CN102688260B - Medicinal composition for treating vaginal dryness - Google Patents

Medicinal composition for treating vaginal dryness Download PDF

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Publication number
CN102688260B
CN102688260B CN2012101534859A CN201210153485A CN102688260B CN 102688260 B CN102688260 B CN 102688260B CN 2012101534859 A CN2012101534859 A CN 2012101534859A CN 201210153485 A CN201210153485 A CN 201210153485A CN 102688260 B CN102688260 B CN 102688260B
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China
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pharmaceutical composition
vaginal dryness
treatment
parts
chinese herbal
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CN2012101534859A
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CN102688260A (en
Inventor
梁磊
吴新荣
张绪慧
严华成
邓虹珠
刘志刚
姚晖
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General Hospital of Guangzhou Military Command
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General Hospital of Guangzhou Military Command
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Abstract

The invention discloses a medicinal composition for treating vaginal dryness. The composition comprises 50-80 wt% of Oviductus Ranae, and 20-50 wt% of Chinese herbal powder. The medicinal composition has effects in invigorating kidney and vital essence, nourishing Yin and blood, promoting qi circulation to remove stagnation; and can be used for treating symptoms such as vaginal dryness, sexual pain and sexual hypoactivity due to perimenopause or ovary dysfunction. The composition is simple in formula and production, and effective in curative effect, is prepared from pure Chinese medicinal materials, and has no toxic and side effects.

Description

A kind of pharmaceutical composition for the treatment of vaginal dryness
Technical field
The present invention relates to a kind of Chinese medicine composition, be specifically related to a kind of pharmaceutical composition for the treatment of vaginal dryness.
Background technology
Colpoxerosis, particularly since after oophorectomize or the menopause because hypo-ovaria, estrogen level reduces, the reproduction of estrogen sensitivity, urinary organs generation atrophic are changed and see a series of changes, disappear with vaginal mucosa atrophy attenuation, pleat, cervical secretions and vagina transudate reduce, and lubricity descends, vagina follows the string and expanding ability is main manifestations, further develops stricture of vagina can occur, shorten.Main manifestations is that hectic fever sweating, dysphoria with smothery sensation are uncomfortable in chest, insomnia, anxiety, and vaginal dryness appears in the generation Urogenital atrophy shape that continues, dyspareunia and vaginal infection etc. repeatedly.
Colpoxerosis belongs to the traditional Chinese medical science " leukorrhagia is very few " category after the menopause, the cloudy liquid of band subordinate, and the internal organs maximum with cloudy liquid relation are kidney, spleen." the contrary opinion of transferring of Plain Questions " says " kidney person water is dirty, main body fluid ".The traditional Chinese medical science thinks that the physiological leukorrhagia is by kidney essense instituteization, and again because The spleen has the function to transport and transform nutrients, transmission body fluid is respectively walked its road, and its infiltrating irrigation is empty key in the external genitalia, is leukorrhagia with closing after the essence, and leukorrhagia takes charge of by conception vessel, and the dai channel constraint by uterus exudation and moistening vagina, and can defend exopathogen to invade.Behind the postmenopausal women, conception vessel is empty, and taichong channel declines few, and so exhaustion of kidney-essence with promoting reproductive function, deficiency of kidney-essence, deficiency of kidney yin are difficult to conserve edema with the liver involved caused by liver and kidney deficiency, the insufficiency of blood damage of essence, and cloudy liquid does not fill, and appoints band to lose and supports, and can not moisten vagina, is primary disease and send out.Doctor trained in Western medicine is treated with complementing estrogen, but oral estrogen has carcinogenic risk, and can cause the discomforts such as headache, edema, pigmentation, and then therapeutic effect is not good for local use estrogen.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of vaginal dryness.
The technical solution adopted in the present invention is:
A kind of pharmaceutical composition for the treatment of vaginal dryness contains the Oviductus Ranae of 50~80% quality.
A kind of pharmaceutical composition for the treatment of vaginal dryness by weight, contains the Oviductus Ranae of 50~80% quality, the Chinese herbal medicine powder of 20~50% quality, described Chinese herbal medicine powder is prepared by following methods: take by weighing 10~40 parts of Fructus Ligustri Lucidi, 10~40 parts of Herba Ecliptaes, 5~20 parts of Radix Angelicae Sinensis, 5~20 parts of Rhizoma Chuanxiongs, the water of 10~20 times of quality of adding, heated and boiled is extracted 1~3h, filters, and filtering residue continues to add entry, repeat to extract 1~3 time, merging filtrate, being dried to water content is 3~10%, namely gets Chinese herbal medicine powder.
Described filtration refers to filter with 20 ~ 120 eye mesh screens.
Described drying refers to that first filtrate being concentrated into solid content is 20~40%, again with concentrated solution heating and spray drying.
Described Oviductus Ranae grinds to form 80~120 purpose fine powders under 4~15 ℃.
The dosage form of described pharmaceutical composition comprises oral formulations.
Described oral formulations comprises tablet, capsule, pill, electuary, powder or oral liquid.
Oviductus Ranae is the fallopian tube of the female frog of ranid Rana temporaria chensinensis David Rana temporaria chensinensis David, gets through gathering and processing drying.Has the kidney invigorating and essence nourishing, the effect of nourishing YIN and moistening the lung.
Fructus Ligustri Lucidi is the dry mature fruit of Oleaceae plants Fructus Ligustri Lucidi Ligustrum lucidum Ait..Have nourishing liver, kidney, the effect of the black hair that makes eye bright.
Herba Ecliptae is the herb of feverfew Eclipta prostrata Eclipta prostrata (L.) L., has removing heat from blood, hemostasis, the kidney invigorating, the effect of tonifying YIN.
When being classified as umbelliferae angelica Angelica sinensis(Oliv.) dry root of Diels.Having enriches blood invigorates blood circulation, menstruction regulating and pain relieving, the effect of loosening bowel to relieve constipation.
Rhizoma Chuanxiong is for being the dry rhizome of samphire Rhizoma Chuanxiong Ligusticum chuanriong Hort..Has blood-activating and qi-promoting, the effect of wind-expelling pain-stopping.
Beneficial effect of the present invention is:
Pharmaceutical composition of the present invention can the kidney invigorating and essence nourishing, nourishing YIN and benefiting blood, and activating QI to alleviate the depression can be used for treating the women owing to enter climacteric or symptoms such as vaginal dryness, dyspareunia and hyposexuality that ovarian function descends and causes.And its prescription is simple, produces easyly, adopts pure Chinese medicine to make, and is evident in efficacy, has no side effect.
The specific embodiment
The present invention is further illustrated below in conjunction with embodiment, but be not limited to this.
Embodiment 1
The preparation method 1 of Chinese herbal medicine powder
Take by weighing 20 parts of Fructus Ligustri Lucidi, 20 parts of Herba Ecliptaes, 10 parts of Radix Angelicae Sinensis, 10 parts of Rhizoma Chuanxiongs, the water of 20 times of quality of adding, behind the immersion 30min, heated and boiled is extracted 2h, filters (100 eye mesh screen); Filtering residue continues to add the water of 10 times of quality, boils and extracts 1h, filters merging filtrate; In filtrate suction concentration tank, vacuum is 0.08Mpa, 90 ℃ of temperature, and being concentrated into solid content is 20.0%; Concentrated solution is heated to 80 ± 5 ℃, 185 ℃ of air intakes, 90 ℃ of air-out, wind flow 1.10m are set 2/ min, atomizing pressure 11 * 10kPa, moisture Control is 3%, and spray drying is collected dry powder, crosses 80 mesh sieves, namely gets Chinese herbal medicine powder, room temperature preservation.
Embodiment 2
The preparation method 2 of Chinese herbal medicine powder
Take by weighing 10 parts of Fructus Ligustri Lucidi, 10 parts of Herba Ecliptaes, 10 parts of Radix Angelicae Sinensis, 5 parts of Rhizoma Chuanxiongs, the water of 10 times of quality of adding, behind the immersion 30min, heated and boiled is extracted 2h, filters (80 eye mesh screen); Filtering residue continues to add the water of 10 times of quality, boils and extracts 1h, filters; Filtering residue continues to add the water of 10 times of quality, boils and extracts 1h, filters merging filtrate; In filtrate suction concentration tank, vacuum is 0.08Mpa, 90 ℃ of temperature, and being concentrated into solid content is 30.0%; Concentrated solution is heated to 80 ± 5 ℃, 185 ℃ of air intakes, 90 ℃ of air-out, wind flow 1.10m are set 2/ min, atomizing pressure 11 * 10kPa, moisture Control is 5%, and spray drying is collected dry powder, namely gets Chinese herbal medicine powder, room temperature preservation.
Embodiment 3
The preparation method 3 of Chinese herbal medicine powder
Take by weighing 40 parts of Fructus Ligustri Lucidi, 20 parts of Herba Ecliptaes, 5 parts of Radix Angelicae Sinensis, 20 parts of Rhizoma Chuanxiongs, the water of 10 times of quality of adding, behind the immersion 30min, heated and boiled is extracted 2h, filters (120 eye mesh screen); Filtering residue continues to add the water of 10 times of quality, boils and extracts 1h, filters; Filtering residue continues to add the water of 10 times of quality, boils and extracts 1h, filters merging filtrate; In filtrate suction concentration tank, vacuum is 0.08Mpa, 90 ℃ of temperature, and being concentrated into solid content is 30.0%; Concentrated solution is heated to 80 ± 5 ℃, 185 ℃ of air intakes, 90 ℃ of air-out, wind flow 1.10m are set 2/ min, atomizing pressure 11 * 10kPa, moisture Control is 5%, and spray drying is collected dry powder, namely gets Chinese herbal medicine powder, room temperature preservation.
Embodiment 4
The preparation method 4 of Chinese herbal medicine powder
Take by weighing 40 parts of Fructus Ligustri Lucidi, 40 parts of Herba Ecliptaes, 20 parts of Radix Angelicae Sinensis, 10 parts of Rhizoma Chuanxiongs, the water of 20 times of quality of adding, behind the immersion 30min, heated and boiled is extracted 2h, filters (100 eye mesh screen); Filtering residue continues to add the water of 10 times of quality, boils and extracts 1h, filters merging filtrate; In filtrate suction concentration tank, vacuum is 0.08Mpa, 90 ℃ of temperature, and being concentrated into solid content is 20.0%; Concentrated solution is heated to 80 ± 5 ℃, 185 ℃ of air intakes, 90 ℃ of air-out, wind flow 1.10m are set 2/ min, atomizing pressure 11 * 10kPa, moisture Control is 3%, and spray drying is collected dry powder, namely gets Chinese herbal medicine powder, room temperature preservation.
Embodiment 5
The preparation method 5 of Chinese herbal medicine powder
Take by weighing 10 parts of Fructus Ligustri Lucidi, 10 parts of Herba Ecliptaes, 5 parts of Radix Angelicae Sinensis, 5 parts of Rhizoma Chuanxiongs, the water of 20 times of quality of adding, behind the immersion 30min, heated and boiled is extracted 3h, filters (100 eye mesh screen); Filtering residue continues to add the water of 10 times of quality, boils and extracts 1h, filters merging filtrate; In filtrate suction concentration tank, vacuum is 0.08Mpa, 90 ℃ of temperature, and being concentrated into solid content is 20.0%; Concentrated solution is heated to 80 ± 5 ℃, 185 ℃ of air intakes, 90 ℃ of air-out, wind flow 1.10m are set 2/ min, atomizing pressure 11 * 10kPa, moisture Control is 3%, and spray drying is collected dry powder, namely gets Chinese herbal medicine powder, room temperature preservation.
Embodiment 6
A kind of pharmaceutical composition for the treatment of vaginal dryness, it is as follows to fill a prescription:
4 ℃ of Oviductus Ranaes are ground to micropowder (80 order), get Chinese herbal medicine powder 50 mass parts of Oviductus Ranae micropowder 50 mass parts, embodiment 1 and mix, and get final product.
Embodiment 7
A kind of pharmaceutical composition for the treatment of vaginal dryness, it is as follows to fill a prescription:
10 ℃ of Oviductus Ranaes are ground to micropowder (120 order), get Chinese herbal medicine powder 20 mass parts of Oviductus Ranae micropowder 80 mass parts, embodiment 1 and mix, and get final product.
Embodiment 8
A kind of pharmaceutical composition for the treatment of vaginal dryness, it is as follows to fill a prescription:
8 ℃ of Oviductus Ranae low temperature are ground to micropowder (100 order), get Chinese herbal medicine powder 40 mass parts of Oviductus Ranae micropowder 60 mass parts, embodiment 2 and mix, and get final product.
Embodiment 9
A kind of pharmaceutical composition for the treatment of vaginal dryness, it is as follows to fill a prescription:
4 ℃ of Oviductus Ranaes are ground to micropowder (80 order), get Chinese herbal medicine powder 20 mass parts of Oviductus Ranae micropowder 80 mass parts, embodiment 3 and mix, and get final product.
Embodiment 10
A kind of pharmaceutical composition for the treatment of vaginal dryness, it is as follows to fill a prescription:
4 ℃ of Oviductus Ranaes are ground to micropowder (80 order), get Chinese herbal medicine powder 30 mass parts of Oviductus Ranae micropowder 70 mass parts, embodiment 4 and mix, and get final product.
Embodiment 11
A kind of pharmaceutical composition for the treatment of vaginal dryness, it is as follows to fill a prescription:
4 ℃ of Oviductus Ranaes are ground to micropowder (80 order), get Chinese herbal medicine powder 40 mass parts of Oviductus Ranae micropowder 60 mass parts, embodiment 5 and mix, and get final product.
The preparation method of medicament composition capsule of the present invention:
Above-mentioned pharmaceutical composition is placed high-speed mixing granulating machine by formula ratio, mix homogeneously; The ethanol that evenly drips slurry 75% is granulated, and starts stirring arm, fly cutter, makes moistening, epigranular soft material; Granule after granulating is tiled in the pallet, puts in the baking oven dryly, temperature is controlled at 55 ℃ ± 5 ℃, stops during moisture≤6%; Granule after the oven dry is crossed 16 mesh sieve granulate; Uniform particles behind the granulate is filled full capsule, namely get medicament composition capsule of the present invention.
The preparation method of medicinal composition tablets of the present invention:
The magnesium stearate that adds 0.5% quality in the above-mentioned pharmaceutical composition, tabletting 9mm scrobicula punching press label (the heavy 0.2g of sheet) rushes scrobicula punching press guar gum clothing 0.08g with 11mm again, namely gets tablet.
The usage and dosage of embodiment 6~11 gained pharmaceutical compositions:
Adult (take 70kg as example) is each serving with pharmaceutical composition 2~10g of the present invention ,Every day 2 times, successive administration 30 days, drug withdrawal repeated a treatment after having a rest 10 days.At least use 2 courses for the treatment of.
Only for introducing preferred case of the present invention, to those skilled in the art, any apparent changes and improvements of carrying out in the scope that does not deviate from spirit of the present invention all should be regarded as a part of the present invention to above embodiment.
Effect experiment
1, pharmacodynamic experiment
For the castration SD female rats (model in menopause) of Bilateral oophorectomy, be divided at random experimental group (minute high, medium and low dosage group), model group and sham operated rats.Model group and sham operated rats gavage vegetable oil, experimental group gavage respectively contain embodiment 6, embodiment 9 drug regimen object heights (5g/kg), in the aqueous solution of (2.5g/kg), low (1.25g/kg) dosage, continuous 4 weeks.
Compare Ovariectomized Rat Serum E with sham operated rats 2Level obviously reduces (p<0.01), and LH, FSH level obviously raise (p<0.01 or<0.05), and be consistent with bibliographical information, and the modeling success is described.
The height of embodiment 6 and embodiment 9 pharmaceutical compositions, middle dosage group all can significantly improve rat model serum E 2Level (P<0.05).Simultaneously, model control group is compared with sham operated rats, and the content of 5-HT, 5-HIAA is obviously rising (P<0.01 or P<0.05) all; DA, NE content (P<0.05).The height of two groups of pharmaceutical compositions, middle dosage group all have remarkable reducing effect (P<0.05) to the content of 5-HT, 5HIAA that castrated rats raises, NE, DA level (P<0.05) that high, middle dosage also can significantly raise and reduce after the rat castration.Rat vagina organizes the HE coloration result to show: administration group rat vagina wall thickens than model group, and the mucous epithelium level significantly increases, surperficial keratinization, lamina propria tissue looseness.
The result shows, the pharmaceutical composition of the present invention castrated rats estrogen level that can raise is regulated NE, DA, 5-HT, 5-HIAA in the brain, repairing model group vaginal mucosa layer.
2, toxicity test
With Cmax, the heap(ed) capacity 249 g/kg disposable pharmaceutical composition that gives mice embodiment 6~11 respectively, to observe 7 days, mice all survives, and has no toxicity.
3, clinical trial
Outpatient service is carried out clinical experiment in order to the tablet (every contains crude drug 3.2g) of the embodiment of the invention 6, treats 50 routine female patients, age 35-58 year, usage is as follows: each 2, and every day 2 times, successive administration 30 days, drug withdrawal repeated a treatment after having a rest 10 days, used 2 courses for the treatment of.In 50 cases, effective 42 examples, 8 examples that take a turn for the better, the patient is without telling discomfort, total effective rate 100%.
Only for introducing preferred case of the present invention, to those skilled in the art, any apparent changes and improvements of carrying out in the scope that does not deviate from spirit of the present invention all should be regarded as a part of the present invention to above embodiment.

Claims (6)

1. pharmaceutical composition for the treatment of vaginal dryness, by weight, by the Oviductus Ranae of 50~80% quality, the Chinese herbal medicine powder of 20~50% quality forms, and described Chinese herbal medicine powder is prepared by following methods: take by weighing 10~40 parts of Fructus Ligustri Lucidi, 10~40 parts of Herba Ecliptaes, 5~20 parts of Radix Angelicae Sinensis, 5~20 parts of Rhizoma Chuanxiongs, the water of 10~20 times of quality of adding, heated and boiled is extracted 1~3h, filters, and filtering residue continues to add entry, repeat to extract 1~3 time, merging filtrate, being dried to water content is 3~10%, namely gets Chinese herbal medicine powder.
2. the pharmaceutical composition for the treatment of vaginal dryness according to claim 1 is characterized in that, described filtration refers to filter with 20 ~ 120 eye mesh screens.
3. the pharmaceutical composition for the treatment of treatment vaginal dryness according to claim 1 is characterized in that described drying refers to that first filtrate being concentrated into solid content is 20~40%, again with concentrated solution heating and spray drying.
4. the pharmaceutical composition for the treatment of vaginal dryness according to claim 1 is characterized in that, described Oviductus Ranae grinds to form 80~120 purpose fine powders under 4~15 ℃.
5. the pharmaceutical composition of each described treatment vaginal dryness is characterized in that according to claim 1 ~ 4, and the dosage form of described pharmaceutical composition comprises oral formulations.
6. the pharmaceutical composition of described treatment vaginal dryness according to claim 5 is characterized in that described oral formulations comprises tablet, capsule, pill, electuary, powder or oral liquid.
CN2012101534859A 2012-05-17 2012-05-17 Medicinal composition for treating vaginal dryness Expired - Fee Related CN102688260B (en)

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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102908398B (en) * 2012-11-06 2014-03-05 南方医科大学 Medicinal composition for relieving female sexual fatigue
CN114949150B (en) * 2022-07-27 2022-11-04 广州科犁医学研究有限公司 Pharmaceutical composition for treating perimenopausal syndrome and preparation method and application thereof

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Publication number Priority date Publication date Assignee Title
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CN1806840A (en) * 2005-01-21 2006-07-26 中国科学院上海药物研究所 Chinese medicinal compound preparation and its preparing process
CN101284121A (en) * 2007-04-13 2008-10-15 范广伦 Combination medicine for curing the hoary hair
CN101361789A (en) * 2008-09-28 2009-02-11 中国人民解放军第四军医大学 Traditional Chinese medicine formulation for treating and preventing lung impairment after tumor controlling radiotherapy

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Inventor after: Liang Lei

Inventor after: Wu Xinrong

Inventor after: Zhang Xuhui

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Inventor after: Deng Hongzhu

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Inventor after: Yao Hui

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Free format text: CORRECT: INVENTOR; FROM: LIANG LEI WU XINRONG ZHANG XUHUI DENG HONGZHU LIU ZHIGANG YAO HUI TO: LIANG LEI WU XINRONG ZHANG XUHUI YAN HUACHENG DENG HONGZHU LIU ZHIGANG YAO HUI

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