CN103948744A - Chinese medicinal composition for treating male infertility and preparation method thereof - Google Patents
Chinese medicinal composition for treating male infertility and preparation method thereof Download PDFInfo
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- CN103948744A CN103948744A CN201410227285.2A CN201410227285A CN103948744A CN 103948744 A CN103948744 A CN 103948744A CN 201410227285 A CN201410227285 A CN 201410227285A CN 103948744 A CN103948744 A CN 103948744A
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Abstract
The invention discloses a Chinese medicinal composition for treating male infertility and a preparation method thereof. The Chinese medicinal composition for treating the male infertility is prepared from active ingredients and pharmaceutical adjuvants, wherein the active ingredients are prepared from the following traditional Chinese medicinal materials in parts by weight through soaking extraction with ethanol and extraction with ethyl acetate: 60-80 parts of medlar leaves and 11-20 parts of morinda officinalis. The traditional Chinese medicine extract prepared by the invention can improve sperm density and sperm motility rate of dyszoospermia model rats and can reduce rate of sperm deformation of the dyszoospermia model rats, so that the Chinese medicinal composition disclosed by the invention can be used for treating the male infertility.
Description
Technical field
The present invention relates to Chinese medicine technical field, in particular to a kind of pharmaceutical composition for the treatment of male infertility and preparation method thereof.
Background technology
Along with social development, the pressure of male's work is also increasing, and physical function also further declines.Add the pollution of environment, increasing male's semen quality constantly declines, and causes temporary transient or permanent sterile, or embryo quality declines, and causes huge stress to individual, brings great misery to family, even lead to life tragedy, become the social problem that must pay attention to.1998 Nian Guo family livehood sections once 1981-1996 published between 16 years, deriving from 39 cities and counties such as Beijing, Shanghai, Tianjin, 256 parts of documents finds after 11726 people's data analysis totally, semen quality just declines with annual 1% speed, and decrease speed is more and more faster.Within 2002, Chengdu family planning technology instructs the people such as the Li Gang of institute after completing 295 student enrollment's investigation of In Chengdu 12Suo colleges and universities, on " modern preventive medicine " magazine, deliver the paper of " investigation of In Chengdu university students's sperm quality and antisperm antibody ", disclose abnormal person 99 people of sperm quality and account for 33.56%; After 549 student enrollment's investigation of expanded scope to 14 colleges and universities, on " the Chinese andrology " of in December, 2003, deliver the paper of " the routine university students's sperm quality investigation in In Chengdu 549 ", disclose abnormal person 204 people of sperm quality and account for 37.16%, and scream " incidence rate of infertility may, higher than the 12%-16% of current bibliographical information, even can surpass 1/3 in the future ".The sperm qualities such as few essence or azoospermia are the main cause of male sterility extremely.Sperm quality declines and the male infertility that causes, must obtain effectively preventing, otherwise affect the normal continuity that mankind itself breeds.
Summary of the invention
In view of the deficiencies in the prior art, the object of the invention is to by folk secret is furtherd investigate, a kind of pharmaceutical composition for the treatment of male infertility is provided.Meanwhile, the present invention also aims to provide a kind of preparation method of this pharmaceutical composition.
First object of the present invention is achieved in that
A kind of pharmaceutical composition for the treatment of male infertility, be prepared from by active component and pharmaceutic adjuvant, wherein said active component is by the traditional Chinese medicinal material raw materials of following weight portion, after soak with ethanol is extracted and be extracted with ethyl acetate and obtain: Folium Lycii 60-80 part, Radix Morindae Officinalis 11-20 part.
First object of the present invention can also realize like this:
The pharmaceutical composition of described treatment male infertility, wherein said active component is by the traditional Chinese medicinal material raw materials of following weight portion, after soak with ethanol is extracted and be extracted with ethyl acetate and obtain: Folium Lycii 65-72 part, Radix Morindae Officinalis 13-17 part.
The pharmaceutical composition of described treatment male infertility, wherein said active component is by the traditional Chinese medicinal material raw materials of following weight portion, after soak with ethanol is extracted and be extracted with ethyl acetate and obtain: 68 parts of Folium Lyciis, 15 parts of Radix Morindae Officinaliss.
The pharmaceutical composition of described treatment male infertility, wherein said pharmaceutical composition is oral solid formulation; Described oral solid formulation comprises tablet, capsule and granule.
Second object of the present invention is to provide a kind of preparation method of pharmaceutical composition of above-mentioned treatment male infertility, and particularly, the method comprises the steps:
(1) take Folium Lycii and Radix Morindae Officinalis, pulverize, doubly measure (v/w) 90%-95% alcohol solution dipping 0.5-1h with 6-12, after room temperature ultrasonic Treatment 0.5-1h, filter, filtering residue adds 6-12 again and doubly measures (v/w) 90%-95% alcoholic solution, after room temperature ultrasonic Treatment 0.5-1h, filters, and merges twice filtrate, reclaim under reduced pressure, to without alcohol taste, obtains extractum;
(2) in step (1) gained extractum, add 0.5-3 doubly to measure (v/w) pure water, fully stir, the ethyl acetate of doubly measuring (v/v) with 1-3 extracts 2-3 time, and combining extraction liquid reclaims ethyl acetate lyophilization, obtains Chinese medicine extract;
(3) step (2) gained Chinese medicine extract is pulverized, sieved, add filler, disintegrating agent and binding agent to mix rear soft material processed, cross 16-32 mesh sieve wet granular processed, wet granular is fully dried in 45-60 DEG C, obtain dry granule;
(4) the dry granule of step (3) gained and lubricant are mixed to rear tabletting or filled capsules shell, obtain tablet or capsule.
The preparation method of the pharmaceutical composition of described treatment male infertility, wherein in step (1), the frequency of ultrasonic Treatment is 20-30Hz.
It should be noted that, traditional Chinese medicinal material raw materials of the present invention has following source: Folium Lycii is selected the dry young stem and leaf of plant of Solanaceae lycium barbarum; Radix Morindae Officinalis is selected the dry root of Maguireothamnus speciosus Radix Morindae Officinalis Morinda officinalis How.
Cyclophosphamide is a kind of alkylating agent class medicine, is conventional antitumor drug and immunosuppressant, and the damage to male reproductive system and the potential teratogenesis danger to offspring have caused showing great attention to of doctor and patient.Clinical studies show, childhood period accept male's infant of treated with cyclophosphamide pulse because of leukemia, tumor, autoimmune disease, after growing up, 80.2%-92.6% is azoospermia or oligospermia, extensively adopts at present cyclophosphamide to prepare dyszoospermia model.Inventor is by caused by cyclophosphamide dyszoospermia model, verified that Chinese medicine extract prepared by the present invention can improve sperm concentration and the sperm motility rate of dyszoospermia rat model, reduces its rate of teratosperm, thereby can be used for the treatment of male infertility.
Detailed description of the invention
the preparation of embodiment 1 tablet
(1) take the Folium Lycii 6.8kg and the Radix Morindae Officinalis 1.5kg that clean up, pulverize, with 65L 95% alcohol solution dipping 0.5h, under room temperature, filter after 25Hz ultrasonic Treatment 0.8h taking frequency, filtering residue adds 65L 95% alcoholic solution again, under room temperature, filters after 30Hz ultrasonic Treatment 0.5h taking frequency, merges twice filtrate, reclaim under reduced pressure, to without alcohol taste, obtains extractum;
(2) in step (1) gained extractum, add 1.5 times of amounts (v/w) pure water, fully stir, extract 2 times with the ethyl acetate of 1.5 times of amounts (v/v), combining extraction liquid, reclaims ethyl acetate lyophilization, obtains Chinese medicine extract;
(3) step (2) gained Chinese medicine extract is pulverized, sieve, add the starch that 5-8 doubly measures, sodium carboxymethyl cellulose and the appropriate amount of starch slurry that 0.2-0.5 doubly measures to mix rear soft material processed, cross 20 mesh sieve wet granular processed, wet granular is fully dried in 45-60 DEG C, obtains dry granule;
(4) the dry granule of step (3) gained and magnesium stearate are mixed to rear tabletting, obtain tablet.
the preparation of embodiment 2 capsules
(1) take the Folium Lycii 6.8kg and the Radix Morindae Officinalis 1.5kg that clean up, pulverize, with 60L 95% alcohol solution dipping 0.5h, under room temperature, filter after 25Hz ultrasonic Treatment 0.8h taking frequency, filtering residue adds 55L 95% alcoholic solution again, under room temperature, filters after 25Hz ultrasonic Treatment 0.5h taking frequency, merges twice filtrate, reclaim under reduced pressure, to without alcohol taste, obtains extractum;
(2) in step (1) gained extractum, add 1 times of amount (v/w) pure water, fully stir, extract 2 times with the ethyl acetate of 2 times of amounts (v/v), combining extraction liquid, reclaims ethyl acetate lyophilization, obtains Chinese medicine extract;
(3) step (2) gained Chinese medicine extract is pulverized, sieve, add the starch that 5-8 doubly measures, sodium carboxymethyl cellulose and the appropriate amount of starch slurry that 0.2-0.5 doubly measures to mix rear soft material processed, cross 20 mesh sieve wet granular processed, wet granular is fully dried in 45-60 DEG C, obtains dry granule;
(4) the dry granule of step (3) gained and Pulvis Talci are mixed to rear filled capsules shell, obtain capsule.
the impact of sperm concentration, motility rate and the abnormal rate of embodiment 3 Chinese medicine extract on dyszoospermia mice
The preparation of sample A: take the Folium Lycii 6.8kg and the Radix Morindae Officinalis 1.5kg that clean up, pulverize, add 80L decocting and boil 1.5h, filter, filtrate is concentrated into extractum, and lyophilization obtains Chinese medicine extraction matter sample A.
The preparation of sample B: take the Folium Lycii 6.8kg and the Radix Morindae Officinalis 1.5kg that clean up, pulverize, with 65L 95% alcohol solution dipping 0.5h, under room temperature, filter after 25Hz ultrasonic Treatment 0.8h taking frequency, filtering residue adds 65L 95% alcoholic solution again, under room temperature, filter after 30Hz ultrasonic Treatment 0.5h taking frequency, merge filtrate twice, reclaim under reduced pressure is extremely without alcohol taste, obtain extractum, add 1.5 times of amounts (v/w) pure water, fully stir, ethyl acetate with 1.5 times of amounts (v/v) extracts 2 times, combining extraction liquid, reclaim ethyl acetate lyophilization, obtain Chinese medicine extraction matter sample B.
40 of the healthy Bal b/c of SPF level male mices, body weight (20 ± 2) g, adaptability is divided into following four groups after feeding immediately: normal group, model group, test A group, test B group, 10 every group.Except normal group, all the other respectively organize mouse peritoneal injection cyclophosphamide 75mg/kg/d, 5d continuously, preparation dyszoospermia animal model.After model preparation, the sample A that test A group gives above-mentioned preparation is by 600mg/kg dosage gavage, and the sample B that test B group gives above-mentioned preparation is by 150mg/kg dosage gavage, and normal group and model group gavage give equal-volume normal saline, every day 1 time, amount to gavage 4 weeks.
After administration finishes, to fill 10 mL sperm BWW culture fluid (Chen Deyu, the impact of anti-semen Antibody on Function of Mitochondria, Medical College of Shantou University journal, the 1st phase in 2008) test tube be placed in constant water bath box and be preheated to 37 DEG C, get respectively every one-sided epididymis of mice and remove connective tissue and fat, eye scissors shreds tissue and puts into test tube, 37 DEG C of static l0min, after sperm is fully free, get 1 and drip on blood cell counting plate, calculate and add up sperm concentration, sperm motility rate, the rate of teratosperm of each group of mice.Statistical result is in table 1.
Table l respectively organizes sperm concentration, motility rate and the abnormal rate comparison of mice
With normal group comparison,
* p< 0.05;
* p< 0.01; With model group comparison,
$ p< 0.05;
$$ p< 0.01; Compare with test A group,
$ p< 0.05;
$ $ p< 0.01.
Result of the test by table 1 can find out, the sperm concentration of model group and test A group mice, sperm motility rate significantly lower than normal group (
p< 0.01), rate of teratosperm be significantly higher than normal group (
p< 0.01).Test B group be significantly increased compared with model group, test A group sperm concentration and sperm motility rate (
p< 0.01), rate of teratosperm significantly reduce (
p< 0.01).
In addition, the extractum that the inventor prepares embodiment step (1) adopts normal hexane, petroleum ether, n-butyl alcohol to replace ethyl acetate to extract, gained Chinese medicine extract is improving sperm concentration and sperm motility rate, and the biological activity of reduction rate of teratosperm aspect is not obvious.
Claims (7)
1. treat the pharmaceutical composition of male infertility for one kind, be prepared from by active component and pharmaceutic adjuvant, it is characterized in that: described active component is by the traditional Chinese medicinal material raw materials of following weight portion, after soak with ethanol is extracted and be extracted with ethyl acetate and obtain: Folium Lycii 60-80 part, Radix Morindae Officinalis 11-20 part.
2. the pharmaceutical composition for the treatment of male infertility according to claim 1, it is characterized in that: described active component is by the traditional Chinese medicinal material raw materials of following weight portion, after soak with ethanol is extracted and be extracted with ethyl acetate and obtain: Folium Lycii 65-72 part, Radix Morindae Officinalis 13-17 part.
3. the pharmaceutical composition for the treatment of male infertility according to claim 2, it is characterized in that: described active component is by the traditional Chinese medicinal material raw materials of following weight portion, after soak with ethanol is extracted and be extracted with ethyl acetate and obtain: 68 parts of Folium Lyciis, 15 parts of Radix Morindae Officinaliss.
4. according to the pharmaceutical composition of the treatment male infertility described in claim 1-3 any one, it is characterized in that: described pharmaceutical composition is oral solid formulation.
5. the pharmaceutical composition for the treatment of male infertility according to claim 4, is characterized in that: described oral solid formulation comprises tablet, capsule and granule.
6. treat a preparation method for the pharmaceutical composition of male infertility, it is characterized in that the method comprises the steps:
(1) take Folium Lycii and Radix Morindae Officinalis, pulverize, doubly measure 90%-95% alcohol solution dipping 0.5-1h with 6-12v/w, after room temperature ultrasonic Treatment 0.5-1h, filter, filtering residue adds 6-12v/w again and doubly measures 90%-95% alcoholic solution, after room temperature ultrasonic Treatment 0.5-1h, filters, and merges twice filtrate, reclaim under reduced pressure, to without alcohol taste, obtains extractum;
(2) in step 1 gained extractum, add 0.5-3v/w doubly to measure pure water, fully stir, the ethyl acetate extraction of doubly measuring with 1-3v/v 2-3 time, combining extraction liquid, reclaims ethyl acetate lyophilization, obtains Chinese medicine extract;
(3) step 2 gained Chinese medicine extract is pulverized, sieved, add filler, disintegrating agent and binding agent to mix rear soft material processed, cross 16-32 mesh sieve wet granular processed, wet granular is fully dried in 45-60 DEG C, obtain dry granule;
(4) dry step 3 gained granule and lubricant are mixed to rear tabletting or filled capsules shell, obtain tablet or capsule.
7. the preparation method for the treatment of according to claim 6 the pharmaceutical composition of male infertility, is characterized in that: in described step 1, the frequency of ultrasonic Treatment is 20-30Hz.
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| CN201410227285.2A CN103948744A (en) | 2014-05-27 | 2014-05-27 | Chinese medicinal composition for treating male infertility and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104127494A (en) * | 2014-08-12 | 2014-11-05 | 崔银方 | Contraception medicine preparation for females |
| CN110840967A (en) * | 2019-12-20 | 2020-02-28 | 中国药科大学 | Chinese wolfberry leaf effective component capsule and preparation method thereof |
| CN115300572A (en) * | 2022-08-02 | 2022-11-08 | 吉林修正药业新药开发有限公司 | Traditional Chinese medicine composition for treating male infertility, preparation method thereof and Jingshun drink |
-
2014
- 2014-05-27 CN CN201410227285.2A patent/CN103948744A/en active Pending
Non-Patent Citations (4)
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| 于成军等: "巴戟天醇提物对大鼠精子的影响及其抗自由基作用", 《山东医药工业》 * |
| 寒冬主编: "《自由基与健康》", 30 September 2012, 辽宁科学技术出版社 * |
| 张俊慧等: "枸杞子在男性不育症中的应用", 《中华男科学杂志》 * |
| 张华峰等: "枸杞叶的生物活性成分及其在食品工业中的应用", 《食品工业科技》 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104127494A (en) * | 2014-08-12 | 2014-11-05 | 崔银方 | Contraception medicine preparation for females |
| CN110840967A (en) * | 2019-12-20 | 2020-02-28 | 中国药科大学 | Chinese wolfberry leaf effective component capsule and preparation method thereof |
| CN110840967B (en) * | 2019-12-20 | 2021-11-16 | 中国药科大学 | Chinese wolfberry leaf effective component capsule and preparation method thereof |
| CN115300572A (en) * | 2022-08-02 | 2022-11-08 | 吉林修正药业新药开发有限公司 | Traditional Chinese medicine composition for treating male infertility, preparation method thereof and Jingshun drink |
| CN115300572B (en) * | 2022-08-02 | 2023-12-26 | 吉林修正药业新药开发有限公司 | A Chinese medicinal composition for treating male infertility, and its preparation method and a beverage for treating male infertility |
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Application publication date: 20140730 |