides a component B, which is: a compound of structural formula (II):
Figure BDA0003836600410000022
the present disclosure illustratively provides a component B, which is: and (2) a compound which adds, replaces and reduces partial groups on the basis of the structural formula (II).
In addition, the present disclosure also provides a method for preparing an oral preparation for treating neocoronary pneumonia, comprising:
s1, preparing an additive A containing a component A and preparing an additive B containing a component B;
s2, mixing the additive A and the additive B, and preparing/processing the mixture into a target dosage form;
the component A is the component A of any one of claims 1 to 3, and the component B is the component B of any one of claims 1 to 3.
The present disclosure illustratively provides a target dosage form comprising: one of oral capsule preparation, oral tablet preparation, oral buccal tablet preparation, oral solution preparation, oral suspension preparation, oral syrup preparation, brewing granule preparation and effervescent tablet preparation.
The present disclosure exemplarily provides a method for preparing an additive a containing a component a, including:
firstly, preparing the following components in percentage by mass: 60-65% of component A, and the balance of processing aid A.
Then, the component a and the processing aid a were mixed to prepare an additive a.
The present disclosure exemplarily provides a method for preparing an additive B containing a component B, including:
firstly, preparing by mass percent: 10-20% of component B and the balance of processing aid B.
Then, the component B and the processing aid B were mixed to prepare an additive B.
The present disclosure exemplarily provides a method for preparing an additive a, including:
first, component a, microcrystalline cellulose, a flavoring agent, and a disintegrating agent are mixed to obtain mixture a.
Then, adding an adhesive into the mixture A for granulation, and drying to obtain particles A; the drying weight loss is controlled to be less than 3 percent.
And finally, adding an anticaking agent, a bulking agent, a lubricant and an adhesive into the particles A for mixing to obtain the additive A.
The present disclosure exemplarily provides a method for preparing an additive a, including:
first, component a, microcrystalline cellulose, a flavoring agent, a disintegrating agent, and lubricant a were mixed to obtain mixture C.
Then, mixture C was prepared as a sheet extrudate by roll pressing.
Thereafter, the obtained sheet extrudate was pulverized into particles to obtain granules C.
And finally, mixing the particles C with an anticaking agent, a loosening agent and a lubricant B, and stamping into a sheet shape to obtain the additive A.
The present disclosure illustratively provides a flavoring agent that is: at least one of white sugar, brown sugar and lactose.
The present disclosure illustratively provides a disintegrant of: at least one of sodium carboxymethyl starch, dry starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone and cross-linked sodium carboxymethyl cellulose.
The present disclosure illustratively provides that the adhesive is: at least one of starch, polyvidone, and gelatin.
The present disclosure illustratively provides that the anticaking agent is: at least one of sodium aluminosilicate, tricalcium phosphate, silicon dioxide and silica gel micropowder.
The present disclosure illustratively provides that the bulking agent is: at least one of sodium bicarbonate, ammonium bicarbonate and microcrystalline cellulose.
The present disclosure illustratively provides that the lubricant a is: at least one of talc powder and magnesium stearate.
The present disclosure illustratively provides that the lubricant B is: at least one of talc powder and magnesium stearate.
The present disclosure exemplarily provides a method for preparing an additive B, including:
first, component B, carrier polymer, surfactant, glidant a are mixed to obtain mixture B.
Then, the mixture B was subjected to hot melt extrusion granulation to obtain granules B.
And finally, mixing the particles B with a filler and a flow aid B, and obtaining the additive B after mixing.
The present disclosure illustratively provides a carrier polymer comprising: at least one of polysaccharide polymer, polyamino acid polymer and polyester polymer.
The present disclosure illustratively provides a carrier polymer that is: copovidone.
The present disclosure illustratively provides a surfactant comprising: at least one of sodium lauryl sulfate, sorbitol laurate, tween 80, cetyl trimethylamine bromide and sodium stearyl alcohol sulfonate.
The present disclosure illustratively provides a glidant a, which is: at least one of talcum powder, micropowder silica gel and colloidal silicon dioxide.
The present disclosure illustratively provides a glidant B that is: at least one of talcum powder, micropowder silica gel, colloidal silicon dioxide and sodium stearate fumarate.
The present disclosure illustratively provides a filler comprising: at least one of calcium sulfate, calcium hydrogen phosphate, calcium carbonate, microcrystalline cellulose, and compressible starch.
The present disclosure illustratively provides an additive a partially coated with a third substance.
The present disclosure illustratively provides an additive B that is partially coated with a third substance.
The present disclosure provides, for example, a third substance, including: at least one of gastric coating powder, enteric coating powder and flavoring agent.
After adopting above-mentioned technical scheme, this disclosure has following beneficial effect:
(1) The compound preparation simultaneously containing the active ingredients of the nemadefovir dipivoxil tablets and the ritonavir tablets can be produced and obtained without large-scale adjustment of the production line of the existing oral dosage form.
(2) The method overcomes the adverse consequences caused by directly mixing the active ingredients in the nelmavir tablets and the ritonavir tablets by processing the active ingredients in the nelmavir tablets and the ritonavir tablets.
(3) The oral preparation obtained by the method has good drug release capacity and human body absorption capacity, and can shorten the onset time of the drug to a certain extent.
Detailed Description
The present disclosure will be described in further detail with reference to the following embodiments. It is to be understood that the specific embodiments described herein are for purposes of illustration only and are not to be construed as limitations of the present disclosure.
It should be noted that the embodiments and features of the embodiments in the present disclosure may be combined with each other without conflict. The present disclosure will be described in detail with reference to embodiments.
Example 1
An oral preparation for treating neocoronary pneumonia comprises the following components in parts by mass: 150 parts of component A1 and 50 parts of component B, wherein:
the component A is:
Figure BDA0003836600410000061
the component B is as follows:
Figure BDA0003836600410000062
the oral preparation for treating the neocoronary pneumonia is prepared by adopting the following preparation method:
s1, preparing an additive A containing the component A and preparing an additive B containing the component B.
S2, mixing the additive A and the additive B to obtain a capsule content, and processing the capsule content into an oral capsule preparation based on the existing capsule preparation process.
Wherein:
the preparation method of the additive A comprises the following steps:
first, 60% of component a,27% of microcrystalline cellulose, 6% of lactose monohydrate, and 3% of croscarmellose sodium were mixed by mass percentage to obtain mixture a.
Then, adding 2% of adhesive into the mixture A by mass percent for granulation, and drying to obtain particles A; the drying weight loss is controlled to be less than 3 percent.
And finally, adding 1% of superfine silica powder and 1% of magnesium stearate into the granules A by mass percent, mixing, and obtaining the additive A.
The preparation method of the additive B comprises the following steps:
firstly, mixing 15% of component B,60% of copovidone, 8.4% of sorbitol laurate and 0.5% of colloidal silicon dioxide in percentage by mass to obtain a mixture B;
then, carrying out hot-melt extrusion granulation on the mixture B to obtain particles B;
and finally, mixing the granular material B with 15 percent of calcium hydrophosphate, 0.7 percent of sodium fumarate stearate and 0.4 percent of colloidal silica by mass percent, and finishing the mixing to obtain the additive B.
Example 2
The remaining steps of this example are the same as example 1, except that: the preparation method of the additive A comprises the following steps:
first, 60% of component a,25% of microcrystalline cellulose, 6.5% of lactose monohydrate, 5% of croscarmellose sodium, and 0.5% of magnesium stearate were mixed by mass percentage to obtain mixture C.
Then, mixture C was prepared as a sheet extrudate by roll pressing.
Thereafter, the obtained sheet extrudate was pulverized into particles to obtain granules C.
Finally, the granules C were mixed with 1% aerosil and 2% magnesium stearate by mass and pressed into a sheet form to obtain additive a.
Example 3
The remaining steps of this example are the same as example 2, except that: the additive A is coated by adopting the common quick-release stomach-soluble coating powder, and the coating weight is increased by 3 percent.
The above embodiments can all obtain a stable mixed nemadefovir-ritonavir compound capsule preparation.
The other dosage forms, such as: the oral tablet preparation is prepared by taking the additive A and the additive B as one of the components and matching with the tabletting technology of the existing tablet medicine or the technology improved aiming at the additive A and the additive B.
Such as: the oral tablet preparation is prepared by taking the additive A and the additive B as one of the components and matching with the tabletting technology of the existing tablet or the technology improved aiming at the additive A and the additive B.
Such as: oral solution formulation: the additive A and the additive B are dissolved in a solvent as one of solutes to prepare the additive.
Such as: oral suspension formulation: the additive A and the additive B are used as one of suspended matters or suspended matters and are mixed with a solvent to prepare the additive.
Such as: oral syrup preparation: mixing the additive A and the additive B as main ingredients with the existing syrup base material or the syrup base material adjusted according to the additive A and the additive B, and preparing the oral syrup preparation by adopting the existing syrup preparation technology or the technology improved aiming at the additive A and the additive B.
Such as: brewing the granular preparation: the brewing granule preparation is prepared by taking the additive A and the additive B as main components and matching with the existing brewing granule preparation technology or the technology improved aiming at the additive A and the additive B.
Such as: the effervescent tablet preparation comprises the following components: the effervescent tablet preparation is prepared by taking the additive A and the additive B as main components and matching with the existing effervescent tablet preparation technology or the technology improved aiming at the additive A and the additive B.
In the description herein, reference to the description of the terms "one embodiment/mode," "some embodiments/modes," "example," "specific example," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment/mode or example is included in at least one embodiment/mode or example of the application. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment/mode or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments/modes or examples. Furthermore, the various embodiments/modes or examples and features of the various embodiments/modes or examples described in this specification can be combined and combined by one skilled in the art without being mutually inconsistent.
It will be understood by those skilled in the art that the foregoing embodiments are merely for clarity of illustration of the disclosure and are not intended to limit the scope of the disclosure. Other variations or modifications may occur to those skilled in the art, based on the foregoing disclosure, and are still within the scope of the present disclosure.

Claims (9)

1. An oral preparation for treating neocoronary pneumonia is characterized by comprising the following components in parts by mass: 100-200 parts of component A and 30-70 parts of component B, wherein the component A and the component B are different or the same protease inhibitor.
2. The oral formulation of claim 1, wherein component a is a covalent inhibitor that binds directly to the cysteine-catalyzed residue of a protease (Cys 145); the component B is an inhibitor of aspartic protease.
3. The oral formulation for treating neocoronary pneumonia according to claim 1, wherein the component a is a compound of structural formula (a) or a compound which adds, replaces or reduces partial groups based on structural formula (a):
Figure FDA0003836600400000011
the component B is a compound shown in a structural formula (II) or a compound for increasing, replacing and reducing partial groups on the basis of the structural formula (II):
Figure FDA0003836600400000021
4. a preparation method of an oral preparation for treating neocoronary pneumonia is characterized by comprising the following steps:
s1, preparing an additive A containing a component A and preparing an additive B containing a component B;
s2, mixing the additive A and the additive B, and preparing/processing the mixture into a target dosage form;
the component A is the component A of any one of claims 1 to 3, and the component B is the component B of any one of claims 1 to 3.
5. The method of preparing an oral dosage form for treating neo-coronary pneumonia according to claim 4, wherein the target dosage form comprises: one of oral capsule preparation, oral tablet preparation, oral buccal tablet preparation, oral solution preparation, oral suspension preparation, oral syrup preparation, brewing granule preparation and effervescent tablet preparation.
6. The method for preparing an oral formulation for treating neocoronary pneumonia according to claim 4, wherein the method for preparing the additive a containing the component a comprises:
firstly, preparing the following components in percentage by mass: 60-65% of component A, and the balance of processing aid A;
then, mixing the component A and the processing aid A to prepare an additive A;
the preparation method of the additive B containing the component B comprises the following steps:
firstly, preparing the following components in percentage by mass: 10-20% of component B, and the balance of processing aid B;
then, the component B and the processing aid B are mixed to prepare an additive B.
7. The method for preparing an oral formulation for treating neocoronary pneumonia according to claim 6, wherein the method for preparing the additive A comprises:
firstly, mixing the component A, microcrystalline cellulose, a flavoring agent and a disintegrating agent to obtain a mixture A;
then, adding an adhesive into the mixture A for granulation, and drying to obtain particles A; the drying weight loss is controlled to be less than 3 percent;
finally, adding the micro-powder silica gel and the magnesium stearate into the particles A for mixing, and obtaining the additive A after mixing;
the preparation method of the additive B comprises the following steps:
firstly, mixing a component B, a carrier polymer, a surfactant and a flow aid A to obtain a mixture B;
then, carrying out hot-melt extrusion granulation on the mixture B to obtain particles B;
and finally, mixing the particles B with a filler, a lubricant and a glidant B to obtain the additive B.
8. The method for preparing an oral formulation for treating neocoronary pneumonia according to claim 6, wherein the method for preparing the additive A comprises:
firstly, mixing the component A, microcrystalline cellulose, a flavoring agent, a disintegrating agent and magnesium stearate A to obtain a mixture C;
then, preparing the mixture C into a sheet extrudate by a rolling method;
then, crushing the obtained sheet extrusion into particles to obtain particles C;
finally, mixing the particles C with the superfine silica gel powder and the magnesium stearate B, and stamping into a sheet shape to obtain an additive A;
the preparation method of the additive B comprises the following steps:
firstly, mixing a component B, a carrier polymer, a surfactant and a flow aid A to obtain a mixture B;
then, carrying out hot-melt extrusion granulation on the mixture B to obtain particles B;
and finally, mixing the particles B with a filling agent, a lubricating agent and a flow aid B, and obtaining the additive B after mixing.
9. The method for preparing an oral formulation for treating neocoronary pneumonia according to claim 7 or 8, wherein additive a and/or additive B is coated with a third substance.
CN202211089915.5A 2022-09-07 2022-09-07 A Chinese medicinal composition for treating new coronary pneumonia and its preparation method Pending CN115501229A (en)

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CN202211089915.5A CN115501229A (en) 2022-09-07 2022-09-07 A Chinese medicinal composition for treating new coronary pneumonia and its preparation method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202211089915.5A CN115501229A (en) 2022-09-07 2022-09-07 A Chinese medicinal composition for treating new coronary pneumonia and its preparation method

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114652811A (en) * 2022-03-25 2022-06-24 乐普制药科技有限公司 Compound tablet containing nelmavir and ritonavir
CN114668737A (en) * 2022-03-02 2022-06-28 乐普制药科技有限公司 Compound bilayer tablet containing ritonavir pellets for treating novel coronavirus

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114668737A (en) * 2022-03-02 2022-06-28 乐普制药科技有限公司 Compound bilayer tablet containing ritonavir pellets for treating novel coronavirus
CN114652811A (en) * 2022-03-25 2022-06-24 乐普制药科技有限公司 Compound tablet containing nelmavir and ritonavir

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