CN103432275A - Sustained-release nano-capsules for improving endometrial receptivity and application thereof - Google Patents
Sustained-release nano-capsules for improving endometrial receptivity and application thereof Download PDFInfo
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- CN103432275A CN103432275A CN2013103884349A CN201310388434A CN103432275A CN 103432275 A CN103432275 A CN 103432275A CN 2013103884349 A CN2013103884349 A CN 2013103884349A CN 201310388434 A CN201310388434 A CN 201310388434A CN 103432275 A CN103432275 A CN 103432275A
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Abstract
The invention discloses sustained-release nano-capsules for improving endometrial receptivity. The capsules are prepared by adopting the following steps: mixing prepared rehmannia, coptis chinensis, radix paeoniae alba, scutellaria baicalensis, donkey-hide gelatin and poria, and crushing into fine powder; putting the fine powder in a super-critical extraction pot to extract brown paste; adding ethanol accounting for 10-15 times that of the volume of the paste and cyclodextrin accounting for 2-4 times that of the weight of the paste into the paste; uniformly mixing by ultrasonic vibration, filtering with a filter membrane; filtering the filtrate with a microporous filter membrane; lyophilizing the filtrate to obtain a traditional Chinese medicinal extract; filling the traditional Chinese medicinal extract in enteric capsules to form the sustained-release nano-capsules for improving endometrial receptivity. The sustained-release nano-capsules can be used for effectively increasing the content of traditional Chinese medicinal active components, favors improvement of endometrial receptivity, and has a certain curative effect in treating infertility.
Description
Technical field
The invention belongs to pharmaceutical field, in particular to a kind of nano controlled-release capsule and application thereof that improves endometrium receptivity.
Background technology
Along with Issues of Human Assisted Reproductive Technologies (assisted reproductivetechnology, carrying out ART), numerous results of study show, there is a temporary window phase in embryo nidation, and the embryo of implantation ability being arranged and have the Endometrium development of accepting embryo's ability is synchronously the key of implantation success.Endometrium receptivity refers to the ability to accept of endometrium to the embryo, allow the embryo to stick on it until the condition of having implanted, comprise developmental condition and the endometrial blood flow state of endometrium thickness, chamber epithelium, glandular epithelium and interstitial, closely related with pregnancy rate.
Kuntai capsule is by Radix Rehmanniae Preparata 600g, Rhizoma Coptidis 300g, Radix Paeoniae Alba 300g, Radix Scutellariae 300g, Colla Corii Asini 100g, Poria 100g, above Six-element, and Poria, Colla Corii Asini mixed powder are broken into fine powder; The decocting that Radix Scutellariae adds 100 ℃ of 5 times of amounts boils secondary, each 1.5 hours, filters merging filtrate; Three flavors such as all the other Radix Rehmanniae Preparata, after adding 5 times of water gaging soaked overnight, decoct secondary, each 1.5 hours, filters, filtrate and above-mentioned filtrate merge, and are concentrated into the about 1.10(70 ℃ of relative density) clear paste, spray drying, powder gets dry extract, mix with above-mentioned fine powder, incapsulate, make 1000, obtain.This product is capsule, and content is yellowish-brown or tan nanometer powder; Bitter in the mouth.Function cures mainly: nourishing YIN and clearing away heat, the relieving restlessness of calming the nerves.For all cards before and after menopause.The hyperactivity of fire caused by deficiency of YIN person, disease sees that hectic fever is flushing, spontaneous sweating, vexed not peaceful, insomnia and dreamful sleep, dizziness and tinnitus, soreness of the waist and knees, feverish sensation in the palms and soles; Women's ovary deterioration climacteric syndrome is shown in above-mentioned shower.
Summary of the invention
The purpose of this invention is to provide a kind of nano controlled-release capsule that improves endometrium receptivity; Further purpose of the present invention is to provide the female production method of improving the nano controlled-release capsule of endometrium receptivity.
In order to realize purpose of the present invention, intend adopting following technical scheme to be achieved:
One aspect of the present invention relates to a kind of nano controlled-release capsule that improves endometrium receptivity, it is characterized in that: get by Radix Rehmanniae Preparata, Rhizoma Coptidis, the Radix Paeoniae Alba, Radix Scutellariae, Colla Corii Asini, Poria, above Six-element, mixed powder is broken into fine powder, insert in the supercritical extraction tank, with pressure 20-24Mpa, temperature is 32-38 ℃, the condition extraction 3-4 hour that flow is 21-25L/h, take pressure as 5-7Mpa, temperature is 42-48 ℃ and is resolved, extract brown paste, add the ethanol of paste 10-15 times volume and the cyclodextrin of 2-4 times of weight, filter membrane sucking filtration after supersonic vibration evenly mixes, filtrate is 0.22 μ m filtering with microporous membrane with aperture again, filtrate obtains Chinese medicine extract through lyophilization, Chinese medicine extract is filled in enteric coated capsule, form the nano controlled-release capsule that improves endometrium receptivity.
In a preferred embodiment of the present invention, in every enteric coated capsule, the content of contained Chinese medicine extract is 0.7-0.8g.
In another preferred embodiment of the present invention, the raw material of Chinese medicine of the Radix Rehmanniae Preparata 500-700 that described Chinese medicine extract is following weight parts, Rhizoma Coptidis 200-400, Radix Paeoniae Alba 200-400, Radix Scutellariae 200-400, Colla Corii Asini 80-120, Poria 80-120, preferably, described raw material of Chinese medicine formula is Radix Rehmanniae Preparata 600 weight portions, Rhizoma Coptidis 300 weight portions, the Radix Paeoniae Alba 300 weight portions, Radix Scutellariae 300 weight portions, Colla Corii Asini 100 weight portions, Poria 100 weight portions.
In another preferred embodiment of the present invention, described cyclodextrin is α cyclodextrin and/or beta-schardinger dextrin-.
In a preferred embodiment of the present invention, the mean diameter of described Chinese medicine extract is 300nm, preferred, the distribution of particles more than 80% between 200-400nm,
In another preferred embodiment of the present invention, also comprise in described enteric coated capsule that other improves the western medicine component of endometrium receptivity.
The present invention also relates to the above-mentioned pharmaceutical applications that improves the nano controlled-release capsule of endometrium receptivity on the other hand.
In one aspect of the invention, the described nano controlled-release capsule of endometrium receptivity that improves is for improving endometrium thickness.
In another aspect of this invention, the described nano controlled-release capsule that improves endometrium receptivity is used for the treatment of infertility.
Nano controlled-release capsule of the present invention can effectively improve the content of active ingredient of Chinese herbs, contributes to improve endometrium receptivity, for the treatment infertility, certain curative effect is arranged.
The specific embodiment
Embodiment 1
Prepared by Chinese medicine extract of the present invention: get by the following method by Radix Rehmanniae Preparata 600g, Rhizoma Coptidis 300g, Radix Paeoniae Alba 300g, Radix Scutellariae 300g, Colla Corii Asini 100g, Poria 100g, above Six-element, mixed powder is broken into fine powder, insert in the supercritical extraction tank, with pressure 22Mpa, temperature is 35 ℃, the condition extraction 3-4 hour that flow is 21-25L/h, take pressure as 6Mpa, temperature is 45 ℃ and is resolved, extract brown paste, add the ethanol of paste 10-15 times volume and the beta-schardinger dextrin-of 3 times of weight, filter membrane sucking filtration after supersonic vibration evenly mixes, filtrate is 0.22 μ m filtering with microporous membrane with aperture again, filtrate obtains Chinese medicine extract through lyophilization, after testing, in the extract that the identical weight raw material obtains, the total content of baicalin is 1.5 times of institute's introduction method in background technology, the content of peoniflorin is 1.42 times, by method of the present invention, also can significantly improve the content of effective ingredient.
Cryodesiccated product redissolves through water, adopts dynamic light scattering to measure the particle diameter of solution, and after testing, mean diameter is 300nm, and the distribution of particles more than 80% is between 200-400nm, and resulting lyophilization product is nano-component.
The cryodesiccated product enteric coated capsule of packing into is made to enteric coated capsule (every capsules containing lyophilization product 0.75g).
Pharmacodynamic experiment:
Object of study all from December, 2012 to 2013 year July in the Zhejiang tertiary hospitals Out-patient Clinic of Department of Gynecology Sterility patient of seeking medical advice, totally 100 examples, 20 examples lost to follow-up, 20～44 years old age, on average (28 ± 2) year old, natural menstrual cycle 25～35d, it is normal that uterus normally reaches at least one side ovary.Get rid of abnormal uterine, polycystic ovarian syndrome (polycystic ovarian syndrome, the PCOS) patient such as intrauterine adhesion, uterus septus, uterine malformation, hysteromyoma and take too drastic plain class medicine person in nearly 1 month.
Therapeutic Method
Positive control: 40 routine Sterility patients start to take commercially available Kuntai capsule on the 5th day in the 3rd menstrual cycle, and each 4 (not having a pastille 0.5g), every day 3 times, 20d is 1 course for the treatment of, treats altogether 2 courses for the treatment of, the drug withdrawal in menstrual period, practise contraception during treatment.
40 routine Sterility patients start to take nano controlled-release capsule of the present invention on the 5th day in the 3rd menstrual cycle, and each 4, every day 3 times, 20d is 1 course for the treatment of, treats altogether 2 courses for the treatment of, and the drug withdrawal in menstrual period, practise contraception during treatment.
Observe endometrium thickness, form with transvaginal sonography before and after treatment, endometrium spiral artery hemodynamic parameter pulsatility index (PI), drag index (RI), statistical result is as shown in table 1.
Before and after table 1 treatment, endometrium thickness, PI and RI are relatively
| Group | Quantity | Inner film thickness/mm | PI | RI |
| Before treatment | 80 | 0.72±0.27 | 2.12±0.54 | 0.72±0.04 |
| Positive control | 40 | 0.95±0.15 | 1.58±0.37 | 0.62±0.05 |
| Treatment group | 40 | 1.08±0.12 | 1.45±0.46 | 0.55±0.03 |
From above statistical data, can find out, than positive controls, the endometrium thickness for the treatment of group, PI and RI and matched group comparing difference all have statistical significance (P<0.05).
The above is the preferred embodiments of the present invention; it should be pointed out that for those skilled in the art, under the prerequisite that does not break away from principle of the present invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (9)
1. a nano controlled-release capsule that improves endometrium receptivity, it is characterized in that: get by Radix Rehmanniae Preparata, Rhizoma Coptidis, the Radix Paeoniae Alba, Radix Scutellariae, Colla Corii Asini, Poria, above Six-element, mixed powder is broken into fine powder, insert in the supercritical extraction tank, with pressure 20-24Mpa, temperature is 32-38 ℃, the condition extraction 3-4 hour that flow is 21-25L/h, take pressure as 5-7Mpa, temperature is 42-48 ℃ and is resolved, extract brown paste, add the ethanol of paste 10-15 times volume and the cyclodextrin of 2-4 times of weight, filter membrane sucking filtration after supersonic vibration evenly mixes, filtrate is 0.22 μ m filtering with microporous membrane with aperture again, filtrate obtains Chinese medicine extract through lyophilization, Chinese medicine extract is filled in enteric coated capsule, form the nano controlled-release capsule that improves endometrium receptivity.
2. nano controlled-release capsule according to claim 1, in every enteric coated capsule, the content of contained Chinese medicine extract is 0.7-0.8g.
3. nano controlled-release capsule according to claim 1 and 2, the raw material of Chinese medicine of the Radix Rehmanniae Preparata 500-700 that described Chinese medicine extract is following weight parts, Rhizoma Coptidis 200-400, Radix Paeoniae Alba 200-400, Radix Scutellariae 200-400, Colla Corii Asini 80-120, Poria 80-120, preferably, described raw material of Chinese medicine formula is Radix Rehmanniae Preparata 600 weight portions, Rhizoma Coptidis 300 weight portions, the Radix Paeoniae Alba 300 weight portions, Radix Scutellariae 300 weight portions, Colla Corii Asini 100 weight portions, Poria 100 weight portions.
4. nano controlled-release capsule according to claim 1, described cyclodextrin is α cyclodextrin and/or beta-schardinger dextrin-.
5. according to the described nano controlled-release capsule of claim 1-4 any one, the mean diameter of described Chinese medicine extract is 300nm, and preferred, the distribution of particles more than 80% is between 200-400nm.
6. nano controlled-release capsule according to claim 5, also comprise in described enteric coated capsule that other improves the western medicine component of endometrium receptivity.
7. the pharmaceutical applications of the described nano controlled-release capsule of claim 1-6 any one.
8. purposes according to claim 7, the described nano controlled-release capsule of endometrium receptivity that improves is for improving endometrium thickness.
9. purposes according to claim 7, the described nano controlled-release capsule that improves endometrium receptivity is used for the treatment of infertility.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103690672A (en) * | 2013-12-31 | 2014-04-02 | 贵阳新天药业股份有限公司 | Controlled release preparation for treating dysfunctional uterine bleeding caused by female ovarian dysfunction and preparation method thereof |
| CN103961457A (en) * | 2013-12-31 | 2014-08-06 | 贵阳新天药业股份有限公司 | Medicine composition for treating colporrhagia in woman climacterium and preparation method of composition |
| CN107648594A (en) * | 2017-11-08 | 2018-02-02 | 广州市桐晖药业有限公司 | Clomiphene citrate capsules and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103690672A (en) * | 2013-12-31 | 2014-04-02 | 贵阳新天药业股份有限公司 | Controlled release preparation for treating dysfunctional uterine bleeding caused by female ovarian dysfunction and preparation method thereof |
| CN103961457A (en) * | 2013-12-31 | 2014-08-06 | 贵阳新天药业股份有限公司 | Medicine composition for treating colporrhagia in woman climacterium and preparation method of composition |
| CN103961457B (en) * | 2013-12-31 | 2016-01-20 | 贵阳新天药业股份有限公司 | Be used for the treatment of pharmaceutical composition of Woman climacteric vaginal hemorrhage and preparation method thereof |
| CN103690672B (en) * | 2013-12-31 | 2016-08-31 | 贵阳新天药业股份有限公司 | For treating controlled release preparation of anovulatory dysfunctional uterine hemorrhage that women's ovary dysfunction causes and preparation method thereof |
| CN107648594A (en) * | 2017-11-08 | 2018-02-02 | 广州市桐晖药业有限公司 | Clomiphene citrate capsules and preparation method thereof |
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| CN103432275B (en) | 2015-07-22 |
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