CN102755304A - Preparation method of guaifenesin and dextromethorphan hydrobromide capsules - Google Patents
Preparation method of guaifenesin and dextromethorphan hydrobromide capsules Download PDFInfo
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- CN102755304A CN102755304A CN2012102748732A CN201210274873A CN102755304A CN 102755304 A CN102755304 A CN 102755304A CN 2012102748732 A CN2012102748732 A CN 2012102748732A CN 201210274873 A CN201210274873 A CN 201210274873A CN 102755304 A CN102755304 A CN 102755304A
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- dextromethorphan hydrobromide
- guaifenesin
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Abstract
The invention discloses a preparation method of guaifenesin and dextromethorphan hydrobromide capsules. The method includes the following steps: A, respectively sieving guaiacol glycerin ether, dextromethorphan hydrobromide and dextrin with the amount according to the prescription through a 100-mesh sieve, and evenly mixing the guaiacol glycerin ether, the dextromethorphan hydrobromide and the dextrin; B, performing dry granulating on the mixture obtained through the step A; C, sieving particles with meshes of 16-60 in the step B, adding magnesium stearate with the amount according to the prescription, evenly mixing, filling, polishing and performing bubble capping to obtain the guaifenesin and dextromethorphan hydrobromide capsules. The preparation method is ingenious in design, simple in process, small in raw material consumption and high in product yield and effectively reduces production cost.
Description
Technical field
The invention belongs to technical field of pharmaceutical chemistry, relate to a kind of U.S. capsular method for preparing that heals.
Background technology
The U.S. capsule (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE CAPSULES) of healing is a compound preparation.Dextromethorphan hydrobromide is the nervus centralis cough medicine in this compound recipe, the antitussive through suppressing the oblongata coughing centre.Its antitussive effect equates with codeine or is strong slightly, no analgesic activity or addiction property.Guaifenesin is through stimulating gastric mucosa, and reflection causes that the bronchus secretion increases, favourable sputum dilution and expectoration, thus remove phlegm and relieving cough.Therefore the cough that cures mainly tracheitis, bronchitis clinically and cause by flu.
At present, the U.S. capsule of healing adopts traditional wet to granulate more, and production process is more; Mainly be through supplementary material mix, preparation soft material, granulation, drying, granulate, always mix, filling, polishing, bubble-cap, operation is loaded down with trivial details relatively, production process is many; Material loss is big, and product yield reduces.Particularly during drying, drying time is longer, directly causes cost to increase.
Summary of the invention
The objective of the invention is to provides a kind of U.S. capsular method for preparing that heals to the deficiency that exists in the prior art.This method for preparing is skillfully constructed, flow process is simple, and material loss is little, and product yield is high, effectively reduces production cost.
For realizing above-mentioned purpose, the technical solution adopted for the present invention to solve the technical problems is:
A kind of U.S. capsular method for preparing that heals may further comprise the steps:
A, get recipe quantity guaifenesin, dextromethorphan hydrobromide, dextrin, cross 100 mesh sieves respectively after, mix homogeneously;
B, with steps A gained mixture dry granulation;
C, sieve are got 16-60 order granule among the step B, and filling behind the adding recipe quantity magnesium stearate mixing, polishing, bubble-cap obtain the required U.S. capsule of healing.
As optimal way, among the said step B, the feeding frequency of dry granulation is 19～24Hz, and the tabletting frequency is 37～41Hz, and the granulation frequency is: 18～23Hz, pressure are 3～5Mpa.
Further preferred, among the said step B, the feeding frequency of dry granulation is 21Hz, and the tabletting frequency is 39Hz, and the granulation frequency is: 20Hz.
The U.S. capsule of healing changes the employing dry granulation into by wet granulation, and is higher to the adjuvant requirement, because of principal agent guaifenesin, dextromethorphan hydrobromide flowability all are not fine, uses dextrin can reach dilution and the mobile effect of increase.Certainly, dry granulation wants to reach the higher effect of yield, must adjust device parameter, and match with selected adjuvant, thereby reach the desirable granule that is fit to capsule charge.
The present invention adopts dry granulation during granule in preparation, for the U.S. capsule of healing that guarantees to prepare has the granule that is fit to filling preferably, selects proper supplementary material, and adjuvant need have good flowability and compressibility, and has certain viscosity; Simultaneously, the present invention has optimized parameter in the preparation process, thereby obtains higher qualified of yield.
The inventor is selected by the adjuvant of the U.S. capsule dry granulation of healing and process parameter optimizing has carried out a large amount of research.Through experiment many times, the discovery that we are surprised is when heal U.S. capsule adjuvant and the method for preparing that adopt that the present invention put down in writing match; This method for preparing has reached the technique effect out of expection on the whole; Material loss is little, and product yield is high, effectively reduces production cost.
Beneficial effect of the present invention is: method for preparing of the present invention is skillfully constructed, flow process is simple, uses dry granulation, can reduce batch production cycle, raises the efficiency, and it is low to solve product yield, reduces cost greatly.
The specific embodiment
Disclosed all characteristics in this description, or the step in disclosed all methods or the process except mutually exclusive characteristic and/or the step, all can make up by any way.
Comparative Examples: a kind of U.S. capsular method for preparing that heals, wet granulation, it is write out a prescription as follows:
Guaifenesin 100g
Dextromethorphan hydrobromide 10g
Dextrin 140g
Magnesium stearate 2g
The 5%HPMC50% alcoholic solution is an amount of
Process 1000
Method for preparing: supplementary material is crossed 100 mesh sieves respectively, subsequent use.Accurately take by weighing raw material and all adjuvants by recipe quantity, mix homogeneously is made soft material in right amount with the 5%HPMC50% alcoholic solution, crosses 16 mesh sieves and granulates, and 55 ℃ of dryings are crossed 16 mesh sieve granulate, filling behind the adding magnesium stearate mixing, polishing, bubble-cap.
Embodiment 1: a kind of U.S. capsular method for preparing that heals, and it is write out a prescription as follows:
Guaifenesin 100g
Dextromethorphan hydrobromide 10g
Dextrin 140g
Magnesium stearate 2g
Process 1000
Preparation technology: supplementary material is crossed 100 mesh sieves respectively, subsequent use.Accurately take by weighing raw material and adjuvant by recipe quantity, and the employing dry granulation (the feeding frequency of dry granulation is 19Hz, and the tabletting frequency is 37Hz, and the granulation frequency is: 18Hz, and after pressure is 3～5MPa), filling behind the adding recipe quantity magnesium stearate mixing, polishing, bubble-cap.
Embodiment 2: a kind of U.S. capsular method for preparing that heals, and it is write out a prescription as follows:
Guaifenesin 100g
Dextromethorphan hydrobromide 10g
Dextrin 140g
Magnesium stearate 2g
Process 1000
Preparation technology: supplementary material is crossed 100 mesh sieves respectively, subsequent use.Accurately take by weighing raw material and adjuvant by recipe quantity, adopting the feeding frequency of dry granulation dry granulation is 21Hz, and the tabletting frequency is 39Hz, and the granulation frequency is: 20Hz, pressure are 3～5MPa, filling behind the adding recipe quantity magnesium stearate mixing, polishing, bubble-cap.The product yield of Comparative Examples and embodiment, a collection of required time of preparation are seen table 1:
Table 1 product yield, a collection of required time table of preparation
| ? | Product yield (%) | Granule obtains the time (h) |
| Comparative Examples | 78% | 6 |
| Embodiment 1 | 87% | 2 |
| Embodiment 2 | 91% | 2 |
Visible from above-mentioned experimental data, the inventive method prepares the U.S. capsular product yield of healing, a collection of required time of preparation all obviously is better than wet granulation technology, thereby has reduced production cost, has improved production efficiency.When adopting optimizing technology parameters, its beneficial effect is the most remarkable, out of expection.
The present invention is not limited to the aforesaid specific embodiment.The present invention expands to any new feature or any new combination that discloses in this manual, and the arbitrary new method that discloses or step or any new combination of process.
Claims (3)
1. U.S. capsular method for preparing that heals is characterized in that may further comprise the steps:
A, get recipe quantity guaifenesin, dextromethorphan hydrobromide, dextrin, cross 100 mesh sieves respectively after, mix homogeneously;
B, with steps A gained mixture dry granulation;
C, sieve are got 16～60 order granules among the step B, and filling behind the adding recipe quantity magnesium stearate mixing, polishing, bubble-cap obtain the required U.S. capsule of healing.
2. a kind of U.S. capsular method for preparing that heals as claimed in claim 1, it is characterized in that: among the said step B, the feeding frequency of dry granulation is 19～24Hz, and the tabletting frequency is 37～41Hz, and the granulation frequency is: 18～23Hz, pressure are 3～5Mpa.
3. a kind of U.S. capsular method for preparing that heals as claimed in claim 1, it is characterized in that: among the said step B, the feeding frequency of dry granulation is 21Hz, and the tabletting frequency is 39Hz, and the granulation frequency is: 20Hz.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012102748732A CN102755304A (en) | 2012-08-03 | 2012-08-03 | Preparation method of guaifenesin and dextromethorphan hydrobromide capsules |
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|---|---|---|---|
| CN2012102748732A CN102755304A (en) | 2012-08-03 | 2012-08-03 | Preparation method of guaifenesin and dextromethorphan hydrobromide capsules |
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| CN102755304A true CN102755304A (en) | 2012-10-31 |
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| CN2012102748732A Pending CN102755304A (en) | 2012-08-03 | 2012-08-03 | Preparation method of guaifenesin and dextromethorphan hydrobromide capsules |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1655766A (en) * | 2002-04-15 | 2005-08-17 | 亚当斯实验室有限公司 | Sustained release of guaifenesin combination drugs |
| CN101099730A (en) * | 2006-07-03 | 2008-01-09 | 天津康鸿医药科技发展有限公司 | Oral solid preparation containing ambroxol hydrochloride and guaifenesin active components |
-
2012
- 2012-08-03 CN CN2012102748732A patent/CN102755304A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1655766A (en) * | 2002-04-15 | 2005-08-17 | 亚当斯实验室有限公司 | Sustained release of guaifenesin combination drugs |
| CN101099730A (en) * | 2006-07-03 | 2008-01-09 | 天津康鸿医药科技发展有限公司 | Oral solid preparation containing ambroxol hydrochloride and guaifenesin active components |
Non-Patent Citations (2)
| Title |
|---|
| 沙杭: "《呼吸系统疾病用药速查》", 31 January 2011, 人民军医出版社 * |
| 赵浩如: "《现代中药制剂新技术》", 28 February 2007, 江苏科学技术出版社 * |
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Application publication date: 20121031 |