CN103239676A - Topical pharmaceutical composition for preventing and treating bacterial vaginosis - Google Patents
Topical pharmaceutical composition for preventing and treating bacterial vaginosis Download PDFInfo
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Abstract
The invention provides a topical pharmaceutical composition for preventing and treating bacterial vaginosis. The pharmaceutical composition comprises the following traditional Chinese medicine materials in parts by mass: 25-35 parts of curcuma zedoary, 20-30 parts of fructus cnidii, 45-55 parts of radix sophorae flavescentis, 5-15 parts of alumen, 10-20 parts of fructus kochiae, 10-20 parts of rhizoma atractylodis, 90-110 parts of flos rosae rugosae, 10-14 parts of golden cypress, 8-10 parts of cortex dictamni, 4-6 parts of borneol, 8-12 parts of aloe vera gel, 1-3 parts of vitamin E, 0.1-0.2 part of hyaluronic acid, 0.2-0.4 part of polyhexamethylene biguanide hydrochloride, and 1-2 parts of lactic acid milk. The pharmaceutical composition provided by the invention has obvious inhibition effect on bacteria, also has obvious inhibition effect on candida albicans, but has no inhibition effect on lactobacillus. The pharmaceutical composition has obvious treatment effect on female bacterial vaginosis after clinical use, and has no stimulation on vagina.
Description
Technical field
The invention belongs to field of traditional Chinese, be specifically related to a kind of externally-applied medicinal composition that is used for the treatment of bacterial vaginosis.
Background technology
Bacterial vaginosis is one of modal vaginal infection disease of women's child-bearing period, cause outside the colpitis, also can cause other many badness come-offs, as sterility and infertility and miscarriage, endometritis, pelvic inflammation etc., its sickness rate occupies first of the colpitis, is a kind of disease of serious threat female reproduction health.
The medicine that is usually used in treating vaginosis at present has ciprofloxacin, ofloxacin, cephalosporin etc., can be used for killing relevant pathogenic microorganism, but also destroyed intravaginal profitable strain simultaneously, so that various antibacterials grow rapidly after the drug withdrawal, occur the various symptoms of vaginitis or vaginosis again, abnormal leucorrhea and foreign odor etc. occur.Other common external used medicines also have some bacterium detergents that are used for fumigation and wash method demibain or vagina lavation, pudendal pruritus lotion etc., these medicines or because using inconvenience, or because of unsatisfactory curative effect, or because of expensive etc., make clinical use limited.
Summary of the invention
The object of the present invention is to provide a kind of externally-applied medicinal composition that is used for the treatment of bacterial vaginosis, it contains the raw material of Chinese medicine of following mass parts: 25～35 parts of Rhizoma Curcumae, 20～30 parts of Fructus Cnidiis, 45～55 parts of Radix Sophorae Flavescentiss, 5～15 parts of Alumens, 10～20 parts of the Fructus Kochiae, 10～20 parts of Rhizoma Atractylodis, 90～110 parts of Flos Rosae Rugosaes, 10～14 parts of Cortex Phellodendris, 8～10 parts of Cortex Dictamni, 4～6 parts of Borneolum Syntheticums, 8～12 parts of Aloe glues, vitamin e1～3 part, 0.1～0.2 part of hyaluronic acid, 0.2～0.4 part of hexamethylene, 1～2 part of milk lactic acid.
Wherein, Rhizoma Curcumae is the dry rhizome of zingiberaceous plant Rhizoma Curcumae Curcuma phaeocaulis Val., Guangxi zedoary Curcuma kwangsiensis S.G.Lee et C.F.Liang or RADIX CURCUMAE Curcuma wenyujin Y.H.Chen et C.Ling.Has the circulation of qi promoting removing blood stasis, the effect of removing food stagnancy pain relieving.
Fructus Cnidii is the dry mature fruit of samphire cnidium monnieri Cnidium monnieri (L.) Cuss..Have warming the kidney to invigorate YANG, dampness is dispeled the wind, the effect of parasite killing.
Radix Sophorae Flavescentis is the dry root of leguminous plant Radix Sophorae Flavescentis Sophora flavescens Ait..Has heat clearing and damp drying, parasite killing, the effect of diuresis.
Alumen is that Sulfates mineral alunite is made through the processing refinement.External detoxifcation parasite killing, dampness removing to stop itchin; Hemostasis antidiarrheal for oral administration is dispeled wind-phlegm.
The Fructus Kochiae is the dry mature fruit of Li Ke plant Fructus Kochiae Kochia scoparia (L.) Schrad..Be used for difficulty and pain in micturition, pudendal pruritus leukorrhagia, rubella, eczema, skin pruritus.
Rhizoma Atractylodis are feverfew Atractylodes lancea (Thunb.) DC. Atractylode lancea (Thunb.) DC. or Atractylis chinensis Atracctylodes chinensis (DC.) Koidz.Dry rhizome.Be used for distension and fullness in the abdomen, have loose bowels edema, beriberi flaccidity of feet with lamenness, rheumatic arthralgia, anemofrigid cold. nyctalopia.
Flos Rosae Rugosae is the dry flower of rosaceous plant Flos Rosae Rugosae Rosa rugosa Thunb..Have promoting QI circulation for relieving depression, and blood, the effect of pain relieving.
Cortex Phellodendri is the dry bark of rutaceae wampee Phellodendron chinenseSchneid..Have heat clearing and damp drying, pathogenic fire purging is except steaming, and the effect of skin ulcer is treated in detoxifcation.
Cortex Dictamni is the drying newspaper skin of rutaceae shaggy-fruited dittany Dictamnus dasycarpus Turcz..Have heat clearing and damp drying. the effect of the detoxifcation of dispeling the wind.
Preferably, described pharmaceutical composition contains the raw material of Chinese medicine of following mass parts: Rhizoma Curcumae 30 mass parts, 25 parts of Fructus Cnidiis, 50 parts of Radix Sophorae Flavescentiss, 10 parts of Alumens, 15 parts of the Fructus Kochiae, 15 parts of Rhizoma Atractylodis, 100 parts of Flos Rosae Rugosaes, 12 parts of Cortex Phellodendris, 9 parts of Cortex Dictamni, 5 parts of Borneolum Syntheticums, 10 parts of Aloe glues, vitamin E2 part, 0.1 part of hyaluronic acid, 0.2 part of hexamethylene, 1 part of milk lactic acid.
Described preparation of drug combination method comprises the steps:
(1) takes by weighing Rhizoma Curcumae, Fructus Cnidii, Radix Sophorae Flavescentis, Alumen, the Fructus Kochiae, Rhizoma Atractylodis, Flos Rosae Rugosae, Cortex Phellodendri, Cortex Dictamni by prescription, after the Mechanical Crushing, add 2～5 times of volume 60%～85% ethanol water reflux, extract, 1～3 time, each 1～2 hour;
(2) merge extractive liquid,, decompression recycling ethanol filters to there not being the alcohol flavor, discards filtering residue, released liquor;
(3) Borneolum Syntheticum of adding formula ratio, Aloe glue, vitamin E, hyaluronic acid, poly-hexamethyl biguanide hydrochloride, milk lactic acid in the medicinal liquid, mix homogeneously adds pharmaceutically acceptable carrier or adjuvant again, is prepared into exterior-applied formulation.
Described exterior-applied formulation comprises: water preparation, gel, tablet, suppository etc.
Beneficial effect of the present invention is:
Pharmaceutical composition of the present invention has the obvious suppression effect to antibacterial, Candida albicans is also had obvious inhibitory action, but lactobacillus is not had inhibitory action.Show that after clinical use this pharmaceutical composition has the obvious treatment effect to women's bacterial vaginosis, and vagina is had no stimulation.
The specific embodiment
Further explain the present invention below in conjunction with embodiment.Should be understood that these embodiment only to be used for explanation the present invention and be not used in and limit the scope of the invention.
Embodiment 1
A kind of externally-applied medicinal composition that is used for the treatment of bacterial vaginosis is made up of the raw material of Chinese medicine of following mass parts: 25 parts of Rhizoma Curcumae, 20 parts of Fructus Cnidiis, 45 parts of Radix Sophorae Flavescentiss, 55 parts of Alumens, 10 parts of the Fructus Kochiae, 10 parts of Rhizoma Atractylodis, 90 parts of Flos Rosae Rugosaes, 10 parts of Cortex Phellodendris, 8 parts of Cortex Dictamni, 4 parts of Borneolum Syntheticums, 8 parts of Aloe glues, vitamin e1 part, 0.1 part of hyaluronic acid, 0.2 part of hexamethylene, 1 part of milk lactic acid.
The water preparation made from aforementioned pharmaceutical compositions comprises the steps:
(1) take by weighing Rhizoma Curcumae, Fructus Cnidii, Radix Sophorae Flavescentis, Alumen, the Fructus Kochiae, Rhizoma Atractylodis, Flos Rosae Rugosae, Cortex Phellodendri, Cortex Dictamni by prescription, after the Mechanical Crushing, the ethanol water reflux, extract, of 2～53 times of volumes 65% of adding 3 times, each 1.5 hours;
(2) merge extractive liquid,, decompression recycling ethanol filters to there not being the alcohol flavor, discards filtering residue, released liquor;
(3) Borneolum Syntheticum, Aloe glue, vitamin E, hyaluronic acid, hexamethylene, the milk lactic acid of adding formula ratio in the medicinal liquid, mix homogeneously, fill is in container after the filtration sterilization.
During use, wash external genital with the water preparation bubble and got final product in 10～30 minutes, one day twice, use continuously more than two weeks.
Embodiment 2
A kind of externally-applied medicinal composition that is used for the treatment of bacterial vaginosis is made up of the raw material of Chinese medicine of following mass parts: Rhizoma Curcumae 30 mass parts, 25 parts of Fructus Cnidiis, 50 parts of Radix Sophorae Flavescentiss, 10 parts of Alumens, 15 parts of the Fructus Kochiae, 15 parts of Rhizoma Atractylodis, 100 parts of Flos Rosae Rugosaes, 12 parts of Cortex Phellodendris, 9 parts of Cortex Dictamni, 5 parts of Borneolum Syntheticums, 10 parts of Aloe glues, vitamin E2 part, 0.1 part of hyaluronic acid, 0.2 part of hexamethylene, 1 part of milk lactic acid.
Preparation method and using method are with embodiment 1.
Embodiment 3
A kind of externally-applied medicinal composition that is used for the treatment of bacterial vaginosis is made up of the raw material of Chinese medicine of following mass parts: 35 parts of Rhizoma Curcumae, 30 parts of Fructus Cnidiis, 55 parts of Radix Sophorae Flavescentiss, 15 parts of Alumens, 20 parts of the Fructus Kochiae, 20 parts of Rhizoma Atractylodis, 110 parts of Flos Rosae Rugosaes, 14 parts of Cortex Phellodendris, 10 parts of Cortex Dictamni, 6 parts of Borneolum Syntheticums, 12 parts of Aloe glues, 3 parts of vitamin Es, 0.2 part of hyaluronic acid, 0.4 part of hexamethylene, 2 parts of milk lactic acid.
Preparation method and using method are with embodiment 1.
Embodiment 4 bacteriostatic experiments
1. experimental strain
Colon bacillus ATCC8739, staphylococcus aureus ATCC25923, Pseudomonas aeruginosa ATCC27853, vagina Gartner bacterium ATCC14018, candida albicans bacterium CMCC85021, staphylococcus epidermidis ATCC26069, proteus vulgaris CMCC49010, streptococcus faecalis CMCC32221, micrococcus luteus CMCC28006, Candida albicans ATCC10231, bacillus acidophilus AS1.1854 (available from microorganism fungus kind preservation center, Guangdong Province).
2. experimental technique
With reference to " antimicrobial drug in-vitro antibacterial experiment principle " and " microbial testing technology " in " Ministry of Public Health bureau of drug administration new drug preclinical study guideline ", adopt continuous two times of gradient liquid diluting methods to measure MIC, the liquid infection protocol is measured MBC.The bacterial strain that liquid diluting method undetermined is gone out MIC adopts agar plate dilution method to measure MIC and MBC.
The medicinal agent lyophilization of embodiment 1～3 being obtained dry powder, be made into the medicinal liquid of 20mg/mL, is that starting point is carried out two times of continuous gradient dilutions with this concentration, and individual gradient concentration medicinal liquid is added in the 96 porocyte culture plates successively, the 0.2mL/ hole.Adding concentration is 10
6The experimental bacteria liquid of CFU/mL (with the allotment of MHB culture medium), 20 μ L/ holes.Set up the contrast of antibacterial and culture medium simultaneously.Put 37 ℃ and cultivated observed result 48 hours.Experimental result sees Table 1.
Table 1 medicine of the present invention is to MIC and the MBC (unit: mg/mL) of 11 strain reference cultures
Table 1 shows that bacterial strain has stronger antibacterial and bactericidal action to medicine of the present invention in selected preceding 10 to testing, but lower to bacillus acidophilus's inhibitory action.
Embodiment 5 clinic trial
Certain patient woman 30 years old, pruritus vulvae, burning sensation 5 days, many with the leucorrhea amount, abnormal flavour is arranged.Prescription on individual diagnosis in the 7th day is had a medical check-up, a large amount of thin foams of intravaginal, and the leucorrhea yellow green is got the leucorrhea picture and is checked leukocyte (+++), candidiasis (+), infusorian (-).The water preparation of use embodiment 2 steeps sooner or later washes external genital once, uses all backs pruritus obviously to alleviate continuously, again with check again after the week, recovery from illness.
Certain patient woman 35 years old, pruritus vulvae, the leucorrhea amount is many, and abnormal flavour is arranged, and is defined as bacterial vaginitis after diagnosing.The water preparation of use embodiment 2 steeps sooner or later washes external genital once, uses all backs pruritus obviously to alleviate continuously, again with check again after the week, recovery from illness.
Certain patient woman 25 years old, pruritus vulvae often, vagina is scorching hot, frequent micturition, urgent micturition, the lower part of the body weighs down and expands, and is diagnosed as bacterial vaginosis through the doctor, and the water preparation of use embodiment 1 steeps sooner or later washes external genital once, pruritus obviously alleviates after using a week continuously, again with check again after the week, recovery from illness.
Claims (5)
1. externally-applied medicinal composition that is used for the treatment of bacterial vaginosis, it is characterized in that described pharmaceutical composition contains the raw material of Chinese medicine of following mass parts: 25～35 parts of Rhizoma Curcumae, 20～30 parts of Fructus Cnidiis, 45～55 parts of Radix Sophorae Flavescentiss, 5～15 parts of Alumens, 10～20 parts of the Fructus Kochiae, 10～20 parts of Rhizoma Atractylodis, 90～110 parts of Flos Rosae Rugosaes, 10～14 parts of Cortex Phellodendris, 8～10 parts of Cortex Dictamni, 4～6 parts of Borneolum Syntheticums, 8～12 parts of Aloe glues, vitamin e1～3 part, 0.1～0.2 part of hyaluronic acid, 0.2～0.4 part of hexamethylene, 1～2 part of milk lactic acid.
2. pharmaceutical composition according to claim 1, it is characterized in that described pharmaceutical composition contains the raw material of Chinese medicine of following mass parts: Rhizoma Curcumae 30 mass parts, 25 parts of Fructus Cnidiis, 50 parts of Radix Sophorae Flavescentiss, 10 parts of Alumens, 15 parts of the Fructus Kochiae, 15 parts of Rhizoma Atractylodis, 100 parts of Flos Rosae Rugosaes, 12 parts of Cortex Phellodendris, 9 parts of Cortex Dictamni, 5 parts of Borneolum Syntheticums, 10 parts of Aloe glues, vitamin E2 part, 0.1 part of hyaluronic acid, 0.2 part of hexamethylene, 1 part of milk lactic acid.
3. pharmaceutical composition according to claim 1 and 2 is characterized in that, also contains acceptable accessories or carrier in the described pharmaceutical composition.
4. claim 1 or 2 described preparation of drug combination methods comprise the steps:
(1) takes by weighing Rhizoma Curcumae, Fructus Cnidii, Radix Sophorae Flavescentis, Alumen, the Fructus Kochiae, Rhizoma Atractylodis, Flos Rosae Rugosae, Cortex Phellodendri, Cortex Dictamni by prescription, after the Mechanical Crushing, add 2～5 times of volume 60%～85% ethanol water reflux, extract, 1～3 time, each 1～2 hour;
(2) merge extractive liquid,, decompression recycling ethanol filters to there not being the alcohol flavor, discards filtering residue, released liquor;
(3) Borneolum Syntheticum of adding formula ratio, Aloe glue, vitamin E, hyaluronic acid, poly-hexamethyl biguanide hydrochloride, milk lactic acid in the medicinal liquid, mix homogeneously adds pharmaceutically acceptable carrier or adjuvant again, is prepared into exterior-applied formulation.
5. require preparation method according to power 4 profits, it is characterized in that described exterior-applied formulation comprises: water preparation, gel, tablet, suppository etc.
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| CN103446439A (en) * | 2013-08-23 | 2013-12-18 | 吴万有 | Traditional Chinese medicine composition for preparing lotion for cleaning genitals of women and preparation method of traditional Chinese medicine composition |
| CN103751300A (en) * | 2013-12-31 | 2014-04-30 | 哈尔滨欧替药业有限公司 | Refined traditional Chinese medicine composition for pyrite nodule vaginal expansion suppository, vaginal expansion suppository and preparation method of vaginal expansion suppository |
| CN109589404A (en) * | 2018-11-27 | 2019-04-09 | 杭州元研细胞生物科技有限公司 | One kind is for anti-ageing reparation product of female reproductive system and preparation method thereof |
| CN110404009A (en) * | 2019-08-09 | 2019-11-05 | 吉安市御美丽健康产业股份有限公司 | A kind of antibacterial gel preparation and its preparation method and application |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103446439A (en) * | 2013-08-23 | 2013-12-18 | 吴万有 | Traditional Chinese medicine composition for preparing lotion for cleaning genitals of women and preparation method of traditional Chinese medicine composition |
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| CN103751300A (en) * | 2013-12-31 | 2014-04-30 | 哈尔滨欧替药业有限公司 | Refined traditional Chinese medicine composition for pyrite nodule vaginal expansion suppository, vaginal expansion suppository and preparation method of vaginal expansion suppository |
| CN103751300B (en) * | 2013-12-31 | 2016-02-24 | 哈尔滨欧替药业有限公司 | For the refining Chinese medicine composition of the yellow vaginal expansion plug agent of Serpentis and expansible plug thereof and method for making |
| CN109589404A (en) * | 2018-11-27 | 2019-04-09 | 杭州元研细胞生物科技有限公司 | One kind is for anti-ageing reparation product of female reproductive system and preparation method thereof |
| CN110404009A (en) * | 2019-08-09 | 2019-11-05 | 吉安市御美丽健康产业股份有限公司 | A kind of antibacterial gel preparation and its preparation method and application |
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