CN100333767C - Medicine for treating male infertility - Google Patents

Medicine for treating male infertility Download PDF

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Publication number
CN100333767C
CN100333767C CNB2004100517014A CN200410051701A CN100333767C CN 100333767 C CN100333767 C CN 100333767C CN B2004100517014 A CNB2004100517014 A CN B2004100517014A CN 200410051701 A CN200410051701 A CN 200410051701A CN 100333767 C CN100333767 C CN 100333767C
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parts
fructus
present
examples
medicine
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CN1634296A (en
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黄清春
吴新荣
韩丽萍
李俭洪
赵树进
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GUANGZHOU HUABO BIOPHARMACEUTICAL INSTITUTE
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GUANGZHOU HUABO BIOPHARMACEUTICAL INSTITUTE
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Abstract

The present invention relates to a medicine for treating male infertility, which is mainly prepared from common curculigo rhizome, epimedium herb, palmleaf raspberry fruit, tuber onion seed, dodder seed, barbary wolfberry fruit, plantain seed, schisandra, mulberry, tangshen and licorice root, and the preparation is an oral administrating preparation. The present invention is mainly used for warming yang, replenishing essence and tonifying the kidney, and is secondarily used for strengthening the spleen and nourishing the liver to obtain the purpose of balancing yin and yang. The present invention has the advantages of moderate medical property, nourishment without a side effect, safety and low toxicity, so the present invention is suitable for long-term administration. The present invention has the function of treating the male infertility and can improve the male function.

Description

A kind of medicine production method for the treatment of male infertility
Technical field
The present invention relates to a kind of medicine production method for the treatment of male infertility, belong to the field of Chinese medicines.
Background technology
According to statistics, infertile person accounts for 15% in the married couple, wherein bridegroom's or husband's side reason account for 50%, find that according to foreign study over nearly 50 years, the sperm concentration of male testical has descended 50% approximately.
Pressgang-the Doherty of the upright university in U.S. Florey Dazhou City discovers, U.S. man's sperm number has reduced almost 1/3rd in half a century in the past.Nineteen twenty-nine, the intermediate value of sperm was 9,000 ten thousand/ml, and intermediate value in 1979 is 6,000 ten thousand/ml.
From the sperm biological characteristics, sperm is the end product that male sex-cell system grows.In the process of spermatogenesis, formation and distortion, because Cytoplasm is escaped, the DNA repairase is lost in the endochylema, makes DNA damage and repair system function lose thereupon.Therefore it can not can repair the damage of the constitutional hereditary material more than 90% voluntarily as somatic cell and ovum.In the various cells of human body, have only sperm to have such characteristic.In addition, compare with other various cells, sperm is more responsive to noxious substance.Spermatogenic cell is in quick splitting status all the time, and the male from embryo's middle and late stage until old, can continuously generate sperm.In spermatogenesis process fast, the damaging effect that various harmful factors produce is obviously increase accumulating and adding up after.
Except that heredity and part organ organic disease, male sterility and living habit are closely related.
1) sexual life is chaotic and unclean;
2) have a liking for cigarette and wine;
3) thermal environment is to the infringement of testis: as wearing panty girdle for a long time;
4) improper diet:, can cause spermatogenic epithelium not long as vitamin A deficiency;
5) contact noxious substance: as organic insecticide, organic phosphates etc.;
6) infringement of medicine: many medicines can cause male sterility, mainly contain antitumor drug, antirheumatic, antihypertensive, amcinonide, tranquilizer etc.;
7) sexual life overfrequency or improper:, also can cause oligospermatism if the sexual life number of times is too much or uncontrolled;
8) the contact female substance is too much: as artificial breeding's fresh-water fishes, poultry etc., this group food of taking food for a long time also is the major reason that causes male's oligospermatism;
For all the foregoing reasons, it is more and more that modern male suffers from the ratio of oligospermatism.
To the treatment of oligospermatism, external many with tamoxifen vitaminize preparation, certain curative effect is arranged.But tamoxifen still exists unsatisfactory curative effect, shortcoming that effective percentage is low.
Motherland's medical science is of long standing and well established, on the treatment male infertility, certain curative effect is arranged, accumulated rich experience, as Chinese patent application number 02158868.6 patent application that is called " a kind of Chinese medicine of kidney invigorating and YANG supporting ", made by Yang invigorating medicine compound recipes such as Cornu Cervi Pantotrichum, Herba Epimedii, Herba Cistanches, the property of medicine is gentle inadequately, though have the effect of certain tonifying YANG, treatment male infertility, but have scorchingly, should not take for a long time; And the treatment of the infertility that causes for the few sperm of treatment is not good.
Summary of the invention
Though purpose of the present invention is exactly to have the tonifying YANG effect for the Chinese medicine that overcomes existing curative effect of medication is not good, effective percentage is low shortcoming and tonifying YANG but shortcoming scorching, that should not take and treat the infertility unsatisfactory curative effect is for a long time arranged, the medicine production method of the treatment male infertility that provide a kind of good effect, effective percentage height, safety and low toxicity, can take for a long time.
The present invention also provides a kind of medicine of the male's of raising function.
The present invention realizes like this.
The present invention selects for use Rhizoma Curculiginis, Herba Epimedii, Fructus Rubi, Semen Allii Tuberosi, Semen Cuscutae, Fructus Lycii, Semen Plantaginis, Fructus Schisandrae Chinensis, Fructus Mori, Radix Codonopsis, Radix Glycyrrhizae to make up, make each efficacy of drugs produce synergism these drug regimens, thereby reach the curative effect of treatment male sterility.Wherein, Rhizoma Curculiginis, Herba Epimedii, Semen Allii Tuberosi warming the kidney to invigorate YANG are agitated kidney qi; The moon of Fructus Lycii, Fructus Mori nourishing the liver and kidney is for spermatogenesis provides material base; Fructus Rubi, Fructus Schisandrae Chinensis reinforcing the kindey to control nocturnal emission have the meaning of conserving strength and store up energy; Semen Plantaginis is rushed down asthenic fire in the kidney, in case the supporing yang heat of giving birth to; The Radix Codonopsis invigorating the spleen and benefiting QI is mended the day after tomorrow with foster congenital; The Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription is played the replenishing essence the kidney invigorating altogether, is agitated the effect of kidney qi.
The present invention is based on warming YANG replenishing essence the kidney invigorating, and the spleen invigorating nourishing the liver is auxilliary, the meaning of residence " treating YANG within YIN ", " treating YIN within YANG ", and the property of medicine is gentle, mends and not dry, should take for a long time.
The consumption of drug component of the present invention carries out a large amount of mould ropes summaries through the inventor and draws, and each crude drug amounts of components all has curative effect preferably in the following weight parts scope:
5~30 parts of 10~40 portions of Fructus Rubies of 4~20 parts of Herba Epimedii of Rhizoma Curculiginis
5~30 parts of 10~40 parts of Fructus Lycii of 5~30 parts of Semen Cuscutae of Semen Allii Tuberosi
5~30 parts of 4~20 parts of Fructus Mori of 5~30 parts of Fructus Schisandrae Chinensis of Semen Plantaginis
3~20 parts in 10~40 portions of Radix Glycyrrhizaes of Radix Codonopsis
Be preferably:
15 parts of 20 portions of Fructus Rubies of 10 parts of Herba Epimedii of Rhizoma Curculiginis
15 parts of 20 parts of Fructus Lycii of 15 parts of Semen Cuscutae of Semen Allii Tuberosi
15 parts of 10 parts of Fructus Mori of 15 parts of Fructus Schisandrae Chinensis of Semen Plantaginis
6 parts in 20 portions of Radix Glycyrrhizaes of Radix Codonopsis
In order to reach better therapeutic, can also add Radix Salviae Miltiorrhizae in the medicine of the present invention, Radix Salviae Miltiorrhizae is the medicine commonly used of blood circulation promoting and blood stasis dispelling simply, can improve the testis disturbance of blood circulation that varicocele causes, promotes the testis blood circulation, has increased the nutrition of sperm.Add Radix Salviae Miltiorrhizae, the pathogenesis at " the many stasis of bloods of prolonged illness " also meets the thinking of Chinese traditional treatment difficult miscellaneous diseases.After adding Radix Salviae Miltiorrhizae, each crude drug amounts of components of the present invention has curative effect preferably in the following weight parts scope:
5~30 parts of 10~40 portions of Fructus Rubies of 4~20 parts of Herba Epimedii of Rhizoma Curculiginis
5~30 parts of 10~40 parts of Fructus Lycii of 5~30 parts of Semen Cuscutae of Semen Allii Tuberosi
5~30 parts of 4~20 parts of Fructus Mori of 5~30 parts of Fructus Schisandrae Chinensis of Semen Plantaginis
3~20 parts in 10~40 portions of Radix Glycyrrhizaes of 10~40 parts of Radix Salviae Miltiorrhizaes of Radix Codonopsis
Be preferably:
15 parts of 20 portions of Fructus Rubies of 10 parts of Herba Epimedii of Rhizoma Curculiginis
15 parts of 20 parts of Fructus Lycii of 15 parts of Semen Cuscutae of Semen Allii Tuberosi
15 parts of 10 parts of Fructus Mori of 15 parts of Fructus Schisandrae Chinensis of Semen Plantaginis
6 parts in 20 portions of Radix Glycyrrhizaes of 20 parts of Radix Salviae Miltiorrhizaes of Radix Codonopsis
Material medicine of the present invention can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional peroral dosage form.For example, these crude drug can be ground into powder mixes and make powder; Also can decoct by water, be processed into decoction; After also can water decocting, further remove slag with ethanol precipitation, supernatant concentration becomes extractum, further is processed into capsule, and oral liquid or further add adjuvant and granulate is made granule, or is processed into tablet; Wherein Radix Glycyrrhizae can directly be used as medicine with powder in the crude drug, both as medicine, again as adjuvant.
Medicine of the present invention has the function of replenishing essence the kidney invigorating, spleen invigorating nourishing the liver, cures mainly sperm power abnormality and oligospermatism, simple oligospermatism, sperm power abnormality.The property of medicine of the present invention is gentle, mends and not dry, and safety and low toxicity can be taken for a long time, and medicine of the present invention also has the effect that improves male's function.
Consumption was 1 course of treatment with 30~60 days for each oral 15~20 gram crude drug that are equivalent to every day 2~3 times.
The present invention is further illustrated below in conjunction with embodiment, and listed examples only is to illustrate of the present invention, is absolutely not the embodiment that the present invention only limits to embodiment.
The specific embodiment
Embodiment 1 capsular preparation
Prescription:
Rhizoma Curculiginis 10g Herba Epimedii 20g Fructus Rubi 15g
Semen Allii Tuberosi 15g Semen Cuscutae 20g Fructus Lycii 15g
Semen Plantaginis 15g Fructus Schisandrae Chinensis 10g Fructus Mori 15g
Radix Codonopsis 20g Radix Salviae Miltiorrhizae 20g Radix Glycyrrhizae 6g
Make 30g
The production method of its preparation
Extracting liquorice is beaten powder, 100 orders that sieve are standby, get remainder ten Chinese medicine simply, decoct with water secondary, each 2 hours, collecting decoction, filtration, cryogenic vacuum are concentrated into relative density 1.26 (60 ℃), put cold, add ethanol to containing alcohol amount 55~60%, placed 12~24 hours, and got supernatant and reclaim ethanol, be concentrated into the thick paste shape, add above-mentioned powder, mix, cold drying is beaten powder and is crossed 100 order (orders, be every square centimeter hole count) sieve, add adjuvant to ormal weight, divide encapsulatedly, every 0.5g makes 60 capsules promptly.
The preparation of embodiment 2 tablets
Remove Radix Salviae Miltiorrhizae in the prescription, all the other are with embodiment 1
The production method of its preparation with embodiment 1, is added Pulvis Talci before beating powder to cross 100 mesh sieves, magnesium stearate is an amount of, tablet machine tabletting, every heavy 0.5g.
The preparation of embodiment 3 decoctions (being oral solution)
Prescription:
Rhizoma Curculiginis 4g Herba Epimedii 10g Fructus Rubi 5g
Semen Allii Tuberosi 30g Semen Cuscutae 40g Fructus Lycii 30g
Semen Plantaginis 5g Fructus Schisandrae Chinensis 4g Fructus Mori 5g
Radix Codonopsis 40g Radix Salviae Miltiorrhizae 40g Radix Glycyrrhizae 20g
All medicines in the side after adding water to submerge, decoct 3 times, and each water yield of using is respectively 6 times, 4 times, 3 times weight Chinese crude drugs, merges three times decoction liquor, promptly gets decoction.
The preparation of embodiment 4 granules
Prescription
Rhizoma Curculiginis 20g Herba Epimedii 40g Fructus Rubi 30g
Semen Allii Tuberosi 5g Semen Cuscutae 10g Fructus Lycii 5g
Semen Plantaginis 30g Fructus Schisandrae Chinensis 20g Fructus Mori 30g
Radix Codonopsis 10g Radix Glycyrrhizae 5g
The production method of its preparation is: all medicines in the side, after adding water to submerge, decoct with water secondary, and make water consumption is respectively 6 times, 4 times of Chinese crude drug at every turn, each 2 hours, collecting decoction filtered, it is 1.20 (60 ℃ of surveys) that cryogenic vacuum is concentrated into relative density, puts coldly, adds ethanol to containing alcohol amount 55~60%, placed 24 hours, and filtered filtrate recycling ethanol, be concentrated into the thick paste shape, add starch and granulate in right amount, oven dry, packing, every bag 8g makes 20 bags.
The preparation of embodiment 5 concentrated pills
Prescription
Rhizoma Curculiginis 4g Herba Epimedii 40g Fructus Rubi 5g
Semen Allii Tuberosi 30g Semen Cuscutae 10g Fructus Lycii 15g
Semen Plantaginis 20g Fructus Schisandrae Chinensis 15g Fructus Mori 8g
Radix Codonopsis 30g Radix Glycyrrhizae 15g
The production method of its preparation is: to get the Herba Epimedii general glycoside with supercritical extraction standby for Herba Epimedii in the side; It is standby that micronization is crossed 180 mesh sieves after the Radix Glycyrrhizae drying; All the other medical materials merge water in the side, extract pure post precipitation and get fluid extract, Herba Epimedii general glycoside, Radix Glycyrrhizae powder are merged make binding agent with fluid extract, make piller.The heavy 0.5g of every piller.
Embodiment 6 clinical trials
1) clinical data
Physical data: this is organized 195 examples and is the medical expert's consultation patient of traditional Chinese medical science andrology, 23~45 years old age, and average 30 years old, be after marriage matrimonial cohabitation contraception and the person of not educating more than 1 year,
Diagnostic criteria: cacospermia mainly is divided into oligospermatism, sperm power abnormality disease and azoospermia, oligospermatism.Sperm count is less than 20 * 10 6Individual/ml; Sperm power abnormality disease: sperm motility rate is lower than 60%, is lower than 50%, azoospermia more than the sperm motility III level: semen efamination does not all have sperm more than 3 times.
The seminal fluid situation: 145 examples are organized in treatment, the sperm power abnormality merges oligospermatism 55 examples, simple oligospermatism 30 examples, simple sperm power abnormality disease 53 examples, azoospermia 7 examples, companion's urogenital infections person 62 examples, companion varicocele person 24 examples, azoospermia confirms constitutional azoospermia 5 examples, deformity of vas deferens 2 examples through testis biopsy.
Because the patient comes applicant hospital out of admiration for a famous person, all require to use treatment by Chinese herbs, so the searching of matched group is difficult, and gets rid of other complication substantially.Matched group 50 examples, the sperm power abnormality merges oligospermatism 20 examples, simple oligospermatism 9 examples, simple sperm power abnormality 19 examples, azoospermia 2 examples.
2) Therapeutic Method
145 routine treatment groups, oral embodiment 1, each 6, every day 3 times, 30 days is 1 course of treatment, observes 2~3 checks course of treatment.Companion's bacterial inflammation the person give oral tarivid 0.1g, every day 3 times, serve on 10 days; Companion's seminal fluid mycoplasma or chlamydia infection person give oral azithromycin 0.5g, every day 1 time, serve on 10 days (initial dose doubles).Follow rope varicosis person to give oral capable capsule, each 4, every day 3 times, 30 days is 1 course of treatment.
50 routine matched groups, the patient gives tamoxifen 10mg/ sheet, and each 1, every day twice, taking medicine continuously three months is a course of treatment.
3) observation of curative effect
Criterion of therapeutical effect is cured: spouse's pregnancy; Produce effects: sperm count 20 * 10 6Individual/more than the ml, sperm motility rate is higher than 60%, and motility of sperm III level is above greater than 50%; Effectively: sperm count, motility rate or vigor have improvement; Invalid: no significant change before and after the treatment.
Therapeutic outcome: the treatment group, sperm power abnormality disease merges oligospermatism 55 examples: cure 7 examples, produce effects 31 examples, effective 14 examples, invalid 3 examples.Simple oligospermatism 30 examples: cure 5 examples, produce effects 21 examples, effective 3 examples, invalid 1 example.Sperm power abnormality disease 53 examples: cure 7 examples, produce effects 31 examples, effective 9 examples, invalid 6 examples.Azoospermia 7 examples: all invalid.Total effective rate is 85.3%, matched group: sperm power abnormality disease merges oligospermatism 20 examples: cure 3 examples, produce effects 6 examples, effective 3 examples, invalid 8 examples.Simple oligospermatism 9 examples: cure 1 example, produce effects 4 examples, effective 1 example, invalid 3 examples.Sperm power abnormality disease 19 examples: cure 2 examples, produce effects 7 examples, effective 2 examples, invalid 8 examples.Azoospermia 2 examples: all invalid.Total effective rate is 58%.
Embodiment 6 shows that the property of medicine of the present invention is gentle, mend and not dry, should take for a long time, compares cure rate, total effective rate all be significantly increased (P<0.01) with the matched group tamoxifen.And the patient reflects that all male's function is significantly increased.(P<0.01)。And the patient reflects that all male's function is significantly increased.
Animal acute toxicity and long term toxicity trial test show that poisonous side effect of medicine of the present invention is little; At process adenine suspension (0.02g/ml) ig, each 1ml/100g body weight, after the use modeling in continuous 45 days, obtains sperm power abnormality disease and merges the oligospermatism model every day 1 time; After finishing, modeling begins administration (embodiment 1), every day 1 time, continuous 6 weeks; The result shows, can the raise serum testosterone content of rat of embodiment 1; Promote sperm count and motility of sperm to raise.
Embodiments of the invention 2~4 show to have akin drug effect with embodiment 1 through clinical preliminary test.Give unnecessary details no longer one by one.

Claims (1)

1, a kind of medicine production method for the treatment of male infertility is characterized in that it is mainly made by following bulk drugs:
5~30 parts of 10~40 portions of Fructus Rubies of 4~20 parts of Herba Epimedii of Rhizoma Curculiginis
5~30 parts of 10~40 parts of Fructus Lycii of 5~30 parts of Semen Cuscutae of Semen Allii Tuberosi
5~30 parts of 4~20 parts of Fructus Mori of 5~30 parts of Fructus Schisandrae Chinensis of Semen Plantaginis
3~20 parts in 10~40 portions of Radix Glycyrrhizaes of 10~40 parts of Radix Salviae Miltiorrhizaes of Radix Codonopsis
Dosage form is the peroral dosage form capsule; Its production method is that extracting liquorice is beaten powder, and 100 orders that sieve are standby, gets remainder ten Chinese medicine simply, decocts with water secondary, each 2 hours, collecting decoction, filtration, cryogenic vacuum is concentrated into 60 ℃ and surveys relative density 1.26, put coldly, add ethanol, placed 12~24 hours to containing alcohol amount 55~60%, get supernatant and reclaim ethanol, be concentrated into the thick paste shape, add above-mentioned powder, mix, cold drying is beaten powder and is crossed 100 mesh sieves, add adjuvant to ormal weight, divide encapsulated, promptly.
CNB2004100517014A 2004-09-30 2004-09-30 Medicine for treating male infertility Expired - Fee Related CN100333767C (en)

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CNB2004100517014A CN100333767C (en) 2004-09-30 2004-09-30 Medicine for treating male infertility

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CN100333767C true CN100333767C (en) 2007-08-29

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Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102885348B (en) * 2011-07-23 2014-04-16 江西江中制药(集团)有限责任公司 Medlar and mulberry beverage with kidney tonifying effect and preparation method thereof
CN103638270A (en) * 2013-11-26 2014-03-19 青岛安信医疗器械有限公司 Traditional Chinese medicine liquid for treating male infertility and preparation method thereof
CN104689025A (en) * 2015-01-29 2015-06-10 福建广生堂药业股份有限公司 Chinese herbal medicine compound preparation for invigorating kidney and strengthening Yang, treating sexual dysfunction and delaying senescence and preparation method thereof
CN113082153A (en) * 2021-04-16 2021-07-09 河南农业大学 Traditional Chinese medicine composite additive for improving quality of semen of bulls in summer and application of traditional Chinese medicine composite additive

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
七子二仙胶囊治疗精子异常145例 黄清春,安徽中医学院学报,第22卷第5期 2003 *
七子二仙胶囊质量控制方法研究 韩丽萍、张延军、黄清春,广东药学院学报,第18卷第4期 2002 *
七子二仙胶囊质量控制方法研究 韩丽萍、张延军、黄清春,广东药学院学报,第18卷第4期 2002;七子二仙胶囊治疗精子异常145例 黄清春,安徽中医学院学报,第22卷第5期 2003 *

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