CN100435834C - Chinese medicinal preparation for treating sterility, its preparation and quality control method - Google Patents
Chinese medicinal preparation for treating sterility, its preparation and quality control method Download PDFInfo
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- CN100435834C CN100435834C CNB2006102003508A CN200610200350A CN100435834C CN 100435834 C CN100435834 C CN 100435834C CN B2006102003508 A CNB2006102003508 A CN B2006102003508A CN 200610200350 A CN200610200350 A CN 200610200350A CN 100435834 C CN100435834 C CN 100435834C
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Abstract
The present invention provides a traditional Chinese medicine for treating acyesis, a preparation method and a quality control method of the traditional Chinese medicine. The medicine is prepared from 31g of Chinese caterpillar fungus, 93g of epimedium herb, 124g of angelica, 93g of radix polygoni multiflori preparata, 93g of glossy privet fruit, 93g of common prism tuber, 124g of psoralea fruit, 93g of barbary wolfberry fruit and 93g of peach seed. Compared with the prior art, the medicine of the present invention has the action of replenishing livers, tonifying kidneys, clearing away heat, benefiting dampness, regulating nutrients and blood, promoting blood circulation and relieving blood stasis, and the advantages of obvious treatment effect, high healing rate and no obvious toxic or side effect, is used for treating acyesis caused by immunity in clinics, and is an effective traditional Chinese medicine for treating acyesis, and furthermore, the traditional Chinese medicine has the advantages of high safety and controllable quality.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation and preparation method and method of quality control for the treatment of infertility, belong to technical field of Chinese medicines.
Background technology:
According to document announcement, existing 10～15% the women of child-bearing age can not give birth to for various reasons, and development along with society, the great variety of people life style and living environment, accelerate such as rhythm of life, stress strengthens, and increasing environmental pollution or the like can not be given birth to phenomenon and be presented the trend that increases.It is multiple to cause the reason of infertility to have, and the women mainly contains vagina, cervix uteri, abnormal uterine, and ovary is unusual, sexually transmitted disease (STD), genital tuberculosis, multiple factors such as immunity reason or repeatability miscarriage; The male mainly contains factors such as seminal fluid cacospermia, sexual dysfunction, genitals are unusual, cryptorrhea.The treatment difficulty of the infertility that the medicine that multiple treatment infertility is arranged in the market, but its clinical therapeutic efficacy is generally not ideal enough, especially immunity reason cause is bigger.
Summary of the invention:
The objective of the invention is to: a kind of Chinese medicine preparation and preparation method and method of quality control for the treatment of infertility is provided.
The present invention constitutes like this: it is made with Cordyceps 31g, Herba Epimedii 93g, Radix Angelicae Sinensis 124g, Radix Polygoni Multiflori Preparata 93g, Fructus Ligustri Lucidi 93g, rhizoma sparganic 93g, Fructus Psoraleae 124g, Fructus Lycii 93g and Semen Persicae 93g.
Described Chinese medicine preparation is capsule, tablet or granule.
The preparation method of the Chinese medicine preparation of treatment infertility of the present invention is: Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of getting 80% amount, the ethanol that adds 6 times of amounts 70%, refluxed 1.5 hours, and filtered, filtrate is put in addition, filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour filters merging filtrate, reclaim ethanol, solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, oven dry, granulate is made different preparations according to a conventional method.
Capsule prepares like this: Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of getting 80% amount, the ethanol that adds 6 times of amounts 70%, refluxed 1.5 hours, and filtered, filtrate is put in addition, filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour filters merging filtrate, reclaim ethanol, solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, oven dry, granulate, filled capsules is made 1000, promptly.
Tablet prepares like this: Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of getting 80% amount, the ethanol that adds 6 times of amounts 70%, refluxed 1.5 hours, and filtered, filtrate is put in addition, filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour filters merging filtrate, reclaim ethanol, solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, oven dry, granulate, tabletting, coating is made 1000, promptly.
Granule prepares like this: Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of getting 80% amount, the ethanol that adds 6 times of amounts 70%, refluxed 1.5 hours, and filtered, filtrate is put in addition, filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour filters merging filtrate, reclaim ethanol, solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, oven dry is made 1000g, promptly.
The method of quality control of the Chinese medicine preparation of treatment infertility of the present invention is: described method of quality control comprises:
Character: for capsule, content is a brown granular, gas perfume (or spice), mildly bitter flavor;
For tablet: medicine shows sepia, gas perfume (or spice), mildly bitter flavor;
For granule: medicine is a brown granular, gas perfume (or spice), mildly bitter flavor;
Differentiate: (1) gets this preparation 0.5g, and porphyrize adds ethanol 50ml, and reflux 1 hour filters, and filtrate is concentrated into 3g, as need testing solution; Other gets Radix Polygoni Multiflori control medicinal material 0.25g, shines medical material solution in pairs with legal system; According to 2005 editions one appendix VIB thin layer chromatography test of Chinese Pharmacopoeia, draw above-mentioned two kinds of each 4ul of solution, put respectively in same be to make into strips on the silica gel II lamellae of adhesive with the sodium carboxymethyl cellulose, with benzene: ethanol=2: 1 is developing solvent, exhibition is to about 3.5cm, take out, dry, again with benzene: ethanol=4: 1 is developing solvent, exhibition is to about 7cm, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence streak of same color, spray the phosphomolybdic acid sulfuric acid solution again, heat is put immediately under the 365nm ultra-violet lamp and is inspected a little; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the streak of same color;
(2) get this preparation 0.5g, porphyrize adds ethyl acetate 20ml, and reflux 1 hour filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Fructus Psoraleae control medicinal material 1g, shines medical material solution in pairs with legal system; According to 2005 editions one appendix VIB thin layer chromatography test of Chinese Pharmacopoeia, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel g thin-layer plate, with ethane: ethyl acetate=4: 1 is developing solvent, launch, take out, dry, spray is put under the 365nm ultra-violet lamp and is inspected with 10% potassium hydroxide alcoholic solution; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show two identical blue and white fluorescence speckles;
Check: should meet relevant every regulation under Chinese Pharmacopoeia 2005 editions appendix capsules, tablet or granule items.
Side of the present invention separates: kidney governing reproduction is to breed originally, the Liver and kidney damage of essence, and the body deficiency of vital QI, diet labor desires not tie the evil poison of infection in addition, causes yin and yang qi and blood disorder, and men and women two " essence " is difficult to fight mutually and can not becomes pregnant.Herba Epimedii, Fructus Psoraleae share with warming and recuperating the kidney-YANG in the side, strong lean marrow; Be aided with Radix Polygoni Multiflori Preparata, Radix Angelicae Sinensis, aweto nourishing lung kidney, nourishing blood to suppress the hyperactive liver is to strengthen the merit of principal agent kidney tonifying, essence replenishing; Assistant is with Fructus Lycii, Fructus Ligustri Lucidi, liver and kidney tonifying, and nourishing YIN and benefiting blood is crossed using warming therapy with flat principal agent; Make it rhizoma sparganic, Semen Persicae with blood circulation promoting and blood stasis dispelling.Cool and the usefulness of full side temperature, resolving and invigoration therapies being applied simultaneously makes its benefit and oiliness, temperature and not dry.All medicines share plays liver and kidney tonifying altogether, mediation nutrient blood, the merit of blood circulation promoting and blood stasis dispelling.
Function of the present invention cures mainly: preparation of the present invention has the liver and the kidney tonifying, and the diarrhea of heat type that disappears is wet, mediation nutrient blood, the function of activating blood circulation to dissipate blood stasis.Be used for the infertility that immunity causes.
In order to verify that preparation of the present invention has excellent curative, the applicant has carried out series of experimental research, and is specific as follows:
Pharmacodynamics test
One, the present invention (anti-exempting from) capsule Pharmacodynamic test of active extract relevant with function
(1) the present invention (anti-exempting from) capsule is to the influence of the positive rat model of antisperm antibody
1 materials and methods
1.1 the anti-capsule of exempting from of trial drug is provided by the Drug Manufacturing Room of Reproductive Medicine Institute of Zunyi production.The prednisone sheet is produced by the celestial jade pendant Pharmaceutical in Zhejiang.
1.2 reagent Freund Freund's complete adjuvant: paraffin oil and anhydrous lanolin add dead bacillus calmette-guerin vaccine 2mg/ml by 2: 1 heating mixings before using.AsAb (antisperm antibody) is provided by Fujian Sanming City Lan Bo Bioisystech Co., Ltd.
1.3 animal SD rat body weight 180～250g, wherein female 60, male 20, is provided by Chongqing medical university of army zoopery center totally by 80.
1.4 method is set up the positive rat model of AsAb with reference to the flat method of Luo Song, as the antigen immune rat, makes it to produce the AsAb of anti-people's sperm with people's sperm.Get 22 parts of centrifugal 30min of normal person's seminal fluid 2000rpm, abandon refining, the normal saline washed twice, fully mixing is deployed into 3000 * 109/L with normal saline, aspirates grinding repeatedly with syringe; It is subcutaneous that the sperm antigen that adds adjuvant is injected female experimental mouse bilateral groin, every side 0.5ml; After the first immunisation 14 days, (concentration is 1 * 109/L), and at same area subcutaneous injection 0.5ml, booster immunization once week about to get blended people's sperm suspension, through 4 immunity, all immune rat serum detect through ELISA and confirm that antisperm antibody (AsAb) is positive at most.
Positive 60 of the female Mus of AsAb are divided into 4 groups at random.Rat 1 week beginning administration or normal saline every day 1 time after the 4th immunity, continuous 4 weeks.Take medicine after 2 weeks, experimental mouse and normal male SD rat were mated for 2 weeks by 3: 1, put to death in the 6th day after the drug withdrawal.Each organizes rat all before first immunisation, 1 week got blood behind each time booster immunization, and 20 ℃ of preservations of separation of serum adopt the ELISA method to measure AsAb; If feminine gender, then booster immunization.Rat is put to death in drug withdrawal the 6th day, gets the uterus, ovum is weighed, and the rat pregnancy rate is respectively organized in the routine pathology cut sections for microscopic examination and the average implantation of pregnant Mus is counted.
Experimental result shows: the anti-Capsules group rat pregnancy rate, AsAb negative conversion rate, uterus ovary weight exempted from all is higher than prednisone and normal saline group.The anti-capsule of exempting from of prompting has the AsAb of inhibition, promotes uterus, the development of ovary, the effect that improves pregnancy rate.
(2) the present invention (anti-exempting from) capsule is to the influence of SD Mus serum antisperm antibody
1 materials and methods
1.1 the anti-capsule of exempting from of trial drug is provided by the Drug Manufacturing Room of Reproductive Medicine Institute of Zunyi production.
40 of Adult SD Mus, female, hero half and half, body weight 180～250g.Male and female sub-cage rearing before the experiment.Divide anti-exempt from capsule and matched group at random, 20 every group (female, hero half and half).
1.3 experimental technique
1.3.1SD the foundation of the positive model of Mus serum AsAb: get 22 parts of people's normal semen, the centrifugal refining that discards, use the normal saline washed twice, mix, being made into concentration is the sperm suspension of 3000 * 109/L, add freund adjuvant (anhydrous lanolin 10g, paraffin oil 20g, heated and stirred mixing), (this moment, sperm concentration was 300 * 109/L) as antigen to add dead bacillus calmette-guerin vaccine (concentration is 2mg/ml) mixing before using.Give respectively to resist and exempt from the SD Mus bilateral groin subcutaneous injection 0.5ml antigen of Capsules group and matched group as first immunisation.After 14 days, get 18 parts of people's seminal fluid mixing, centrifugal, washed twice again, adjusting sperm concentration is the suspension of 1 * 109/L, in each 0.5ml of same area subcutaneous injection, carries out booster immunization.
1.3.2 administration and blood sampling: begin in a week to exempt from capsular SD Mus and irritate stomach to anti-after first immunisation, irritating with the anti-capsule dosage of exempting from is 3 times of adult's dosage; Matched group is irritated the clear water with same capability; Every day 1 time, continuous 4 weeks.Eyeball blood sampling under etherization respectively in the 1st day, the 6th day before immunity and after the drug withdrawal, separation of serum, 20 ℃ of preservations, the unified level of measuring serum AsAb.
1.3.3SD the mensuration of Mus serum AsAb: adopt the tray agglutination.Tray is home-made 72 holes trace serum screening plates.When beginning to test,, (note not staying bubble in the hole) when treating that it is all sealed each aperture remaining paraffin oil is poured out prior to adding liquid paraffin in the plate.The different dilution factors of adding in every aperture (dilution factor is 1: 20,1: 40, and 1: 80,1: 160,1: 320,1: 640) SD Mus serum 2 μ l, sperm suspension 1 μ l (concentration 30 * 109/L, activity ratio＞50%, no coagulation), hatched observed result under inverted microscope under the room temperature 60 minutes.Interpretation standard as a result: the coagulation number＞motile sperm sum of L motile sperm 10% positive.
The result shows: the anti-serum AsAb negative rate of exempting from Capsules group SD Mus illustrates to have the effect that AsAb produces that suppresses apparently higher than matched group (P＜0.05).
Results of pharmacodynamic test shows: pharmaceutical preparation of the present invention is effective to the barrenness that the treatment immunity causes.
Two, acute toxicity test
Capsule suspension one twice-daily of the present invention is with 16g/kg, symphysis medicine 36.48g/kg, be equivalent to 300 times of clinical plan dosage and irritate the stomach mices.Observed 7 days continuously, do not see animal dead and any toxic reaction, show that capsule of the present invention does not have acute toxic reaction.
Capsule of the present invention is as hospital preparation, clinic trial for many years, by clinical observation on the therapeutic effect, effective percentage reaches 96%.In thousands of routine cases, there is no serious and obvious toxic and side effects.
Three, clinical data
Attached institute of Reproductive Medicine Institute of Zunyi preserves and resists over thousands of part on the case history of exempting from capsule for treating immune infertility infertility clinical patient.
Compared with prior art, preparation of the present invention has the liver and the kidney tonifying, the diarrhea of heat type that disappears is wet, be in harmonious proportion nutrient blood, the effect of activating blood circulation to dissipate blood stasis clinically is used for the infertility that immunity causes, it is evident in efficacy, cure rate height, and do not have obvious toxic-side effects is a kind of Chinese medicine of safe, effective, quality controllable treatment infertility.
The specific embodiment:
Embodiments of the invention 1: Cordyceps 31g, Herba Epimedii 93g, Radix Angelicae Sinensis 124g, Radix Polygoni Multiflori Preparata 93g, Fructus Ligustri Lucidi 93g, rhizoma sparganic 93g, Fructus Psoraleae 124g, Fructus Lycii 93g, Semen Persicae 93g
Get Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of 80% amount, the ethanol that adds 6 times of amounts 70%, refluxed 1.5 hours, and filtered, filtrate is put in addition, filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour filters merging filtrate, reclaim ethanol, solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, oven dry, granulate, filled capsules is made 1000, promptly gets capsule.This product oral, 3 times on the one, one time 5.
Embodiments of the invention 2: Cordyceps 31g, Herba Epimedii 93g, Radix Angelicae Sinensis 124g, Radix Polygoni Multiflori Preparata 93g, Fructus Ligustri Lucidi 93g, rhizoma sparganic 93g, Fructus Psoraleae 124g, Fructus Lycii 93g, Semen Persicae 93g
Get Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of 80% amount, the ethanol that adds 6 times of amounts 70%, refluxed 1.5 hours, and filtered, filtrate is put in addition, filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour filters merging filtrate, reclaim ethanol, solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, oven dry, granulate, tabletting, coating is made 1000, promptly gets tablet.
Embodiments of the invention 3: Cordyceps 31g, Herba Epimedii 93g, Radix Angelicae Sinensis 124g, Radix Polygoni Multiflori Preparata 93g, Fructus Ligustri Lucidi 93g, rhizoma sparganic 93g, Fructus Psoraleae 124g, Fructus Lycii 93g, Semen Persicae 93g
Get Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of 80% amount, the ethanol that adds 6 times of amounts 70%, refluxed 1.5 hours, and filtered, filtrate is put in addition, filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour filters merging filtrate, reclaim ethanol, solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, 1000g is made in oven dry, promptly gets granule.
Embodiments of the invention 4: the method for quality control of preparation of the present invention is:
Character: for capsule, content is a brown granular, gas perfume (or spice), mildly bitter flavor;
For tablet: medicine shows sepia, gas perfume (or spice), mildly bitter flavor;
For granule: medicine is a brown granular, gas perfume (or spice), mildly bitter flavor;
Differentiate: (1) gets this preparation 0.5g, and porphyrize adds ethanol 50ml, and reflux 1 hour filters, and filtrate is concentrated into 3g, as need testing solution; Other gets Radix Polygoni Multiflori control medicinal material 0.25g, shines medical material solution in pairs with legal system; According to 2005 editions one appendix VIB thin layer chromatography test of Chinese Pharmacopoeia, draw above-mentioned two kinds of each 4ul of solution, put respectively in same be to make into strips on the silica gel H lamellae of adhesive with the sodium carboxymethyl cellulose, with benzene: ethanol=2: 1 is developing solvent, exhibition is to about 3.5cm, take out, dry, again with benzene: ethanol=4: 1 is developing solvent, exhibition is to about 7cm, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence streak of same color, spray the phosphomolybdic acid sulfuric acid solution again, heat is put immediately under the 365nm ultra-violet lamp and is inspected a little; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the streak of same color;
(2) get this preparation 0.5g, porphyrize adds ethyl acetate 20ml, and reflux 1 hour filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Fructus Psoraleae control medicinal material 1g, shines medical material solution in pairs with legal system; According to 2005 editions one appendix VIB thin layer chromatography test of Chinese Pharmacopoeia, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel g thin-layer plate, with ethane: ethyl acetate=4: 1 is developing solvent, launch, take out, dry, spray is put under the 365nm ultra-violet lamp and is inspected with 10% potassium hydroxide methanol solution; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show two identical blue and white fluorescence speckles;
Check: should meet relevant every regulation under Chinese Pharmacopoeia 2005 editions appendix capsules, tablet or granule items.
Claims (7)
1. Chinese medicine preparation for the treatment of infertility, it is characterized in that: it is made by following raw material medicaments: Cordyceps 31g, Herba Epimedii 93g, Radix Angelicae Sinensis 124g, Radix Polygoni Multiflori Preparata 93g, Fructus Ligustri Lucidi 93g, rhizoma sparganic 93g, Fructus Psoraleae 124g, Fructus Lycii 93g and Semen Persicae 93g.
2. according to the Chinese medicine preparation of the described treatment infertility of claim 1, it is characterized in that: described Chinese medicine preparation is capsule, tablet or granule.
3. treat the preparation method of the Chinese medicine preparation of infertility as claimed in claim 1 or 2, it is characterized in that: get Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of 80% amount, add the ethanol of 6 times of amounts 70%, refluxed 1.5 hours, filter, filtrate is put in addition, and filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour, filter, merging filtrate reclaims ethanol, and solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, oven dry, granulate is made different preparations according to a conventional method.
4. according to the preparation method of the Chinese medicine preparation of the described treatment infertility of claim 3, it is characterized in that: capsule prepares like this: get Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of 80% amount, add the ethanol of 6 times of amounts 70%, refluxed 1.5 hours, filter, filtrate is put in addition, and filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour, filter, merging filtrate reclaims ethanol, and solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, oven dry, granulate, filled capsules is made 1000, promptly.
5. according to the preparation method of the Chinese medicine preparation of the described treatment infertility of claim 3, it is characterized in that: tablet prepares like this: get Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of 80% amount, add the ethanol of 6 times of amounts 70%, refluxed 1.5 hours, filter, filtrate is put in addition, and filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour, filter, merging filtrate reclaims ethanol, and solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, oven dry, granulate, tabletting, coating is made 1000, promptly.
6. according to the preparation method of the Chinese medicine preparation of the described treatment infertility of claim 3, it is characterized in that: granule prepares like this: get Herba Epimedii, Radix Angelicae Sinensis, Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi, rhizoma sparganic, Fructus Psoraleae, Fructus Lycii and the Semen Persicae of 80% amount, add the ethanol of 6 times of amounts 70%, refluxed 1.5 hours, filter, filtrate is put in addition, and filtering residue adds 4 times of amounts of ethanol of 70%, reflux 1 hour, filter, merging filtrate reclaims ethanol, and solution is put in addition; The decocting that filtering residue adds 5 times of amounts boiled 1.5 hours, filtered, and merged solution, concentrate, and oven dry, dried cream powder is broken; Get Cordyceps again and remain the 20% eight flavor medical materials of measuring, be ground into fine powder; Dried cream and protogenic medicinal powder mixing granulation, oven dry is made 1000g, promptly.
7. treat the method for quality control of the Chinese medicine preparation of infertility as claimed in claim 1 or 2, it is characterized in that: described method of quality control comprises:
Character: for capsule, content is a brown granular, gas perfume (or spice), mildly bitter flavor;
For tablet: medicine shows sepia, gas perfume (or spice), mildly bitter flavor;
For granule: medicine is a brown granular, gas perfume (or spice), mildly bitter flavor;
Differentiate: (1) gets this preparation 0.5g, and porphyrize adds ethanol 50ml, and reflux 1 hour filters, and filtrate is concentrated into 3g, as need testing solution; Other gets Radix Polygoni Multiflori control medicinal material 0.25g, shines medical material solution in pairs with legal system; According to 2005 editions one appendix VIB thin layer chromatography test of Chinese Pharmacopoeia, draw above-mentioned two kinds of each 4ul of solution, put respectively in same be to make into strips on the silicon foot lamellae of adhesive with the sodium carboxymethyl cellulose, with benzene: ethanol=2: 1 is developing solvent, exhibition is to about 3.5cm, take out, dry, again with benzene: ethanol=4: 1 is developing solvent, exhibition is to about 7cm, take out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence streak of same color, spray the phosphomolybdic acid sulfuric acid solution again, heat is put immediately under the 365nm ultra-violet lamp and is inspected a little; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the streak of same color;
(2) get this preparation 0.5g, porphyrize adds ethyl acetate 20ml, and reflux 1 hour filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Fructus Psoraleae control medicinal material 1g, shines medical material solution in pairs with legal system; According to 2005 editions one appendix VIB thin layer chromatography test of Chinese Pharmacopoeia, draw above-mentioned two kinds of each 4ul of solution, put respectively on same silica gel g thin-layer plate, with ethane: ethyl acetate=4: 1 is developing solvent, launch, take out, dry, spray is put under the 365nm ultra-violet lamp and is inspected with 10% potassium hydroxide methanol solution; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show two identical blue and white fluorescence speckles;
Check: should meet relevant every regulation under Chinese Pharmacopoeia 2005 editions appendix capsules, tablet or granule items.
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| CNB2006102003508A CN100435834C (en) | 2006-04-14 | 2006-04-14 | Chinese medicinal preparation for treating sterility, its preparation and quality control method |
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| CNB2006102003508A CN100435834C (en) | 2006-04-14 | 2006-04-14 | Chinese medicinal preparation for treating sterility, its preparation and quality control method |
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| CN1827151A CN1827151A (en) | 2006-09-06 |
| CN100435834C true CN100435834C (en) | 2008-11-26 |
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| CN (1) | CN100435834C (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1660404A (en) * | 2005-01-19 | 2005-08-31 | 雷小平 | Health product of preserving health, invigorating the kidney and supporting yang for male |
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2006
- 2006-04-14 CN CNB2006102003508A patent/CN100435834C/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1660404A (en) * | 2005-01-19 | 2005-08-31 | 雷小平 | Health product of preserving health, invigorating the kidney and supporting yang for male |
Non-Patent Citations (4)
| Title |
|---|
| "抗免胶囊"治疗免疫性不孕不育症临床疗效观察. 马静，古泽等.中国实验方剂学杂志，第10卷第4期. 2004 |
| "抗免胶囊"治疗免疫性不孕不育症临床疗效观察. 马静，古泽等.中国实验方剂学杂志，第10卷第4期. 2004 * |
| 生精胶囊中何首乌与补骨脂的薄层色谱专属性鉴别. 聂明华.时珍国医国药，第16卷第1期. 2005 |
| 生精胶囊中何首乌与补骨脂的薄层色谱专属性鉴别. 聂明华.时珍国医国药，第16卷第1期. 2005 * |
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| Publication number | Publication date |
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| CN1827151A (en) | 2006-09-06 |
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