CN103301374A - Pharmaceutical composition for treating postpartum non-specificity vaginitis - Google Patents
Pharmaceutical composition for treating postpartum non-specificity vaginitis Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating postpartum non-specificity vaginitis, so as to solve the problem of treatment of the postpartum non-specificity vaginitis. The pharmaceutical composition is characterized by being prepared from the following crude drugs: bark of himalayan coralbean, smallflower bracketplant herb, bobbin, alpinia japonica, parasitic loranthus, radix ranunculi ternate, dark malt, burnt medicated leaven, Chinese ephedra root, spina gleditsiae, peach gum, and cassia twig. The clinical test shows that the pharmaceutical composition has the characteristics of good curative effect and high safety on treatment of the postpartum non-specificity vaginitis, and is worthy of clinical application and popularization.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of pharmaceutical composition for the treatment of the nonspecific vaginitis in puerperal.
Background technology
The postpartum vaginal inflammation is that the puerpera infects within 1 month after having given birth to child and the colpitis sent out, is more common in the normal natural labor of vagina.In the postpartum vaginal inflammation, the ratio that puerperal, nonspecific vaginitis accounted for is very large, namely is not the caused vaginitis of Candida albicans, trichomonal vaginitis or gonorrhea.Its reason is, puerperal, estrogen level descended rapidly, caused the relative atrophy of vaginal wall, the mucosa attenuation, and glycogen content reduces in the epithelial cell, and intravaginal Ph value rises, and local resistance reduces, and pathogenic bacterium are easily invaded to breed and cause and inflammation.Cardinal symptom is that vaginal secretions increases and pruritus vulvae, burning sensation.The vagina epithelium atrophy is seen in inspection, and pleat disappears, and it is sliding, poor that epithelium flattens.Vaginal mucosa is congested, and little petechia is arranged, and sometimes sees shallow table ulcer.
The Therapeutic Principle is for increasing the growth and breeding of vagina resistance and anti-bacteria.Present western medical treatment mostly is in intravaginal and puts into the antibiotic powder, but life-time service can cause local dysbacteriosis, causes larger puzzlement.
And the colpitic suppository of Chinese traditional treatment, outer lotion are many, but be mostly for Women of Childbearing Age, contain Radix Sophorae Flavescentis, Fructus Cnidii, the Fructus Kochiae, Rhizoma Smilacis Glabrae etc. in the prescription except the medicine of noxious dampness more, and puerperal nonspecific vaginitis cause mainly be that the mucosa attenuation causes, the medicine external of above dispelling the damp pathogen with drugs of bitter in taste and cold in nature, then irritates nucous membrane more causes aggravation.And the said medicine bitter cold is unfavorable for postpartum recovery.
Summary of the invention
Technical assignment of the present invention is for above the deficiencies in the prior art, provides a kind of curative effect certainly and the pharmaceutical composition of the treatment nonspecific vaginitis in puerperal that side effect is little.
The technical scheme that the present invention solves its technical problem is: a kind of pharmaceutical composition for the treatment of the nonspecific vaginitis in puerperal is characterized in that being prepared from by the crude drug of following weight proportion: 10 ~ 30 parts of Cortex erythrinaes, 6 ~ 12 parts of Herba Chlorophyti Laxis, go back 3 ~ 10 parts in bobbin, 6 ~ 12 parts of Alpinia japonica (Thunb.) Miq.s, 3 ~ 10 parts of Herba Taxillis, 6 ~ 12 parts of Radix Ranunculi Ternatis, 6 ~ 12 parts of Fructus Hordei Germinatus (parched to brown)s, 6 ~ 12 parts of Massa Medicata Fermentata (parched to brown), 6 ~ 12 parts of Radix Ephedraes, 1 ~ 5 part of Spina Gleditsiae, 3 ~ 10 parts of gumshiraz, 10 ~ 25 parts of Ramulus Cinnamomi.
Chinese medicine of the present invention is that the raw material by following optimum weight part proportioning is prepared from: 20 parts of Cortex erythrinaes, 10 parts of Herba Chlorophyti Laxis, go back 6 parts in bobbin, 10 parts of Alpinia japonica (Thunb.) Miq.s, 6 parts of Herba Taxillis, 10 parts of Radix Ranunculi Ternatis, 10 parts of Fructus Hordei Germinatus (parched to brown)s, 10 parts of Massa Medicata Fermentata (parched to brown), 10 parts of Radix Ephedraes, 2 parts of Spina Gleditsiaes, 6 parts of gumshiraz, 20 parts of Ramulus Cinnamomi.
Wherein said: Cortex erythrinae is bark or the root bark of pulse family Erythrinae Arborescentis Erythrina indica Lam..Nature and flavor are bitter, and are flat.Return liver, kidney channel.But the merit wind-damp dispelling, channels sootheing and network vessel quickening.Wind-damp dispelling, the meridian dredging, parasite killing.
Herba Chlorophyti Laxi is herb or the root of feverfew Prenanthes henryi Dunn Prenanthes henryi Dunn.Bitter in the mouth; Cold in nature.But merit heat-clearing and toxic substances removing; The dissipating blood stasis hemostasis.
Also bobbin is the fruit of orchid Rhizoma Gastrodiae Gastrodia elata Bl..Sweet in the mouth; Cold in nature.But merit tonify deficiency subduing the wind syndrome.Main dizzy; Pupil; The wind syndrome of head headache; The weak breath consumption of essence; Early whitening of beard and hair.
Alpinia japonica (Thunb.) Miq. for Zingiberaceae Alpinia plants Alpinia japonica (Thunb.) Miq. Alpinia japonica Miq., is used as medicine with root stock.Nature and flavor are hot, warm.Return lung, spleen, Liver Channel.But the merit dispelling wind and removing obstruction in the collateral, regulating QI to relieve pain.
Herba Taxilli is the dry stem and branch with leaf of Loranthaceae plant Herba Taxilli Taxillus chinensis (DC.) Danser for Herba Taxilli.Nature and flavor are bitter, sweet, and are flat.Return liver, kidney channel.But the merit invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit.
Radix Ranunculi Ternati is the dried root of the little Herba Ranunculi Japonici Ranunculus of ranunculaceae plant ternatus Thunb..Nature and flavor are sweet, hot, temperature.Return liver, lung meridian.But the merit eliminating stagnation, detumescence.
Fructus Hordei Germinatus (parched to brown), for the mature fruit of grass Fructus Hordei Vulgaris Hordeum vulgare L. through the drying of germinateing, fry to burnt brown according to the method for frying, cool sieve dedust bits.Nature and flavor are sweet, and are flat.Return spleen, stomach warp.But the merit promote qi circulation digestion promoting, spleen benefiting and stimulating the appetite moves back newborn relieving distension.
Massa Medicata Fermentata (parched to brown), for the medicines such as Herba polygoni hydropiperis, Herba Artemisiae Annuae, Semen Armeniacae Amarum add flour or wheat bran mixed after, through the herbal leaven that fermentation forms, fry to burnt brown according to frying method.The sweet suffering of nature and flavor, temperature.Enter spleen, stomach warp.But the merit invigorating the spleen and regulating the stomach is in the accent that helps digestion.
Radix Ephedrae is the dry root and rhizome of Ephedraceae plant plait Herba Ephedrae Ephedra sinica Stapf or epheday intermedia Ephedra intermedia Schrenk et C. A. Mey..Nature and flavor are sweet, and are flat.GUIXIN, lung meridian.But merit hidroschesis.
Spina Gleditsiae is the dry Spina jujubae of leguminous plant Fructus Gleditsia Gleditsia sinensis Lam..Nature and flavor are hot, temperature.Return liver, stomach warp.The merit poison holding of can subsiding a swelling, evacuation of pus, parasite killing.
Gumshiraz is rosaceous plant peach Prunus persica (L.) Batsch, the resin that flows out on the trunk.Nature and flavor are bitter, flat.Merit can be invigorated blood circulation, and QI invigorating is quenched the thirst.
Ramulus Cinnamomi is the dry twig of canella Cortex Cinnamomi Cinnamomum cassia Presl.Nature and flavor are hot, sweet, temperature.GUIXIN, lung, urinary bladder channel.But merit diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the flat gas that spins.
Composition principle: puerperal, nonspecific vaginitis often reduced because of estrogen level, the attenuation of vaginal wall mucosa, and glycogen content reduces in the epithelial cell, and intravaginal Ph value rises, and local resistance reduces, and pathogenic bacterium are easily invaded to breed and cause and inflammation.Cardinal symptom is that vaginal secretions increases and pruritus vulvae, burning sensation.At present the colpitic suppository of Chinese traditional treatment, outer lotion are many, but be mostly for Women of Childbearing Age, contain Radix Sophorae Flavescentis, Fructus Cnidii, the Fructus Kochiae, Rhizoma Smilacis Glabrae etc. in the prescription except the medicine of noxious dampness more, and puerperal nonspecific vaginitis cause mainly be that the mucosa attenuation causes, the medicine external of above dispelling the damp pathogen with drugs of bitter in taste and cold in nature, then irritates nucous membrane more causes aggravation.The object of the invention is to avoid using the dispelling the damp pathogen with drugs of bitter in taste and cold in nature medicine, and reduce from estrogen level, the vaginal wall atrophy, this pathological change angle of mucosa attenuation is started with, and reaches the purpose of " treatment of disease must aim at its pathogenesis ".
Compared with prior art, the present invention has following characteristics:
1, prescription is unique, avoids using the dispelling the damp pathogen with drugs of bitter in taste and cold in nature antipruritic agent: get Cortex erythrinae in the side, go back bobbin and be monarch, Cortex erythrinae dosage of record is in " China's book on Chinese herbal medicine ": " taking orally: fry in shallow oil soup, 6-12g "; The inventor experimental results show that (10 ~ 30g) can recover by specific promotion vaginal wall mucosa middle heavy dose of Cortex erythrinae, and go back bobbin the similar plants estrogen action is arranged, but this act as two-ways regulation, can not produce the low differentiation of the excessive stimulation reproductive system of estrogen cell;
2, characteristic of the present invention also is balance and restriction: record Cortex erythrinae in 1. " must joining book on Chinese herbal medicine ": " insufficiency of blood heated person forbidding ", but puerperal often with the resembling of deficiency of YIN-blood, and use Cortex erythrinae this moment, its hematozemia of fearing is then arranged and causes the yin asthenia generating intrinsic heat appearance; Therefore add Herba Chlorophyti Laxi and go back bobbin, also but the training of bobbin merit tonify deficiency is basic, and can prevent that Cortex erythrinae from consuming cloudy blood and liver-wind stirring up internally, and the Herba Chlorophyti Laxi bitter in the mouth is cold in nature, utilize its cold heated that prevents on the one hand, but on the other hand its merit dissipating blood stasis hemostasis there is out entire merit in blood system, prevent the Cortex erythrinae moving blood of wandering away, also can not affect Cortex erythrinae simultaneously and work orderly effect; 2. the use of Ramulus Cinnamomi is among the we: a promoting the flow of QI-blood by warming the meridian, and supporing yang activating QI, two Yin Yang balancings are with the bitter cold of balance we invasion by pathogenic cold medicine of a cold nature thing; The application characteristic of Ramulus Cinnamomi is in the prescription of the present invention: measure that larger (" consumption in the Chinese pharmacopoeia is 3 ~ 9g), so too disperse for preventing, gets again Radix Ephedrae convergence assistant system;
3, the supplementary drug thing is fewer but better: get the Alpinia japonica (Thunb.) Miq. assistant in the side and help Herba Chlorophyti Laxi, it act as giving treatment in accordance with the tendency of pathological change, and heat conduction is descending; Radix Ranunculi Ternati and Herba Chlorophyti Laxi collocation have the effect of detoxifcation, eliminating stagnation, pain relieving; The Herba Taxilli assistant helps goes back the bobbin vital base and primordial QI consolidating; Gumshiraz is invigorated blood circulation, and helps medicine to stay in mucomembranous surface, promotes to absorb;
4, inventor's clinical research is found, Fructus Hordei Germinatus (parched to brown), the external of Massa Medicata Fermentata (parched to brown) decoct can promote the local mucous membrane blood circulation;
5, Spina Gleditsiae is the supplementary drug thing, and the consumption of record is in " China's book on Chinese herbal medicine ": " for oral administration: as to fry in shallow oil soup, 6 ~ 12g ", inventor's experimental study are found, get low dose of Spina Gleditsiae decocting liquid and can improve the vaginal mucosa cytoactive that exsomatizes;
6, the thing homogeneous medicine multiple-effect of getting it filled in the side helps to reduce drug kinds and consumption, does not increase local excitation;
7, medicine material consumption of the present invention is groped to sum up to draw through the inventor in a large number, and each raw material consumption is for all to have preferably curative effect in the following weight parts scope.
The specific embodiment
Below in conjunction with practical situation, the specific embodiment of the present invention is elaborated.
Embodiment 1, the crude drug weight proportion: Cortex erythrinae 20g, Herba Chlorophyti Laxi 10g, go back bobbin 6g, Alpinia japonica (Thunb.) Miq. 10g, Herba Taxilli 6g, Radix Ranunculi Ternati 10g, Fructus Hordei Germinatus (parched to brown) 10g, Massa Medicata Fermentata (parched to brown) 10g, Radix Ephedrae 10g, Spina Gleditsiae 2g, gumshiraz 6g, Ramulus Cinnamomi 20g.
The preparation method of embodiment 1 is: with Cortex erythrinae, Herba Chlorophyti Laxi, go back bobbin, Alpinia japonica (Thunb.) Miq., Herba Taxilli, Radix Ranunculi Ternati, Fructus Hordei Germinatus (parched to brown), Massa Medicata Fermentata (parched to brown), Radix Ephedrae, Spina Gleditsiae, gumshiraz, Ramulus Cinnamomi mixing and water adding and decoct, get filtrate after 30 minutes, medicinal residues add water continuation decoction and get filtrate after 20 minutes, twice filtrate merges washout, once a day.
Embodiment 2, the crude drug weight proportion: 10 parts of Cortex erythrinaes, 6 parts of Herba Chlorophyti Laxis, go back 3 parts in bobbin, 6 parts of Alpinia japonica (Thunb.) Miq.s, 3 parts of Herba Taxillis, 6 parts of Radix Ranunculi Ternatis, 6 parts of Fructus Hordei Germinatus (parched to brown)s, 6 parts of Massa Medicata Fermentata (parched to brown), 6 parts of Radix Ephedraes, 1 part of Spina Gleditsiae, 3 parts of gumshiraz, 10 parts of Ramulus Cinnamomi.
Embodiment 3, the crude drug weight proportion: 20 parts of Cortex erythrinaes, 10 parts of Herba Chlorophyti Laxis, go back 6 parts in bobbin, 10 parts of Alpinia japonica (Thunb.) Miq.s, 6 parts of Herba Taxillis, 10 parts of Radix Ranunculi Ternatis, 10 parts of Fructus Hordei Germinatus (parched to brown)s, 10 parts of Massa Medicata Fermentata (parched to brown), 10 parts of Radix Ephedraes, 2 parts of Spina Gleditsiaes, 6 parts of gumshiraz, 20 parts of Ramulus Cinnamomi.
Embodiment 4, the crude drug weight proportion: 30 parts of Cortex erythrinaes, 12 parts of Herba Chlorophyti Laxis, go back 10 parts in bobbin, 12 parts of Alpinia japonica (Thunb.) Miq.s, 10 parts of Herba Taxillis, 12 parts of Radix Ranunculi Ternatis, 12 parts of Fructus Hordei Germinatus (parched to brown)s, 12 parts of Massa Medicata Fermentata (parched to brown), 12 parts of Radix Ephedraes, 5 parts of Spina Gleditsiaes, 10 parts of gumshiraz, 25 parts of Ramulus Cinnamomi.
The Chinese medicine of embodiment 2 ~ 4 can be prepared from by following method:
(1) volatile oil is extracted in Cortex erythrinae, Radix Ranunculi Ternati, the distilling under reduced pressure of Radix Ephedrae coarse powder difference, and mixing for standby use after collecting, the medicinal residues mixing for standby use;
(2) will go back the bobbin decompression and decoct 2 times, each 30min, collecting decoction leaves standstill rear filtration, gets filtrate for later use;
(3) gained medicinal residues in Herba Chlorophyti Laxi, Alpinia japonica (Thunb.) Miq., Herba Taxilli, Fructus Hordei Germinatus (parched to brown), Massa Medicata Fermentata (parched to brown), Spina Gleditsiae, gumshiraz, Ramulus Cinnamomi and the step 1 are added 10 times of water yields, decoct with water 2 times, each 1 hour, collecting decoction left standstill rear filtration, gets filtrate for later use;
(4) step 2 gained filtrate and step 3 gained filtrate are merged, concentrating under reduced pressure becomes dry extract, pulverizes to get dry extract;
(5) gained volatile oil in the step 1 is sprayed in the step 4 gained dry extract, mixing is crossed 100 mesh sieves, and packing forms.
Effective combination of said medicine is coordinated mutually, effectively reach the purpose for the treatment of nonspecific vaginitis in puerperal, and side effect is less.The above results is the clinical data sufficient proof, and interrelated data is as follows.
1 object and method.
1.1 object.
1 data and method.
1.1.1 case is selected: in January, 2011 ~ 2013 are diagnosed as nonspecific vaginitis 110 examples in puerperal year June, are the full-term normal delivery primipara, get rid of trichomonal vaginitis, monilial vaginitis, urine is cultivated negative, without vulvar dystrophy and dermatosis.
1.1.2 diagnostic criteria: with reference to " obstetrics and gynecology " (the 5th edition), all cases is all clarified a diagnosis according to medical history, gynecologial examination.Symptom is pruritus vulvae, drying, the pale or flushing of vaginal mucosa or little petechia is arranged, vaginal health scoring<15 minutes.
1.1.3 grouping: be divided into matched group 37 examples, washout group 37 example and powder group 36 examples.Compare in age, the state of an illness, the course of disease before three groups of patient treatments, and the difference not statistically significant (P〉0.05), have comparability.
1.2 method.
1.2.1 Therapeutic Method: matched group adopts 1% lactic acid solution washout, the red and swollen significantly local use antibiotic Emulsion of pudendum, 1 time/d.The washout group is with gained decoct washout in the embodiment of the invention 1,1 time/d.The powder group is blown deposited with gained powder pudendum and intravaginal in the embodiment of the invention 3,1 time/d.7 days is a course for the treatment of.
1.2.2 observation index: conventional inquiry medical history before and after the medication, and according to vaginal health point system (VHS) scoring, determine the doing well,improving situation.
1.2.3 criterion of therapeutical effect: with reference to " obstetrics and gynecology ", recovery from illness: clinical symptoms, sign disappear; Produce effects: clinical symptoms, sign turn for the better by and large; Effectively: clinical symptoms, sign alleviate; Invalid: clinical symptoms, sign are unchanged.
1.2.4 statistical analysis: SPSS 16.0 carries out statistical analysis.Vaginal health scoring single index adopts nonparametric statistics.Measurement data is checked with t, enumeration data χ
2Check.
2 results
2.1 vaginal symptoms is improved situation: behind the medication 3d, matched group 51.35%(19/37) patient, and washout group and all case pruritus of vagina of powder group, drying, pain symptom all begin to obtain improvement in various degree.Gynecologial examination vaginal wall elasticity increases, and fold is deepened, and the surface is pale, flushing and bleeding are clearly better.According to the vaginal health standards of grading, the vaginal health scoring is the summation of elasticity, wettability, pH, mucosa, 5 project score values of secretions.Scoring is 9.44 ± 2.10 before the washout group patient medication, and the scoring average is 14.76 ± 2.83 behind the medication 7d.Scoring is 10.05 ± 2.27 before the powder group patient medication, and the scoring average is 17.11 ± 2.93 behind the medication 7d.Relatively, (P<0.05) is all obviously increased in the vaginal health scoring behind two groups of patient treatments before and after the medication.
2.2 three groups of Comprehensive Clinical curative effects relatively: behind the medication 7d, matched group cure rate, obvious effective rate, effective percentage, inefficiency are respectively 18.92%, 35.14%, 37.84%, 8.11%; The cure rate of washout group, obvious effective rate, effective percentage, inefficiency are respectively 56.76%, 35.14%, 8.11%, 0.00%; The cure rate of powder group, obvious effective rate, effective percentage, inefficiency are respectively 69.44%, 19.44%, 11.11%, 0.00%.Three groups relatively, and the cure rate of washout group and powder group, total effective rate are apparently higher than matched group (P<0.05), and the cure rate of powder group is apparently higher than washout group (P<0.05).
2.3 adverse reaction rate: obvious adverse reaction does not all appear in three groups of patients.
3. conclusion.
The demonstration of this result of study, washout group of the present invention and powder group treatment nonspecific vaginitis total effective rate in puerperal are 100%, the cure rate of powder group is higher than the washout group.Have that untoward reaction is light, the higher advantage of safety.
Claims (2)
1. pharmaceutical composition for the treatment of the nonspecific vaginitis in puerperal is characterized in that being prepared from by the crude drug of following weight proportion: 10 ~ 30 parts of Cortex erythrinaes, 6 ~ 12 parts of Herba Chlorophyti Laxis, go back 3 ~ 10 parts in bobbin, 6 ~ 12 parts of Alpinia japonica (Thunb.) Miq.s, 3 ~ 10 parts of Herba Taxillis, 6 ~ 12 parts of Radix Ranunculi Ternatis, 6 ~ 12 parts of Fructus Hordei Germinatus (parched to brown)s, 6 ~ 12 parts of Massa Medicata Fermentata (parched to brown), 6 ~ 12 parts of Radix Ephedraes, 1 ~ 5 part of Spina Gleditsiae, 3 ~ 10 parts of gumshiraz, 10 ~ 25 parts of Ramulus Cinnamomi.
2. a kind of pharmaceutical composition for the treatment of the nonspecific vaginitis in puerperal according to claim 1 is characterized in that being prepared from by the crude drug of following weight proportion: 20 parts of Cortex erythrinaes, 10 parts of Herba Chlorophyti Laxis, go back 6 parts in bobbin, 10 parts of Alpinia japonica (Thunb.) Miq.s, 6 parts of Herba Taxillis, 10 parts of Radix Ranunculi Ternatis, 10 parts of Fructus Hordei Germinatus (parched to brown)s, 10 parts of Massa Medicata Fermentata (parched to brown), 10 parts of Radix Ephedraes, 2 parts of Spina Gleditsiaes, 6 parts of gumshiraz, 20 parts of Ramulus Cinnamomi.
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