CN101390846A - Amoxicillin capsule and production method thereof - Google Patents
Amoxicillin capsule and production method thereof Download PDFInfo
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- CN101390846A CN101390846A CNA2008101758957A CN200810175895A CN101390846A CN 101390846 A CN101390846 A CN 101390846A CN A2008101758957 A CNA2008101758957 A CN A2008101758957A CN 200810175895 A CN200810175895 A CN 200810175895A CN 101390846 A CN101390846 A CN 101390846A
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- amoxicillin
- capsules
- amoxicillin capsules
- micronization technology
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Abstract
The invention relates to an amoxicillin capsule and the preparation method thereof, in particular to a method of adopting the micropowder technology to prepare amoxicillin capsules. The method utilizes the micropowder technology to overcome the bad dissolution of the amoxicillin capsule in the prior art; meanwhile, the amoxicillin capsule prepared by the method has the advantages of improving the preparation stability, simplifying the preparation process, reducing the toxic and side effects.
Description
Technical field
The present invention relates to a kind of method for preparing Amoxicillin Capsules, relate in particular to a kind of method that adopts micronization technology to prepare Amoxicillin Capsules.This method utilizes micronization technology to overcome the problem of Amoxicillin Capsules dissolution difference in the prior art, but also improves stability of formulation, has simplified preparation process, has reduced toxic and side effects.The invention belongs to medical technical field.
Background technology
The amoxicillin is a kind of semi-synthetic penbritin class medicine, is characterized in has a broad antifungal spectrum, and sterilizing power is strong, and clinical practice at present is extensive, is mainly used in respiratory tract infection, digestive tract infection, urinary tract infection, skin and soft tissue infection etc., also can promote wound healing.
The amoxicillin is slightly soluble in water, and is almost insoluble in ethanol, and relatively poor dissolubility has determined that the dissolution of its capsule preparations is relatively poor, solves the dissolution problem, becomes the difficult problem that Amoxicillin Capsules faces at present.There is document announcement to add surfactants such as Tween 80, sodium lauryl sulphate, it not only has very big toxic and side effects to human body, and DeGrain, uniformity is very poor, also have report that nanoscale, microcapsule etc. are made in the amoxicillin, the drug action that this has delayed the amoxicillin has greatly reduced its inherent curative effect, and preparation technology is complicated.A kind of dissolution is good, side effect is little, the simple Amoxicillin Capsules preparation of preparation technology, becomes the hot issue of present research gradually.
Micronization technology is a nearly new and high technology that developed rapidly in 20 years, can be processed into micron even nano level micropowder to raw material, has obtained using widely in every profession and trade.The air-flow superfine communication technique is a kind of of superfine communication technique, it utilizes material under the effect of high velocity air, obtain huge energy, in pulverizing chamber, cause the high velocity impact between the material particles, violent friction, high velocity air produces shear action to material simultaneously, thereby reach the purpose of comminuting matter, it can be processed into raw material superfine fine powder, present technique is mainly used in the Chinese medicine aspect at present, almost micronization technology is not applied to chemical drugs or Western medicine aspect, is used to improve the application of the defective that pharmaceutical preparation exists.
Summary of the invention
The object of the present invention is to provide that a kind of dissolution is good, side effect is little, the preparation method of the simple Amoxicillin Capsules preparation of preparation technology, promptly adopt micronization technology to prepare the method for Amoxicillin Capsules.
For achieving the above object, technical solution of the present invention is as follows:
The invention provides a kind of method that adopts micronization technology to prepare Amoxicillin Capsules, it comprises:
(1) with amoxicillin and filler mix homogeneously;
(2) hybrid medicine and exsiccant noble gas are injected super micron mill jointly and pulverize, particle diameter be 500～1000 purpose fine powders;
(3) with fine powder and remaining other adjuvant mix homogeneously, granulate, encapsulated, promptly get Amoxicillin Capsules.
Above-mentioned described employing micronization technology prepares the method for Amoxicillin Capsules, it is characterized in that described noble gas is air or nitrogen.
Above-mentioned described employing micronization technology prepares the method for Amoxicillin Capsules, and the operating pressure that it is characterized in that described super micron mill is 0.8～1.5MP, preferred 1.0～1.2MP.
Above-mentioned described employing micronization technology prepares the method for Amoxicillin Capsules, it is characterized in that the internal work temperature of described super micron mill is≤70 ℃, and is preferred≤50 ℃.
Above-mentioned described employing micronization technology prepares the method for Amoxicillin Capsules, it is characterized in that the pulverizing time is 20～60min, preferred 30～40min.
Above-mentioned described employing micronization technology prepares the method for Amoxicillin Capsules, it is characterized in that micronization technology adopts high velocity air to pulverize, and equipment is the CWJ-30 super micron mill.
In addition, above-mentioned described employing micronization technology prepares the method for Amoxicillin Capsules, it is characterized in that remaining other adjuvants are selected from filler, disintegrating agent, binding agent, lubricant and/or fluidizer.
Above-mentioned described employing micronization technology prepares the method for Amoxicillin Capsules, it is characterized in that described filler is selected from lactose, mannitol, sucrose, starch, sorbitol, microcrystalline Cellulose etc., preferred lactose.
Above-mentioned described employing micronization technology prepares the method for Amoxicillin Capsules, it is characterized in that described disintegrating agent is selected from carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, preferred carboxymethylstach sodium.
Above-mentioned described employing micronization technology prepares the method for Amoxicillin Capsules, it is characterized in that described binding agent is selected from 30 POVIDONE K 30 BP/USP 30, hypromellose, syrup, starch slurry, sodium carboxymethyl cellulose, preferred 30 POVIDONE K 30 BP/USP 30.
Above-mentioned described employing micronization technology prepares the method for Amoxicillin Capsules, it is characterized in that described lubricant and/or fluidizer are selected from magnesium stearate, Pulvis Talci, colloidality silicon dioxide, polyethylene glycol 6000 or 4000, sodium lauryl sulphate etc., preferred magnesium stearate.
The preferred above-mentioned described method for preparing Amoxicillin Capsules, wherein preparation process (3) is: with fine powder and filler and/or disintegrating agent mix homogeneously, add binder solution, the preparation soft material is crossed 20 mesh sieve system wet granulars, 50 ℃ of dryings, 20 mesh sieve granulate add proper amount of lubricating agent and/or fluidizer, mixing, filled capsules gets Amoxicillin Capsules.
The above-mentioned described method for preparing Amoxicillin Capsules, every Amoxicillin Capsules of preferred wherein said Amoxicillin Capsules contains amoxicillin 0.125～0.5g.
Micronization technology provided by the invention prepares the method for Amoxicillin Capsules, its advantage shows prepared Amoxicillin Capsules, has good dissolution, thereby solve the problem of amoxicillin dissolution difference, and more surprised is, prepared Amoxicillin Capsules, also have good stability, place every quality index for a long time and do not have significant change, preparation stabilization is good.In addition, the Amoxicillin Capsules that technology of the present invention makes has reduced supplementary product consumption, has reduced toxic and side effects; Preparation technology of the present invention is simple, easily operation.
The specific embodiment
Further explain and describe content of the present invention by the following examples.Described embodiment only in order to help to understand content of the present invention, should not be understood that the qualification to purport of the present invention and protection domain.
The preparation of embodiment 1 Amoxicillin Capsules
Take by weighing amoxicillin 1250g and lactose 300g mix homogeneously, mixture and exsiccant nitrogen are injected super micron mill jointly, adopt high velocity air to pulverize, operating pressure 1.2MP, the internal work temperature is 50 ℃, and the pulverizing time is 40min, takes out fine powder then, cross 500 mesh sieves, all pass through,, add 5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution and be mixed with soft material fine powder and 100g carboxymethylstach sodium mix homogeneously, cross 20 mesh sieve system wet granulars, 50 ℃ of dryings, 20 mesh sieve granulate add the 13.46g magnesium stearate, mixing, filled capsules.
The preparation of embodiment 2 Amoxicillin Capsules
Take by weighing amoxicillin 1000g and mannitol 240g mix homogeneously, mixture and exsiccant air are injected super micron mill jointly, adopt high velocity air to pulverize, operating pressure 1.0MP, the internal work temperature is 45 ℃, and the pulverizing time is 30min, takes out fine powder then, cross 1000 mesh sieves, all pass through,, add 5% 30 POVIDONE K 30 BP/USP, 30 alcoholic solution and be mixed with soft material fine powder and 80g low-substituted hydroxypropyl cellulose mix homogeneously, cross 20 mesh sieve system wet granulars, 50 ℃ of dryings, 20 mesh sieve granulate add 10.57g magnesium stearate and 12.33g Pulvis Talci, mixing, filled capsules.
The preparation of embodiment 3 Amoxicillin Capsules
Take by weighing amoxicillin 500g and starch 100g mix homogeneously, mixture and exsiccant nitrogen are injected super micron mill jointly, adopt high velocity air to pulverize, operating pressure 1.1MP, the internal work temperature is 40 ℃, and the pulverizing time is 40min, takes out fine powder then, cross 800 mesh sieves, all pass through,, add 2% hypromellose, 70% alcoholic solution and be mixed with soft material fine powder and 80g microcrystalline Cellulose, 20g polyvinylpolypyrrolidone mix homogeneously, cross 20 mesh sieve system wet granulars, 50 ℃ of dryings, 20 mesh sieve granulate add the 5.014g magnesium stearate, mixing, filled capsules.
The preparation of embodiment 4 Amoxicillin Capsules
Take by weighing amoxicillin 500g and lactose 200g mix homogeneously, mixture and exsiccant air are injected super micron mill jointly, adopt high velocity air to pulverize, operating pressure 1.2MP, the internal work temperature is 50 ℃, and the pulverizing time is 30min, takes out fine powder then, cross 800 mesh sieves, all pass through,, add 2% hypromellose, 70% alcoholic solution and be mixed with soft material fine powder and 120g microcrystalline Cellulose, 30g carboxymethylstach sodium mix homogeneously, cross 20 mesh sieve system wet granulars, 50 ℃ of dryings, 20 mesh sieve granulate add the 8.501g magnesium stearate, mixing, filled capsules.
Beneficial effect below by description of test technical scheme provided by the present invention.Embodiment 1～4 prepared Amoxicillin Capsules is carried out quality testing.Carried out under 40 ℃ of high temperature, relative humidity 75% ± 5% condition accelerated test simultaneously 6 months and 25 ℃ of temperature, relative humidity 60% ± 10% condition under 18 months investigation of long term test, detect the variation of every quality index, the gained data are shown in table 1-3:
0 day quality testing result of table 1
Accelerated test is 6 months under 40 ℃ of table 2 high temperature, relative humidity 75% ± 5% condition
Long term test is 18 months under 25 ℃ of table 3 temperature, relative humidity 60% ± 10% condition
By above data result as can be seen, the Amoxicillin Capsules dissolution that the present invention makes is fine, and through acceleration to wait in 6 months and long-term 18 months test after, every quality index does not have significant change, all meet quality standard, illustrated that the sample quality stability of the present invention's preparation is fine.
According to the above embodiments the present invention has been made detailed description.It should be noted that above embodiment is just to illustrating the present invention.Under the prerequisite that does not depart from spirit of the present invention and essence, those skilled in the art can design multiple alternative of the present invention and improvement project, and it all should be understood to be within protection scope of the present invention.
Claims (10)
1, a kind of method that adopts micronization technology to prepare Amoxicillin Capsules, it comprises:
(1) with amoxicillin and filler mix homogeneously;
(2) hybrid medicine and exsiccant noble gas are injected super micron mill jointly and pulverize, particle diameter be 500～1000 purpose fine powders;
(3) with fine powder and remaining other adjuvant mix homogeneously, granulate, encapsulated, promptly get Amoxicillin Capsules.
2, the method for preparing Amoxicillin Capsules by the described employing micronization technology of claim 1 is characterized in that described noble gas is air or nitrogen.
3, the method for preparing Amoxicillin Capsules by the described employing micronization technology of claim 1-2 is characterized in that micronization technology adopts high velocity air to pulverize, and equipment is the CWJ-30 super micron mill.
4, prepare the method for Amoxicillin Capsules by the described employing micronization technology of claim 1-3, the operating pressure that it is characterized in that described super micron mill is 0.8～1.5MP, preferred 1.0～1.2MP.
5, the method for preparing Amoxicillin Capsules by the described employing micronization technology of claim 1-4 is characterized in that internal work temperature≤70 ℃ of described super micron mill, and is preferred≤50 ℃.
6, the method for preparing Amoxicillin Capsules by the described employing micronization technology of claim 1-5 is characterized in that the pulverizing time is 20～60min, preferred 30～40min.
7, the method for preparing Amoxicillin Capsules by the described employing micronization technology of claim 1-6 is characterized in that described remaining other adjuvants comprise filler, disintegrating agent, binding agent and/or fluidizer.
8, the method for preparing Amoxicillin Capsules by the described employing micronization technology of claim 7 is characterized in that described filler is selected from lactose, mannitol, sucrose, starch, sorbitol, microcrystalline Cellulose etc., preferred lactose; Described disintegrating agent is selected from carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, preferred carboxymethylstach sodium; Described binding agent is selected from 30 POVIDONE K 30 BP/USP 30, hypromellose, syrup, starch slurry, sodium carboxymethyl cellulose, preferred 30 POVIDONE K 30 BP/USP 30; Described fluidizer is selected from magnesium stearate, Pulvis Talci, colloidality silicon dioxide, polyethylene glycol 6000 or 4000, sodium lauryl sulphate etc., preferred magnesium stearate.
9, the method for preparing Amoxicillin Capsules by the described employing micronization technology of claim 1-8, it is characterized in that preparation process (3) is: with fine powder and filler and/or disintegrating agent mix homogeneously, add binder solution, the preparation soft material is crossed 20 mesh sieve system wet granulars, 50 ℃ of dryings, 20 mesh sieve granulate add an amount of fluidizer, mixing, filled capsules gets Amoxicillin Capsules.
10, the method for preparing Amoxicillin Capsules by the described employing micronization technology of claim 1-9 is characterized in that described Amoxicillin Capsules per unit preparation contains amoxicillin 0.125～0.5g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101758957A CN101390846B (en) | 2008-11-10 | 2008-11-10 | Amoxicillin capsule and production method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008101758957A CN101390846B (en) | 2008-11-10 | 2008-11-10 | Amoxicillin capsule and production method thereof |
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| CN101390846A true CN101390846A (en) | 2009-03-25 |
| CN101390846B CN101390846B (en) | 2010-06-16 |
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| CN2008101758957A Expired - Fee Related CN101390846B (en) | 2008-11-10 | 2008-11-10 | Amoxicillin capsule and production method thereof |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104706618A (en) * | 2015-02-04 | 2015-06-17 | 上海华源安徽仁济制药有限公司 | Amoxicillin capsules and preparation method thereof |
| CN104856972A (en) * | 2015-03-27 | 2015-08-26 | 华北制药股份有限公司 | Amoxicillin capsules and preparation method thereof |
| CN107095857A (en) * | 2017-04-26 | 2017-08-29 | 四川制药制剂有限公司 | The production technology of Biomox |
| CN107875136A (en) * | 2017-12-27 | 2018-04-06 | 广州白云山医药集团股份有限公司白云山制药总厂 | A kind of Amoxicillin pharmaceutical preparation and preparation method thereof |
| CN107898760A (en) * | 2017-12-27 | 2018-04-13 | 广州白云山医药集团股份有限公司白云山制药总厂 | A kind of Wymox and preparation method thereof |
| CN108210475A (en) * | 2016-12-13 | 2018-06-29 | 河南后羿实业集团有限公司 | A kind of amoxil capsule and preparation method thereof |
| CN112263569A (en) * | 2020-11-05 | 2021-01-26 | 南京致中生物科技有限公司 | Amoxicillin capsule and preparation method thereof |
| CN113069418A (en) * | 2021-04-21 | 2021-07-06 | 海南通用三洋药业有限公司 | Preparation method of amoxicillin granules |
-
2008
- 2008-11-10 CN CN2008101758957A patent/CN101390846B/en not_active Expired - Fee Related
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104706618A (en) * | 2015-02-04 | 2015-06-17 | 上海华源安徽仁济制药有限公司 | Amoxicillin capsules and preparation method thereof |
| CN104856972A (en) * | 2015-03-27 | 2015-08-26 | 华北制药股份有限公司 | Amoxicillin capsules and preparation method thereof |
| CN104856972B (en) * | 2015-03-27 | 2018-03-27 | 华北制药股份有限公司 | Amoxil capsule and preparation method thereof |
| CN108210475A (en) * | 2016-12-13 | 2018-06-29 | 河南后羿实业集团有限公司 | A kind of amoxil capsule and preparation method thereof |
| CN107095857A (en) * | 2017-04-26 | 2017-08-29 | 四川制药制剂有限公司 | The production technology of Biomox |
| CN107875136A (en) * | 2017-12-27 | 2018-04-06 | 广州白云山医药集团股份有限公司白云山制药总厂 | A kind of Amoxicillin pharmaceutical preparation and preparation method thereof |
| CN107898760A (en) * | 2017-12-27 | 2018-04-13 | 广州白云山医药集团股份有限公司白云山制药总厂 | A kind of Wymox and preparation method thereof |
| CN107875136B (en) * | 2017-12-27 | 2021-03-05 | 广州白云山医药集团股份有限公司白云山制药总厂 | Amoxicillin medicinal preparation and preparation method thereof |
| CN112263569A (en) * | 2020-11-05 | 2021-01-26 | 南京致中生物科技有限公司 | Amoxicillin capsule and preparation method thereof |
| CN112263569B (en) * | 2020-11-05 | 2022-07-08 | 贝克诺顿(浙江)制药有限公司 | Amoxicillin capsule and preparation method thereof |
| CN113069418A (en) * | 2021-04-21 | 2021-07-06 | 海南通用三洋药业有限公司 | Preparation method of amoxicillin granules |
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| Publication number | Publication date |
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| CN101390846B (en) | 2010-06-16 |
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Granted publication date: 20100616 Termination date: 20161110 |