CN1548114A - Blood stasis eliminating and mass dissipating bolus and its prepn - Google Patents
Blood stasis eliminating and mass dissipating bolus and its prepn Download PDFInfo
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- CN1548114A CN1548114A CNA031244572A CN03124457A CN1548114A CN 1548114 A CN1548114 A CN 1548114A CN A031244572 A CNA031244572 A CN A031244572A CN 03124457 A CN03124457 A CN 03124457A CN 1548114 A CN1548114 A CN 1548114A
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- radix notoginseng
- borneolum syntheticum
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Abstract
The present invention discloses blood stasis eliminating and mass dissipating bolus of 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 removing blood stasis, eliminating swelling, dissipating mass and relieving pain, and has obvious curative effect on blood stasis caused breast nodule, breast swelling and pain and hyperplasia of mammary glands.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to eliminating stasis and resolving masses ball and 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 has the eliminating stasis and resolving masses capsule, and listed in National Drug Administration's country's standard for traditional Chinese medicines compilation Chinese patent medicine provincial standard rising national standard part " surgery fascicle ", form by 15 flavor Chinese medicines.The technology of former dosage form is: it is standby that the part Radix Notoginseng beats fine powder, and the residue Radix Notoginseng is made dried cream powder with 13 medicines of distinguishing the flavor of except that Borneolum Syntheticum through the decocting in water precipitate with ethanol, adds above-mentioned fine powder and Borneolum Syntheticum fine powder, and mixing incapsulates and forms.Most of medical material carries out the processing of decocting in water precipitate with ethanol in the technology, must some active ingredient loss.Though containing the fine powder of beating of volatile ingredient Borneolum Syntheticum in the technology adds, but in storage process, also can lose, this capsule dose is big, ampoule is 4 large capsules, Ms difficulty swallows, and control product quality quality standard still can further improve, with further control product quality, this product forms is single simultaneously, far can not satisfy people's medication demand.We use the modern pharmaceutical technology this product technology are done necessary the improvement based on this, form new preparation, guarantee 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 eliminating stasis and resolving masses ball and preparation method, improve the quality of products and curative effect, increase the stability of product, the Ms is more pleased to take to satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. eliminating stasis and resolving masses ball and preparation method comprise the steps:
1.1 the prescription of eliminating stasis and resolving masses ball is formed
Herba Hedyotidis Diffusae 600-1200g Herba Solani Lyrati 600-1200g Pseudobulbus Cremastrae Seu Pleiones 600-1200g
Spica Prunellae 600-1200g Radix Notoginseng 600-1200g Eupolyphaga Seu Steleophaga 600-1200g
Scolopendra 400-800g Fructus Crataegi 600-1200g Fructus Aurantii 300-600g
Herba Agrimoniae 600-1200g Cortex Meliae 400-800g Borneolum Syntheticum 10-20g
Radix Astragali 600-1200g Fructus Hordei Germinatus 300-600g Radix Glycyrrhizae 300-600g
Right amount of auxiliary materials is made 1000g altogether.
Optimum formula is:
Herba Hedyotidis Diffusae 800g Herba Solani Lyrati 800g Pseudobulbus Cremastrae Seu Pleiones 800g
Spica Prunellae 800g Radix Notoginseng 800g Eupolyphaga Seu Steleophaga 800g
Scolopendra 534g Fructus Crataegi 800g Fructus Aurantii 400g
Herba Agrimoniae 800g Cortex Meliae 534g Borneolum Syntheticum 13.4g
Radix Astragali 800g Fructus Hordei Germinatus 400g Radix Glycyrrhizae 400g
Right amount of auxiliary materials is made 1000g altogether.
1.2 the preparation technology of eliminating stasis and resolving masses ball
Technology one cleans ten five kinds of Chinese medicine respectively, removes impurity, and it is standby to be up to the standards; It is standby with an amount of anhydrous alcohol solution to get Borneolum Syntheticum; Radix Notoginseng (recipe quantity 21%) is ground into fine powder, 13 flavor pulverizing medicinal materials such as remaining Radix Notoginseng and all the other Herba Hedyotidis Diffusaes become coarse powder/be cut into decoction pieces, decoct with water 1-3 hour at every turn 2-3 time, collecting decoction, filter, filtrate is condensed into clear paste, puts cold, add ethanol and be 30-70% to containing the alcohol amount, stir evenly, leave standstill, filter, filtrate recycling ethanol, be condensed into thick paste or concentrate drying is made dried cream powder, add above-mentioned Radix Notoginseng fine powder and appropriate amount of auxiliary materials mixing, make ball, dry, spray adds above-mentioned Borneolum Syntheticum ethanol solution, mixing, promptly.
Technology two cleans ten five kinds of Chinese medicine respectively, removes impurity, and it is standby to be up to the standards; It is standby with an amount of anhydrous alcohol solution to get Borneolum Syntheticum; Radix Notoginseng (recipe quantity 21%) is ground into fine powder, and 13 flavor pulverizing medicinal materials such as remaining Radix Notoginseng and all the other Herba Hedyotidis Diffusaes become coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filters, and filtrate is condensed into thick paste or concentrate drying is made dried cream powder, add above-mentioned Radix Notoginseng fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds above-mentioned Borneolum Syntheticum ethanol solution, mixing, promptly.
Technology three cleans ten five kinds of Chinese medicine respectively, removes impurity, and it is standby to be up to the standards; Getting Borneolum Syntheticum, to make the Borneolum Syntheticum cyclodextrin clathrate standby; Getting Radix Notoginseng (recipe quantity 21%), to be ground into fine powder standby; 13 flavor pulverizing medicinal materials such as residue Radix Notoginseng and all the other Herba Hedyotidis Diffusaes become coarse powder/be cut into decoction pieces, decoct with water 1-3 hour at every turn 2-3 time, collecting decoction filters, and filtrate is condensed into clear paste, put coldly, add ethanol and be 30-70%, stir evenly to containing alcohol amount, leave standstill, filter filtrate recycling ethanol, be condensed into thick paste or concentrate drying is made dried cream powder, add above-mentioned Radix Notoginseng fine powder, Borneolum Syntheticum cyclodextrin clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
Technology four cleans ten five kinds of Chinese medicine respectively, removes impurity, and it is standby to be up to the standards; Getting Borneolum Syntheticum, to make the Borneolum Syntheticum cyclodextrin clathrate standby; Getting Radix Notoginseng (recipe quantity 21%), to be ground into fine powder standby; Residue Radix Notoginseng and all the other Herba Hedyotidis Diffusaes etc. 13 pulverizing medicinal materials of distinguishing the flavor of become coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is condensed into thick paste or concentrate drying is made dried cream powder, add above-mentioned Radix Notoginseng fine powder, Borneolum Syntheticum cyclodextrin clathrate and appropriate amount of auxiliary materials, mixing is made ball, drying, promptly.
1.3 by technology one, two, three, four prepared balls is the eliminating stasis and resolving masses 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.
Radix Notoginseng powder is broken into fine powder and was generally 80-160 purpose fine powder in the technology, and the best is broken into 200-300 order fine powder for superfine powder.
Pulverizing medicinal materials such as Herba Hedyotidis Diffusae becomes coarse powder/be cut into decoction pieces to be generally 5-30 purpose coarse powder/be cut into decoction pieces in the technology, and the best was a 10-20 order coarse powder.
The condition that decocting boils in the technology is: decoct 2-3 time, amount of water is doubly measured for the 6-12 of dose for the first time, and second and third time doubly measured each 1-3 of the time of decoction hour for the 4-10 of dose; The best is: decoct 2 times, amount of water is 10 times of amounts of dose for the first time, is 8 times of amounts of dose for the second time, each 2 hours.
Extracting solution is condensed into the clear paste precipitate with ethanol in the technology one, three, and the relative density of clear paste is 1.05-1.25 (80 ℃), and best relative density is 1.10-1.15 (80 ℃); Precipitate with ethanol is 30-70% for adding ethanol to containing alcohol, and it is 60% that the best contains the alcohol amount.
The relative density that is condensed into thick paste in the technology is 1.15-1.45 (80 ℃), and best relative density is 1.30-1.35 (80 ℃).
The extract drying can adopt vacuum drying or spray drying in the technology, vacuum drying, and temperature is controlled at 50-90 ℃, preferably is controlled at 70 ℃.Spray drying is for to be concentrated into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, best relative density is 1.08-1.10 (60 ℃), spray drying, inlet temperature is 100～200 ℃, leaving air temp is 50～150 ℃, best inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
Borneolum Syntheticum cyclodextrin 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: 10 (ml/g), the ratio of volatile oil and HP-is 1: 2-10 (ml/g), optimal proportion are 1: 6 (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. the quality control of this product mainly is discriminating, inspection, three aspects of assay.
This product has increased the thin layer discriminating of Fructus Crataegi, Radix Glycyrrhizae, the Radix Astragali, Herba Hedyotidis Diffusae in the prescription on the basis of former dosage form; Increased to heavy metal only 10/1000000ths, arsenic salt 2/1000000ths limit examine only; Increased on the assay to Radix Glycyrrhizae quantitatively.
This invention its superiority compared with the prior art is: production technology more becomes fully rationally, can keep more active substances, and quality standard improves comprehensively, makes product that the qualitative, quantitative control method of science be arranged, and makes the quality of product that better guarantee arranged.
The specific embodiment
The optimum implementation of this invention is that ten five kinds of Chinese medicine are cleaned respectively, removes impurity, and it is standby to be up to the standards; Getting Borneolum Syntheticum, to make the Borneolum Syntheticum Benexate Hydrochloride standby; Getting Radix Notoginseng (recipe quantity 21%), to be ground into fine powder standby; Residue Radix Notoginseng and all the other Herba Hedyotidis Diffusaes etc. 13 pulverizing medicinal materials of distinguishing the flavor of become coarse powder, decoct with water each 2 hours 2 times, collecting decoction, filter, filtrate is concentrated into the concentrated solution that relative density is 1.10-1.15 (60 ℃), and spray drying is collected dried cream powder, add above-mentioned Radix Notoginseng fine powder, Borneolum Syntheticum cyclodextrin clathrate and appropriate amount of auxiliary materials, mixing is made ball, drying, coating, promptly.
Claims (10)
1. eliminating stasis and resolving masses ball and preparation method is characterized in that:
(1) Herba Hedyotidis Diffusae, Herba Solani Lyrati, Pseudobulbus Cremastrae Seu Pleiones, Spica Prunellae, Radix Notoginseng, Eupolyphaga Seu Steleophaga, Scolopendra, Fructus Crataegi, Fructus Aurantii, Herba Agrimoniae, Cortex Meliae, Borneolum Syntheticum, the Radix Astragali, Fructus Hordei Germinatus, Radix Glycyrrhizae ten five kinds of Chinese medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; It is standby with an amount of anhydrous alcohol solution to get Borneolum Syntheticum; Radix Notoginseng (recipe quantity 21%) is ground into fine powder, 13 flavor pulverizing medicinal materials such as remaining Radix Notoginseng and all the other Herba Hedyotidis Diffusaes become coarse powder/be cut into decoction pieces, decoct with water 1-3 hour at every turn 2-3 time, collecting decoction, filter, filtrate is condensed into clear paste, puts cold, add ethanol and be 30-70% to containing the alcohol amount, stir evenly, leave standstill, filter, filtrate recycling ethanol, be condensed into thick paste/concentrate drying and make dried cream powder, add Radix Notoginseng fine powder and appropriate amount of auxiliary materials mixing, make ball, dry, spray adds the Borneolum Syntheticum ethanol solution, mixing, promptly.
(2) Herba Hedyotidis Diffusae, Herba Solani Lyrati, Pseudobulbus Cremastrae Seu Pleiones, Spica Prunellae, Radix Notoginseng, Eupolyphaga Seu Steleophaga, Scolopendra, Fructus Crataegi, Fructus Aurantii, Herba Agrimoniae, Cortex Meliae, Borneolum Syntheticum, the Radix Astragali, Fructus Hordei Germinatus, Radix Glycyrrhizae ten five kinds of Chinese medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; It is standby with an amount of anhydrous alcohol solution to get Borneolum Syntheticum; Radix Notoginseng (recipe quantity 21%) is ground into fine powder, and 13 flavor pulverizing medicinal materials such as remaining Radix Notoginseng and all the other Herba Hedyotidis Diffusaes become coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, add Radix Notoginseng fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the Borneolum Syntheticum ethanol solution, mixing, promptly.
(3) Herba Hedyotidis Diffusae, Herba Solani Lyrati, Pseudobulbus Cremastrae Seu Pleiones, Spica Prunellae, Radix Notoginseng, Eupolyphaga Seu Steleophaga, Scolopendra, Fructus Crataegi, Fructus Aurantii, Herba Agrimoniae, Cortex Meliae, Borneolum Syntheticum, the Radix Astragali, Fructus Hordei Germinatus, Radix Glycyrrhizae ten five kinds of Chinese medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Getting Borneolum Syntheticum, to make the Borneolum Syntheticum cyclodextrin clathrate standby; Getting Radix Notoginseng (recipe quantity 21%), to be ground into fine powder standby; 13 flavor pulverizing medicinal materials such as residue Radix Notoginseng and all the other Herba Hedyotidis Diffusaes become coarse powder/be cut into decoction pieces, decoct with water 1-3 hour at every turn 2-3 time, collecting decoction filters, and filtrate is condensed into clear paste, put coldly, add ethanol and be 30-70%, stir evenly to containing alcohol amount, leave standstill, filter filtrate recycling ethanol, be condensed into thick paste/concentrate drying and make dried cream powder, add Radix Notoginseng fine powder, Borneolum Syntheticum cyclodextrin clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
(4) Herba Hedyotidis Diffusae, Herba Solani Lyrati, Pseudobulbus Cremastrae Seu Pleiones, Spica Prunellae, Radix Notoginseng, Eupolyphaga Seu Steleophaga, Scolopendra, Fructus Crataegi, Fructus Aurantii, Herba Agrimoniae, Cortex Meliae, Borneolum Syntheticum, the Radix Astragali, Fructus Hordei Germinatus, Radix Glycyrrhizae ten five kinds of Chinese medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Getting Borneolum Syntheticum, to make the Borneolum Syntheticum cyclodextrin clathrate standby; Getting Radix Notoginseng (recipe quantity 21%), to be ground into fine powder standby; Residue Radix Notoginseng and all the other Herba Hedyotidis Diffusaes etc. 13 pulverizing medicinal materials of distinguishing the flavor of become coarse powder/be cut into decoction pieces, decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, add Radix Notoginseng fine powder, Borneolum Syntheticum cyclodextrin clathrate and appropriate amount of auxiliary materials, mixing is made ball, drying, promptly.
2. according to described eliminating stasis and resolving masses ball 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 eliminating stasis and resolving masses ball of claim 1 and preparation method, it 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. according to described eliminating stasis and resolving masses ball of claim 1 and preparation method, it is characterized in that: Radix Notoginseng powder is broken into fine powder and was generally 80-160 purpose fine powder, and the best is broken into 200-300 order fine powder for superfine powder; Pulverizing medicinal materials such as Herba Hedyotidis Diffusae become 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 order coarse powder.
5. according to described eliminating stasis and resolving masses ball of claim 1 and preparation method, it is characterized in that: the condition that decocting boils is: decoct 2-3 time, amount of water is doubly measured for the 6-12 of dose for the first time, and second and third time doubly measured each 1-3 of the time of decoction hour for the 4-10 of dose; The best is: decoct 2 times, amount of water is 10 times of amounts of dose for the first time, is 8 times of amounts of dose for the second time, each 2 hours.
6. according to described eliminating stasis and resolving masses ball of claim 1 and preparation method, it is characterized in that: extracting solution is condensed into the clear paste precipitate with ethanol, and the relative density of clear paste is 1.05-1.25 (80 ℃), and best relative density is 1.10-1.15 (80 ℃); Precipitate with ethanol is 30-70% for adding ethanol to containing alcohol, and it is 60% that the best contains the alcohol amount; The relative density that is condensed into thick paste is 1.15-1.45 (80 ℃), and best relative density is 1.30-1.35 (80 ℃).
7. according to described eliminating stasis and resolving masses ball of claim 1 and preparation method, it is characterized in that: the extract drying can adopt vacuum drying/spray drying, vacuum drying, temperature is controlled at 50-90 ℃, Optimal Control is at 70 ℃, spray drying is for to be concentrated into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, best relative density is 1.08-1.10 (60 ℃), spray drying, inlet temperature is 100～200 ℃, leaving air temp is 50～150 ℃, and best inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
8. according to described eliminating stasis and resolving masses ball of claim 1 and preparation method, it is characterized in that: Borneolum Syntheticum cyclodextrin 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: 10 (ml/g), the ratio of volatile oil and HP-is 1: 2-10 (ml/g), optimal proportion are 1: 6 (ml/g).
9. according to described eliminating stasis and resolving masses ball of claim 1 and preparation method, it 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. according to described eliminating stasis and resolving masses ball of claim 1 and preparation method, it is characterized in that: the quality standard control of this product differentiates have: the thin layer of Fructus Crataegi, Radix Glycyrrhizae, the Radix Astragali, Herba Hedyotidis Diffusae is differentiated; Have in the inspection heavy metal only 10/1000000ths, arsenic salt 2/1000000ths limit examine only; The quantitative of Radix Glycyrrhizae arranged on the assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244572A CN1548114A (en) | 2003-05-24 | 2003-05-24 | Blood stasis eliminating and mass dissipating bolus and its prepn |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031244572A CN1548114A (en) | 2003-05-24 | 2003-05-24 | Blood stasis eliminating and mass dissipating bolus and its prepn |
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| Publication Number | Publication Date |
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| CN1548114A true CN1548114A (en) | 2004-11-24 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA031244572A Pending CN1548114A (en) | 2003-05-24 | 2003-05-24 | Blood stasis eliminating and mass dissipating bolus and its prepn |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101401871B (en) * | 2008-11-05 | 2011-06-15 | 邓新民 | Pseudo-ginseng medical ointment prescription |
| CN103156943A (en) * | 2013-03-25 | 2013-06-19 | 薛洪喜 | Medicament for treating infertility of obstructive uterine tube |
-
2003
- 2003-05-24 CN CNA031244572A patent/CN1548114A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101401871B (en) * | 2008-11-05 | 2011-06-15 | 邓新民 | Pseudo-ginseng medical ointment prescription |
| CN103156943A (en) * | 2013-03-25 | 2013-06-19 | 薛洪喜 | Medicament for treating infertility of obstructive uterine tube |
| CN103156943B (en) * | 2013-03-25 | 2014-12-03 | 薛洪喜 | Medicament for treating infertility of obstructive uterine tube |
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