CN100569277C - A kind of effervescent tablet for the treatment of female vagina and its production and use - Google Patents
A kind of effervescent tablet for the treatment of female vagina and its production and use Download PDFInfo
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Abstract
The present invention relates to a kind of effervescent formulation that is used for the treatment of female vagina, said preparation is by the crude drug Rhizoma Coptidis, Semen Strychni, Rhizoma Smilacis Chinensis, Rhizoma Curcumae, Galla Turcica (Galla Helepensis), Pericarpium Granati, beta-schardinger dextrin-, sodium bicarbonate, Polyethylene Glycol, lactose, citric acid, magnesium stearate, carboxymethyl starch sodium is made, it mainly is according to the Uygur medicine theory, concentrate the length of medicine and uighur medicine, follow the aim of excavating the ethnic drug elite, the doctor passes on from generation to generation proved recipe in conjunction with the modern pharmacy research method with dimension, research and development are bacillary to treat, colpitis mycotica is main gynecological external use preparation---vagina effervescence, by killing and suppress women's pudendum pathogenic bacterium, reach treatment and prevention bacterial vaginitis, the generation of gynecological diseases such as leucorrhoea grow in quantity.Said preparation has been developed uighur medicine and has been treated colpitic invaluable experience, refining formula, convenient drug administration, and the treatment female vagina is obtained good effect surely.
Description
Technical field
The present invention relates to a kind of external effervescent tablet that is used for the treatment of female vagina
Background technology
Vaginitis is very common gynaecopathia.Because vagina is positioned at the human body concealment part, communicates with the external world again, very easily causes external microbe and infect.Doctor trained in Western medicine is divided into it nonspecific vaginitis, monilial vaginitis, senile vaginitis etc. again.Generally vagina also has some resident floras, when low or vaginal mucosa damage and vagina acid-base value change at Abwehrkraft des Koepers, can cause a large amount of breedings of these antibacterials or the invasion of external pathogenic bacterium and causes the vaginitis morbidity.Staphylococcus, escherichia coli, Candida albicans and protozoon etc. are the commonly encountered diseases substances that causes vaginal infection.The traditional Chinese medical science is then thought damp and hot being harmonious, inside and outside wet excessive stain, or dye cloudy worm, and the three is assorted mutually to be swashed mutually, damp invasion of lower energizer, pents up and does not loose and send out this disease.The vaginitis sickness rate is on the rise in recent years, and many patients are because of malpractice, and the state of an illness is shown effect repeatedly, protracted course of disease, even cause other gynaecopathias, have a strong impact on women's physical and mental health.
Vaginitis is the inflammation that infects connective tissue under the vaginal mucosa cause and the mucosa owing to pathogenic microorganism (comprising microorganisms such as coccus, dried bacterium), is gynecological's common disease.Normal health women, because anatomy and biochemical characteristics, vagina has the nature defense function to the intrusion of pathogen, when the natural defense function of vagina was destroyed, pathogen was easy to invade, and causes colpitis.Youngest daughter and postmenopausal women are owing to estrogen deficiency, and vagina epithelium is poor, and the former content of endocellular sugar reduces, and vagina pH is up to about 7, and is so vagina is lower for the resistance, easier to be more infected than the adolescence and the women of child-bearing age.Normal health women's vagina is because its histology and biological characteristics have the ability that prevents extraneous pathogenic microorganism invasion and attack.
Vaginitis changes with the character of leucorrhea clinically and the pudendum infections is itched, and causalgia is a main feature, and sexual anhedonia is also more common, infects when involving urethra, and symptoms such as dysurea, urgent micturition can be arranged.Vaginitis is different according to the age and the source of infection, can be divided into senile vaginitis, trichomonal vaginitis, colpitis mycotica, gonococcal vaginitis, amebic vaginitis, vaginitis hemoptulus vaginalis, infantile vaginitis, emphysematous vaginitis and nonspecific vaginitis etc., common vaginitis has bacterial vaginitis, trichomonal vaginitis, colpitis mycotica, senile vaginitis.
Because the special physiological structure of women causes it easily to cause various acute and chronic gynecological inflammations, gynecological inflammation is women's commonly encountered diseases and frequently-occurring disease, and higher sickness rate and relapse rate are arranged.From the investigation of urban and rural women gynaecopathia, find have crowd's ratio of various gynecological inflammations very high, about more than 90%.Along with increasing that the progress of society, growth in the living standard and women support oneself, the women more and more payes attention to self health, and past is the sort of, and gynecological inflammation is arranged is that normal idea is constantly negated, so the ratio regular meeting of women's usefulness medicinal health-care and treatment is more and more higher; Chance social, amusement is more and more because the women goes out in addition, and the defective of the health of national various public places of entertainment, management has caused the infection chance of gynecological inflammation to increase, and forms potential gynecological antiseptic hygiene product new markets again.Because women's self the physiological characteristics and the repeatability of gynecological inflammation, add because the sickness rate of women's gynecological inflammation is very high, and easily repeated infection, so the development of gynecological's antiseptic hygiene produce market is very promising, gynecological's antiseptic hygiene product new markets development space is wide.
The clinical treatment vaginitis is divided into treatment by oral administration of medicines, external treatment, Chinese medicine and therapy of combining Chinese and Western medicine substantially.The internal treatment is based on oral medication, and external treatment is based on topical therapeutic, and Chinese medicine and therapy of combining Chinese and Western medicine then are the oral topical therapeutic that adds.In, western medical treatment has his own strong points, Western medicine instant effect, but easily produce drug resistance is often because of thoroughly outbreak repeatedly of treatment; The Chinese medicine effect is lasting relatively, and curative effect is more stable.External therapy of Chinese herb is with a long history, is one of traditional Chinese medical science traditional remedies, uses very extensively, and method comprises fumigation and wash method demibain method, nanofarad, application method etc., and preparation research is also obtained remarkable progress in recent years, and the Chinese medicine preparation that has gone on the market has JIEERYIN PAOTENGPIAN, the clean easypro washing liquid of woman etc.
Because the external treatment medicine directly acts on disease sites, and is with strong points, absorb rapidly, little to the organismic internal environment interference, it is fast, easy and simple to handle to prove effective, and is beneficial to popularization, is popular clinical.At present, the product that suppresses to cause the vagina inflammation though have curative effect preferably, also has certain toxic and side effects based on chemical medicine, and antibacterial forms drug resistance easily.Though commercially available Chinese medicine for external application is relief of symptoms to some extent, unsatisfactory to the inhibitory action of pathogen, some preparation medication is numerous and jumbled, affects the treatment.Therefore, it is very urgent to develop the dimension medicine sterilization compound preparation that a kind of inhibition causes vagina inflammation antibacterial.
Along with improving constantly of living standards of the people, requirement to quality of life is also more and more higher, the antibacterial sterile products that is applicable to the women mostly is chemicals, side effect is big, angle from the market demand, in conjunction with the pathogenic bacterium characteristics, this has for many years under battle conditions that the proved recipe on basis is developed as modern plants compound recipe antibacterial with " vagina effervescence ", and this new product that has market potential is introduced to the market early.
Summary of the invention
The object of the invention is, develop a kind of female vagina medicine for external use effervescent tablet that is used for the treatment of, this effervescent tablet is by the crude drug Rhizoma Coptidis, Semen Strychni, Rhizoma Smilacis Chinensis, Rhizoma Curcumae, Galla Turcica (Galla Helepensis), Pericarpium Granati, the adjuvant beta-schardinger dextrin-, sodium bicarbonate, Polyethylene Glycol, citric acid, magnesium stearate, lactose, carboxymethyl starch sodium is made, it mainly is a medical drugs theory in the basis, concentrate the length of doctor and uighur medicine, follow the aim of excavating the ethnic drug elite, the doctor passes on from generation to generation proved recipe in conjunction with the modern pharmacy research method with dimension, research and development with antibacterial be the compound preparation of main prophylaxis of gynaecological disorders---FUKANG vagina effervescence, by to women's pudendum staphylococcus aureus, escherichia coli, read the inhibition of pathogenic bacterium such as coccus and kill, reach treatment and prevention bacterial vaginitis, the generation of gynecological diseases such as leucorrhoea grow in quantity.Thereby strengthened this product competitiveness in the gynecological inflammation product on market greatly.Traditional Chinese Medicine experts thinks that the FUKANG vagina effervescence is inherited and developed the colpitic invaluable experience of Chinese medicine, refining formula, convenient drug administration, and the external curing female vagina is obtained good effect surely.The present invention's process is on probation to 1000 routine women patients', and its effective percentage is 97.88%.
The medicine for external use effervescent tablet that is used for the treatment of female vagina of the present invention, this effervescent tablet is a radix to make 1000, is to be made by crude drug Rhizoma Coptidis 50-150g, Semen Strychni 20-150g, Rhizoma Smilacis Chinensis 200-660g, Rhizoma Curcumae 140-560g, Galla Turcica (Galla Helepensis) 170-630g, Pericarpium Granati 140-660g, adjuvant beta-schardinger dextrin-5-300g, sodium bicarbonate 50-550g, Polyethylene Glycol 500-9000 10-200g, lactose 20-300g, citric acid 50-500g, magnesium stearate 3-100g, carboxymethyl starch sodium 20-200g; The crude drug Rhizoma Curcumae is pulverized in employing, adds water, extracts volatile oil, and volatile oil carries out enclose with beta-schardinger dextrin-, sucking filtration, and drying, porphyrize sieves, and is standby; Rhizoma Coptidis, Semen Strychni are pulverized, added 30-95% alcohol reflux 1-4 time, merging filtrate concentrates, and is standby; In the medicinal residues after Rhizoma Smilacis Chinensis, Galla Turcica (Galla Helepensis), Pericarpium Granati adding Rhizoma Curcumae and Rhizoma Coptidis, the Semen Strychni extraction, decoct with water 1-4 time, merging filtrate, concentrate, merge with alcohol-extracted extract, mixing, spray drying gets extract powder, in pharmaceutical methods routinely adjuvant and extract powder, volatile oil clathrate compound is mixed and makes the effervescence solid preparation.
The preparation method of the effervescent tablet of treatment female vagina follows these steps to carry out:
A, the crude drug Rhizoma Curcumae is ground into coarse powder, adds 3-15 times of water gaging, extracted volatile oil 0.3-15 hour, volatile oil carries out enclose with beta-schardinger dextrin-, and 15-45 ℃ of constant temperature of enclose process stirred 0.1-4 hour, sucking filtration, and drying, porphyrize, mistake 20-140 mesh sieve, standby;
B, with crude drug Rhizoma Coptidis, Semen Strychni, be ground into coarse powder, add 3-15 and doubly measure the 30-95% ethanol extraction 1-4 time, each 0.1-4 hour, merging filtrate concentrates, and was standby;
C, the medicinal residues after crude drug Rhizoma Smilacis Chinensis, Galla Turcica (Galla Helepensis), Pericarpium Granati and step a and b extracted merge, and add 3-20 times of water gaging and decoct 1-4 time, 0.1-4 hour at every turn, merging filtrate, concentrating under reduced pressure, standby;
D, combining step c and step b extractum, mixing, the dry extract powder that gets, standby;
E, taking polyethylene glycol, fusion adds sodium bicarbonate, stir, cooling is pulverized, cross the 20-140 mesh sieve, with extract powder, volatile oil clathrate compound, citric acid, lactose, carboxymethyl starch sodium mixing, with the anhydrous alcohol solution system soft material that contains 2-20%PVP, sieve 15-90 ℃ of drying, granulate, with magnesium stearate mix homogeneously, tabletting, check, packing promptly gets the effervescence solid preparation;
The purposes of the effervescent tablet of treatment female vagina in the medicine of preparation treatment women vaginitis.
The effervescent tablet of treatment female vagina of the present invention is according to theory of Chinese medical science, in line with the principle prescription for the treatment of both the principal and secondary aspects of a disease, monarch drug Rhizoma Coptidis big bitter Great Cold, the wet fire that all are had a surplus can fall clearly, just in time the hit pathogenesis of vaginitis damp invasion of lower energizer is used for the treatment of the outer swelling of the vulva of women and itches, and have existed since ancient times; Rhizoma Smilacis Chinensis detoxifcation diuresis, minister can be showed its merit fully from Rhizoma Coptidis; Pericarpium Granati anthelmintic analgesic therapy, ancient books claim it " disconnected purgation merit to be arranged ", should be adjuvant drug; But the pain relieving of Semen Strychni counteracting toxic substances, mass dissipating and swelling eliminating closes among we assistant and helps the monarch and his subjects, not only can control disease that pudendal pruritus become, but also disease such as the living erosion of vulva of can preapring for an unfavorable turn of events; The debug of Galla Turcica (Galla Helepensis) leukorrhagia stopping is included Fang Zhongneng in symptom is alleviated as early as possible; Rhizoma Curcumae assistant principal drug assistance is eliminated damp and hot heresy.The all medicines of we are respectively taken charge of its position, complement each other, and play the effect of heat clearing and damp drying, analgesic therapy detumescence, leukorrhagia stopping dirt eliminating altogether.Because of this medicine directly acts on diseased region, the efficacy of a drug sick institute that goes directly, thereby not if medicine, this prescription selects YAOJING to work as, framework is reasonable.
This effervescent tablet prescription had both been abided by through holding on even to dead in order to perfect one's virtue, complementing each other, and lattice are kept modern science again, and at causing colpitic common pathogen, the Rhizoma Coptidis of selecting to have broad-spectrum antibacterial action is as monarch drug, and pharmacological research confirms that it has very strong inhibitory action to staphylococcus aureus; Rhizoma Smilacis Chinensis, Rhizoma Curcumae also have stronger bacteriostasis to golden Portugal bacterium and escherichia coli according to another report; Pericarpium Granati can suppress fungus and escherichia coli etc.More than a few flavor Chinese medicines share, suppressing and killing and bring into play significant curative effect surely aspect the common pathogen.As seen this medicine bases oneself upon and effects a permanent cure, and takes into account the alleviation and the elimination of symptom simultaneously, and all medicine mutual reinforcement between mutual-assistances in the side demonstrate fully its reasonability of selecting medicine and science.
Because the vagina mucosa has a lot of pleats, select for use effervescent formulation can guarantee that medicine discharges preferably and distributes and fully absorb for vaginal mucosa in intravaginal, brings into play curative effect to greatest extent.
The present invention has 1, can dissolve rapidly in vagina special physiological environment, thereby bactericidal action is played in release, medicine protection pudendum self-cleaning ability again.2, rapid combining of effervescent and inclusion essential oil technology and traditional Uygur medicine proved recipe makes the raising of this product therapeutic effect.3 effervescent tablet novel forms be used for first tieing up recurrence due to taking drug square preparation, medication convenient, without washbasin, need not wash towel, avoid contacting unclean utensil, avoid antibacterial, virus to invade the characteristics of health superinfection.
Vagina effervescence drug efficacy study of the present invention
Material
Medicine and reagent: vagina effervescence is provided 0.75g (being equivalent to crude drug 1.35g)/sheet, lot number 041005 by Xinjiang English derivatives scientific and technological development company limited; Be made into the suspension administration with distilled water during test; JIEERYIN PAOTENGPIAN, the accurate word Z10930008 of traditional Chinese medicines, Chengdu En Wei pharmaceutical Co. Ltd, lot number 041001; Dimethylbenzene: Xi'an chemical reagent factory, lot number 030701; Histamine phosphate: the calibrating of Ministry of Public Health pharmaceutical biological product provides lot number 030309.
Laboratory animal: Kunming kind white mice, female, body weight 20 ± 2g; The Wistar rat, female, body weight 150 ± 10g; Cavia porcellus, body weight 240 ± 30g provides by Xinjiang Medicine University zoopery center, moving word syxk (newly) 2003-0001 of new doctor.
Method and result
Xylol causes the bullate influence of mouse ear:
Get 50 of female mices, body weight 25-30g, be divided into five groups at random: matched group, three dosage groups of JIEERYIN vagina effervescence group (40mg/kg) and vagina effervescence preparation (50mg/kg, 100mg/kg, 200mg/kg) are tried thing and are made into the suspension administration with distilled water.The same day was respectively organized Mice Auricle by setting the dosage coating once in experiment, and matched group is coated with isopyknic distilled water.The administration group is cleaned with cotton balls with distilled water flush away medicinal liquid behind the 1h.The two sides was coated with dimethylbenzene before and after each organized mouse right ear, and 0.05ml/, left ear compares.Put to death mice behind the 15min, with diameter 6mm card punch ears are downcut with the position homalographic, precision is weighed, and represents the swelling degree with left and right sides ear weight difference, obtains suppression ratio (%).Three dosage of vagina effervescence all obviously suppress mice ear as a result.
Table 1. xylol cause the bullate influence of mouse ear (X ± SD, n=10)
Compare * P＜0.05, * * P＜0.01 with matched group.
Xylol causes the influence that the mouse skin capillary permeability increases:
Get 50 of female mices, grouping and dosage are tried thing and are made into suspension with distilled water with 2.1, coating (divide and smear for four times, be coated with once in per 15 minutes) according to dosage on the skin of unhairing of position, mouse web portion center, and matched group is coated with the equivalent distilled water.Wipe medicinal liquid behind the 1h, in the blue normal saline solution 0.1ml/10g of tail vein injection 0.5% ivens, drip dimethylbenzene 0.03ml/ immediately in the coating position only, take off cervical vertebra behind the 20min and put to death, peel the skin that the locus coeruleus position occurs and shred back input tool plug in vitro, add acetone-sodium sulfate extracting solution 10ml, put the dark place and place, shake 2-3 every day, the centrifugal 10min of 2000rpm/min after three days, getting supernatant and survey absorption value in the 590nm place, is blank with acetone-sodium sulfate liquid.As a result, three dosage of vagina effervescence all can suppress capillary permeability hyperfunction (table 2).
Table 2. xylol causes the influence that the capillary of skin permeability increases (X ± SD)
Compare * P＜0.05, * * P＜0.01 with matched group.
To the swollen outgrowth influence of rat granuloma:
Get 50 of rats, body weight 150 ± 10g, be divided into matched group, JIEERYIN PAOTENGPIAN (30mg/kg) group, three dosage of FUKANG source vagina effervescence (35,70,140mg/kg) group at random, each treated animal is with the ether light anaesthesia, make otch under aseptic condition, each forelimb oxter, the Mus left and right sides is implanted the sterilization cotton balls of 20mg respectively.Postoperative is pressed and is set the dosage vagina administration, once a day, and continuous seven days.Matched group gives the distilled water of equivalent.After weighing in the 8th day rat taken off cervical vertebra and put to death, peel off and take out the granuloma induced by implantation of cotton pellets tissue,, weigh in 60 ℃ of baking oven inner dryings 12 hours.Cut off the raw cotton ball weight, promptly get granuloma weight.As a result, three dosage of vagina effervescence all can suppress the swollen hypertrophy (table 3) of rat granuloma.
The influence that table 3 granuloma forms (X ± SD)
Compare * P＜0.05 with matched group
The itching-relieving action experiment:
Get 50 of Cavia porcelluss, body weight 240 ± 30g is divided into 5 groups at random with Cavia porcellus, is divided into matched group, JIEERYIN PAOTENGPIAN (25mg/kg) group, three dosage of vagina effervescence (30,60,120mg/kg) group at random, 10 every group.The experiment proxima luce (prox. luc) picks hair to each right back instep of group Cavia porcellus, and according to dosage coating once; Experiment is shaved the area 1m of hair place when daily Coarse Mesh Gauze abrades right back instep
2, according to dosage coating once, matched group is coated with the equivalent distilled water.10min behind the coating, beginning is dripped histamine phosphate's solution at wound surface, every interval 3min once, concentration is by 0.02%, 0.04%, 0.06%, 0.08%...... increase progressively successively, volume only is 0.025ml/, later licks right back foot until Cavia porcellus occurring, the histamine phosphate's total amount that gives with this moment is an itch-threshold, record and itch-threshold of relatively respectively organizing.As a result, each dosage group of vagina effervescence effect (table 4) of Cavia porcellus itch-threshold that all is significantly improved.
Table 4. pair Cavia porcellus histamine phosphate causes the influence (X ± SD) of the reaction of itching
Compare * * P＜0.01 with matched group
Antibacterial action: experimental bacteria is provided by Chinese medicine bioassay.
Staphylococcus aureus ATCC 25923, escherichia coli ATCC 25922, candida albicans bacterium ATCC;
Culture medium: MH broth bouillon lot number: 200020919; Husky Bo Shi culture medium lot number: 20010808; MH agar culture medium lot number: 20030515; Nutrient agar lot number: 20040602; Blood agar culture-medium (the aseptic defiber Sanguis caprae seu ovis of Nutrient agar+7%) self-control.
Be subjected to the reagent pretreatment:
Vagina effervescence 15g+30ml sterile distilled water fully dissolves, and dissolubility is better, is khaki thickness turbid liquid, transfers PH=7.0, and it is 1g/ml that the water proof heating is concentrated into drug level.Do sterility test (-).
JIEERYIN PAOTENGPIAN 1.5g+3ml sterile distilled water fully dissolves.Processing method is the same, and drug level is 0.5g/ml, does sterility test (-).
Experimental technique:
Get the staphylococcus aureus and the escherichia coli reference culture of recovery, inoculate 37 ℃ of MH broth bouillons respectively, 6h is hatched.
Get the candida albicans bacterium reference culture of recovery, 25 ℃ of inoculation Sha Shi fluid mediums, 24h are hatched.
Respectively depletion Staphylococcus aureus, escherichia coli 6h cultured solution of broth, with the Maxwell than the turbid 109/ml that is about, candida albicans bacterium 24h Sha Shi fluid medium with the Maxwell than the turbid 109/ml that is about.
Determine working concentration:
Staphylococcus aureus is through 10
-5Dilution, escherichia coli are through 10
-6Dilution, candida albicans bacterium are through 10
-4Dilution is done colony counting by pour plate.By counting, determine to add in every ml fluid medium in the experiment 0.1ml bacterium liquid.The results are shown in Table 5.
The final experimental bacteria concentration of table 5.
| Experimental bacteria | Colony counting | Working concentration (CFU/ml) | Final experimental bacteria concentration (CFU/ml) |
| Staphylococcus aureus | 56 | 5.6×10 7 | 5.6×10 6 |
| Escherichia coli | 24 | 2.4×10 8 | 2.4×10 7 |
| The candida albicans bacterium | 71 | 7.1×10 6 | 7.1×10 5 |
That gets pretreatment is subjected to reagent vagina effervescence solution 1ml (1g/ml), respectively staphylococcus aureus, escherichia coli are done doubling dilution to 17 pipe with MH meat soup, 1-17 pipe medicinal liquid dilution factor was respectively 1: 2,1: 4,1: 8,1: 16,1: 32,1: 64 ... 1: 131072.The 1-18 pipe adds staphylococcus aureus bacterium liquid 0.1ml, and the 18th pipe is the medicine contrast for test organisms contrast, the 19th pipe for meat soup blank, the 20th pipe.Escherichia coli the 11st pipe is the medicine contrast for test organisms contrast, the 12nd pipe for meat soup blank, the 13rd pipe.The candida albicans bacterium hatches through 37 ℃, 24h, does doubling dilution with the Sha Shi fluid medium and manages to 1-10, and the 11st pipe contrasts (show 6-1) for meat soup blank, the 13rd pipe for medicine for test organisms contrast, the 12nd pipe.
The test of table 6-1. vagina effervescence in-vitro antibacterial
| The pipe number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Dilution factor | 1∶2 | 1∶4 | 1∶8 | 1∶16 | 1∶32 | 1∶64 | 1∶128 | 1∶256 | 1∶512 | 1∶1024 |
| Staphylococcus aureus | - | - | - | - | - | - | - | - | - | - |
| The candida albicans bacterium | - | - | - | - | Little turbid | Turbid | Turbid | Turbid | Turbid | Turbid |
| Escherichia coli | - | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid |
| The pipe number | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 |
| Dilution factor | 1∶2048 | 1∶4095 | 1∶8192 | 1∶16384 | 1∶32768 | 1∶65536 | 1∶131072 | |||
| Staphylococcus aureus | Little turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | - | - |
| The candida albicans bacterium | Turbid | - | - | |||||||
| Escherichia coli | Turbid | - | - |
Annotate: "-" represents this dilution factor asepsis growth.
Get the positive control drug JIEERYIN PAOTENGPIAN solution 1ml (1g/ml) of pretreatment, respectively staphylococcus aureus, candida albicans bacterium, escherichia coli are done doubling dilution to 10 pipe with MH meat soup, 1-10 pipe medicinal liquid dilution factor was respectively 1: 2,1: 4,1: 8,1: 16,1: 32,1: 64 ... 1: 1024.The 11st pipe is medicine contrast (table 6-2) for test organisms contrast, the 12nd pipe for meat soup blank, the 13rd pipe.
The test of table 6-2. JIEERYIN PAOTENGPIAN in-vitro antibacterial
| The pipe number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
| Dilution factor | 1∶2 | 1∶4 | 1∶8 | 1∶16 | 1∶32 | 1∶64 | 1∶128 | 1∶256 | 1∶512 | 1∶1024 | - | - | - |
| Gold Portugal bacterium | - | - | Little turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | - | - |
| Bai Nian | - | - | - | - | - | Little turbid | Turbid | Turbid | Turbid | Turbid | Turbid | - | - |
| Coliform | - | Little turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | Turbid | - | - |
Annotate: "-" represents this dilution factor asepsis growth.
Each pipe (1-18 pipe) of staphylococcus aureus, the candida albicans bacterium (1-11 pipe) of vagina effervescence solution are done 10 respectively
-2, 10
-3, 10
-4, 10
-5, 10
-6, 10
-7Dilution, the different dilution factors of every pipe are got 0.1ml respectively and are added drop-wise to the nutrient agar surface, smoothen (the candida albicans bacterium is used sabouraud's agar) with aseptic L type Glass rod.The different dilution factors of every pipe all pour into three flat boards, hatch through 37 ℃, 24h.The candida albicans bacterium hatches through 25 ℃, 3d, and note survival clump count is got average.
Table 7. numeration average result (CFU/ml)
Experimental result:
Vagina effervescence:
Staphylococcus aureus MIC 1:2048 4.8828125 * 10-1mg/ml
MBC 1：1024 9.765625×10-1mg/ml
Candida albicans bacterium MIC 1:32 31.25mg/ml
MBC 1：16 62.5mg/ml
Escherichia coli MIC 1:2 500mg/ml
MBC 1≤2
JIEERYIN PAOTENGPIAN:
Staphylococcus aureus MIC 1:8
MBC 1：4
Candida albicans bacterium MIC 1:8
MBC 1：4
Escherichia coli MIC 1:4
MBC 1：2
Conclusion: showing by above experiment that mouse ear that the vagina effervescence xylol causes is swollen has an obvious suppression effect; Also can obviously suppress the mouse skin capillary permeability that dimethylbenzene causes increases; The swollen hypertrophy of rat granuloma also there is good inhibitory effect; Good antipruritic effect is arranged simultaneously.Treated in vitro can suppress staphylococcus aureus, candida albicans bacterium and escherichia coli, and is remarkable to the bacteriostasis and sterilization effect of staphylococcus aureus and candida albicans bacterium, obviously is better than JIEERYIN PAOTENGPIAN.
Vagina effervescence pharmacological toxicology research of the present invention
Main pharmacodynamics research
In view of vagina effervescence is the colpitic external preparation of treatment, select staphylococcus aureus (gram negative bacteria), candida albicans bacterium (Candida albicans) and escherichia coli (escherichia coli) to carry out extracorporeal bacteria inhibitor test at gynecological's common pathogen; And select that the most frequently used animal inflammatory model mice caused by dimethylbenzene xylene ear is swollen, mice caused by dimethylbenzene xylene capillary of skin permeability increases and rat granuloma is swollen, investigate the vagina effervescence vagina effervescence and whether have bacteriostasis and sterilization, alleviate active chronic inflammation and suppress early stage blood capillary inflammatory and oozes out; Vaginitis is often with pruritus vulvae in addition, thereby needs to investigate the influence of this medicine to Cavia porcellus histamine phosphate itch-threshold.The vagina effervescence vagina effervescence is established three dosages, and the every day clinical consumption of being equivalent to respectively to be grown up is converted into 0.5,1.0,2.0 times of corresponding animals administer dosage; The JIEERYIN vagina effervescence is established a dosage, and the every day clinical consumption of being equivalent to be grown up is converted into the dosage of corresponding animal.
Antibacterial action:
External bacteriostatic experiment shows that vagina effervescence has significant bacteriostasis and sterilization effect to staphylococcus aureus (MIC:0.49mg/ml, MBC:0.98mg/ml) and candida albicans bacterium (MIC:31.25mg/ml, MBC:62.5mg/ml), also has certain inhibitory action to escherichia coli.Its bacteriostasis and sterilization effect to staphylococcus aureus and candida albicans bacterium obviously is better than the JIEERYIN vagina effervescence.
Xylol causes the influence of Mice Auricle inflammatory swelling:
Vagina effervescence 50,100, three dosage of 200mg/kg are made into suspension with distilled water and give the Mice Auricle coating, auris dextra is coated with the caused by dimethylbenzene xylene inflammation after 1 hour, left side ear compares, put to death mice after 15 minutes, ears are weighed with the cutting-out of position homalographic, with left and right sides ear weight difference is the swelling degree, obtain inhibitory rate of intumesce (%), three dosage of vagina effervescence all have the obvious suppression effect to mice ear as a result, suppression ratio is respectively 20.8% (P＜0.05), 25.0% (P＜0.01) and 33.3% (P＜0.01), curative effect is suitable with positive control drug JIEERYIN vagina effervescence.The prompting vagina effervescence has tangible mitigation to acute inflammation.
1.3 xylol causes the influence that the mouse skin capillary permeability increases
Vagina effervescence 50,100, three dosage of 200mg/kg are made into suspension with distilled water and give coating on the mouse web portion skin of unhairing, wipe medicinal liquid after 1 hour, in the blue normal saline solution of tail vein injection 0.5% ivens, an amount of in coating position melted paraxylene immediately, put to death after 20 minutes, peel skin that the locus coeruleus position occurs after acetone-sodium sulfate extracting solution extracts, get supernatant and survey absorption value.The result, the absorption value of three dosage groups of vagina effervescence all is lower than the normal saline matched group, explanation can suppress the capillary of skin permeability that dimethylbenzene causes and increase, in, heavy dose of suppression ratio is respectively 32.5% (P＜0.05), 39.6% (P＜0.01), and the inhibitory action of inflammatory exudation is better than the JIEERYIN vagina effervescence.
1.4 to the swollen outgrowth influence of rat granuloma
The sterilization cotton balls of implanting 20mg respectively under aseptic condition, for forelimb oxter, the rat left and right sides, vagina effervescence with 35,70, three dosage of 140mg/kg give the administration of postoperative rat vagina, once a day, continuous seven days.After weighing in the 8th day rat is put to death, take out the granuloma induced by implantation of cotton pellets tissue, weigh after the oven dry, calculate granuloma weight.Three dosage of vagina effervescence all suppress the swollen hypertrophy of rat granuloma as a result, in, heavy dose of suppression ratio is respectively 10.6% (P＜0.05) and 14.9% (P＜0.05), its effect is suitable with the JIEERYIN vagina effervescence.Prompting also has certain inhibitory action to chronic inflammatory disease.
Itching-relieving action:
Three dosage of vagina effervescence 30,60,120mg/kg give the right back sufficient abrasive surface coating of Cavia porcellus, and give histamine phosphate's solution of series concentration at wound surface, measure Cavia porcellus and lick right back histamine phosphate total amount itch-threshold required when sufficient, three dosage of vagina effervescence all can obviously improve the Cavia porcellus itch-threshold as a result, and itching-relieving action is close with the JIEERYIN vagina effervescence.
The effect that above result of study explanation vagina effervescence suppresses pathogen obviously is better than the JIEERYIN vagina effervescence, and good antiinflammatory, itching-relieving action are arranged, and curing mainly for it is clinical provides scientific basis.
Toxicologic study:
Rat acute toxicity test: vagina effervescence was equivalent to clinical plan 50 times with dosage with maximum dosage-feeding 625mg/kg in one day) to behind the female rats vagina administration, dead and other acute toxic reactions did not appear in 14 day observation period, each administration group body weight and matched group compare there was no significant difference when observing end, the abnormal change relevant with medicine also do not seen in the gross anatomy inspection, illustrates that this medicine does not have obvious acute toxicity rat to receive most the amount of reagent vagina administration greatly.
45 days long term toxicity tests of rat: 120 of Wistar rats, male and female half and half, be divided into three dosage groups of NS matched group, FUKANG source vagina effervescence 0.11g/kg.d, 0.32g/kg.d, 0.66g/kg.d (be equivalent to respectively 60kg adult per kilogram of body weight consumption every day 8.8,25.6,52.8 times) at random, vagina administration, every day 1 time, continuous 45 days.The daily check rat outward appearance and the mental status claimed a body weight, and calculated inflow, food-intake in per 7 days.Dead 1/3rd animals in 14 natural gift other places do organ coefficient, routine blood test and blood biochemistry index inspection after administration 30 days, 45 days and the drug withdrawal, and make the organs and tissues pathological examination.The result shows that the FUKANG source vagina effervescence administration group of three dosage and matched group compare, and the variation relevant with administration all appears in every index, also do not see the tissue pathologies change relevant with drug effect.Prompting vagina effervescence successive administration 45 days under three dosage of regulation does not have overt toxicity to rat.
The result of above-mentioned safety research shows in the FUKANG source vagina effervescence one day with the dosage of 52.8 times of the clinical plan consumptions of being equivalent to be grown up and acute toxicity or local excitation reaction do not occur for the rat vagina administration; And also do not cause toxic reaction with same dose administration in continuous 45 days, the consumption that poisonous medical material in the said preparation prescription is described is in safety range, and preparation technology is reasonable, has guaranteed the safety of medication.
Local irritation and sensitivity test:
Vagina effervescence with two dosage of 12.5mg/kg and 62.5mg/kg (being respectively clinical plan 1 times and 5 times) with dosage in the rat vagina administration, once a day, continuous seven days, observe local organization and do not have phenomenons such as hyperemia, edema, get vagina, uterus, the ovary of heavy dose of administration treated animal and make histopathological examination, and with matched group relatively, also do not see the abnormal change relevant with medicine, illustrate that FUKANG source vagina effervescence does not have obvious local irritation with prescribed dose in the rat vagina administration.
Vagina effervescence with two dosage of 12.5mg/kg, 62.5mg/kg be administered three times at guinea pig skin (at interval 6 days) carry out sensitization, excite contact with same dose again after 14 days, symptoms of allergic such as erythema and edema all do not appear in the administration group in the observation period of regulation, and promptly vagina effervescence does not cause initiatively skin allergy under rated condition the Cavia porcellus external.
Vagina effervescence acute toxicity testing of the present invention
Experiment material:
Animal: the Wistar rat, female, body weight 200 ± 10g, medical experiment animal supply center provides by Xinjiang, the quality certification number: No. (1996) 16001, the moving word of new doctor.
Tried thing: vagina effervescence, brown tablet, specification 0.75g (being equivalent to crude drug in whole 1.35g)/sheet, clinical plan dosage is adult's (body weight is by 60kg) a slice every day, be 12.5mg/kg, English derivatives scientific and technological development company limited medicament chamber provides lot number 041015 by Xinjiang.
Method and result:
Get 40 of healthy rats, female unpregnancy, body weight 150 ± 10g is divided into the administration group of blank group (giving the distilled water with volume) and 156.2mg/kg, 312.5mg/kg, three dosage of 625mg/kg at random.Tried thing and be made into the suspension vagina administration 0.05ml/100g of Cmax (31.2%), small dose group administration 1 time, middle dosed administration 2 times, heavy dose of group administration 4 times with distilled water.Multiple dosing all at interval one hour.Animal overall health of patients and local response in 14 days after the observed and recorded administration were put to death each treated animal in the 15th day and to be done the gross anatomy inspection, and the visible unusual organ of naked eyes is carried out histopathological examination.
As a result, death does not appear in experimental observation phase internal reference group and administration treated animal; Outward appearance sign, behavioral activity and diet etc. there is no unusually; Each administration group body weight and matched group compare there was no significant difference when observing end, and it is obviously unusual that the gross anatomy inspection does not also find that histoorgan has.
Conclusion: give with maximum dosage-feeding 625mg/kg (being equivalent to clinical plan 50 times) in the vagina effervescence one day and tried the rat vagina administration, in the observation period of regulation, do not cause tangible acute toxic reaction with dosage.
Vagina effervescence vaginal irritation of the present invention test
Medicine and reagent: vagina effervescence, brown tablet, specification 0.75g (being equivalent to crude drug in whole 1.35g)/sheet, clinical plan dosage is adult's (body weight is by 60kg) a slice every day, be 12.5mg/kg, English derivatives scientific and technological development company limited medicament chamber provides lot number 041015 by Xinjiang; Be made into the suspension administration with distilled water during test.
Laboratory animal: the Wistar rat, female, body weight 150 ± 10g; Moving word syxk (newly) 2003-0001 of new doctor is provided by Xinjiang Medicine University's Experimental Animal Center.
Method and result:
Get 30 of healthy rats, female unpregnancy, body weight 150.5 ± 5.2g is divided into the administration group of solvent matched group (giving the distilled water with volume), FUKANG source vagina effervescence 12.5mg/kg and two dosage of 62.5mg/kg, 10 every group at random.Tried thing and be made into the suspension of 2.5% (low dose), 12.5% (heavy dose) with distilled water, vagina administration 0.05ml/100g, once a day, continuous seven days.Close observation medicine-feeding part situation, outward appearance sign etc., animal dead and postmortem situation after the record administration, local organization has or not phenomenons such as hyperemia, edema, and carries out vaginal canal and reproductive system histopathologic examination.
As a result, each is organized rat and dead or other abnormal symptoms all occur, phenomenons such as the hyperemia of the local nothing of administration, redness; Get vagina, uterus, the ovary of heavy dose of administration treated animal and make histopathological examination, and compare, do not see the abnormal change relevant (seeing pathological replacement and photo) with medicine with matched group,
Conclusion: vagina effervescence does not have obvious local irritation in the rat vagina administration under prescribed dose.
Vagina effervescence of the present invention is skin anaphylactic test initiatively
Medicine and reagent: vagina effervescence, brown tablet, specification 0.75g (being equivalent to crude drug in whole 1.35g)/sheet, clinical plan dosage is adult's (body weight is by 60kg) a slice every day, be 12.5mg/kg, English derivatives scientific and technological development company limited medicament chamber provides lot number 041015 by Xinjiang; Being made into suspension with distilled water during test smears.2,4-dinitrochlorobenzene, Tianjin recovery fine chemistry industry institute, lot number 050323; 95% ethanol, the special wine head factory in Anhui, lot number 0405093602.
Laboratory animal: Cavia porcellus, female, body weight 250-300g provides by Xinjiang Medicine University zoopery center, moving word syxk (newly) 2003-0001 of new doctor.
Method and result:
Get 40 of healthy albino guinea-pigs, female unpregnancy, body weight 251-296g.Be divided into four groups at random, every group 10, be respectively negative control group (giving distilled water) with volume, positive controls (2, the 4-dinitrochlorobenzene is prepared with 70% ethanol, sensitization is concentration 1%, and exciting concentration is 0.1%), the administration group of vagina effervescence 12.5mg/kg, two dosage of 62.5mg/kg; Tried thing and be made into the suspension of 1.25% (low dose), two concentration of 6.25% (heavy dose) with distilled water, the previous day is respectively organized Cavia porcellus in the about 4-6cm of back left side unhairing in experiment
2, tried thing and distinguished coating 0.1ml/100g, partial closure 6 hours in depilation with the suspension of respective concentration.According to dosage carried out sensitization respectively in the 0th, 7,14 day with the method administration.After the last sensitization 14 days, each treated animal excited contact by setting dosage with the method administration again, removed after 6 hours to be tried thing and begin at once to observe, and write down anaphylaxis situation in 72 hours, and marked.
As a result, serious systemic anaphylaxis such as death, shock does not all appear in each treated animal; Positive controls is subjected to the examination district all erythema to occur and edema is reacted, and wherein 8 are severe erythema companion intermediate edema, and 2 are moderate erythema companion Mild edema, and the sensitization incidence rate is 100%; Anaphylaxiss such as erythema and edema all do not appear in the administration group of two dosage.
Conclusion: vagina effervescence does not cause initiatively skin allergy under rated condition the Cavia porcellus external.
Vagina effervescence rat long term toxicity test of the present invention
Summary: vagina effervescence is with three dosage 0.11g/kg.d, 0.32g/kg.d, 0.65g/kg.d (be equivalent to respectively be grown up per kilogram of body weight consumption every day 8.8,25.6,52.8 times), vagina administration, every day 1 time, continuous 45 days.The daily check rat mental status, feces, fur claimed a body weight, and calculated inflow, food-intake in per 7 days./ 3rd animals are put to death in administration 30 days, 45 days and drug withdrawal respectively after 14 days, do organ coefficient, routine blood test and blood biochemistry index inspection, and make the internal organs pathologic finding.The result shows, three dosed administration group rats and control rats relatively, every index does not have the variation relevant with administration, does not see the pathological change relevant with drug effect.Prompting vagina effervescence successive administration 45 days under three dosage of regulation does not have overt toxicity to rat.
Material
Animal: 120 of Wistar rats, female, body weight 90.3 ± 8.1g in about 7 ages in week, is divided into 4 groups, 30 every group at random.Moving word syxk (newly) 2003-0001 of new doctor is provided by Xinjiang Medicine University zoopery center.Before on-test, observe 1 weeks of situation such as animal feed, activity and feces, the normal animal of selection mode enters test.
Be subjected to reagent product and reagent: vagina effervescence, 0.75g (being equivalent to crude drug 1.35g)/sheet.Be grown up each 1, once a day, vagina is placed, and English derivatives scientific and technological development company limited medicament chamber provides lot number by Xinjiang: 041015.
The administration explanation: medicine is made into 7.3%, 21.3% with distilled water during administration, and 43.3% suspension is pressed 0.15ml/100g body weight vagina administration.
Dosage regimen:
The test grouping: rat is weighed, and divides 4 groups according to body weight is balanced at random, and promptly the normal saline matched group is little, in, the administration group of big three dosage, 30 every group.
Dosage is provided with: with reference to " Chinese medicine, natural drug long term toxicity investigative technique guideline " the 3rd original text select little, in, be three dosage of 0.11g/kg.d, 0.32g/kg.d, 0.65g/kg.d (be equivalent to respectively be grown up per kilogram of body weight consumption every day 8.8,25.6,52.8 times) greatly.
Medication: every morning vagina administration once, continuous 45 days.
Observation index, method and time:
Overview is observed rat ergasia, feces and fur outward appearance situation every day, claims 1 body weight in per 7 days, and checks food-intake and inflow.
After administration 30,45 days and drug withdrawal 14 days respectively, put to death 10 rats for every group.Get blood EDTA-K from postcava
2The peripheral blood picture is made in the anticoagulant tube anticoagulant; Get blood with disposable blood taking tube, and centrifugal absorption serum is done the blood biochemical analysis.
Experimental result
Overview, matched group and administration group rat are in 45 day experimental period and drug withdrawal convalescent period, and spirit is all no abnormal with active state, outward appearance sign etc.
Medicine is to the influence of body-mass index: claimed 1 body weight in per 7 days, and checked food-intake and inflow, and take statistics though indivedual time period statistics is variant, not have obvious dependency with administration, so abiology meaning (seeing Table 1).
Medicine is to the influence of each main organs: will cut open the internal organs of getting are respectively organized the rat main organs according to the calculating of " internal organs weight/body weight " formula organ coefficient.As a result, each time period Rats Organs and Tissues coefficient of each administration group and matched group compare, all zero difference (table 2).
The peripheral blood picture is checked: get and respectively organize the rat anticoagulation cirumferential blood and make routine blood test and measure (RBC, HB, PLT, WBC and classification).As a result, administration group rat each the time and the normal saline group relatively, indivedual indicator-specific statisticss are variant, but all in normal range (table 3).
The blood biochemical analysis: each group rat blood serum sample is made the blood biochemical analysis, administration group rat each the time with the normal saline group relatively, indicator-specific statisticss are variant individually, but all in normal range (table 4).
System becomes celestial and histopathologic examination: with 10% formalin fixed such as each group Rats Organs and Tissues brain (brain, cerebellum, medulla oblongata), spinal cord, hypophysis, parathyroid gland, esophagus, submaxillary gland, intestinal, pancreas, trachea, the heart, liver, spleen, lung, kidney, adrenal gland, thymus, uterus, ovary, mammary gland, sciatic nerve, bladder, vagina, lymph node, thyroid, stomach, make section, HE dyeing, do perusal substantially, and histopathologic examination.Each administration group rat and NS group are not relatively seen the pathological change relevant with drug effect.
Conclusion: vagina effervescence is with 0.11g/kg.d, 0.32g/kg.d, three dosage vagina administrations of 0.65g/kg.d, every day 1 time, continuous 45 days, the rat of administration group as a result, index and matched group comparisons such as organ coefficient, routine blood test, blood biochemistry, though add up variant individually, do not see the variation relevant with administration; The pathological change relevant with drug effect (pathological replacement is attached) do not seen by histopathologic examination; Think that vagina effervescence does not have overt toxicity in prescribed dose and time limit per vaginam administration to rat.
Description of drawings
Referring to accompanying drawing
Fig. 1 is a vagina effervescence process chart of the present invention
The specific embodiment
Embodiment 1
Rhizoma Coptidis 50g Semen Strychni 20g Rhizoma Smilacis Chinensis 200g
Rhizoma Curcumae 140g Galla Turcica (Galla Helepensis) 170g Pericarpium Granati 140g
Beta-schardinger dextrin-40g sodium bicarbonate 150g Polyethylene Glycol 50g
Citric acid 300g magnesium stearate 10g lactose 50g
Carboxymethyl starch sodium 200g
A, crude drug Rhizoma Curcumae 140g is ground into coarse powder, adds 5 times of water gagings, extracted volatile oil 0.3 hour, volatile oil carries out enclose with beta-schardinger dextrin-5g, and 15 ℃ of constant temperature stirred 0.1 hour, sucking filtration, and drying 0.2 hour, porphyrize, mistake 20 mesh sieves, standby;
B, with crude drug Rhizoma Coptidis 50g, Semen Strychni 20g, be ground into coarse powder, add 3 times of amount 30% alcohol reflux 1 time, 0.1 hour time, merging filtrate, concentrating under reduced pressure makes extractum, and is standby;
C, the medicinal residues after crude drug Rhizoma Smilacis Chinensis 200g, Galla Turcica (Galla Helepensis) 170g, Pericarpium Granati 140g and step a and b extracted merge, and add 3 times of water gagings and decoct 1 time, 0.1 hour time, merging filtrate, concentrating under reduced pressure, standby;
D, combining step c and step b extractum mixing, spray drying gets extract powder, and is standby;
After e, the taking polyethylene glycol 500 10g fusions, add sodium bicarbonate 50g, stir, cooling is pulverized, and crosses 20 mesh sieves, with extract powder, volatile oil clathrate compound, citric acid 50g, lactose 20g, carboxymethyl starch sodium 20g mixing,, cross mesh sieve with the anhydrous alcohol solution system soft material that contains 2%PVP, 15 ℃ of dryings, the sieve granulate is with magnesium stearate 3g mix homogeneously, tabletting according to a conventional method, check, packing promptly gets effervescent tablet.
This product is yellow or little yellow ellipse effervescent tablet, and tablet is placed the vagina depths, and once, four to six times was a course of treatment before each one, every day slept.
Embodiment 2
A, crude drug Rhizoma Curcumae 250g is ground into coarse powder, adds 8 times of water gagings, extracted volatile oil 3 hours, volatile oil carries out enclose with beta-schardinger dextrin-20g, and 20 ℃ of constant temperature stirred 1.0 hours, sucking filtration, and drying, porphyrize, mistake 60 mesh sieves, standby;
B, with crude drug Rhizoma Coptidis 200g, Semen Strychni 80g, be ground into coarse powder, add 8 times of amount 50% alcohol reflux 2 times, each 1.5 hours, merging filtrate is evaporated to extractum, and was standby;
C, the medicinal residues after crude drug Rhizoma Smilacis Chinensis 350g, Galla Turcica (Galla Helepensis) 260g, Pericarpium Granati 250g and step a and b extracted merge, and add 8 times of water gagings and decoct 2 times, each 1 hour, merging filtrate, concentrating under reduced pressure, standby;
D, combining step c and step b extractum, mixing, spray drying gets extract powder, and is standby;
After e, the taking polyethylene glycol 1000 80g fusions, add sodium bicarbonate 250g, stir, cooling is pulverized, and crosses 80 mesh sieves, with extract powder, volatile oil clathrate compound, citric acid 150g, lactose 100g, carboxymethyl starch sodium 150g mixing, the anhydrous alcohol solution system soft material with containing 8%PVP sieves, 55 ℃ of dryings, granulate is with magnesium stearate 25g mix homogeneously, tabletting according to a conventional method, check, packing promptly gets effervescent tablet.
This product is yellow or little yellow ellipse effervescent tablet, and tablet is placed the vagina depths, and once, four to six times was a course of treatment before each one, every day slept.
Embodiment 3
A, crude drug Rhizoma Curcumae 360g is ground into coarse powder, adds 10 times of water gagings, extracted volatile oil 10 hours, volatile oil carries out enclose with beta-schardinger dextrin-200g, and 25 ℃ of constant temperature stirred 2.5 hours, sucking filtration, and drying, porphyrize, mistake 100 mesh sieves, standby;
B, with crude drug Rhizoma Coptidis 300g, Semen Strychni 100g, be ground into coarse powder, add 10 times of amount 85% alcohol reflux 3 times, each 2.5 hours, merging filtrate is evaporated to extractum, and was standby;
C, the medicinal residues after crude drug Rhizoma Smilacis Chinensis 450g, Galla Turcica (Galla Helepensis) 430g, Pericarpium Granati 460g and step a and b extracted merge, and add 15 times of water gagings and decoct 3 times, each 2.5 hours, merging filtrate, concentrating under reduced pressure, standby;
D, combining step c and step b extractum, mixing, spray drying gets extract powder, and is standby;
After e, the taking polyethylene glycol 7000 150g fusions, add sodium bicarbonate 350g, stir, cooling is pulverized, and crosses 100 mesh sieves, with extract powder, volatile oil clathrate compound, lactose 200g, citric acid 300g, carboxymethyl starch sodium 100g mixing, the anhydrous alcohol solution system soft material with containing 15%PVP sieves, 70 ℃ of dryings, granulate is with magnesium stearate 50g mix homogeneously, tabletting according to a conventional method, check, packing promptly gets the effervescence solid tablet.
This product is yellow or little yellow ellipse effervescent tablet, and tablet is placed the vagina depths, and once, four to six times was a course of treatment before each one, every day slept.
Embodiment 4
A, crude drug Rhizoma Curcumae 560g is ground into coarse powder, adds 15 times of water gagings, extracted volatile oil 15 hours, volatile oil carries out enclose with beta-schardinger dextrin-300g, and 35 ℃ of constant temperature stirred 4 hours, sucking filtration, and drying, porphyrize, mistake 140 mesh sieves, standby;
B, with crude drug Rhizoma Coptidis 500g, Semen Strychni 120g, be ground into coarse powder, add 12 times of amount 95% alcohol reflux 4 times, each 3.5 hours, merging filtrate is evaporated to extractum, and was standby;
C, the medicinal residues after crude drug Rhizoma Smilacis Chinensis 600g, Galla Turcica (Galla Helepensis) 590g, Pericarpium Granati 600g and step a and b extracted merge, and add 18 times of water gagings and decoct 4 times, each 3.5 hours, merging filtrate, concentrating under reduced pressure, standby;
D, combining step c and step b extractum, mixing, spray drying gets extract powder, and is standby;
After e, the taking polyethylene glycol 7000180g fusion, add sodium bicarbonate 520g, stir, cooling is pulverized, and crosses 120 mesh sieves, with extract powder, volatile oil clathrate compound, citric acid 500g, lactose 300g, carboxymethyl starch sodium 190g mixing, the anhydrous alcohol solution system soft material with containing 18%PVP sieves, 85 ℃ of dryings, granulate is with magnesium stearate 100g mix homogeneously, tabletting according to a conventional method, check, packing promptly gets the effervescence solid tablet.
This product is yellow or little yellow ellipse effervescent tablet, and tablet is placed the vagina depths, and once, four to six times was a course of treatment before each one, every day slept.
Embodiment 5
A, crude drug Rhizoma Curcumae 450g is ground into coarse powder, adds 13 times of water gagings, extracted volatile oil 12 hours, standby;
B, with crude drug Rhizoma Coptidis 450g, Semen Strychni 150g, be ground into coarse powder, add 13 times of amount 95% alcohol reflux 4 times, each 4 hours, merging filtrate is evaporated to extractum, and was standby;
C, the medicinal residues after crude drug Rhizoma Smilacis Chinensis 510g, Galla Turcica (Galla Helepensis) 490g, Pericarpium Granati 550g and step a and b extracted merge, and add 20 times of water gagings and decoct 4 times, each 4 hours, merging filtrate, concentrating under reduced pressure, standby;
D, combining step c and step b extractum, mixing, spray drying gets extract powder, and is standby;
After e, the taking polyethylene glycol 9000 200g fusions, add sodium bicarbonate 450g, stir, cooling is pulverized, and crosses 90 mesh sieves, with extract powder, volatile oil clathrate compound, citric acid 450g, lactose 90g, carboxymethyl starch sodium 95g mixing, the anhydrous alcohol solution system soft material with containing 5%PVP sieves, 55 ℃ of dryings, granulate is with magnesium stearate 10g mix homogeneously, make tablet according to a conventional method, check, packing promptly gets the oval tablet of effervescence solid.
This product is yellow or the oval tablet of little yellow, and tablet is placed the vagina depths, and once, four to six times was a course of treatment before each one, every day slept.
Embodiment 6
A, crude drug Rhizoma Curcumae 200g is ground into coarse powder, adds 6 times of water gagings, extracted volatile oil 9 hours, standby;
B, with crude drug Rhizoma Coptidis 550g, Semen Strychni 150g, be ground into coarse powder, add 6 times of amount 75% alcohol reflux 2 times, each 1.0 hours, merging filtrate is evaporated to extractum, and was standby;
C, the medicinal residues after crude drug Rhizoma Smilacis Chinensis 660g, Galla Turcica (Galla Helepensis) 630g, Pericarpium Granati 660g and step a and b extracted merge, and add 20 times of water gagings and decoct 4 times, each 4 hours, merging filtrate, concentrating under reduced pressure, standby;
D, combining step c and step b extractum, mixing, spray drying gets extract powder, and is standby;
After e, the taking polyethylene glycol 800 60g fusions, add sodium bicarbonate 550g, stir, cooling is pulverized, and crosses 140 mesh sieves, with extract powder, volatile oil clathrate compound, citric acid 90g, lactose 90g, carboxymethyl starch sodium 200g mixing, the anhydrous alcohol solution system soft material with containing 18%PVP sieves, 85 ℃ of dryings, granulate is with magnesium stearate 75g mix homogeneously, tabletting according to a conventional method, check, packing promptly gets the effervescence solid tablet.
This product is yellow or little yellow ellipse effervescent tablet, and tablet is placed the vagina depths, and once, four to six times was a course of treatment before each one, every day slept.
Claims (3)
1, a kind of external vagina effervescence that is used for the treatment of female vagina, it is characterized in that this effervescent tablet is a radix to make 1000, be by crude drug Rhizoma Coptidis 50-550g, Semen Strychni 20-150g, Rhizoma Smilacis Chinensis 200-660g, Rhizoma Curcumae 140-560g, Galla Turcica (Galla Helepensis) 170-630g, Pericarpium Granati 140-660g, adjuvant beta-schardinger dextrin-5-300g, sodium bicarbonate 50-550g, Polyethylene Glycol 500-9000 10-200g, lactose 20-300g, citric acid 50-500g, magnesium stearate 3-100g, carboxymethyl starch sodium 20-200g make; The crude drug Rhizoma Curcumae is pulverized in employing, adds water, extracts volatile oil, and volatile oil carries out enclose with beta-schardinger dextrin-, sucking filtration, and drying, porphyrize sieves, and is standby; Rhizoma Coptidis, Semen Strychni are pulverized, added 30-95% alcohol reflux 1-4 time, merging filtrate concentrates, and is standby; In the medicinal residues after Rhizoma Smilacis Chinensis, Galla Turcica (Galla Helepensis), Pericarpium Granati adding Rhizoma Curcumae and Rhizoma Coptidis, the Semen Strychni extraction, decoct with water 1-4 time, merging filtrate, concentrate, merge with alcohol-extracted extract, mixing, dry extract powder is mixed adjuvant and extract powder, volatile oil clathrate compound in pharmaceutical methods routinely and makes effervescent tablet.
2, the preparation method of the effervescent tablet of treatment female vagina according to claim 1 is characterized in that following these steps to carrying out:
A, the crude drug Rhizoma Curcumae is ground into coarse powder, adds 3-15 times of water gaging, extracted volatile oil 0.3-15 hour, volatile oil carries out enclose with beta-schardinger dextrin-, and 15-35 ℃ of constant temperature of enclose process stirred 0.1-4 hour, sucking filtration, and drying, porphyrize, mistake 20-140 mesh sieve, standby;
B, with crude drug Rhizoma Coptidis, Semen Strychni, be ground into coarse powder, add 3-15 and doubly measure the 30-95% ethanol extraction 1-4 time, each 0.1-4 hour, merging filtrate concentrates, and was standby;
C, the medicinal residues after crude drug Rhizoma Smilacis Chinensis, Galla Turcica (Galla Helepensis), Pericarpium Granati and step a and b extracted merge, and add 3-20 times of water gaging and decoct 1-4 time, 0.1-4 hour at every turn, merging filtrate, concentrating under reduced pressure, standby;
D, combining step c and step b extractum, mixing, the dry extract powder that gets, standby;
E, taking polyethylene glycol, fusion adds sodium bicarbonate, stir, cooling is pulverized, cross the 20-140 mesh sieve, with extract powder, volatile oil clathrate compound, citric acid, lactose, carboxymethyl starch sodium mixing, with the anhydrous alcohol solution system soft material that contains 2-20%PVP, sieve 15-90 ℃ of drying, granulate, with magnesium stearate mix homogeneously, tabletting, check, packing promptly gets effervescent tablet.
3, the purposes of the effervescent tablet of treatment female vagina according to claim 1 in the medicine of preparation treatment women vaginitis.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2006101643761A CN100569277C (en) | 2006-12-08 | 2006-12-08 | A kind of effervescent tablet for the treatment of female vagina and its production and use |
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| CNB2006101643761A CN100569277C (en) | 2006-12-08 | 2006-12-08 | A kind of effervescent tablet for the treatment of female vagina and its production and use |
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| CN100569277C true CN100569277C (en) | 2009-12-16 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2006101643761A Expired - Fee Related CN100569277C (en) | 2006-12-08 | 2006-12-08 | A kind of effervescent tablet for the treatment of female vagina and its production and use |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100569277C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101485749B (en) * | 2009-03-03 | 2011-03-16 | 中国科学院新疆理化技术研究所 | Effervescent tablets for women as well as preparation method and application thereof |
| CN102641320B (en) * | 2012-05-09 | 2013-12-04 | 皖南医学院 | Gynaecological effervescent tablet and preparation method thereof |
| CN103463224B (en) * | 2013-09-22 | 2015-03-25 | 艾克白尔·买买提 | Drug for colpitis and preparation method thereof |
-
2006
- 2006-12-08 CN CNB2006101643761A patent/CN100569277C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CN1970068A (en) | 2007-05-30 |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
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| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Xinjiang Ipar Biological Scientific and Technological Development Co., Ltd. Assignor: Abu Lemumu*Maimaiti Ming Contract record no.: 2010650000013 Denomination of invention: Effervescence tablet for treating colpitis, preparation method and use thereof Granted publication date: 20091216 License type: Exclusive License Open date: 20070530 Record date: 20100716 |
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| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20091216 Termination date: 20171208 |