CN106265573A - The preparation technology of HPMC slurry in the production of a kind of paracetamol tablet - Google Patents
The preparation technology of HPMC slurry in the production of a kind of paracetamol tablet Download PDFInfo
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- CN106265573A CN106265573A CN201610848494.8A CN201610848494A CN106265573A CN 106265573 A CN106265573 A CN 106265573A CN 201610848494 A CN201610848494 A CN 201610848494A CN 106265573 A CN106265573 A CN 106265573A
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- hpmc
- slurry
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- paracetamol
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- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pain & Pain Management (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention belongs to medicine field shaping technique, disclose the preparation technology of HPMC slurry during a kind of paracetamol tablet produces.Described preparation technology comprises the steps: to be dissolved in by HPMC in the hot water of 45～100 DEG C, it is prepared as the HPMC solution that mass concentration is 7%～10%, the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 2%～5%, stand bubble slurry 18～48h after being uniformly mixed, obtain HPMC slurry；Then through pelletizing, be dried, select grain, tabletting after adding, toward gained HPMC slurry, the acetaminophen that mass fraction is 10%～20%, paracetamol tablet is obtained.The HPMC obtained by the preparation technology of the present invention is starched when preparing paracetamol tablet, and one-pass finished rate is greatly improved, and every quality index of tablet all reaches requirement, Granulation time is stable, tablet tabletting increases especially without sliver, the dissolution of tablet, remarkable in economical benefits.
Description
Technical field
The invention belongs to medicine field shaping technique, be specifically related to the preparation work of HPMC slurry during a kind of paracetamol tablet produces
Skill.
Background technology
Acetaminophen is one of conventional antipyretic-antalgic anti-inflammatory agent, is synthesized by suppression central nervous system's prostaglandin,
Producing antipyretic-antalgic effect, its safety and effectiveness are confirmed through Clinical practice for many years.Due to its determined curative effect, safety
Good, also it is used widely in department of pediatrics, is usually used in being caused by diseases such as flu, acute upper respiratory tract infection, acute pharyngolaryngitises
Fever of children.As the first-line drug of antipyretic-antalgic, more to the related preparations of acetaminophen, list marketing or Shen the most
The preparation of patent please be broadly divided into two kinds: one is peroral dosage form, as conventional tablet, capsule, granule, syrup, oral liquid,
Dry suspension, suspension, soft capsule, chewable tablet, dispersible tablet, oral cavity disintegration tablet, slow releasing tablet, slow releasing capsule etc.；Another kind is parenteral
The preparation of medication, such as ointment, liniment, suppository.
But during existing manufacture antipyretic analgesic Paracetamol tablets, find that its granulating process is inenough perfect, thing
Material granulation time is different in size, it is difficult to controls a stability range, thus causes acetaminophen crystal to fail fully and wrapped
Wrapping up in, granulating size is uneven, granule compressibility, poor fluidity, and when causing granulation, mold filling is uneven, and tablet weight variation is big, and
Make punch pressure skewness, easily produce the problem such as quick-fried, thus greatly reduce the disposable qualification rate of finished product, produce
The reason of this phenomenon is hydroxypropyl methyl cellulose (HPMC) slurry preparing process not section in Paracetamol tablets production process
Learn.
Summary of the invention
In place of solving the shortcoming and defect of above prior art, it is an object of the invention to provide a kind of acetaminophen
The preparation technology that in sheet production, hydroxypropyl methyl cellulose (HPMC) is starched.
The object of the invention is achieved through the following technical solutions:
The preparation technology that in a kind of paracetamol tablet production, hydroxypropyl methyl cellulose (HPMC) is starched, comprises the steps:
(1) preparation of HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is dissolved in the hot water of 45～100 DEG C, is prepared as
Mass concentration is the HPMC solution of 7%～10%, be diluted with water to after naturally cooling to room temperature the mass concentration of HPMC be 2%～
5%, stand bubble slurry 18～48h after being uniformly mixed, obtain HPMC slurry；
(2) through pelletizing, doing after adding, toward step (1) gained HPMC slurry, the acetaminophen that mass fraction is 10%～20%
Dry, select grain, tabletting, obtain paracetamol tablet.
Preferably, the hot water temperature described in step (1) is 60 DEG C.
Preferably, described in step (1), the mass concentration of HPMC solution is 8%.
Preferably, the mass concentration being diluted to HPMC described in step (1) is 4%.
Preferably, the time steeping slurry described in step (1) is 20h.
Preferably, the mass fraction that acetaminophen described in step (2) adds is 15%.
Preferably, select grain to refer to 16 eye mesh screens described in step (2) and select grain.
In paracetamol tablet of the present invention production, the preparation technology of HPMC slurry has the advantage that and beneficial effect:
The present invention prepares HPMC by ad hoc approach and starches, and by dilution, bubble slurry step, gained HPMC slurry is stable, in system
During standby paracetamol tablet, acetaminophen crystal can be wrapped up by HPMC fully, and granulating size is uniform, granule compressibility, stream
Dynamic property is good, and during granulation, mold filling is uniform, and tablet weight variation is little, and makes punch pressure be evenly distributed so that the system of paracetamol tablet
Standby technique one-pass finished rate is greatly improved, and every quality index of tablet all reaches requirement, and Granulation time is stable, tablet tabletting without
Sliver, the dissolution of tablet increases especially.
Accompanying drawing explanation
Fig. 1 is the one-pass finished rate curve chart producing each batch products with the technique of embodiment 4.
Fig. 2 is that embodiment 4 is molten with the finished product rate of comparative example 1 gained paracetamol tablet, sheeting process yield and tablet
Out-degree results contrast figure.
Detailed description of the invention
Below in conjunction with embodiment and accompanying drawing, the present invention is described in further detail, but embodiments of the present invention do not limit
In this.
Embodiment 1
(1) configuration HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is dissolved in the hot water of 60 DEG C, is prepared as quality dense
Degree is the HPMC solution 150g of 8%, and the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 2%, stirring mixing
Stand bubble slurry 20h after uniformly, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be the acetaminophen of 10%, then through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
Embodiment 2
(1) configuration HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is dissolved in the hot water of 60 DEG C, is prepared as quality dense
Degree is the HPMC solution 150g of 8%, and the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 4%, stirring mixing
Stand bubble slurry 20h after uniformly, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be the acetaminophen of 10%, then through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
Embodiment 3
(1) configuration HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is dissolved in the hot water of 60 DEG C, is prepared as quality dense
Degree is the HPMC solution 150g of 8%, and the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 5%, stirring mixing
Stand bubble slurry 20h after uniformly, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be the acetaminophen of 10%, then through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
Embodiment 4
(1) configuration HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is dissolved in the hot water of 60 DEG C, is prepared as quality dense
Degree is the HPMC solution 150g of 8%, and the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 2%, stirring mixing
Stand bubble slurry 20h after uniformly, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be the acetaminophen of 15%, then through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
With the technique of the present embodiment through the production testing of 32 batches of 15,650,000 paracetamol tablets, one-pass finished rate carries significantly
Height, every quality index of tablet all reaches requirement, and Granulation time is stable, and tablet tabletting is without sliver.The dissolution of tablet is especially
Increase.The one-pass finished rate curve chart of each batch products is as shown in Figure 1.
Embodiment 5
(1) configuration HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is dissolved in the hot water of 60 DEG C, is prepared as quality dense
Degree is the HPMC solution 150g of 8%, and the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 4%, stirring mixing
Stand bubble slurry 20h after uniformly, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be the acetaminophen of 15%, then through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
Embodiment 6
(1) configuration HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is dissolved in the hot water of 60 DEG C, is prepared as quality dense
Degree is the HPMC solution 150g of 8%, and the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 5%, stirring mixing
Stand bubble slurry 20h after uniformly, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be the acetaminophen of 15%, then through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
Embodiment 7
(1) configuration HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is dissolved in the hot water of 60 DEG C, is prepared as quality dense
Degree is the HPMC solution 150g of 8%, and the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 2%, stirring mixing
Stand bubble slurry 20h after uniformly, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be the acetaminophen of 20%, then through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
Embodiment 8
(1) configuration HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is dissolved in the hot water of 60 DEG C, is prepared as quality dense
Degree is the HPMC solution 150g of 8%, and the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 4%, stirring mixing
Stand bubble slurry 20h after uniformly, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be the acetaminophen of 20%, then through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
Embodiment 9
(1) configuration HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is dissolved in the hot water of 60 DEG C, is prepared as quality dense
Degree is the HPMC solution 150g of 8%, and the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 5%, stirring mixing
Stand bubble slurry 20h after uniformly, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be the acetaminophen of 20%, then through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
The complete slice ratio of paracetamol tablet prepared by the technique of employing embodiment 1～9 and dissolution test result such as table 1
Shown in.
Table 1
Comparative example 1
(1) configuration HPMC slurry: hydroxypropyl methyl cellulose (HPMC) is directly dissolved in the hot water of 100 DEG C, is prepared as
Mass concentration is the HPMC solution of 2%, then stand bubble slurry < 15 hours, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be the acetaminophen of 15%, then through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
By embodiment 4 and the finished product rate of comparative example 1 gained paracetamol tablet, sheeting process yield and tablet dissolution
Comparing, result is as shown in Figure 2.As seen from Figure 2, after using the technique of the present invention, finished product rate, sheeting process are received
The technical specifications such as rate, tablet dissolution are significantly improved.
Paracetamol tablet one-pass finished rate is increased to 98% by original 91%, increases production 1,300,000 tablets of tablets, creates economy effect
Benefit 130 × 0.3 yuan/sheet=39.00 ten thousand yuan；Use the technique gained paracetamol tablet of the present invention without sliver phenomenon, saved and chosen
The sheet time, save 120 days man-hours, create economic benefit 120 × 98 yuan/day=1.176 ten thousand yuan.Above two amount to create economy
Benefit 39.00+1.176=40.176 ten thousand yuan.
Above-described embodiment is the present invention preferably embodiment, but embodiments of the present invention are not by above-described embodiment
Limit, the change made under other any spirit without departing from the present invention and principle, modify, substitute, combine, simplify,
All should be the substitute mode of equivalence, within being included in protection scope of the present invention.
Claims (7)
1. the preparation technology of HPMC slurry during a paracetamol tablet produces, it is characterised in that comprise the steps:
(1) preparation of HPMC slurry: being dissolved in by HPMC in the hot water of 45～100 DEG C, being prepared as mass concentration is 7%～10%
HPMC solution, the mass concentration being diluted with water to HPMC after naturally cooling to room temperature is 2%～5%, quiet after being uniformly mixed
Put bubble slurry 18～48h, obtain HPMC slurry；
(2) toward step (1) gained HPMC slurry add mass fraction be 10%～20% acetaminophen after through pelletize, be dried,
Select grain, tabletting, obtain paracetamol tablet.
The preparation technology of HPMC slurry in a kind of paracetamol tablet the most according to claim 1 production, it is characterised in that: step
(1) hot water temperature described in is 60 DEG C.
The preparation technology of HPMC slurry in a kind of paracetamol tablet the most according to claim 1 production, it is characterised in that: step
(1) mass concentration of HPMC solution described in is 8%.
The preparation technology of HPMC slurry in a kind of paracetamol tablet the most according to claim 1 production, it is characterised in that: step
(1) mass concentration being diluted to HPMC described in is 4%.
The preparation technology of HPMC slurry in a kind of paracetamol tablet the most according to claim 1 production, it is characterised in that: step
(1) time steeping slurry described in is 20h.
The preparation technology of HPMC slurry in a kind of paracetamol tablet the most according to claim 1 production, it is characterised in that: step
(2) mass fraction that acetaminophen described in adds is 15%.
The preparation technology of HPMC slurry in a kind of paracetamol tablet the most according to claim 1 production, it is characterised in that: step
(2) select grain to refer to 16 eye mesh screens described in and select grain.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610848494.8A CN106265573A (en) | 2016-09-23 | 2016-09-23 | The preparation technology of HPMC slurry in the production of a kind of paracetamol tablet |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610848494.8A CN106265573A (en) | 2016-09-23 | 2016-09-23 | The preparation technology of HPMC slurry in the production of a kind of paracetamol tablet |
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| CN106265573A true CN106265573A (en) | 2017-01-04 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201610848494.8A Pending CN106265573A (en) | 2016-09-23 | 2016-09-23 | The preparation technology of HPMC slurry in the production of a kind of paracetamol tablet |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101466359A (en) * | 2006-04-07 | 2009-06-24 | 史密丝克莱恩比彻姆公司 | Fast release paracetamol tablets |
| CN105055329A (en) * | 2015-08-05 | 2015-11-18 | 安丘市鲁安药业有限责任公司 | Composite paracetamol instant particle and preparation method thereof |
-
2016
- 2016-09-23 CN CN201610848494.8A patent/CN106265573A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101466359A (en) * | 2006-04-07 | 2009-06-24 | 史密丝克莱恩比彻姆公司 | Fast release paracetamol tablets |
| CN105055329A (en) * | 2015-08-05 | 2015-11-18 | 安丘市鲁安药业有限责任公司 | Composite paracetamol instant particle and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 叶勇主编: "《制药工艺学》", 28 February 2014, 华南理工大学出版社 * |
| 潘卫三主编: "《工业药剂学 第3版》", 31 August 2015, 中国医药科技出版社 * |
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