CN105497221A - Preparation method of infantile antitussive granules - Google Patents
Preparation method of infantile antitussive granules Download PDFInfo
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- CN105497221A CN105497221A CN201410536029.1A CN201410536029A CN105497221A CN 105497221 A CN105497221 A CN 105497221A CN 201410536029 A CN201410536029 A CN 201410536029A CN 105497221 A CN105497221 A CN 105497221A
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Abstract
The invention relates to a preparation method of infantile antitussive granules and belongs to the technical field of pharmaceutical preparation. The preparation method of the infantile antitussive granules includes the following steps: mixing well mannitol, dextrin and ammonium chloride to obtain mixed powder; mixing well Radix Glycyrrhizae liquid extract, Radix Platycodonis liquid extract and orange tincture to obtain mixed liquid medicine for use; adding the obtained mixed liquid medicine into the mixed powder to obtain a soft material; adding sucrose and stevioside into the soft material, and mixing to obtain wet granules; drying the wet granules at 45-55 DEG C, and stabilizing the size; adding orange flavor to the granules, and carrying out total mixing to obtain the infantile antitussive granules. The preparation method is simple and feasible, safe and energy efficient, and high in yield, and the prepared target finished granules are uniform and highly fluidic.
Description
Technical field
The present invention relates to a kind of preparation method of child cough granule, belong to field of medicine preparing technology.
Background technology
The medicine of current child cough has a variety of formula, is guaranteeing drug effectiveness, while improving drug safety, Quality Control, selects for doctor provides more multi-pharmaceutics.Record the XIAOER ZHIKE TANGJIANG in " Chinese Pharmacopoeia " (version in 2010); belong to OTC Class A; non-Chinese medicine protection kind, its main component is Radix Glycyrrhizae fluidextract, Radix Platycodonis fluidextract, ammonium chloride, Pericarpium Citri junoris tincture, but with prescription kind only a kind of dosage form of XIAOER ZHIKE TANGJIANG on market.Syrup mouthfeel is sweet greasy, and the preservative sodium benzoate wherein added affects the absorption of medicine and himself can be with and serve untoward reaction, mainly comprises vomiting, hyperglycemia, hypokalemia, convulsions and moral damage etc.; Accurately cannot take medicine with disease, repeatedly uncap and easily pollute, carry, preserve, transport certain inconvenience, thus cause clinical application to have significant limitation.
CN200810105789.1 discloses a kind of child cough granule and preparation method thereof, and preparation method is as follows: after principal agent and adjuvant combination drying, add Icing Sugar, with the ethanol water soft material of suitable concn, then wet granular processed, dry obtained child cough granule.This technique must adopt twice dry and twice granulation, and baking temperature is higher, and additional ethanol is as binding agent, complex operation, and cost is high, and energy consumption is large, there is potential safety hazard.
Summary of the invention
The object of the present invention is to provide a kind of preparation method of child cough granule, it is simple, energy-saving safe, yield be high, the target product uniform particles of preparation, good fluidity.
The preparation method of a kind of child cough granule of the present invention, comprises the following steps:
(1) mix: get load weighted mannitol, dextrin, ammonium chloride mix homogeneously, obtain mixed powder; Get load weighted Radix Glycyrrhizae fluidextract, Radix Platycodonis fluidextract and Pericarpium Citri junoris tincture mix homogeneously, obtain admixing medical solutions, for subsequent use;
(2) granulate: step (1) gained admixing medical solutions is joined in mixed powder, stir and make soft material; Again load weighted sucrose, stevioside are joined in soft material, mix homogeneously, obtained wet granular;
(3) dry, granulate: get step (2) gained wet granular 45 ~ 55 DEG C of dryings, then carry out granulate;
(4) always mix: get load weighted orange flavor and join in the granule of step (3) gained, always mix to evenly, obtain child cough granule.
According to the content of actual measurement child cough granule, determine that pack scope is packed, and its content uniformity is monitored at any time; Get full inspection qualified after finished product carries out mounted box, vanning warehouse-in preserve.
The preparation method of described child cough granule, its formula is as follows:
The child cough granule that above formula finally obtains is 200 bags.
Optimization formula is as follows:
The child cough granule that above formula finally obtains is 200 bags.
The present invention no longer needs to add antiseptic-sodium benzoate, thus avoids the absorption that sodium benzoate affects medicine and the untoward reaction self brought thereof, and ensure that the safety of medication.
Child cough granule prepared by the present invention, not only remain former syrup mouthfeel good, the advantage that sugar content is high, and dosage form is still traditional oral solid preparation, each effective ingredient all can exist under dry states of matter, esophagus and gastrointestinal tract are had no stimulation, need not worry that some effective ingredient can because being hydrolyzed in certain media environment solution, degraded fracture, side reactions such as open loop and to cause in effect duration drug failure or rotten problem produces, harmful haemolysate is produced because of degraded fracture as saponin composition (active ingredient) in Radix Platycodonis or Radix Glycyrrhizae can also exist as injection, therefore granular preparation has higher safety compared with syrup.
Child cough granule prepared by the present invention, it is convenient to take, and avoids the repeated pollution that uncork lid repeatedly causes; The unit dose package adopted makes dosage accurate, reduces personal error or takes randomness, doctor can be made for the different state of an illness of patient, provide dosage therapeutic regimen more accurately.
Domestic without import with prescription kind at present, without tablet and liquid drugs injection, powder injection formulation, syrup has 221 (being 10 ~ 50 times more than of similar medicine), and granule is without manufacturer production.
The present invention adopts one-shot forming granulating process, the solid material that first mixing cohesive is less, remixes three liquid extracts, and powders mixture moistening granulated in this, as wetting agent and binding agent, the material that viscosity is larger in the end feeds intake.The present invention is without the need to additional ethanol as binding agent, and production operability is good, and equipment is relatively simple, and the grain forming only having the above charging sequence of employing obtained and mobility are just better, and yield is up to 95%.The critical process that the present invention prepares granule is relatively less, and under wet grain drying operation is placed in 50 ± 5 DEG C of temperature, in technique, each material is all without pyroprocess, and cost is low, energy-saving safe.
Compared with prior art, the present invention has following beneficial effect:
(1) child cough granule prepared of the present invention, not only remains the feature that former syrup mouthfeel is good, and the stability of medicine and curative effect are largely increased;
(2) child cough granule prepared of the present invention, it is convenient to take; The unit dose package adopted makes dosage accurate;
(3) the present invention no longer needs to add preservative sodium benzoate, ensure that the safety of medication;
(4) child cough granule that prepared by the present invention carries, preserve, convenient transportation, can be medicine flow enterprise and reduces shipping storage cost, is that enterprise increases economic benefit;
(5) simple, the energy-saving safe of preparation method of the present invention, yield is up to 95%; Target product uniform particles, the good fluidity of preparation.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is further illustrated, but do not limit enforcement of the present invention.
The preparation method of a kind of child cough granule of the present invention, comprises the following steps:
(1) mix: get load weighted mannitol, dextrin, ammonium chloride mix homogeneously, obtain mixed powder; Get load weighted Radix Glycyrrhizae fluidextract, Radix Platycodonis fluidextract and Pericarpium Citri junoris tincture mix homogeneously, obtain admixing medical solutions, for subsequent use;
(2) granulate: step (1) gained admixing medical solutions is joined in mixed powder, makes soft material; Again load weighted sucrose, stevioside are joined in soft material, the obtained wet granular of mixing;
(3) dry, granulate: get step (2) gained wet granular 50 ± 5 DEG C of dryings, then carry out granulate;
(4) always mix: get load weighted orange flavor and join in the granule of step (3) gained, carry out always mixing and obtaining child cough granule.
According to the content of actual measurement child cough granule, determine that pack scope is packed, and its content uniformity is monitored at any time; Get full inspection qualified after finished product carries out mounted box, vanning warehouse-in preserve.
Manufacture experimently three batches according to above-mentioned preparation method in GMP workshop, embodiment 1-3 prepares the formula of child cough granule in table 1.
Table 1 embodiment 1-3 prepares the formula of child cough granule
The child cough granule that above formula finally obtains is 200 bags.
Child cough granule prepared by embodiment 1-3 by quality standard draft testing result in table 2.
The testing result of child cough granule prepared by table 2 embodiment 1-3
As can be seen from Table 2, the child cough granule that prepared by embodiment 1-3 all meets quality standard.
The yield of child cough granule prepared by embodiment 1-3 is respectively 93%, 95%, 94%.
Claims (4)
1. a preparation method for child cough granule, is characterized in that comprising the following steps:
(1) mix: by mannitol, dextrin, ammonium chloride mixing, obtain mixed powder; Radix Glycyrrhizae fluidextract, Radix Platycodonis fluidextract and Pericarpium Citri junoris tincture are mixed, obtains admixing medical solutions, for subsequent use;
(2) granulate: step (1) gained admixing medical solutions is joined in mixed powder, makes soft material; Again sucrose, stevioside are joined in soft material, the obtained wet granular of mixing;
(3) dry, granulate: by step (2) gained wet grain drying, then carry out granulate;
(4) always mix: orange flavor is joined in the granule of step (3) gained, carry out always mixing and obtaining child cough granule.
2. the preparation method of child cough granule according to claim 1, is characterized in that formula is as follows:
3. the preparation method of child cough granule according to claim 1 and 2, is characterized in that formula is as follows:
4. the preparation method of child cough granule according to claim 1 and 2, is characterized in that: in step (3), and wet granular is 45 ~ 55 DEG C of dryings.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410536029.1A CN105497221A (en) | 2014-10-11 | 2014-10-11 | Preparation method of infantile antitussive granules |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410536029.1A CN105497221A (en) | 2014-10-11 | 2014-10-11 | Preparation method of infantile antitussive granules |
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| Publication Number | Publication Date |
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| CN105497221A true CN105497221A (en) | 2016-04-20 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201410536029.1A Pending CN105497221A (en) | 2014-10-11 | 2014-10-11 | Preparation method of infantile antitussive granules |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1363293A (en) * | 2001-01-10 | 2002-08-14 | 杨孟君 | Nano medicine for treating baby cough and its preparing process |
| CN101574425A (en) * | 2008-05-05 | 2009-11-11 | 北京瑞伊人科技发展有限公司 | Child cough granule and preparation method of same |
| CN103099789A (en) * | 2013-02-21 | 2013-05-15 | 河北维尔康制药有限公司 | Preparation method of vitamin C granules |
-
2014
- 2014-10-11 CN CN201410536029.1A patent/CN105497221A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1363293A (en) * | 2001-01-10 | 2002-08-14 | 杨孟君 | Nano medicine for treating baby cough and its preparing process |
| CN101574425A (en) * | 2008-05-05 | 2009-11-11 | 北京瑞伊人科技发展有限公司 | Child cough granule and preparation method of same |
| CN103099789A (en) * | 2013-02-21 | 2013-05-15 | 河北维尔康制药有限公司 | Preparation method of vitamin C granules |
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Application publication date: 20160420 |