CN1159033C - Composite Chinese medicine for gynopathy - Google Patents

Abstract

The present invention relates to a Chinese medicine composition for gynecological diseases, which comprises the following components of 30 to 60g of milkvetch root, 20 to 35g of red sage root, 24 to 40g of raw typha pollen, 15 to 25g of trogopterus dung, 6 to 10g of myrrh, 15 to 25g of common prism tuber, 15 to 25g of zedoray rhizome, 30 to 50g of sargentodoxa and 30 to 50g of patrinia (measured by the quantity of raw medicines). The Chinese medicine composition has good therapeutic effects on various kinds of gynecological diseases including EM sterility and has no side effect of Western medicines, such as fertility inhibition, immune suppression, harm to the hepatic function, osteoporosis, etc. Moreover, the Chinese medicine composition has low price, and is suitable for long-term use.

Description

A kind of gynecological Chinese medicine compositions

The invention belongs to tcm field, be specifically related to treat the Chinese medicine of gynaecopathia.

Gynaecopathia is commonly encountered diseases, frequently-occurring disease in accounting for the women of population about half.Therefore wherein, the sickness rate of dysmenorrhea is 33.19%, and has a strong impact on work, gives birth to the reviver and account for 13.59%, and its Central Plains is sore through accounting for 36.06%.The sickness rate of endometriosis (being called for short gynecopathy or EM) obviously rises in recent years, its The main symptoms still has dysmenorrhea in various degree except infertile, therefore dysmenorrhea morbidity crowd has been increased, part patient's gynecopathy focus is also not serious, and the dysmenorrhea symptom is quite serious.Because the morbidity of dysmenorrhea is periodic outbreak along with menstruation, therefore seriously influenced patient's quality of life.In the U.S. the former sore warp of 40-50% there is every year, loses 600,000,000 working hours for this reason.And TREATMENT OF DYSMENORRHOEA still adopts steroid hormone and prostaglandin antagonists at present, the former is accepted by the patient be difficult for more, the latter can only respite pain can not thoroughly cure because of it, and certain side effect is arranged, so unsuitable life-time service can not be considered to be a kind of ideal medicine and Therapeutic Method.The medicine that can be used for the treatment of dysmenorrhea at present on Chinese medicine market has YUEYUESHU, dysmenorrhea spirit, WUJIBAIFENG WAN, four Rhizoma Cyperi (processed) balls, YIMUCAO CHONGJI etc., these medicines are effective to part dysmenorrhea patient, but also not ideal to part serious symptom dysmenorrhea such as membranous dysmenorrhea, gynecopathy dysmenorrhea curative effect.

The incidence rate of endometriosis (EM) is in rising trend in recent years, its complication performance multiformity.EM clinically mainly show as dysmenorrhea that carrying out property increases the weight of, infertile, pelvic cavity tuberosity and enclosed mass, infertilely mainly one of show, often the main cause of seeking medical advice for the patient for it.Medicines such as normal application progestogen, danazol, nemestran, the moving agent of gonadotropin releasing hormone and Mi Feisi in the Drug therapy, but some clinical drug effects are unsatisfactory.Particularly used these medicines are powerful fertility inhibitor, and significant side effects is arranged.Operative treatment has conservative operation and radical surgery.Obviously be inappropriate for EM patient's radical surgery, and the operation of conservative usually cooperate the treatment of medicine.

The traditional Chinese medical science causes infertile understanding to endometriosis, belongs to the category of " dysmenorrhea " " little abdominal mass " " infertile " of the traditional Chinese medical science, thinks that its pathogenesis is how relevant with qi depression to blood stasis, cold coagulation stagnation of phlegm or deficiency of both QI and blood, deficiency of kidney-essence." stasis of blood " is the key that produces endometriosis, so it is fundamentum that blood circulation promoting and blood stasis dispelling is gone up in treatment, other has methods such as blood stasis dispelling the kidney invigorating, blood stasis dispelling purging FU-organs, or based on blood circulation promoting and blood stasis dispelling, with card hold concurrently the ginseng temperature, cool, attack, method such as benefit, clinical and zoopery confirms, blood stasis dispelling purging FU-organs Chinese medicine can improve whole body and local microcirculation, has the effect that reduces prostaglandin and regulate body function, the endometriosis patient there is certain curative effect, but its fertility that whether can improve EM patient's infertility is waited further research.

The present inventor finds can treat the various gynaecopathias that comprise the EM infertility with QI invigorating heat clearing and blood stasis dispersing method, thereby has finished the present invention by to clinical observation on the therapeutic effect and research that reproduction-endocrine-immunity or metabolism are regulated.

The object of the present invention is to provide a kind of good effect, few side effects, gynecological Chinese medicine compositions easy to use.

Gynecological Chinese medicine compositions provided by the invention comprises: process stilbene 30-60 gram, Radix Salviae Miltiorrhizae 20-30 gram, Pollen Tyjphae 24-30 gram, fry Oletum Trogopterori 15-20 gram, Myrrha 6-9 gram, rhizoma sparganic 15-20 gram, Rhizoma Curcumae 15-20 gram, Caulis Sargentodoxae 30-40 gram, Herba Patriniae 30-40 gram, by the crude drug amount.

Comprise following monarch, minister in the gynecological Chinese medicine compositions provided by the invention, make, adjuvant drug.

Monarch drug: the Radix Astragali, Radix Salviae Miltiorrhizae, ancient literature are all on the books.The Radix Astragali is the QI invigorating key medicine, and " the dirty ailment said due to cold or exposure gas of housewife people's is by stagnant blood between the five internal organs as putting down in writing it in " Mingyi Bielu "."; " the sweet tepor of the Radix Astragali helps the gas strengthening bone and muscle, puts on flesh and enriches blood, and broken disease addiction is controlled tired pestilence " (" Japan hanako materia medica ") " though the property temperature compensation, and can lead to blood circulation regulating, popular pathway, fourth is deep and remote to stagnate also can not hinder." (" book on Chinese herbal medicine meets former "); Radix Salviae Miltiorrhizae is bitter and be slightly cold GUIXIN, pericardium, Liver Channel.Have the stasis of blood of invigorating blood circulation effect, institute says that Radix Salviae Miltiorrhizae is specially gone into blood system as " book on Chinese herbal medicine justice ", and its merit is to control the blood promoting the circulation of blood, interior reaches internal organs and blood stasis dispelling stagnates ... outer profit joint and the network of promoting blood circulation.Can be used for each section's stagnation of blood stasis disease.The Radix Astragali, the Radix Salviae Miltiorrhizae compatibility, the two going property is deposited usefulness, is applicable to all blood stasis symptoms.Especially suitable to blood stasis due to qi deficiency person.The woman is congenital with liver, superior doctor treating the disease before its onset, and knowing the liver disease will be transmitted into the spleen, tonifying the spleen has embodied the organic conception of the traditional Chinese medical science and the idea of putting prevention first in the ban.

Ministerial drug: Pollen Tyjphae, nine Oletum Trogopterori.The Pollen Tyjphae sweet in the mouth is flat, goes into spleen channel." Japan hanako materia medica " said: " wanting the removing blood stasis detumescence promptly to give birth to makes ".Fry the bitter sweet temperature of Oletum Trogopterori, return Liver Channel.Get " formulary of peaceful benevolent dispensary volume nine " SHIXIAO SAN and abdominal pain during menstruation is had the merit of stasis-dispelling and pain-killing.Say as " wooden careless detailed outline is rolled up 48 cold bow worms ": " fry Oletum Trogopterori, the liver channel of foot-Jueyin medicine also, abnormal smells from the patient is all thick, the yin aspect of yin is so go into blood system.Liver master blood, this medicine can be controlled disorders of blood, looses blood and blood and ends all pains ... SHIXIAO SAN is not only controlled the pained blood pain of married woman, and all trusted subordinates of all men and women, old and young coerce rib lower abdominal pain hernia ... all can yield result.”

Adjuvant drug: rhizoma sparganic, Rhizoma Curcumae, Myrrha.Abdominal pain during menstruation, lump in the abdomen mostly are the card of stagnation of blood stasis, must use the product of removing blood stasis.Rhizoma sparganic is bitter flat, returns the liver spleen channel, and blood circulation promoting and blood stasis dispelling is gone into blood system partially.Rhizoma Curcumae is returned the liver spleen channel, goes into edema caused by disorder of QI partially.The Myrrha bitter in the mouth is flat, is good at eliminating stasis to stop pain, cures mainly dysmenorrhea.

Messenger drug: Caulis Sargentodoxae, Herba Patriniae are heat and toxic materials clearing away medicine.Caulis Sargentodoxae is bitter flat, returns large intestine channel, can strengthen the effect of heat-clearing and toxic substances removing stasis-dispelling and pain-killing; Herba Patriniae is arduous to be slightly cold, and returns stomach, large intestine, Liver Channel.Both are together with controlling dysmenorrhes.

Above-mentioned all medicines have the merit of QI invigorating clearing away heat to alleviate pain to return liver spleen two through in the majority.Because of blood stasis is the key of endometriosis, dysmenorrhea etc., some pelvic inflammatory disease and blood stasis, heat in blood are in close relations, especially the pathology of endometriosis is in the nature deficiency in origin and excess in superficiality, the medicine card conforms to, so Chinese medicine composition of the present invention has curative effect preferably, there are not the side effect such as fertility inhibition, immunosuppressant, liver function injury and osteoporosis of Western medicine again.For example, be the clinical application of generally acknowledging at present though be used as the Western medicine danazol of positive control in this description, its liver function injury and acne etc. have limited its application.Some Western medicine cost an arm and a leg, and are unfavorable for life-time service.And Chinese medicine composition few side effects of the present invention, cheap, so be suitable for life-time service.

Chinese medicine composition of the present invention can be treated various gynaecopathias, mainly comprises: after endometriosis, dysmenorrhea, pelvic inflammatory disease and pelvic pain, non-operation indication pelvic lump and the operation of endometriosis conservative.

Chinese medicine composition of the present invention can be made into dosage forms such as oral liquid, soft extract, tablet, capsule, electuary.

According to the difference of dosage form, Chinese medicine composition of the present invention can contain various pharmaceutical carriers, excipient and other additive, is prepared by the conventional preparation method of Chinese medicine preparation.As can making use or non-aqueous excipient or their combination in the oral liquid, and can be added with sweeting agent, correctives, suspending agent and antiseptic etc.; Can be added with excipient, lubricant and disintegrating agent etc. in the tablet; Can be added with sweeting agent and correctives etc. in the electuary; Can be added with sweeting agent, correctives and antiseptic etc. in the soft extract.

The consumption of the present composition and the course of treatment can suitably be adjusted according to the kind and the degree of dosage form, patient's age, disease, divide and take for 2-3 time but be generally one day oral dose, with 3 months be a course of treatment, can use 1-2 the course of treatment or longer time continuously.

Below with embodiment and experimental example the present invention is illustrated, they are intended to set forth optimum implementation of the present invention.Those skilled in the art are according to enlightenment of the present invention, and the various changes in conjunction with the general knowledge of this area is done all drop in the scope of the application's claim.

By the elaboration of these embodiment and experimental example, it is more clear that above-mentioned purpose of the present invention and effect also will become.

The preparation of embodiment 1 oral liquid

Prescription: process stilbene 400 gram Radix Salviae Miltiorrhizaes 250 gram rhizoma sparganic 200 grams

Rhizoma Curcumae 200 gram Pollen Typhaes 300 gram Myrrhas 100 grams

Caulis Sargentodoxae 350 gram Herba Patriniae 350 grams are fried Oletum Trogopterori 200 grams

Method for making: get each decoction pieces and decoct with water three times, collecting decoction filters, and filtrate decompression is concentrated into 1: 1, handles secondary with ethanol precipitation, and to contain amount of alcohol be 70% to solution for the first time, is 80% for the second time, and after-filtration is placed in each all cold preservation.Filtrate recycling ethanol, an amount of with sucrose, adjusting pH value is 7.0, adds distilled water to 1000 milliliter.

The preparation of embodiment 2 soft extracts

Prescription: process stilbene 5000 gram Herba Patriniae 5000 grams

Radix Salviae Miltiorrhizae 3000 gram rhizoma sparganic 2000 grams

Pollen Tyjphae 4000 gram Rhizoma Curcumae 2500 grams

Fry Oletum Trogopterori 2500 gram Myrrhas 1000 grams

Caulis Sargentodoxae 5000 grams

Method for making: each medicine decoction pieces water is decocted 2-3 time, seethed with excitement 2 hours at every turn, filter, merging filtrate leaves standstill, and gets supernatant, after suitably concentrating, adds an amount of sucrose and receives cream.

The preparation of embodiment 3 tablets

Prescription: 1000 consumptions

Process stilbene 5000 gram Herba Patriniae 4500 grams

Radix Salviae Miltiorrhizae 3000 gram rhizoma sparganic 2500 grams

Pollen Tyjphae 4000 gram Rhizoma Curcumae 2500 grams

Fry Oletum Trogopterori 2500 gram Myrrhas 1000 grams

Caulis Sargentodoxae 4500 gram starch are an amount of

Magnesium stearate is an amount of

Method for making: each flavor Chinese medicine powder is broken into coarse powder, puts jar interior 10 times of amounts of ethanol that add, heating pressurised extraction 15 hours.Collect extracting solution, reclaim ethanol, add starch, magnesium stearate is an amount of, makes granule to the thick paste shape, granulate, mixing, compacting in flakes, coating.

Embodiment 4 capsular preparations

The crude drug decoction pieces that will be equivalent to 1000 tablets of tablets decocts with water three times, and collecting decoction filters, filtrate decompression is concentrated into the thick paste shape, 100 mesh sieves are crossed in dry, pulverizing, obtain even particulate, add an amount of mixing of starch, pour in the pot, intermittently be sprayed on the fine powder, make into granule with 70% ethanol, 50-60 ℃ of drying, 1000 capsules of packing.

The preparation of embodiment 5 electuaries

Press the prescription of embodiment 1, each medicine decoction pieces water is decocted 2-3 time, seethed with excitement 2 hours at every turn, filter, merging filtrate suitably concentrates the back and adds equivalent 95% ethanol, and placement is spent the night.Get the fluid of inclining, precipitation is cleaned with a small amount of 95% ethanol, and washing liquid is filtered, and merges with the fluid of inclining, and reduction vaporization reclaims ethanol, continues evaporation and concentration again, adds an amount of Icing Sugar, and mix homogeneously intermittently sprays with an amount of ethanol, makes granule, 50-60 ℃ of drying, packing.

The one clinical pharmacology research of test example

Object of study:

Object of study is from Yueyang gynecological of the hospitals of traditional Chinese and western medicine, Longhua gynecological of hospital, and Jiading District healthcare hospital for women ﹠ children, Jiading District institute of traditional Chinese medicine, 61 parts of cases of in December, 1997 to 2000 year December, wherein 55 examples turn out to be gynecopathy through pathologic finding.

Include the gynecopathy diagnostic criteria of the 3rd academic conference revision of standard reference nineteen ninety CAIM (Chinese Association Of Integrative Medicine) department of obstetrics and gynecology Professional Committee and diagnostic criteria (combination of Chinese and Western medicine magazine, 1991,11 (6): 376-379) of infertility in.Stipulate that the patient did not use the hormone medicine of danazol or other treatment gynecopathy in half a year.

Include the observation case in and be divided into treatment by Chinese herbs group (46 example) and danazol treatment group (15 example) at random.Other establishes the normal control group: 15 examples have the women of normal ovulatory cycle, age 20-40 year, 30.12 ± 1.25 years old mean age.

1. physical data:

The average infertile merging fallopian tube of example

Age course of disease POOS

Age several years, time limit muscular tumor was obstructed

Chinese drug-treated group 46 20-40 39.32 ± 3.16 4.58 ± 2.05 5.17 ± 1.45 93 10

Danazol group 15 20-40 39.52 ± 3.29 5.03 ± 2.37 5.36 ± 1.20 212

Both are no significant difference (P＞0.05) on every index, illustrates that two groups have comparability.

2. main clinical shows and sign

Chinese drug-treated group (n.%) danazol group (n.%)

Dysmenorrhea 40 (86.96%) 12 (80.00%)

Menoxenia 10 (21.74%) 4 (26.67%)

Infertile 46 (100%) 15 (100%)

Sexual anhedonia 16 (34.78%) 6 (40.00%)

Rectal tenesmus 15 (32.61%) 5 (33.33%)

Pelvic cavity tenderness tuberosity 32 (69.57%) 11 (73.33%)

Chocolate cyst of ovary 23 (50.00%) 8 (53.33%)

Curative effect determinate standard: with reference to the criterion of therapeutical effect of the endometriosis of pelvis of nineteen ninety CAIM (Chinese Association Of Integrative Medicine) department of obstetrics and gynecology Professional Committee the 3rd academic conference revision.

1. recovery from illness:

(1) symptom (comprising the blood stasis syndrome) all disappears;

(2) local sign such as pelvic lump disappears substantially;

(3) infertility patient gestation or fertility in 3 years.

2. produce effects:

(1) symptom (comprising the blood stasis syndrome) is basic disappears;

(2) pelvic lump dwindles (the same time inspection contrast of menstrual cycle; Contrast of the same period before and after the ultrasound diagnosis treatment)

3. effective:

(1) sx

(2) pelvic lump does not have increase or slightly dwindles (the same time inspection contrast of menstrual cycle; Contrast of the same period before and after the ultrasound diagnosis treatment)

(3) symptom does not increase the weight of in the drug withdrawal 3 months

4. invalid:

(1) cardinal symptom no change or deterioration

(2) local patholoic change has the trend of increasing the weight of

The method and the course of treatment:

The treatment by Chinese herbs group adopts Chinese medicine composition of the present invention, makes decoct by Yueyang hospital pharmacy unification.Every milliliter contains crude drug 2.5g, each 40ml, a twice-daily.Three months is a course of treatment.

Danazol group danazol capsule (specification 100mg/ grain, Hua Lian, Shanghai pharmaceutical factory produces), each oral 200mg, a twice-daily.Three months is a course of treatment.

Observation index:

1. clinical symptoms and sign situation

2. the situation of medicine typing and curative effect

3. lab testing

1. the mensuration of serum endocrine indexes before and after treating

Get proliferative phase (menstrual cycle 7-10 days) and secretory phase the peripheric venous blood 3ml of (behind the body temperature rise the 7th day), the conventional separation, it is to be measured to get serum, adopts the magnetic enzyme linked immunosorbent assay, and medicine box is provided by Switzerland sernon company.

2. peripheral blood CA before and after treating ₁₂₅, the mensuration of EmAb

Get peripheric venous blood, conventional separation of serum, to be measured.CA125 employing time explanation fluorescent immune method detects, and EmAb adopts the ELISA method to detect.

3. the detection of normal group, gynecopathy group and Chinese drug-treated group peritoneal fluid cellular immune function

Get in the Rhizoma Atractylodis Macrocephalae about peritoneal fluid (the obviously the blood contamination person discards) 10ml that respectively organizes the patient, put into the anticoagulant heparin pipe, wash secondary with PBS, slowly add behind the mixing and fill in the test tube of lymphocyte separation medium, centrifugal 2000r/min 20 minutes, draws the mononuclearcell layer.Flow cytometer detects the t lymphocyte subset group, and FACSCalibur flow cytometer and monoclonal antibody are B-D company product.

4. normal group and gynecopathy group peritoneal fluid Prostaglandin PGF _{1 α}, PGE ₂Mensuration

Get and respectively organize about patient's peritoneal fluid 2ml, put into indometacin one calparine pipe, add the ethyl acetate extraction secondary in the supernatant after centrifugal, collect supernatant, be put in the cold wind place and dry up ,-20 ℃ of preservations are to be measured, put the method for exempting from and measure, and medicine box is provided by Suzhou Medical College.

Statistical method:

Quantity represents that with x ± s measurement data is checked with t, and ranked data are checked with Ridit.

Result: see Table 1-7.

1. the improvement of clinical symptoms and sign

Table 1

Chinese drug-treated group danazol group

After treating before the preceding treatment of the treatment back treatment

Dysmenorrhea 40 2 12 1

Infertile 46 35 15 10

Menoxenia 10 243

Sexual anhedonia 16 265

Rectal tenesmus 15 255

Pelvic cavity tenderness tuberosity 32 4 11 1

Chocolate cyst of ovary 23 487

2. clinical efficacy

Table 2

Example number clinical recovery produce effects enabledisable total effective rate

Chinese drug-treated group 46 11 17 13 5 89.13%

Danazol group 15 5631 93.33%

The total effective rate of Chinese drug-treated group and danazol group is respectively 89.13%, 93.330%, compares there was no significant difference between two groups.

3. the relation of medicine typing and clinical efficacy

Table 3

Example number clinical recovery produce effects enabledisable total effective rate

Qi depression to blood stasis 10 2332 80.00%

Blood stasis due to renal deficiency 15 3552 86.87%

Dampness and heat stasis 91242 77.78%

Blood stasis due to qi deficiency 12 5511 91.67%

4. the serum endocrine is measured

(1) proliferative phase:

Table 4 (1) is to the endocrine influence of proliferative phase

(n) Chinese drug-treated group (n) danazol group (n) before normal group (n) treatment

FSH 4.71±2.13(13) 3.73±2.86(16) 5.78±5.08(16) 5.13±1.86(11)

LH 6.59±5.54(14) 4.86±2.59(16) 6.62±3.12(16) 2.93±1.49(11)

E ₂ 62.79±63.65(13) 126.94±81.46(15) 76.16±33.63(15) 50.84±30.79(10)

P 4.74±9.44(12) 5.22±5.12(15) 3.02±5.17(15) 0.49±0.31(10)

PRL 334.98±245.43(12) 513.58±454.37(17) 228.46±144.41(17) 176.04±170.57(9)

T 0.74±0.81(10) 0.31±0.30(14) 0.31±0.18(11) 0.47±0.10(6)

By table 4 (1) as seen, E before the treatment of proliferative phase gynecopathy group ₂Apparently higher than normal group (p=0.03), significant difference is arranged, Chinese drug-treated group and danazol group all make the E that increases ₂Descend, with relatively there were significant differences (p is respectively 0.045 and 0.005) before the treatment, Chinese drug-treated group and danazol group be no significant difference relatively.In addition, the danazol group significantly reduces the content of blood-serum P, with the preceding relatively p=0.003 of treatment.Gynecopathy group levels of serum PRL increases than normal group, but two groups of comparison there was no significant differences, after the treatment, Chinese drug-treated group and danazol group PRL all descend, and the p value is respectively 0.028,0.015.

(2) secretory phase:

Table 4 (2) is to endocrine influence of secretory phase

Normal group gynecopathy group Chinese drug-treated group danazol group

E ₂ 227.54±97.61 468.14±144.60 ^Δ 284.12±258.72 195.55±73.25 ^*

P 17.68±6.41 10.23±2.55 ^Δ 13.94±5.70 ^* 5.706±3.06 ^*

^ΔCompare P＜0.05 with normal group

^*Compare p＜0.05 with the gynecopathy group

By table 4 (2) as seen, secretory phase gynecopathy group E ₂With normal group significant difference (P=0.047) is arranged relatively, back danazol group E is treated in smelting ₂Descend, difference has significance meaning (p=0.010); Gynecopathy group P has remarkable reduction (p=0.047) before the treatment, there is the significance meaning danazol group treatment back with normal group, gynecopathy group comparison p value, and (p is respectively 0.007,0.046), Chinese drug-treated group treatment back serum progesterone content increases, with the preceding relatively p=0.043 of treatment, compare p=0.016 with danazol, significant difference is arranged.

5. change of serum C A ₁₂₅, EmAb mensuration

CA after the treatment by Chinese herbs ₁₂₅Decline is arranged, but the front and back comparing difference does not have the significance meaning, the routine number of EmAb (+) is 5 examples before the treatment by Chinese herbs, and treatment back 3 examples are turned out cloudy, and less because of this routine number, the result awaits further observation.

Table 5

After treating before the treatment

The routine number x ± s of routine number x ± s＞35 of＞35n/ml

CA ₁₂₅

112.70±124.78(25) 117.94±144.34

The negative routine number of the positive routine number of the total routine number of EmAb

Treat preceding 10 55

Treatment back 10 28

6. peritoneal fluid t lymphocyte subset group's mensuration

Table 6

Example number CD ₃ ⁺CD ₄ ⁺CD ₈ ⁺CD ₄ ⁺/ CD ₈ ⁺

Normal group 8 45.65 ± 6.39 19.61 ± 5.64 25.58 ± 5.46 0.77 ± 0.32

Gynecopathy group 8 51.00 ± 17.22 27.35 ± 5.41 ^Δ20.75 ± 15.45 1.94 ± 0.99

Chinese drug-treated group 7 48.71 ± 21.94 19.36 ± 7.25 ^*25.83 ± 14.37 0.98 ± 0.57 ^*

By table 6 as seen, CD in the gynecopathy group peritoneal fluid ₄ ⁺Obviously raise than normal group, two groups relatively have significant difference (p=0.020), CD ₄ ⁺/ CD ₈ ⁺Also significantly raise than normal group, two groups of comparing differences have significance meaning (p=0.017), CD after the treatment by Chinese herbs ₄ ⁺And CD ₄ ⁺/ CD ₈ ⁺All significantly descend, and before the treatment significance meaning (p is respectively 0.043,0.049) is arranged relatively.

7. peritoneal fluid Prostaglandin PGF _{1 α}, PGE ₂Mensuration

Table 7

PGF _1α(n) PGE ₂

Normal group 4.46 ± 3.81 (6) 8.32 ± 2.61 (7)

Gynecopathy group 18.72 ± 12.13 ^Δ(6) 8.60 ± 1.03 (8)

^ΔP＜0.05

By table 7 as seen, Prostaglandin PGF in the gynecopathy group peritoneal fluid _{1 α}Significantly raise, significance meaning (p=0.046), PGE are arranged with comparing difference before the treatment ₂Normal group and gynecopathy group be there was no significant difference relatively.

Test example two Chinese medicine compositions of the present invention are to the adjusting of reproductive endocrine-immunity-PGs system of EM

Adopt 70 of not copulation female sd inbred rats of 9 cleaning levels in age in week, body weight 200 ± 10g provides lot number by Chinese Academy of Sciences's Shanghai Experimental Animal Center: 0-03.70 rats are divided into 7 groups at random, and except that normal group and sham operated rats, all the other are that model group, model Chinese drug-treated group, model danazol group, model Chinese medicine and western medicine are in conjunction with organizing and model prevention group every group of each 10 rat.

With reference to Vernon, the method for Hahn and Kajkumark (Fertil Strril, 1985,44 (5): 684-693:ibid., 1985,44 (3): 410-415; Fertil, 1990,53 (5): 921) set up Mus EM model.Get to divide about the one cross-talk palace 15mm of right side and get each three of 5 * 5mm, inner membrance is planted respectively in the corresponding stomach wall of left ovary, the other mesentery of opening the 1cm place of left ovary, left uterus combines the other mesentery of opening of portion with fallopian tube.The residue inner membrance carries out histological examination, to confirm that implant is an endometrium.The sham operated rats modeling method is substantially with the EM model, but not with the endometrial implantation of excision, and at corresponding site fat is sewed up.After the modeling conventional raised for 4 weeks after, except normal group and the sham operated rats, all the other each groups are cut open the belly for the second time, observe plantation inner membrance survival condition.The survival standard forms for vesicles is arranged, and confirms through the histology.

All rats are conventional to be raised, ad lib, the Shi Jian Give medicine that reproductive function was had the greatest impact in 50-70 days after selecting to transplant (Biol Reprod 1999,60:954-958).The 6th week beginning timing in morning every day medicine feed after the modeling, Chinese drug-treated group gavages Chinese medicine suspension 3ml with stomach tube; The prevention group gavaged Chinese medicine in advance in 2 weeks, and Chinese medicine is by Yueyang hospital pharmacy preparation (crude drug content 5g/ml); The Western medicine group gavages danazol (production of Hua Lian, Shanghai pharmaceutical factory) solution 3ml (10.05mg/ml); Chinese medicine and western medicine adds danazol 1/2 dosage in conjunction with group with Chinese medicine.Lian Xu Give 4 weeks of medicine.Below respectively organize the rat vagina plate coating checking, put to death preceding 24 hours lumbar injection 0.5% lactoalbumin hydrolysate (import is given by Shanghai Institute of Pharmaceutical Industry) 1ml rutting period, get peritoneal fluid after 24 hours, abdominal aortic blood is to be measured then.

Observation index and assay method

1.PGs (6-ketone-PGF1 α, PGE2)

Adopt measured by radioimmunoassay blood plasma 6-ketone-PGF1 α, PGE2, medicine box is provided by Suzhou Medical College, lot number: 000106

2.E2，P

Adopt the Switzerland product SEROZYME I of Sernon company magnetic microplate reader to detect.

Adopt the magnetic enzyme linked immunosorbent assay to measure serum E2, P, reagent is provided by Switzerland Sernon company

Lot number is respectively CHBJ015, and 001102.

3.T cell subsets

Adopt the FACSCalibur flow cytometer, B-D Asia company limited product, reagent are Cataloq340499, and centrifugal peritoneal fluid sedimentation cell with extracting mononuclearcell with lymphocyte separation medium behind the PBS washing secondary, adds CD ₃, CD ₄, CD ₈Monoclonal antibody, placement add erythrocyte cracked liquid (Tris-NH4CL) clarification and go supernatant to be measured after half an hour.

Statistical method: adopt the t check

The result

1. to blood plasma 6-ketone-PGF _{1 α}, PGE ₂Influence

Experimental result shows: PGF _{1 α}Normal group and sham operated rats do not have significant difference (p=0.8332), and there were significant differences (p=0.0013) with model group, confirm that in conjunction with other detection index and pathology this experimental model is reliable.Model group and Chinese drug-treated group difference have significance (p=0.0183).

The PGE2 model group combines group difference with Chinese medicine and western medicine have significance (p=0.0074).The results are shown in Table 8.

Table 8 Chinese medicine composition is to blood plasma 6-ketone-PGF _{1 α}, PGE ₂Influence

Group n 6-ketone-PGF _{1 α}PGE ₂(pg/ml)

(pg/ml)

Normal group 10 16.33 ± 3.30 13.84 ± 4.99

Sham operated rats 10 15.84 ± 6.00 9.73 ± 4.29

Model group 10 10.86 ± 2.75 ^^8.68 ± 2.87

Model Chinese drug-treated group 10 14.92 ± 3.75* 10.19 ± 2.70

Model danazol group 10 9.87 ± 3.55 8.53 ± 4.02

The model Chinese medicine and western medicine is in conjunction with group 10 10.27 ± 3.26 5.10 ± 2.01**

The model prevention organizes 10 13.20 ± 3.53 8.38 ± 3.91

Annotate: compare with normal group, ^^p＜0.01,

Compare with model group, ^*P＜0.05, ^*P＜0.01

2. to the influence of serum E2, P

There were significant differences for P normal group and model group (P=0.0463), all do not have significant difference with other each group.Compare with model group, Chinese drug-treated group P raises (P=0.0450), and the danazol group reduces (P=0.0015).E2 model group and each group comparing difference there are no significant meaning.See Table 9.

Table 9 Chinese medicine composition is to serum E ₂, P influence

Group n E ₂(pg/ml) P (ng/ml)

Normal group 8 12.51 ± 5.64 18.88 ± 5.96

Sham operated rats 8 10.77 ± 4.80 18.10 ± 7.94

Model group 8 13.89 ± 9.16 13.94 ± 3.02

Model Chinese drug-treated group 8 13.54 ± 8.78 18.13 ± 3.52*

Model danazol group 8 12.46 ± 9.70 7.96 ± 3.24**

The model Chinese medicine and western medicine is in conjunction with group 8 12.30 ± 5.31 12.99 ± 2.60

The model prevention organizes 8 14.02 ± 5.3 13.9 ± 7.42

Annotate: compare with normal group, ^p＜0.05,

Compare * p＜0.05, * * p＜0.01 with model group.

3. to the influence of T cell subsets in the peritoneal fluid

CD ₄ ⁺Normal group is apparently higher than model group (p=0.0010), and difference has the significance meaning.All the other each groups more all have notable difference (seeing Table 3) with model group.CD ₈ ⁺Each group difference there are no significant meaning.CD ₄ ⁺/ CD ₈ ⁺Normal group combines group relatively, CD with model group, model group with Chinese drug-treated group and Chinese medicine and western medicine ₄ ⁺/ CD ₈ ⁺Ratio reduces, and its difference has the significance meaning.See Table 10.

Table 10 Chinese medicine composition is to the influence of T cell subsets in the peritoneal fluid

Group n CD ₄ ⁺(%) CD ₈ ⁺(%) CD ₄ ⁺/ CD ₈ ⁺

Normal group 8 55.53 ± 7.74 37.43 ± 4.39 1.49 ± 0.17

Sham operated rats 8 62.94 ± 8.30* 39.95 ± 7.27 1.62 ± 0.29

Model group 8 70.47 ± 2.36 ^^41.20 ± 5.05 1.82 ± 0.19^^

Model Chinese drug-treated group 8 59.71 ± 11.84* 40.65 ± 5.23 1.48 ± 0.33*

Model danazol group 8 59.88 ± 5.06** 36.39 ± 3.80 1.66 ± 0.20

The model Chinese medicine and western medicine is in conjunction with group 8 62.34 ± 1.75** 39.35 ± 3.62 1.58 ± 0.09*

8 59.58 ± 5.33** 35.00 ± 6.43 1.78 ± 0.45 are organized in the model prevention

Annotate: compare ^p＜0.05, ^^p＜0.01 with normal group

Compare * p＜0.05, * * p＜0.01 with model group.

Claims (7)

1. gynecological Chinese medicine compositions, it is characterized in that, this Chinese medicine composition is made by following raw materials according: process stilbene 30-60 gram, Radix Salviae Miltiorrhizae 20-35 gram, Pollen Tyjphae 24-40 gram, Oletum Trogopterori 15-25 gram, Myrrha 6-10 gram, rhizoma sparganic 15-25 gram, Rhizoma Curcumae 15-25 gram, Caulis Sargentodoxae 30-50 gram, Herba Patriniae 30-50 gram, by the crude drug amount, and acceptable carrier, excipient and additive on the materia medica.

2. gynecological Chinese medicine compositions as claimed in claim 1, described Chinese medicine composition are oral liquid.

3. gynecological Chinese medicine compositions as claimed in claim 1, described Chinese medicine composition are soft extract.

4. gynecological Chinese medicine compositions as claimed in claim 1, described Chinese medicine composition are tablet.

5. gynecological Chinese medicine compositions as claimed in claim 1, described Chinese medicine composition are capsule.

6. gynecological Chinese medicine compositions as claimed in claim 1, described Chinese medicine composition are electuary.

7. as the described gynecological Chinese medicine compositions of one of claim 1-6, wherein also comprise pharmaceutically acceptable excipient.