CN103301374B - Pharmaceutical composition for treating postpartum non-specificity vaginitis - Google Patents
Pharmaceutical composition for treating postpartum non-specificity vaginitis Download PDFInfo
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- CN103301374B CN103301374B CN201310270989.3A CN201310270989A CN103301374B CN 103301374 B CN103301374 B CN 103301374B CN 201310270989 A CN201310270989 A CN 201310270989A CN 103301374 B CN103301374 B CN 103301374B
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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 nonspecific vaginitis in puerperal.
Background technology
Postpartum vaginal inflammation be puerpera after having given birth to child within 1 month infect and send out colpitis, be more common in the normal natural labor of vagina.In postpartum vaginal inflammation, the ratio that puerperal, nonspecific vaginitis accounted for is very large, is not namely the vaginitis caused by Candida albicans, trichomonal vaginitis or gonorrhea.Its reason is, puerperal, estrogen level declined rapidly, and cause the relative atrophy of vaginal wall, mucosa is thinning, and in epithelial cell, glycogen content reduces, and intravaginal Ph value rises, and local resistance reduces, and pathogenic bacterium are easily invaded breeding and cause and inflammation.Cardinal symptom is that vaginal secretions increases and pruritus vulvae, burning sensation.Vagina epithelium atrophy is shown in inspection, and pleat disappears, and epithelium flattens sliding, poor.Vaginal mucosa is congested, has little petechia, sometimes sees shallow table ulcer.
Therapeutic Principle is for increasing the growth and breeding of vagina resistance and anti-bacteria.Current western medical treatment mostly is puts into antibiotic powder in intravaginal, but life-time service can cause local flora to be lacked of proper care, and causes larger puzzlement.
And the colpitic suppository of Chinese traditional treatment, outer lotion are many, but be mostly for Women of Childbearing Age, many containing the medicine except noxious dampness such as Radix Sophorae Flavescentis, Fructus Cnidii, the Fructus Kochiae, Rhizoma Smilacis Glabrae in prescription, and puerperal nonspecific vaginitis cause mainly mucosa is thinning 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 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 little treatment nonspecific vaginitis in puerperal of side effect.
The technical scheme that the present invention solves its technical problem is: a kind of pharmaceutical composition for the treatment of nonspecific vaginitis in puerperal, it is characterized in that being prepared from by the crude drug of following weight proportion: Cortex erythrinae 10 ~ 30 parts, Herba Chlorophyti Laxi 6 ~ 12 parts, go back 3 ~ 10 parts, bobbin, Alpinia japonica (Thunb.) Miq. 6 ~ 12 parts, Herba Taxilli 3 ~ 10 parts, Radix Ranunculi Ternati 6 ~ 12 parts, Fructus Hordei Germinatus (parched to brown) 6 ~ 12 parts, Massa Medicata Fermentata (parched to brown) 6 ~ 12 parts, Radix Ephedrae 6 ~ 12 parts, Spina Gleditsiae 1 ~ 5 part, gumshiraz 3 ~ 10 parts, Ramulus Cinnamomi 10 ~ 25 parts.
Chinese medicine of the present invention is prepared from by the raw material of following optimum weight part proportioning: Cortex erythrinae 20 parts, Herba Chlorophyti Laxi 10 parts, go back 6 parts, bobbin, Alpinia japonica (Thunb.) Miq. 10 parts, Herba Taxilli 6 parts, Radix Ranunculi Ternati 10 parts, Fructus Hordei Germinatus (parched to brown) 10 parts, Massa Medicata Fermentata (parched to brown) 10 parts, Radix Ephedrae 10 parts, Spina Gleditsiae 2 parts, gumshiraz 6 parts, Ramulus Cinnamomi 20 parts.
Wherein said: Cortex erythrinae is bark or the root bark of pulse family Erythrinae Arborescentis Erythrina indica Lam..Nature and flavor are bitter, flat.Return liver, kidney channel.Merit can 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.Merit can heat-clearing and toxic substances removing; Dissipating blood stasis stops blooding.
Also bobbin is the fruit of orchid Rhizoma Gastrodiae Gastrodia elata Bl..Sweet in the mouth; Cold in nature.Merit can tonify deficiency subduing the wind syndrome.Main dizzy; Pupil; Wind syndrome of head is had a headache; Weak breath consumption of essence; Early whitening of beard and hair.
Alpinia japonica (Thunb.) Miq., is Zingiberaceae Alpinia plants Alpinia japonica (Thunb.) Miq. Alpinia japonica Miq., is used as medicine with root stock.Nature and flavor are pungent, warm.Return lung, spleen, Liver Channel.Merit can dispelling wind and removing obstruction in the collateral, regulating QI to relieve pain.
Herba Taxilli, for Herba Taxilli is the dry stem and branch with leaf of Loranthaceae plant Herba Taxilli Taxillus chinensis (DC.) Danser.Nature and flavor bitter, sweet, flat.Return liver, kidney channel.Merit can invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit.
Radix Ranunculi Ternati is the dried root of ranunculaceae plant Seynuns Kugelann Ranunculus ternatus Thunb..Nature and flavor sweet, acrid, warm.Return liver, lung meridian.Merit can eliminating stagnation, detumescence.
Fructus Hordei Germinatus (parched to brown), for the mature fruit of grass Fructus Hordei Vulgaris Hordeum vulgare L. is through drying of germinateing, fries to burnt brown according to frying method, cooling, sieve dedust bits.Nature and flavor are sweet, flat.Return spleen, stomach warp.Merit can promote qi circulation digestion promoting, and 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 of fermentation, fry to burnt brown according to frying method.Nature and flavor sweet, acrid, warm.Enter spleen, stomach warp.Merit can invigorating the spleen and regulating the stomach, helps digestion in adjusting.
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, flat.GUIXIN, lung meridian.Merit can hidroschesis.
Spina Gleditsiae is the dry Spina jujubae of leguminous plant Fructus Gleditsia Gleditsia sinensis Lam..Nature and flavor are pungent, temperature.Return liver, stomach warp.Merit can be subsided a swelling poison holding, evacuation of pus, parasite killing.
Gumshiraz is rosaceous plant Fructus Persicae Prunus persica (L.) Batsch, the resin that trunk flows out.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 acrid, sweet, warm.GUIXIN, lung, urinary bladder channel.Merit can 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 was often because estrogen level reduces, and vaginal wall mucosa is thinning, and in epithelial cell, glycogen content reduces, and intravaginal Ph value rises, and local resistance reduces, and pathogenic bacterium are easily invaded breeding and cause and inflammation.Cardinal symptom is that vaginal secretions increases and pruritus vulvae, burning sensation.The colpitic suppository of current Chinese traditional treatment, outer lotion are many, but be mostly for Women of Childbearing Age, many containing the medicine except noxious dampness such as Radix Sophorae Flavescentis, Fructus Cnidii, the Fructus Kochiae, Rhizoma Smilacis Glabrae in prescription, and puerperal nonspecific vaginitis cause mainly mucosa is thinning 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 dispelling the damp pathogen with drugs of bitter in taste and cold in nature medicine, and reduce from estrogen level, vaginal wall atrophy, mucosa this pathological change angle thinning is started with, and reaches the object 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 dispelling the damp pathogen with drugs of bitter in taste and cold in nature antipruritic agent: get Cortex erythrinae in side, go back bobbin for monarch, the Cortex erythrinae dosage recorded in " China's book on Chinese herbal medicine " is: " for oral administration: to decoct soup, 6-12g "; Inventor to test in proof heavy dose of Cortex erythrinae (10 ~ 30g) and can recover by specific promotion vaginal wall mucosa, and goes back bobbin and have similar plants estrogen action, but this act as two-ways regulation, can not produce the low differentiation of estrogen excessive stimulation reproductive system cell;
2, characteristic of the present invention is also balance and restriction: records Cortex erythrinae in 1. " must joining book on Chinese herbal medicine ": " insufficiency of blood heated person forbid ", but puerperal resembling often with deficiency of YIN-blood, and now use Cortex erythrinae, then have and fear its hematozemia and cause yin asthenia generating intrinsic heat to occur; Therefore add Herba Chlorophyti Laxi and go back bobbin, also bobbin merit can train base by tonify deficiency, and can prevent Cortex erythrinae from consuming cloudy blood and liver-wind stirring up internally, and Herba Chlorophyti Laxi bitter in the mouth is cold in nature, utilize on the one hand it coldly to prevent heated, its merit can dissipating blood stasis hemostasis on the other hand, has out entire merit in blood system, prevent Cortex erythrinae to wander away dynamic blood, also can not affect Cortex erythrinae works orderly effect simultaneously; 2. in we, the use of Ramulus Cinnamomi is: a promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, two Yin Yang balancings, to balance the bitter cold of our invasion by pathogenic cold medicine of a cold nature thing; In prescription of the present invention, the application characteristic of Ramulus Cinnamomi is: measure larger (consumption in " Chinese Pharmacopoeia " is 3 ~ 9g), so too disperse for preventing, gets again Radix Ephedrae convergence assistant system;
3, supplementary drug thing is fewer but better: get Alpinia japonica (Thunb.) Miq. assistant in 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 are arranged in pairs or groups the effect of removing toxic substances, eliminating stagnation, pain relieving; Herba Taxilli assistant helps goes back bobbin vital base and primordial QI consolidating; Gumshiraz is invigorated blood circulation, and contributes to drag residence in mucomembranous surface, penetration enhancement;
4, inventor's clinical research finds, Fructus Hordei Germinatus (parched to brown), the external of Massa Medicata Fermentata (parched to brown) decoct can promote local mucous membrane blood circulation;
5, Spina Gleditsiae is supplementary drug thing, and the consumption recorded in " China's book on Chinese herbal medicine " is: " for oral administration: to decoct soup, 6 ~ 12g ", and the present inventor's experimental study finds, gets low dose of Spina Gleditsiae decocting liquid and can improve in vitro vaginal mucosa cytoactive;
6, the homogeneous medicine multiple-effect of institute's thing of getting it filled in side, contributes to reducing medicament categories and consumption, does not increase local excitation;
7, medicine material consumption of the present invention is groped to sum up to draw through inventor in a large number, and each raw material dosage is for all to have good curative effect in following weight parts scope.
Detailed description of the invention
Below in conjunction with practical situation, the specific embodiment of the present invention is elaborated.
Embodiment 1, 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: by 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, the decoction of Ramulus Cinnamomi mixing and water adding, filtrate is got after 30 minutes, medicinal residues add water continue decoction get filtrate after 20 minutes, twice filtrate merges washout, once a day.
Embodiment 2, crude drug weight proportion: Cortex erythrinae 10 parts, Herba Chlorophyti Laxi 6 parts, go back 3 parts, bobbin, Alpinia japonica (Thunb.) Miq. 6 parts, Herba Taxilli 3 parts, Radix Ranunculi Ternati 6 parts, Fructus Hordei Germinatus (parched to brown) 6 parts, Massa Medicata Fermentata (parched to brown) 6 parts, Radix Ephedrae 6 parts, Spina Gleditsiae 1 part, gumshiraz 3 parts, Ramulus Cinnamomi 10 parts.
Embodiment 3, crude drug weight proportion: Cortex erythrinae 20 parts, Herba Chlorophyti Laxi 10 parts, go back 6 parts, bobbin, Alpinia japonica (Thunb.) Miq. 10 parts, Herba Taxilli 6 parts, Radix Ranunculi Ternati 10 parts, Fructus Hordei Germinatus (parched to brown) 10 parts, Massa Medicata Fermentata (parched to brown) 10 parts, Radix Ephedrae 10 parts, Spina Gleditsiae 2 parts, gumshiraz 6 parts, Ramulus Cinnamomi 20 parts.
Embodiment 4, crude drug weight proportion: Cortex erythrinae 30 parts, Herba Chlorophyti Laxi 12 parts, go back 10 parts, bobbin, Alpinia japonica (Thunb.) Miq. 12 parts, Herba Taxilli 10 parts, Radix Ranunculi Ternati 12 parts, Fructus Hordei Germinatus (parched to brown) 12 parts, Massa Medicata Fermentata (parched to brown) 12 parts, Radix Ephedrae 12 parts, Spina Gleditsiae 5 parts, gumshiraz 10 parts, Ramulus Cinnamomi 25 parts.
The Chinese medicine of embodiment 2 ~ 4 can be prepared from by following method:
(1) by Cortex erythrinae, Radix Ranunculi Ternati, Radix Ephedrae coarse powder distilling under reduced pressure extraction volatile oil respectively, and mixing for standby use after collecting, medicinal residues mixing for standby use;
(2) will go back bobbin decompression decoction 2 times, each 30min, collecting decoction, filters after leaving standstill, obtains filtrate for subsequent 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 step 1 are added 10 times of water yields, decoct with water 2 times, each 1 hour, collecting decoction, filter after leaving standstill, obtain filtrate for subsequent use;
(4) step 2 gained filtrate and step 3 gained filtrate are merged, concentrating under reduced pressure becomes dry extract, pulverizes to obtain dry extract;
(5) spray in step 4 gained dry extract by gained volatile oil in step 1, mixing, cross 100 mesh sieves, subpackage forms.
The efficient combination of said medicine, coordinates mutually, effectively reach the object for the treatment of nonspecific vaginitis in puerperal, and side effect is less.The above results is 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 selection: in January, 2011 ~ 2013 are diagnosed as nonspecific vaginitis 110 example in puerperal year June, and be 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 have little petechia, and vaginal health scoring <15 divides.
1.1.3 divide into groups: be divided into matched group 37 example, washout group 37 example and powder group 36 example.Compare in age, the state of an illness, the course of disease before three groups of patient treatments, no significant difference (P>0.05), has comparability.
1.2 method.
1.2.1 Therapeutic Method: matched group adopts 1% lactic acid solution washout, the red and swollen significantly local of pudendum uses antibiotic Emulsion, 1 time/d.Washout group with gained decoct washout in the embodiment of the present invention 1,1 time/d.Powder group is blown deposited with gained powder pudendum and intravaginal in the embodiment of the present invention 3,1 time/d.It within 7 days, is a course for the treatment of.
1.2.2 observation index: conventional inquiry medical history before and after medication, and according to vaginal health point system (VHS) scoring, determine that symptom improves situation.
1.2.3 criterion of therapeutical effect: with reference to " obstetrics and gynecology ", recovery from illness: clinical symptoms, sign disappear; Effective: clinical symptoms, sign turn for the better by and large; Effective: 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 t checks, enumeration data χ
2inspection.
2 results
2.1 vaginal symptoms improve situations: after 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 start the improvement that obtains in various degree.Gynecologial examination vaginal wall elasticity increases, and fold is deepened, and pale, the flushing in surface and bleeding are clearly better.According to vaginal health standards of grading, vaginal health scoring is the summation of elasticity, wettability, pH, mucosa, secretions 5 project score values.Before washout group patient medication, scoring is 9.44 ± 2.10, and average of marking after medication 7d is 14.76 ± 2.83.Before powder group patient medication, scoring is 10.05 ± 2.27, and average of marking after medication 7d is 17.11 ± 2.93.Compare before and after medication, after two groups of patient treatments, vaginal health scoring is all obviously increased (P<0.05).
2.2 3 groups of Comprehensive Clinical comparitive study: after 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 are compared, 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 rates: three groups of patients all do not occur obvious adverse reaction.
3. conclusion.
This result of study shows, and washout group of the present invention and powder group treatment nonspecific vaginitis total effective rate in puerperal are 100%, and the cure rate of powder group is higher than washout group.Have the advantage that untoward reaction is comparatively light, safety is higher.
Claims (1)
1. treat a pharmaceutical composition for nonspecific vaginitis in puerperal, it is characterized in that: described pharmaceutical composition occupation mode is that powder pudendum and intravaginal are blown deposited; Be prepared from by the crude drug of following weight proportion: Cortex erythrinae 20 parts, Herba Chlorophyti Laxi 10 parts, go back 6 parts, bobbin, Alpinia japonica (Thunb.) Miq. 10 parts, Herba Taxilli 6 parts, Radix Ranunculi Ternati 10 parts, Fructus Hordei Germinatus (parched to brown) 10 parts, Massa Medicata Fermentata (parched to brown) 10 parts, Radix Ephedrae 10 parts, Spina Gleditsiae 2 parts, gumshiraz 6 parts, Ramulus Cinnamomi 20 parts.
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