CN1548102A - Menstruation regulating and spot eliminating bolus and its prepn - Google Patents

Menstruation regulating and spot eliminating bolus and its prepn Download PDF

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Publication number
CN1548102A
CN1548102A CNA031244424A CN03124442A CN1548102A CN 1548102 A CN1548102 A CN 1548102A CN A031244424 A CNA031244424 A CN A031244424A CN 03124442 A CN03124442 A CN 03124442A CN 1548102 A CN1548102 A CN 1548102A
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radix
drying
powder
fine powder
preparation
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CN100430083C (en
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毛友昌
毛小敏
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JIANGXI BAISHEN PHARMACEUTICAL CO Ltd
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Individual
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Abstract

The present invention discloses menstruation regulating and spot eliminating bolus and its preparation. The present invention relates to preparation form innovation on the basis of available capsule, and the medicine has the advantages of fast release speed, high bioavailability, less irritation, etc. The medicine has the functions of nourishing blood, regulating menstruation, eliminating blood clots and eliminating spot and is used in treating blood deficiency, vital energy stagnation, blood stasis, hypermenorrhea, chloasma, etc. with high curative effect.

Description

TIAOJINGQUBANWAN and its preparation method
Technical field
This invention relates to the processing technology technical field of the making of Chinese patent medicine pill, relates in particular to TIAOJINGQUBANWAN and its preparation method.
Background technology
Pill is a kind of conventional dosage forms, because quick development of modern science and technology, the pharmacy structural establishment 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 ", it is fast that the pill that makes it to produce has drug release rate, the bioavailability height, zest is little, divided dose is accurate, take, advantage such as easy to carry, according to the relevant drug act of China, change dosage form as a kind of new drug research, former dosage form menstruation-regulating and speckle-dispelling capsule has been listed country of national Bureau of Drugs Supervision standard for traditional Chinese medicines compilation terrestrial reference in and has been risen in the tentative standard of GB.The technology characteristics of former dosage form is: eight flavors such as Radix Angelicae Sinensis are beaten powder in the prescription, and seven flavors such as the Radix Astragali decoct with water, and are condensed into thick paste, add above-mentioned fine powder, and oven dry is pulverized, and granulation is encapsulated, promptly.This medicine in process of production, closely the medical material of half is beaten powder, dose is big, fine powders such as next Radix Angelicae Sinensis, add in the thick paste of the Radix Astragali etc., oven dry, volatile ingredient easily lose and dosage form single, application forms still has only capsule, far can not satisfy people's medication demand, its quality standard still can further improve simultaneously, 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, 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 TIAOJINGQUBANWAN and its 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. TIAOJINGQUBANWAN and its preparation method comprises the steps:
1.1 the prescription of menstruation-regulating and speckle-dispelling ball is formed
The Radix Astragali 160~320g Semen Cuscutae 80~160g Herba Ecliptae 100~200g
Fructus Ligustri Lucidi 80~160g Fructus Lycii 80~160g Radix Angelicae Sinensis 80~160g
The Radix Paeoniae Alba 100~200g Radix Polygoni Multiflori 80-160g Radix Rehmanniae 100-200g
Radix Rehmanniae Preparata 120-240g Semen Persicae 60-120g Radix Bupleuri 60-120g
Colla Corii Asini 25-50g Rhizoma Gymnadeniae 80-160g Flos Carthami 20-40g
Right amount of auxiliary materials is made 1000g altogether
Optimum formula:
Radix Astragali 240g Semen Cuscutae 120g Herba Ecliptae 150g Fructus Ligustri Lucidi 120g Fructus Lycii 120g
Radix Angelicae Sinensis 120g Radix Paeoniae Alba 150g Radix Polygoni Multiflori 120g Radix Rehmanniae 150g Radix Rehmanniae Preparata 180g
Semen Persicae 90g Radix Bupleuri 90g Colla Corii Asini 36g Rhizoma Gymnadeniae 120g Flos Carthami 30g
Right amount of auxiliary materials is made 1000g altogether
1.2 the preparation technology of menstruation-regulating and speckle-dispelling ball
Technology one is got in the prescription 15 flavor medicines and is up to the standards standby respectively; Get Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae, Flos Carthami powder and be broken into fine powder, seven flavor medicine materials such as all the other Semen Cuscutae are ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, collecting decoction, filter, filtrate is concentrated into thick paste, adds above-mentioned fine powder and appropriate amount of auxiliary materials, mixing, make ball, drying, promptly.
Technology two is got in the prescription 15 flavor medicines and is up to the standards standby respectively; Get Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae, Flos Carthami powder and be broken into fine powder, seven flavor medicine materials such as all the other Semen Cuscutae are ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, collecting decoction, filter, the filtrate concentrate drying is made dried cream powder, with above-mentioned fine powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
Technology three is got in the prescription 15 flavor medicines and is up to the standards standby respectively; It is standby that Colla Corii Asini is ground into fine powder; It is standby that ten four Chinese medicines such as all the other Radix Angelicae Sinensis are ground into coarse powder/be cut into decoction pieces; Radix Angelicae Sinensis, Flos Carthami, Fructus Ligustri Lucidi, Radix Bupleuri, the Radix Paeoniae Alba, Rhizoma Gymnadeniae, Fructus Lycii 50-95% ethanol extraction, extracting solution reclaims ethanol, is concentrated into standby in right amount; Seven flavor medicine materials such as medicinal residues and all the other Semen Cuscutae decoct with water 2-3 time, and collecting decoction filters, and filtrate is concentrated in right amount, merge with above-mentioned alcohol extract, be condensed into thick paste or concentrate drying is made dried cream powder, with above-mentioned donkey-hide gelatin fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
Technology four is got in the prescription 15 flavor medicines and is up to the standards standby respectively; It is standby that Colla Corii Asini is ground into fine powder; Ten four Chinese medicines such as all the other Radix Angelicae Sinensis are ground into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-3 time, and it is standby to collect volatile oil and water boiling liquid; Above-mentioned volatile oil is with cyclodextrin inclusion compound or standby with anhydrous alcohol solution; Above-mentioned water boiling liquid merges, and filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with donkey-hide gelatin fine powder, volatile oil clathrate compound and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.Or above-mentioned thick paste/dried cream powder and donkey-hide gelatin fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the volatile oil ethanol solution, mixing, promptly.
1.3 the ball by above-mentioned technology gained is the menstruation-regulating and speckle-dispelling ball.
The ball of gained can wrap film-coat in the technology, 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 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, and optimum grain-diameter is 1.5-4mm.
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: amount of water is doubly measured for 6-12 for the first time, and second and third time doubly measured for 4-10, decoction/steaming and decocting 2-3 time, 1-3 hour at every turn.Best is decoction/steaming and decocting 2 times, and amount of water is 10 times of amounts for the first time, is 8 times of amounts for the second time, each 2 hours.
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 condensed 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 and also can adopt conventional the filtration, centrifugal, ultrafiltration, add filter behind the clarifier, centrifugal, add the method that filters ultrafiltration again 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 capsular basis of original menstruation-regulating and speckle-dispelling, differentiating that the Central Plains dosage form has the thin layer of a microscopical identification and Radix Angelicae Sinensis, Fructus Ligustri Lucidi, Fructus Lycii to differentiate, now gives reservation, and increases the thin layer of the Radix Astragali is differentiated; 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 carries out quantitatively now being kept to the Radix Paeoniae Alba on assay, and 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
The optimum implementation of this invention is: get in the prescription 15 flavor medicines and be up to the standards standby respectively; Get Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae, Flos Carthami powder and be broken into fine powder, seven flavor medicine materials such as all the other Semen Cuscutae are ground into coarse powder and decoct with water 2 times, and each 2 hours, collecting decoction, filter, filtrate is concentrated into relative density 1.08-1.10 (60 ℃), and spray drying is made dried cream powder, with above-mentioned fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, coating, promptly.

Claims (10)

1. TIAOJINGQUBANWAN and its preparation method is characterized in that:
(1) getting the Radix Astragali in the prescription, Semen Cuscutae, Herba Ecliptae, Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Polygoni Multiflori, Radix Rehmanniae, Radix Rehmanniae Preparata, Semen Persicae, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae, Flos Carthami ten five kinds of Chinese medicine is up to the standards standby respectively; Get Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae, Flos Carthami powder and be broken into fine powder, seven flavor medicine materials such as all the other Semen Cuscutae are ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, collecting decoction, filter, filtrate is concentrated into thick paste, adds fine powder and appropriate amount of auxiliary materials, mixing, make ball, drying, promptly.
(2) getting the Radix Astragali in the prescription, Semen Cuscutae, Herba Ecliptae, Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Polygoni Multiflori, Radix Rehmanniae, Radix Rehmanniae Preparata, Semen Persicae, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae, Flos Carthami ten five kinds of Chinese medicine is up to the standards standby respectively; Get Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae, Flos Carthami powder and be broken into fine powder, seven flavor medicine materials such as all the other Semen Cuscutae are ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, collecting decoction, filter, the filtrate concentrate drying is made dried cream powder, with fine powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
(3) getting the Radix Astragali in the prescription, Semen Cuscutae, Herba Ecliptae, Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Polygoni Multiflori, Radix Rehmanniae, Radix Rehmanniae Preparata, Semen Persicae, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae, Flos Carthami ten five kinds of Chinese medicine is up to the standards standby respectively; It is standby that Colla Corii Asini is ground into fine powder; It is standby that all the other ten four Chinese medicines are ground into coarse powder/be cut into decoction pieces; Radix Angelicae Sinensis, Flos Carthami, Fructus Ligustri Lucidi, Radix Bupleuri, the Radix Paeoniae Alba, Rhizoma Gymnadeniae, Fructus Lycii 50-95% ethanol extraction, extracting solution reclaims ethanol, is concentrated into standby in right amount; Seven flavor medicine materials such as medicinal residues and all the other Semen Cuscutae decoct with water 2-3 time, and collecting decoction filters, and filtrate is concentrated in right amount, merge with alcohol extract, are condensed into thick paste/concentrate drying and make dried cream powder, with donkey-hide gelatin fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
(4) getting the Radix Astragali in the prescription, Semen Cuscutae, Herba Ecliptae, Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Polygoni Multiflori, Radix Rehmanniae, Radix Rehmanniae Preparata, Semen Persicae, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae, Flos Carthami ten five kinds of Chinese medicine is up to the standards standby respectively; It is standby that Colla Corii Asini is ground into fine powder; Ten four Chinese medicines such as all the other Radix Angelicae Sinensis are ground into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-3 time, and it is standby to collect volatile oil and water boiling liquid; Volatile oil is standby with cyclodextrin inclusion compound/usefulness anhydrous alcohol solution; Water boiling liquid merges, and filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with donkey-hide gelatin fine powder, volatile oil clathrate compound and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly; Or thick paste/dried cream powder and donkey-hide gelatin fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the volatile oil ethanol solution, mixing, promptly.
2. TIAOJINGQUBANWAN and its preparation method according to claim 1, 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. TIAOJINGQUBANWAN and its preparation method according to claim 1 is characterized in that: the particle diameter of the ball of gained is 0.5-6mm, and optimum grain-diameter is 1.5-4mm; 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. TIAOJINGQUBANWAN and its preparation method according to claim 1 is characterized in that: pulverizing medicinal materials becomes coarse powder/be cut into decoction pieces to be generally 5-30 purpose coarse powder/be cut into decoction pieces, and the best was a 10-20 purpose coarse powder; It was 80-160 purpose fine powder that pulverizing medicinal materials becomes fine powder, and the best is standby for superfine powder is broken into 200-300 purpose fine powder.
5. TIAOJINGQUBANWAN and its preparation method according to claim 1, it is characterized in that: decoct with water/condition of steaming and decocting is: amount of water is doubly measured for 6-12 for the first time, second and third time doubly measured for 4-10, decoction/steaming and decocting 2-3 time, each 1-3 hour, best was decoction/steaming and decocting secondary, and amount of water is 10 times of amounts for the first time, be 8 times of amounts for the second time, each 2 hours.
6. TIAOJINGQUBANWAN and its preparation method according to claim 1, it is characterized in that: the alcohol extraction condition can adopt percolation/heating reflux method for the ethanol with 50-95% is solvent in 1 (3), and is best for being solvent with 70-75% ethanol, reflux, extract, 2 times, each 1.5 hours.
7. TIAOJINGQUBANWAN and its preparation method according to claim 1, 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 condensed 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. TIAOJINGQUBANWAN and its preparation method according to claim 1, 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. TIAOJINGQUBANWAN and its preparation method according to claim 1 is characterized in that: filter and also can adopt conventional the filtration, centrifugal, ultrafiltration, add filter behind the clarifier, centrifugal, add the method that filters ultrafiltration again behind the clarifier.
10. TIAOJINGQUBANWAN and its preparation method according to claim 1 is characterized in that: quality standard of the present invention is controlled at the thin layer that a microscopical identification Radix Astragali is arranged in the discriminating and differentiates; Have heavy metal must not cross 10/1000000ths on checking, arsenic salt must not limit the quantity of 2/1000000ths limit detection; The quantitative of Radix Angelicae Sinensis arranged on assay.
CNB031244424A 2003-05-24 2003-05-24 Menstruation regulating and spot eliminating bolus and its prepn Expired - Fee Related CN100430083C (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100336544C (en) * 2005-03-01 2007-09-12 重庆大易科技投资有限公司 Chinese medicinal composition with beautifying function and method for preparing the same
CN110339177A (en) * 2019-08-20 2019-10-18 广西万寿堂药业有限公司 Puerperal blood clot dispersing tablet and preparation method thereof
CN111249409A (en) * 2020-04-20 2020-06-09 宋俊青 Traditional Chinese medicine formula for treating lilac melanosis

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1100948A (en) * 1994-03-01 1995-04-05 段炜 Health and beauty oral liquor for female

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100336544C (en) * 2005-03-01 2007-09-12 重庆大易科技投资有限公司 Chinese medicinal composition with beautifying function and method for preparing the same
CN110339177A (en) * 2019-08-20 2019-10-18 广西万寿堂药业有限公司 Puerperal blood clot dispersing tablet and preparation method thereof
CN111249409A (en) * 2020-04-20 2020-06-09 宋俊青 Traditional Chinese medicine formula for treating lilac melanosis

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