CN102813628A - Method for improving dissolubility of phlegm-contained traditional Chinese medicine formula granule - Google Patents
Method for improving dissolubility of phlegm-contained traditional Chinese medicine formula granule Download PDFInfo
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- CN102813628A CN102813628A CN201210301349XA CN201210301349A CN102813628A CN 102813628 A CN102813628 A CN 102813628A CN 201210301349X A CN201210301349X A CN 201210301349XA CN 201210301349 A CN201210301349 A CN 201210301349A CN 102813628 A CN102813628 A CN 102813628A
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Abstract
The invention relates to a method for improving dissolubility of a phlegm-contained traditional Chinese medicine formula granule. The method comprises the following steps of: adding an effervescent disintegrant which is equivalent to 10-50 percent of extract powder in weight percentage, a high-efficiency disintegrant which is equivalent to 0.5-10 percent of the extract powder in weight percentage and a solubilizer which is equivalent to 0.05-2 percent of the extract powder in weight percentage to the phlegm-contained traditional Chinese medicine extract powder; evenly mixing; and then, preparing the traditional Chinese medicine formula granule by adopting dry granulation. The effervescent disintegrant is a mixture of which the acidic system and the alkalic system are in (1:0.5)-(1:3) in molar ratio, wherein the acidic system is citric acid or tartaric acid, and the alkalic system is sodium bicarbonate or sodium carbonate; the high-efficiency disintegrant is polyvinylpolypyrrolidone, croscarmellose sodium, sodium carboxymethyl starch or low-substituted hydroxypropyl cellulose; and the solubilizer is a surface active agent of which the hydrophile-lipophile balance (HLB) value is greater than 15. The granule prepared by the method is good in dissolubility in water and simple in preparation process and can be easily realized in industrial production.
Description
Technical field
The present invention relates to a kind of method of improving mucous matter class Chinese medicinal granule melting.Belong to the Chinese medicine preparation technical field.
Background technology
Chinese medicinal granule is that the prepared slices of Chinese crude drugs of concocting processing with standard are raw material under Chinese medical theory instructs, the standardization, the standardization single medicinal material granule that adopt modern pharmaceutical technology such as extraction, cryoconcentration, wink-dry and granulating process to process.
Phlegmatic temperament is a kind of polysaccharide derivatives of complicacy; Be the normal secretion of plant, be present in the parenchymatous myxocyte of plant more that in water, can expand is heavy-gravity colloid solution; Exsiccant phlegmatic temperament is a white powder; Intensive hygroscopicity is arranged, in water, can expand rapidly, dissolving forms heavy-gravity rubber cement.
Mucilaginous above-mentioned character causes the more Chinese medicine of mucous matter (like Semen Plantaginis, Semen Cuscutae, the Fructus Kochiae etc.) to contain a large amount of mucilaginous viscous solutions through forming behind the water extraction; Solubility is very poor in the dried Chinese medical concrete water; Even under intense stirring condition, also slowly be difficult to dissolve, influence the convenience of clinical application and the accuracy of dosage.
Summary of the invention
The objective of the invention is to overcome above-mentioned deficiency, a kind of method of improving mucous matter class Chinese medicinal granule melting is provided.
The objective of the invention is to realize like this: a kind of method of improving mucous matter class Chinese medicinal granule melting; Said method is in the pelletization of mucous matter class Chinese medicine extract powder, to add the gas-producing disintegrant be equivalent to extract powder 10 ~ 50% percentage by weights, be equivalent to the efficient disintegrating agent of extract powder 0.5 ~ 10% percentage by weight and the solubilizing agent that is equivalent to extract powder 0.05 ~ 2% percentage by weight; Behind the mix homogeneously, adopt dry granulation to be prepared into Chinese medicinal granule.
If need, in the pelletization of mucous matter class Chinese medicine extract powder, also can add soluble oil polyethylene glycol 6000 or the Macrogol 4000 that is equivalent to extract powder 0.5 ~ 5% percentage by weight, be used to improve the problem of pelletization material roll banding wheel.
Said gas-producing disintegrant is pressed the mixture of 1:0.5 ~ 1:3 mol ratio for acid system and alkaline system, and wherein acid system is citric acid or tartaric acid, and alkaline system is sodium bicarbonate or sodium carbonate.
Said efficient disintegrating agent is for polyvinylpolypyrrolidone, cross-linked carboxymethyl cellulose are received, carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose etc.
Said solubilizing agent is a HLB value (hydrophile-lipophile balance value) greater than 15 surfactant, preferably sodium dodecyl sulfate, polysorbate 20 or polyoxyethylene sorbitan monoleate etc.
The inventor finds through test of many times; Adopt a kind of or wherein any two kinds of combinations of above-mentioned gas-producing disintegrant, efficient disintegrating agent and solubilizing agent; All can't improve and play ideal effect, must adopt the collaborative solution of three kinds of adjuvant schemes the particulate melting of mucous matter class Chinese medicine preparation.With the stir-baked SEMEN PLANTAGINIS with salt solution is example, and it is as shown in the table to measure the result:
* adjuvant weight unanimity in the stir-baked SEMEN PLANTAGINIS with salt solution granule in upward showing.
In general; Generally adopt single alternative to solve the disintegrate or the problems of dissolution of solid preparation on the galenic pharmacy; And the present invention adopts three kinds of synergistic technical schemes of adjuvant, and in the hope of solving the problem of mucous matter class Chinese medicinal granule melting difference, the synergism mechanism of analyzing this three is:
The one, utilize the aerogenesis mechanism of gas-producing disintegrant: gas-producing disintegrant generally uses in effervescent formulation, and by the mixture that the soda acid system forms, acid-base reaction produces carbon dioxide when meeting water, makes granule disintegrate rapidly in a few minutes.
The 2nd, utilize the capillarity and the expansion of efficient disintegrating agent: efficient disintegrating agent can form the capillary channel that is easy to moistening in granule, and when granule contacted with water, water can get into granule interior with capillary tube rapidly, makes the whole particle moistening and disintegrate; And can produce very strong expansion after the efficient disintegrating agent suction, thus disintegrate particulate internal bond strength, with the gas expansion synergism of gas-producing disintegrant, make the quick disintegrate of granule.
The 3rd, utilize the wetting action of solubilizing agent: when granule contacts with water; The use of solubilizing agent can impel moisture to be easier to sprawl in solid particles surface; And then infiltration granule interior duct; With the gas expansion three synergism of the capillarity of efficient disintegrating agent and imbibition effect, gas-producing disintegrant, accelerate particulate disintegrate and dissolve again.
The 4th, can adopt soluble oil like the needs lubricant: lubricant select hydrophobic lubricants such as magnesium stearate for use; This series lubricant agent can cause particle surface hydrophobic; Slow down the seepage velocity of water to granule interior; And the present invention adopts the hydrophilic lubricant Polyethylene Glycol can avoid this problem, plays beneficial effect to improving particulate melting.
Compared with prior art, the present invention has following advantage:
1, the collaborative technical scheme that adopts gas-producing disintegrant, efficient disintegrating agent and solubilizing agent and four kinds of adjuvants of soluble oil; Solve the problem of the particulate melting difference of mucous matter class Chinese medicine preparation, improved the compliance of clinical this type of medicine of use and the accuracy of dosage.
2, compare with common effervescent granule preparation technology; Common effervescent granule is used wet granulation always; Acidic excipient often will be granulated at twice with basic auxiliary and mixed, and operation is complicated, the difficult control of product quality; And the present invention only needs mixed once, granulating gets final product, and preparation technology is simple, constant product quality.
The specific embodiment
Embodiment 1:
Get stir-baked SEMEN PLANTAGINIS with salt solution extract powder 1kg; Add citric acid 130g, sodium bicarbonate 170g (citric acid: the sodium bicarbonate mol ratio is 1:3), polyvinylpolypyrrolidone 20g, polyethylene glycol 6000 10g; Mix homogeneously; Dry granulation, gained 14-60 order granule can dissolve rapidly in water, does not have insoluble solids precipitation problem.
Embodiment 2:
Get Fructus Kochiae extract powder 1kg; Add citric acid 390g, sodium carbonate 110g (citric acid: the sodium carbonate mol ratio is 1:0.5), cross-linking sodium carboxymethyl cellulose 50g, polyethylene glycol 6000 10g; Mix homogeneously; Dry granulation, gained 14-60 order granule can dissolve rapidly in water, does not have insoluble solids precipitation problem.
Embodiment 3:
Get Semen Cuscutae extract powder 1kg; Add tartaric acid 95g, sodium bicarbonate 105g (tartaric acid: the sodium bicarbonate mol ratio is 1:2), carboxymethyl starch sodium 100g, Macrogol 4000 20g; Mix homogeneously; Dry granulation, gained 14-60 order granule can dissolve rapidly in water, does not have insoluble solids precipitation problem.
Claims (3)
1. method of improving mucous matter class Chinese medicinal granule melting; It is characterized in that: said method is in the pelletization of mucous matter class Chinese medicine extract powder, to add the gas-producing disintegrant be equivalent to extract powder 10 ~ 50% percentage by weights, be equivalent to the efficient disintegrating agent of extract powder 0.5 ~ 10% percentage by weight and the solubilizing agent that is equivalent to extract powder 0.05 ~ 2% percentage by weight; Behind the mix homogeneously, adopt dry granulation to be prepared into Chinese medicinal granule;
Said gas-producing disintegrant is pressed the mixture of 1:0.5 ~ 1:3 mol ratio for acid system and alkaline system, and wherein acid system is citric acid or tartaric acid, and alkaline system is sodium bicarbonate or sodium carbonate;
Said efficient disintegrating agent is for polyvinylpolypyrrolidone, cross-linked carboxymethyl cellulose are received, carboxymethyl starch sodium or low-substituted hydroxypropyl cellulose;
Said solubilizing agent is the HLB value greater than 15 surfactant.
2. a kind of method of improving mucous matter class Chinese medicinal granule melting according to claim 1, it is characterized in that: said solubilizing agent is sodium lauryl sulphate, polysorbate 20 or polyoxyethylene sorbitan monoleate.
3. a kind of method of improving mucous matter class Chinese medicinal granule melting according to claim 1 and 2 is characterized in that: in the pelletization of mucous matter class Chinese medicine extract powder, also be added with soluble oil polyethylene glycol 6000 or the Macrogol 4000 that is equivalent to extract powder 0.5 ~ 5% percentage by weight.
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| CN201210301349XA CN102813628A (en) | 2012-08-23 | 2012-08-23 | Method for improving dissolubility of phlegm-contained traditional Chinese medicine formula granule |
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| CN201210301349XA CN102813628A (en) | 2012-08-23 | 2012-08-23 | Method for improving dissolubility of phlegm-contained traditional Chinese medicine formula granule |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106983725A (en) * | 2017-04-12 | 2017-07-28 | 华润三九医药股份有限公司 | A kind of new application for the method and PVPP for improving the molten extract content of Chinese medicinal granule alcohol |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101138554A (en) * | 2006-09-05 | 2008-03-12 | 云南白药集团股份有限公司 | Effervescence dispersible tablet |
| CN102100902A (en) * | 2011-02-15 | 2011-06-22 | 江西本草天工科技有限责任公司 | Counterflow cold effervescent tablets |
| CN102247503A (en) * | 2010-12-23 | 2011-11-23 | 祝凤仪 | Formula of external washing medicine powder and effervescent tablets for treating cold lower limb and preparation method thereof |
-
2012
- 2012-08-23 CN CN201210301349XA patent/CN102813628A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101138554A (en) * | 2006-09-05 | 2008-03-12 | 云南白药集团股份有限公司 | Effervescence dispersible tablet |
| CN102247503A (en) * | 2010-12-23 | 2011-11-23 | 祝凤仪 | Formula of external washing medicine powder and effervescent tablets for treating cold lower limb and preparation method thereof |
| CN102100902A (en) * | 2011-02-15 | 2011-06-22 | 江西本草天工科技有限责任公司 | Counterflow cold effervescent tablets |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106983725A (en) * | 2017-04-12 | 2017-07-28 | 华润三九医药股份有限公司 | A kind of new application for the method and PVPP for improving the molten extract content of Chinese medicinal granule alcohol |
| CN106983725B (en) * | 2017-04-12 | 2020-12-29 | 华润三九医药股份有限公司 | Method for improving content of alcohol-soluble extract of traditional Chinese medicine particles and new application of crospovidone |
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Application publication date: 20121212 |