CN103055083B - Chinese medicine for treating women dysmenorrhea and preparation method of external patch of Chinese medicine - Google Patents
Chinese medicine for treating women dysmenorrhea and preparation method of external patch of Chinese medicine Download PDFInfo
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- CN103055083B CN103055083B CN201310016133.3A CN201310016133A CN103055083B CN 103055083 B CN103055083 B CN 103055083B CN 201310016133 A CN201310016133 A CN 201310016133A CN 103055083 B CN103055083 B CN 103055083B
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Abstract
The invention discloses a Chinese medicine for treating women dysmenorrhea. The Chinese medicine comprises the following compositions in percentage by weight: 10.25-39.48% of folium artemisiae argyi, 12.78-39.48% of paederia scandens, 7.69-31.58% of dogwood, 3.84-23.68% of cassia twig, 7.69-23.68% of rhizoma cyperi, 3.84-23.68% of rhizoma corydalis and 2.56-23.68% of cinnamon. The preparation method of an external patch of the Chinese medicine comprises the steps of: mixing the medicinal herbs extract with the accessory preparing a hydrogel patch to obtain a carrier cream, and coating, cutting, standing, moisture absorbing, quality testing, packaging, etc. According to the therapeutic formula of warming channel and expelling cold, activating blood and eleminating stasis, dredging meridian and relieving pain, as well as tonifying essence and blood, the invention selects Chinese herbal medicines on the basis of the reasons of women dysmenorrhea and the body physiological characteristics, combined with clinical application experiences, and the research results of pathology and modern Chinese medicine pharmacology, which improves treatment effect. The Chinese medicine for treating women dysmenorrhea and the preparation method of the external patch of the Chinese medicine disclosed by the invention have the advantages of large medicine loading capacity of external patches, high medicine transdermal absorption efficiency, and no irritating and allergic effects for skins.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of Chinese medicine that is used for the treatment of menalgia, also relate to the preparation method of this Traditional Chinese medicine external patch.
Background technology
Dysmenorrhea, is commonly encountered diseases and the frequently-occurring disease of gynecological, is to occur periodically lower abdomen pain between menstrual period or before and after row, or pain draw waist sacrum even severe pain to faint be the menstruation class disease of main manifestations.China women's dysmenorrhea incidence rate is 3.1% left and right, and dysmenorrhea is sent out with menstrual cycle, and severe patient can accompany nausea and vomiting, dripping cold sweat, deadly cold hand and foot even to faint, and brings to routine work, study and life and has a strong impact on.According to clinical statistics, approximately have more than 30% hyperplasia of mammary glands to be caused by dysmenorrhea, and cyclomastopathy patient to develop into the probability of breast carcinoma be 25%, therefore, dysmenorrhea can also cause the generation of breast carcinoma indirectly; Most dysmenorrhea is all because endometriosis is caused, and in uterus, in the patient of endometriosis, wherein the people of about 50% left and right can cause infertile.As can be seen here, dysmenorrhea very harmful, needs active treatment.
Doctor trained in Western medicine is divided into constitutional and Secondary cases by dysmenorrhea, and primary dysmenorrhea refers to that genitals, without obvious pathological changes person, therefore claim again primary dysmenorrhea, is more common in adolescent girls, the unmarried and married person of not educating more; Secondary dysmenorrhea is many because genitals has organic disease, and due to endometriosis, adenomyosis etc., pain time is longer, can be in premenstrual appearance, even there is pain the onset of ovulation.Clinically, doctor trained in Western medicine adopts Oral Chemical pharmaceutical preparation as prostaglandin synthesis inhibitors, quinolones, calcium channel blocker and gossypol acetate etc. for the treatment of dysmenorrhea more, these medicines take stopgap measures and do not effect a permanent cure, prolongation with administration time is easy to cause patient to weaken curative effect to the Reduced susceptibility of medicine, in addition, can also cause lesions of liver and kidney and gastrointestinal side effect.The traditional Chinese medical science is thought, dysmenorrhea is to be mainly subject to paathogenic factor as feelings will is hindered, multiparity is unclean, daily life is careless or six climate exopathogens cause harm etc. impact in menstrual period, cause punching to appoint stasis blocking or cold accumulating in meridian, make QI-blood circulation not smooth, the circulation of uterus menses is hindered, and consequently " stagnation of QI and blood may bring about pain ", appoint in punching its sick position, uterus, variation, in QI and blood, shows as pain card.The 22 > > is demonstrate,proved and controlled to < < Medical Treasures of the Golden Chamber the miscellaneous internal diseases in woman arteries and veins that the traditional Chinese medical science sees Zhang Zhongjing about the description head of dysmenorrhea, in scripture, have: " menstrual disorders with leukorrhagia; lower abdominal pain and fullness; through goodbye person in January; the loose master's of soil melon root ", described symptom and the treatment of dysmenorrhea; The < < General Treatise on the Cause and Symptoms of Diseases miscellaneous gynecological diseases nobility one > > first vertical " menstrual abdominalgia time " of Chao Yuanfang (550-630 A.D.), discusses the syndrome of dysmenorrhes and the cause of disease; Sun Simiao has also been done detailed record to the treatment of dysmenorrhea in < < Essential Recipes for Emergent Use Worth A Thousand Gold > >.Compare Western medicine, Chinese medicine can regulate internal organs function on the whole, reaches treating both the principal and secondary aspects of a disease, has embodied obvious advantage improving aspect symptom and late result, and side effect is simultaneously less.
At present, for the treatment of dysmenorrhea, still take oral drugs as main clinically.Not only there is liver first-pass effect and GI irritation in oral drugs, has also increased the weight of patient's Liver and kidney burden, and the drug effect persistent period is also short.External treatment of tcm is one of Therapeutic Method of Chinese medicine tradition specially good effect, has the double treatment effect of percutaneous drug absorption and stimulation meridian point, and evident in efficacy, side effect is low, and easy to use.But traditional transdermal administration dosage form is as black plaster, rubber paste etc., exist that serious drawback is as little in drug loading, Drug Percutaneous Absorption efficiency is low, compared with strong skin irritation and anaphylaxis, airtight, take off from time epilation produce pain etc. and make patient be difficult for accepting.
Summary of the invention
The object of this invention is to provide a kind of Chinese medicine for the treatment of menalgia, solved that existing chemicals medicine is cured the symptoms, not the disease and long-time medication is easy to cause patient the Reduced susceptibility of medicine to be weakened to the problem of curative effect.
Another object of the present invention is to provide the preparation method of above-mentioned Traditional Chinese medicine external patch.
The object of the present invention is achieved like this, the Chinese medicine for the treatment of menalgia, according to percentage by weight, composed of the following components: Folium Artemisiae Argyi 10.25～39.48%, fevervine 12.78～39.48%, Fructus Corni 7.69～31.58%, Ramulus Cinnamomi 3.84～23.68%, Rhizoma Cyperi 7.69～23.68%, Rhizoma Corydalis 3.84～23.68%, Cortex Cinnamomi 2.56～23.68%, the percentage by weight sum of each component is 100%.
Another object of the present invention is achieved in that the preparation method of the Traditional Chinese medicine external patch of above-mentioned treatment menalgia, specifically according to following steps, implements:
Step 1: according to percentage by weight, take 10.25～39.48% Folium Artemisiae Argyi, 12.78～39.48% fevervine, 7.69～31.58% Fructus Corni, 3.84～23.68% Ramulus Cinnamomi, 7.69～23.68% Rhizoma Cyperi, 3.84～23.68% Rhizoma Corydalis, 2.56～23.68% Cortex Cinnamomi, the mass percent sum of each component is 100%; The above component taking is mixed, with alcohol reflux, extracting solution is merged, concentrated, obtain drug extract;
Step 2: take adjuvant according to percentage by weight, comprise 1.56%～4.45% sodium polyacrylate, 3.05%～9.55% polyvidone, 30.50%～56.78% glycerol, 30.50%～50.67% purified water, 1.00%～5.15% filler, 0.05%～0.55% trivalent aluminium ion cross-linking agent, 0.05%～0.35% disodiumedetate, 0.11%～0.75% organic acid, 0.10%～0.35% antiseptic, 1.50%～9.55% 95% ethanol, the percentage by weight sum of each component of adjuvant is 100%;
Step 3: join in glycerol after the sodium polyacrylate that step 2 is taken, filler, trivalent aluminium ion cross-linking agent, disodiumedetate mix homogeneously, under vacuum condition, be stirred to mix homogeneously, obtain glycerol phase;
Step 4: the organic acid that step 2 is taken and polyvidone are dissolved in purified water jointly, is stirred to completely and dissolves, and obtains water;
Step 5: the antiseptic that step 2 is taken is dissolved in 95% ethanol, obtains ethanol phase;
Step 6: the water that the ethanol phase that step 5 is obtained, drug extract and the step 4 that step 1 obtains obtain joins the glycerol phase in step 3 successively, under vacuum condition, is stirred to mix homogeneously, obtains medicine carrying mastic; Step 7: the medicine carrying mastic that step 6 is obtained is transferred on coating cutting machine, is coated with, cuts, and the semi-finished product after cutting are standing, then carries out quality inspection, packing, obtains the Traditional Chinese medicine external patch that the present invention treats menalgia.
Feature of the present invention is also:
In above-mentioned steps 1, with 75%～90% alcohol reflux of 8～12 times of mixture qualities 2 times, each 1～3 hour.
In above-mentioned steps 3, vacuum condition refers to be not less than-0.06MPa of vacuum; Stirring is 3～10 minutes.
In above-mentioned steps 6, vacuum condition refers to be not less than-0.06MPa of vacuum, and stirring is 5～20 minutes.
In above-mentioned steps 7, semi-finished product after cutting are standing is under humidity 20%～60%, 20 ℃～35 ℃ conditions of temperature, standing 12～48 hours; Be placed in again under humidity 70%～90%, 15 ℃～30 ℃ conditions of temperature standing 6～24 hours.
In above-mentioned steps 2, filler adopts a kind of, two or more the mixture in ceramics, Kaolin, kaolin, kieselguhr, silica gel; Trivalent aluminium ion cross-linking agent in step 2 adopts dihydroxyaluminum aminoacetate or aluminium hydroxide, or the mixture of the two; Organic acid in step 2 adopts tartaric acid or citric acid, or the mixture of the two; Parabens antiseptic in step 2 adopts a kind of, two or more the mixture in ethyl hydroxybenzoate, propyl ester, butyl ester or methyl ester.
The invention has the beneficial effects as follows:
1, the present invention is used for the treatment of the Chinese medicine of menalgia, according to the physiological characteristics of the reason of dysmenorrhes and health, in conjunction with the pharmacological result of study of Clinical Experience, pathology and modern Chinese medicine, select Chinese herbal medicine according to the rule for the treatment of prescription of " dispelling cold by warming the meridian, blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain, enrich and benefit essence and blood ", improved therapeutic effect, solved and used that chemicals medicine is cured the symptoms, not the disease, long-time medication is easy to cause patient the Reduced susceptibility of medicine to be weakened to the problem that curative effect and oral administration exist liver first-pass effect and GI irritation etc.
2, the present invention is according to the feature of point medicine, adopt the preparation technique of Modern Pharmaceutics that the Chinese medicine for the treatment of menalgia is developed into hydrogel external use plaster, drug loading large, Drug Percutaneous Absorption efficiency is high, and to skin nonirritant and anaphylaxis, solved traditional transdermal administration dosage form as black plaster, rubber paste etc. exist that drug loading is little, Drug Percutaneous Absorption efficiency is low, compared with strong skin irritation and anaphylaxis, airtight, take off from time epilation produce pain etc. and make the not acceptant drawback of patient.
The specific embodiment
Below in conjunction with the specific embodiment, the present invention is described in detail.
The present invention is used for the treatment of the Chinese medicine of menalgia, according to percentage by weight, composed of the following components: Folium Artemisiae Argyi 10.25～39.48%, fevervine 12.78～39.48%, Fructus Corni 7.69～31.58%, Ramulus Cinnamomi 3.84～23.68%, Rhizoma Cyperi 7.69～23.68%, Rhizoma Corydalis 3.84～23.68%, Cortex Cinnamomi 2.56～23.68%, the percentage by weight sum of each component is 100%.
The above-mentioned preparation method that is used for the treatment of the Traditional Chinese medicine external patch of menalgia, specifically according to following steps, implement:
Step 1: according to percentage by weight, take 10.25～39.48% Folium Artemisiae Argyi, 12.78～39.48% fevervine, 7.69～31.58% Fructus Corni, 3.84～23.68% Ramulus Cinnamomi, 7.69～23.68% Rhizoma Cyperi, 3.84～23.68% Rhizoma Corydalis, 2.56～23.68% Cortex Cinnamomi, the mass percent sum of each component is 100%, and the above component taking is mixed, with 75%～90% alcohol reflux of 8～12 times of mixture qualities 2 times, each 1～3 hour, 2 extracting solution are merged, concentrated, obtain drug extract;
Step 2: take adjuvant according to percentage by weight, comprise 1.56%～4.45% sodium polyacrylate, 3.05%～9.55% polyvidone, 30.50%～56.78% glycerol, 30.50%～50.67% purified water, 1.00%～5.15% filler, 0.05%～0.55% trivalent aluminium ion cross-linking agent, 0.05%～0.35% disodiumedetate, 0.11%～0.75% organic acid, 0.10%～0.35% antiseptic, 1.50%～9.55% 95% ethanol, the percentage by weight sum of each component of adjuvant is 100%;
Step 3: join in glycerol after the sodium polyacrylate that step 2 is taken, filler, trivalent aluminium ion cross-linking agent, disodiumedetate mix homogeneously, under be not less than in vacuum-0.06MPa condition, stir 3～10 minutes to mix homogeneously, obtain glycerol phase;
Step 4: the organic acid that step 2 is taken and polyvidone are dissolved in purified water jointly, is stirred to completely and dissolves, and obtains water;
Step 5: the antiseptic that step 2 is taken is dissolved in 95% ethanol, obtains ethanol phase;
Step 6: the water that the ethanol phase that step 5 is obtained, drug extract and the step 4 that step 1 obtains obtain joins the glycerol phase in step 3 successively, under be not less than-0.06MPa condition, stirs 5～20 minutes to mix homogeneously in vacuum, obtains medicine carrying mastic;
Step 7: the medicine carrying mastic that step 6 is obtained is transferred on coating cutting machine, is coated with, cuts by specification, the semi-finished product after cutting is placed under humidity 20%～60%, 20 ℃～35 ℃ conditions of temperature to standing 12～48 hours; Be placed in again under humidity 70%～90%, 15 ℃～30 ℃ conditions of temperature, standing 6～24 hours, then carry out quality inspection, packing, obtain the Traditional Chinese medicine external patch that the present invention treats menalgia.
Key point of the present invention place is described from principle aspect below:
The present invention is according to the physiological characteristics of the reason of dysmenorrhes and health, in conjunction with the pharmacological result of study of Clinical Experience, pathology and modern Chinese medicine, select Chinese herbal medicine according to the rule for the treatment of prescription of " dispelling cold by warming the meridian, blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain, enrich and benefit essence and blood ", and adopt the preparation capable of permeating skin technology of Modern Pharmaceutics to develop; The feature of have that drug loading is large, Drug Percutaneous Absorption is effective, easy to use, long-acting slow-release, curative effect are reliable, safety non-toxic and patient are easy to acceptance, the present invention has also kept the comprehensive function feature of Chinese herbal medicine multicomponent, many target spots and many effects, thereby, for dysmenorrhea treating both the principal and secondary aspects of a disease, for menalgia tool, have significant therapeutic effect.
1. the present invention adopts Folium Artemisiae Argyi, fevervine, Fructus Corni, Ramulus Cinnamomi, Rhizoma Cyperi, Rhizoma Corydalis, Cortex Cinnamomi, wherein Folium Artemisiae Argyi has the effect of dispersing cold for relieving pain, warming the meridian for stopping bleeding, is gynecological's key medicine, can be used for the cold and deficiency of CHONG and REN meridians, menoxenia, few abdomen cold type of pain, cold womb is infertile, and metrorrhagia warp is many, gestation hemorrhage etc.; Fevervine has the effect of expelling wind and removing dampness, removing toxic substances and promoting subsidence of swelling and promoting blood circulation and stopping pain, can be used for rheumatism, food stagnation and cough with asthma and multiple pain etc.; Fructus Corni has the effect of liver and kidney tonifying, essence astringing and desertion stemming, can be used for bleeding not during menses menoxenia, vertigo and tinnitus, soreness of waist and knee joint, impotence and seminal emission, enuresis frequent micturition and profuse sweating collapse etc.; Ramulus Cinnamomi has the effect of diaphoresis expelling pathogenic factors from muscles, warming the meridian and promoting blood circulation, supporing yang activating QI, dispersing cold for relieving pain, can be used for arthralgia due to cold-dampnes, extreme cold of the limbs, amenorrhea dysmenorrhea, lump in the abdomen caking etc.; Rhizoma Cyperi has the effect of the resolving depression of regulating the flow of vital energy, menstruction regulating and pain relieving, can be used for distending pain over the hypochondrium, and mammary swelling is educated, menoxenia, amenorrhea dysmenorrhea, gastral cavity abdomen feeling of fullness pain, abdominal pain during menstruation, bleeding not during menses, frequent fetal movement etc.; Rhizoma Corydalis has the effect of promoting blood circulation to remove blood stasis, regulating QI to relieve pain, can be used for pain of each qi depression to blood stasis of whole body, dysmenorrhea amenorrhea, and lump in the abdomen, postpartum stagnation, injury from falling down, hernia is had a pain etc.; Cortex Cinnamomi have mend that fire is supporing yang, the effect of let the fire back to its origin, dispersing cold for relieving pain, promoting blood circulation to restore menstrual flow, can be used for colic of cold type pain, cold womb, trusted subordinate's cold type of pain, amenorrhea dysmenorrhea, the stagnant stomachache of the stasis of blood in puerperal etc.Pharmaceutical composition of the present invention has the effect of dispelling cold by warming the meridian, blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain, enrich and benefit essence and blood in span of the present invention, have the effect for the treatment of both the principal and secondary aspects of a disease for dysmenorrhes.
2. in external use plaster preparation method of the present invention, adopted applicable to all types of drug molecules and water solublity pharmaceutic adjuvant skin good biocompatibility, guaranteed that drug loading of the present invention is large, active constituents of medicine Transdermal absorption is effective, long-acting slow-release, non-stimulated, without irritated, comfortable, safe and reliable feature easy to use, met the demand of women for dysmenorrhea treatment.
Embodiment 1
Step 1: take Folium Artemisiae Argyi 800g, fevervine 1500g, Fructus Corni 600g, Ramulus Cinnamomi 900g, Rhizoma Cyperi 600g, Rhizoma Corydalis 300g, Cortex Cinnamomi 900g; Coarse pulverization, with 75% alcohol reflux of 8 times of medical material mixture qualities 2 times, each 1 hour, by 2 extracting solution merge, concentrated, obtain drug extract;
Step 2: take sodium polyacrylate 95g, ceramics 72g, dihydroxyaluminum aminoacetate 8.71g, disodiumedetate 2.62g join in 1540g glycerol, under be not less than-0.06MPa of vacuum condition, stir 5 minutes, obtain glycerol phase, standby;
Step 3: get purified water 1400ml, add 9.50g tartaric acid and 215g polyvidone, be stirred to and be uniformly dissolved, obtain water, standby;
Step 4: the parabens antiseptic of 7.28g is dissolved in to 10ml95% ethanol, is stirred to and is uniformly dissolved, obtain ethanol phase;
Step 5: the water that the ethanol phase that step 4 is obtained, drug extract 350g and the step 3 that step 1 obtains obtain joins the glycerol phase in step 2 successively, under be not less than-0.06MPa condition, stirs 5 minutes to mix homogeneously in vacuum, obtains medicine carrying mastic;
Step 6: the medicine carrying mastic that step 5 is obtained is transferred on coating cutting machine, is coated with, cuts by specification, the semi-finished product after cutting is placed under humidity 55%～60%, 28 ℃～30 ℃ conditions of temperature to standing 24 hours; Be placed in again under humidity 75%～80%, 18 ℃～20 ℃ conditions of temperature, standing 12 hours, then carry out quality inspection, packing, obtain the Traditional Chinese medicine external patch that the present invention treats menalgia.
Embodiment 2
Step 1: take Folium Artemisiae Argyi 1100g, fevervine 1200g, Fructus Corni 900g, Ramulus Cinnamomi 600g, Rhizoma Cyperi 800g, Rhizoma Corydalis 600g, Cortex Cinnamomi 600g; Coarse pulverization, with 80% alcohol reflux of 10 times of medical material mixture qualities 2 times, each 1.5 hours, by 2 extracting solution merge, concentrated, obtain drug extract;
Step 2: take sodium polyacrylate 126g, ceramics 80g, dihydroxyaluminum aminoacetate 9.15g, disodiumedetate 2.70g join in 1590g glycerol, under be not less than-0.06MPa of vacuum condition, stir 8 minutes, obtain glycerol phase, standby;
Step 3: get purified water 1600ml, add 10.15g tartaric acid and 246g polyvidone, be stirred to and be uniformly dissolved, obtain water, standby;
Step 4: the parabens antiseptic of 7.68g is dissolved in to 12ml95% ethanol, is stirred to and is uniformly dissolved, obtain ethanol phase;
Step 5: the water that the ethanol phase that step 4 is obtained, drug extract 550g and the step 3 that step 1 obtains obtain joins the glycerol phase in step 2 successively, under be not less than in vacuum-0.06MPa condition, stir 10 minutes to mix homogeneously, obtain medicine carrying mastic;
Step 6: the medicine carrying mastic that step 5 is obtained is transferred on coating cutting machine, is coated with, cuts by specification, the semi-finished product after cutting is placed under humidity 55%～60%, 28 ℃～30 ℃ conditions of temperature to standing 24 hours; Be placed in again under humidity 75%～80%, 18 ℃～20 ℃ conditions of temperature, standing 12 hours, then carry out quality inspection, packing, obtain the Traditional Chinese medicine external patch that the present invention treats menalgia.
Embodiment 3
Step 1: take Folium Artemisiae Argyi 1500g, fevervine 1000g, Fructus Corni 1200g, Ramulus Cinnamomi 300g, Rhizoma Cyperi 900g, Rhizoma Corydalis 900g, Cortex Cinnamomi 300g; Coarse pulverization, with 85% alcohol reflux of 12 times of medical material mixture qualities 2 times, each 2 hours, by 2 extracting solution merge, concentrated, obtain drug extract;
Step 2: take sodium polyacrylate 142g, ceramics 98g, dihydroxyaluminum aminoacetate 9.75g, disodiumedetate 2.75g join in 1650g glycerol, under be not less than-0.06MPa of vacuum condition, stir 10 minutes, obtain glycerol phase, standby;
Step 3: get purified water 1800ml, add 11.00g tartaric acid and 275g polyvidone, be stirred to and be uniformly dissolved, obtain water, standby;
Step 4: the parabens antiseptic of 7.70g is dissolved in to 15ml95% ethanol, is stirred to and is uniformly dissolved, obtain ethanol phase;
Step 5: the water that the ethanol phase that step 4 is obtained, drug extract 750g and the step 3 that step 1 obtains obtain joins the glycerol phase in step 2 successively, under be not less than in vacuum-0.06MPa condition, stir 13 minutes to mix homogeneously, obtain medicine carrying mastic;
Step 6: the medicine carrying mastic that step 5 is obtained is transferred on coating cutting machine, is coated with, cuts by specification, the semi-finished product after cutting is placed under humidity 55%～60%, 28 ℃～30 ℃ conditions of temperature to standing 24 hours; Be placed in again under humidity 75%～80%, 18 ℃～20 ℃ conditions of temperature, standing 12 hours, then carry out quality inspection, packing, obtain the Traditional Chinese medicine external patch that the present invention treats menalgia.
From clinical practice result, further illustrate the beneficial effect that the present invention produces below:
1. patient's data
According to < < tcm clinical practice Illnesses Diagnoses criterion of therapeutical effect > >, clinical main manifestations be menstrual period or through after lower abdomen pain on the one, two or lower abdomen and the empty pendant of pudendum, swollen sense, likes warm pain relieved by pressing, Hypomenorrhea, the light matter of color is thin, or spiritlessness and weakness, or lustreless complexion, or anorexia loose stool, pale tongue, thready and weak pulse.Wherein cardinal symptom is indispensable, has 2 above simultaneous phenomenons, and the positive pathological changes of eliminating such as gynaecological examination (anus is looked into) or B ultrasonic can be made a definite diagnosis.68 routine dysmenorrhea patients, 14～27 years old age, 56 examples, 28～36 years old 12 example; 44 examples in the course of disease 1 year, 1～3 year 15 example, 4～6 years 9 examples.
2. Therapeutic Method and therapeutic evaluation
The present invention according to " umbilicus person; interrenal qi; gas leads to hundred arteries and veins; the cloth vital organs of the human body; for life basic " with < < Li Yue Pianwen, Rhymed Discourse for Topical Remedies > >, the theory of " medicine is entered by umbilicus; be tantamount to entrance also " is proposed, selection SHENQUE acupoint is medicine-feeding part.By patient's SHENQUE acupoint position skin clean, note applies patch of the present invention, and replacing in every 1 day 1 time, 7 days is a course for the treatment of, totally 2 courses for the treatment of.
The < < traditional Chinese medical science disease Standardization of diagnosis and curative effect > > promulgating with reference to State Administration of Traditional Chinese Medicine carries out therapeutic evaluation: 1. cure: pain disappears, and continuous 3 menstrual cycle have no recurrence; 2. take a turn for the better: pain relief or disappearance, but can not maintain more than 3 months; 3. invalid: pain has no improvement.
3. therapeutic outcome
Cure 60 examples, account for 88.24%; 8 examples that take a turn for the better, account for 11.76%; Total effective rate 100%.And the present invention in use patient to reflect that the present invention uses comfortable, reliable for effect, there is not untoward reaction.
Claims (6)
1. treat the preparation method of the Traditional Chinese medicine external patch of menalgia, it is characterized in that, according to percentage by weight, composed of the following components: Folium Artemisiae Argyi 10.25～39.48%, fevervine 12.78～39.48%, Fructus Corni 7.69～31.58%, Ramulus Cinnamomi 3.84～23.68%, Rhizoma Cyperi 7.69～23.68%, Rhizoma Corydalis 3.84～23.68%, Cortex Cinnamomi 2.56～23.68%, the percentage by weight sum of each component is 100%; According to following steps, implement:
Step 1: take above component and mix, with alcohol reflux, extracting solution is merged, concentrated, obtain drug extract;
Step 2: take adjuvant according to percentage by weight, comprise 1.56%～4.45% sodium polyacrylate, 3.05%～9.55% polyvidone, 30.50%～56.78% glycerol, 30.50%～50.67% purified water, 1.00%～5.15% filler, 0.05%～0.55% trivalent aluminium ion cross-linking agent, 0.05%～0.35% disodiumedetate, 0.11%～0.75% organic acid, 0.10%～0.35% antiseptic, 1.50%～9.55% 95% ethanol, the percentage by weight sum of each component of adjuvant is 100%;
Step 3: join in glycerol after the sodium polyacrylate that step 2 is taken, filler, trivalent aluminium ion cross-linking agent, disodiumedetate mix homogeneously, under vacuum condition, be stirred to mix homogeneously, obtain glycerol phase;
Step 4: the organic acid that step 2 is taken and polyvidone are dissolved in purified water jointly, is stirred to completely and dissolves, and obtains water;
Step 5: the antiseptic that step 2 is taken is dissolved in 95% ethanol, obtains ethanol phase;
Step 6: the water that the ethanol phase that step 5 is obtained, drug extract and the step 4 that step 1 obtains obtain joins the glycerol phase in step 3 successively, under vacuum condition, is stirred to mix homogeneously, obtains medicine carrying mastic;
Step 7: the medicine carrying mastic that step 6 is obtained is transferred on coating cutting machine, is coated with, cuts, and the semi-finished product after cutting are standing, then carries out quality inspection, packing, the Traditional Chinese medicine external patch of the menalgia that obtains medical treatment.
2. the preparation method of the Traditional Chinese medicine external patch for the treatment of menalgia as claimed in claim 1, is characterized in that, in step 1, and with 75%～90% alcohol reflux of 8～12 times of mixture qualities 2 times, each 1～3 hour.
3. the preparation method of the Traditional Chinese medicine external patch for the treatment of menalgia as claimed in claim 1, is characterized in that, in step 2, and the mixture of one or more in filler employing ceramics, Kaolin, kaolin, kieselguhr, silica gel; Trivalent aluminium ion cross-linking agent adopts dihydroxyaluminum aminoacetate or aluminium hydroxide, or the mixture of the two; Organic acid adopts tartaric acid or citric acid, or the mixture of the two; The mixture of one or more in antiseptic employing ethyl hydroxybenzoate, propyl ester, butyl ester or methyl ester.
4. the preparation method of the Traditional Chinese medicine external patch for the treatment of menalgia as claimed in claim 1, is characterized in that, in step 3, vacuum condition refers to be not less than-0.06MPa of vacuum; Stirring is 3～10 minutes.
5. the preparation method of the Traditional Chinese medicine external patch for the treatment of menalgia as claimed in claim 1, is characterized in that, in step 6, vacuum condition refers to be not less than-0.06MPa of vacuum, and stirring is 5～20 minutes.
6. the preparation method of the Traditional Chinese medicine external patch for the treatment of menalgia as claimed in claim 1, is characterized in that, in step 7, semi-finished product after cutting are standing is under humidity 20%～60%, 20 ℃～35 ℃ conditions of temperature, standing 12～48 hours; Be placed in again under humidity 70%～90%, 15 ℃～30 ℃ conditions of temperature standing 6～24 hours.
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