CN1552364A - Xuefu ecchymosis eliminating pills and their preparation - Google Patents
Xuefu ecchymosis eliminating pills and their preparation Download PDFInfo
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- CN1552364A CN1552364A CNA031244866A CN03124486A CN1552364A CN 1552364 A CN1552364 A CN 1552364A CN A031244866 A CNA031244866 A CN A031244866A CN 03124486 A CN03124486 A CN 03124486A CN 1552364 A CN1552364 A CN 1552364A
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Abstract
A Chinese medicine 'Xuefu Zhuyu pill' for promoting blood circulation, removing blood stasis and stagnant heat, and treating insomnia, headache and thoracalgia is an improvement to existing relative medicine in the form of capsule. Its preparing process is also disclosed. Its advantages are high curative effect, high release speed and high biologic utilization rate.
Description
Technical field
This invention relates to the processing technology technical field of the making of Chinese patent medicine pill, relates in particular to Xuefu ecchymosis eliminating pill and preparation method.
Background technology
Pill is a kind of conventional dosage forms, because quick development of modern science and technology, pharmaceutical machine equipment is brought in constant renewal in and is regenerated, the extensive use of the appearance of novel pellet processing machine and new adjuvant, for this ancient dosage form of medicine pill has shone youthful vigor, it has changed people to the traditional prejudice of traditional pill " black, big, thick ", advantages such as the pill that makes it to produce has that drug release rate is fast, bioavailability is high, divided dose is accurate, takes, easy to carry, good looking appearance.According to the relevant drug act of China, change dosage form as a kind of new drug research, former dosage form XUEFU ZHUYU JIAONANG has been listed the 5th of People's Republic of China's drug standard " Chinese traditional patent formulation preparation " in.The technology characteristics of former dosage form is: the five tastes such as Semen Persicae in the prescription (recipe quantity 1/2) and Radix Angelicae Sinensis are beaten powder, and remaining medical material decocts with water, and is condensed into thick paste, adds above-mentioned fine powder, granulates, and oven dry is pulverized, and is encapsulated, promptly.This medicine in process of production, closely the medical material of half is beaten powder, dose is big, dysphagia; Fine powders such as next Radix Angelicae Sinensis in the thick paste of adding Radix Rehmanniae etc., are granulated, oven dry, and volatile ingredient easily loses, and dosage form is single, far can not satisfy people's medication demand, and its quality standard is low simultaneously, no quantitative target.Based on this, we use the modern pharmaceutical technology this product technology are done necessary improvement, form new preparation, the control criterion that improves the quality simultaneously guarantees the quality monitoring of product to improve drug effect, benefit the common people, this is significant to inheriting and develop motherland's medicine legacy.
Summary of the invention
The purpose of this invention is to provide a kind of novel Xuefu ecchymosis eliminating pill and preparation method, improve the quality of products and curative effect, increase the stability of product, enrich medicine variety, to satisfy and to ensure people's medication demand better.
The present invention is such enforcement:
1. Xuefu ecchymosis eliminating pill and preparation method comprise the steps:
1.1 the prescription of Xuefu ecchymosis eliminating pill is formed
Semen Persicae (stir-fry) 200-1000 Radix Angelicae Sinensis 150-750g Fructus Aurantii (parched with bran) 100-500g
Rhizoma Chuanxiong 75-375g Radix Bupleuri 50-250g Flos Carthami 150-750g
Radix Achyranthis Bidentatae 150-750g Radix Paeoniae Rubra 100-500g Radix Rehmanniae 150-750g
Radix Platycodonis 75-375g Radix Glycyrrhizae 50-250g
Right amount of auxiliary materials is made 1000g altogether
Optimum formula:
Semen Persicae (stir-fry) 250-600 Radix Angelicae Sinensis 187.5-450g Fructus Aurantii (parched with bran) 125-300g
Rhizoma Chuanxiong 93.75-225g Radix Bupleuri 62.5-150g Flos Carthami 187.5-450g
Radix Achyranthis Bidentatae 187.5-450g Radix Paeoniae Rubra 125-300g Radix Rehmanniae 187.5-450g
Radix Platycodonis 93.75-225g Radix Glycyrrhizae 62.5-150g
Right amount of auxiliary materials is made 1000g altogether
1.2 the preparation technology of Xuefu ecchymosis eliminating pill
Technology one is got in the prescription 11 flavor medicines and is up to the standards standby respectively; Get Semen Persicae (recipe quantity 1/2), Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri and be ground into fine powder, 5 flavor medical materials such as all the other Flos Carthamis and Semen Persicae (recipe quantity has 1/2) decoct with water 2-4 time, filter, merging filtrate, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, adds above-mentioned fine powder and appropriate amount of auxiliary materials, mixing, make ball, drying, promptly.
Technology two is got in the prescription 11 flavor medicines and is up to the standards standby respectively; Get Semen Persicae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri, Flos Carthami powder and be broken into coarse powder, use the 50-95% ethanol extraction, extracting solution reclaims ethanol, is concentrated into standby in right amount; 4 flavor medicines such as medicinal residues and all the other Radix Glycyrrhizaes decoct with water 2-4 time, and merging filtrate filters, and filtrate is concentrated in right amount, merges with above-mentioned alcohol extract, is condensed into thick paste/concentrate drying and makes dried cream powder, with the appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
Technology three is got in the prescription 11 flavor medicines and is up to the standards standby respectively; Get in the prescription ten Herba indigoferae Pseudotinctoriae and be ground into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-3 time, it is standby to collect volatile oil and water boiling liquid; Above-mentioned volatile oil is with cyclodextrin inclusion compound or standby with an amount of anhydrous alcohol solution; Above-mentioned water boiling liquid filters, and is condensed into thick paste/concentrate drying and makes dried cream powder, with above-mentioned volatile oil clathrate compound and appropriate amount of auxiliary materials mixing, pill, drying, promptly.Or above-mentioned thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the volatile oil ethanol solution, promptly.
1.3 the ball by above-mentioned technology gained is an Xuefu ecchymosis eliminating pill.
The ball of gained can wrap film-coat in the technology, and the film-coat material adopts stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, polyvinyl alcohol, one or more mixing of methylcellulose to use.
Used adjuvant can be that one or more mixing such as sucrose, lactose, starch, beta-schardinger dextrin-, HP-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 POVIDONE K 30 BP/USP 30 are used in the technology.
The particle diameter of the ball of gained is 0.5-6mm in the technology, is preferably 1-4mm.
In the technology ball of gained can directly use or the capsulae vacuus of packing in use.
The ball drying can adopt vacuum drying, fluid bed drying, lyophilization etc. in the technology.
The technology Chinese crude drug is ground into coarse powder/be cut into decoction pieces and was generally 5-30 purpose coarse powder/be cut into decoction pieces, is preferably 10-20 purpose coarse powder.
It was 80-160 purpose fine powder that the technology Chinese crude drug is ground into fine powder, and the best is standby for superfine powder is broken into 200-300 purpose fine powder.
Decoct with water in the technology/condition of water steaming and decocting is: decoction/steaming and decocting 2-4 time, amount of water is doubly measured for 6-12 for the first time, second and third, doubly measure 1-3 hour at every turn for 4-10 four times.Best is decoction/steaming and decocting 3 times, and amount of water is 10 times of amounts for the first time, and second and third time is 8 times of amounts, each 2 hours.Medicinal residues in the technology two after the alcohol extraction such as Radix Angelicae Sinensis can add when second fries in shallow oil.
The alcohol extraction condition can adopt percolation or heating reflux method for being solvent with the ethanol of 50-95% in the technology three, and is best for being solvent with 70-75% ethanol, reflux, extract, 2 times, each 1.5 hours.
The drying of extract can adopt vacuum drying or spray drying in the technology.The vacuum drying temperature is controlled at 50-80 ℃, and the best is 60 ℃.Spray drying is for to be concentrated into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-200 ℃, and leaving air temp is 50-150 ℃.Best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
Cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the HP-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 5-15 (ml/g), optimal proportion is 1: 8 (ml/g), the ratio of volatile oil and HP-is 1: 2-10 (ml/g), optimal proportion are 1: 5 (ml/g).
Filter in the technology to adopt and conventionally filter, centrifugal, ultrafiltration, add filtration/centrifugal/methods such as ultrafiltration behind the clarifier.
2. quality standard control of the present invention mainly is discriminating, inspection and three aspects of assay.
This product is further to improve on the basis of original XUEFU ZHUYU JIAONANG, and dosage form has been carried out the thin layer discriminating to Fructus Aurantii in discriminating Central Plains, now gives reservation, and increases the thin layer discriminating to Rhizoma Chuanxiong, Radix Angelicae Sinensis, Flos Carthami; Increased the limit examine of heavy metal, arsenic salt on checking, the regulation heavy metal limit must not cross 10/1000000ths, and arsenic salt must not limit the quantity of 2/1000000ths; Former dosage form does not have quantitative target on assay, existing increased to Radix Angelicae Sinensis quantitatively.
The present invention is dosage form technological innovation on the basis of existing capsule, and quality standard has new raising again, is of great importance to improving the quality of products, and has enriched medicine variety, satisfies and ensured people's medication demand.
The specific embodiment
Embodiment 1: get in the prescription 11 flavor medicines and be up to the standards standby respectively; Get Semen Persicae (recipe quantity 1/2), Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri and be ground into fine powder, 5 flavor medical materials such as all the other Flos Carthamis and Semen Persicae (recipe quantity has 1/2) decoct with water each 2 hours 3 times, merging filtrate, filter, it is 1.05-1.15 (60 ℃) that filtrate is concentrated into relative density, and spray drying is made dried cream powder, add above-mentioned fine powder and appropriate amount of auxiliary materials, mixing, pill, drying, coating, promptly.
Embodiment 2: get in the prescription 11 flavor medicines and be up to the standards standby respectively; Get Semen Persicae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri, Flos Carthami powder is broken into coarse powder, is solvent with 70-75% ethanol, reflux, extract, 2 times, each 1.5 hours, extracting solution reclaimed ethanol, was concentrated into an amount of; 4 flavor medicines such as medicinal residues and all the other Radix Glycyrrhizaes decoct with water 3 times, and each 2 hours, merging filtrate filtered, and filtrate is concentrated in right amount, merge with above-mentioned alcohol extract, being concentrated into relative density is 1.05-1.15 (60 ℃), and spray drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, pill, drying, coating, promptly.
Embodiment 3: get in the prescription 11 flavor medicines and be up to the standards standby respectively; Get that ten Herba indigoferae Pseudotinctoriae are ground into coarse powder in the prescription, add the water steaming and decocting 3 times, it is standby to collect volatile oil and water boiling liquid; Above-mentioned volatile oil beta-cyclodextrin inclusion compound; Above-mentioned water boiling liquid filters, and being concentrated into relative density is 1.05-1.15 (60 ℃), and spray drying is made dried cream powder, with above-mentioned volatile oil beta cyclodextrin inclusion complex and appropriate amount of auxiliary materials mixing, pill, drying, coating, promptly.
Claims (10)
1. Xuefu ecchymosis eliminating pill and preparation method is characterized in that:
(1) getting Semen Persicae in the prescription, Radix Angelicae Sinensis, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri, Flos Carthami, Radix Achyranthis Bidentatae, Radix Paeoniae Rubra, Radix Rehmanniae, Radix Platycodonis, Radix Glycyrrhizae ten Herba indigoferae Pseudotinctoriae is up to the standards standby respectively; Get Semen Persicae (recipe quantity 1/2), Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri and be ground into fine powder, 5 flavor medical materials such as all the other Flos Carthamis and Semen Persicae (recipe quantity has 1/2) decoct with water 2-4 time, filter, merging filtrate, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, adds fine powder and appropriate amount of auxiliary materials, mixing, pill, drying, promptly.
(2) getting Semen Persicae in the prescription, Radix Angelicae Sinensis, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri, Flos Carthami, Radix Achyranthis Bidentatae, Radix Paeoniae Rubra, Radix Rehmanniae, Radix Platycodonis, Radix Glycyrrhizae ten Herba indigoferae Pseudotinctoriae is up to the standards standby respectively; Get Semen Persicae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri, Flos Carthami powder and be broken into coarse powder, use the 50-95% ethanol extraction, extracting solution reclaims ethanol, is concentrated into standby in right amount; 4 flavor medicines such as medicinal residues and all the other Radix Glycyrrhizaes decoct with water 2-4 time, and merging filtrate filters, and filtrate is concentrated in right amount, merges with alcohol extract, and be condensed into thick paste/concentrate drying and make dried cream powder, with the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
(3) getting Semen Persicae in the prescription, Radix Angelicae Sinensis, Fructus Aurantii, Rhizoma Chuanxiong, Radix Bupleuri, Flos Carthami, Radix Achyranthis Bidentatae, Radix Paeoniae Rubra, Radix Rehmanniae, Radix Platycodonis, Radix Glycyrrhizae ten Herba indigoferae Pseudotinctoriae is up to the standards standby respectively; Get in the prescription ten Herba indigoferae Pseudotinctoriae and be ground into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-3 time, it is standby to collect volatile oil and water boiling liquid; Volatile oil cyclodextrin inclusion compound/standby with an amount of anhydrous alcohol solution; Water boiling liquid filters, and is condensed into thick paste/concentrate drying and makes dried cream powder, with volatile oil clathrate compound and appropriate amount of auxiliary materials mixing, pill, drying, promptly; Or thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, pill, drying, spray adds the volatile oil ethanol solution, promptly.
2. according to described Xuefu ecchymosis eliminating pill of claim 1 and preparation method, it is characterized in that: the ball of gained can wrap film-coat, the film-coat material adopt stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, polyvinyl alcohol, methylcellulose a kind of/multiple mixing uses; Used adjuvant can be sucrose, lactose, starch, beta-schardinger dextrin-, HP-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 1 kinds/multiple mixing use of 30 POVIDONE K 30 BP/USP.
3. according to described Xuefu ecchymosis eliminating pill of claim 1 and preparation method, it is characterized in that: the particle diameter of the ball of gained is 0.5-6mm, and the best is 1-4mm; The ball drying can adopt vacuum drying, fluid bed drying, lyophilization; The ball of gained can directly use/pack in the capsulae vacuus and use.
4. according to described Xuefu ecchymosis eliminating pill of claim 1 and preparation method, it is characterized in that: what pulverizing medicinal materials became coarse powder/be cut into decoction pieces was generally 5-30 purpose coarse powder/be cut into decoction pieces, and the best was a 10-20 purpose coarse powder; What pulverizing medicinal materials became fine powder was 80-160 purpose fine powder, and the best is standby for superfine powder is broken into 200-300 purpose fine powder.
5. according to described Xuefu ecchymosis eliminating pill of claim 1 and preparation method, it is characterized in that: decoct with water/condition of water steaming and decocting is: decoction/steaming and decocting 2-4 time, amount of water is that 6-12 doubly measures for the first time, second and third, doubly measure for 4-10 for four times, each 1-3 hour, bestly be decoction/steaming and decocting 3 times, amount of water is 10 times of amounts for the first time, second and third time is 8 times of amounts, and each 2 hours, the medicinal residues in the technology two after the alcohol extraction such as Radix Angelicae Sinensis can add when second fries in shallow oil.
6. according to described Xuefu ecchymosis eliminating pill of claim 1 and preparation method, it is characterized in that: the alcohol extraction condition can adopt percolation/heating reflux method for being solvent with the ethanol of 50-95% in the technology, and is best for being solvent with 70-75% ethanol, reflux, extract, 2 times, each 1.5 hours.
7. according to described Xuefu ecchymosis eliminating pill of claim 1 and preparation method, it is characterized in that: the drying of extract can adopt vacuum drying/spray drying, the vacuum drying temperature is controlled at 50-80 ℃, the best is 60 ℃, spray drying is for to be concentrated into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, spray drying, inlet temperature is 100-200 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.10 (60 ℃), inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
8. according to described Xuefu ecchymosis eliminating pill of claim 1 and preparation method, it is characterized in that: cyclodextrin of volatile oil clathrate preparation: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the HP-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 5-15 (ml/g), optimal proportion is 1: 8 (ml/g), the ratio of volatile oil and HP-is 1: 2-10 (ml/g), optimal proportion are 1: 5 (ml/g).
9. according to described Xuefu ecchymosis eliminating pill of claim 1 and preparation method, it is characterized in that: filtration can adopt and conventional filter, centrifugal, ultrafiltration, add the method for filtration/centrifugal/ultrafiltration behind the clarifier.
10. according to described Xuefu ecchymosis eliminating pill of claim 1 and preparation method, it is characterized in that: the quality standard of this product is controlled at the thin layer that Rhizoma Chuanxiong, Radix Angelicae Sinensis, Flos Carthami are arranged in the discriminating and differentiates; Have heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection; The quantitative of Radix Angelicae Sinensis arranged on assay.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1320904C (en) * | 2004-12-28 | 2007-06-13 | 天津药物研究院 | Xuefuzhuyu drop pills and preparing technique |
| CN1331465C (en) * | 2005-09-05 | 2007-08-15 | 天津宏仁堂药业有限公司 | Blood stasis dispelling dripping pills for treating coronary heart disease, angina pectoris and hyperlipemia and preparation process thereof |
| CN1981836B (en) * | 2005-09-05 | 2010-05-19 | 天津宏仁堂药业有限公司 | Stasis-expelling drop pills for treating coronary heart disease, angina cordis and high blood fat and thereof making method |
| CN103690719A (en) * | 2013-09-26 | 2014-04-02 | 青岛盛嘉信息科技有限公司 | Traditional Chinese medicine composition for treating intractable insomnia |
| CN106074842A (en) * | 2016-08-22 | 2016-11-09 | 曹蕊 | A kind of preparation method for cardiopathic Chinese medicine extract |
-
2003
- 2003-05-29 CN CNA031244866A patent/CN1552364A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1320904C (en) * | 2004-12-28 | 2007-06-13 | 天津药物研究院 | Xuefuzhuyu drop pills and preparing technique |
| CN1331465C (en) * | 2005-09-05 | 2007-08-15 | 天津宏仁堂药业有限公司 | Blood stasis dispelling dripping pills for treating coronary heart disease, angina pectoris and hyperlipemia and preparation process thereof |
| CN1981836B (en) * | 2005-09-05 | 2010-05-19 | 天津宏仁堂药业有限公司 | Stasis-expelling drop pills for treating coronary heart disease, angina cordis and high blood fat and thereof making method |
| CN103690719A (en) * | 2013-09-26 | 2014-04-02 | 青岛盛嘉信息科技有限公司 | Traditional Chinese medicine composition for treating intractable insomnia |
| CN106074842A (en) * | 2016-08-22 | 2016-11-09 | 曹蕊 | A kind of preparation method for cardiopathic Chinese medicine extract |
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