CN100430083C - Menstruation regulating and spot eliminating bolus and its prepn - Google Patents
Menstruation regulating and spot eliminating bolus and its prepn Download PDFInfo
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- CN100430083C CN100430083C CNB031244424A CN03124442A CN100430083C CN 100430083 C CN100430083 C CN 100430083C CN B031244424 A CNB031244424 A CN B031244424A CN 03124442 A CN03124442 A CN 03124442A CN 100430083 C CN100430083 C CN 100430083C
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Abstract
The present invention discloses a menstruation regulating and spot eliminating pill and a preparation method thereof. The present invention reforms the dosage form on the basis of the existing capsules and has the advantages of high medicine release peed, high bioavailability, light stimulation, accurate fractional dose, convenient administration, portability, etc. The pill overcomes the defects of easy loss of volatile ingredients, high dosage and difficulty in swallow of the original dosage form, enriches medication varieties, improves quality standard and further satisfies and ensures the medication requirements of people. The pill has the functions of nourishing blood for regulating menstruation, dispelling stasis and eliminating spots and has conspicuous curative effects on the insufficiency of nutrition and blood, qi stagnation, blood stasis, menorrhagia, chloasma, etc. The pill is a popular, safe, stable and effective medicine in clinic and is an ideal product in the modern pharmacy enterprises.
Description
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 for O.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 l: 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 (4)
1, a kind of preparation method of menstruation-regulating and speckle-dispelling ball, its characteristic is, prepare by following Chinese medicine raw materials by weight proportion: 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, make the 1000g pill; Preparation method is: 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, promptly.
2, the preparation method of menstruation-regulating and speckle-dispelling ball according to claim 1 is characterized in that: used adjuvant is 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, the preparation method of menstruation-regulating and speckle-dispelling ball according to claim 1 is characterized in that: the particle diameter of the ball of gained is 0.5-6mm; The ball of gained directly uses/packs in the capsulae vacuus and uses.
4, TIAOJINGQUBANWAN and its preparation method according to claim 1 is characterized in that: the condition that decocts with water is: amount of water is that 6-12 doubly measures for the first time, and second and third time doubly measured for 4-10, decocts each 1-3 hour 2-3 time.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031244424A CN100430083C (en) | 2003-05-24 | 2003-05-24 | Menstruation regulating and spot eliminating bolus and its prepn |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031244424A CN100430083C (en) | 2003-05-24 | 2003-05-24 | Menstruation regulating and spot eliminating bolus and its prepn |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1548102A CN1548102A (en) | 2004-11-24 |
| CN100430083C true CN100430083C (en) | 2008-11-05 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB031244424A Expired - Fee Related CN100430083C (en) | 2003-05-24 | 2003-05-24 | Menstruation regulating and spot eliminating bolus and its prepn |
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Families Citing this family (3)
| 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 |
Citations (1)
| 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 |
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2003
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Patent Citations (1)
| 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 |
Non-Patent Citations (2)
| Title |
|---|
| 活血化瘀法治疗面部皮肤病验案举隅. 戚玉华.甘肃中医，第14卷第4期. 2001 |
| 活血化瘀法治疗面部皮肤病验案举隅. 戚玉华.甘肃中医，第14卷第4期. 2001 * |
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| CN1548102A (en) | 2004-11-24 |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Jiangxi Baishen Pharmaceutical Group Co., Ltd. Assignor: Mao Youchang Contract fulfillment period: 2009.4.22 to 2019.4.21 contract change Contract record no.: 2009360000032 Denomination of invention: Menstruation regulating and spot eliminating bolus and its prepn Granted publication date: 20081105 License type: Exclusive license Record date: 2009.6.18 |
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Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2009.4.22 TO 2019.4.21; CHANGE OF CONTRACT Name of requester: JIANGXI BAISHEN MEDICINE GROUP CO.,LTD. Effective date: 20090618 |
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Owner name: JIANGXI BAISHEN PHARMACEUTICAL GROUP CO., LTD. Free format text: FORMER OWNER: MAO YOUCHANG Effective date: 20100408 |
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Free format text: CORRECT: ADDRESS; FROM: 330002 ROOM 301, UNIT 3, BUILDING 34, XIANSHIHU RESIDENTIAL AREA, XIANSHI 1ST ROAD, NANCHANG CITY, JIANGXI PROVINCE TO: 336000 MEDICAL INDUSTRIAL PARK, YUANZHOU DISTRICT, YICHUN CITY, JIANGXI PROVINCE |
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Effective date of registration: 20100408 Address after: 336000 Yuanzhou Jiangxi Pharmaceutical Industrial Park Patentee after: Jiangxi Baishen Pharmaceutical Group Co., Ltd. Address before: 330002 Jiangxi city in Nanchang Province, a residential area of Lake Magi Magi building 3 unit 34 Room 301 Patentee before: Mao Youchang |
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Owner name: JIANGXI BAISHEN PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: JIANGXI BAISHEN PHARMACEUTICAL GROUP CO., LTD. |
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| CP01 | Change in the name or title of a patent holder |
Address after: 336000 Yuanzhou Jiangxi Pharmaceutical Industrial Park Patentee after: Jiangxi Baishen Pharmaceutical Co.,Ltd. Address before: 336000 Yuanzhou Jiangxi Pharmaceutical Industrial Park Patentee before: Jiangxi Baishen Pharmaceutical Group Co., Ltd. |
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Granted publication date: 20081105 Termination date: 20130524 |