CN101152532B - Traditional Chinese medicine preparations for treating gynecology disease - Google Patents
Traditional Chinese medicine preparations for treating gynecology disease Download PDFInfo
- Publication number
- CN101152532B CN101152532B CN200710030695A CN200710030695A CN101152532B CN 101152532 B CN101152532 B CN 101152532B CN 200710030695 A CN200710030695 A CN 200710030695A CN 200710030695 A CN200710030695 A CN 200710030695A CN 101152532 B CN101152532 B CN 101152532B
- Authority
- CN
- China
- Prior art keywords
- chinese medicine
- radix
- preparation
- medicine preparation
- clear paste
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a traditional Chinese medicine preparation. the weight portion of the raw materials for preparing effective components are: 2.0 to 2.4 portion of Chinese thorowax root, 4.2 to4.6 portion of white peony alba, 4.3 to 4.5 portion of glehnia root, 3.0 to 3.5 portion of nutgrass galingale rhizome (prepared with vinegar), 3.0 to 3.5 portion of turmeric root tuber, 4.2 to 4.6 portion of medlar, 4.2 to 4.6 portion of spine date seed, 4.2 to 4.6 portion of dragon bone, 4.2 to 4.6 portion of oyster, 3.0 to 3.5 portion of orange fruit, 1.5 to 1.8 portion of fingered citron and 1.5 to 1.8 portion of common aucklandia root. The invention also discloses a method of preparing the traditional Chinese medicine preparation and application of the method in preparing the medicine forcuring premenstrual tension syndrome. The traditional Chinese medicine preparation has definite curative effect without obvious toxicity and side effect.
Description
Technical field
The invention belongs to Chinese medicine preparation, relate to a kind of Chinese medicine preparation for the treatment of gynecological's premenstrual tension syndrome disease specifically.
Background technology
Premenstrual tension syndrome (PMS) is meant a series of neural mental symptom that the women was occurred in 7～14 days and one group of comprehensive syndrome of water liquid metabolism disorder before menstrual onset, often show as in clinical through preceding be in a very depressed state, irritated irritability, insomnia and dreamful sleep, distending pain of the breast, malaise, abdominal distention edema etc., belong to traditional Chinese medical science symptoms around menstruation category, be mainly in the child-bearing period women between 20～40 years old.Because this disease follows menstruation whenever to be outbreak periodically repeatedly, and the course of disease is longer, therefore not only seriously influence patient's physical and mental health, work, study and the daily life to the patient all produced many unfavorable factors simultaneously, and can cause menoxenia, other gynecological diseases such as infertile.This sick sickness rate is about 30%～90%, and wherein 8% serious symptom person needs treatment.The retrieval of Internet web material is same to show that it is 79.18% that this disease shows prevalence abroad, domestic patient's sickness rate about 89%.High speed development along with modern society, work, rhythm of life are obviously accelerated, this sick sickness rate is the trend that continue to rise, thereby becomes multiple disease very common in the gynecological clinic, the research of relevant this disease and treat the extensive attention that also more and more is subjected to people.
In recent years, the research of relevant premenstrual tension syndrome is more, find in the premenstrual tension syndrome patients ' psychological is inquired into as people such as Xu Songquan, the cognitive unconventional and escape mode of this type of patient more employing when handling stressor, and the solution of use problem is dealt with less, Gu in treatment, should carry out necessary psychological intervention and build instrument, improve stress ability.People such as Qiao Mingqi explore macaque simulation premenstrual tension syndrome reversed syndrome of mepatic qi pathological changes, to seeking the mixing together point of Chinese and western medical science in the rationale aspect, all have crucial meaning.The clinical research aspect, except conventional Comprehensive Treatment, external report has thinks that replenishing calcium preparation is a kind of simple but effective method for the treatment of premenstrual tension syndrome, can obviously improve pmgravid various symptom.Also there is report to think, has efficiently alleviating the premenstruum mazalgia with danazol in luteal phase, and almost be free from side effects [6].
The traditional Chinese medical science is more to the clinical research report of premenstrual tension syndrome, fragrant Yun Shi is guidance with internal organs QI and blood theory as beam, adopt bupleurum powder for relieving liver-qi, strong solid soup, ZHIBAIDIHUANG Tonga to subtract treatment primary disease 60 examples respectively, cure 37 examples and account for 62%, clinical total effective rate 93%.Gao Zhange is with from intending dispersing the stagnated live-QI to relieve the stagnation of QI soup treatment primary disease 60 examples, and cure rate is up to 83.33%, total effective rate 96.37%.Chen Xiaoling reduces qi depression to blood stasis with primary disease, ties through foremilk; Nourishing kidney-yin is through preceding edema; Hyperactivity of YANG due to deficiency of YIN, premenstrual headache.Adopt depressed liver-energy dispersing and QI regulating respectively, blood circulation promoting and blood stasis dispelling; Warming and recuperating the spleen and kidney, promote the circulation of qi and water; Liver and kidney tonifying, primary disease is treated in ruling by law such as suppressing the hyperactive liver and subsiding YANG, has all obtained gratifying curative effect.Shen Weiping sums up its clinical gains in depth of comprehension and thinks, primary disease belong to more conscience heat very, insufficiency of the spleen wet the moon, expectorant excess syndrome of covering the mental derangement due to the clear key, control with eliminating pathogen in the liver and clear away heart-fire, the spleen invigorating eliminating phlegm, cleansing gastrointestinal is method, thinks that to anovulatory menstruation with nourishing the liver and kidney, nourishing blood and replenishing essence is main; Ovulation is arranged and the unstrong person of luteal function, the emphasis tonifying speen and tonifying kidney, and must serve on 3 menstrual cycle in began to take medicine through preceding 14 days at every turn.In addition, people such as Zhang Lin take acupuncture Chinese medicine and use the treatment premenstrual tension syndrome, the utmost point, cv, tsu san li, sp 6 in the acupoint selection, and the side shows that by clinical 50 example observations cure 39 examples and reach 78%, clinical total effective rate reaches 96% with the XIAOYAO POWDER plus-minus.Human Chinese medicine Semen Vaccariae treated with auricular-plaster therapy primary disease 56 examples such as Ma Zhiqin are cured 39 examples and are accounted for 69.6%, clinical total effective rate 91%.People such as Wang Min start with from the dietary therapy of Chinese medicine especially, by augmenting and strengthening desired nutritional to eliminate premenstrual tension syndrome.They think, the diet nutritional dysequilibrium can increase the weight of the generation and the development of primary disease, thereby adopt treat primary disease " Sang Lihong treasured holiday " (forming) of being rich in nutrients such as ferrum, vitamin, protein of development voluntarily by blood powder, soy milk powder, Semen Sesami Nigrum powder, Fructus Mori, Fructus Litchi essence, Flos Chrysanthemi, Flos Carthami etc., obtained the obvious treatment effect.More than attempt, expanded the research field of non-drug therapy premenstrual tension syndrome undoubtedly.
The way of Comprehensive Treatment is adopted in the treatment of relevant premenstrual tension syndrome, doctor trained in Western medicine at present mostly, as psychology or spiritual healing, correction water-sodium retention, hormone therapy, tranquilizer and psychosis, analeptic symptomatic treatment etc.As for a certain this sick Western medicine of specific treatment, still do not have to making.The traditional Chinese medical science mainly is based on clinical dialectical opinion to the treatment of this disease and is controlled, and the clinician is according to the conditions of patients side of executing, based on the Chinese medicine decoction treatment often.Relevant this sick Chinese patent medicine of treatment select the Chinese medicine ease pill mostly for use in clinical, but effect is not satisfactory.As for new Chinese medicine, the JINGQIANPING KELI of Jiangsu Yangzijiang Pharmaceutical Group's development is only arranged at present, and the minority new Chinese medicine kind in development process still, can not satisfy the demand of clinical application far away.
Summary of the invention
The technical issues that need to address of the present invention provide a kind of Chinese medicine preparation for the treatment of premenstrual tension syndrome, this Chinese medicine preparation determined curative effect and do not have obvious toxic-side effects.
The technical scheme that solves the problems of the technologies described above is:
A kind of Chinese medicine preparation, make the raw materials of effective components weight portion and consist of:
Radix Bupleuri 2.0-2.4 part Radix Paeoniae Alba 4.2-4.6 part Radix Glehniae 4.3-4.5 part
Rhizoma Cyperi (processed with vinegar) 3.0-3.5 part Radix Curcumae 3.0-3.5 part Fructus Lycii 4.2-4.6 part
Semen Ziziphi Spinosae 4.2-4.6 part Os Draconis 4.2-4.6 part Concha Ostreae 4.2-4.6 part
Fructus Aurantii (parched) 3.0-3.5 part Fructus Citri Sarcodactylis 1.5-1.8 part Radix Aucklandiae 1.5-1.8 part.
Preferably, the raw materials of effective components weight portion of making of described Chinese medicine preparation consists of:
4.4 parts of 4.4 portions of Radix Glehniaes of 2.2 portions of Radix Paeoniae Albas of Radix Bupleuri
4.4 parts of 3.3 parts of Fructus Lycii of 3.3 portions of Radix Curcumaes of Rhizoma Cyperi (vinegar system)
4.4 parts of 4.4 portions of Concha Ostreaes of 4.4 parts of Os Draconis of Semen Ziziphi Spinosae
1.65 parts of 1.65 parts of Radix Aucklandiae of 3.3 portions of Fructus Citri Sarcodactylis of Fructus Aurantii (parched).
But described Chinese medicine preparation oral liquid, mixture, syrup, unguentum, tablet, powder, pill, capsule or granule.
Another object of the present invention provides the preparation method of stating Chinese medicine preparation.
A kind of method for preparing above-mentioned Chinese medicine preparation mainly may further comprise the steps:
(1) get Os Draconis, Concha Ostreae mixing, standby after decocting with water, concentrating;
(2) get Radix Bupleuri, Rhizoma Cyperi, Radix Curcumae, Radix Aucklandiae distillating extracting oil, adopt β-CD saturated water solution method, make β-CD (beta-schardinger dextrin-) clathrate, leave standstill, filter, the filtering residue low-temperature vacuum drying, standby, the aqueous solution after distillation device is in addition collected;
(3) with step (2) Chinese medicine slag and the Radix Paeoniae Alba, Radix Glehniae, Fructus Lycii, Semen Ziziphi Spinosae, Fructus Citri Sarcodactylis, Fructus Aurantii (parched) merges, decoct with water, filter, the aqueous solution in filtrate and the step (2) after the distillation merges, and being concentrated into relative density is the clear paste of 1.10～1.12 (70～75 ℃), adding ethanol makes and contains alcohol amount and reach 60%, stir evenly, leave standstill, filter; Filtrate recycling ethanol adds the concentrated solution in the step (1) then, mixing, and continuing to be concentrated into relative density is 1.00～1.10 (70～75 ℃), promptly gets described Chinese medicine preparation clear paste.
Then, add an amount of dextrin in step (3) gained Chinese medicine preparation clear paste, spray drying adds an amount of dextrin, stevioside and beta-CD inclusion again, and mixing, granulation, cold drying promptly get granule;
With step (3) gained Chinese medicine preparation clear paste spray drying, granulate, incapsulate, get capsule;
With step (3) gained Chinese medicine preparation clear paste spray drying, add appropriate amount of auxiliary materials, repressed, promptly can be made into tablet;
After dilution, fill can become oral liquid, syrup, mixture, unguentum etc. with the Chinese medicine preparation clear paste of step (3) gained.
Another object of the present invention provides the application of above-mentioned Chinese medicine preparation.
The application of above-mentioned Chinese medicine preparation in the medicine of preparation treatment premenstrual tension syndrome.
Chinese medicine preparation of the present invention is monarch with Radix Bupleuri, get the using of its dispersing the stagnated live-QI to relieve the stagnation of QI just as " book on Chinese herbal medicine through separating " institute day: " Radix Bupleuri; stagnation of QI person in its main trusted subordinate's gastrointestinal, all ten once all depending on gallbladder, Radix Bupleuri is gently clear; rise and reach courage; the courage bar reaches, then 11 hide from Xuanhua, so in trusted subordinate's the intestines and stomach; all have a stagnation of QI, all can loose also ".Radix Paeoniae Alba yin nourishing easing the affected liver, relieving spasm to stop pain, " the southern regions of the Yunnan Province book on Chinese herbal medicine " are referred to as " receive the adverse flow of liver-QI disease, take good care of conscience spleen channel blood, the soothing liver-QI sending down the abnormal ascending QI ends irritability pain "; Radix Adenophorae (Radix Glehniae) clearing lung and nourishing yin, reinforcing stomach reg fluid, " excessive thirst is coughed for all deficiency of YIN fire inflammation, seemingly empty seemingly heat; do not fall against gas, clear QI failing to ascend, and distension is not eaten " " the secondary first case of woods " of leading, with the Radix Paeoniae Alba 5 energy that more increase nourishing YIN to relieve dryness mutually, with property, so the minister in the side of being along the liver preferring moisture to dryness.The Fructus Lycii liver and kidney tonifying, the Semen Ziziphi Spinosae tranquilizing by nourishing the heart, two medicines are harmonious, and help Radix Paeoniae Alba altogether, Radix Adenophorae (Radix Glehniae) replenishing the kidney(water)to nourish the liver(wood), slow liver is anxious.The sweet puckery liver that goes into of Os Draconis has the convergence anti-avulsion, tranquillizing the mind by relieving convulsion wonderful; The Concha Ostreae suppressing the hyperactive liver and subsiding YANG, salty is the profit of softening the hard mass, two medicine important city sending down the abnormal ascending QI, contrary with suppressing the hyperactive liver gas, the also assistant in the side of being.Fructus Aurantii Immaturus dispelling the stagnated QI removing food stagnancy, Fructus Citri Sarcodactylis regulate the flow of vital energy and in, Radix Aucklandiae promoting the circulation of QI to relieve pain, three medicines are normal to be used with medicine compatibilities such as Radix Bupleuri, Rhizoma Cyperi, Radix Curcumaes, is depressed liver-energy dispersing and QI regulating pain relieving medicine commonly used, really makes it usefulness for Fang Zhongzuo.Full side is mutual 5, dispersing the stagnated live-QI to relieve the stagnation of QI, regulate the flow of vital energy and in, thereby reach the purpose for the treatment of above-mentioned disease.
Chinese medicine preparation of the present invention is with single herbal species treatment premenstrual tension syndrome, is different from the means that doctor trained in Western medicine adopts Comprehensive Treatment, and its method innovation is convenient to clinical expansion simultaneously and is used.
Chinese medicine preparation of the present invention adopts water extract-alcohol precipitation, spray-dired preparation technology, and method is simple, is fit to the requirement of industrialized great production.The product quality control method of being formulated, good stability, repeatability is strong, can control the product quality of this product preferably.And show described Chinese medicine preparation determined curative effect according to pharmacological testing; Toxicological test shows, takes no obvious toxic-side effects in prescribed dose for a long time.
Pharmacodynamic study:
Chinese medicine preparation of the present invention can make diethylstilbestrol cause that the cardiac index,contrast index,cornification index of the average vagina epithelium exfoliative cyte that the horizontal model of female rats high estrogen raises reduces serum E
2, P, PRL level descend, reductions such as uterus ovary index make uterus, ovary, mammary gland, relevant internal organs pathology variation such as large intestine has certain improvement.In addition, certain analgesic activity is arranged, the writhing response that reduction ip glacial acetic acid, oxytocin cause improves the threshold of pain percentage rate of hot plate analgesic test; Certain sedation is arranged, can reduce the autonomic activities number of mice, increase the sleeping percentage rate of pentobarbital sodium sub-threshold dose mice; To rabbit normally the contraction movement in the body uterus obvious suppression effect is arranged, and can antagonism the excitement of oxytocin causing uterine contraction activity, contraction frequency, amplitude and vigor are all reduced.
Toxicologic study:
1, acute toxicity test Chinese medicine preparation mice of the present invention repeatedly to irritate the maximum dosage-feeding of stomach on the 1st be 480 gram crude drug/kg, by adult 60kg, the heavy 76g of daily crude drug calculates, and is 380 times of clinical application; The maximum dosage-feeding that stagnation of liver-QI relaxation grain rat was repeatedly irritated stomach on the 1st is 240g crude drug/kg, is 190 times of clinical application.
2, long term toxicity test Chinese medicine preparation 68g of the present invention crude drug/1kgd
-1, 34g crude drug/kgd
-1With 17g crude drug/kgd
-1(54 times, 27 times and 13.5 times of suitable people's consumption respectively), 24 weeks of logotype, the animal appearance sign, crawler behavior is ingested, no abnormality seens such as feces; Every index such as hematology and hepatic and renal function and blood glucose, blood fat all fluctuate in normal range; Organ coefficient administration group and normal group are relatively.Do not see significant difference.Pathology report proof, this product does not cause that to the infringement of rat substantial viscera (heart, liver, kidney, brain) avirulence endocrine (thyroid, adrenal gland, pancreas), immunity (thymus), digestion (stomach, intestinal), reproduction (ovary, uterus, testis, epididymis, prostate) wait other organ lesions yet.
The specific embodiment
Embodiment 1
The raw materials of effective components weight portion of making of the Chinese medicine preparation of present embodiment consists of
Radix Bupleuri 220g Radix Paeoniae Alba 440g Radix Glehniae 440g
Rhizoma Cyperi (vinegar system) 330g Radix Curcumae 330g Fructus Lycii 440g
Semen Ziziphi Spinosae 440g Os Draconis 440g Concha Ostreae 440g
Fructus Aurantii (parched) 330g Fructus Citri Sarcodactylis 165g Radix Aucklandiae 1.65g.
The preparation method of the Chinese medicine preparation of present embodiment is as follows:
(1) get Os Draconis, Concha Ostreae mixing, it is standby to get concentrated solution after decocting with water, concentrating;
(2) get Radix Bupleuri, Rhizoma Cyperi, Radix Curcumae, Radix Aucklandiae distillating extracting oil, adopt β-CD saturated water solution method, make β-CD (beta-schardinger dextrin-) clathrate, leave standstill, filter, the filtering residue low-temperature vacuum drying, standby, the aqueous solution after distillation device is in addition collected;
(3) with step (2) Chinese medicine slag and the Radix Paeoniae Alba, Radix Glehniae, Fructus Lycii, Semen Ziziphi Spinosae, Fructus Citri Sarcodactylis, Fructus Aurantii (parched) merges, decoct with water, filter, the aqueous solution in filtrate and the step (2) after the distillation merges, and being concentrated into relative density is the clear paste of 1.10～1.12 (70～75 ℃), adding ethanol makes and contains alcohol amount and reach 60%, stir evenly, leave standstill, filter; Filtrate recycling ethanol adds standby concentrated solution then, and mixing continues to be concentrated into the clear paste that relative density is 1.05 (70～75 ℃), adds an amount of dextrin, spray drying.Add an amount of dextrin, stevioside and β-CD (beta-schardinger dextrin-) clathrate again, the 1000g granule is made in mixing, granulation, cold drying altogether.
Quality standard: this standard adopts that thin layer chromatography is qualitative to detect Radix Bupleuri in this product (control medicinal material), the Radix Paeoniae Alba (peoniflorin), Fructus Lycii (control medicinal material), Fructus Aurantii (naringin), Fructus Citri Sarcodactylis (control medicinal material); Adopt the every 1g of quantitative determination of high-performance liquid this product to contain the Radix Paeoniae Alba with peoniflorin (C
23H
28O
11) meter, must not be less than 2.5mg.Above detection method is reliable, favorable reproducibility.
Stability test this product stability test shows, this product stable in properties, the equal conformance with standard requirement of every index.
Embodiment 2
The raw materials of effective components weight portion of making of the Chinese medicine preparation of present embodiment consists of
Radix Bupleuri 210g Radix Paeoniae Alba 420g Radix Glehniae 430g
Rhizoma Cyperi (vinegar system) 300g Radix Curcumae 300g Fructus Lycii 430g
Semen Ziziphi Spinosae 420g Os Draconis 420g Concha Ostreae 420g
Fructus Aurantii (parched) 300g Fructus Citri Sarcodactylis 160g Radix Aucklandiae 160g.
Preparation method and quality standard detecting method and embodiment 1 are basic identical, and different is, after being concentrated into the clear paste that relative density is 1.05 (70～75 ℃), spray drying is granulated, incapsulate, capsule,
Embodiment 3
The raw materials of effective components weight portion of making of the Chinese medicine preparation of present embodiment consists of:
Radix Bupleuri 240g Radix Paeoniae Alba 455g Radix Glehniae 450g
Rhizoma Cyperi (vinegar system) 350g Radix Curcumae 350g Fructus Lycii 455g
Semen Ziziphi Spinosae 460g Os Draconis 460g Concha Ostreae 460g
Fructus Aurantii (parched) 340g Fructus Citri Sarcodactylis 170g Radix Aucklandiae 180g.
Preparation method and quality standard detecting method and embodiment 1 are basic identical, and different is that after being concentrated into the clear paste that relative density is 1.05 (70～75 ℃), with the clear paste dilution, fill can become oral liquid.
Embodiment 4
Treat premenstrual tension syndrome with the resulting Chinese medicine preparation of embodiment 1-3:
One, physical data
The clinical observation case history amounts to 80 examples, wherein treatment group, each 40 example of matched group, and the age is 18～40 years old premenstrual tension syndrome patient and meets traditional Chinese medical science syndrome of stagnation of liver qi typing standard.Patient's age, the course of disease and severe extent basically identical between group, no significant difference has comparability.
Two, Therapeutic Method
Adopt the randomized, double-blind parallel control, treatment group stagnation of liver-QI relaxation grain, oral, 3 times on the 1st, 1 time 6 gram, 2 weeks were 1 course of treatment, observed 3 menstrual cycle continuously; Matched group XIAOYAO POWDER granule, oral, 3 times on the 1st, 1 time 6 gram, 2 weeks were 1 course of treatment, observed 3 menstrual cycle continuously.All the patient stops using the medicine relevant with treating primary disease and other Therapeutic Method during treating.
Three, diagnostic criteria
1, Western medicine diagnose
(1) menstrual onset is preceding 7-14 days, and psychentonia, melancholy, agitation, insomnia, dreaminess, distending pain of the breast, dizziness, headache etc. follow menstrual cycle to occur, and promptly disappear after passing through.
(2) examination of basal body temperature can have shorten luteal phase, and ovulation back body temperature rise is slow or irregular.
(3) endocrine is measured, and estrogen can be arranged, and progestogen ratio raises, and the body inner estrogen too much or too much relatively.
2, differential diagnosis in tcm
Syndrome of stagnation of liver qi
Distention and pain of breast before menstruation, mastalgia, fullness and distention in the chest and hypochondrium or distending pain, dizziness headache, irritated irritability, dry mouth with bitter taste, insomnia and dreamful sleep, the few tongue of red tongue, stringy and rolling pulse.
3, clinical symptoms standards of grading
Do to expand 2 fens through fore udder
Through fore udder distending pain 4 minutes
Distending pain of the breast, can not touch clothing 6 minutes
Little have 2 minutes uncomfortable in chest
Side of body rib distension 4 minutes
Distending pain over the hypochondrium 6 minutes
In a disturbed state of mind 2 minutes
Psychentonia or melancholy 4 minutes
Irritated irritability 6 minutes
The dreaminess 2 minutes of sleeping night
Had difficulty in going to sleep 4 fens
Lay awake all night 6 fens
4, state of an illness weight grade scale
Slightly: tcm syndrome integration≤8 minute
Moderate: tcm syndrome integration 9-16 branch
Severe: tcm syndrome integration 〉=17 minute
Four, test case standard
1, includes the case standard in
All primary disease diagnostic criteria and differential diagnosis in tcm standards of meeting, the age through signature informed consent postscript, all can be included test standard in the patient between 18-40 year.Wherein, the above patient of moderate is no less than 2/3.
2, get rid of the case standard
(1) age belongs to the women of adolescence or climacteric menstruation dysfunction at under-18s or more than 40 years old, allergic constitution or to this medicine allergy sufferers.
(2) fail to get rid of patients such as above hypertension of II phase, visual disorder, vestibular dysfunction (Meniere's is levied), mammary neoplasms, chronic colitis or intestinal canal tumour.
(3) be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychotic.
(4) do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safety judgement person.
3, end test standard
(1) in the process of the test, the patient of other serious concurrent diseases appears.
(2) in the process of the test, serious adverse reaction takes place, judge the patient that should stop to test according to the doctor.
(3) non-curative effect is former thereby fail to adhere to treatment initiatively to propose the patient who withdraws from test.
4, the case standard of rejecting and coming off
(1) experimenter fails to finish test for some reason and drops by the wayside the patient of test, merges the medicine person who uses this test determination mustn't merge use, is the case that comes off.
(2) do not meet that this clinical research scheme is included standard in and the patient that by mistake included in, should be as rejecting case.
4, curative effect determinate standard
(1) clinical recovery: clinical symptom disappearance, clinical integration returned to 0 fen, and examination of basal body temperature or endocrine are measured normal substantially, and treatment finishes back 3 menstrual cycle of observation does not have recurrence.
2, produce effects: cardinal symptom is clearly better, clinical integration reduce to before the treatment below 1/2, basal body temperature or endocrine are measured near normal, treatment finishes the back and observes 3 menstrual cycle and do not increase the weight of.
3, effective: cardinal symptom is controlled, and degree is turn reducing to some extent, and clinical integration is reduced to the 1/2-3/4 before the treatment, though treatment finishes the rear section symptom repeatedly, has before the treatment to alleviate.
4, invalid: clinical symptoms does not have improvement or increases the weight of.
Five, therapeutic outcome
Clinical observation result shows that 40 examples are organized in treatment, and 25 examples of fully recovering account for 62.5%, and produce effects 7 examples account for 17.5%, and effective 5 examples account for 125.%, and invalid 3 examples account for 7.5%, cure-remarkable-effectiveness rate 80%, total effective rate 925%; Matched group 40 examples, 17 examples of fully recovering account for 42.5%, and produce effects 11 accounts for 27.5%, and effective 4 examples account for 10%, cure-remarkable-effectiveness rate 70%, total effective rate 80%.Two groups relatively, and treatment group curative effect is apparently higher than matched group.In the clinical observation process, two groups of patients all do not find any untoward reaction.
Claims (8)
1. Chinese medicine preparation for the treatment of premenstrual tension syndrome is characterized in that: make the raw materials of effective components weight portion and consist of:
Radix Bupleuri 2.0-2.4 part Radix Paeoniae Alba 4.2-4.6 part Radix Glehniae 4.3-4.5 part
Rhizoma Cyperi (processed with vinegar) 3.0-3.5 part Radix Curcumae 3.0-3.5 part Fructus Lycii 4.2-4.6 part
Semen Ziziphi Spinosae 4.2-4.6 part Os Draconis 4.2-4.6 part Concha Ostreae 4.2-4.6 part
Fructus Aurantii (parched) 3.0-3.5 part Fructus Citri Sarcodactylis 1.5-1.8 part Radix Aucklandiae 1.5-1.8 part.
2. the Chinese medicine preparation of treatment premenstrual tension syndrome according to claim 1 is characterized in that: make the raw materials of effective components weight portion and consist of:
4.4 parts of 4.4 portions of Radix Glehniaes of 2.2 portions of Radix Paeoniae Albas of Radix Bupleuri
4.4 parts of 3.3 parts of Fructus Lycii of 3.3 portions of Radix Curcumaes of Rhizoma Cyperi (processed with vinegar)
4.4 parts of 4.4 portions of Concha Ostreaes of 4.4 parts of Os Draconis of Semen Ziziphi Spinosae
1.65 parts of 1.65 parts of Radix Aucklandiae of 3.3 portions of Fructus Citri Sarcodactylis of Fructus Aurantii (parched).
3. the Chinese medicine preparation of treatment premenstrual tension syndrome according to claim 1 and 2 is characterized in that, this Chinese medicine preparation is oral liquid, mixture, syrup, unguentum, tablet, powder, pill, capsule or granule.
4. method for preparing the Chinese medicine preparation for the treatment of premenstrual tension syndrome according to claim 1 mainly may further comprise the steps:
(1) get Os Draconis, Concha Ostreae mixing, it is standby to get concentrated solution after decocting with water, concentrating;
(2) get Radix Bupleuri, Rhizoma Cyperi, Radix Curcumae, Radix Aucklandiae distillating extracting oil, adopt the beta-schardinger dextrin-saturated water solution method, make Benexate Hydrochloride, leave standstill, filter, the filtering residue low-temperature vacuum drying, standby, collect the aqueous solution after distilling;
(3) with step (2) Chinese medicine slag and the Radix Paeoniae Alba, Radix Glehniae, Fructus Lycii, Semen Ziziphi Spinosae, Fructus Citri Sarcodactylis, Fructus Aurantii (parched) merges, decoct with water, filter, the aqueous solution in filtrate and the step (2) after the distillation merges, and the relative density when being concentrated into 70～75 ℃ is 1.10～1.12 clear paste, adding ethanol makes and contains alcohol amount and reach 60%, stir evenly, leave standstill, filter; With filtrate recycling ethanol, add the concentrated solution in the step (1) then, mixing, the relative density when continuing to be concentrated into 70～75 ℃ is 1.00～1.10, gets described Chinese medicine preparation clear paste, again clear paste is made preparation.
5. preparation method according to claim 4, it is characterized in that, in the step (3) clear paste being made preparation is: add an amount of dextrin in gained Chinese medicine preparation clear paste, spray drying, add an amount of dextrin, stevioside and Benexate Hydrochloride again, mixing, granulation, cold drying promptly get granule.
6. preparation method according to claim 4 is characterized in that, with described in the step (3) clear paste being made preparation is: gained Chinese medicine preparation clear paste spray drying, granulate, and incapsulate, get capsule.
7. preparation method according to claim 4 is characterized in that, described in the step (3) clear paste is made preparation to be: with gained Chinese medicine preparation clear paste spray drying, add appropriate amount of auxiliary materials, and repressed, make tablet.
8. preparation method according to claim 4 is characterized in that, described in the step (3) clear paste is made preparation to be: after dilution, fill can become oral liquid, syrup, mixture or unguentum with the Chinese medicine preparation clear paste of gained.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200710030695A CN101152532B (en) | 2007-09-30 | 2007-09-30 | Traditional Chinese medicine preparations for treating gynecology disease |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200710030695A CN101152532B (en) | 2007-09-30 | 2007-09-30 | Traditional Chinese medicine preparations for treating gynecology disease |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101152532A CN101152532A (en) | 2008-04-02 |
| CN101152532B true CN101152532B (en) | 2010-05-19 |
Family
ID=39254552
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200710030695A Expired - Fee Related CN101152532B (en) | 2007-09-30 | 2007-09-30 | Traditional Chinese medicine preparations for treating gynecology disease |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101152532B (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20220054570A1 (en) * | 2018-12-11 | 2022-02-24 | Genencell Inc. | Composition comprising elecampane extract for alleviating premenstrual syndrome symptom |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102225188A (en) * | 2011-06-27 | 2011-10-26 | 广州市荔湾区中医医院 | Medicament for treating infertility by using liver-soothing and depression-relieving method and preparation method thereof |
| CN113925946A (en) * | 2021-11-25 | 2022-01-14 | 回音必集团浙江齐齐制药有限公司 | Traditional Chinese medicine for soothing liver and relieving depression and preparation method thereof |
-
2007
- 2007-09-30 CN CN200710030695A patent/CN101152532B/en not_active Expired - Fee Related
Non-Patent Citations (6)
| Title |
|---|
| 张继美.中西医结合治疗经前期紧张综合征84 例疗效观察.山东医药43 7.2003,43(7),26. |
| 张继美.中西医结合治疗经前期紧张综合征84 例疗效观察.山东医药43 7.2003,43(7),26. * |
| 赵国祥.经前期紧张症的辩证分型治疗.中医函授通讯1996年 5.1996,1996年(5),40. |
| 赵国祥.经前期紧张症的辩证分型治疗.中医函授通讯1996年 5.1996,1996年(5),40. * |
| 邸若虹.中医药治疗经前期综合征的研究进展.上海中医药杂志2001年 6.2001,2001年(6),46-48. |
| 邸若虹.中医药治疗经前期综合征的研究进展.上海中医药杂志2001年 6.2001,2001年(6),46-48. * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20220054570A1 (en) * | 2018-12-11 | 2022-02-24 | Genencell Inc. | Composition comprising elecampane extract for alleviating premenstrual syndrome symptom |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101152532A (en) | 2008-04-02 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103638451B (en) | A kind of Chinese medicine for the treatment of chronic hepatitis and preparation method thereof | |
| CN101152532B (en) | Traditional Chinese medicine preparations for treating gynecology disease | |
| CN106266999A (en) | A kind of Chinese medicine composition treating irritability and palpitation and insomnia and preparation method thereof | |
| CN103920058A (en) | Traditional Chinese medicine preparation for treating headache and preparation method thereof | |
| CN101194982B (en) | Antidepressive Chinese medicine composition and method of preparing the same | |
| CN103285212A (en) | Traditional Chinese medicine preparation for treating pediatric epilepsy and preparation method thereof | |
| CN105194355A (en) | Traditional Chinese medicine preparation for treating primary hypertension | |
| CN104800553A (en) | Traditional Chinese medicine composition for treating climacteric insomnia and preparation method of traditional Chinese medicine composition | |
| CN104906394A (en) | Traditional Chinese medicine for treating liver and kidney yin deficiency and qi and blood deficiency type hypertension | |
| CN104491316B (en) | A kind of Chinese medicine preparation for the treatment of deficiency of QI in middle-JIAO type hyperplasia of prostate | |
| CN102274472A (en) | Traditional Chinese medicine patch for treating female dysmenorrhoea and preparation thereof | |
| CN102824594B (en) | Traditional Chinese medicine for treating vital myocarditis | |
| CN101862376B (en) | Medicament for treating oviduct obstructive infertility and preparation method thereof | |
| CN104491556B (en) | A kind of Chinese medicine composition for the treatment of caused by hepatic stagnation qi stagnation prostatic hyperplasia | |
| CN104740148A (en) | Traditional Chinese medicine composition for treating post-stroke depression and preparation method of composition | |
| CN104306708A (en) | Medicine for treating spleen deficiency type menstrual period irregularity and application thereof | |
| CN102961680B (en) | Traditional Chinese medicine preparation for treating gallstone and cholecystitis and preparation method thereof | |
| CN104887949B (en) | A kind of Chinese medicine preparation for the treatment of DCM (dilated cardiomyopathy) and preparation method thereof | |
| CN104524423A (en) | Traditional Chinese medicine for treating depression after myocardial infarction due to liver stangation and spleen deficiency as well as preparation method thereof | |
| CN102961676B (en) | Traditional Chinese medicine preparation for treating gallstone and cholecystitis and preparation method thereof | |
| CN104436064A (en) | Pharmaceutical composition for treating dysmenorrhea | |
| CN103768536B (en) | A kind of Chinese medicine for the treatment of dysmenorrhea and preparation method thereof | |
| CN103301354B (en) | Preparation method of powder for treating infantile vaginitis | |
| CN102961677B (en) | Traditional Chinese medicine preparation for treating gallstone and cholecystitis and preparation method thereof | |
| CN102961678B (en) | Traditional Chinese medicine preparation for treating gallstone and cholecystitis and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20100519 Termination date: 20150930 |
|
| EXPY | Termination of patent right or utility model |