CN101757119B - Medicine composition for treating vaginitis as well as gel and preparation method thereof - Google Patents

Medicine composition for treating vaginitis as well as gel and preparation method thereof Download PDF

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CN101757119B
CN101757119B CN201010128491XA CN201010128491A CN101757119B CN 101757119 B CN101757119 B CN 101757119B CN 201010128491X A CN201010128491X A CN 201010128491XA CN 201010128491 A CN201010128491 A CN 201010128491A CN 101757119 B CN101757119 B CN 101757119B
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gel
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preparation
medicine composition
pharmaceutical composition
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CN101757119A (en
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柯缨
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Hunan Tianlong Pharmaceutical Co ltd
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Hunan Tianlong Pharmaceutical Co ltd
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Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a medicine composition for treating vaginitis, which comprises the following components in percentage by weight: 0.1-20.0 percent of blue lotus essential oil, 0.1-20.0 percent of borneol essence, 0.5-5.0 percent of vitamin E, 0.5-15.0 percent of arginine and 0.5-1.0 percent of nitroglycerin or pentaerythritol tetranitrate. The invention also provides a gel of the medicine composition and a preparation method thereof. The medicine composition and the gel thereof can improve the blood circulation around vagina and prevent premature aging of epithelial cells of the vagina, and have no side effect and potential risk on human bodies after long-time use. In the invention, antibiosis experiments show that the medicine composition can inhibit the growth of various pathogenic bacteria, acute skin irritancy tests show that no toxic reaction is found, the microbiological indices of the medicine composition reach the standard, and no pathogenic bacteria exists, thereby the invention has a wide application prospect.

Description

The colpitic pharmaceutical composition of a kind of treatment, gel and preparation method thereof
Technical field
The present invention relates to tcm field, be specifically related to the colpitic pharmaceutical composition of a kind of treatment, gel and preparation method thereof.
Background technology
Vaginitis is gynecological's common disease, and especially the atrophic vaginitis sickness rate brings very big influence for women's work and life up to 40-60%.Atrophic vaginitis is that estrogen level reduces because of the ovarian function decline, the vaginal wall atrophy, and the mucosa attenuation, glycogen content reduces in the epithelial cell, and the intravaginal pH value rises, and local resistance reduces, the inflammation that pathogenic bacterium invasion breeding causes.
Colpitic treatment mainly is that application estrogen and antibiotic carry out symptomatic treatment at the vagina drying symptom to the atrophy class clinically.Such as application number is that 89105335.2 the disclosed prescription of Chinese patent is glycerol, Mel, liquid paraffin; Application number is 89102479.4 Chinese patent selection antibiotic tylosin, cellulose; Application number is 99123092.2 Chinese patent selection chemosynthesis anti-infective quinolones, metronidazole treatment atrophic vaginitis.Notification number be 1077373 Chinese patent select cellulose, antimicrobial drug to wash must the Qin, the antitrichomonal drug metronidazole, the Chinese patent selection chemosynthesis nanometer silver preparation of number of patent application 03130426.5 and Borneolum Syntheticum, Mentholum etc., the Chinese patent selection chemosynthesis nanometer silver of number of patent application 200310107042.7 and nature of glass acid sodium, glycerol are treated atrophic vaginitis.
They have potential danger discovered in recent years.The life-time service antibiotic is easy to generate fastbacteria and the vaginal dysbacteriosis that is difficult to give treatment to, and protective potential causes repeated infection on the contrary when reducing.Life-time service estrogen stimulates liver to produce liver albumen easily, causes hyperlipidemia, bile duct disease, causes the people to get fat, or even carcinoma of endometrium, incidence of breast cancer are increased.Nano material may be absorbed by the body and cause the existing report of nanometer syndrome.
In sum, the side effect of hormone, antibiotic drug resistance and cause that the potential hazard of the normal group of human body bacterium imbalance, the safety of nano material have caused people's attention, are badly in need of finding a kind of alternative medicine for the treatment of atrophic vaginitis safely and effectively.
Summary of the invention
The antibiotic that the present invention is directed to existing treatment atrophic vaginitis is easy to produce fastbacteria and causes that vaginal dysbacteriosis, estrogen Excessive Intake are easily caused a disease, the safety defect of insufficient of nano material, provides a kind of new treatment colpitic pharmaceutical composition.
In order to realize the foregoing invention purpose, the invention provides following technical scheme:
The colpitic pharmaceutical composition of a kind of treatment comprises following component by weight percentage:
LANHE quintessence oil 0.1-20.0%
The smart 0.1-20.0% of Borneolum Syntheticum
Vitamin E 0.5-5.0%
Arginine 0.5-15.0%
Nitroglycerin or pentaerithrityl tetranitrate 0.5-1.0%
Described LANHE quintessence oil is that Eucalyptus globulus Labill leaf and mentha leave mixed by 1: 1, adds 3-5 times of 80 ℃ of hot water and carries out vapor distillation, and the collection distillate adds Nacl saltouts, and leaves standstill, and divides and gets the top oil reservoir promptly; Described Borneolum Syntheticum essence is doubly carried out vapor distillation behind 80 ℃ of hot water for Folium cinnamomi camphorae adds 3-5, collects distillation liquid and saltouts the crystallization of separating out after the cooling through NaCl.
As preferably, described medicine composite for curing atrophic vaginitis effect is more remarkable.
Atrophic vaginitis mainly reduces because of the women's ovary estrogen secretion, and asthenia of essence and blood makes the vaginal epithelial cell hypofunction, and except that the vagina tissue blood supply insufficiency, the epithelial damage of endogenous radical pair also is one of key factor.
Vitamin E has the promotion cell division, prevents the vagina attenuation, recovers elasticity, retractility.Vitamin E also has powerful anti-radical action, and it can promote the epithelial cell division simultaneously, and cellular layer thickens, and recovers elasticity, delays the epithelial cell senescence process.
In the present invention, arginine has triple role: as amino acid whose Nutrition, vascular relaxing factor, regulation and control pH value.Arginine, nitroglycerin, discharge vascular relaxing factor NO expansion blood vessel and improve the local blood supply under the effect of human body NOS enzyme as nitric oxide donors, nutrition vaginal mucosa epithelial cell, and the active cell activity, prevention senilism recovers normal physiological function.The also adjustable pH value of arginine.The regulation and control pH value is 4.0-5.0, helps beneficial bacteria such as lactobacillus is bred, and suppresses other pathogen growths, keeps the effect of vaginal microbial flora balance performance biological antibiotic, and need not to rely on antibiosis eliminating pathogen usually.
The Borneolum Syntheticum essence is pulverized by the fresh leaf of China canella [Cinnamomum Camphor (L.) presl] Lignum cinnamomi camphorae, add 3-5 and doubly carry out vapor distillation behind 80 ℃ of hot water, collecting distillation liquid does not steam to there being oil droplet, gained distillation liquid measure is about 1-2 times of leaf amount, add Nacl and saltout, quiet amount is spent the night, after the cooling, the white crystals that collection is separated out promptly gets the Borneolum Syntheticum essence.
The LANHE quintessence oil is to press from the fresh leaf of the fresh leaf of myrtle [Eucalyptus Globulus Labill.] Eucalyptus globulus Labill and labiate [Mentha Haplocalyx Briq] Herba Menthae to mix at 1: 1, pulverize, after adding 3-5 times of 80 ℃ of hot water, promptly carry out vapor distillation, collect distillate and do not steam to there being oil droplet, gained distillation liquid measure is about 1~2 times of leaf amount, adding Nacl saltouts, standing over night is divided and is got the top oil reservoir, promptly gets the LANHE quintessence oil.The LANHE quintessence oil has the effect of broad-spectrum disease resistance substance, comprise Gram-positive, gram negative bacteria, mycete and infusorian, acarid etc., antibacterial experiment shows that it can suppress staphylococcus aureus, Streptococcus mutans, suppurative staphylococcus, bacillus acidophilus, Aerugo pus pseudomonas, streptococcus albus.
Borneolum Syntheticum essence and LANHE quintessence oil be except directly antibiotic, also can promote to remove by promoting the secretion of vagina epithelium mucomembranous cell attached to mucus on the inflammation mucosa, and composite factor performance antiphlogistic effects such as local blood circulation improvement.
That Borneolum Syntheticum essence and LANHE quintessence oil also have is refrigerant, deodorization, antipruritic, pain relieving, the effect of excited peripheral nerve sensor.But the fragrance covering smell of Borneolum Syntheticum essence and LANHE quintessence oil also can produce abnormal flavour by suppressing the vaginal bacteria fermentation, fundamentally reaches deodorization.Borneolum Syntheticum essence and LANHE quintessence oil can produce refrigerant impression by stimulating excitor nerve tip Cold receptor, help alleviating the vagina burning sensation.
Substitute the antibiotic infection with Borneolum Syntheticum essence and LANHE quintessence oil as antimicrobial component, has a broad antifungal spectrum, life-time service are difficult for producing drug resistance, and have multiple function as fragrant, antipruritic, refrigerant, pain relieving, improve teleneuron sensitivity, help treating the various symptoms of vaginitis and improve life quality.
The present invention is absorbed by body easily according to cavity/canal drug administration effective active composition, but because the gravity effect medicinal liquid flows out easily, vaginal secretion can quicken the external defective that causes the drug effect loss of medicinal liquid outflow again simultaneously, design has the gel prescription of bioadhesive, keep lasting medicine, a kind of particularly gel of atrophic vaginitis of vaginitis for the treatment of is provided, by by weight percentage:
LANHE quintessence oil 0.1-20.0%
The smart 0.1-20.0% of Borneolum Syntheticum
Vitamin E 0.5-5.0%
Arginine 0.5-15.0%
Nitroglycerin or pentaerithrityl tetranitrate 0.5-1.0%
Adding acceptable accessories makes.
As preferably, described gel PH is between 4.0-5.0.
Safeguard that vagina self physiological function protection capability is the greatest factor that the various vaginitiss of prevention take place.For adapting to the requirement of vagina normal physiological, gel of the present invention is kept PH4.0-5.0.Exceed this pH value scope, then easily cause group bacterium wadding disorderly, cause the pathogen breeding.The pH value of gel of the present invention is regulated and control by arginine.The suitable pH value 4.0-5.0 of regulation and control vagina, help beneficial bacteria such as lactobacillus is bred, suppress the growth of other pathogen such as HPV human papillomavirus and infusorian, the self-cleaning self-purification capacity of performance vagina tissue self-defence, keep the effect of vaginal microbial flora balance performance biological antibiotic, and need not to rely on antibiosis eliminating pathogen usually.
As preferably, described adjuvant comprises sorbic acid, polyacrylic resin, glycerol, liquid paraffin.
Polyacrylic resin is a bioadhesive polymer, with body cavities such as nose, oral cavity, vaginal mucosa tissue good adhesiveness is arranged, and can prevent that medicine from being washed away by tract such as vaginal secretion, can delay active component again and discharges because of it has stickiness, and bring into play lasting drug effect.
The present invention also specifically provides a kind of particularly gel of atrophic vaginitis of vaginitis for the treatment of, and its prescription is by weight percentage:
LANHE quintessence oil 0.1-20.0%
The smart 0.1-20.0% of Borneolum Syntheticum
Vitamin E 0.5-5.0%
Arginine 0.5-15.0%
Nitroglycerin or pentaerithrityl tetranitrate 0.5-1.0%
Sorbic acid 0.05-3.0%
Polyacrylic resin 0.05-5.0%
Glycerol 5.0-20.0%
Liquid paraffin 5.0-30.0%
Surplus is a water.
The present invention also provides the preparation method of the colpitic gel of treatment, comprises following steps:
Step 1: polyacrylic resin is uniformly dispersed in the sorbic acid aqueous solution, and standing over night adds glycerol and nitroglycerin or pentaerithrityl tetranitrate mix homogeneously;
Step 2: get LANHE quintessence oil, Borneolum Syntheticum essence and vitamin E and be dissolved in the liquid paraffin;
Step 3: with the solution of step 1 preparation and the solution mix homogeneously of step 2 preparation; Add arginine, and control solution pH value promptly gets gel of the present invention between 4.0-5.0.
Described LANHE quintessence oil is that Eucalyptus globulus Labill leaf and mentha leave mixed by 1: 1, adds 3-5 times of 80 ℃ of hot water and carries out vapor distillation, and the collection distillate adds Nacl saltouts, and leaves standstill, and divides and gets the top oil reservoir promptly; Described Borneolum Syntheticum essence is doubly carried out vapor distillation behind 80 ℃ of hot water for Folium cinnamomi camphorae adds 3-5, collects distillation liquid and saltouts the crystallization of separating out after the cooling through NaCl.
The present invention considers vagina anatomical location particularity of living in, is positioned at anus, two human body scavenge ports of urethral orifice crossover location, is subjected to the exotic disease substance easily and invades, and resists the intrusion pathogen with the vegetalitas antimicrobial component of non-antibiotic.Emphasize to keep the physiological requirement of intravaginal environment to be fit to pH value, safeguard the beneficial bacteria growing environment, keep colony balance; Improve local blood circulation by blood vessel dilating, replenish epithelial cell nutrition and promote propagation; Remove free radical, the delaying cell aging process realizes the various vaginitiss therapeutic purposes of atrophic vaginitis particularly.
Pharmaceutical composition of the present invention can improve the circulation of vagina peripheral blood, the prevention premature aging of epithelial cells, and life-time service is without any side effects and potential danger to human body.Antibacterial experiment shows that it can suppress staphylococcus aureus, Streptococcus mutans, suppurative staphylococcus, bacillus acidophilus, Aerugo pus pseudomonas, streptococcus albus, and minimal inhibitory concentration is followed successively by 15.6,31.2,31.2,7500,125 μ g/ml.In addition, also can kill infusorian, acarid.
Pharmaceutical composition of the present invention carries out acute skin irritation test by the national cosmetic implementation method, animal subject is observed 24h, 36h, 72h continuously do not see zest toxicity reactions such as skin erythema, edema, belongs to nontoxic level product.Test by the national cosmetic experimental technique, toxic component content all is lower than national Specification and limits the quantity of in the physical and chemical index, meets the requirement of limiting the quantity of of microbiology index, and no pathogenic bacterium exist, and are with a wide range of applications.
The specific embodiment
The invention discloses the colpitic pharmaceutical composition of a kind of treatment, gel and preparation method thereof.Those skilled in the art can use for reference this paper content, suitably improve technological parameter and realize.Special needs to be pointed out is that all similarly replace and change apparent to those skilled in the art, they all are regarded as being included in the present invention.Gel of the present invention and preparation method thereof is described by preferred embodiment, the related personnel obviously can change or suitably change and combination methods described herein in not breaking away from content of the present invention, spirit and scope, realizes and use the present invention.
Below in conjunction with embodiment, further set forth the present invention:
Embodiment 1: prepare pharmaceutical composition of the present invention
The colpitic pharmaceutical composition of a kind of treatment, component is by weight percentage:
LANHE quintessence oil 0.1%
Borneolum Syntheticum essence 20.0%
Vitamin E 0.5%
Arginine 0.5%
Nitroglycerin or pentaerithrityl tetranitrate 1.0%
Surplus is a water.
Described LANHE quintessence oil is that Eucalyptus globulus Labill leaf and mentha leave mixed by 1: 1, adds 3-5 times of 80 ℃ of hot water and carries out vapor distillation, and the collection distillate adds Nacl saltouts, and leaves standstill, and divides and gets the top oil reservoir promptly; Described Borneolum Syntheticum essence is doubly carried out vapor distillation behind 80 ℃ of hot water for Folium cinnamomi camphorae adds 3-5, collects distillation liquid and saltouts the crystallization of separating out after the cooling through NaCl.
Embodiment 2: prepare pharmaceutical composition of the present invention
The colpitic pharmaceutical composition of a kind of treatment, component is by weight percentage:
LANHE quintessence oil 20.0%
Borneolum Syntheticum essence 0.1%
Vitamin E 5.0%
Arginine 15.0%
Nitroglycerin or pentaerithrityl tetranitrate 0.5%
Surplus is a water.
Embodiment 3: the gel for preparing pharmaceutical composition of the present invention
Its prescription is by weight percentage:
LANHE quintessence oil 20.0%
Borneolum Syntheticum essence 0.1%
Vitamin E 5.0%
Arginine 0.5%
Nitroglycerin or pentaerithrityl tetranitrate 1.0%
Sorbic acid 0.05%
Polyacrylic resin 5.0%
Glycerol 5.00%
Liquid paraffin 30.0%
Surplus is a water.
Described LANHE quintessence oil is that Eucalyptus globulus Labill leaf and mentha leave mixed by 1: 1, adds 3-5 times of 80 ℃ of hot water and carries out vapor distillation, and the collection distillate adds Nacl saltouts, and leaves standstill, and divides and gets the top oil reservoir promptly; Described Borneolum Syntheticum essence is doubly carried out vapor distillation behind 80 ℃ of hot water for Folium cinnamomi camphorae adds 3-5, collects distillation liquid and saltouts the crystallization of separating out after the cooling through NaCl.
Embodiment 4: the gel for preparing pharmaceutical composition of the present invention
Its prescription is by weight percentage:
LANHE quintessence oil 0.1%
Borneolum Syntheticum essence 20.0%
Vitamin E 0.5%
Arginine 15.0%
Nitroglycerin or pentaerithrityl tetranitrate 0.5%
Sorbic acid 3.0%
Polyacrylic resin 0.05%
Glycerol 20.0%
Liquid paraffin 5.0%
Surplus is a water.
Described LANHE quintessence oil is that Eucalyptus globulus Labill leaf and mentha leave mixed by 1: 1, adds 3-5 times of 80 ℃ of hot water and carries out vapor distillation, and the collection distillate adds NaCl saltouts, and leaves standstill, and divides and gets the top oil reservoir promptly; Described Borneolum Syntheticum essence is doubly carried out vapor distillation behind 80 ℃ of hot water for Folium cinnamomi camphorae adds 3-5, collects distillation liquid and saltouts the crystallization of separating out after the cooling through NaCl.
Embodiment 5, pharmaceutical composition of the present invention and gel thereof are to the oidiomycetic bactericidal effect of white
One, experiment material
1, Candida albicans ATCC10231 is provided by Military Medical Science Institute five: the fresh slant culture (the 4th generation) that the 24h that learns from else's experience cultivates washes lawn with PBS earlier.Reuse PBS is diluted to desired concn.Get the 20ul bacteria suspension in sterilization slide (1cm with dripping the method for dying 2) oven dry, make recovery bacterium number reach 1 * 10 4Cfu/ sheet~9 * 10 4The cfu/ sheet.
2, the pharmaceutical composition of the present invention and the gel thereof of embodiment 1-4 preparation.
3, aseptic filtration flushing liquor: the PBS buffer that contains 0.3% Tween 80.
4, husky Bao Shi agar culture medium.
5, the microporous filter membrane and the defecator (U.S.'s import) of process sterilization treatment.
Two, method
Test basis: " disinfection technology standard " 2002 editions
Pharmaceutical composition of the present invention and the gel thereof of getting embodiment 1-4 preparation of the present invention place in the sterilization plate, getting the above-mentioned carrier that has prepared makes it to soak into respectively in the said medicine sample, affact 2min respectively, 5min, 10min, take out above-mentioned carrier with aseptic nipper during 20min, move into the mixing in vitro that contains 5.0mlPBS respectively, shake and strike 80 times, after doing suitably dilution, get aggregate sample diluent 1.0ml respectively and add filter, with aseptic filtration flushing liquor flushing 3 times, each 15.00ml puts 37 ℃ in husky Bao Shi culture medium and cultivates 48h and do the viable bacteria colony counting filter membrane is smooth.
Three, result
Under 20 ℃ ± 1 ℃ water bath condition, test repeats 3 times, the results are shown in Table 1, shows that pharmaceutical composition of the present invention and gel effect 2-20min thereof are 100.00% to the oidiomycetic average bactericidal rate of white.
Table 1 pharmaceutical composition of the present invention and gel thereof are to the oidiomycetic bactericidal effect of white
Figure GSA00000043390900101
Annotate: positive control bacterium amount and scope thereof: 2.85 * 10 4(2.25 * 10 4-3.40 * 10 4) the cfu/ sheet
Embodiment 6, pharmaceutical composition of the present invention and gel thereof are to the bactericidal effect of staphylococcus aureus
One, experiment material
1, staphylococcus aureus ATCC6538 is provided by Military Medical Science Institute five: the fresh slant culture (the 4th generation) that the 24h that learns from else's experience cultivates, wash lawn with TPS earlier, and be diluted to desired concn, make and reclaim the bacterium number 1 * 10 4Cfu/ sheet~9 * 10 4The cfu/ sheet.
2, the pharmaceutical composition of the present invention and the gel thereof of embodiment 1-4 preparation.
3, aseptic filtration flushing liquor: the PBS buffer that contains 0.3% Tween 80.
4, tryptose soya agar culture medium (TSA).
5, the microporous filter membrane and the defecator (U.S.'s import) of process sterilization treatment.
Two, method
Test basis: " disinfection technology standard " 2002 editions
Get the pharmaceutical composition of the present invention and the gel thereof of embodiment 1-4 preparation.Place in the sterilization plate.Getting the above-mentioned carrier that has prepared makes it to soak into respectively in the said medicine sample, take out above-mentioned carrier with aseptic nipper when affacting 2min, 5min, 10min, 20min respectively, move into the mixing in vitro that contains 5.0mlPBS respectively, shake and strike 80 times, after doing suitably dilution, get aggregate sample diluent 1.0ml and add filter, with aseptic filtration flushing liquor flushing 3 times, each 15.00ml puts 37 ℃ in the tryptose soya agar culture medium and cultivates 48h and do the viable bacteria colony counting filter membrane is smooth.
Three, result
Under 20 ℃ ± 1 ℃ water bath condition, test repeats 3 times, the results are shown in Table 2, shows that pharmaceutical composition of the present invention and gel effect 2-20min thereof are 100.00% to the average bactericidal rate of staphylococcus aureus.
Table 2 pharmaceutical composition of the present invention and gel thereof are to the bactericidal effect of staphylococcus aureus
Figure GSA00000043390900111
Annotate: positive control bacterium amount and scope thereof: 2.18 * 10 4(1.75 * 10 4-2.45 * 10 4) the cfu/ sheet
Embodiment 7, pharmaceutical composition of the present invention and gel thereof are to colibacillary bactericidal effect
One, experiment material
1, escherichia coli 8099 are provided by Military Medical Science Institute: the fresh slant culture (the 6th generation) that the 24h that learns from else's experience cultivates, wash lawn with TPS earlier, and reuse PBS is diluted to desired concn.Make the recovery clump count reach 1 * 10 4Cfu/ sheet~9 * 10 4The cfu/ sheet.
2, the pharmaceutical composition of the present invention and the gel thereof of embodiment 1-4 preparation.
3, aseptic filtration flushing liquor: the PBS buffer that contains 0.3% Tween 80.
4, the microporous filter membrane and the defecator (U.S.'s import) of process sterilization treatment.
Two, method
1, test basis: " disinfection technology standard " 2002 editions 2.1.11.3.
2, pharmaceutical composition of the present invention and the gel thereof of getting embodiment 1-4 preparation place in the sterilization plate, getting the above-mentioned carrier that has prepared makes it to soak into respectively in the said medicine sample, affact 2min respectively, 5min, 10min, take out above-mentioned carrier with aseptic nipper during 20min, move into the mixing in vitro that contains 5.0mlPBS respectively, shake and strike 80 times, after doing suitably dilution, get aggregate sample diluent 1.0ml and add filter, with aseptic filtration flushing liquor flushing 3 times, each 15.00ml puts 37 ℃ in the old soy agar culture medium of Trypsin and cultivates 48h and do the viable bacteria colony counting filter membrane is smooth.
Three, result
Under 20 ℃ ± 1 ℃ water bath condition.Test repeats 3 times, sees Table 3, shows that pharmaceutical composition of the present invention and gel effect 2-20min thereof are 100.00% to the average bactericidal rate of colibacillus.
Table 3 pharmaceutical composition of the present invention and gel thereof are to colibacillary bactericidal effect
Figure GSA00000043390900121
Annotate: positive control bacterium amount and scope thereof: 3.50 * 10 4(3.30 * 10 4-3.75 * 10 4) the cfu/ sheet.
The vaginal mucomembranous irritant test of embodiment 8, pharmaceutical composition of the present invention and gel thereof
1 experiment material and animal
Tried thing: the pharmaceutical composition of the present invention and the gel thereof of embodiment 1-4 preparation.
Laboratory animal: the healthy white female man that Kaifu District east wound laboratory animal science service portion provides exempts from 6, body weight 2.1~2.4kg.Animal is bought the back and observed 3 days.Feedstuff is provided by same unit.The laboratory animal production licence number is SCXK (Hunan) 2006-0001.
The experimental situation condition: 23 ℃~24 ℃ of temperature, humidity 66%~68%, the laboratory animal occupancy permit number is SYXK (Hunan) 2005-0001.
2, method
Laboratory animal is divided into contamination group and matched group at random, 3 every group.With length is that blunt nosed flexible pipe about 8cm is connected with the 2ml syringe, fills with to be subjected to test solution standby.Every animal is prepared a cover.It is fixing that animal is faced upward, and exposes perineum and vaginal orifice.With conduit with gently insert after being subjected to test solution moistening vagina (4~5cm), and slowly inject 2ml with syringe and be subjected to test solution, extract conduit out, finish contamination.Control animals is done same the processing with sterile saline.Contamination back 24h adopts the aeroembolism method to put to death animal, cuts open the belly and takes out complete vagina, vertically cuts, and whether perusal has performances such as hyperemia, edema.Then vagina is put into 10% formalin solution fixedly more than the 24h, choose the film-making of organizing at 3 positions in vagina two ends and central authorities, after the HE dyeing, carry out histopathological examination, irritant reaction is marked by " disinfection technology standard " (version in 2002) 2.3.5 medial vagina mucous membrane irritation reaction standards of grading.
3, result
Perusal shows no obvious abnormalities.Pathological examination results sees Table 4.
Table 4 pharmaceutical composition of the present invention and gel thereof are to rabbit vagina mucous membrane irritation reaction grade form
4, conclusion
Pharmaceutical composition of the present invention and gel thereof are 0.78 minute to the stimulation index of white rabbit vagina mucous membrane irritation, according to " disinfection technology standard " (version in 2002), belong to nonirritant.

Claims (10)

1. treat colpitic pharmaceutical composition for one kind, comprise following component by weight percentage:
Figure FDA0000054470870000011
Described LANHE quintessence oil is that Eucalyptus globulus Labill leaf and mentha leave mixed by 1: 1, adds 3-5 times of 80 ℃ of hot water and carries out vapor distillation, and the collection distillate adds Nacl saltouts, and leaves standstill, and divides and gets the top oil reservoir promptly; Described Borneolum Syntheticum essence is doubly carried out vapor distillation behind 80 ℃ of hot water for Folium cinnamomi camphorae adds 3-5, collects distillate and saltouts the crystallization of separating out after the cooling through NaCl.
2. pharmaceutical composition according to claim 1 is characterized in that, described vaginitis is an atrophic vaginitis.
3. the colpitic gel of treatment is characterized in that, adds acceptable accessories by the described pharmaceutical composition of claim 1 and makes.
4. gel according to claim 3 is characterized in that, described gel PH is between 4.0-5.0.
5. according to claim 3 or 4 described gels, it is characterized in that described adjuvant comprises sorbic acid, polyacrylic resin, glycerol, liquid paraffin.
6. gel according to claim 5 is characterized in that, the percentage by weight of described adjuvant is sorbic acid 0.05-3.0%, polyacrylic resin 0.05-5.0%, glycerol 5.0-20.0%, liquid paraffin 5.0-30.0%.
7. according to claim 3,4 or 6 described gels, it is characterized in that described vaginitis is an atrophic vaginitis.
8. according to the preparation method of the described gel of claim 6, comprise following steps:
Step 1: polyacrylic resin is uniformly dispersed in the sorbic acid aqueous solution, and standing over night adds glycerol and nitroglycerin or pentaerithrityl tetranitrate mix homogeneously;
Step 2: get LANHE quintessence oil, Borneolum Syntheticum essence and vitamin E and be dissolved in the liquid paraffin;
Step 3:, add arginine control solution pH value between 4.0-5.0 with the solution of step 1 preparation and the solution mix homogeneously of step 2 preparation.
9. the described preparation method of claim 8 is characterized in that, described LANHE quintessence oil is that Eucalyptus globulus Labill leaf and mentha leave mixed by 1: 1, adds 3-5 times of 80 ℃ of hot water and carries out vapor distillation, and the collection distillate adds Nacl saltouts, and leaves standstill, and divides and gets the top oil reservoir promptly.
10. the described preparation method of claim 8 is characterized in that, described Borneolum Syntheticum essence is doubly carried out vapor distillation behind 80 ℃ of hot water for Folium cinnamomi camphorae adds 3-5, collects distillate and saltouts the crystallization of separating out after the cooling through NaCl.
CN201010128491XA 2010-03-03 2010-03-03 Medicine composition for treating vaginitis as well as gel and preparation method thereof Expired - Fee Related CN101757119B (en)

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