CN101002926A - Traditional Chinese medicine for treating menorrhalgia - Google Patents
Traditional Chinese medicine for treating menorrhalgia Download PDFInfo
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Abstract
A Chinese medicine for treating menalgia is prepared from 12 Chinese-medicinal materials including Chinese angelica root, white peony root, Chuan-xiong rhizome, Cyprus tuber, etc.
Description
(1) technical field under
The present invention relates to a kind of Chinese medicine, particularly a kind of Chinese medicine preparation for the treatment of dysmenorrhea.
(2) background technology
Dysmenorrhea is common gynecological disease and frequently-occurring disease, show as gynecologic menstrual or pass through front and back, hypogastric region distending pain, dull pain, bob pain, angor, cold type of pain, twinge periodically take place, often with General Symptoms: agitation uncomfortable in chest, nausea and vomiting, stomachache diarrhoea, pale complexion, extremity are ice-cold, have a strong impact on working and learning.Clinically basically with Western medicine analgesic or hormone medicine treatment, long-term efficacy is poor, easy to be recurred, and side effect is big at present.In the medicine of this type of disease of treatment, effectively Chinese medicine is less, can't satisfy the demand far away.
(3) summary of the invention
The present invention provides the Chinese medicine preparation of a kind of side effect treatment dysmenorrhea little, evident in efficacy in order to remedy the deficiencies in the prior art.
The present invention is achieved through the following technical solutions:
A kind of Chinese medicine preparation for the treatment of dysmenorrhea, its special character is: mainly be to be made by the raw material of following parts by weight:
Radix Angelicae Sinensis 6-15g, Radix Paeoniae Alba 6-15g, Radix Bupleuri 3-12g, Rhizoma Chuanxiong 6-15g, Radix Curcumae 6-15g, Rhizoma Cyperi 6-15g, Rhizoma Corydalis (vinegar system) 6-15g, Radix Ginseng 3-10g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 6-15g.
The Chinese medicine preparation of treatment dysmenorrhea of the present invention, other contains the raw material of following parts by weight:
Semen Cuscutae 6-15g, Fructus Foeniculi 3-12 g, Radix Glycyrrhizae 3-9g.
But described Chinese medicine preparation is the dosage form of water decoction, granule, capsule, tablet or other pharmacy.
Function cures mainly: nourishing the liver and blood, depressed liver-energy dispersing and QI regulating, menstruction regulating and pain relieving.Cure mainly the stagnation of QI due to depression of the liver syndrome of blood stasis person of dysmenorrhea, card is seen through hypogastralgia in preceding or menstrual period, blockage of menstruation, few through blood volume, purple dim, piece arranged, menstrual period or before or after, through preceding or menstrual period the breast side of body and distending pain of the breast, irascible temperament or depression, body of the tongue is purple dim or petechia, ecchymosis, stringy pulse etc. are arranged.
In the raw material of the present invention: the Radix Angelicae Sinensis suffering is sweet, warm in nature, goes into Liver Channel, and main nourishing the liver is invigorated blood circulation with regulating menstruation, is monarch drug." book on Chinese herbal medicine is just " cloud: " so specially can enrich blood, its gas is light and hot for Radix Angelicae Sinensis, its sweet in the mouth and weighing, thus again can promoting the circulation of blood, and invigorating middle warmer has, in the row benefit is arranged, the gas medicine in the sincere blood, the also panacea in the blood." the Radix Angelicae Sinensis sweet in the mouth go into liver can nourishing the liver blood, the hot benefaction of gas can be lived liver blood and be helped catharsis, so Radix Angelicae Sinensis is mended logical having both, can transfer liver and and freely towards a QI and blood, be the choice drug of menstruction regulating and pain relieving.Radix Paeoniae Alba sour in the mouth cool in nature, main receipts are main quiet, nourishing blood to suppress the hyperactive liver, relieving spasm to stop pain; The Radix Bupleuri acrid in the mouth is slightly cold, main main liter of loosing, and soothing the liver dissipating depression of QI, elevate a turnable ladder yang-energy, both all go into Liver Channel, are ministerial drug altogether.Two minister compatibilities are held back the body of nourishing the liver with Radix Paeoniae Alba acid, and Radix Bupleuri is hot to loose along the usefulness of liver, and coordination of potent and mild therapies presses down short making the best use of the advantages, and has both reached the soothing the liver effect of nourishing the liver, and anti-again Radix Bupleuri is robbed impairing the liver the moon; From full side, the monarch and his subjects mutually 5, join Radix Angelicae Sinensis with the Radix Paeoniae Alba, and sound is suitable, makes liver blood filled and agile, nourishing the liver body and help liver to use.With Radix Bupleuri 5 Radix Angelicae Sinensis, bar reaches irritability with promoting blood, make gas along blood and, body and function mutually the benefit.The usefulness that above the monarch and his subjects' compatibility all opposes each other and yet also complement each other.Rhizoma Chuanxiong, Radix Curcumae, Rhizoma Cyperi, Rhizoma Corydalis, Fructus Foeniculi etc. all suffering spill into liver, Rhizoma Chuanxiong is warm in nature, the up head, following regulating menstruation water, merit is in activating QI to alleviate the depression, promoting blood circulation and stopping pain, Radix Curcumae is cool in nature, the diffusing stasis of energy, and broken stagnant blood is good at promoting QI circulation for relieving depression, stasis-dispelling and pain-killing, two medicines are all the gas medicine in the blood, to be in harmonious proportion blood system; Rhizoma Cyperi property is flat, be longer than the resolving depression of regulating the flow of vital energy, menstruction regulating and pain relieving, Compendium of Material Medica is called " chief commander of the Directorate-General DG of disorder of QI, women section ", Rhizoma Corydalis is warm in nature, be good at promoting flow of QI and blood, eliminating stasis to stop pain, " Bencao Jingshu " calls it can " manage all over the body all pains up and down ", and two medicines all belong to the blood medicine in the gas, to transfer smooth edema caused by disorder of QI.The Fructus Foeniculi warming the meridian is regulated the flow of vital energy, and good analgesic effect is arranged.More than all flavors be harmonious, the QI and blood regulating of holding concurrently is strengthened dispersing the stagnated live-QI to relieve the stagnation of QI, is regulated the flow of vital energy and the effect of blood." difficult through 77 difficulties " said: " see the disease of liver, then know liver when biographys and spleen, so first its temper in fact." Radix Ginseng, the sweet temperature of the Rhizoma Atractylodis Macrocephalae go into spleen, main invigorating the spleen and benefiting QI, one can support the QI and blood source, and ridging is to support wood, and two can consolidate spleen soil, and anti-edema with the liver involved is taken advantage of and is attacked; The hot sweet property of Semen Cuscutae is flat, returns liver, kidney two warps, can kidney-replenishing, again can the kidney tonifying essence, and the Yu Fangzhong water intaking can be contained the justice of wood.Above-mentioned eight flavors are adjuvant drug altogether.Radix Glycyrrhizae is sweet flat, can work in coordination with Radix Paeoniae Alba easing the affected liver to relieve pain, QI invigorating and in helping taste, and coordinating the actions of various ingredients in a prescription and for making.Compatibility in the side, QI and blood is taken into account, and body and function is helped each other, and dredges and mends combination, and liver spleen kidney is ruled together, and plays the effect of nourishing the liver and blood, depressed liver-energy dispersing and QI regulating, menstruction regulating and pain relieving altogether.Because we look after comprehensively, and the merit of outstanding depressed liver-energy dispersing and QI regulating, wherein Radix Angelicae Sinensis, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Radix Curcumae, Rhizoma Cyperi, Rhizoma Corydalis, Fructus Foeniculi all have analgesic effect in various degree, so the menstruction regulating and pain relieving effect is remarkable.
Now, be summarized as follows 120 routine stagnation of QI due to depression of the liver blood stasis type dysmenorrhea medical records of in JIUYUE, 1998 diagnosis and treatment during the calendar year 2001 JIUYUE:
1 clinical data
1.1 physical data 120 examples are the outpatient.Minimum 14 years old of age, maximum 42 years old, 26 years old mean age; Unmarried 77 examples, married 43 examples; The course of disease is the shortest 3 months, and is the longest 20 years, average 5.6 years.Its mild or moderate 32 examples, moderate 69 examples, severe 19 examples.There is 3/5 patient to accept treatment approximately in the past.
1.2 diagnostic criteria in conjunction with clinical experience, is determined pattern of syndrome with reference to Ministry of Public Health " the clinical research guideline of treatment by Chinese herbs dysmenorrhea " and State Administration of Traditional Chinese Medicine " traditional Chinese medical science disease diagnosis criterion of therapeutical effect " (1994).
The stagnation of QI due to depression of the liver syndrome of blood stasis
Main symptom: (1) is through inferior belly gas pain in preceding or menstrual period; (2) stringy pulse.
Inferior card: (1) menstrual blood volume is few; (2) dim through color; (3) menses accompany stasis of blood piece; (4) menstrual period or before or after; (5) the breast side of body or distending pain of the breast; (6) irascible temperament or depression; (7) body of the tongue is purple dim or petechia, ecchymosis arranged.
Possess whole main symptoms and two time cards and can be diagnosed as Liver depression and Qi stagnation.
The dysmenorrhea calibration
Slightly: through preceding or abdominal pain in menstruation is obvious, but can adhere to work, no General Symptoms need be obeyed analgesic sometimes.
Moderate: through preceding or abdominal pain in menstruation unbearably, nausea and vomiting, extremity are not warm, postpone with pain relieving measure pain.
Severe: through preceding or abdominal pain in menstruation unbearably, feel restless, have a strong impact on work and study and daily life, must lie up, companion's complexion white light is white, dripping cold sweat, and extreme cold of the limbs, vomiting and diarrhoea, or rectal tenesmus adopt the pain relieving measure not have obvious alleviation.
Include in and exclusion standard
Include standard in: Western medicine diagnose is a primary dysmenorrhea, and Chinese medical discrimination belongs to Liver depression and Qi stagnation person.
Exclusion standard: (1) secondary dysmenorrhea; (2) important organ pathological changes person and psychotics such as severe cardiac, liver, kidney are arranged; (3) pill taker in accordance with regulations not.
2 Therapeutic Method
2.1 square medicine is formed Radix Angelicae Sinensis 6g, Radix Paeoniae Alba 6g, Radix Bupleuri 6g, Rhizoma Chuanxiong 6g, Radix Curcumae 6g, Rhizoma Cyperi 6g, Rhizoma Corydalis (vinegar system) 6g, Radix Ginseng 10g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 9g, Semen Cuscutae 9g, Fructus Foeniculi 6g, Radix Glycyrrhizae 3g.
2.2 usage is decocted in water for oral dose, 1 dose of day, decoction being taken warmly at twice.In beginning to take medicine through preceding 5-7 days, till menstrual onset, 3 menstrual cycle of taking medicine continuously.
3 criterions of therapeutical effect
With reference to Ministry of Public Health " the clinical research guideline of treatment by Chinese herbs dysmenorrhea ", formulate in conjunction with TCM Syndrome Type and clinical practice:
Cure: stomachache disappears, and other symptoms disappear substantially, and 3 menstrual cycle of drug withdrawal do not recur.
Produce effects: stomachache obviously alleviates, other transference cures or obviously improvement, and the disobedience analgesic can be adhered to work.
Effectively: stomachache alleviates, and other symptoms take a turn for the better, and the clothes analgesic can be adhered to work.
Invalid: stomachache and other symptoms do not have the changer.
4 therapeutic outcomes
Cure 31 examples among the 120 routine patients, produce effects 63 examples, effective 22 examples, invalid 4 examples, total effective rate is 96.67%.The relation of the curative effect and the course of disease and dysmenorrhea degree such as table 1, table 2.
Table 1 course of disease and therapeutic effect relationship
| The course of disease (year) | The example number | Cure | Produce effects | Effectively | Invalid | Total effective rate (%) |
| ～5 | 74 | 24 | 40 | 9 | 1 | 98.65 |
| 6～10 | 31 | 6 | 17 | 7 | 1 | 96.77 |
| 10～ | 15 | 1 | 6 | 6 | 2 | 86.67 |
X
2＝5.56 P＞0.05
Table 2 dysmenorrhea degree and therapeutic effect relationship
| The dysmenorrhea degree | The example number | Cure | Produce effects | Effectively | Invalid | Total effective rate (%) |
| Slightly | 32 | 16 | 11 | 5 | 0 | 100 |
| Moderate | 69 | 12 | 45 | 10 | 2 | 97.10 |
| Severe | 19 | 3 | 7 | 7 | 2 | 89.47 |
X
2＝4.19 P＞0.05
Conclusion: the pathogenesis of stagnation of QI due to depression of the liver blood stasis type dysmenorrhea is an irritability stasis, and qi disease involving blood is not smooth towards appointing.Adopting nourishing the liver and blood, depressed liver-energy dispersing and QI regulating is main method prescription therapeutic assertive evidence, and the result shows: (1) we have the obvious effectiveness of menstruction regulating and pain relieving; (2) software EPI6.0 analyzes that (X2 (R * C) method), there are no significant the difference of three groups of total effective rates in display list 1, the table 2 illustrate that we are all suitable to the different courses of disease or dysmenorrhea in various degree by statistics.
In sum, the present invention has advantage safe and reliable, evident in efficacy, that side effect is little, cure rate is high.
(4) specific embodiment
Embodiment 1:
Get Radix Angelicae Sinensis 6g, Radix Paeoniae Alba 6g, Radix Bupleuri 3g, Rhizoma Chuanxiong 6g, Radix Curcumae 6g, Rhizoma Cyperi 6g, Rhizoma Corydalis (vinegar system) 6g, Radix Ginseng 3g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 6g, Semen Cuscutae 6g, Fructus Foeniculi 3g, Radix Glycyrrhizae 3g.Above medicament mixed decocting concentrates, and makes granule, and is every day 2-3 time, oral.
Embodiment 2:
Get Radix Angelicae Sinensis 10g, Radix Paeoniae Alba 10g, Radix Bupleuri 8g, Rhizoma Chuanxiong 10g, Radix Curcumae 10g, Rhizoma Cyperi 10g, Rhizoma Corydalis (vinegar system) 8g, Radix Ginseng 8g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 10g, Semen Cuscutae 10g, Fructus Foeniculi 8g, Radix Glycyrrhizae 6g.Above medicament mixed decocting concentrates, and makes water decoction according to a conventional method, and is every day 2-3 time, oral.
Embodiment 3:
Get Radix Angelicae Sinensis 15g, Radix Paeoniae Alba 15g, Radix Bupleuri 12g, Rhizoma Chuanxiong 15g, Radix Curcumae 15g, Rhizoma Cyperi 15g, Rhizoma Corydalis (vinegar system) 15g, Radix Ginseng 10g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 15g.Above medicament mixed decocting concentrates, and makes capsule according to a conventional method, and is every day 2-3 time, oral.
Embodiment 4: the medicine of the present invention (hereinafter to be referred as through relaxation grain) of pressing embodiment 1 preparation
The main pharmacodynamics experimental data
We have carried out experimentation to the main pharmacodynamics through relaxation grain, now the result are reported as follows:
1 experiment material
1.1 laboratory animal
Wistar kind rat, Kunming mouse are all purchased the Experimental Animal Center in Shandong medical university.
The animal quality certification number: Shandong kinoplaszm 200001002 (mice)
200001003 (rats)
1.2 experimental drug
Through relaxation grain, press the medicine of the present invention of embodiment 1 preparation.Lot number: 20010522
TONGJINGBAO KELI, the Yuan Xi of Henan Province Pharmacy stock Co., Ltd produces.Lot number: 20000115
2 experiment contents
2.1 through the relaxation grain analgesic activity
2.1.1. cause the analgesic activity of pain mice through the relaxation grain Dichlorodiphenyl Acetate
Get 50 of 18-22g mices, female, be divided into 5 groups at random, the 1st group is through the heavy dose of group of relaxation grain, dosage is 30.4g crude drug/kg (is equivalent to people's clinical dosage 20 times); The 2nd group is dosage group in relaxation grain, and dosage is 15.2g crude drug/kg (is equivalent to people's clinical dosage 10 times); The 3rd group is through the relaxation grain small dose group, and dosage is 7.6g crude drug/kg (is equivalent to people's clinical dosage 5 times); The 4th group of positive medicine (TONGJINGBAO KELI) group, dosage are 1.7g granule/kg (be equivalent to people's clinical dosage 5 times); The 5th group is the ordinary water group, gives isopyknic ordinary water.Irritate stomach every day once, continuous irrigation stomach 7 days.Behind last administration 30min, every Mus lumbar injection 0.6% acetic acid 0.2ml/20g, that writes down that mice in time of the 1st writhing response and the 10min appears in each Mus turns round the body number of times.
The results are shown in Table 3.
Table 3 causes the analgesic activity n=10 of pain mice through the relaxation grain Dichlorodiphenyl Acetate
| Group | Dosage (g/kg) | Incubation period (min) | Turn round the body number of times |
| Through the heavy dose of group of relaxation grain | 30.4 | 7.2±2.9** | 12.3±11.3** |
| Dosage group in relaxation grain | 15.2 | 5.2±2.7* | 15.1±12.6* |
| Through the relaxation grain small dose group | 7.6 | 5.9±2.7* | 19.1±11.4 |
| The TONGJINGBAO KELI group | 1.7 | 5.4±3.3 | 14.7±11.1* |
| The ordinary water group | Equal-volume water | 3.9±1.1 | 32.1±15.6 |
Annotate with the ordinary water group and compare * p＜0.05, * * p＜0.01
The result shows: with the ordinary water group relatively, through the large, medium and small dosage group of relaxation grain all can the analgesia of significant prolongation mice incubation period, what big or middle dosage group can reduce mice turns round the body number of times, illustrating through relaxation grain has analgesic activity preferably.
2.1.2. through the analgesic activity of relaxation grain to the hot plate method induced mice
Get the 18-22g female mice, put into 55 ± 0.5 ℃ of hot plate water-baths, the metapedes required time to occur licking, as the pain threshold of mice.The mice of pain threshold within 30 seconds is shown qualified mice.Select 50 qualified mices and be divided into 5 groups at random, grouping and the same 2.1.1 of dosage.Irritate stomach every day once, continuous irrigation stomach 7 days, the pain threshold of 0.5h, 1h, 1.5h the results are shown in Table 4 after surveying medicine respectively after the last administration.
Table 4 causes the analgesic activity n=10 of mice to hot plate method through relaxation grain
| Group | Dosage (g/kg) | Pain threshold before the medicine | 0.5h pain threshold | The 1h pain threshold | 1.5h pain threshold |
| Through the heavy dose of group of relaxation grain | 30.4 | 17.4±4.1 | 33.0±15.2* | 29.3±11.2* | 22.0±14.6 |
| Dosage group in relaxation grain | 15.2 | 17.4±4.4 | 24.1±10.2 | 28.2±14.2 | 28.0±17.6 |
| Through the relaxation grain small dose group | 7.6 | 17.4±4.5 | 17.4±6.3 | 19.2±5.0 | 23.5±11.9 |
| The TONGJINGBAO KELI group | 1.7 | 17.9±4.2 | 20.5±9.5 | 32.2±15.8* | 22.5±9.3 |
| The ordinary water group | Equal-volume water | 17.4±5.7 | 17.6±8.1 | 18.6±10.3 | 18.4±2.7 |
Annotate with the ordinary water group and compare * p＜0.05
The result shows: with the ordinary water group relatively, behind medicine, can significantly improve mice pain threshold when 0.5h and 1h through the heavy dose of group of relaxation grain, illustrate to cause bitterly through the heavy dose of group of relaxation grain to hot plate that mice has analgesic activity preferably.
2.2 through the relaxation grain antiinflammatory action
2.2.1 through the influence of relaxation grain to mice auricle swelling
Get 50 of body weight 24-28g healthy mices, female, be divided into 5 groups at random, the difference gastric infusion, the same 2.1.1 of dosage, be administered once every day, successive administration 7 days behind last administration 30min, is coated with dimethylbenzene with mice left side auricle, 0.05ml/ only, behind the 15min, mice is taken off cervical vertebra put to death, card punch with diameter 6.5cm sweeps away left and right sides auricle, weighs on electronic balance respectively, heavily deducts the wide heavy difference of auris dextra with left auricle and carries out the t check.The results are shown in Table 5.
Table 5 is through the influence n=10 of relaxation grain to mice auricle swelling
| Group | Dosage (g/kg) | Two auricle differences (mg) |
| Through the heavy dose of group of relaxation grain | 30.4 | 6.84±3.25 |
| Dosage group in relaxation grain | 15.2 | 5.95±3.24* |
| Through the relaxation grain small dose group | 7.6 | 6.12±2.07** |
| The TONGJINGBAO KELI group | 1.7 | 6.66±2.47* |
| The ordinary water group | Equal-volume water | 9.64±2.91 |
Annotate with the ordinary water group and compare * p＜0.05, * * p＜0.01
The result shows: with ordinary water group ratio, in relaxation grain, small dose group all can suppress the mice auricle swelling that caused by dimethylbenzene, and antiinflammatory action is preferably arranged.
2.2.2. through relaxation grain to the bullate influence of rat granuloma
Get 40 of the female rats of body weight 150g ± 20g, be divided into 5 groups at random, 8 every group.The 1st group through the heavy dose of group of relaxation grain, and dosage is 15.2g crude drug/kg (is equivalent to people's clinical dosage 10 times); The 2nd group of dosage group in relaxation grain, dosage are 7.6g crude drug/kg (be equivalent to people's clinical dosage 5 times); The 3rd group through the relaxation grain small dose group, and dosage is 3.8g crude drug/kg (is equivalent to people's clinical dosage 2.5 times); The 4th group of positive drug group, dosage are 0.8g/kg (be equivalent to people's clinical dosage 2.5 times); The 5th group of ordinary water group gives equal-volume water.Rat is used etherization, and at the right groin iodine disinfection of each Mus, after 75% ethanol took off iodine, each cut the osculum of 1cm length.The sterilization cotton balls (adding penicillin and mixed liquor of gentamicin 0.1ml and oven dry) that will be weighed as 10mg with the ophthalmology tweezers is subcutaneous from the osculum implantation, immediately skin suture.Began gastric infusion, successive administration 6 days the same day from performing the operation.Rat was weighed in the 7th day, opened former otch, and cotton balls is taken out together with connective tissue on every side, rejected fatty tissue, put in the baking oven oven dry and weighed.With claim weight deduct the former weight of cotton balls and promptly get granulomatous weight.Calculate per 100 gram body weight rat granulations and weigh and organize a t check.The results are shown in Table 6.
Table 6 through relaxation grain to the bullate n=8 that influences of rat granuloma
| Group | Agent (g/kg) | Granulation dry weight (mg/100g) |
| Through the heavy dose of group of relaxation grain | 15.2 | 13.2±3.6* |
| Dosage group in relaxation grain | 7.6 | 12.1±1.5** |
| Through the relaxation grain small dose group | 3.8 | 11.7±1.7** |
| The precious group of dysmenorrhea | 0.8 | 11.7±1.9** |
| The ordinary water group | Equal-volume water | 16.4 ±1.8 |
Annotate with the ordinary water group and compare * p＜0.05, * * p＜0.01
The result shows with ordinary water group ratio, to rat granuloma is swollen remarkable inhibitory action is arranged through the large, medium and small dosage group of relaxation grain, and illustrating through relaxation grain has antiinflammatory action preferably to chronic inflammatory disease.
2.2.3 the dysmenorrhea granule is to the effect of rat paw edema
Get 40 of the female healthy rats of 120-150g, be divided into 5 groups at random.The 1st group is through the heavy dose of group of relaxation grain, and dosage is 15.2g crude drug/kg (the clinical consumption of behaving 10 times); The 2nd group is dosage group in relaxation grain, and dosage is 7.6g crude drug/kg (the clinical consumption of behaving 5 times); The 3rd group is through the relaxation grain small dose group, and dosage is 3.8g crude drug/kg (the clinical consumption of behaving 2.5 times); The 4th group of positive medicine TONGJINGBAO KELI group, dosage are 0.8g granule/kg (the clinical consumption of behaving 2.5 times); The 5th group gives isopyknic ordinary water for the ordinary water group.Gastric infusion before the Yu Zhiyan, once a day, one week of continuous irrigation stomach, 30min behind the last filling stomach, right sufficient plantar subcutaneous injection 1% agar 0.05ml/ only causes inflammation at rat hindlimb, measures to cause scorching front and back rat paw perimeter change, calculate and relatively cause inflammation after respectively organize the swelling degree, carry out the t check.The results are shown in Table 7.
The scorching front foot sole of the foot girth of the scorching metapedes sole of the foot girth of swelling degree=cause-cause
Table 7 is through the influence n=8 of relaxation grain to rat paw edema
| Group | Dosage (g/kg) | Different time (h) paw swelling (cm) | ||||
| 1h | 2h | 4h | 6h | 8h | ||
| Through the heavy dose of group of relaxation grain | 15.2 | 0.29±0.13 | 0.40±0.12 | 0.60±0.15* | 0.50±0.13** | 0.40±0.10 |
| Dosage group in relaxation grain | 7.6 | 0.34±0.18 | 0.43±0.11 | 0.76±0.13 | 0.57±0.15* | 0.40±0.09 |
| Through the relaxation grain small dose group | 3.8 | 0.28±0.21 | 0.59±0.21 | 0.77±0.16* | 0.64±0.17* | 0.33±0.17 |
| The precious group of dysmenorrhea | 0.8 | 0.36±0.07 | 0.48±0.13 | 0.71±0.15 | 0.58±0.16* | 0.47±0.17 |
| The ordinary water group | Equal-volume water | 0.33±0.12 | 0.42±0.12 | 0.70±0.13 | 0.76±0.19 | 0.49±0.15 |
Annotate with the ordinary water group and compare * p＜0.05, * * p＜0.01
The result shows, with the ordinary water group relatively, giving agar 4h, 6h through the heavy dose of group of relaxation grain rat has remarkable inhibitory action to its foot swelling, in, small dose group is when 6h, foot swelling is all had remarkable inhibitory action, and illustrating through relaxation grain has antiinflammatory action preferably to chronic inflammatory disease.
2.3 through the sedation of relaxation grain to mice
Get 50 of body weight 18-22g healthy mices, female, be divided into 5 groups at random, grouping and the same 2.1.1 of dosage.Irritate stomach every day once, a continuous week.After last was irritated stomach 30min, every Mus lumbar injection 0.45% pentobarbital sodium 0.2ml/10g observed the mice time for falling asleep (incubation period) and the length of one's sleep, compares.
The results are shown in Table 8.
Table 8 is through the sedation n=10 of relaxation grain to mice
| Group | Dosage (g/kg) | Incubation period (min) | The length of one's sleep (min) | Sleeping rate (%) |
| Through the heavy dose of group of relaxation grain | 30.4 | 9.2±8.2 | 30.7±16.3 | 70 |
| Dosage group in relaxation grain | 15.2 | 14.4±8.0 | 32.2±13.6* | 80 |
| Through the relaxation grain small dose group | 7.6 | 7.6±2.1 | 59.2±20.2**△△ | 100 |
| The TONGJINGBAO KELI group | 1.7 | 9.0±4.0 | 32.5±15.5* | 100 |
| The ordinary water group | Equal-volume water | 12.1±2.6 | 17.0±7.9 | 60 |
Annotate with the ordinary water group and compare * p＜0.05, * * p＜0.01; Compare △ △ p＜0.01 with the positive drug group
The result shows, with the ordinary water group relatively, in relaxation grain, small dose group has remarkable synergism to pentobarbital sodium sleep mice, low dose of effect is better than big or middle dosage and positive drug.
2.4 through the influence of relaxation grain to dysmenorrhea model mice due to the oxytocin
Get 50 of body weight 18-22g healthy mices, female mice is divided into 5 groups at random, grouping and the same 2.1.1 of dosage.Irritate stomach every day once, after the continuous week, every mice only gavages 0.04% diethylstilbestrol 0.2ml/ every day again, and for three days on end, the 4th day lumbar injection 2 μ/oxytocin only turned round the body number of times in the record 20min, and carries out the t check.The results are shown in Table 9.
Table 9 is through the influence n=10 of relaxation grain to dysmenorrhea model mice due to the oxytocin
| Group | Dosage (g/kg) | Turn round the body number of times | Incubation period (min) |
| Through the heavy dose of group of relaxation grain | 30.4 | 6.4±7.2** | 10.5±6.8** |
| Dosage group in relaxation grain | 5.2 | 4.3±5.8** | 11.3±8.8** |
| Through the relaxation grain small dose group | 7.6 | 6.2±6.3** | 8.8±8.0* |
| The TONGJINGBAO KELI group | 1.7 | 8.4±10.5* | 5.9±7.2* |
| The ordinary water group | Equal-volume water | 19.7±11.3 | 1.3±1.3 |
Annotate with the ordinary water group and compare * p＜0.05, * * p＜0.01
The result shows, compares with the ordinary water group, through the large, medium and small dosage group of relaxation grain, can significantly reduce oxytocin dysmenorrhea model mouse writhing number of times and incubation period, and the dysmenorrhea model mice is had significant therapeutic effect.
2.5 through the influence of relaxation grain to female young rat reproductive organs growth
Get 50 of the female young Mus of 4 week 90～110g in age, be divided into 5 groups at random, grouping and the same 2.2.2 of dosage.Irritate stomach every day once, the continuous irrigation stomach is after 30 days, and lumbar injection 45mg/kg pentobarbital sodium is anaesthetized, and postcava is got blood and surveyed progesterone, estradiol, lactotropin (heavy dose of group has 1 and gets the blood failure).Dissect rat and get uterus, ovary, weigh.The results are shown in Table 10～11.
Table 10 is through the influence n=10 of relaxation grain to female young rat reproductive organs
| Group | Dosage (g/kg) | Body weight (g) | Uterus coefficient (mg/100g) | Ovary coefficient (mg/100g) |
| Through the heavy dose of group of relaxation grain | 15.2 | 180.0±15.7 | 28.6±6.4* | 35.7±7.9 |
| Dosage group in relaxation grain | 7.6 | 186.6±10.5 | 32.2±8.0 | 36.8±5.0 |
| Through the relaxation grain small dose group | 3.8 | 185.2±15.9 | 39.9±9.2 | 45.0±7.9 |
| The TONGJINGBAO KELI group | 0.8 | 185.4±16.4 | 32.4±11.7 | 35.5±5.0 |
| The ordinary water group | Equal-volume water | 193.3±21.6 | 39.3±10.4 | 39.8±5.6 |
Annotate with the ordinary water group and compare * p＜0.05
Table 11 is through the influence of relaxation grain to rat estrogen
| Group | Dosage (g/kg) | Sample number | E 2(pg/ml) | P (ng/ml) | PRL (ng/ml) |
| Through the heavy dose of group of relaxation grain in relaxation grain the dosage group through relaxation grain small dose group TONGJINGBAO KELI group ordinary water group | 15.2 7.6 3.8 0.8 equal-volume water | 9 10 10 10 10 | 27.8±15.2** 30.3±8.9* 37.5±8.2 32.4±6.8* 42.9±11.7 | 0.58±0.16** 0.74±0.20 0.94±0.85 0.74±0.20 0.92±0.24 | 2.45±1.28**△△ 5.27±1.62**△△ 6.63±2.84** 8.27±1.61 9.62±1.29 |
Annotate with the ordinary water group and compare * p＜0.05, * * p＜0.01; Compare △ △ p＜0.01 with the rigidity medicine
The result shows, with the ordinary water group relatively, in, small dose group do not have the significance influence to body weight and the sexual organ's weight of female young rat, heavy dose of group does not have the significance influence to body weight and the ovary weight of female young rat yet, but can alleviate uterus weight; Large, medium and small dosage group all has remarkable reduction effect to lactotropin, and big or middle dosage group all has remarkable reduction effect to estradiol, and heavy dose of group has remarkable reduction effect to progesterone; Compare with positive drug, big or middle dosage group all has remarkable reduction effect to lactotropin.
3 conclusions
Pharmacodynamic experiment shows to have obvious anti-inflammatory and analgesic effect through relaxation grain, and the dysmenorrhea model mice is had significant analgesic effect; In, small dose group do not have the significance influence to the body weight of female young rat and sexual organ's weight, heavy dose of group can be reduced uterus weight.Large, medium and small dosage group all has remarkable reduction effect to lactotropin, and big or middle dosage group all has remarkable reduction effect to estradiol, and heavy dose of group has remarkable reduction effect to progesterone; In relaxation grain, small dose group has remarkable synergism to the calm mice of pentobarbital sodium.Above pharmacodynamic result is the pharmacological basis of its performance clinical efficacy.
Embodiment 5: through relaxation grain animal acute toxicity test research (maximum dosage-feeding test)
According to prerun, can not survey LD through relaxation grain
50(9.1g crude drug/ml) and maximum volume (1.2ml/10g mice every day) record maximum dosage-feeding 1092g crude drug/kg, are equivalent to 719.84 times of the clinical consumption of people to give the mouse stomach Cmax.
1 test objective
For the safety of medication, undertaken observing through the acute toxicity test of relaxation grain by the new drug requirement.
2 test materials
2.1 animal
Kunming mouse, 20, female, body weight 18 ~ 20g is provided by Shandong University's Experimental Animal Center.The quality certification numbers 200001002, raising condition are that the plastic box bottom shop soft sawdust of one deck is raised, 5 in every box, temperature is controlled at 20～25 ℃, the well-ventilated, humidity 55～60%, normally raise one week the back for examination.
2.2 medicine
Through relaxation grain, lot number: 20010522, press the medicine of the present invention of embodiment 1 preparation.People's clinical dosage is 21g granule/day (containing crude drug amount 91g), and the people presses the 60kg body weight and calculates, and then clinical dosage is 91g crude drug/60kg=1.517g crude drug/kg.Be made into flowable Cmax suspension with ordinary water, concentration is 9.1g crude drug/ml.
3 test methods
Get 20 mices, female, fasting 12 hours (can't help water), (concentration is that the 9.1g crude drug/ml), the maximum that tolerates was administered three times on the 1st to gavage the medicinal liquid that has prepared, each 0.4ml/10g mice, administration accumulated dose on the one is 1.2ml/10g mice (containing crude drug amount 10.92g/10g mice).Irritate the stomach time and be 8:30 in the morning, noon 1:30, evening 6:30.Feeding behind the filling stomach, feedwater.At once observe mice diet, activity, defecation, fur etc. behind the medicine, observed continuously 7 days.
4 result of the tests
At once reach behind the relaxation grain medicine in 7 days, animal does not all have death, and its body weight gain and appetite is there was no significant difference also, the mice perusal, and appetite is good, and defecation is normal, and fur is smooth, does not have any poisoning symptom.So the maximum dosage-feeding that we can only obtain mice is 1092g crude drug/kg, be 719.84 times of the clinical consumption of people.
Through the anxious poison of relaxation grain mice n=20 that influences to body weight gain in one week
| Sex | Before the medicine | Behind the medicine |
| Female | 18.70±0.63 | 20.83±1.35* |
Annotate: compare P＜0.05 before the medicine, behind the medicine.
Through relaxation grain maximum dosage-feeding number is 719.84 times, has surpassed the requirement of 100 times of regulation trial drugs.
5 conclusion (of pressure testing)s
Through the relaxation grain clinical practice in oral administration, by the specification requirement of " about the supplementary provisions and the explanation of Chinese medicine problem " toxicity research in the provisions for new drugs approval following regulation that remarks additionally: when the preparation that has can't be by injection administration, only consider gastrointestinal administration, little through relaxation grain toxicity, can not survey LD
50So,, can only adopt the oral administration gavage administration, give its Cmax, maximum volume, obtaining the mice maximum dosage-feeding is 1092g crude drug/kg, is 719.84 times of the clinical consumption of people.Observed 7 days behind the mouse stomach, do not see death and other abnormal phenomenas, body weight gain is normal, and appetite is good.Put to death after 7 days, the ANOMALOUS VARIATIONS of internal organs is not seen in perusal yet, and the overt toxicity reaction does not appear in mice, and it is safe pointing out clinical use.
Claims (3)
1. a Chinese medicine preparation for the treatment of dysmenorrhea is characterized in that: mainly by following parts by weight
Raw material is made:
Radix Angelicae Sinensis 6-15g, Radix Paeoniae Alba 6-15g, Radix Bupleuri 3-12g, Rhizoma Chuanxiong 6-15g, Radix Curcumae 6-15g, Rhizoma Cyperi 6-15g, Rhizoma Corydalis (vinegar system) 6-15g, Radix Ginseng 3-10g, the Rhizoma Atractylodis Macrocephalae (stir-fry) 6-15g.
2. the Chinese medicine preparation of treatment dysmenorrhea according to claim 1 is characterized in that: other contains the raw material of following parts by weight:
Semen Cuscutae 6-15g, Fructus Foeniculi 3-12g, Radix Glycyrrhizae 3-9g.
3. the Chinese medicine preparation of treatment dysmenorrhea according to claim 1 is characterized in that: but described Chinese medicine preparation is the dosage form of water decoction, granule, capsule, tablet or other pharmacy.
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