CN103432275B - 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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- CN103432275B CN103432275B CN201310388434.9A CN201310388434A CN103432275B CN 103432275 B CN103432275 B CN 103432275B CN 201310388434 A CN201310388434 A CN 201310388434A CN 103432275 B CN103432275 B CN 103432275B
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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 the nano controlled-release capsule and the application thereof that improve endometrium receptivity.
Background technology
Along with Issues of Human Assisted Reproductive Technologies (assisted reproductivetechnology, carrying out ART), numerous result of study display, there is a temporary window phase in embryo nidation, having the embryo of implantation ability and having the Endometrium development accepting embryo's ability is synchronously that implantation is successfully crucial.Endometrium receptivity refers to the ability to accept of endometrium to embryo, namely embryo is allowed to stick on it until the condition implanted, comprise the developmental condition of endometrium thickness, chamber epithelium, glandular epithelium and interstitial and endometrial blood flow state, 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; Radix Scutellariae adds the soak by water secondary of 5 times amount 100 DEG C, each 1.5 hours, filters, merging filtrate; Three tastes such as all the other Radix Rehmanniae Preparata, add after 5 times amount water soakings spend the night, decoct secondary, each 1.5 hours, filter, filtrate and above-mentioned filtrate merge, and are concentrated into relative density and are about 1.10(70 DEG C) clear paste, spraying dry, get dry extract powder, mix with above-mentioned fine powder, incapsulate, make 1000, to obtain final product.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, relieving restlessness of calming the nerves.For cards all before and after menopause.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 object of this invention is to provide a kind of nano controlled-release capsule improving endometrium receptivity; A further object of the present invention is to provide the female production method improving the nano controlled-release capsule of endometrium receptivity.
In order to realize object 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 improving 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 supercritical extraction tank, with pressure 20-24Mpa, temperature is 32-38 DEG C, flow is the condition extraction 3-4 hour of 21-25L/h, take pressure as 5-7Mpa, temperature is 42-48 DEG C and resolves, 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 Homogeneous phase mixing, filtrate is 0.22 μm of 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 improving endometrium receptivity.
In a preferred embodiment of the present invention, the content of contained in every enteric coated capsule Chinese medicine extract is 0.7-0.8g.
In another preferred embodiment of the present invention, described Chinese medicine extract is the raw material of Chinese medicine of Radix Rehmanniae Preparata 500-700, the Rhizoma Coptidis 200-400 of following weight parts, 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 portion, Rhizoma Coptidis 300 weight portion, the Radix Paeoniae Alba 300 weight portion, Radix Scutellariae 300 weight portion, Colla Corii Asini 100 weight portion, Poria 100 weight portion.
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, preferably, the distribution of particles of more than 80% between 200-400nm,
In another preferred embodiment of the present invention, in described enteric coated capsule, also comprise the western medicine component that other improves endometrium receptivity.
The present invention also relates to the above-mentioned pharmaceutical applications improving the nano controlled-release capsule of endometrium receptivity on the other hand.
In one aspect of the invention, the nano controlled-release capsule of described improvement endometrium receptivity is for improving endometrium thickness.
In another aspect of this invention, the nano controlled-release capsule of described improvement endometrium receptivity is used for the treatment of infertility.
Nano controlled-release capsule of the present invention effectively can improve the content of active ingredient of Chinese herbs, contributes to improving endometrium receptivity, has certain curative effect for treatment infertility.
Detailed description of the invention
Embodiment 1
Chinese medicine extract of the present invention is prepared by the following method: get 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 supercritical extraction tank, with pressure 22Mpa, temperature is 35 DEG C, flow is the condition extraction 3-4 hour of 21-25L/h, take pressure as 6Mpa, temperature is 45 DEG C and resolves, 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 Homogeneous phase mixing, filtrate is 0.22 μm of filtering with microporous membrane with aperture again, filtrate obtains Chinese medicine extract through lyophilization, after testing, 1.5 times that in the extract that identical weight raw material obtains, the total content of baicalin is institute's introduction method in background technology, the content of peoniflorin is 1.42 times, also can be significantly improved the content of effective ingredient by method of the present invention.
Cryodesiccated product redissolves through water, and adopt dynamic light scattering to measure the particle diameter of solution, after testing, mean diameter is 300nm, and the distribution of particles of more than 80% is between 200-400nm, and namely obtained lyophilization product is nano-component.
Cryodesiccated product is loaded enteric coated capsule and make enteric coated capsule (every capsules is containing lyophilization product 0.75g).
Pharmacodynamic experiment:
Object of study all to be sought medical advice Sterility patient, 100 examples in Zhejiang tertiary hospitals Out-patient Clinic of Department of Gynecology from December, 2012 to 2013 year July totally, 20 examples lost to follow-up, 20 ~ 44 years old age, on average (28 ± 2) year, natural menstrual cycle 25 ~ 35d, normally and at least side ovary is normal in uterus.Get rid of abnormal uterine, polycystic ovarian syndrome (polycystic ovariansyndrome, the PCOS) patients such as intrauterine adhesion, uterus septus, uterine malformation, hysteromyoma and in nearly 1 month, take too drastic plain class medicine person.
Therapeutic Method
Positive control: 40 routine Sterility patients start to take commercially available Kuntai capsule in the 3rd menstrual cycle on the 5th day, each 4 (not having a pastille 0.5g), every day 3 times, 20d is 1 course for the treatment of, treats 2 courses for the treatment of altogether, drug withdrawal in menstrual period, and treatments period is practised contraception.
40 routine Sterility patients start to take nano controlled-release capsule of the present invention, each 4, every day 3 times in the 3rd menstrual cycle on the 5th day, and 20d is 1 course for the treatment of, treat 2 courses for the treatment of altogether, drug withdrawal in menstrual period, and treatments period is practised contraception.
Treatment front and back transvaginal sonography observes endometrium thickness, form, and endometrial spiral dynamics of arterial flow parameter beat index (PI), drag index (RI), statistical result is as shown in table 1.
Front and back endometrium thickness treated by table 1, PI and RI compares
| 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 |
As can be seen from above statistical data, compared to 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 not departing 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 (5)
1. one kind is improved the nano controlled-release capsule of 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 supercritical extraction tank, with pressure 20-24Mpa, temperature is 32-38 DEG C, flow is the condition extraction 3-4 hour of 21-25L/h, take pressure as 5-7Mpa, temperature is 42-48 DEG C and resolves, 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 Homogeneous phase mixing, filtrate is 0.22 μm of 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 improving endometrium receptivity, described Chinese medicine extract is made up of the raw material of Chinese medicine of the weight portion of Radix Rehmanniae Preparata 500-700, Rhizoma Coptidis 200-400, Radix Paeoniae Alba 200-400, Radix Scutellariae 200-400, Colla Corii Asini 80-120, Poria 80-120, and the mean diameter of described Chinese medicine extract is 300nm.
2. nano controlled-release capsule according to claim 1, the content of Chinese medicine extract contained in every enteric coated capsule is 0.7-0.8g.
3. nano controlled-release capsule according to claim 1 and 2, described raw material of Chinese medicine formula is Radix Rehmanniae Preparata 600 weight portion, Rhizoma Coptidis 300 weight portion, the Radix Paeoniae Alba 300 weight portion, Radix Scutellariae 300 weight portion, Colla Corii Asini 100 weight portion, Poria 100 weight portion.
4. nano controlled-release capsule according to claim 1, described cyclodextrin is α cyclodextrin and/or beta-schardinger dextrin-.
5. nano controlled-release capsule according to claim 1, the particle size distribution of the Chinese medicine extract of more than 80% is between 200-400nm.
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| 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 |
| 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 |
| 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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| JPH06107555A (en) * | 1992-04-17 | 1994-04-19 | Chong-Kook Kim | Oriental bezoar microcapsule and preparation thereof |
| CN100363031C (en) * | 2005-09-21 | 2008-01-23 | 江西心正药业有限责任公司 | Kuntai tablet preparation and preparation thereof |
| CN101439188B (en) * | 2008-12-15 | 2010-11-10 | 中国人民武装警察部队医学院 | Polymer lyophilized preparation of insoluble anti-tumor medicament |
| CN101524404B (en) * | 2009-04-09 | 2012-05-16 | 淄博开发区亚大制药有限责任公司 | Enteric sustained and controlled release capsule |
| CN101940745B (en) * | 2010-09-07 | 2012-01-18 | 哈药集团三精千鹤望奎制药有限公司 | Jinji blood stasis eliminating particles and preparation method thereof |
| CN102309414B (en) * | 2011-09-22 | 2014-02-26 | 贵阳新天药业股份有限公司 | Dry-process granulation method of kuntai capsule |
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