CN101623368A - Drug for treating gynecological diseases and preparation technology thereof - Google Patents
Drug for treating gynecological diseases and preparation technology thereof Download PDFInfo
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Abstract
The invention relates to a drug for treating gynecological diseases and a preparation technology thereof, belonging to the technical field of drug manufacture and including the preparation technology of the drug. The components of the main raw materials are characterized by: 30-350 parts of bark of chinese corktree, 30-350 parts of lightyellow sophora root, 20-250 parts of fructus kochiae, 10-110 parts of Hairyvein Agrimonia Herb and Bud and 1-8 parts of borneol. The raw materials are mixed to be prepared into a suppository dosage form through ethanol extraction. When in use, the active ingredients of the drug can reach the focus directly, therefore the drug has strong pertinence and concentrated acting force and causes no irritation and very little toxic or side effect to the digestive system of human body after use. The drug has few raw materials and simple preparation technology, and is proved to have rather obvious effect of treating bacterial vaginosis and colpomycosis by die pharmakodynamik experiments, as well as the functions of clearing heat and drying dampness, killing insects and relieving itching.
Description
One, technical field
The present invention relates to a kind of Chinese medicine for the treatment of gynaecopathia, specifically a kind of medicine and preparation technology thereof who treats gynaecopathia belongs to medicine manufacture technology field, comprises the preparation technology of medicine.
Two, background technology
Bacterial vaginosis and colpitis mycotica are the clinical common frdquently encountered diseases of TCM Gynecology, because vagina communicates with the external world, often bad because of menstrual period or sexual life health, or factors such as childbirth and uteroventral operation cause vaginal infection, even can make inflammation invasion and attack internal genitalia, 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, and sickness rate is on the rise in recent years, is common gynecological disease and frequently-occurring disease, because its sickness rate height, clinical symptoms is heavier and have a strong impact on women's physical and mental health.
At present, be used for the treatment of the method that bacterial vaginosis and colpitis mycotica take and mainly contain Chinese medicine and two kinds of Therapeutic Method of Western medicine, the western medicine gynaecopathia is mainly oral drugs, its advantage is a disease controlling in a short period of time, treatment speed is fast, and its shortcoming is that side effect is big, cures back recurrence easily, particularly antibiotics makes antibacterial produce drug resistance easily, and antifungal drug also can not be used for bacterial infection disease.Though oral Chinese medicine treatment gynaecopathia has very big advantage than Western medicine aspect toxic and side effects, the gynopathic raw material of Chinese medicine component of existing treatment is many, generally reaches tens kinds more than, complicated process of preparation, and the utilization rate of pharmaceutical compositions is lower.
Also have a kind of Chinese medicine and Western medicine lotion for the treatment of bacterial vaginosis and colpitis mycotica, this method is littler than oral drugs side effect, medicine also can directly act on diseased region, but, because medicine is a liquid structure, medicine is shorter attached to the time ratio of lesions position, needs constantly diseased region to be carried out medicine and cleans, and uses very inconvenient.
Three, summary of the invention
Chinese medical theory is thought, causes the main pathomechanism of primary disease, and the hepatic and renal YIN deficiency is arranged, pudendum failure of skin and muscle to be nourished, wind syndrome due to dryness of blood and itching; Dampness-heat of the liver is made a bet, and the leukorrhagia contamination is had an itch; Parasite caused by accumulation of damp-heat in the body, the worm-eaten pruritus vulvae.Cortex Phellodendri in the raw material components: bitter in the mouth, cold in nature, return kidney, bladder, large intestine channel, merit is arrogated to oneself heat clearing and damp drying, and diseases such as treatment skin eczema, skin sore are longer than in detoxifcation.It in this prescription monarch drug.
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.Fang Zhongyong strengthens the merit of its heat clearing and damp drying with principal drug assistance, and can play the merit of wind dispelling insecticide at the diseases such as pudendal pruritus leukorrhagia that gynaecopathia showed, and is ministerial drug in the side
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.
Borneolum Syntheticum: acrid in the mouth, hardship, cool in nature, function heat radiation pain relieving.
More than three flavors or strengthening the merit of monarch-minister drug heat clearing and damp drying, or help the power of its killing parasites for relieving itching, or, be to be adjuvant drug in the side at the diseases such as pudendal pruritus leukorrhagia pain that primary disease occurs.
Purpose of the present invention is exactly that the material composition that exists for the medicine that solves existing treatment gynaecopathia is many, the prescription preparation is unreasonable, complicated process of preparation, and curative effect is undesirable, treatment back is recurrence easily, thereby a kind of medicine and preparation technology thereof of new treatment gynaecopathia are provided.
For achieving the above object, the present invention can realize by following scheme:
The medicine of treatment gynaecopathia, it is the medicament of being made according to the weight portion proportioning by following raw materials according:
Cortex Phellodendri 30-350 part Radix Sophorae Flavescentis 30-350 part Fructus Kochiae 20-250 part
Herba Agrimoniae 10-110 part Borneolum Syntheticum 1-8 part.
The medicine of treatment gynaecopathia, it is the medicament of being made according to the weight portion proportioning by following raw materials according:
200 parts of 300 parts of Fructus Kochiae of 300 parts of Radix Sophorae Flavescentiss of Cortex Phellodendri
5 parts of 100 parts of Borneolum Syntheticums of Herba Agrimoniae.
The dosage form of the medicament made from the above-mentioned raw materials prescription is an acceptable forms on the clinical medicine.
By the suppository medicine of above-mentioned raw materials production for treating gynaecopathia, its preparation technology is prepared from by following method and step:
In above-mentioned five tastes raw material, get Cortex Phellodendri, Radix Sophorae Flavescentis, the Fructus Kochiae, Herba Agrimoniae four flavor raw material of Chinese medicine, add 6 times of amounts, 5 times of amount 85% alcohol reflux secondaries respectively, each 1.5 hours, merge extractive liquid,, decompression recycling ethanol is to not having alcohol flavor, drying under reduced pressure, be ground into fine powder, add in the mixed fatty glycerides substrate of having dissolved by amount, add Borneolum Syntheticum again, stir, pour in the suppository mould, taking-up after cooling gets final product.
The advantage that the present invention had is: ingredient is few, has only the Chinese medicine of the five flavours raw material, and the prescription preparation is reasonable, and preparation technology is simple, and medicine is with low cost.The Chinese medicine medicine is made suppository formulation, and the active ingredient in the medicine directly arrives focus, and pointed strong, drug effect power is concentrated, and uses the back that digestion is not had any stimulation, and toxic and side effects is very little.Through clinical trial, have the function of heat clearing and damp drying and killing parasites for relieving itching, treatment bacterial vaginosis and colpitis mycotica effect are very obvious.
Four, the specific embodiment
Embodiment one:
The raw material prescription is got according to weight portion (gram):
Cortex Phellodendri 300g Radix Sophorae Flavescentis 300g Fructus Kochiae 200g
Herba Agrimoniae 100g Borneolum Syntheticum 5g.
The dosage form of the medicament made from above-mentioned prescription is a suppository.
Preparation technology is: in above-mentioned five tastes raw material, get Cortex Phellodendri, Radix Sophorae Flavescentis, the Fructus Kochiae, Herba Agrimoniae four flavor raw material of Chinese medicine, add 6 times of amounts, 5 times of amount 85% alcohol reflux secondaries respectively, each 1.5 hours, merge extractive liquid,, decompression recycling ethanol is to there not being the alcohol flavor, drying under reduced pressure, be ground into fine powder, add in the mixed fatty glycerides substrate of having dissolved, add Borneolum Syntheticum again by amount, stir, pour in the suppository mould, make 100 suppository medicines, taking-up after cooling gets final product.
Specification: every of 2.6g/.
Using method: clean external genital, the suppository medicine is filled in the vagina deep, 1 every night.
Clinical course of treatment: 7 days.
Embodiment two:
The raw material prescription is got according to weight portion (gram):
Cortex Phellodendri 350g Radix Sophorae Flavescentis 350g Fructus Kochiae 250g
Herba Agrimoniae 110g Borneolum Syntheticum 8g.
Preparation technology is with embodiment one.
The name of product that the present invention produced is: the Bai Xian anti-inflammatory suppository for gynecopathy
The Pharmacodynamic test of active extract of the medicine Bai Xian anti-inflammatory suppository for gynecopathy that the present invention produces
Purpose: investigate Bai Xian anti-inflammatory suppository for gynecopathy pharmacodynamic action.
Method: 1, the Bai Xian anti-inflammatory suppository for gynecopathy is tested the in-vitro antibacterial of the common infectious bacteria of vagina: adopt the flat sesquialter of ware to mix the MIC that method is measured the Bai Xian anti-inflammatory suppository for gynecopathy.
2, the Bai Xian anti-inflammatory suppository for gynecopathy is to the influence of rabbit colpitis mycotica: adopt rabbit vaginal injection Candida albicans bacterium liquid, cause rabbit colpitis mycotica model, determine model establishment back topical treatment, continuous 7 days, observe the pathological change of rabbit vagina outward appearance, and do fungal culture and histopathologic examination, to judge the curative effect of test sample.
3, Bai Xian anti-inflammatory suppository for gynecopathy xylol causes the influence of Mice Auricle inflammation: successive administration 7 days, 30min after the last administration, evenly smear trimethylbenzene 50 μ l at mouse right ear and cause inflammation, cause scorching back 1h and take off cervical vertebra execution mice, two ears about cutting, puncher with diameter 8mm punches along the same position of left and right sides ear homalographic, sweeps away the both sides auricle and weighs respectively, and two auricle weight differences are the swelling degree.
4, the Bai Xian anti-inflammatory suppository for gynecopathy is to the influence of mice granuloma inflammation: the method modeling of adopting filter paper to implant the left and right shoulder of mice or go up wrist, successive administration is 7 days after the modeling, 30min puts to death mice after the last administration, the scraps of paper and granulation tissue are extracted in the lump, weigh in 60 ℃ of dry 24h, dry weight deducts scraps of paper weight, is the granulation net weight.
5, the Bai Xian anti-inflammatory suppository for gynecopathy is to the influence of mouse peritoneal capillary permeability: successive administration 7 days, 60min after the last administration, each caudal vein is injected 0.5% azovan blue normal saline solution 0.1ml/10g, except that the blank group, only inject 0.6% acetum 0.2ml/ for all the other every group, take off cervical vertebra behind the 25min and put to death mice, 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, the centrifugal 15min of 3000rpm gets supernatant and measures absorbance in the 590nm place.
Experimental results show that: etidocine tablet can obviously reduce the mouse peritoneal capillary permeability, compares with model control group, and difference has significance (P＜0.01).Bai Xian anti-inflammatory suppository for gynecopathy administration group has tangible reduction effect to the mouse peritoneal capillary permeability, its OD value and model control group compare, and the difference of Bai Xian anti-inflammatory suppository for gynecopathy high dose vagina administration group and middle dosage gastric infusion group all has significance (P＜0.01 or P＜0.05).
Gave the Bai Xian anti-inflammatory suppository for gynecopathy 7 days to mice, high dose group, middle dosage gastric infusion group all can significantly reduce the permeability of abdominal cavity blood capillary, show that the Bai Xian anti-inflammatory suppository for gynecopathy has certain antiinflammatory action.
The result: the Bai Xian anti-inflammatory suppository for gynecopathy has certain antibacterial activity to common infectious bacterias of vagina such as staphylococcus aureus, staphylococcus epidermidis, gonococcus, escherichia coli, group B streptococcus, Candida albicans, and is especially remarkable to the antibacterial effect of staphylococcus aureus, staphylococcus epidermidis, group B streptococcus; The Bai Xian anti-inflammatory suppository for gynecopathy is definite to rabbit colpitis mycotica therapeutic effect; The Bai Xian anti-inflammatory suppository for gynecopathy 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; The Bai Xian anti-inflammatory suppository for gynecopathy has certain itching-relieving action.
Conclusion: the Bai Xian anti-inflammatory suppository for gynecopathy has antibiotic, the antifungic action of remarkable vitro, and rabbit colpitis mycotica model is all had good curative effect, has tangible antiinflammatory action, and has certain itching-relieving action.
By investigate Bai Xian anti-inflammatory suppository for gynecopathy vitro antibacterial activity, 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 Bai Xian anti-inflammatory suppository for gynecopathy is for the clinical research of this product provides experimental basis.
Experiment content
1, experimental drug and main Experimental Establishment:
1.1 test sample, name of product of the present invention: Bai Xian anti-inflammatory suppository for gynecopathy.
Main uses: heat clearing and damp drying, killing parasites for relieving itching.Clinical bacterial vaginitis, the colpitis mycotica syndrome of dampness-heat diffusing downward of being used for.
Specification: 2.6g/ grain (9.05g crude drug/grain).
Character: sepia suppository.
Lot number: 20061201.
Usage: intravaginal medication.
Draft clinical usage and consumption: clean external genital, the suppository medicine is filled in the vagina deep.1 every night.
Compound method: 37 ℃ dissolve.
Storage procedures: stored refrigerated.
The unit of providing: Shaanxi three positive pharmaceutcal corporation, Ltds.
1.1.2 test sample dosage is provided with foundation:
With clinical plan dosage vagina administration, as middle dosed administration, 2 times of clinical plans use dosage as high dose, and 0.5 times of clinical plan uses dosage as low dosage.
1.2 contrast medicine
1.2.1 levofloxacin hydrochloride content: 3mg/ml.
Production unit: Shandong Bo Shi Lunfuruida pharmaceutical Co. Ltd.
1.2.2 miconazole:
Lot number: 061217.
Specification: 20mg * 7/box
Production unit: Xian-Janssen Pharmaceutical Ltd..
1.2.3 indomethacin ointment:
Lot number: 060312.
Specification: 1%.
Production unit: Shengyang City Xingqi Pharmaceutical Co.
1.2.4 etidocine tablet:
Lot number: 20051221.
Specification: 25mg/ sheet
Production unit: Qinghai Dadi Pharmacy Co., Ltd.
1.2.5 diphenhydramine hydrochloride injection:
Lot number: 20050913.
Specification: 1ml:20mg.
Production unit: Wuhan pharmacy Group Plc.
1.3 the feeding and management of laboratory animal
1.3.1 experiment condition
Chengdu University of Traditional Chinese Medicine's Experimental Animal Center, experimental temperature: 18-26 ℃, relative humidity: 40-70%, illumination condition: the 12h/12h light and shade replaces, the ventilation situation: brand-new wind.
1.3.2 drinking-water
Freely drink Drinking Water.
1.3.3 feedstuff
The rabbit pellet, nutritional labeling: crude fibre 17.45%, crude protein 18.03%, crude fat 4.52%, ash 5.04%. production unit one: Sichuan Academy of Medical Sciences institute of lab animals.
The Mus full-valence pellet feed, nutritional labeling meets GB14924.3-2001, production unit: Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.
2 Bai Xian anti-inflammatory suppository for gynecopathies are to the in-vitro antibacterial test of the common infectious bacteria of vagina
2.1 experiment material
2.1.1 test sample: Bai Xian anti-inflammatory suppository for gynecopathy
2.1.2 reference substance: levofloxacin hydrochloride eye drop.
2.1.3 main experimental apparatus and reagent: all from market and specified department.
2.1.4 experimental strain
2.1.4.1 6 kinds of clinical isolates kinds:
Staphylococcus aureus;
Staphylococcus epidermidis;
Gonococcus;
Escherichia coli;
White is read the ball coccus.
Above strain is clinical separation pathogenic bacterium of collecting in the area, Chengdu in 2006.
2.1.4.2 standard Quality Control bacterial strain
Large intestine Ai Xi Salmonella ATCC25922, staphylococcus aureus ATCC25923.
Experimental result
2.3.1 the in-vitro antibacterial test to the common infectious bacteria of vagina sees Table 1
Table 1 Bai Xian anti-inflammatory suppository for gynecopathy external to antibacterial half Mlc (MIC
50)
| Strain name | ??MIC 50(the mg crude drug/ml) | 95% fiducial limit |
| Staphylococcus aureus | ??182.3 | ??124.1～247.2 |
| Staphylococcus epidermidis | ??226.7 | ??143.1～297.6 |
| Group B streptococcus | ??281.4 | ??189.0～395.2 |
| Gonococcus | ??671.6 | ??490.1～895.3 |
| Escherichia coli | ??805.3 | ??552.1～1175.1 |
| White is read the ball coccus | ??312.7 | ??251.8～423.1 |
2.3.2 experiment brief summary:
By the result of table 1 as seen, the Bai Xian anti-inflammatory suppository for gynecopathy is read the common infectious bacterias of vagina such as ball coccus and is had certain antibacterial activity to staphylococcus aureus, staphylococcus epidermidis, gonococcus, escherichia coli, group B streptococcus, white, especially remarkable to the antibacterial effect of staphylococcus aureus, staphylococcus epidermidis, group B streptococcus.
3, the Bai Xian anti-inflammatory suppository for gynecopathy is to the influence of rabbit colpitis mycotica
3.1 experiment material
3.1.1 test sample: Bai Xian anti-inflammatory suppository for gynecopathy
3.1.2 reference substance: miconazole.
3.1.3 experimental strain: candida albicans derives from area, the Chengdu clinical hospital of 2006 White Tigers isolated strains.
3.1.4 laboratory animal:
Japan large rabbit, one-level, 36, body weight 2.0～3.0kg, female.Credit number: SCXK (river) 2004-14.Supplying unit: Sichuan Academy of Medical Sciences institute of lab animals.Full price rabbit pellet, nutrition: meet GB14924.3-2001.Freely drink Drinking Water.
3.2 experimental technique
3.2.1 grouping and dosage setting
The Bai Xian anti-inflammatory suppository for gynecopathy sees Table 2 to rabbit colpitis mycotica influence experiment grouping and dosage setting
Table 2 Bai Xian anti-inflammatory suppository for gynecopathy is to the influence experiment grouping and the dosage setting of rabbit vagina fungal infection
| Group | Medicine | Medication | Dosage (the g crude drug/only) |
| The blank group | Suppository base | Vagina administration | ??/ |
| Model control group | Suppository base | Vagina administration | ??/ |
| The test sample low dose group | The Bai Xian anti-inflammatory suppository for gynecopathy | Vagina administration | ??4.03 |
| Dosage group in the test sample | The Bai Xian anti-inflammatory suppository for gynecopathy | Vagina administration | ??9.05 |
| The test sample high dose group | The Bai Xian anti-inflammatory suppository for gynecopathy | Vagina administration | ??18.10 |
| Positive amount group | Miconazole | Vagina administration | ??20mg |
3.3 experimental result
3.3.1 the Bai Xian anti-inflammatory suppository for gynecopathy is to the influence of rabbit colpitis mycotica.
3.3.1.1 perusal result
Tangible inflammatory reaction all appears in the modeling animal before the medication: the hyperemia of vagina periphery, edema, yellow secretions increase; Blank treated animal pudendum cleaning, no abnormal secretions.After 7 days, the red and swollen phenomenon of test sample group and positive control treated animal pudendum all has alleviation in various degree through medication, but model group animal local inflammatory response is still more obvious.
3.3.1.2 treatment back vagina cleanness degree changes and efficacy result sees Table 3.
Table 3 Bai Xian anti-inflammatory suppository for gynecopathy changes and efficacy result vagina cleanness degree before and after the treatment of rabbit colpitis mycotica.
Annotate: compare * * P＜0.01 with model control group.
Experimental result shows: except that the blank group, all the other are respectively organized vagina cleanness degree and are III or IV degree before the treatment, use test sample and positive reference substance after, vagina clean be improved significantly, cure rate and effective percentage are significantly increased.
3.3.1.3 bacteriology checking after the medication.
Table 4 result showed treatment after 7 days, and 6 animal intravaginal of model group all go out antibacterial in fungal culture, the model establishment is described, and administration group positive rate of bacteria reduced obviously, illustrates that test sample and reference substance have the obvious suppression effect in animal body to fungus.
Table 4 treatment after 7 days secretions cultivate the plate number that has or not colony growth
Annotate: compare * * P＜0.01 with model control group.
3.3.2 experimental result proves:
The Bai Xian anti-inflammatory suppository for gynecopathy is definite to rabbit colpitis mycotica therapeutic effect, and basic, normal, high dosage group and the miconazole positive controls therapeutic effect extremely significant difference of having compared with model control group proves the obvious treatment effect.
4, Bai Xian anti-inflammatory suppository for gynecopathy xylol causes the influence of Mice Auricle inflammation.
4.1 experiment material
4.1.1 test sample: Bai Xian anti-inflammatory suppository for gynecopathy
4.1.2 reference substance: indomethacin ointment.
4.1.3 main experimental apparatus and reagent:
FA1104 type trace electronic analytical balance, Shanghai Precision Scientific Apparatus Co., Ltd.
Dimethylbenzene, lot number: 20050201, Shanghai organic chemical industry's reagent institute.
4.1.4 laboratory animal:
Kunming mice, one-level, 60, body weight 18～22g, female, hero half and half.The animal quality certification number: SCXK (river) 2004-11.Supplying unit: Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.
4.2 experimental result
4.3.1 Bai Xian anti-inflammatory suppository for gynecopathy xylol causes the influence of Mice Auricle inflammation and sees Table 5
The influence of the induced mice auricle edema of table 5 Bai Xian anti-inflammatory suppository for gynecopathy xylol (X ± s)
Annotate: compare * P＜0.05, * * P＜0.01 with model control group.
By table 5 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).Bai Xian anti-inflammatory suppository for gynecopathy administration group xylol causes mice auricle swelling the obvious suppression effect, compares with model control group, and the difference of Bai Xian anti-inflammatory suppository for gynecopathy 9.050g/ml dosage group, 4.525g/ml dosage group auricle swelling degree has significance (P＜0.01).
4.3.2 experiment conclusion:
Mice was through 7 days topical administration Bai Xian anti-inflammatory suppository for gynecopathies, and middle and high dosage group all can significantly alleviate mice caused by dimethylbenzene xylene auricle inflammation, showed that the Bai Xian anti-inflammatory suppository for gynecopathy has certain antiinflammatory action.
5, the Bai Xian anti-inflammatory suppository for gynecopathy is to the influence of mice granuloma inflammation.
5.1 experiment material
5.1.1 test sample: Bai Xian anti-inflammatory suppository for gynecopathy.
5.1.2 reference substance: etidocine tablet.
5.1.3 main experimental apparatus and reagent
FA1104 type trace electronic analytical balance, Shanghai Precision Scientific Apparatus Co., Ltd.
Filter paper (the about 8mm of diameter, thick about 1.5mm, heavily about 1.9mg), dry sterilization 30 minutes.Pentobarbital sodium, lot number: F20061017, Chemical Reagent Co., Ltd., Sinopharm Group.
5.1.4 laboratory animal:
Kunming mice, one-level, 60, body weight 18～22g, female.Credit number: SCXK (river) 2004-11.Supplying unit: Chengdu University of Traditional Chinese Medicine's Experimental Animal Center.
5.2 experimental technique:
5.2.1 grouping and dosage setting:
Because the Bai Xian anti-inflammatory suppository for gynecopathy is a vaginal suppository, mice auricle swelling proves that it has tangible local anti-inflammatory effect, because topical approach animal blood drug level is lower, and difficult its whole body antiinflammatory action of investigating, so increase by a treated animal gastric infusion, dosage is clinical every day of a topical dose.See Table 6.
Table 6 Bai Xian anti-inflammatory suppository for gynecopathy influences the design of grouping and dosage to mice granuloma inflammation
5.2.2 operating procedure.
5.2.2.1 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.
Be divided into 6 groups at random by body weight behind all mice modeling 24h.The vagina administration method is: with the mouse tail vein injection holder mice is fixed, the agent of Bai Xian anti-inflammatory suppository for gynecopathy 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 divided every day give for 3 times, successive administration 7 days, gastric infusion is once a day.30min puts to death animal after the last administration, and the scraps of paper and granulation tissue are extracted in the lump, weighs in 60 ℃ of dryings.Dry weight deducts scraps of paper weight and is granulation weight.
5.2.3 data processing method:
Adopt SPSS 13.0 statistical analysis softwares to carry out t check or variance analysis.
5.3 experimental result
5.3.1 the Bai Xian anti-inflammatory suppository for gynecopathy is to the influence of mice granuloma inflammation.See Table 7
Table 7 Bai Xian anti-inflammatory suppository for gynecopathy is to the influence of mice granuloma inflammation (X ± s)
Annotate: compare * P＜0.05, * * P＜0.01 with model control group.
By last table result as seen, the etidocine tablet 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).Bai Xian anti-inflammatory suppository for gynecopathy administration group has the obvious suppression effect to mice granuloma inflammation, and granulation net weight and model control group compare, and the difference of Bai Xian anti-inflammatory suppository for gynecopathy high dose vagina administration group and middle dosage gastric infusion group all has significance (P＜0.01 or P＜0.05).
5.3.2 experiment trifle:
Under this experiment condition, mice gave Bai Xian anti-inflammatory suppository for gynecopathy through 7 days, and high dose group and middle dosage gastric infusion group can significantly suppress the granulomatous formation of mice, show that the Bai Xian anti-inflammatory suppository for gynecopathy has certain antiinflammatory action.
6, the Bai Xian anti-inflammatory suppository for gynecopathy causes the influence of itching to Guinea Pig Histamine.
6.1 experiment material
6.1.1 test sample: Bai Xian anti-inflammatory suppository for gynecopathy.
6.1.2 reference substance: diphenhydramine hydrochloride injection.
6.1.3 laboratory animal:
Animal: Cavia porcellus, grade: one-level, quantity: 60, weight: 180～220g, sex: female, hero half and half.Supplying unit: plant of Sichuan Province's laboratory animal special commission.The animal quality certification number: SCXK (river) 2004-14.
6.2 experimental technique:
6.2.1 grouping and dosage setting:
Animal is adopted the completely random method respectively by sex, is divided into 5 groups, and 10 every group, male and female half and half, each is organized dosage and sees Table 8.
Antipruritic test grouping of table 8 Bai Xian anti-inflammatory suppository for gynecopathy and dosage design
6.2.2 operating procedure:
Test and shaved hair to each group Cavia porcellus right back instep in preceding 1 day, locally go up design dosage by table and smear medicinal liquid 1 time, the 0.1ml/ foot.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 medicinal liquid once.Behind the last administration 10min, every 3min successively by low concentration to high concentration, smear histamine 0.025ml/ only to every Cavia porcellus wound surface, histamine concentration is followed successively by 1.0 * 10
-4, 2.0 * 10
-4, 3.0 * 10
-4, 4.0 * 10
-4... 13.0 * 10
-4, 14.0 * 10
-4, 15.0 * 10
-4When pruritus reaction appears in Cavia porcellus, promptly lick right back sufficient wound face position, or till not occurring the pruritus reaction yet to maximum concentration.Every Cavia porcellus of accumulative total licks the right back histamine total amount (the histamine amount of Cavia porcellus tolerance) that is given when sufficient and as the itch-threshold of Cavia porcellus, its result is carried out statistical analysis.
6.2.3 data processing method:
The SPSS11.0 statistical software carries out one factor analysis of variance.
6.3 experimental result:
6.3.1 the Bai Xian anti-inflammatory suppository for gynecopathy causes the influence of itching to Guinea Pig Histamine.See Table 9.
Table 9 Bai Xian anti-inflammatory suppository for gynecopathy causes the influence (x ± s) of the effect of itching to Guinea Pig Histamine
Compare * P＜0.05, * * P＜0.01 with negative control group.
Last table result shows: 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).Bai Xian anti-inflammatory suppository for gynecopathy administration group makes a speech to itch to Guinea Pig Histamine tangible itching-relieving action, compares with negative control group, and Bai Xian anti-inflammatory suppository for gynecopathy high dose group difference has significance (P＜0.01).
6.3.2 experiment brief summary:
Under this experiment condition, give Bai Xian anti-inflammatory suppository for gynecopathy high dose group histamine to Cavia porcellus and cause to itch remarkable inhibitory action is arranged, show that the Bai Xian anti-inflammatory suppository for gynecopathy has certain itching-relieving action.
Experimental results show that: the Bai Xian anti-inflammatory suppository for gynecopathy has significant inhibition effect to common susceptible microorganisms of vagina such as staphylococcus aureus, staphylococcus epidermidis, group B streptococcus, gonococcus, Candida albicans, gonococcuss; Right
Rabbit colpitis mycotica therapeutic effect is definite; Have tangible antiinflammatory action, can significantly alleviate mice caused by dimethylbenzene xylene auricle inflammation, suppress the granulomatous formation of mice and reduce the mouse peritoneal capillary permeability; And has certain itching-relieving action.
The medicine Bai Xian anti-inflammatory suppository for gynecopathy that the present invention produced has good antibacterium, antifungal, antiinflammatory and itching-relieving action, and the rabbit colpitis mycotica is had bright significant therapeutical effect.
The acute toxicity test of Bai Xian anti-inflammatory suppository for gynecopathy
Purpose: after 1, repeatedly vagina gave rabbit Bai Xian anti-inflammatory suppository for gynecopathy in 24 hours, investigating the main of toxic reaction that animal occurs may target organ, for the monitoring of clinical toxicity provides reference frame.
2, measure the acute toxicity parameter of Bai Xian anti-inflammatory suppository for gynecopathy rabbit, select to provide reference frame for calculating this test sample relative toxicity parameter and long term toxicity dosage.
Method: (the 4.525g crude drug/ml), dosage is that 27.15g crude drug// day vagina gives rabbit to the maximum concentration Bai Xian anti-inflammatory suppository for gynecopathy that can reach with said preparation, administration 1 day, 3 times/day, promptly 6ml//day.Matched group gives equal-volume 0.9% sodium chloride injection.Every group of 6 rabbit.Carry out toxic reaction every day and observe, weekly weighed object body weight and food ration.After drug withdrawal recovers to observe 14 days, put to death whole rabbit, become celestial substantially, the pathological tissues that is observed visually is carried out histopathological examination.
The result: compare with matched group, give 3 times continuously after the administration treated animal obvious whole body and local toxic reaction all do not appear, observe after 14 days also no abnormality seen continuously, before the administration and convalescent period finish the weight of animals, food ration, become celestial etc. and to show no obvious abnormalities substantially.
Conclusion: in 24 hours repeatedly vagina give Bai Xian anti-inflammatory suppository for gynecopathy maximum concentration maximal dose, dosage is that the 27.15g crude drug/only, rabbit does not have obvious drug-induced toxic reaction.
Bai Xian anti-inflammatory suppository for gynecopathy long term toxicity test
Purpose: 1, investigate continuous vagina and give in 1 month the toxicity research process of Bai Xian anti-inflammatory suppository for gynecopathy, the toxic reaction that rabbit occurs, dosage poisonous effect relation; 2 judge the main target organ and the reversibility of toxic reaction and prolong toxic reaction; 3, the emphasis that dosage designs and clinical toxicity the reacts monitoring for data for clinical drug use provides foundation.
Method: with dosage be 4.525,9.05,18.1g crude drug/only (being 2/day of every days), administration concentration is 1.13125,2.2625, the Bai Xian anti-inflammatory suppository for gynecopathy vagina of 4.525g crude drug/ml gives rabbit, matched group gives equal-volume 0.9% sodium chloride injection.Every group 10 (female) rabbit, be administered once every day, and administration is 7 days weekly, successive administration 1 month.Before administration, after the administration and convalescent period, carry out cage every day and look on and examine, weigh weekly, food ration 1 time.2 weeks before administration (2 week), preceding 1 week of administration (1 week), administration January and convalescent period are carried out ecg analysis, urinalysis, get hematometry hematology and blood biochemical indexes, carry out ophthalmologic examination etc.The dead part rabbit in each component other places of administration January (administration latter stage) carries out that system becomes celestial and histopathological examination.In each group residue rabbit 2 week of drug withdrawal, routine feeding carries out reversibility and delayed toxicity and observes.
Result: carry out repeatedly inspections such as body weight, food ration, optical fundus, electrocardiogram, urine, hematology, blood biochemical in administration latter stage and convalescent period, show no obvious abnormalities.Histopathologic examination sees: each treated animal liver, lungs all have some pathological changes that are dispersed in to take place, but do not have obvious dose-effect, time-effect relationship, infer that tentatively these pathological changes are the common idiopathy of rabbit.
Conclusion: The above results shows, under this experimental condition, continuous 1 month vagina gives the Cmax Bai Xian anti-inflammatory suppository for gynecopathy that the rabbit preparation may reach (4.525g crude drug/ml), dosage be 18.1g crude drug/only/day, remove in administration and cause accidental the increasing of part rabbit vagina secretions latter stage, the individual animal vagina has slight stimulation but outside drug withdrawal promptly recovers, rabbit is not had other obvious drug-induced toxic reactions.Prompting should be noted the administration frequency and the successive administration time of Bai Xian anti-inflammatory suppository for gynecopathy when clinical use, avoid long-term continuous use because the colpitis reaction that local irritant effect causes.Emphasis is monitored the vagina local inflammation reaction that may cause behind the long-term successive administration.Continuous 1 month vagina administration basic security dosage of Bai Xian anti-inflammatory suppository for gynecopathy rabbit tentative for 18.1g crude drug/only/day, toxic action may main target organ be the vagina local excitation that multifrequency vice-minister time administration causes.
Claims (4)
1, a kind of medicine for the treatment of gynaecopathia is characterized in that the medicament of being made according to the weight portion proportioning by following raw materials according:
Cortex Phellodendri 30-350 part Radix Sophorae Flavescentis 30-350 part Fructus Kochiae 20-250 part
Herba Agrimoniae 10-110 part Borneolum Syntheticum 1-8 part.
2, a kind of medicine for the treatment of gynaecopathia according to claim 1 is characterized in that the medicament of being made according to the weight portion proportioning by following raw materials according:
200 parts of 300 parts of Fructus Kochiae of 300 parts of Radix Sophorae Flavescentiss of Cortex Phellodendri
5 parts of 100 parts of Borneolum Syntheticums of Herba Agrimoniae.
3, a kind of medicine for the treatment of gynaecopathia according to claim 1 and 2, the dosage form that it is characterized in that making with above-mentioned raw materials medicine is an acceptable forms on the clinical medicine.
4, the described a kind of preparation technology who treats the drug suppository of gynaecopathia of production claim 3 is characterized in that being prepared from following method:
In above-mentioned five tastes raw material, get Cortex Phellodendri, Radix Sophorae Flavescentis, the Fructus Kochiae, Herba Agrimoniae four flavor raw material of Chinese medicine, add 6 times of amounts, 5 times of amount 85% alcohol reflux secondaries respectively, each 1.5 hours, merge extractive liquid,, decompression recycling ethanol is to not having alcohol flavor, drying under reduced pressure, be ground into fine powder, add in the mixed fatty glycerides substrate of having dissolved by amount, add Borneolum Syntheticum again, stir, pour in the suppository mould, taking-up after cooling gets final product.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105687626A (en) * | 2016-02-26 | 2016-06-22 | 李洪颜 | Medicine for treating bacterial vaginitis and preparation method |
| CN107519302A (en) * | 2016-06-21 | 2017-12-29 | 蒋秋萍 | A kind of external Chinese medicinal liquid for treating gynecological disease |
| CN109010644A (en) * | 2018-10-23 | 2018-12-18 | 邱其振 | A kind of gynaecology's draft antibacterial liquid |
| CN110179880A (en) * | 2019-07-09 | 2019-08-30 | 许富明 | A kind of draft bacteriostatic agent and preparation method thereof |
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2008
- 2008-07-11 CN CN200810150303A patent/CN101623368A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105687626A (en) * | 2016-02-26 | 2016-06-22 | 李洪颜 | Medicine for treating bacterial vaginitis and preparation method |
| CN107519302A (en) * | 2016-06-21 | 2017-12-29 | 蒋秋萍 | A kind of external Chinese medicinal liquid for treating gynecological disease |
| CN109010644A (en) * | 2018-10-23 | 2018-12-18 | 邱其振 | A kind of gynaecology's draft antibacterial liquid |
| CN110179880A (en) * | 2019-07-09 | 2019-08-30 | 许富明 | A kind of draft bacteriostatic agent and preparation method thereof |
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