CN101284066B - Suppositorium for treating gynaecologic inflammation - Google Patents
Suppositorium for treating gynaecologic inflammation Download PDFInfo
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- CN101284066B CN101284066B CN2008100183153A CN200810018315A CN101284066B CN 101284066 B CN101284066 B CN 101284066B CN 2008100183153 A CN2008100183153 A CN 2008100183153A CN 200810018315 A CN200810018315 A CN 200810018315A CN 101284066 B CN101284066 B CN 101284066B
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Classifications
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Medicinal Preparation (AREA)
Abstract
A suppository for treating gynecological inflammation is prepared from amur corktree 20-100 weight parts, lightyellow sophora root 30-100 weight parts, belvedere fruit 20-90 weight parts, agrimony 10-40 weight parts, and borneol 0.4-3 parts in conventional preparation method. The pharmacodynamic test indicates that the suppository has certain antibacterial activity against vagina common infectious bacteria such as staphylococcus aureus, staphylococcus epidermidis, gonococcus, escherichia coli, beta streptococcus, etc., particularly staphylococcus aureus, staphylococcus epidermidis, and beta streptococcus. The suppository has remarkable anti-inflammatory effect, and is effective in remarkably relieving auricular inflammation of mouse caused by xylene, inhibiting formation of mouse granuloma and reducing capillary permeability of mouse abdominal cavity, and relieving itching. The suppository can be used for treating gynecological inflammation such as bacterial vaginosis, colpitis mycotica, etc.
Description
Technical field
The invention belongs to the medicinal preparation technical field of the product that contains raw material or itself and not clear structure, be specifically related to derive from the material of plant.
Background technology
Bacterial vaginosis and colpitis mycotica are TCM Gynecology common clinical frequently-occurring diseases, because vagina communicates with the external world, often bad because of menstrual period or sexual life health, or because of giving a birth and factor such as uteroventral operation causes vaginal infection, even can make inflammation invasion and attack internal reproductive organ, cause pelvic inflammation.Suffer from diabetes, vitamin B group shortage, ovarian function decline in addition, some allergy or infectious disease person be easy infection more, sickness rate is on the rise in recent years, it is the commonly encountered diseases frequently-occurring disease of gynecological's outpatient service, because its sickness rate height, clinical symptoms is heavier and have a strong impact on women's physical and mental health, routine work and life.
The external used medicine that is used for the treatment of bacterial vaginosis and colpitis mycotica clinically has Radix Sophorae Flavescentis Suppositoria, the function removing damp-heat, and anti-inflammation is used for leucorrhea with red and white discharge, female chronic inflammations such as vaginitis and vagina fungal infection; Fudekang foam dose, function heat clearing away humidity, parasite killing is used for the syndrome of dampness-heat diffusing downward of vaginitis, and earlier with 0.1% potassium permanganate solution or 0.1% bromo geramine solution washing vagina, reuse this product is sprayed in the cervix uteri district, 2～3 times weekly; Rehabilitation spirit bolt, the function heat-clearing and toxic substances removing, removing dampness and killing parasites is restrained antipruriticly, is used for the colpitis due to the various causes of disease; Rehabilitation antiinflammatory bolt, the function heat-clearing and toxic substances removing, the dampness removing eliminating stagnation, the function of killing parasites for relieving itching, be used for damp and hot, the leukorrhagia pudendal pruritus due to the noxious dampness, cloudy disease such as turbid; FUNINGSHUAN, the function heat clearing and damp drying, putrefaction-removing granulation-promoting, blood-activating analgetic is used for damp-heat vaginal discharge, cards such as pudendal pruritus.The medicine of above-mentioned treatment gynaecopathia uses the back local excitation bigger, and the patient is difficult for accepting.
Summary of the invention
Technical problem to be solved by this invention is to overcome the shortcoming of said medicine, and the suppository of a kind of toxic and side effects treatment gynecological inflammation little, evident in efficacy is provided.
It comprises with the following Chinese medicinal raw materials in portion by weight suppository made of formulation method routinely to solve the problems of the technologies described above the technical scheme that adopted:
20～100 parts of Cortex Phellodendris
30～100 parts of Radix Sophorae Flavescentiss
20～90 parts of the Fructus Kochiae
10～40 parts of Herba Agrimoniaes
0.4～3 part of Borneolum Syntheticum
The preferred raw material of Chinese medicine weight portion proportioning of preparation drug suppository of the present invention is:
30～90 parts of Cortex Phellodendris
40～90 parts of Radix Sophorae Flavescentiss
30～80 parts of the Fructus Kochiae
15～35 parts of Herba Agrimoniaes
0.5～2.5 part of Borneolum Syntheticum
The best raw material of Chinese medicine weight portion proportioning of preparation drug suppository of the present invention is:
60 parts of Cortex Phellodendris
60 parts of Radix Sophorae Flavescentiss
40 parts of the Fructus Kochiae
20 parts of Herba Agrimoniaes
1 part of Borneolum Syntheticum
Also contain the used mixed with excipients fatty glyceride of preparation suppository in the said ratio, mixed fatty glycerides is the commodity of selling on the market, also can adopt cocoa butter, Oleum Linderae and hydrogenated vegetable oils as excipient.
The Cortex Phellodendri bitter in the mouth is cold in nature in the proportioning of the present invention, returns kidney, bladder, large intestine channel, and merit is arrogated to oneself heat clearing and damp drying, and detoxifcation is usually used in treating diseases such as skin eczema, skin sore; Radix Sophorae Flavescentis, bitter in the mouth, cold in nature, GUIXIN, lung, kidney, large intestine channel, the function heat clearing and damp drying, wind dispelling insecticide cures mainly damp-heat dysentery, leukorrhagia, pudendal pruritus, scabies, noxious dampness skin infection; Herba Agrimoniae, bitter in the mouth, puckery, property is flat, function astringing to arrest bleeding, parasite killing, detoxifcation; The Fructus Kochiae, suffering, hardship, cold, return kidney, urinary bladder channel, the function clearing away heat-damp and promoting diuresis, dispelling wind for relieving itching is used for stranguria with turbid discharge, pudendal pruritus leukorrhagia, rubella, skin pruritus etc.; Borneolum Syntheticum acrid in the mouth, hardship, cool in nature, function heat radiation pain relieving.
The preparation method of drug suppository of the present invention is as follows:
1, the above five tastes are got Cortex Phellodendri, Radix Sophorae Flavescentis, the Fructus Kochiae and Herba Agrimoniae four Chinese medicine material, add 6 times, 5 times amount 85% alcohol reflux secondaries respectively, and each 1.5 hours, merge extractive liquid,, decompression recycling ethanol is not to there being the alcohol flavor, and drying under reduced pressure is ground into fine powder.
2, dissolve mixed fatty glycerides substrate.
3, the fine powder with step 1 preparation adds in the mixed fatty glycerides substrate of dissolving by amount, adds Borneolum Syntheticum again, stirs.
4, pour in the suppository mold, take out the cooling back, after the passed examination, and packing.
Medicine of the present invention proves through the test of pesticide effectiveness, medicine of the present invention has certain antibacterial activity to common infectious bacterias of vagina such as staphylococcus aureus, staphylococcus epidermidis, gonococcus, escherichia coli, group B streptococcus, candida albicanses, and is especially remarkable to the antibacterial effect of staphylococcus aureus, staphylococcus epidermidis, group B streptococcus; Medicine of the present invention is definite to rabbit colpitis mycotica therapeutic effect; Medicine of the present invention has tangible antiinflammatory action, can significantly alleviate mice caused by dimethylbenzene xylene auricle inflammation, suppresses the granulomatous formation of mice and reduce the mouse peritoneal capillary permeability; Medicine of the present invention has certain itching-relieving action.Medicine of the present invention can be used for treating gynaecopathias such as bacterial vaginosis, colpitis mycotica.
The specific embodiment
The present invention is described in more detail below in conjunction with embodiment, but the invention is not restricted to these embodiment.
Embodiment 1
With 1000 of production drug suppository products of the present invention is that the used crude drug of example and adjuvant and weight proportion thereof are:
Cortex Phellodendri 3000g
Radix Sophorae Flavescentis 3000g
Fructus Kochiae 2000g
Herba Agrimoniae 1000g
Borneolum Syntheticum 50g
Mixed fatty glycerides adds to 2600g
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
60 parts of Cortex Phellodendris
60 parts of Radix Sophorae Flavescentiss
40 parts of the Fructus Kochiae
20 parts of Herba Agrimoniaes
1 part of Borneolum Syntheticum
Its preparation method is as follows:
1, the above five tastes are got Cortex Phellodendri, Radix Sophorae Flavescentis, the Fructus Kochiae and Herba Agrimoniae four Chinese medicine material, add 6 times, 5 times amount 85% alcohol reflux secondaries respectively, and each 1.5 hours, merge extractive liquid,, decompression recycling ethanol is not to there being the alcohol flavor, and drying under reduced pressure is ground into fine powder.
2, dissolve mixed fatty glycerides substrate.
3, the fine powder with step 1 preparation adds in the mixed fatty glycerides substrate of dissolving by amount, adds Borneolum Syntheticum again, stirs.
4, pour in the suppository mold, take out the cooling back, after the passed examination, and packing.Every heavy 2.6g, every contains raw material of Chinese medicine 9.05g.
Embodiment 2
With 1000 of production drug suppository products of the present invention is that the used crude drug of example and adjuvant and weight proportion thereof are:
Cortex Phellodendri 2251g
Radix Sophorae Flavescentis 3377g
Fructus Kochiae 2251g
Herba Agrimoniae 1126g
Borneolum Syntheticum 45g
Mixed fatty glycerides adds to 2600g
Its preparation method is identical with embodiment 1, every heavy 2.6g, and every contains raw material of Chinese medicine 9.05g.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
20 parts of Cortex Phellodendris
30 parts of Radix Sophorae Flavescentiss
20 parts of the Fructus Kochiae
10 parts of Herba Agrimoniaes
0.4 part of Borneolum Syntheticum
Embodiment 3
With 1000 of production drug suppository products of the present invention is that the used crude drug of example and adjuvant and weight proportion thereof are:
Cortex Phellodendri 2718g
Radix Sophorae Flavescentis 2718g
Fructus Kochiae 2445g
Herba Agrimoniae 1087g
Borneolum Syntheticum 82g
Mixed fatty glycerides adds to 2600g
Its preparation method is identical with embodiment 1, every heavy 2.6g, and every contains raw material of Chinese medicine 9.05g.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
100 parts of Cortex Phellodendris
100 parts of Radix Sophorae Flavescentiss
90 parts of the Fructus Kochiae
40 parts of Herba Agrimoniaes
3 parts of Borneolum Syntheticums
Embodiment 4
With 1000 of production drug suppository products of the present invention is that the used crude drug of example and adjuvant and weight proportion thereof are:
Cortex Phellodendri 2351g
Radix Sophorae Flavescentis 3134g
Fructus Kochiae 2351g
Herba Agrimoniae 1175g
Borneolum Syntheticum 39g
Mixed fatty glycerides adds to 2600g
Its preparation method is identical with embodiment 1, every heavy 2.6g, and every contains raw material of Chinese medicine 9.05g.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
30 parts of Cortex Phellodendris
40 parts of Radix Sophorae Flavescentiss
30 parts of the Fructus Kochiae
15 parts of Herba Agrimoniaes
0.5 part of Borneolum Syntheticum
Embodiment 5
With 1000 of production drug suppository products of the present invention is that the used crude drug of example and adjuvant and weight proportion thereof are:
Cortex Phellodendri 2738g
Radix Sophorae Flavescentis 2738g
Fructus Kochiae 2433g
Herba Agrimoniae 1065g
Borneolum Syntheticum 76g
Mixed fatty glycerides adds to 2600g
Its preparation method is identical with embodiment 1, every heavy 2.6g, and every contains raw material of Chinese medicine 9.05g.
In the proportioning of present embodiment, the weight portion of each component of raw material of Chinese medicine is:
90 parts of Cortex Phellodendris
90 parts of Radix Sophorae Flavescentiss
80 parts of the Fructus Kochiae
35 parts of Herba Agrimoniaes
2.5 parts of Borneolum Syntheticums
In order to verify the therapeutic effect of medicine of the present invention to gynecological inflammation, the applicant adopts suppository (name is called the Bai Xian anti-inflammatory suppository for gynecopathy during test) the consignment test unit of the embodiment of the invention 1 weight proportion preparation to carry out the test of pesticide effectiveness, and various test situation are as follows:
Test objective: by investigate medicine vitro antibacterial activity of the present invention, to influence, the xylol of rabbit colpitis mycotica cause the influence of Mice Auricle inflammation, to the influence of mice granuloma inflammation, to the influence of mouse peritoneal capillary permeability, the pharmacology pharmacodynamic effect of clear and definite medicine of the present invention is for the clinical research of medicine of the present invention provides experimental basis.
Experimental drug: medicine of the present invention (name is called the Bai Xian anti-inflammatory suppository for gynecopathy during experiment), three positive pharmaceutcal corporation, Ltds provide by Shaanxi; Specification: 2.6g/ grain, 9.05g crude drug/grain; Character: sepia suppository; Lot number is 20061201.
The contrast medicine: levofloxacin hydrochloride eye drop, specification are the 5ml/ bottle, and levofloxacin hydrochloride content is 3mg/ml, is produced by Shandong Bausch ﹠ Lomb Freda Pharmaceutical Co., Ltd.; Miconazole, specification are 20mg * 7/box, are produced by Xian-Janssen Pharmaceutical Ltd.; Indomethacin ointment, specification are 1%, are produced by the Shengyang City Xingqi Pharmaceutical Co; Etidocine tablet, specification are the 25mg/ sheet, are produced by Qinghai Dadi Pharmacy Co., Ltd; Diphenhydramine hydrochloride injection: specification is 1ml:20mg, is produced by Wuhan pharmacy Group Plc.
Main experimental apparatus and reagent: MH agar culture medium, lot number are 20060802, are produced by sky, Hangzhou and microorganism reagent company limited; MH broth bouillon, lot number are 040801, are produced by Chinese medicine bioassay; Azovan blue is produced by China Medicine (Group) Shanghai Chemical Reagent Co.; Biochemical incubator, model is KXB-150, analyses the complete company of instrument by Chengdu section and produces; Colonometer, model are TYJ-2A, are produced by Shanghai Hong Hui electrical equipment; Clean work station, model are SW-CJ-1F, are produced by SuZhou Antai Air Tech Co., Ltd.; Electronic analytical balance, model are AB204-N, are produced by Mettler-Toledo Instrument (Shanghai) Co., Ltd.; Multiple spot inoculation instrument, model is Denley A400, is produced by Britain Denley company; Spectrophotometer, model are TU-1901, are produced by the Beijing Puxi General Instrument Co., Ltd.
Laboratory animal: Japan large ear rabbit, one-level, 36,2.0～3.0kg, female, credit number is SCXK (river) 2004-14, is provided by Sichuan Academy of Medical Sciences institute of lab animals, full price rabbit pellet, nutrition meets GB14924.3-2001, freely drinks Drinking Water; Kunming mouse, one-level, 60,18～22g, female, male half and half, the animal quality certification number is SCXK (river) 2004-11, is provided by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.The rabbit pellet is by Sichuan Academy of Medical Sciences institute of lab animals, and the Mus full-valence pellet feed is by Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.
1. medicine of the present invention is to the in-vitro antibacterial test of the common infectious bacteria of animal vagina
Clinical isolates strain 60 strains: staphylococcus aureus 10 strains, numbering is respectively 06-01,06-02,06-03,06-04,06-05,06-06,06-07,06-08,06-09,06-10; Staphylococcus epidermidis 10 strains, numbering is respectively 06-01,06-02,06-03,06-04,06-05,06-06,06-07,06-08,06-09,06-10; Gonococcus 10 strains, numbering is respectively 06-01,06-02,06-03,06-04,06-05,06-06,06-07,06-08,06-09,06-10; Escherichia coli 10 strains, numbering is respectively 06-01,06-02,06-03,06-04,06-05,06-06,06-07,06-08,06-09,06-10; Group B streptococcus 10 strains, numbering is respectively S1, S2, S3, S4,06-01,06-02,06-03,06-04,06-05,06-06; Candida albicans 10 strains, numbering is respectively 06-01,06-02,06-03,06-04,06-05,06-06,06-07,06-08,06-09,06-10.Be the clinical separation pathogenic bacterium in the collection of area, Chengdu in 2006.
Standard Quality Control bacterial strain: large intestine Ai Xi Salmonella ATCC25922, staphylococcus aureus ATCC25923.
Experiment adopts the plate sesquialter to mix the MIC that method is measured the Bai Xian anti-inflammatory suppository for gynecopathy.
(1) MH culture medium
MH agar culture medium: claim this product 38g, add the 1000ml distilled water, sterilized 15 minutes for 115 ℃, put refrigerator and preserve standby.
Blood agar culture-medium: the MH agar culture medium cooling after the sterilization causes 50-60 ℃, adds 5% aseptic Sanguis Leporis seu oryctolagi rapidly, mixing.
GC medium: agar 34g, aseptic anticoagulant Sanguis Leporis seu oryctolagi 100ml, 20% glucose solution 10ml, water 900ml.Get agar and be soaked in the water, heated and boiled dissolving, 121 ℃ of autoclavings 20 minutes.Add Sanguis Leporis seu oryctolagi and glucose, in 90 ℃ of water-baths, heat, shake frequently and make coffee color.Be cooled to 60 ℃, shake up and pour flat board into, solidify standby.(do not add agar and can be made into fluid medium).
(2) sabouraud culture medium
The Sha Shi fluid medium: take by weighing peptone 20g, glucose 40g adds distilled water 1000ml, sterilizes 15 minutes for 115 ℃, puts refrigerator and preserves standby.
Sabouraud's agar: in the Sha Shi fluid medium, add 2% agar powder, sterilized 15 minutes for 115 ℃, standby.
(3) preparation bacteria suspension
Gold-coloured staphylococci, staphylococcus epidermidis, escherichia coli: bacterial strain sectional streak on the MH agar culture medium that the inclined-plane is preserved is inoculated; Group B streptococcus: with bacterial strain sectional streak inoculation on blood agar culture-medium that the inclined-plane is preserved, put 37 ℃ of biochemical incubator overnight incubation, select single colony inoculation blood-bouillon test tube respectively, overnight incubation, standby.Gonococcus: with bacterial strain sectional streak inoculation on gonococcal agar that the inclined-plane is preserved, put 37 ℃ of biochemical incubator overnight incubation, select single colony inoculation GC medium test tube respectively, overnight incubation, standby.Candida albicans: with bacterial strain sectional streak inoculation on sabouraud's agar that the inclined-plane is preserved, put 37 ℃ of biochemical incubators and cultivated 24 hours, select single colony inoculation Sha Shi fluid medium test tube respectively, cultivated 24 hours, standby.
(4) preparation medicine plate of the present invention
Accurately measuring the drug suppository 20ml aseptic of the present invention (10) that dissolves after the heating puts in the sterilization plate, add 20ml thawing cooling and cause 50～60 ℃ of MH agar culture mediums, mixing, sucking-off 20ml is in another plate, in the remaining 20ml pastille MH agar culture medium, add the 20mlMH agar culture medium again, mixing, the sucking-off 20ml system plate that inclines again ... the rest may be inferred, and the medicine series final concentration that makes the pastille plate is 2263,1131,566,283,141,71,35,18,9mg crude drug/ml; The pastille BAP dilutes preparation by the same method with containing blood agar.
(5) preparation levofloxacin hydrochloride eye drop plate
Accurately measure levofloxacin hydrochloride 6ml, add 34ml thawing cooling and cause 45～50 ℃ of MH agar culture mediums, mixing, by the dilution of the invention described above medicine plate and the method for the system plate that inclines, the plate final concentration that makes hydrochloric levofloxacin is 450,225,112,56,28,14,7,4,2,1,0.5,0.25 μ g/ml.
(6) inoculation
Get aforementioned standby bacterium liquid, every inoculation point inoculation 2ul bacterium liquid (contains antibacterial 10 approximately
5CFU) in the pastille culture medium of correspondence, inoculate corresponding not pastille culture medium simultaneously, as positive control; Each concentration pastille plate 1 of inoculated bacteria does not overlap, as negative control.
Put 37 ℃ of biochemical incubators and cultivate 24～48 hours observed results, data processing method adopts the Bliss analysis software to calculate MIC
50Experimental result sees Table 1 and table 2.
Table 2 medicine of the present invention external to antibacterial half Mlc (MIC
50)
By table 1, table 2 as seen, drug suppository of the present invention has certain antibacterial activity to common infectious bacterias of vagina such as staphylococcus aureus, staphylococcus epidermidis, gonococcus, escherichia coli, group B streptococcus, candida albicanses, and is especially remarkable to the antibacterial effect of staphylococcus aureus, staphylococcus epidermidis, group B streptococcus.
2, medicine of the present invention is to the influence of rabbit colpitis mycotica
Experimental strain: candida albicans (06-07) derives from area, Chengdu clinical hospital isolated strains in 2006.
Laboratory animal: Japan large ear rabbit, one-level, 36,2.0～3.0kg, female.
Grouping sees Table 3 with the dosage setting.
Table 3 drug suppository of the present invention is to the influence test grouping and the dosage setting of rabbit vagina fungal infection
Annotate: is middle dosage with clinical plan with the dosage vagina administration, and 2 times of clinical plans use dosage as high dose, and 0.5 times of clinical plan uses dosage as low dosage.
Modeling: Candida albicans was inoculated in the sabouraud culture medium in experiment in preceding 2 days, cultivates after 24 hours for 37 ℃, and measure its concentration with colony counting method, it is 3.6 * 10 that concentration is adjusted with normal saline in centrifugal back
7CFU/ml, standby.
6 Japan large ear rabbits of picked at random are the blank group, the conventional raising; Other gets 30 Japan large ear rabbits, smear aseptic paraffin oil with 5 number sword-shaped needle silica gel tubes after, slowly insert intravaginal 5～8cm, implantation concentration is 3.6 * 10
7The Candida albicans suspension 0.25ml of CFU/ml is in the intravaginal modeling.After the modeling the 6th day, get vaginal swab smear, Gram dyeing microscopic examination, bacteriological detection is carried out in the clean degree classification of vagina, determines that model sets up.
Medication: after model is set up, 30 rabbit of modeling are divided into 5 groups at random, 6 every group, add totally 6 groups of blank groups, as table 3.The administration group is pressed table 3 dosage and is given and corresponding medicine of the present invention respectively, and blank and model control group are given and the equal-volume suppository base.37 ℃ of suppositorys are dissolved the back inject vagina 5～8cm depths with the scalp silica gel tube, successive administration is 7 days once a day, observes the clean situation of growth of animal, activity and pudendum, checks the clean degree of vagina, carries out bacteriological detection and get vagina tissue and carry out pathological examination.
Criterion: clean degree classification of vagina and vaginitis take a turn for the better, criterion of cure, with reference to " obstetrics and gynecology " the 5th edition state-compiled textbook; Modeling success criterion is with reference to " pharmacological experimental methodology ".
Cure rate and efficient calculating:
The number of animals of cure rate (%)=recovery from illness/respectively organize total number of animals * 100
The number of animals of effective percentage (%)=improvement/respectively organize total number of animals * 100
Data processing method: data are carried out X
2Check.
Observed result: tangible inflammation appears in modeling animal vagina periphery hyperemia before the medication, edema, yellow secretions increase; Blank treated animal pudendum cleaning, no abnormal secretions.After 7 days, the red and swollen phenomenon of drug study group of the present invention and positive control treated animal vaginal congest all has alleviation in various degree through medication, but model group animal local inflammatory response is still more obvious.Experimental result sees Table 4.
Table 4 drug suppository of the present invention changes and efficacy result the clean degree of vagina before and after the treatment of rabbit colpitis mycotica
Annotate: compare * * P＜0.01 with model control group.
By table 4 as seen, except that the blank group, all the other are respectively organized vagina cleanness degree and are III or IV degree before the treatment, uses medicine of the present invention and positive reference substance after, vagina clean be improved significantly, cure rate and effective percentage are significantly increased.Medication after 7 days bacteriology checking the results are shown in Table 5.
Table 5 treatment after 7 days secretions cultivate the plate number that has or not colony growth
Annotate: compare * * P＜0.01 with model control group.
By table 5 as seen, treat after 7 days 6 animal intravaginal of model group and all in fungi culture medium, turn out antibacterial, the model establishment is described, and administration group positive rate of bacteria reduces obviously, illustrates that medicine of the present invention and reference substance have the obvious suppression effect in animal body to fungus.
Check result under the histopathology light microscopic: model group rabbit vagina epithelium thickens, level increases, the necrosis of the visible strip epithelial cell of epithelial surface, and visible part epithelial cell shedding reach between epithelium and go up visible more cell infiltration or kitchen range shape cell infiltration in the subcutaneous lamina propria.The surface minority epithelial cell degeneration of the rarely seen vagina epithelium of drug suppository low dose group rabbit of the present invention, indivedual necrosis, lamina propria are not seen inflammatory reaction; The dosage group only has to look under the vagina epithelium mucosa of a rabbit and sees a little cell infiltration kitchen range in the drug suppository of the present invention, and epithelial structure is complete, does not see epithelial cell shedding or necrosis.Drug suppository high dose group of the present invention and positive controls rabbit vagina epithelial cell structural integrity are methodically arranged, and not seeing has obvious inflammatory cell infiltration.
Drug suppository of the present invention is definite to rabbit colpitis mycotica therapeutic effect, and basic, normal, high dosage group and the miconazole positive controls therapeutic effect utmost point significant difference of having compared with model control group proves that medicine of the present invention has the obvious treatment effect.
3, medicine xylol of the present invention causes the influence of Mice Auricle inflammation
Kunming mouse is used in experiment, one-level, and 60,18～22g, female, hero half and half is divided into 6 groups at random, male and female half and half, experiment grouping and dosage see Table 6.
Table 6 medicine xylol of the present invention causes Mice Auricle inflammation influence experiment grouping and dosage design
After 37 ℃ of drug suppositories of the present invention are dissolved, be applied in each dosage group mice bilateral auricle portion of Bai Xian anti-inflammatory suppository for gynecopathy agent equably, the about 0.25ml of each amount, blank group and model control group are smeared the equal-volume normal saline respectively, and positive controls is smeared indomethacin ointment.Every day 2 times, successive administration 7 days, after the last administration 30 minutes, evenly smear analytical pure dimethylbenzene 50 μ l at each mouse right ear and cause inflammation (the blank group is evenly smeared normal saline 50 μ l at mouse right ear), cause scorching back 1 hour and take off cervical vertebra execution mice, cut left and right two ears, use the card punch of diameter 8mm to punch along the same position of left and right auricle homalographic, sweep away the both sides auricle and weigh record respectively.Two auricle weight differences are the swelling degree, and the result carries out statistical analysis, and calculate inhibitory rate of intumesce.
Data processing method is carried out t check or variance analysis by the SPSS13.0 statistical analysis software.Experimental result sees Table 7.
The influence of table 7 medicine xylol of the present invention induced mice auricle edema
Annotate: compare * P＜0.05, * * P＜0.01 with model control group.
By table 7 result as seen, indomethacin ointment group xylol causes mice auricle swelling the obvious suppression effect, compares with model control group, and the difference of auricle swelling degree has significance (P＜0.01).Drug administration group xylol of the present invention causes mice auricle swelling the obvious suppression effect, compares with model control group, and the difference of drug suppository 9.05g/ml dosage group of the present invention, 4.525g/ml dosage group auricle swelling degree has significance (P＜0.01).The middle and high dosage group of medicine of the present invention all can significantly alleviate mice caused by dimethylbenzene xylene auricle inflammation, shows that medicine of the present invention has certain antiinflammatory action.
4, medicine of the present invention is to the influence of mice granuloma inflammation
Medicine of the present invention is a vaginal suppository, it has tangible local anti-inflammatory effect the mice auricle swelling evidence, because topical approach animal blood drug level is lower, and difficult its whole body antiinflammatory action of examination, so increase by a treated animal gastric infusion, dosage is clinical every day of a topical dose.Grouping and dosage design see Table 8.
Table 8 medicine of the present invention influences the design of grouping and dosage to mice granuloma inflammation
Modeling: under the anesthesia of 0.3% pentobarbital sodium, the scraps of paper are implanted 60 left and right shoulders of animal respectively or go up subcutaneous each 1 of wrist, sew up.
Medication: all mice modelings were divided into 6 groups at random by body weight after 24 hours.With the mouse tail vein injection holder mice is fixed, suppository is dissolved in 37 ℃, the ophthalmology tweezer struts mouse vagina, splash into the suppository that dissolves with little syringe gradation, and kept the handstand position 15 minutes, total dosage is divided every day give for 3 times, successive administration 7 days, gastric infusion once a day.Put to death animal in 30 minutes after the last administration, the scraps of paper and granulation tissue are extracted in the lump, claimed dry weight in 24 hours in 60 ℃ of dryings.Dry weight deducts scraps of paper weight, is the granulation net weight.
Adopt the SPSS13.0 statistical analysis software to carry out t check or variance analysis.
Experimental result sees Table 9.
Table 9 medicine of the present invention is to the influence of mice granuloma inflammation
Annotate: compare * P＜0.05, * * P＜0.01 with model control group.
By table 9 as seen, the indometacin group has the obvious suppression effect to mice granuloma inflammation, and granulation net weight and model control group compare, and difference has significance (P＜0.01).Drug administration group of the present invention has the obvious suppression effect to the mice granuloma, and granulation net weight and model control group compare, and the difference of medicine high dose vagina administration group of the present invention and middle dosage gastric infusion group all has significance (P＜0.01 or P＜0.05).Medicine high dose group of the present invention and middle dosage gastric infusion group can significantly suppress the granulomatous formation of mice, show that medicine of the present invention has certain antiinflammatory action.
5, medicine of the present invention is to the influence of mouse peritoneal capillary permeability
Grouping is identical with experiment 4 with the dosage setting.With self-control mouse tail vein injection holder mice is fixed, suppository is dissolved in 37 ℃, the ophthalmology tweezer struts mouse vagina, splash into the drug suppository of the present invention that dissolves with little syringe gradation, and kept the handstand position 15 minutes, total dosage divided every day give for 3 times, successive administration 7 days, gastric infusion is once a day.After the last administration 60 minutes, each caudal vein plastic injection quality concentration is 0.5% azovan blue normal saline solution 0.1ml/10g, except that the blank group, all the other every group of plastic injection quality concentration are 0.6% acetum 0.2ml/, take off cervical vertebra after 25 minutes and put to death animal, open the abdominal cavity, divide several to wash the abdominal cavity with the 6ml normal saline, with the whole washing liquids of suction pipe sucking-off, add normal saline to 10ml, centrifugal 15 minutes of 3000rpm gets supernatant and uses spectrophotometer in 590nm place colorimetric determination absorbance (OD), and the result carries out statistical analysis.
Data processing method is carried out t check or variance analysis by the SPSS13.0 statistical analysis software.
Experimental result sees Table 10.
Table 10 medicine of the present invention is to the influence of mouse peritoneal capillary permeability
Compare * P＜0.05, * * P＜0.01 with model group.
By table 10 as seen, indometacin can obviously reduce the mouse peritoneal capillary permeability, compares with model control group, and difference has significance (P＜0.01).Drug administration group of the present invention has tangible reduction effect to the mouse peritoneal capillary permeability, its OD value and model control group compare, and the difference of medicine high dose vagina administration group of the present invention and middle dosage gastric infusion group all has significance (P＜0.01 or P＜0.05).Medicine high dose group of the present invention, middle dosage gastric infusion group all can significantly reduce the abdominal cavity capillary permeability, show that medicine of the present invention has certain antiinflammatory action.
6, medicine of the present invention causes the influence of itching to Guinea Pig Histamine
50 of Cavia porcelluss weigh 180～220g, are divided into 5 groups at random by sex, and 10 every group, male and female half and half, each organizes dosage referring to table 11.
Antipruritic test grouping of table 11 medicine of the present invention and dosage
Test and shaved hair to each group Cavia porcellus right back instep in preceding 1 day, locally smear the medicine medicine 1 time, the 0.1mL/ foot by last table design dosage.Test the same day, the scratch gently of hair place, the about 1cm of area are shaved in the right back instep of Cavia porcellus with coarse sandpaper
2, local repaste medicine 1 time.After the last administration 10 minutes, every 3 minutes successively by low concentration to high concentration, to every Cavia porcellus wound surface smearing histamine 0.025mL/ only, histamine concentration is followed successively by 1.0 * 10
-4, 2.0 * 10
-4, 3.0 * 10
-4, 4.0 * 10
-413 * 10
-4, 14 * 10
-4, 15 * 10
-4When pruritus reaction appears in Cavia porcellus, promptly lick right back sufficient wound site, or till not occurring the pruritus reaction yet to maximum concentration.Accumulating every Cavia porcellus licks the right back histamine total amount that is given when sufficient (the histamine amount of Cavia porcellus tolerance) as the itch-threshold of Cavia porcellus, the result carries out statistical analysis.Data processing method is carried out one factor analysis of variance by the SPSS11.0 statistical software.Experimental result sees Table 12.
Table 12 medicine of the present invention causes the influence of the effect of itching to histamine
Compare * P＜0.05, * * P＜0.01 with negative control group.
By table 12 as seen, diphenhydramine hydrochloride injection causes to itch to Guinea Pig Histamine tangible itching-relieving action, compares with model control group, and difference has significance (P＜0.01).Drug administration group of the present invention causes to itch to Guinea Pig Histamine tangible itching-relieving action, compares with negative control group, and medicine high dose group difference of the present invention has significance (P＜0.01).Medicine high dose group of the present invention causes to itch to mouse Histamine significant inhibitory effect, shows that medicine of the present invention has certain itching-relieving action.
Experiment conclusion: medicine of the present invention has certain antibacterial activity to common infectious bacterias of vagina such as staphylococcus aureus, staphylococcus epidermidis, gonococcus, escherichia coli, group B streptococcus, candida albicanses, and is especially remarkable to the antibacterial effect of staphylococcus aureus, staphylococcus epidermidis, group B streptococcus; Medicine of the present invention is definite to rabbit colpitis mycotica therapeutic effect; Medicine of the present invention has tangible antiinflammatory action, can significantly alleviate mice caused by dimethylbenzene xylene auricle inflammation, suppresses the granulomatous formation of mice and reduce the mouse peritoneal capillary permeability; Medicine of the present invention has certain itching-relieving action.
Function of the present invention cures mainly: heat clearing and damp drying, killing parasites for relieving itching.Cure mainly women's pudendal pruritus leukorrhagia damp-heat syndrome, disease is seen profuse leukorrhea, and yellow skin or HUANGBAI(sic) are alternate, and matter is sticky, foul smell is arranged, pruritus vulvae, or pain is arranged, lower abdomen is done to expand or pain, and bitter taste is sticky, and few, puckery pain of yellow urine and doctor trained in Western medicine bacterial vaginosis, colpitis mycotica etc. are seen above-mentioned patient.
Usage of the present invention and consumption: clean external genital, suppository is filled in the vagina deep.1 every night.
Specification of the present invention: 2.6g/ grain.
Storage of the present invention: airtight, put the moon and dry dry place.
Table 1 medicine of the present invention external to antibacterial minimal inhibitory concentration (MIC)
Table 1 (continuing)
Annotate: this inoculation of "/" expression.
Claims (3)
1. suppository for the treatment of gynecological inflammation is characterized in that it is by the following weight parts Chinese medicinal raw materials suppository of formulation method preparation routinely:
20～100 parts of Cortex Phellodendris
30～100 parts of Radix Sophorae Flavescentiss
20～90 parts of the Fructus Kochiae
10～40 parts of Herba Agrimoniaes
0.4～3 part of Borneolum Syntheticum.
2. according to the suppository of the described treatment gynecological inflammation of claim 1, it is characterized in that wherein the weight portion proportioning of each raw material of Chinese medicine is:
30～90 parts of Cortex Phellodendris
40～90 parts of Radix Sophorae Flavescentiss
30～80 parts of the Fructus Kochiae
15～35 parts of Herba Agrimoniaes
0.5～2.5 part of Borneolum Syntheticum.
3. according to the suppository of the described treatment gynecological inflammation of claim 1, it is characterized in that wherein the weight portion proportioning of each raw material of Chinese medicine is:
60 parts of Cortex Phellodendris
60 parts of Radix Sophorae Flavescentiss
40 parts of the Fructus Kochiae
20 parts of Herba Agrimoniaes
1 part of Borneolum Syntheticum.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1223142A (en) * | 1998-11-17 | 1999-07-21 | 杜仲成 | Liquid medicine for prevention and cure of gynecopathy and preparation process thereof |
| CN1448162A (en) * | 2002-04-02 | 2003-10-15 | 孙润民 | Female external sterilization film |
| CN101167894A (en) * | 2007-11-09 | 2008-04-30 | 北京中科雍和医药技术有限公司 | Traditional Chinese medicinal washing lotion for treating dermatitis, vulvitis and vaginitis |
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2008
- 2008-05-28 CN CN2008100183153A patent/CN101284066B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1223142A (en) * | 1998-11-17 | 1999-07-21 | 杜仲成 | Liquid medicine for prevention and cure of gynecopathy and preparation process thereof |
| CN1448162A (en) * | 2002-04-02 | 2003-10-15 | 孙润民 | Female external sterilization film |
| CN101167894A (en) * | 2007-11-09 | 2008-04-30 | 北京中科雍和医药技术有限公司 | Traditional Chinese medicinal washing lotion for treating dermatitis, vulvitis and vaginitis |
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| 刘荣茂.中药洗剂治疗皮肤病80例.《陕西中医》.1990,(第09期),418. * |
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