CN1985933A - preparing method of gentian capsule for purging liver fire - Google Patents
preparing method of gentian capsule for purging liver fire Download PDFInfo
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- CN1985933A CN1985933A CN 200610022099 CN200610022099A CN1985933A CN 1985933 A CN1985933 A CN 1985933A CN 200610022099 CN200610022099 CN 200610022099 CN 200610022099 A CN200610022099 A CN 200610022099A CN 1985933 A CN1985933 A CN 1985933A
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Abstract
The preparation process of gentian capsule for purging liver fire with ten kinds of Chinese medicinal materials, including gentian, bupleurum root, skullcap root, cape jasmine, oriental water plantain, etc. includes the following steps: twice decoction for 1.5 hr each, filtering, merging the filtrate, concentrating to density of 1.25-1.28, adding alcohol to alcohol content of 70 %, standing for over 24 hr, filtering and recovering alcohol from the filtrate, adding dextrin to density of 1.18, spray drying to obtain extractum powder, mixing with dextrin, pelletizing, low temperature drying and encapsulating. The gentian capsule has less moisture absorption and high stability.
Description
Technical field
The present invention relates to medicine and engineering in medicine field, especially preparation method of gentian capsule for purging liver fire.
Background technology
The Longdanxiegan Capsule preparation, granulation is a Technology crucial in the dosage form preparation process, present industrial method of granulating can be divided into: extrusion granulator, wet-mixing granulation, fluidized-bed spray granulation, spray-drying process etc. are several, and fluidized-bed spray granulation and spray-drying process are used for the preparation of granules of capsule more.See 21 century higher vocational college teaching material " pharmacy of Chinese materia medica ", the cleer and peaceful Ni Jian of the Beijing University of Chinese Medicine chief editor of the Liu Han of Nanjing University of Traditional Chinese Medicine, Science Press publishes.The problem that the preparation of Longdanxiegan Capsule now exists is: easily the moisture absorption is rotten, and poor stability is difficult for molten loosing.
Summary of the invention
For overcoming the problem that existing preparation method of gentian capsule for purging liver fire exists, the invention provides a kind of new preparation method, have be easy to dissolve, the characteristics of good stability.
The technical solution adopted for the present invention to solve the technical problems is:
[prescription] Radix Gentianae 120g Radix Bupleuri 120g Radix Scutellariae 60g Fructus Gardeniae (stir-fry) 60g
Rhizoma Alismatis 120g Caulis Akebiae 60g Semen Plantaginis (salt stir-fry) 60g Radix Angelicae Sinensis (wine stir-fry) 60g
Radix Rehmanniae 120g Radix Glycyrrhizae (processed with honey) 60g
[method for making] above ten flavors decoct with water twice, each 1.5 hours, filter, merging filtrate, being concentrated into relative density is 1.25～1.28 (80 ℃), adding ethanol makes and contains the alcohol amount and reach 70%, leave standstill more than 24 hours, filter filtrate recycling ethanol, it is an amount of to add dextrin, being adjusted to relative density is that spray drying is made extract powder about 1.18 (80 ℃).Get 1 part of extract powder, 1.5 parts of adjuvants (amount that contains aforementioned dextrin), mixing is made granule, and cold drying incapsulates, and makes 1000, promptly.
For the first time 0.5 times of amount dextrine powder is added spray drying in the clear paste, this extract powder is put in the boiling granulating machine, make little shape parent nucleus as adhesive, divide 4 addings with 1 times of amount dextrine powder again, be wrapped in the parent nucleus outside, make fine grained, cold drying with 95% ethanol.
When decocting boils, add 8 times of water gagings, decoct 2 times.When reclaiming ethanol, need to there not being the alcohol flavor.
The invention has the beneficial effects as follows: 1, owing to added the dextrin of 0.5 times of amount in the parent nucleus, the parent nucleus quality is loose, is easy to molten loosing.2, the parent nucleus outside is the dextrin parcel, drug extract and outside air is isolated, thereby make granule be difficult for the moisture absorption, has strengthened stability of drug, has solved the rotten difficult problem of the easy moisture absorption of capsule.
Experimentation traditional method and the granule hygroscopicity and the dissolution of improving one's methods and making:
Experiment 1: the traditional method and the granule hygroscopicity that makes of improving one's methods compare
Make two batches of Longdanxiegan Capsule fine graineds with traditional method and new method respectively, be designated granule 1, granule 2, get 6 parts of granules respectively, every part of about 2.5g, the accurate title, decide, and puts in the weighing botle, opens the weighing bottle cap, put into relative humidity respectively and be 20%, 33%, 43%, 60%, 75%, 92% constant humidity environment, placed 48 hours in 25 ℃ of incubators, take out weighing botle, accurate title is fixed after adding a cover, calculate the moisture absorption percentage rate of two each parts of batch sample, the result is as follows.
With the moisture absorption percentage rate is vertical coordinate, and relative humidity is an abscissa, makes curve, the results are shown in figure below.
The particulate moisture absorption results of various relative humidity conditions (n=2)
| Constant humidity solution (25 ℃) | CH 3COOK | MgCL 2 | K 2CO 3 | NaBr | NaCL | KNO 3 |
| RH (%) granule 1 equilibrium moisture content (%) granule 2 equilibrium moisture contents (%) | 20 0.68 0.36 | 33 1.11 0.73 | 43 1.79 1.45 | 60 3.25 2.11 | 75 6.76 5.35 | 92 11.41 7.26 |
Result of the test shows: the anti-wettability power of granule 2 (series 2) obviously is better than granule 1 (series 1), with the capsule that granule 2 is dressed up, stability is preferably arranged.
Test after granule that 2 traditional methods and improving one's methods make incapsulates, carry out determination of dissolution rate with high performance liquid chromatography
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water (10: 90) is a mobile phase; Detect wavelength 270nm.Number of theoretical plate is pressed the gentiopicrin peak and is calculated, and should be not less than 2000.
The preparation precision of reference substance solution takes by weighing gentiopicrin reference substance 10mg, puts in the 100ml measuring bottle, adds dissolve with methanol to scale, shakes up, promptly.
Two batch samples that the preparation of need testing solution is taken traditional method and improved one's methods and make according to dissolution method (two appendix X of Chinese Pharmacopoeia version in 2005 C, second method), are solvent with water 900ml, rotating speed is that per minute 50 changes, and in the time of 20 minutes, gets solution and filters, measure subsequent filtrate 500ml, water-bath is concentrated near doing, and residue adds 50% dissolve with methanol, quantitatively change in the 10ml measuring bottle, add 50% methanol to scale, shake up, filter, get subsequent filtrate, promptly.
Other gets capsule 's content 1.0g, and accurate the title decides, and puts in the 50ml measuring bottle, adds 50% methanol 40ml, supersound process 15 minutes is put coldly, adds methanol and is diluted to scale, shakes up, filter, discard filtrate just, get subsequent filtrate, the real content of index components-gentiopicrin in the working sample.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, and the result is as follows.
| The real content of every gentiopicrin of Longdanxiegan Capsule | 1.14mg |
| The capsule gentiopicrin average dissolution that granule 1 makes accounts for the percentage ratio of real content | 89.1％ |
| The capsule gentiopicrin average dissolution that granule 2 makes accounts for the percentage ratio of real content | 89.6％ |
Above description of test, the granule that makes of improving one's methods are dressed up the granule that capsule and traditional method make and are dressed up capsule, and dissolution does not have the change of matter, does not promptly influence the stripping and the absorption of effective ingredient, and the innovation of method of granulating is feasible.
The specific embodiment
The invention will be further described below in conjunction with most preferred embodiment.
By State Food and Drug Administration's standard (trying) YBZ06152005 Longdanxiegan Capsule
[prescription] Radix Gentianae 120g Radix Bupleuri 120g Radix Scutellariae 60g Fructus Gardeniae (stir-fry) 60g
Rhizoma Alismatis 120g Caulis Akebiae 60g Semen Plantaginis (salt stir-fry) 60g Radix Angelicae Sinensis (wine stir-fry) 60g
Radix Rehmanniae 120g Radix Glycyrrhizae (processed with honey) 60g
The preparation method step is as follows:
(1) take by weighing 10 flavor medical materials in the Medicine prescription ratio, add 8 times of water gagings and decoct 2 times, each 1.5 hours, filter, merging filtrate, filtrate is concentrated into the clear paste that relative density is 1.25～1.28 (80 ℃).This step the best for the orthogonal experiment screening decocts scheme (effective ingredient is in gentiopicrin, and the rate of transform is 92%).
(2) " clear paste adds ethanol to be made and contains the alcohol amount and reach 70%, leaves standstill 24 hours, filters, and filtrate recycling ethanol adds the dextrin of 0.5 times of dried approximately cream amount, and being adjusted to relative density is 1.18 (80 ℃), and spray drying is made extract powder ".Under this relative density, precipitate with ethanol is most effective, contains the alcohol amount and reaches at 70% o'clock, can dispel the impurity of dried cream amount 40%, and the effective ingredient rate of transform is more than 90%.The key technology in this step is, reclaims ethanol to there not being the alcohol flavor, adds the dextrin of 0.5 times of dried cream amount, stirs evenly, and continuing to be concentrated into relative density is 1.18 (80 ℃).Spray easily after adding dextrin, be easy to drying, recovery rate is more than 96%.The extract powder granule that makes is loose, is difficult for moisture absorption, is easy to preserve.
(3) " get 1 part of extract powder, 1.5 parts of adjuvants (amount that contains aforementioned dextrin) are made granule, and cold drying incapsulates, promptly ".This goes on foot granulation technique, is this preparation technology's innovative point.
Longdanxiegan Capsule method of granulating: dextrin is added at twice; for the first time 0.5 times of amount is added spray drying in the clear paste; this extract powder is put in the boiling granulating machine; make little shape parent nucleus with 95% ethanol as adhesive; divide 4 addings with 1 times of amount dextrine powder again; be wrapped in the parent nucleus outside, make fine grained, cold drying.
Accompanying drawing is sucting wet curve figure.
Claims (3)
1. preparation method of gentian capsule for purging liver fire, Radix Gentianae, Radix Bupleuri, Radix Scutellariae, Fructus Gardeniae, Rhizoma Alismatis, Caulis Akebiae, Semen Plantaginis, Radix Angelicae Sinensis, Radix Rehmanniae, Radix Glycyrrhizae ten flavors decoct with water twice, each 1.5 hours, filter merging filtrate, being concentrated into relative density is 1.25～1.28, adds ethanol and makes and contain the alcohol amount and reach 70%, leaves standstill more than 24 hours, filter, filtrate recycling ethanol adds dextrin, and being adjusted to relative density is 1.18, spray drying is made extract powder.Get extract powder, add dextrin, mixing; make granule; cold drying incapsulates, and it is characterized in that: for the first time 0.5 times of amount dextrine powder is added spray drying in the clear paste; this extract powder is put in the boiling granulating machine; make little shape parent nucleus with 95% ethanol as adhesive, divide 4 addings with 1 times of amount dextrine powder again, be wrapped in the parent nucleus outside; make fine grained, cold drying.
2. a kind of preparation method of gentian capsule for purging liver fire according to claim 1 is characterized in that: when decocting boils, add 8 times of water gagings, decoct 2 times.
3. a kind of preparation method of gentian capsule for purging liver fire according to claim 1 is characterized in that: when reclaiming ethanol, need to there not being the alcohol flavor.
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| CNB2006100220990A CN100484544C (en) | 2006-10-24 | 2006-10-24 | Preparing method of gentian capsule for purging liver fire |
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| CNB2006100220990A CN100484544C (en) | 2006-10-24 | 2006-10-24 | Preparing method of gentian capsule for purging liver fire |
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| CN1985933A true CN1985933A (en) | 2007-06-27 |
| CN100484544C CN100484544C (en) | 2009-05-06 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101554436B (en) * | 2008-04-09 | 2010-12-15 | 北京绿源求证科技发展有限责任公司 | Traditional Chinese medicine for treating diabetic stubborn insomnia |
| CN102423380A (en) * | 2011-12-17 | 2012-04-25 | 李承平 | Drug composition with effects of liver and gallbladder sthenic fire clearing and dampness eliminating |
| CN104799284A (en) * | 2015-04-29 | 2015-07-29 | 广西大学 | Health and nutritional powder containing lotus root, red bean and carambola and preparation method of health and nutritional powder |
| CN105640893A (en) * | 2015-12-29 | 2016-06-08 | 广东方制药有限公司 | Preparation method and quality control method of Gentiana scabra Bunge liver fire purging formula particles |
| CN107496375A (en) * | 2017-07-31 | 2017-12-22 | 陕西医药控股医药研究院有限公司 | A kind of preparation method of herbal mixture granule |
-
2006
- 2006-10-24 CN CNB2006100220990A patent/CN100484544C/en not_active Expired - Fee Related
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101554436B (en) * | 2008-04-09 | 2010-12-15 | 北京绿源求证科技发展有限责任公司 | Traditional Chinese medicine for treating diabetic stubborn insomnia |
| CN102423380A (en) * | 2011-12-17 | 2012-04-25 | 李承平 | Drug composition with effects of liver and gallbladder sthenic fire clearing and dampness eliminating |
| CN104799284A (en) * | 2015-04-29 | 2015-07-29 | 广西大学 | Health and nutritional powder containing lotus root, red bean and carambola and preparation method of health and nutritional powder |
| CN105640893A (en) * | 2015-12-29 | 2016-06-08 | 广东方制药有限公司 | Preparation method and quality control method of Gentiana scabra Bunge liver fire purging formula particles |
| CN105640893B (en) * | 2015-12-29 | 2019-11-12 | 广东一方制药有限公司 | A kind of preparation method and its method of quality control of Longdan Xiegan Tang granule |
| CN107496375A (en) * | 2017-07-31 | 2017-12-22 | 陕西医药控股医药研究院有限公司 | A kind of preparation method of herbal mixture granule |
| CN107496375B (en) * | 2017-07-31 | 2020-06-16 | 陕西医药控股医药研究院有限公司 | Preparation method of compound traditional Chinese medicine granules |
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| CN100484544C (en) | 2009-05-06 |
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Effective date of registration: 20090911 Address after: 3-1-801, Chengdu garden, 8 Qingyang Avenue, Sichuan, Chengdu Province, China: 610000 Co-patentee after: Jiang Ping Patentee after: Wen Yongsheng Co-patentee after: Tang Mingchang Address before: 3-1-801, Chengdu garden, 8 Qingyang Avenue, Sichuan, Chengdu Province, China: 610000 Patentee before: Wen Yongsheng |
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Granted publication date: 20090506 Termination date: 20211024 |