CN101669974A - Traditional Chinese medicine prescription granule preparation by melted extrusion method - Google Patents
Traditional Chinese medicine prescription granule preparation by melted extrusion method Download PDFInfo
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- CN101669974A CN101669974A CN200910184836A CN200910184836A CN101669974A CN 101669974 A CN101669974 A CN 101669974A CN 200910184836 A CN200910184836 A CN 200910184836A CN 200910184836 A CN200910184836 A CN 200910184836A CN 101669974 A CN101669974 A CN 101669974A
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Abstract
The invention relates to a melted extrusion method for preparing traditional Chinese medicine prescription granules, comprising the following steps: using an auxiliary material with a low melting point as a binding agent and evenly mixing with traditional Chinese medicine extract powder according to a certain ratio; placing the mixture in an extrusion pelletiser to prepare into granules in the extrusion process; straightening granules after cooling to obtain the traditional Chinese medicine prescription granules, wherein 40-70 DEG C is preferably used as the melting point or melting range of the low melting point auxiliary material; and the dosage ratio of the auxiliary material accounts for 10-40% of the total weight of the auxiliary material to the traditional Chinese medicine extract powder. The invention has higher molding efficiency, avoids the phenomena such as change of medicine tincture and active ingredients caused by repeated extrusion, weakened dissolubility and the like, thus especially being suitable for traditional Chinese medicine extract powder with poor viscosity and varieties such as fruit and seeds containing high fatty oil and starch, roots and tubers, parts offlowers and plants, leather and the like. The granules prepared by the invention have fine mobility, compressibility and dissolubility, and the granules prepared by using hydrophobic auxiliary materials have lower hygroscopicity.
Description
(1) technical field
The present invention relates to a kind of method for preparing Chinese medicinal granule, especially relate to a kind of extrusion by melting and prepare Chinese medicinal granule.Be applicable to the herbal species that extract powder viscosity is relatively poor, comprise fatty oil, fruit and seed class and tubers and part flower class, careless class and skin class etc. that content of starch is high.Belong to the oral preparation of Chinese traditional medicinal technical field.
(2) background technology
Chinese medicinal granule is to be raw material with the prepared slices of Chinese crude drugs, the Chinese medicine granules that adopts methods such as extraction, concentrating under reduced pressure, drying to make.Both the flexible prescription of clinician can be supplied, the raw materials for production of Chinese medicine preparation such as Chinese patent medicine can be made again.
Traditional Chinese medicine method of granulating comprises wet granulation, high-speed stirred granulation, spray-drying process and fluid bed one-step palletizing etc.Because it is strong that the Chinese medicine material has hygroscopicity, characteristics such as viscosity is big behind the chance water, there is certain defective in aforementioned method of granulating in application process.
There is following problems in wet granulation technology in the full extract powder pelletization of Chinese medicine:
(1) to the full extract powder of bibulous Chinese medicine, adopt wet granulation technique to prepare granule, granule is prone to phenomenons such as adhesion, strip soft material, sticking net, and made granule is really up to the mark and poorly soluble, causes the quality instability;
(2) the drug powder chance water capacity that contains damp and hot sensitive composition is easily degraded, and is unsuitable for adopting wet granulation technology;
(3) process route complexity, energy consumption is very high, and often adds entry or other organic solvent in the pelletization, needs heat drying, and the production cycle is long.
Although fluidized bed granulation integrates mixing, granulation, dry, can realize one-step palletizing, but for the full extract powder of Chinese medicine, take place softening in may the full extract powder pelletization of Chinese medicine and cause problem such as the bed that collapses, control is had relatively high expectations to technological parameter, the equipment early investment is higher, has increased the cost expenditure.
Spray-drying process is used ripe in Chinese medicine is granulated, but obtained Chinese medicinal granule granularity is thinner, causes powder to fly upward in the back in the operation easily, generally need carry out secondary and granulate.
The method of granulating of Chinese medicinal granule mainly is a dry granulation at present.The dry granulation explained hereafter cycle is short, production efficiency is higher, and for the relatively poor herbal species of extract powder viscosity, comprise fatty oil, fruit and seed class and tubers and kinds such as part flower class, careless class and skin class that content of starch is high, granule one-shot forming rate is lower in its dry granulation process, need push repeatedly under high pressure, and production efficiency is very low, and cause that the medicine color and luster changes or active component changes, the melting variation because of pushing repeatedly.
(3) summary of the invention
The objective of the invention is at the relatively poor herbal species of extract powder viscosity, comprise fatty oil, fruit and seed class and tubers and kinds such as part flower class, careless class and skin class that content of starch is high, provide a kind of new medicine granule method of granulating, to improve the grain forming rate and the quality of aforementioned kind.
The object of the present invention is achieved like this: a kind of extrusion by melting prepares Chinese medicinal granule; adopt low-melting adjuvant to make binding agent; make mixture with Chinese medical concrete powder mix homogeneously by a certain percentage; this moment, the binding agent fusion made mixture be agglomerated into open structure; put into Squeezinggranulator and make granule by extrusion process with certain degree of hardness; be shaped as cylindrically after the gained granule cooling, granulate gets final product again.
Above-mentioned low melting point adjuvant is selected from low melting point ester, fatty acid, aliphatic alcohol etc., preferred hydrophilic adjuvant Polyethylene Glycol and hydrophobic auxiliary glyceryl monostearate, glyceryl tristearate, stearic acid, mountain Yu acid glyceride, cetylate, insect wax or Cera Flava.
Preferred 40～70 ℃ of the fusing point of described low melting point adjuvant or melting range.
Preferred 20～200 orders of the granularity of described low melting point adjuvant.
The usage ratio of described low melting point adjuvant is preferably 10～40% of described adjuvant and Chinese medical concrete powder mixture weight.
Described heating-up temperature and heat time heating time, be preferably respectively and be higher than 10～30 ℃ of adjuvant fusing points, 5～120 minutes.
The adding mode of described low melting point adjuvant has two kinds: can be earlier and behind the Chinese medical concrete powder mix homogeneously, and heated and stirred, preparation granule; Also can be earlier separately behind the heating and melting, after mixing with the Chinese medical concrete powder again, the preparation granule.
If the caking property of material is still lower after heating, in low melting point adjuvant and Chinese medical concrete powder mixture, spray into the dehydrated alcohol that accounts for described adjuvant and Chinese medical concrete powder gross weight 1～5%, push granulation again, to improve the grain forming rate.
The selected main adjuvant of the present invention is the low melting point adjuvant, these adjuvants also have application in others, such as pharmaceutical bases such as drop pill, suppository, ointment, and this adjuvant can become granule as binding agent with powder bonded during the heating and melting state in the present invention.
Extrusion by melting of the present invention prepares Chinese medicinal granule, it is the bridging action that utilizes the binding agent of heating and melting, make the Chinese medical concrete powder be agglomerated into granule by extrusion process again, this method prepares the influence that the molding particles rate is not subjected to Chinese medical concrete powder micromeritis character substantially, and shaping efficiency is higher.And can not occur pushing repeatedly and cause that the medicine color and luster changes or active component changes, phenomenons such as melting variation.Therefore be particularly useful for the relatively poor Chinese medical concrete powder of viscosity, comprise fatty oil, fruit and seed class and tubers and kinds such as part flower class, careless class and skin class that content of starch is high.
The made granule of the present invention has good flowability, compressibility and melting, and the granule that adopts hydrophobic auxiliary to make has lower hygroscopicity.
Advantage of the present invention is:
1. melt granulation technology is to make binding agent with the low melting point adjuvant, the influence of the material properties that grain forming is not granulated substantially, can not cause in the pelletization that most of Chinese medical concrete powder has draw moist by force, be clamminess easily, characteristic such as deliquescing, be the desirable method of granulating of the relatively poor Chinese medicinal granule of Chinese medicinal granule, especially viscosity;
2. whole melt granulation technical process does not directly contact with water, so be applicable to the Chinese medicinal granule that contains the water sensitivity active component;
3. melt granulation technology need not to add entry or organic solvent etc. and makes binding agent, has reduced dry run, shortens operation, and is simple for process;
4. the prepared Chinese medicinal granule of melt granulation has good flowability, melting and compressibility, but the direct heating mixing in water for oral taking also can be used for tabletting or capsule and fills;
5. adopt hydrophobicity low melting point adjuvant to make binding agent, also can reduce the hygroscopicity of Chinese medicinal granule, reduce moisture absorption caking phenomenon in the Chinese medicinal granule put procedure;
6. adopt the extruding granulating process, the constant and scalable of extruding force can guarantee that product is stable, is suitable for continuous mass production.
(5) specific embodiment
Embodiment 1:
Follow the example of Rhizoma Pinelliae extract powder 1000g; add 200g polyethylene glycol 6000 (granularity is 60 orders); fully behind the mix homogeneously, place 100 ℃ of electric ovens, heated 30 minutes; place extruding granulator; cross 25 eye mesh screens, extruding is granulated, after 20 eye mesh screen granulate; promptly get the Rhizoma Pinelliae Preparatum Chinese medicinal granule, this granule has good flowability, melting and moisture resistance.
Embodiment 2:
Get Cortex Phellodendri extract powder 1000g; add the 150g glycerol monostearate and refer to (granularity is 80 orders); fully behind the mix homogeneously, place 80 ℃ of electric ovens, heated 10 minutes; taking-up is poured in the extruding granulator; stir, 25 eye mesh screen granulate are crossed in cooling; make the Cortex Phellodendri Chinese medicinal granule, this granule has good flowability, melting and moisture resistance.
Embodiment 3:
Get Dan Semen Persicae extract powder 1000g, add 300g Cera Flava (granularity is 100 orders), fully behind the mix homogeneously; place the trough type mixing machine that has zone of heating; heat after 120 minutes, in mixture, spray into a small amount of ethanol solution, again mixture is placed extruding granulator; screen cloth is 25 orders; extruding is granulated, and 20 eye mesh screen granulate are crossed in cooling; promptly get Dan Semen Persicae Chinese medicinal granule, this granule has good flowability, melting and moisture resistance.
Embodiment 4:
Get Radix Trichosanthis extract powder 1000g; add 300g stearic acid (granularity is 80 orders), fully behind the mix homogeneously, place 80 ℃ of electric ovens; heated 50 minutes; taking-up is poured in the extruding granulator, and screen cloth is 30 orders, and extruding is granulated; cooling; cross 25 eye mesh screen granulate, make the Radix Trichosanthis Chinese medicinal granule, this granule has good flowability, melting and moisture resistance.
Embodiment 5:
Get Radix Scrophulariae extract powder 1000g; add 400g cetylate (granularity is 120 orders), fully behind the mixing, place the trough type mixing machine that has zone of heating; heated 5 minutes; taking-up is poured in the extruding granulator, and screen cloth is 30 orders, and extruding is granulated; cooling; cross 20 eye mesh screen granulate, promptly get the Radix Scrophulariae Chinese medicinal granule, this granule has good flowability, melting and moisture resistance.
Embodiment 6:
Get eumenol powder 1000g; add 150g mountain Yu acid glyceride (granularity is 100 orders), fully behind the mix homogeneously, place 100 ℃ of electric ovens; heat after 100 minutes; place extruding granulator, screen cloth is 25 orders, and extruding is granulated; cooling; cross 20 eye mesh screen granulate, promptly get the Radix Angelicae Sinensis Chinese medicinal granule, this granule has good flowability, melting and moisture resistance.
Claims (4)
1, a kind of extrusion by melting prepares Chinese medicinal granule, it is characterized in that described method is to adopt the low melting point adjuvant to make binding agent, by a certain percentage with Chinese medical concrete powder mix homogeneously, put into Squeezinggranulator and make granule, promptly get Chinese medicinal granule through granulate again after the cooling of gained granule by extrusion process;
Described low melting point adjuvant is selected from low melting point ester, low melting point fatty acid or low melting point aliphatic alcohol;
Preferred 40～70 ℃ of the fusing point of described low melting point adjuvant or melting range;
The usage ratio of described low melting point adjuvant is 10～40% of described adjuvant and a Chinese medical concrete powder gross weight;
The adding mode of described low melting point adjuvant has two kinds: a kind of is low melting point adjuvant elder generation and Chinese medical concrete powder mix homogeneously, reheat is melt into soft material, put into Squeezinggranulator and make granule by extrusion process, another kind is that the low melting point adjuvant joins mix homogeneously in the Chinese medical concrete powder with liquid form behind the heating and melting separately earlier, puts into Squeezinggranulator again and makes granule by extrusion process;
Described heating-up temperature is for being higher than 10～30 ℃ of low melting point adjuvant fusing points, and be 5～120 minutes heat time heating time;
The granularity of described low melting point adjuvant is 20～200 orders.
2, a kind of extrusion by melting according to claim 1 prepares Chinese medicinal granule, it is characterized in that described low-melting hydrophilicity condiment is a Polyethylene Glycol.
3, a kind of extrusion by melting according to claim 1 prepares Chinese medicinal granule, it is characterized in that described low-melting hydrophobic auxiliary is glyceryl monostearate, glyceryl tristearate, stearic acid, mountain Yu acid glyceride, cetylate, insect wax or Cera Flava.
4, prepare Chinese medicinal granule according to claim 1,2 or 3 described a kind of extrusion by meltings, it is characterized in that if the caking property of material is still lower after heating, in low melting point adjuvant and Chinese medical concrete powder mixture, spray into the dehydrated alcohol that accounts for described adjuvant and Chinese medical concrete powder gross weight 1～5%.
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| CN200910184836A CN101669974A (en) | 2009-10-15 | 2009-10-15 | Traditional Chinese medicine prescription granule preparation by melted extrusion method |
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| CN200910184836A CN101669974A (en) | 2009-10-15 | 2009-10-15 | Traditional Chinese medicine prescription granule preparation by melted extrusion method |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102499890A (en) * | 2011-09-30 | 2012-06-20 | 沈阳药科大学 | Preparation method of hot melt extrusion moisture-proof preparation for medicaments |
| CN102988181A (en) * | 2012-12-31 | 2013-03-27 | 广州白云山天心制药股份有限公司 | Granulating method and application for oral solid preparation |
| CN105101793A (en) * | 2013-03-26 | 2015-11-25 | 日本曹达株式会社 | Method for manufacturing agricultural and horticultural granule formulation |
| CN107095899A (en) * | 2017-06-27 | 2017-08-29 | 西安远大德天药业股份有限公司 | A kind of preparation method and application of Swertia mussotii pharmaceutical composition |
| CN107875125A (en) * | 2016-09-30 | 2018-04-06 | 天士力医药集团股份有限公司 | A kind of Chinese medicinal granule and preparation method thereof |
| CN110526761A (en) * | 2019-10-16 | 2019-12-03 | 贵州西洋实业有限公司 | A kind of granulated fertilizer and its dry technology for production |
| CN112353845A (en) * | 2021-01-14 | 2021-02-12 | 上海智同医药科技有限公司 | Hot-melt extrusion composition containing traditional Chinese medicine volatile oil, preparation method thereof and pharmaceutical preparation |
-
2009
- 2009-10-15 CN CN200910184836A patent/CN101669974A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102499890A (en) * | 2011-09-30 | 2012-06-20 | 沈阳药科大学 | Preparation method of hot melt extrusion moisture-proof preparation for medicaments |
| CN102988181A (en) * | 2012-12-31 | 2013-03-27 | 广州白云山天心制药股份有限公司 | Granulating method and application for oral solid preparation |
| CN105101793A (en) * | 2013-03-26 | 2015-11-25 | 日本曹达株式会社 | Method for manufacturing agricultural and horticultural granule formulation |
| CN105101793B (en) * | 2013-03-26 | 2017-04-19 | 日本曹达株式会社 | Method for manufacturing agricultural and horticultural granule formulation |
| CN107875125A (en) * | 2016-09-30 | 2018-04-06 | 天士力医药集团股份有限公司 | A kind of Chinese medicinal granule and preparation method thereof |
| CN107875125B (en) * | 2016-09-30 | 2021-11-09 | 天士力医药集团股份有限公司 | Traditional Chinese medicine formula granule and preparation method thereof |
| CN107095899A (en) * | 2017-06-27 | 2017-08-29 | 西安远大德天药业股份有限公司 | A kind of preparation method and application of Swertia mussotii pharmaceutical composition |
| CN107095899B (en) * | 2017-06-27 | 2020-06-09 | 西安远大德天药业股份有限公司 | Preparation method and application of Tibetan capillary artemisia pharmaceutical composition |
| CN110526761A (en) * | 2019-10-16 | 2019-12-03 | 贵州西洋实业有限公司 | A kind of granulated fertilizer and its dry technology for production |
| CN112353845A (en) * | 2021-01-14 | 2021-02-12 | 上海智同医药科技有限公司 | Hot-melt extrusion composition containing traditional Chinese medicine volatile oil, preparation method thereof and pharmaceutical preparation |
| CN112353845B (en) * | 2021-01-14 | 2021-04-16 | 上海智同医药科技有限公司 | Hot-melt extrusion composition containing traditional Chinese medicine volatile oil, preparation method thereof and pharmaceutical preparation |
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Open date: 20100317 |