CN100493569C - Medicament for preventing and treating benign hyperplasia of mammary glands for women and preparation process thereof - Google Patents
Medicament for preventing and treating benign hyperplasia of mammary glands for women and preparation process thereof Download PDFInfo
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- CN100493569C CN100493569C CNB2006100663433A CN200610066343A CN100493569C CN 100493569 C CN100493569 C CN 100493569C CN B2006100663433 A CNB2006100663433 A CN B2006100663433A CN 200610066343 A CN200610066343 A CN 200610066343A CN 100493569 C CN100493569 C CN 100493569C
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- rhizoma corydalis
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Abstract
Disclosed is a medicament for preventing and treating women's mammary gland benign hyperplasia and its preparation method, wherein the constituents of the medicament comprise Bupleurum root, reddish orange, green tangerine orange peel, cyperus rotundus, Chinese angelica root, root of herbaceous peony, white atractylodes rhizome, poria cocos, thunberg fritillary bulb, oyster shell, Chinese honey locust, selfheal, seed of cowherb, rhizoma corydalis, toosendan fruit, and sweetgum fruit.
Description
Invention field
The present invention relates to a kind of medicine, particularly a kind ofly be used to prevent and treat Chinese patent medicine of benign hyperplasia of mammary glands in women and preparation method thereof.
Background technology
Mastopathy is modal in the current gynaecological disease generaI investigation, good sending out in young woman's benign breast disease, shows as breast list or bilateral lump, mastalgia and lump and menstrual cycle and feelings will and changes closely related.According to Guangzhou 288857 routine women's mastopathy examination situation analysis during the decade in 1994-2003 years, mastopathy recall rate front three from high to low is arranged as: cyclomastopathy (average out to 49.30%), congenital or abnormal development (average out to 1.78%), mammary gland fibroadenoma (average out to 1.63%).There are confidential relation at the sickness rate and the age of several main diseases kinds of mammary gland.The cyclomastopathy age of onset is an adolescence to any age in menopause, but with 25-50 year for seeing more, with 35-45 year be onset peak, the cyclomastopathy more than 75% is the women of child-bearing age's a main diseases kind in 35-49 year.Nearly 85% mammary gland fibroma patient age is not higher than 35 years old, surpasses 70% in 20-34 year.Tianjin tumour hospital 10316 routine statistics, the mean age is 28 years old.
Cyclomastopathy belongs to the nodules of the breast category in motherland's medical science, many duties in the stagnation of liver-QI and the expectorant stasis of blood, be divided into liver energy depression and phlegm stagnation, Chong and Ren channel disorder amphitypy.The traditional Chinese medical science thinks that primary disease is because the unsuccessful melancholy of feelings will is not understood, and strongly fragrant impairing the liver of a specified duration, or be subjected to direct stimulation is irritable angry, can cause depression of liver-QI, and the mechanism of qi stasis of blood stagnates, and pents up in breast stomach network, and newborn network meridian and vessels obstruction is obstructed, stagnation of QI and blood may bring about pain and cause mastalgia; Hepatic depression heat-transformation of a specified duration, the bright body fluid of heat is expectorant, stagnation of QI expectorant coagulates, and can form lump in breast.Dash wantonly two arteries and veins and arise from uterus, dash the QI and blood of appointing, last behavior breast, the following behavior moon water, if Chong and Ren channel disorder, stagnation of QI-blood accumulates in breast, uterus, or mastalgia and luming, or the menses disorder is lacked of proper care.
Modern study points out the imbalance of this sick cause of disease Chong and Ren channel disorder and endocrine hormone that certain dependency is arranged, periodic disorder of hormone secretion especially the preovulatory phase interstitialcellstimulating hormone (ICSH), estradiol hyposecretion be cause a disease crucial.Clinical researches such as Que Shi show liver energy depression and phlegm stagnation type patients serum E
2, PRL, CD
4 +, CD
8 +, CD
4 +3CD
8 +Raise CD
3 +Descend; Disharmony of Chong and Conception Channels type levels of serum PRL, E
23P, E
23T raises, and P, T descend, and point out this disease and endocrine immunity closely related, and clinical treatment suitably carries out the dialectical curative effect that helps to improve in conjunction with the endocrine immune level.
The treatment present situation: the common pilosity of benign hyperplasia of mammary glands disease, can stop at a certain stage in morbidity back several months or several years spontaneous remission or spontaneous recovery, also can progressively develop, in, canceration takes place in late period.Cyclomastopathy, cystic hyperplasia, adenopathy, fiber disease etc. are outgrowth different stages of development, also can appear in the same tissue.Various multi-form cyclomastopathy all can be with epithelial proliferation in various degree, breast carcinoma all is the atypical epithelial proliferation that comes from continuous development, the canceration rate of bibliographical information cystic hyperplasia of breast is 2-4%, and this danger can continue until 30 years that make a definite diagnosis behind the cystic disease of breast.Therefore, the optimum cyclomastopathy of active treatment is improving the WomanHealth level, reduces the rate aspect that cancerates and has very positive meaning.Treatment with western application hormone and incretotherapy treatment primary disease, though curative effect is good, side effect is bigger, gonadal hormone especially may further disturb the balance between the hormone of human body after the application, and increases the possibility of canceration.So generally not them as routine administration, only when serious symptom, just consider to use.The severe hypertrophy there is the tendency person of cancerating, then takes operative therapy.Use the Chinese medicine primary disease, except that Chinese patent medicines commonly used such as XIAOYAO POWDER, Yueju Wan, XIAOJIN DAN, RUKANG PIAN, PINGXIAO JIA0NANG and asparagine sheet, curative effects such as a large amount of proved recipes, folk prescription, acupuncture-moxibustion, massage, cupping jar, applying Chinese medicine to the umbilicus, magnetic medicine chest protecting device and iontophoresis are reliable, almost have no side effect.
Treating in the medicine of cyclomastopathy at present, the Western medicine side effect causes anxiety, Chinese medicine is comparatively commonly used, no matter be the pharmacy or the treatment of hospital preparation cyclomastopathy all based on Chinese patent medicine, as BAIXIAO DAN, auspicious dragon breast peace sheet, RUKANG PIAN, breast rather increase, products such as Traditional Chinese medicinal liquid for eliminating module in breast, RUKUAIXIAO, RUJILING CHONGJI, mammary gland health paste, the sharp XIAOJIN WAN in sky.The Chinese medicine primary disease has actual advantage, thus as adopting the length of Chinese medicine, develop taking convenience, the novel formulation of determined curative effect, tool has very important significance.The Chinese patent medicine that the present invention relates to can be widelyd popularize aspect the dissipation of tuberosity lump and the pain relieving tangible objective curative effect being arranged.
Summary of the invention
The invention provides a kind of medicine that is used to prevent and treat benign hyperplasia of mammary glands in women, this medicine is made by the former medicine of following ratio of weight and number:
42.5-127.5 parts of 28-84 parts of Folium Citri tangerinae of Radix Bupleuri
22.5-67.5 parts of 22.5-67.5 parts of Rhizoma Cyperi of Pericarpium Citri Reticulatae Viride
22.5-67.5 parts of 34-102 parts of Radix Paeoniae Albas of Radix Angelicae Sinensis
22.5-67.5 parts of Poria 22.5-67.5 of Rhizoma Atractylodis Macrocephalae part
19-57 parts of 17-51 parts of Concha Ostreaes of Bulbus Fritillariae Thunbergii
42.5-127.5 parts of 28-84 parts of Spica Prunellaes of Spina Gleditsiae
19-57 parts of 31.5-94.5 parts of Rhizoma Corydalis of Semen Vaccariae
14-42 parts of 28-84 parts of Fructus Liquidambaris of Fructus Toosendan
Medicine of the present invention is preferably made by the former medicine of following percentage by weight:
45 parts of 45 parts of Rhizoma Cyperi of 85 parts of Pericarpium Citri Reticulatae Virides of 56 parts of Folium Citri tangerinae of Radix Bupleuri
45 parts in 45 parts of Poria of 45 parts of Rhizoma Atractylodis Macrocephalaes of 68 portions of Radix Paeoniae Albas of Radix Angelicae Sinensis
85 parts of 56 parts of Spica Prunellaes of 38 parts of Spina Gleditsiaes of 34 portions of Concha Ostreaes of Bulbus Fritillariae Thunbergii
28 parts of 56 parts of Fructus Liquidambaris of 38 parts of Fructus Toosendans of 63 parts of Rhizoma Corydalis of Semen Vaccariae
Said medicine can be made this area dosage form commonly used, for example tablet, slow releasing tablet, capsule, slow releasing capsule or granule etc.
The present invention also provides manufacturing method for above mentioned medicine, and this method comprises described ten Six-element Chinese medicines, except that Bulbus Fritillariae Thunbergii, Concha Ostreae, Rhizoma Corydalis are ground into fine powder sieves, 13 flavor Chinese medicines such as all the other Radix Bupleuri decoct with water twice, collecting decoction filters, and concentrates, add Bulbus Fritillariae Thunbergii, Concha Ostreae, the abundant mixing of Rhizoma Corydalis fine powder, make extractum, drying under reduced pressure becomes dried cream, crushing screening, add adjuvant, mixing is made granule.
Medicine preferred manufacturing procedure of the present invention is with described ten Six-element Chinese medicines, remove Bulbus Fritillariae Thunbergii, Concha Ostreae, Rhizoma Corydalis is ground into outside fine powder sieves, 13 flavor Chinese medicines such as all the other Radix Bupleuri decoct with water twice, 2 hours for the first time, 1.5 hours for the second time, collecting decoction, filter, it is about 1.3 to be concentrated into relative density, adds Bulbus Fritillariae Thunbergii, Concha Ostreae, the abundant mixing of Rhizoma Corydalis fine powder is made extractum, drying under reduced pressure becomes dried cream between 40 ℃ to 50 ℃, pulverized 120 mesh sieves, added starch or pregelatinized Starch or Pulvis Talci or dextrin or carboxymethyl starch sodium, made granule with micropowder silica gel or 80-85% ethanol or water mixing.As required, can be with gained granule tabletting or encapsulated.Preferably described granule is pressed into the sheet of every heavy 0.25 gram.
Detailed Description Of The Invention
The present invention follows in the theory of Chinese medical science many because of depressed rage impairing the liver, stagnation of QI due to depression of the liver about cyclomastopathy (a kind of mastopathy that belongs to motherland's medical science nodules of the breast category); Worry impairing spleen, dysfunction of the spleen in transportation accumulates in the phlegm-damp, causes liver spleen two wounds, stagnation of Qi and phelgm, the stasis of blood stagnates and lumps; Or because of deficiency of the liver and kindey, Chong and Ren channel disorder, knot in the yang deficiency phlegm-damp, and the lump in breast that occurs, through before swelling and ache through after the foundation of disease such as alleviate, be stagnation of QI due to depression of the liver, dysfunction of the spleen in transportation, deficiency of the liver and kindey and setting up.Radix Bupleuri, Folium Citri tangerinae, Pericarpium Citri Reticulatae Viride, Rhizoma Cyperi dispersing the stagnated live-QI to relieve the stagnation of QI in the side have Radix Angelicae Sinensis, Radix Paeoniae Alba nourishing blood to suppress the hyperactive liver again, Chong and Ren Meridians regulating, and the Rhizoma Atractylodis Macrocephalae, Poria spleen invigorating are dried, and fortuneization is had the right, and QI and blood is active.Bulbus Fritillariae Thunbergii, Concha Ostreae, Spica Prunellae, Spina Gleditsiae dissipating phlegm and resolving masses, detumescence.Fructus Liquidambaris, Semen Vaccariae promoting blood circulation to remove obstruction in the collateral, the operation QI and blood.Rhizoma Corydalis, Fructus Toosendan promoting the circulation of QI to relieve pain, thus reach unobstructed vessel, move without hindrancely, dash to appoint coordinate, so our compatibility logos with nourishing blood to suppress the hyperactive liver, soothing liver and strengthening spleen, QI and blood is taken into account, the liver spleen is also controlled.
The function of medicine of the present invention with cure mainly: dispersing the stagnated live-QI to relieve the stagnation of QI, dissipating phlegm and resolving masses, promoting blood circulation to remove obstruction in the collateral, Chong and Ren Meridians regulating.Be used for mastopathy such as cyclomastopathy, mammary gland fibroma, distending pain of the breast.
Medicine of the present invention studies show that through animal experiment:
1. acute toxicity test: the mice lavage administration, recording mice is 20 gram/kilograms to the maximum tolerated dose of medicine of the present invention (embodiment 1 preparation medicine), is about 220 times of clinical people's consumption.
2. to rabbit, the outgrowth preventive and therapeutic effect of rat mammary gland: Female rabbits and rat, intramuscular injection every day estradiol (E are adopted in experiment
2), continuous 28 days, duplicate hyperplasia of mammary gland model, be index with mammary gland mode of appearance size, histology's om observation, sex hormone level, the evaluation pathological model is observed the prevention effect of this product to cyclomastopathy.Animal is divided into normal control group, model group, this product and positive drug control group, oral administration, continuous use 28 days.The result as seen, the medicine of the present invention of 1.5 and 4.5 gram/kilogram dosage (embodiment 1 preparation medicine) can obviously suppress rabbit and rat mammary gland enlargement and mammoplasia that estradiol causes, can reduce estradiol (E in the blood
2) and progesterone (P) level.Show that this product is to E
2The animal's mammary gland hypertrophy disease model that duplicates has the better prevention effect.
3. analgesic activity: this product can improve the burning pain fault value of mice, and can suppress the writhing response that acetic acid causes, shows that this product has certain analgesic activity.
4. antiinflammatory action: this product can suppress dimethylbenzene and smear the mice auricle swelling that skin causes, subcutaneous cotton balls is implanted the rat granuloma that causes form and also have stronger inhibitory action.
5. to the mouse cell Immune Effects: this product can strengthen mouse monokaryon and engulf the clean up function of system to dyestuff, also can increase mouse thymus weight, has certain immunologic enhancement.
6. to the microcirculatory influence of mouse ear: this product has some improvement to mice microcirculation tool.
Embodiment
Embodiment 1
Raw material:
11.25 kilograms of Radix Bupleuri, 16.9 kilograms of Folium Citri tangerinae, 9 kilograms on Pericarpium Citri Reticulatae Viride, 9 kilograms of Rhizoma Cyperi, 13.5 kilograms of Radix Angelicae Sinensis, 9 kilograms of the Radix Paeoniae Albas, 9 kilograms of the Rhizoma Atractylodis Macrocephalaes, 9 kilograms in Poria, 6.75 kilograms of Bulbus Fritillariae Thunbergii, 7.5 kilograms of Concha Ostreaes, 11.25 kilograms of Spina Gleditsiaes, 16.9 kilograms of Spica Prunellaes, 12.5 kilograms of Semen Vaccariae, 7.5 kilograms of Rhizoma Corydalis, 11.25 kilograms of Fructus Toosendans, 5.6 kilograms of Fructus Liquidambaris;
Preparation:
Bulbus Fritillariae Thunbergii, Concha Ostreae, Rhizoma Corydalis are ground into fine powder and sieve, and 13 flavor Chinese medicines such as all the other former medicine Radix Bupleuri decoct with water twice, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, it is about 1.3 to be concentrated into relative density, adds Bulbus Fritillariae Thunbergii, Concha Ostreae, the abundant mixing of Rhizoma Corydalis fine powder, makes extractum, drying under reduced pressure becomes dried cream between 40 ℃ to 50 ℃, pulverized 120 mesh sieves, added starch, and added 80% ethanol behind the mixing and make granule, compacting is in blocks, every heavy 0.25 gram.
Embodiment 2
Raw material:
6.78 kilograms of Radix Bupleuri, 10.19 kilograms of Folium Citri tangerinae, 5.42 kilograms on Pericarpium Citri Reticulatae Viride, 5.42 kilograms of Rhizoma Cyperi, 8.14 kilograms of Radix Angelicae Sinensis, 5.42 kilograms of the Radix Paeoniae Albas, 5.42 kilograms of the Rhizoma Atractylodis Macrocephalaes, 5.42 kilograms in Poria, 4.07 kilograms of Bulbus Fritillariae Thunbergii, 4.52 kilograms of Concha Ostreaes, 6.78 kilograms of Spina Gleditsiaes, 10.19 kilograms of Spica Prunellaes, 7.53 kilograms of Semen Vaccariae, 4.52 kilograms of Rhizoma Corydalis, 6.78 kilograms of Fructus Toosendans, 3.38 kilograms of Fructus Liquidambaris;
Preparation:
Bulbus Fritillariae Thunbergii, Concha Ostreae, Rhizoma Corydalis are ground into fine powder and sieve, and 13 flavor Chinese medicines such as all the other former medicine Radix Bupleuri decoct with water twice, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, it is about 1.3 to be concentrated into relative density, adds Bulbus Fritillariae Thunbergii, Concha Ostreae, the abundant mixing of Rhizoma Corydalis fine powder, makes extractum, drying under reduced pressure becomes dried cream between 40 ℃ to 50 ℃, pulverized 120 mesh sieves, and added Pulvis Talci, the water mixing is made granule, compacting is in blocks, every heavy 0.25 gram.
Pharmacodynamics test
Test objective
Medicine of the present invention is made up of flavour of a drug such as Radix Bupleuri, Radix Angelicae Sinensis, has the effect that dispersing the stagnated live-QI to relieve the stagnation of QI, dissipating phlegm and resolving masses, promoting blood circulation to remove obstruction in the collateral, conditioning are filled the post of, and is used for treatment of diseases such as cyclomastopathy, mammary gland fibroma.Cure mainly according to its function, carry out following pharmacodynamics test.
Test material
1. given the test agent (hereinafter to be referred as " this product "):
According to the medicated powder of the method for embodiment 1 preparation, 4.1475g crude drug/gram, lot number: 20050501.
Provided by Asource pharmaceutcal corporation, Ltd of Shenzhen Tsing-Hua University, sample room temperature is preserved, and faces the time spent to be mixed with debita spissitudo for the animal gastric infusion with distilled water.
2. laboratory animal:
The Wistar rat, the court animal housing provides, the quality certification: No. 001, the accurate word of the real kinoplaszm R in W-J Tianjin.
Animal feeding is having in the observation ward of central air-conditioning (accurate No. 012 of the real facility in Tianjin meets the barrier grade standard).The special-purpose full nutrition piece of feed Mus material (Tianjin China flourish laboratory animal Science and Technology Ltd. produces), the drink tap water.
3. reagent:
3.1 estradiol benzoate injection: Tianjin gold credit aminoacid company limited is produced lot number 0410291.
3.2 estradiol radioimmunological kit: Tianjin Jiuding Medical Biological Engineering Co., Ltd, lot number: RG6510A.
3.3 progesterone radioimmunological kit: Tianjin Jiuding Medical Biological Engineering Co., Ltd, lot number: RG5510.
3.4 lactotropin radioimmunological kit: Tianjin Jiuding Medical Biological Engineering Co., Ltd, lot number: RG3510.
3.5 interstitialcellstimulating hormone (ICSH) radioimmunological kit: Tianjin Jiuding Medical Biological Engineering Co., Ltd, lot number: RG2510.
3.6 follicle stimulating hormone radioimmunological kit: Tianjin Jiuding Medical Biological Engineering Co., Ltd, lot number: RG1510.
3.7 testosterone radioimmunological kit: Tianjin Jiuding Medical Biological Engineering Co., Ltd, lot number: RG4510
3.8 positive control medicine: RUKUAIXIAO PIAN (Beilin Pharmaceutical Co., Ltd., Xi'an, lot number 200412086)
Test method and result
1. to the preventive effect of hyperplasia of mammary gland model rat
Positive drug RUKUAIXIAO medication: RUKUAIXIAO PIAN is pulverized, and the adding distil water dilution is ground in mortar, is made into the debita spissitudo suspension, and for the animal gastric infusion, dosage is 6/kg, quite 20 times of clinical dosage.Also quite 20 times of clinical dosage of RUKANG PIAN high doses.
Test is selected 60 of Wistar female rats for use, random packet, 10 every group.Press gastric infusion every day of dosage shown in the table 11 time, gave for 6 weeks continuously, matched group and model group are irritated stomach and are given with the volume distilled water.At gastric infusion simultaneously, except that matched group, peritoneal injection estradiol benzoate injection 0.6mg/kg next day that all the other respectively organizing rat injects 20 times continuously, and the matched group peritoneal injection is with the volume normal saline.Respectively at 4 weeks and six weeks after the administration respectively organizing preceding 2 pairs of papilla diameters of rat and length, calculate the nipple volume as nipple swelling degree with the precimeter measurement.Behind last injection estradiol benzoate 24 hours, rat is weighed, pluck eyeball after the record body weight and get blood, 3000r/min is centrifugal, and separation of serum is measured estradiol, progesterone content in the serum with estradiol, progesterone radioimmunological kit.Put to death rat, get the 1st, the 2 pairs of mammary gland in front and weigh, calculate the mammary gland coefficient.And mammary gland is done histopathologic slide check after 10% formalin is fixing.Every computation of mean values is as a result carried out statistics T check.
Result's (seeing Table 1-4) shows, compares the obvious swelling of rat model nipple with the blank group; Mammary gland weight obviously increases; Serum estradiol content raises, and progesterone content obviously reduces, the hormone secretion disorder; Histopathologic examination can see that acinus counts that showed increased, acinus and ductal ectasia, secretions increase, epithelial proliferation.After giving this product, can reduce hyperplasia of mammary gland model rat papilla diameter, length and nipple volume by highly significant, suppress the swelling of nipple; Highly significant alleviates mammary gland weight; In addition, RUKANG PIAN can suppress the rising of estradiol level in the rat model body, though because model group SD is higher, statistics unknown significance difference, but the suppression ratio of three dosage groups reaches 46%, 44.5%, 43.6% respectively, and the progesterone content of reduction is increased, regulating action is played in disorder to hormone secretion.Significantly improve breast disease form of science, the acinus number obviously reduces, epithelial hyperplasia disappears, and ductal ectasia and conduit endocrine are all had slight inhibitory action.The above results shows, this product prevention administration has significant inhibitory effect to the rat mammary gland hypertrophy of estrogen-induced, not only can suppress the increase of nipple swelling, mammary gland weight, can also suppress the raising of estrogen level, the progesterone content of decline is increased, thereby play the effect of control agent internal hormone parasecretion, improve mammary gland histopathology form, suppress the generation of cyclomastopathy.
Table 1 this product to the influence of hyperplasia of mammary gland model rat modeling 4 all nipple swelling degree (X ± SD, n=10)
Model group and blank group are relatively
△ △ △P＜0.001,
Administration group and model group are relatively
*P＜0.01,
* *P＜0.001
Table 2 this product to the influence of hyperplasia of mammary gland model rat modeling 6 all nipple swelling degree (X ± SD, n=10)
Model group and blank group are relatively
△ △ △P＜0.001, administration group and model group are relatively
* *P＜0.001
Table 3 this product to the influence of hyperplasia of mammary gland model rat mammary gland weight (X ± SD, n=10)
Model group and blank group are relatively
△ △P＜0.01,
△ △ △P＜0.001
Administration group and model group are relatively
*P＜0.05,
*P＜0.01
Table 4 this product to the influence of hyperplasia of mammary gland model rat blood serum gonadal hormone content (X ± SD, n=10)
Model group and blank group are relatively
△ △P＜0.01, administration group and model group are relatively
*P＜0.05
*P＜0.01
2. to the therapeutical effect of hyperplasia of mammary gland model rat
60 of Wistar female rats are selected in test for use, and except that matched group, peritoneal injection estradiol benzoate injection 0.6mg/kg next day that all the other respectively organizing rat, matched group peritoneal injection every day be with the volume normal saline, continuously 6 weeks of modeling.After the pathological tissue inspection showed the hyperplasia of mammary gland model success, the modeling rat was divided into 5 groups at random, 10 every group.Press gastric infusion every day of dosage shown in the table 51 time, gave for 4 weeks continuously, matched group and model group are irritated stomach and are given with the volume distilled water.4 weeks after the administration, respectively organize rat the 1st, 2 pairs of papilla diameters and length with the precimeter measurement, calculate the nipple volume, as nipple swelling degree.After the last administration 2 hours, rat is weighed, pluck eyeball after the record body weight and get blood, 3000r/min is centrifugal, separation of serum is measured estradiol, progesterone, lactotropin, interstitialcellstimulating hormone (ICSH), follicle stimulating hormone and testosterone concentration in the serum with estradiol, progesterone, lactotropin, interstitialcellstimulating hormone (ICSH), follicle stimulating hormone and testosterone radioimmunological kit.Put to death rat, get the 1st, the 2 pairs of breast mammary gland in front and weigh, and mammary gland is done histopathologic slide check after 15% formalin is fixing, calculate organ coefficient.Every computation of mean values is as a result carried out statistics T check.The result (sees Table 5, table 6) shows, RUKANG PIAN is the begin treatment administration after modeling, can reduce rat model papilla diameter, length and mammary gland volume by highly significant, highly significant alleviates mammary gland weight, shows that this product has significant therapeutic effect to nipple swelling, the increase of mammary gland weight of the hyperplasia of mammary gland model rat of estrogen-induced.
Table 5 this product treatment administration to the influence of hyperplasia of mammary gland model rat nipple swelling degree (X ± SD, n=10)
Model group and blank group are relatively
△ △ △P＜0.001, administration group and model group are relatively
* *P＜0.001
Table 6 this product treatment administration to the influence of hyperplasia of mammary gland model rat mammary gland weight (X ± SD, n=10)
Model group and blank group are relatively
△ △ △P＜0.001
Administration group and model group are relatively
*P＜0.01,
*P＜0.001
Table 7 this product to the influence of hyperplasia of mammary gland model rat blood serum gonadal hormone content (X ± SD, n=10)
Model group and blank group are relatively
△ △ △ △P＜0.001
Administration group and model group are relatively
*P＜0.05,
*P＜0.01
The anti-inflammatory and antalgic test
One, analgesic activity
1. the influence that mice water-bath whipping is reacted
Will every before the test mouse tail point 1.5cm immerse in the thermostatic water-circulator bath (55 ± 0.5 ℃), write down the Mus tail Zi immersing in the water with the Casio stopwatch to the time that whipping moves occurring, as TFL, promptly basic pain threshold.60 of the qualified mices of pain threshold are selected in test for use, are divided into 6 groups at random by pain threshold, and 10 every group, male and female half and half.Except that the indometacin matched group in test ig1 administration on the same day, other each organize and press ig every day of dosage shown in the table 1 administration 1 time, successive administration 3 days.Matched group is irritated the distilled water with volume.The TFL of different time mice after 0.5h, 1h, 2h, 3h measure administration as stated above after the last administration.The average TFL and the average TFL of matched group of each group of administration are compared, carry out statistics t test.Result's (seeing Table 8) shows, but this product significant prolongation mice whipping response latency shows that this medicine has significant analgesic activity to the mice pain that warm stimulation causes.
Table 8 this product is to the influence of the mice whipping reaction (n=10 of X ± SD)
Compare with the blank group
*P＜0.05,
*P＜0.01,
* *P＜0.001
2. the influence that rat water-bath whipping is reacted
Will every before the test rat tail point 1.5cm immerse in the thermostatic water-circulator bath (55 ± 0.5 ℃), write down the Mus tail Zi immersing in the water with the Casio stopwatch to the time that whipping moves occurring, as TFL, promptly basic pain threshold.60 of the qualified rats of pain threshold are selected in test for use, are divided into 6 groups at random by pain threshold, and 10 every group, male and female half and half.Except that the indometacin matched group in test ig1 administration on the same day, other each organize and press gastric infusion every day of dosage shown in the table 21 time, successive administration 3 days.Matched group is irritated the distilled water with volume.The TFL of different time rat after 0.5h, 1h, 2h measure administration as stated above after the last administration.The average TFL and the average TFL of matched group of each group of administration are compared, carry out statistics t test.Result's (seeing Table 9) shows, but this product significant prolongation rat whipping response latency shows that this medicine also has significant analgesic activity to the rat pain that warm stimulation causes.
Table 9 this product is to the influence of the rat whipping reaction (n=10 of X ± SD)
Compare with the blank group
*P＜0.05
*P＜0.01
* *P＜0.001
3. the influence that the mice acetic acid twisting is reacted
50 mices are selected in test for use, and body weight 18-23g is divided into 5 groups at random, and 10 every group, male and female half and half.Irritate stomach (ig) every day by dosage shown in the table 3 and be administered once, successive administration 3 days, matched group is irritated stomach and is given with the volume distilled water.Each organizes after the last administration 40 minutes, and the glacial acetic acid solution 0.2ml/ of lumbar injection 0.67% only turns round the body number of times with every mice in second of the counter records 10 minutes then.On average turn round body number and the matched group of each group of administration are on average turned round the body number relatively, carry out statistics t test, result's (seeing Table 10) demonstration, and the high, medium and low dosage of this product all can reduce the acetic acid induced mice significantly and turn round the body number of times, shows that it has significant analgesic activity.
Table 10 this product is to the influence (X ± SD time) of mice acetic acid twisting reaction
Compare with the blank group
*P＜0.01,
* *P＜0.001
Two, antiinflammatory action
1. to the bullate influence of rat carrageenan foot
The Wistar male rat is selected in this test for use, is divided into 5 groups at random, 10 every group.Press the dosage ig every day administration shown in the table 41 time, for three days on end.After the last administration 30 minutes, the right back sufficient pad subcutaneous injection 1% lrish moss mucilage 0.05ml/ of portion only caused inflammation rat.Respectively cause scorching before and cause scorching back 1,2,3 hour, measure 0.5cm place, every rat right hind leg ankle joint below diameter with projector (amplifying 8 times), preceding and cause difference after the inflammation with causing inflammation as the swelling degree.Get each class mean and matched group average relatively, carry out statistics t check.Result's (seeing Table 11) shows that this product can suppress sufficient the swelling of rat that carrageenin causes very significantly, demonstrates the antiinflammatory action of highly significant on this model.
Table 11 this product is to the bullate n=10 that influences of rat carrageenan foot
Compare with the blank group
*P＜0.05,
*P＜0.01,
* *P＜0.001
2. to the bullate influence of rat granuloma
Wistar male rat, random packet are selected in test for use.Press ig every day of dosage shown in the table 5 administration 1 time, matched group ig gives the equal volume distilled water.After the 3rd administration, under the ether light anaesthesia, rat back is shaved hair, sterilization, incision skin, it is subcutaneous that 30mg sterilization cotton balls is imbedded the both sides armpit, continued administration again 7 days.After the last administration 24 hours, put to death rat with urethane anesthesia, strip out the granuloma induced by implantation of cotton pellets thing, remove materials such as the fat that adheres to the outside, connective tissue, claim weight in wet base, to claim dry weight after the constant weight then 60-70 ℃ of oven dry.Average and the matched group of getting each administration group granuloma heavy (deducting cotton balls weight) compare, and carry out statistics t test, and result's (seeing Table 12) shows that each dosage group of this product is to the swollen inhibitory action that highly significant is arranged of rat granuloma.
Table 12. this product is to the bullate influence of rat granuloma (X ± SD)
Compare with the blank group
*P＜0.05,
*P＜0.01,
* *P＜0.001
Above-mentioned result of the test shows that this product has significant analgesia, antiinflammatory action, shows that it swells and ache and can have clear improvement what cyclomastopathy caused.
Claims (7)
1, a kind of medicine that is used to prevent and treat benign hyperplasia of mammary glands in women is characterized in that being made by the former medicine of following ratio of weight and number:
42.5-127.5 parts of 28-84 parts of Folium Citri tangerinae of Radix Bupleuri
22.5-67.5 parts of 22.5-67.5 parts of Rhizoma Cyperi of Pericarpium Citri Reticulatae Viride
22.5-67.5 parts of 34-102 parts of Radix Paeoniae Albas of Radix Angelicae Sinensis
22.5-67.5 parts of Poria 22.5-67.5 of Rhizoma Atractylodis Macrocephalae part
19-57 parts of 17-51 parts of Concha Ostreaes of Bulbus Fritillariae Thunbergii
42.5-127.5 parts of 28-84 parts of Spica Prunellaes of Spina Gleditsiae
19-57 parts of 31.5-94.5 parts of Rhizoma Corydalis of Semen Vaccariae
14-42 parts of 28-84 parts of Fructus Liquidambaris of Fructus Toosendan.
2, the described medicine of claim 1 is characterized in that being made by the former medicine of following percentage by weight:
45 parts of 45 parts of Rhizoma Cyperi of 85 parts of Pericarpium Citri Reticulatae Virides of 56 parts of Folium Citri tangerinae of Radix Bupleuri
45 parts in 45 parts of Poria of 45 parts of Rhizoma Atractylodis Macrocephalaes of 68 portions of Radix Paeoniae Albas of Radix Angelicae Sinensis
85 parts of 56 parts of Spica Prunellaes of 38 parts of Spina Gleditsiaes of 34 portions of Concha Ostreaes of Bulbus Fritillariae Thunbergii
28 parts of 56 parts of Fructus Liquidambaris of 38 parts of Fructus Toosendans of 63 parts of Rhizoma Corydalis of Semen Vaccariae.
3, claim 1 or 2 described medicines is characterized in that this medicine is tablet, capsule or granule.
4, the described medicine of claim 3 is characterized in that this medicine is slow releasing tablet or slow releasing capsule.
5, the preparation method of claim 1 or 2 described medicines is characterized in that described ten Six-element Chinese medicines, except that Bulbus Fritillariae Thunbergii, Concha Ostreae, Rhizoma Corydalis are ground into fine powder sieves, 13 flavor Chinese medicines such as all the other Radix Bupleuri decoct with water twice, collecting decoction filters, and concentrates, add Bulbus Fritillariae Thunbergii, Concha Ostreae, the abundant mixing of Rhizoma Corydalis fine powder, make extractum, drying under reduced pressure becomes dried cream, crushing screening, add adjuvant, mixing is made granule.
6, the described preparation method of claim 5, it is characterized in that described ten Six-element Chinese medicines, remove Bulbus Fritillariae Thunbergii, Concha Ostreae, Rhizoma Corydalis is ground into outside fine powder sieves, 13 flavor Chinese medicines such as all the other Radix Bupleuri decoct with water twice, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and is concentrated into relative density about 1.3, add Bulbus Fritillariae Thunbergii, Concha Ostreae, the abundant mixing of Rhizoma Corydalis fine powder, make extractum, drying under reduced pressure becomes dried cream between 40 ℃ to 50 ℃, pulverizes 120 mesh sieves, add starch or pregelatinized Starch or Pulvis Talci or dextrin or carboxymethyl starch sodium, make granule with micropowder silica gel or 80-85% ethanol or water mixing.
7, the described preparation method of claim 6 is characterized in that gained granule tabletting or encapsulated.
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| CN102716424B (en) * | 2012-06-25 | 2014-07-09 | 四川省中医药科学院中医研究所 | Breast nodule treatment medicine composition and preparation process and application thereof |
| CN104147296A (en) * | 2013-05-15 | 2014-11-19 | 董福华 | Traditional Chinese medicine composition for treating hyperplasia of mammary glands and preparation method thereof |
| CN103446536B (en) * | 2013-08-28 | 2015-08-05 | 贵州鸿德中药开发有限公司 | A kind of Miao Ethnomedicine for the treatment of cyclomastopathy |
| CN104258219A (en) * | 2014-09-10 | 2015-01-07 | 王力力 | Traditional Chinese medicine decoction for treating hyperplasia of mammary glands |
| CN107737216B (en) * | 2017-10-20 | 2021-04-02 | 河北中医学院 | Traditional Chinese medicine composition for preventing and treating hyperplasia of mammary glands and preparation method thereof |
| CN112791147A (en) * | 2021-02-03 | 2021-05-14 | 张文博 | Traditional Chinese medicine for treating nodules of breast and preparation method thereof |
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Non-Patent Citations (2)
| Title |
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| 乳腺增生病的中医药治疗研究. 秦元刚，张翠英，芦锰.中原医刊，第32卷第24期. 2005 |
| 乳腺增生病的中医药治疗研究. 秦元刚，张翠英，芦锰.中原医刊，第32卷第24期. 2005 * |
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