CN103055083A - 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 PDF

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CN103055083A
CN103055083A CN2013100161333A CN201310016133A CN103055083A CN 103055083 A CN103055083 A CN 103055083A CN 2013100161333 A CN2013100161333 A CN 2013100161333A CN 201310016133 A CN201310016133 A CN 201310016133A CN 103055083 A CN103055083 A CN 103055083A
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chinese medicine
menalgia
preparation
external patch
weighing
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CN103055083B (en
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李伟泽
赵宁
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Xian Medical University
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Xian Medical University
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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

The preparation method that is used for the treatment of Chinese medicine and the external use plaster thereof of menalgia
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 occurring periodically lower abdomen pain between menstrual period or before and after row, or pain is drawn waist sacrum even severe pain and fainted and be the menstruation class disease of main manifestations.China women's dysmenorrhea incidence rate is about 3.1%, and dysmenorrhea is sent out with menstrual cycle, and severe patient can be accompanied nausea and vomiting, dripping cold sweat, deadly cold hand and foot even faintness, brings for routine work, study and life and has a strong impact on.According to clinical statistics, approximately have the hyperplasia of mammary glands more than 30% to be caused by dysmenorrhea, and the 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 all is that in uterus among the patient of endometriosis, wherein about people of about 50% can cause infertile because endometriosis is caused.This shows that dysmenorrhea very harmful needs active treatment.
Doctor trained in Western medicine is divided into constitutional and Secondary cases with dysmenorrhea, and primary dysmenorrhea refers to that the 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 then many, and due to endometriosis, adenomyosis etc., pain time is longer because the genitals has organic disease, but the Yu Jingqian appearance, even the onset of ovulation namely occurs pain.Clinically, doctor trained in Western medicine adopts Oral Chemical pharmaceutical preparation such 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, be easy to cause the patient to the Reduced susceptibility of the medicine curative effect that weakens with the prolongation of administration time, in addition, can also cause lesions of liver and kidney and gastrointestinal side effect.The traditional Chinese medical science is thought, dysmenorrhea mainly is in the impact that be subject to paathogenic factor menstrual period such as feelings will is hindered, multiparity is unclean, daily life is careless or six climate exopathogens cause harm etc., 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 shows as the pain card in QI and blood.The traditional Chinese medical science has in the scripture about " Medical Treasures of the Golden Chamber the miscellaneous internal diseases in woman arteries and veins card also controls the 22 " that the description head of dysmenorrhea sees Zhang Zhongjing: " menstrual disorders with leukorrhagia, lower abdominal pain and fullness, through goodbye person in January, the loose master's of soil melon root ", recorded and narrated symptom and the treatment of dysmenorrhea; " General Treatise on the Cause and Symptoms of Diseases miscellaneous gynecological diseases nobility one " of Chao Yuanfang (550-630 A.D.) first vertical " menstrual abdominalgia time " discusses syndrome and the cause of disease of dysmenorrhes; Sun Simiao has also been done detailed record to the treatment of dysmenorrhea in Prescriptions Worth Thousand Gold for Emergencies.Compare Western medicine, Chinese medicine can be regulated the internal organs function on the whole, reaches treating both the principal and secondary aspects of a disease, has embodied obvious advantage aspect symptom and the late result improving, and simultaneously side effect is less.
At present, clinically for the treatment of dysmenorrhea still take oral drugs as main.Oral drugs not only exist liver first-pass effect and GI irritation, have 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 such as black plaster, rubber paste etc., exist serious drawback such as drug loading are little, Drug Percutaneous Absorption efficient is low, stronger skin irritation and anaphylaxis, airtight, take off from the time epilation produce pain etc. and make the patient be difficult for accepting.
Summary of the invention
The purpose 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 the patient to the Reduced susceptibility of medicine and the problem of the curative effect that weakens.
Another object of the present invention provides 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 implements according to following steps:
Step 1: according to percentage by weight, take by weighing 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 that takes by weighing is mixed, use alcohol reflux, extracting solution is merged, concentrates, obtain drug extract;
Step 2: take by weighing 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 the glycerol behind the sodium polyacrylate that step 2 is taken by weighing, filler, trivalent aluminium ion cross-linking agent, the disodiumedetate mix homogeneously, under vacuum condition, be stirred to mix homogeneously, obtain the glycerol phase;
Step 4: organic acid and polyvidone that step 2 is taken by weighing are dissolved in purified water jointly, are stirred to fully dissolving, obtain water;
Step 5: the antiseptic that step 2 is taken by weighing is dissolved in 95% ethanol, obtains the 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 the step 3 successively, under vacuum condition, is stirred to mix homogeneously, obtains the medicine carrying mastic; Step 7: the medicine carrying mastic that step 6 is obtained is transferred on the coating cutting machine, is coated with, cuts, and the semi-finished product after the cutting are left standstill, and then carries out quality inspection, packing, namely obtains the Traditional Chinese medicine external patch that the present invention treats menalgia.
Characteristics of the present invention also are:
In the above-mentioned steps 1, with 75%~90% alcohol reflux of 8~12 times of mixture qualities 2 times, each 1~3 hour.
In the above-mentioned steps 3, vacuum condition refers to that vacuum is not less than-0.06MPa; Stirring is 3~10 minutes.
In the above-mentioned steps 6, vacuum condition refers to that vacuum is not less than-0.06MPa, and stirring is 5~20 minutes.
In the above-mentioned steps 7, the semi-finished product after the cutting leave standstill as under humidity 20%~60%, 20 ℃~35 ℃ conditions of temperature, leave standstill 12~48 hours; Place again under humidity 70%~90%, 15 ℃~30 ℃ conditions of temperature, left standstill 6~24 hours.
In the above-mentioned steps 2, filler adopts a kind of, two or more the mixture in ceramics, Kaolin, kaolin, kieselguhr, the silica gel; Trivalent aluminium ion cross-linking agent in the step 2 adopts dihydroxyaluminum aminoacetate or aluminium hydroxide, the perhaps mixture of the two; Organic acid in the step 2 adopts tartaric acid or citric acid, the perhaps mixture of the two; Parabens antiseptic in the step 2 adopts a kind of, two or more the mixture in ethyl hydroxybenzoate, propyl ester, butyl ester or the 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 reason of dysmenorrhes and the physiological characteristics of health, 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 " in conjunction with the pharmacological result of study of Clinical Experience, pathology and modern Chinese medicine, improved therapeutic effect, solved and used that chemicals medicine is cured the symptoms, not the disease, long-time medication is easy to cause the patient's Reduced susceptibility of medicine weakened curative effect and oral administration to have the problem of liver first-pass effect and GI irritation etc.
2, the present invention is according to the characteristics of point medicine, the Chinese medicine that the preparation technique of employing Modern Pharmaceutics will be treated menalgia is developed into the hydrogel external use plaster, drug loading large, Drug Percutaneous Absorption efficient is high, and to skin nonirritant and anaphylaxis, solved traditional transdermal administration dosage form such as black plaster, rubber paste etc. exist drug loading is little, Drug Percutaneous Absorption efficient is low, stronger skin irritation and anaphylaxis, airtight, take off from the time epilation produce pain etc. and make the not acceptant drawback of patient.
The specific embodiment
The present invention is described in detail below in conjunction with the specific embodiment.
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 implement according to following steps:
Step 1: according to percentage by weight, take by weighing 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 that takes by weighing 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, concentrate, obtain drug extract;
Step 2: take by weighing 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 the glycerol behind the sodium polyacrylate that step 2 is taken by weighing, filler, trivalent aluminium ion cross-linking agent, the disodiumedetate mix homogeneously, be not less than in vacuum-the 0.06MPa condition under, stir 3~10 minutes to mix homogeneously, obtain the glycerol phase;
Step 4: organic acid and polyvidone that step 2 is taken by weighing are dissolved in purified water jointly, are stirred to fully dissolving, obtain water;
Step 5: the antiseptic that step 2 is taken by weighing is dissolved in 95% ethanol, obtains the 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 the step 3 successively, be not less than in vacuum-the 0.06MPa condition under, stir 5~20 minutes to mix homogeneously, obtain the medicine carrying mastic;
Step 7: the medicine carrying mastic that step 6 is obtained is transferred on the coating cutting machine, is coated with, cuts by specification, and the semi-finished product after the cutting are placed under humidity 20%~60%, 20 ℃~35 ℃ conditions of temperature, leaves standstill 12~48 hours; Place again under humidity 70%~90%, 15 ℃~30 ℃ conditions of temperature, left standstill 6~24 hours, then carry out quality inspection, packing, namely obtain the Traditional Chinese medicine external patch that the present invention treats menalgia.
Below key point of the present invention place is described from the principle aspect:
The present invention is according to the reason of dysmenorrhes and the physiological characteristics of health, 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 " in conjunction with the pharmacological result of study of Clinical Experience, pathology and modern Chinese medicine, and adopt the preparation capable of permeating skin technology of Modern Pharmaceutics to develop; The characteristics 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 accept, the present invention has also kept the comprehensive function characteristics of Chinese herbal medicine multicomponent, many target spots and many effects, thereby, for the dysmenorrhea treating both the principal and secondary aspects of a disease, has significant therapeutical effect for menalgia.
1. the present invention Folium Artemisiae Argyi, fevervine, Fructus Corni, Ramulus Cinnamomi, Rhizoma Cyperi, Rhizoma Corydalis, Cortex Cinnamomi of adopting, 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 the 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 the 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, the 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, the amenorrhea dysmenorrhea, puerperal the stasis of blood stomachache etc. that stagnates.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 the external use plaster preparation method of the present invention, adopted applicable to all types of drug molecules and the water solublity pharmaceutic adjuvant skin good biocompatibility, guaranteed that drug loading of the present invention is large, the active constituents of medicine Transdermal absorption is effective, long-acting slow-release, non-stimulated, without irritated, comfortable, safe and reliable characteristics easy to use, satisfied the demand of women for dysmenorrhea treatment.
Embodiment 1
Step 1: take by weighing 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, with 2 extracting solution merge, concentrated, obtain drug extract;
Step 2: take by weighing sodium polyacrylate 95g, ceramics 72g, dihydroxyaluminum aminoacetate 8.71g, disodiumedetate 2.62g join in the 1540g glycerol, vacuum is not less than-the 0.06MPa condition under, stirred 5 minutes, obtain the glycerol phase, for subsequent use;
Step 3: get purified water 1400ml, add 9.50g tartaric acid and 215g polyvidone, be stirred to dissolving evenly, obtain water, for subsequent use;
Step 4: the parabens antiseptic of 7.28g is dissolved in 10ml95% ethanol, is stirred to dissolving evenly, obtain the 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 the step 2 successively, be not less than in vacuum-the 0.06MPa condition under, stir 5 minutes to mix homogeneously, obtain the medicine carrying mastic;
Step 6: the medicine carrying mastic that step 5 is obtained is transferred on the coating cutting machine, is coated with, cuts by specification, and the semi-finished product after the cutting are placed under humidity 55%~60%, 28 ℃~30 ℃ conditions of temperature, leaves standstill 24 hours; Place again under humidity 75%~80%, 18 ℃~20 ℃ conditions of temperature, left standstill 12 hours, then carry out quality inspection, packing, namely obtain the Traditional Chinese medicine external patch that the present invention treats menalgia.
Embodiment 2
Step 1: take by weighing 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, with 2 extracting solution merge, concentrated, obtain drug extract;
Step 2: take by weighing sodium polyacrylate 126g, ceramics 80g, dihydroxyaluminum aminoacetate 9.15g, disodiumedetate 2.70g join in the 1590g glycerol, vacuum is not less than-the 0.06MPa condition under, stirred 8 minutes, obtain the glycerol phase, for subsequent use;
Step 3: get purified water 1600ml, add 10.15g tartaric acid and 246g polyvidone, be stirred to dissolving evenly, obtain water, for subsequent use;
Step 4: the parabens antiseptic of 7.68g is dissolved in 12ml95% ethanol, is stirred to dissolving evenly, obtain the 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 the step 2 successively, be not less than in vacuum-the 0.06MPa condition under, stir 10 minutes to mix homogeneously, obtain the medicine carrying mastic;
Step 6: the medicine carrying mastic that step 5 is obtained is transferred on the coating cutting machine, is coated with, cuts by specification, and the semi-finished product after the cutting are placed under humidity 55%~60%, 28 ℃~30 ℃ conditions of temperature, leaves standstill 24 hours; Place again under humidity 75%~80%, 18 ℃~20 ℃ conditions of temperature, left standstill 12 hours, then carry out quality inspection, packing, namely obtain the Traditional Chinese medicine external patch that the present invention treats menalgia.
Embodiment 3
Step 1: take by weighing 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, with 2 extracting solution merge, concentrated, obtain drug extract;
Step 2: take by weighing sodium polyacrylate 142g, ceramics 98g, dihydroxyaluminum aminoacetate 9.75g, disodiumedetate 2.75g join in the 1650g glycerol, vacuum is not less than-the 0.06MPa condition under, stirred 10 minutes, obtain the glycerol phase, for subsequent use;
Step 3: get purified water 1800ml, add 11.00g tartaric acid and 275g polyvidone, be stirred to dissolving evenly, obtain water, for subsequent use;
Step 4: the parabens antiseptic of 7.70g is dissolved in 15ml95% ethanol, is stirred to dissolving evenly, obtain the 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 the step 2 successively, be not less than in vacuum-the 0.06MPa condition under, stir 13 minutes to mix homogeneously, obtain the medicine carrying mastic;
Step 6: the medicine carrying mastic that step 5 is obtained is transferred on the coating cutting machine, is coated with, cuts by specification, and the semi-finished product after the cutting are placed under humidity 55%~60%, 28 ℃~30 ℃ conditions of temperature, leaves standstill 24 hours; Place again under humidity 75%~80%, 18 ℃~20 ℃ conditions of temperature, left standstill 12 hours, then carry out quality inspection, packing, namely obtain the Traditional Chinese medicine external patch that the present invention treats menalgia.
Below further specify the beneficial effect that the present invention produces from the clinical practice result:
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, warm pain relieved by pressing is liked in swollen sense, Hypomenorrhea, the light matter of color is thin, or spiritlessness and weakness, or lustreless complexion, or the anorexia loose stool, pale tongue, thready and weak pulse.Wherein cardinal symptom is indispensable, and 2 above simultaneous phenomenons are arranged, 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 " gas leads to hundred arteries and veins for umbilicus person, interrenal qi, the cloth vital organs of the human body, for life basic " with " Li Yue Pianwen, Rhymed Discourse for Topical Remedies " theory of " medicine is entered by umbilicus, is tantamount to entrance also " is proposed, the selection SHENQUE acupoint is medicine-feeding part.With patient's SHENQUE acupoint position skin clean, note applies patch of the present invention, changes 1 time in per 1 day, and 7 days is a course for the treatment of, totally 2 courses for the treatment of.
" traditional Chinese medical science disease Standardization of diagnosis and curative effect " promulgated 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 keep 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 the patient to reflect that the present invention uses comfortable, reliable for effect, untoward reaction does not occur.

Claims (7)

1. treat the Chinese medicine 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%.
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, implements according to following steps:
Step 1: according to percentage by weight, take by weighing 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 that takes by weighing is mixed, use alcohol reflux, extracting solution is merged, concentrates, obtain drug extract;
Step 2: take by weighing 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 the glycerol behind the sodium polyacrylate that step 2 is taken by weighing, filler, trivalent aluminium ion cross-linking agent, the disodiumedetate mix homogeneously, under vacuum condition, be stirred to mix homogeneously, obtain the glycerol phase;
Step 4: organic acid and polyvidone that step 2 is taken by weighing are dissolved in purified water jointly, are stirred to fully dissolving, obtain water;
Step 5: the antiseptic that step 2 is taken by weighing is dissolved in 95% ethanol, obtains the 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 the step 3 successively, under vacuum condition, is stirred to mix homogeneously, obtains the medicine carrying mastic;
Step 7: the medicine carrying mastic that step 6 is obtained is transferred on the coating cutting machine, is coated with, cuts, and the semi-finished product after the cutting are left standstill, and then carries out quality inspection, packing, namely obtains the Traditional Chinese medicine external patch that the present invention treats menalgia.
3. the preparation method of the Traditional Chinese medicine external patch for the treatment of menalgia as claimed in claim 2 is characterized in that, in the step 1, and with 75%~90% alcohol reflux of 8~12 times of mixture qualities 2 times, each 1~3 hour.
4. the preparation method of the Traditional Chinese medicine external patch for the treatment of menalgia as claimed in claim 2 is characterized in that, in the step 2, filler adopts a kind of, two or more the mixture in ceramics, Kaolin, kaolin, kieselguhr, the silica gel; The trivalent aluminium ion cross-linking agent adopts dihydroxyaluminum aminoacetate or aluminium hydroxide, the perhaps mixture of the two; Organic acid adopts tartaric acid or citric acid, the perhaps mixture of the two; The parabens antiseptic adopts a kind of, two or more the mixture in ethyl hydroxybenzoate, propyl ester, butyl ester or the methyl ester.
5. the preparation method of the Traditional Chinese medicine external patch for the treatment of menalgia as claimed in claim 2 is characterized in that, in the step 3, vacuum condition refers to that vacuum is not less than-0.06MPa; Stirring is 3~10 minutes.
6. the preparation method of the Traditional Chinese medicine external patch for the treatment of menalgia as claimed in claim 2 is characterized in that, in the step 6, vacuum condition refers to that vacuum is not less than-0.06MPa, and stirring is 5~20 minutes.
7. the preparation method of the Traditional Chinese medicine external patch for the treatment of menalgia as claimed in claim 2 is characterized in that, in the step 7, the semi-finished product after the cutting leave standstill as under humidity 20%~60%, 20 ℃~35 ℃ conditions of temperature, leave standstill 12~48 hours; Place again under humidity 70%~90%, 15 ℃~30 ℃ conditions of temperature, left standstill 6~24 hours.
CN201310016133.3A 2013-01-17 2013-01-17 Chinese medicine for treating women dysmenorrhea and preparation method of external patch of Chinese medicine Expired - Fee Related CN103055083B (en)

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CN111658716A (en) * 2020-05-07 2020-09-15 广州贝奥吉因生物科技股份有限公司 Hydrogel magnetic therapy traditional Chinese medicine plaster and preparation method thereof

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