CN102688374A - Medicament for treating hyperplasia of mammary glands - Google Patents
Medicament for treating hyperplasia of mammary glands Download PDFInfo
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Abstract
The invention discloses a medicament for treating hyperplasia of mammary glands. The medicament is prepared by decocting Chinese herbal medicines, namely 6 to 30 weight parts of green tangerine peel, 6 to 20 weight parts of nutgrass galingale rhizome, 6 to 20 weight parts of Chinese thorowax root, 6 to 30 weight parts of white paeony root, 10 to 30 weight parts of red-rooted salvia root, 10 to 30 weight parts of cowherb seed, 6 to 30 weight parts of fritillary, 10 to 30 weight parts of common selfheel fruit spike and 1 to 15 weight parts of notoginseng root by using water, concentrating decoction into a concentrated solution, drying to obtain the medicament, and further preparing any conventional oral formulation in pharmaceutics by the conventional method for a Chinese medicinal preparation. The medicament sooths the liver and regulates qi, activates blood and removes stasis. Pharmacodynamic trials prove that the medicament has an obvious therapeutic effect on model rats suffering from hyperplasia of mammary glands, can improve the immunity of the model rats and has the effects of resisting oxidative stress, improving hemorheology, resisting inflammation and easing pain. Preliminary clinical application shows that the total effective rate of the medicament is 96.0 percent.
Description
Technical field
The present invention relates to a kind of medicine of treating cyclomastopathy, particularly relating to a kind of is the medicine of the treatment cyclomastopathy of crude drug preparation with Chinese medicine.
Background technology
Cyclomastopathy (hyperplastic disease of breast; HDB) being is the general name of one type of disease changing of basic pathology with the epithelial tissue cell of mammary gland acinus, conduit and connective tissue proliferation; Be a kind of neither tumor noninflammatory again be the breast lesion of special disease with mastalgia and lump in breast; Be the modal cystic hyperplasia of breast of women, its sickness rate accounts for the first place of mastopathy.Along with social rhythm accelerates, life stress strengthens, dietary structure changes, its sickness rate was the trend of obvious rising in recent years, and the age also more and more becomes younger.There is 70%～80% women that cyclomastopathy is in various degree all arranged according to investigations approximately, is more common in 25～45 years old women.Clinically mainly show as one-sided or bilateral breast and the chronic lump that size, form differ occurs, accompany local distending pain, string pain or dull pain, its form, size and hardness receive factor affecting such as menstrual cycle, emotion, fatigue.And primary disease is one of multiple risk factor of breast carcinoma, and the cercinoma prophase pathologic change of breast carcinoma was just classified the atypia cyclomastopathy as in national treatment and prevention of tumour meeting as far back as 1978, to the harm paid more and more attention of women's health.So effectively the treatment primary disease can improve the women 's life quality, the generation of Breast Cancer Prevention, epidemiological study show that the women who suffers from cyclomastopathy obviously increases than the danger that normal population suffers from breast cancer.
Doctor trained in Western medicine thinks that newborn film hypertrophy is a kind of newborn film benign proliferative diseases; Breast is the target organ of sex hormone function, and it takes place progressively to grow from the embryo under the comprehensive function of hypothalamus-hypophysis-hypothalamic pituitary ovarium axis and other endocrine hormone; Propagation replaces with restoration of old ways, final a series of complicated variation of degenerating.The morbidity of cyclomastopathy is lacked of proper care mainly due to endocrine hormone, and incidence and development and ovary endocrinosity are closely related, and its reason is that progesterone secretion reduces or deficiency, and estrogen level normally or relatively increases, and causes female/progestogen out of proportion.And mammary gland tissue is the target organ of estrogen; Growth promoter is influenced by estradiol and progesterone directly; Endocrine disorder can cause that breast duct epithelium and fibrous tissue hypertrophy and tip glandular tube or acinus in various degree forms cyst, periodic disorder of hormone secretion with (or) mammary gland tissue increases the sensitivity of hormone is the main cause of primary disease morbidity.
Etiology according to sexual hormone disturbance is theoretical, and the treatment key of cyclomastopathy is to regulate the normal or blocking-up hormonal action target spot of ovary endocrine trend, relieve clinical symptoms.Doctor trained in Western medicine adopts endocrine therapy scheme and operative therapy more, also has auxiliary treatment such as vitamin, Operand, diuretic in addition.Medicine commonly used at present has: Progesterone, 3 1) estrogen antagonist medicine tamoxifen, 2)) androgens medicine methyl testosterone, testosterone propionate etc., 4) lisuride class medicine bromocriptine.Vitamin A, B, C, E etc. can improve liver function, and the metabolism of modulability hormone can also improve neuro vegetative function simultaneously, can be used as the adjuvant drug of cyclomastopathy.Cyclomastopathy belongs to endocrine system disease, the indication of no operative treatment own, and how not easy for patients to accept local excision is, and relapse rate is high, and the purpose of operative treatment mainly is to avoid by mistake, fail to pinpoint a disease in diagnosis breast carcinoma at present.In a word, symptom is just alleviated or improved to the western medical treatment primary disease how, and side effect is big, and is disorderly more with it improper hormone in vivo balance that instead can make, and is difficult to make the Histological change after the cyclomastopathy to obtain restoring.
Summary of the invention
The purpose of this invention is to provide a kind of medicine that is used to treat cyclomastopathy, this medicine depressed liver-energy dispersing and QI regulating, blood circulation promoting and dispersing pathogen accumulation, it is remarkable to be used to treat the cyclomastopathy effect.
Cyclomastopathy belongs to Chinese medicine " nodules of the breast ", " newborn painful abdominal mass ", " nodule in the breast " category, thinks that not smooth, the melancholy anger of feelings will, diet internal injury, innate deficiency, seven emotions overstrain etc. all are paathogenic factors of cyclomastopathy at present more.Depression of liver-QI, the expectorant blood coagulation stasis of blood are for falling ill originally, and sick position is liver.The liver failing to maintain the normal flow of QI, dysfunction of the spleen in transportation, deficiency of the kidney, so that stagnation of Qi and phelgm, blood stasis in bulk, Chong and Ren channel disorder hinder in newborn network and form nodules of the breast.
The present invention is directed to the above-mentioned pattern of syndrome characteristics of cyclomastopathy, a kind of medicine that is used to treat cyclomastopathy is provided, this medicine is prepared by the crude drug of following parts by weight:
Pericarpium Citri Reticulatae Viride 6～30 Rhizoma Cyperis 6～20 Radix Bupleuri 6～20 Radix Paeoniae Albas 6～30
Radix Salviae Miltiorrhizae 10～30 Semen Vaccariae 10～30 Bulbus Fritillariae Uninbracteataes 6～30 Spica Prunellaes 10～30
Radix Notoginseng 1～15.
More than the selection and the consumption of various crude drug be that the inventor draws through groping in a large number to sum up, facts have proved that various crude drug all have curative effect preferably in above-mentioned weight range.
The conventional method of Chinese medicine preparation can be adopted, above-mentioned raw materials medicine of the present invention is prepared into the conventional peroral dosage form on any pharmaceutics, but these dosage forms protection scope of the present invention can not be used to limit.It is emphasized that before any dosage form of preparation, all need prepare the active component of medicine of the present invention earlier.
The concrete method for preparing of above-mentioned each crude drug being processed medicine activity component of the present invention is:
1) Radix Salviae Miltiorrhizae of the Radix Notoginseng of said parts by weight, said parts by weight and the part of Bulbus Fritillariae Uninbracteatae are ground into fine powder;
2) get Pericarpium Citri Reticulatae Viride, Rhizoma Cyperi, Radix Bupleuri, the Radix Paeoniae Alba, Semen Vaccariae, the Spica Prunellae of said parts by weight, mix with the Radix Salviae Miltiorrhizae and the Bulbus Fritillariae Uninbracteatae of residuals weight umber, decocte with water three times, collecting decoction filters, and filtrating is condensed into concentrated solution;
3) said fine powder is added in the said concentrated solution, stir, low-temperature reduced-pressure is dry, pulverizes, and obtains the active component of medicine.
Wherein, during the decocte with water medicine, each amount of water is 8～10 times of weight of medicine, decocts 1～2h at every turn.
The filtrating that obtains after the decoction need further be condensed into concentrated solution, and usually, it is 1.10～1.30 concentrated solution that the present invention is concentrated into 80 ℃ of relative densities with filtrating.
Preferably, be used to be ground into the part Radix Salviae Miltiorrhizae of fine powder and the consumption of Bulbus Fritillariae Uninbracteatae is respectively the Bulbus Fritillariae Uninbracteatae of the Radix Salviae Miltiorrhizae and 1/5～1/2 parts by weight of 1/5～1/3 parts by weight.
The present invention can further be prepared into any peroral dosage form commonly used with conventional method of Chinese medicinal with the medicine activity component that obtains, like pill, tablet, capsule, granule etc.
In the medicine of the present invention, Radix Bupleuri bitter in the mouth, cold nature are returned the liver and gall warp, dispersing the stagnated live-QI to relieve the stagnation of QI, reducing fever by reconciliation; Pericarpium Citri Reticulatae Viride bitter in the mouth, suffering, warm in nature, go into liver, gallbladder, stomach warp, but dispersing the stagnated liver-QI for regulating the stomach, removing food stagnancyization stagnates, promoting the circulation of QI to relieve pain; The two is monarch altogether, with dispersing the stagnated live-QI to relieve the stagnation of QI, and regulating QI to relieve pain.Rhizoma Cyperi acrid in the mouth, little hardship, sweet, property is flat, is " Directorate-General DG of disorder of QI, the chief commander of women section " to have promoting QI circulation for relieving depression, catharsis bar soothing the liver merit, helps Radix Bupleuri, Pericarpium Citri Reticulatae Viride depressed liver-energy dispersing and QI regulating, transfers smooth QI and blood; The acid of Radix Paeoniae Alba bitter in the mouth, cold nature, the yin fluid astringing that nourishes blood, easing the affected liver and blood, relieving spasm to stop pain with Radix Bupleuri 5 usefulness, is made its weak point mutually, and Zhan Qichang, to reach the yang invigorating yin fluid astringing, soothing the liver and blood, the merit of resolving depression pain relieving; Two medicines are all minister, to strengthen the power of monarch drug.Spica Prunellae acrid in the mouth, hardship, cold in nature, clearing away liver-fire, resolving depression eliminating stagnation; The Bulbus Fritillariae Uninbracteatae bitter in the mouth, cold in nature, the eliminating stagnation of relieving inflammation or internal heat, 5 with the Spica Prunellae clearing away liver-fire, separate scorchingly hot, Disperse hepatic depression; Two medicines are altogether for assisting a ruler in governing a country, in case with the passing of time heat-transformation of stagnation of liver-QI.Radix Salviae Miltiorrhizae bitter in the mouth, cold nature, blood circulation promoting and blood stasis dispelling; Sweet, the little hardship of Radix Notoginseng, temperature, dissipating blood stasis hemostasis, reducing swelling and alleviating pain; Semen Vaccariae is bitter, and is flat, promoting blood circulation to restore menstrual flow, stimulating milk secretion detumescence; Three flavors altogether figure invigorate blood circulation, softening the hard mass, eliminating stagnation.Above-mentioned all medicine compatibilities, giving consideration to both the incidental and fundamental, coordination of potent and mild therapies, cold temperature collocation, the merit of long memorial liver and qi, removing obstruction for relieving pain is mainly used in the highest caused by hepatic stagnation qi stagnation cyclomastopathy of sickness rate altogether.
Pharmacodynamics test proves that medicine of the present invention has significant therapeutic effect to the hyperplasia of mammary gland model rat.Its mechanism of action is regulated E in the serum for through regulating the function of model HPO gonad axis
2, P, PRL, T hormonal readiness, suppress ER, the proteic expressional function of PR, and reach the purpose of treatment cyclomastopathy.Medicine of the present invention can improve rat model immunity, and have anti-oxidation stress, improve hemorheology and antiinflammatory, analgesic activity.
Through Preliminary Clinical, Drug therapy cyclomastopathy determined curative effect of the present invention, safe and reliable, its treatment total effective rate reaches 96.0%.
The specific embodiment
Embodiment 1
Get Radix Notoginseng 8kg, Radix Salviae Miltiorrhizae 8kg, Bulbus Fritillariae Uninbracteatae 15kg, it is for use that mixed powder is broken into fine powder.
Get Pericarpium Citri Reticulatae Viride 33kg, Rhizoma Cyperi 28kg, Radix Bupleuri 28kg, Radix Paeoniae Alba 28kg, Radix Salviae Miltiorrhizae 32kg, Semen Vaccariae 40kg, Bulbus Fritillariae Uninbracteatae 15kg, Spica Prunellae 40kg mixing, add in the 2400kg water, decoct 1.5h.Leach decocting liquid, decoct twice again with the water of same amount, merge three times decocting liquid, filter, it is 1.25 concentrated solution that filtrating is concentrated into relative density.
Above-mentioned fine powder is added in the above-mentioned concentrated solution, stir, 65～85 ℃ of low-temperature reduced-pressure dryings were pulverized 80 mesh sieves, obtained medicine activity component.Press common process and add conventional preparation adjuvants such as microcrystalline Cellulose, mixing, the capsule of packing into No. 0 is processed capsule.
Embodiment 2
Get Radix Notoginseng 5kg, Radix Salviae Miltiorrhizae 7kg, Bulbus Fritillariae Uninbracteatae 13kg, it is for use that mixed powder is broken into fine powder.
Get Pericarpium Citri Reticulatae Viride 28kg, Rhizoma Cyperi 23kg, Radix Bupleuri 23kg, Radix Paeoniae Alba 23kg, Radix Salviae Miltiorrhizae 28kg, Semen Vaccariae 35kg, Bulbus Fritillariae Uninbracteatae 13kg, Spica Prunellae 35kg mixing, add in the 2000kg water, decoct 1.5h.Leach decocting liquid, decoct twice again with the water of same amount, merge three times decocting liquid, filter, it is 1.22～1.25 concentrated solution that filtrating is concentrated into relative density.
Above-mentioned fine powder is added in the above-mentioned concentrated solution, stir, 65～85 ℃ of low-temperature reduced-pressure dryings were pulverized 80 mesh sieves, obtained medicine activity component.Press common process and add adjuvants such as starch, magnesium stearate, mixing, tabletting is processed tablet.
Embodiment 3
Get Radix Notoginseng 5kg, Radix Salviae Miltiorrhizae 7kg, Bulbus Fritillariae Uninbracteatae 13kg, it is for use that mixed powder is broken into fine powder.
Get Pericarpium Citri Reticulatae Viride 25kg, Rhizoma Cyperi 20kg, Radix Bupleuri 23kg, Radix Paeoniae Alba 25kg, Radix Salviae Miltiorrhizae 32kg, Semen Vaccariae 40kg, Bulbus Fritillariae Uninbracteatae 12kg, Spica Prunellae 30kg mixing, add in the 2000kg water, decoct 1.5h.Leach decocting liquid, decoct twice again with the water of same amount, merge three times decocting liquid, filter, it is 1.22～1.25 concentrated solution that filtrating is concentrated into relative density.
Above-mentioned fine powder is added in the above-mentioned concentrated solution, stir, 65～85 ℃ of low-temperature reduced-pressure dryings were pulverized 80 mesh sieves, obtained medicine activity component.Press common process and add conventional adjuvants such as starch, correctives, mixing is granulated, and processes granule.
Application examples 1
Purpose: study the therapeutical effect of medicine of the present invention to the hyperplasia of mammary gland model rat, to the influence of immunologic function index of correlation, to the regulating action of endocrine hormone, and the anti-oxidation stress effect; Observe the influence of medicine of the present invention to the rheology of blood stasis model rat serum; Observe antiinflammatory, the analgesic activity of medicine of the present invention.
Method: 1) hyperplasia of mammary gland model is duplicated in the intramuscular injection of estradiol benzoate associating Progesterone, and medicine gastric infusion of the present invention is after 5 weeks, and slide gauge is measured second pair of height of nipples and diameter; Calculate uterus, ovary exponential sum thymus, index and spleen index; The ELISA method detects estradiol (E in the serum
2), the content of progesterone (P), testosterone (T), lactotropin (PRL); Chemical colorimetry detects the content of SOD, MDA in the serum; The pathological change of mammary gland tissue is observed in HE dyeing.2) the compound ice-water bath of rat skin lower injection adrenalin hydrochloride duplicates the stasis syndrome rat model, and medicine gastric infusion of the present invention adopted full-automatic hemorheology to learn appearance and measures hemorheology indexs of correlation such as whole blood viscosity, blood plasma viscosity after 1 week.3) adopt the rat skin lower injection agar method to form chronic granuloma model, mice caused by dimethylbenzene xylene ear swelling model, observe the effect of the anti-acute and chronic inflammation of medicine of the present invention.4) adopt mice acetic acid twisting method to observe the analgesic activity of medicine of the present invention.
1 test material
1.1 receive the reagent thing:
Embodiment 1 medicament capsule; Specification: every 0.57g; Usage and dosage: oral, one time 4,3 times on the one.
1.2 positive control medicine:
The Tamoxifen Citrate sheet: Yangzijiang Pharmaceutical Group Co., Ltd produces, lot number: 11042711; Usage and dosage: each 10mg (1) is oral, every day 2 times, also 20mg (2) at every turn, every day 2 times.
Newborn eliminating stagnation capsule disappears: Shandong ShenZhou Pharmaceutical Co., Ltd, lot number: 101106; Usage and dosage: oral, one time 3,2 times on the one, every 0.4g.
Aspirin effervescent tablets: AstraZeneca pharmaceutical Co. Ltd, lot number: 1108114; Usage and dosage: take after putting into the dissolving of eliminating cold for resuscitation water.Oral 1) adult's antipyretic-antalgic a: 0.5g, 1～4 time on the one.Rheumatism: a 0.5～1g, 3～4g on the one.2) child's antipyretic-antalgic: 1～2 years old, a 0.05～0.1g, 3 times on the one; 3～5 years old, a 0.2～0.3g, 3 times on the one; 6～12 years old, a 0.3～0.5g, 3 times on the one.Rheumatism: divided clothes 3～4 times on 1st by body weight 0.08～0.1g/kg.
Aspirin Enteric-coated Tablets (Baysprin): Bayer Health Care AG, lot number: BTA84G6; Usage and dosage: oral, every day 100mg.
1.3 estradiol benzoate (1ml/1mg): Tianjin gold credit aminoacid company limited, lot number: 1005071; Be used for duplicating of hyperplasia of mammary gland model rat.
1.4 Progesterone (1ml/20mg): celestial jade pendant pharmaceutical factory of Zhejiang medicine limited company, lot number: 101108; Be used for duplicating of hyperplasia of mammary gland model rat.
1.5 adrenalin hydrochloride injection (1ml/1mg): Tianjin gold credit aminoacid company limited, lot number: 1103141; Be used for duplicating of stasis syndrome rat model.
1.6 main test reagent, instrument: SOD, MDA test kit: bio-engineering research institute is built up in Nanjing; E
2, P, T, PRL ELISA test kit: go up Haifeng county Xiang biology and Science and Technology Ltd..The automatic enzyme micro-plate reader of AT-858 type, Shanghai ANTAI Diagnostics Co., Ltd.; The KDC-2046 low speed refrigerated centrifuge, good branch company in the Keda Innovation Co., Ltd; TU-1901 dual-beam ultraviolet-uisible spectrophotometer, the Beijing Puxi General Instrument Co., Ltd.
1.7 experimental animal: healthy SD rat, regular grade, body weight 200～250g, female unpregnancy, totally 210; Healthy Kunming mouse, regular grade, body weight 18～23g, female unpregnancy, totally 210, all available from zooscopy institute of medical courses in general institute, licence numbering: SCXK (capital) 2009-0008.Raise in the cleaning isoperibol feed of freely drinking water after reclaiming.
The design of 2 dosage, positive control drug are selected and main test index design considerations
2.1 dosage design principle
Embodiment 1 capsule specification 0.57g/ grain, clinical dose be one time 4,3 times on the one, clinical every day, dose was: 4 * 3 * 0.57g/60kg=0.114g/kg.The dose,equivalent (middle dosage) that converts rat into is: 0.114g/kg * 7.5 times=0.856g/kg, and then low dosage is 0.428g/kg, and high dose is 1.712g/kg, and the basic, normal, high dosage of rat is equivalent to 3.8,7.5,15 times of clinical dose respectively; The dose,equivalent (middle dosage) that converts mice into is: 0.114g/kg * 15 times=1.712g/kg, and then low dosage is 0.856g/kg, and high dose is 3.42g/kg, and the basic, normal, high dosage of mice is equivalent to 7.5,15,30 times of clinical dose respectively.The general routine that meets the design of new Chinese medicine pharmacodynamics test dosage.
The medicine preparation: rat administration volume is 1ml/100g, and mice administration volume is 0.2ml/10g, is mixed with 0.043g/ml with distilled water respectively, 0.085g/ml, and 0.171g/ml is used for basic, normal, high dose groups mice of embodiment 1 capsule and rat oral gavage administration.
2.2 positive control drug is chosen and the dosage design considerations
The Tamoxifen Citrate sheet cures mainly the mastopathy due to the endocrine disturbance, so choose the positive Western medicine contrast medicine as pharmacodynamics test.Tamoxifen Citrate sheet specification 10mg/ sheet, clinical dose is a 10mg, 2 times on the one.Clinical adult's taking dose is 2 * 10mg/60kg=0.33mg/kg, is converted into the rat dose,equivalent to be: 0.33mg/kg * 5=1.65mg/kg, mice dose,equivalent are 0.33mg/kg * 10=3.3mg/kg.The medicine preparation: the administration volume is the same, is mixed with 0.165mg/ml respectively with distilled water and is respectively applied for positive Western medicine group rat and mouse stomach administration.
Disappear newborn eliminating stagnation capsule and pharmic function of the present invention cure mainly basic identical, the indication basically identical, also identical with embodiment 1 dosage form, so choose positive Chinese medicine contrast medicine as pharmacodynamics test.The newborn eliminating stagnation capsule specification 0.4g/ grain that disappears, clinical use amount is a 1.2g, 3 times on the one.The clinical dose of newborn eliminating stagnation capsule that disappears is 1.2g * 3/60kg=0.06g/kg, and be converted into the rat dose,equivalent and be: 0.06g/kg * 7.5=0.45g/kg, mice dose,equivalent are 0.06mg/kg * 15=0.9g/kg.The medicine preparation: the administration volume is the same, is mixed with 0.045g/ml respectively with distilled water and is respectively applied for positive Chinese drug-treated group rat and mouse stomach administration.
Clinical heating, pain and the rheumatoid arthritiss etc. of being used for of aspirin effervescent tablets can be alleviated periphery property analgesic, and the material of inhibition inflammatory reaction is synthetic and play antiinflammatory action, so be used for the positive Western medicine contrast medicine of antalgic and inflammation relieving test.Aspirin effervescent tablets specification 0.5g/ sheet, clinical dose is: oral, a 0.5g, 3 times on the one.Clinical adult's taking dose is 3 * 0.5g/60kg=25mg/kg, and being converted into the mice dose,equivalent is 25mg/kg * 10=250mg/kg.The medicine preparation: the administration volume is the same, is mixed with 2.5mg/ml respectively with distilled water and is respectively applied for the administration of positive Western medicine group mouse stomach.
Aspirin Enteric-coated Tablets (Baysprin) is clinical to be used to suppress platelet adhesion and to assemble, and the formation of prevention thrombosis has the effect that improves hemorheology, is used for the Western medicine contrast of hemorheology test.Clinical use amount is 100mg every day, is converted into the rat dose,equivalent and is 100mg/60kg * 6 times=10mg/kg.The medicine preparation: the administration volume is the same, is mixed with 1mg/ml with distilled water.
3 test methods, step and result
3.1 the experimentation of Drug therapy hyperplasia of mammary gland model rat of the present invention
3.1.1 duplicating of hyperplasia of mammary gland model rat: with 60 female rats, adopt estradiol benzoate intramuscular injection 0.5mg/kg, after continuous 30 days, reuse Progesterone intramuscular injection 4mg/kg, be 5d inject time, duplicates the rat mammary gland model of hyperplasia.Other gets 10 rats, injection equal-volume normal saline.
3.1.2 divide into groups and administration: above-mentioned 60 rats are divided into model group, western medicine group (Tamoxifen Citrate sheet), Chinese medicine matched group (newborn eliminating stagnation capsule disappears), the basic, normal, high dose groups of medicine of the present invention, 10 every group by table of random number.Other 10 as blank control group.By aforementioned dosage, every day, gastric infusion was 1 time, in continuous 5 weeks, detected body weight weekly one time, the adjustment dosage.
3.1.3 sample preparations: last administration fasting 12h, to weigh, rats by intraperitoneal injection 1% pentobarbital sodium (0.5ml/100g) anesthesia is respectively organized the wide, highly of second pair of nipple of rat abdomen with vernier caliper measurement; Get second pair of complete mammary gland tissue in left side, do pathological observation, accomplish by Chinese Radiation Protection Research Inst GIP center with 10% formalin fixed; Get second pair of complete mammary gland tissue in right side, do tissue homogenate, the ELISA method detects ER, and PR content is operated by the test kit description.Heart extracting blood, the centrifugal 15min of 3000r/min, preparation serum, chemical colorimetry detect SOD, MDA content in the serum, and the ELISA method detects E in the serum
2, P, PRL, T content, all operate by the test kit description.Win thymus, spleen, uterus, ovary calculating organ index.
3.1.4 statistical procedures: experimental data with means standard deviation (
± S) expression adopts SPSS13. 0 statistical software to carry out date processing, relatively adopts variance analysis and LSD-t check between group,
P<0. 05 has statistical significance for difference.
3.1.5 result of the test
3.1.5.1 medicine of the present invention is to the influence of each group model rat breast diameter, height of nipples
Compare with the blank group after the modeling, all significantly increases of breast diameter and height of nipples (
P<0.01), the hints model success.After each organizes administration, with model control group relatively, medicine of the present invention can significantly reduce hyperplasia of mammary gland model rat breast diameter and height of nipples (
P<0.01), see table 1.
3.1.5.2 medicine of the present invention is to the influence of each group model rat uterus, ovary, thymus, index and spleen index
Hyperplasia of mammary gland model rat group ovary, thymus, index and spleen index are all lower, with the blank group relatively there were significant differences (
P<0.01); Positive Western medicine group (Tamoxifen Citrate) ovary, index and spleen index than model group more variant (
P<0.05), thymus index obviously raises than model group, with model group relatively there were significant differences (
P<0.01); Medicine small dose group index and spleen index of the present invention is high than model group, with model group more variant (
P<0.05); The high, medium and low dose groups thymus of medicine of the present invention, the ovary index all has obvious rising than model group, with model group relatively there were significant differences (
P<0.01).Model group uterus index is higher, with the blank group more variant (
P<0.05); Positive Western medicine group (Tamoxifen Citrate) uterus index is compared low with model group, compare with model group that there were significant differences (
P<0.01); Positive Chinese drug-treated group (newborn eliminating stagnation capsule disappears) uterus index is lower than model group, with model group more variant (
P<0.05); The basic, normal, high dose groups of medicine of the present invention uterus index all has decline than model group, with model group more variant (
P<0.05), see table 2.
3.1.5.3 medicine of the present invention is to E in each group model serum
2, P, PRL, T content influence
Hyperplasia of mammary gland model rat group E
2, P, PRL content all obviously reduce, T obviously rises, with the blank group relatively there were significant differences (
P<0.01); Positive Western medicine group (Tamoxifen Citrate) E
2, P, PRL content all obviously rise, T obviously descends, with model group relatively there were significant differences (
P<0.01); Positive Chinese drug-treated group (newborn eliminating stagnation capsule disappears) E
2, P, PRL content all rise, T descends to some extent, with model group more variant (
P<0.05); The high, medium and low dose groups E of medicine of the present invention
2, P, PRL content all obviously rise, with model group relatively there were significant differences (
P<0.01).Medicine of the present invention is high, middle dose groups T content all obviously rises, with model group relatively there were significant differences (
P<0.01), see table 3.
3.1.5.4 medicine of the present invention is to the influence of SOD, MDA content in each group model rat blood serum
Hyperplasia of mammary gland model rat group SOD content is lower, with the blank group relatively there were significant differences (
P<0.01); Relatively there were significant differences for positive Western medicine group (Tamoxifen Citrate) SOD content and model group (
P<0.01), positive Chinese drug-treated group (newborn eliminating stagnation capsule disappears) SOD content obviously raises than model group, with model group relatively there were significant differences (
P<0.01); The high, medium and low dose groups SOD content of medicine of the present invention all has obvious rising than model group, with model group relatively there were significant differences (
P<0.01).Rat model group MDA content is higher, with the blank group more variant (
P<0.05); Positive Western medicine group (Tamoxifen Citrate) MDA content is lower, with model group more variant (
P<0.05); Medicine high dose group MDA content of the present invention obviously reduces, with model group relatively there were significant differences (
P<0.01); Dose groups MDA content has reduction in the medicine of the present invention, with model group more variant (
P<0.05) see table 4.
3.2 medicine of the present invention is to the influence of stasis syndrome rat model hemorheology
3.2.1 the stasis syndrome rat model duplicates, grouping, administration, and hemorheology detects
With 60 female rats subcutaneous injection 1ml/1mg adrenalin hydrochlorides, 0.08ml/100g body weight, totally 2 times; 4h at interval in injection back 2h for the first time, puts into 0 ℃ of frozen water 5min that swims with rat; Take out the water of drying animal hair then; After water 24h is can't help in fasting, be divided into model group, western medicine group (Aspirin Enteric-coated Tablets), Chinese medicine matched group (newborn eliminating stagnation capsule disappears), the basic, normal, high dose groups of medicine of the present invention by table of random number, other gets 10 normal rats as blank control group.By aforementioned dosage, every day, gastric infusion was 1 time, continuous 1 week, behind the last administration 2h, press preceding method anesthesia, heart extracting blood, and place anticoagulant tube and blood sedimentation tube respectively, deliver to clinical laboratory of Shanxi Institute of Traditional Chinese Medicine and detect hemorheology.
3.2.2 result of the test
The model group plasma viscosity is higher, compare with blank control group that there were significant differences (
P<0.01); Positive Western medicine group (Tamoxifen Citrate sheet) plasma viscosity obviously reduces than model group, with model group relatively there were significant differences (
P<0.01); Positive Chinese drug-treated group (newborn eliminating stagnation capsule disappears) plasma viscosity has reduction than model group, with model group more variant (
P<0.05); Medicine high dose group plasma viscosity of the present invention all has obviously than model group and falls at the end, with model group more all there were significant differences (
P<0.01); Model group WBV 1 [1S ~-1], 5 [5S ~-1], 200 [200S ~-1] are higher, compare with blank control group variant (
P<0.05); Positive Western medicine group (Tamoxifen Citrate sheet) WBV 1 [1S ~-1], 5 [5S ~-1] obviously reduce than model group, with model group relatively there were significant differences (
P<0.01); All there is reduction medicine high dose group WBV 1 of the present invention [1S ~-1], 5 [5S ~-1], 30 [30S ~-1], 200 [200S ~-1] than model group, with model group more variant (
P<0.05), see table 5.
3.3 the antiinflammatory action of medicine of the present invention research
3.3.1 the influence of the rat granuloma inflammatory model that medicine of the present invention causes agar
60 female rats are divided into model group, western medicine group (aspirin effervescent tablets sheet), Chinese medicine matched group (newborn eliminating stagnation capsule disappears), the basic, normal, high dose groups of medicine of the present invention by table of random number.With each group rat sterile working under the ether light anaesthesia, at rat dorsal line subcutaneous injection 2% agar solution 2ml, by aforementioned dosage gastric infusion, every day, gastric infusion was 1 time, successive administration 7 days.Behind the last administration 2h, rat is respectively organized in anesthesia, separates the granuloma agar block, blots with filter paper, and be placed on the cellophane and take by weighing weight in wet base with torsion balance, record, and calculate suppression ratio.
3.3.2 the influence of the mice ear that medicine xylol of the present invention causes
60 of KM kind female mices, the animal same 2.3.1 that divides into groups, by aforementioned dosage gastric infusion, every day 1 time, continuous 1 week.At mouse right ear coating proinflammatory agent xylene (concentration 100%) 0.05ml/ only, left ear is left intact behind last administration 30min.Put to death mice behind the 30min, cut ears and lay round auricle at same position respectively with 8mm diameter card punch, weigh, every Mus auris dextra sheet weight deducts left auricle weight and is the swelling degree, calculates ear swelling degree and suppression ratio.
3.3.3 experimental result
3.3.3.1 model group agar weight is higher, positive Western medicine group (aspirin effervescent tablets) agar weight obviously reduces than model group, with model group relatively there were significant differences (
P<0.01); Positive Chinese drug-treated group (newborn eliminating stagnation capsule disappears) agar weight has reduction than model group, with model group more variant (
P<0.05); The middle and high dose groups thymus index of medicine of the present invention has reduction than model group, with model group more variant (
P<0.05).Medicine low dose group thymus index of the present invention significantly reduces than model group, with model group relatively there were significant differences (
P<0.01), the result sees table 6.
3.3.3.2 model group ear swelling degree is higher, with the blank group relatively there were significant differences (
P<0.01); Positive Western medicine group (aspirin effervescent tablets) ear swelling degree obviously reduces than model group, with model group relatively there were significant differences (
P<0.01); Positive Chinese drug-treated group (newborn eliminating stagnation capsule disappears) ear swelling degree obviously reduces than model group, with model group relatively there were significant differences (
P<0.01); The basic, normal, high dose groups ear swelling of medicine of the present invention degree all has obvious reduction than model group, with model group more all there were significant differences (
P<0.01), the result sees table 7.
3.4 the analgesic activity of medicine of the present invention research
60 of KM kind female mices, grouping, the same 2.3.2 of administration, behind the last administration 2h, acetic acid 0.2 ml of every mouse peritoneal injection 0.6% turns round the body number of times in the record mice 10min, compares with model group, calculates the minimizing percentage rate.
Result of the test: it is higher that model group is turned round the body number of times, and positive Western medicine group (aspirin effervescent tablets) is turned round the body number of times and obviously reduced than model group, with model group relatively there were significant differences (
P<0.01); Positive Chinese drug-treated group (newborn eliminating stagnation capsule disappears) is turned round the body number of times and is obviously reduced than model group, with model group relatively there were significant differences (
P<0.01); The basic, normal, high dose groups of medicine of the present invention is turned round the body number of times all has obvious reduction than model group, with model group more all there were significant differences (
P<0.01).See table 8.
The result: 1) medicine of the present invention can suppress height of nipples and the diameter of cyclomastopathy rat; Reduce uterus, ovary index, rising thymus, index and spleen index; Can improve P, E in the hyperplasia of mammary gland model rat blood serum
2, the PRL level, reduce the serum T level; SOD content in the rising serum reduces MDA content; With model group relatively, all have statistical significance (
P<0.05 or
P<0.01).2) medicine of the present invention can improve hemorheology, improve the anti-oxidation stress ability, with model group relatively, have statistical significance (
P<0.05 or
P<0.01).3) medicine of the present invention can alleviate agar method chronic granuloma that forms and the ear swelling that suppresses mice caused by dimethylbenzene xylene, and the effect of anti-acute and chronic inflammation is arranged, with normal group relatively have statistical significance (
P<0.05 or
P<0.01).4) medicine of the present invention can significantly reduce the mouse writhing stoichiometric number, with normal group relatively have statistical significance (
P<0.05 or
P<0.01).
Conclusion: medicine of the present invention has significant therapeutic effect to the hyperplasia of mammary gland model rat, can improve rat model immunity, and anti-oxidation stress is arranged and improve hemorheology and antiinflammatory, analgesic activity.Its mechanism of action and the function of passing through to regulate model HPO gonad axis, thus E in the serum regulated
2, P, PRL, T hormonal readiness relevant.
Application examples 2
Select cyclomastopathy patient 90 examples, be the women, at 18～49 years old age, average 33.5 years old, year did not wait course of disease February～10, is divided into two groups at random, and 50 examples are organized in treatment, matched group 40 examples.
Case is selected diagnostic criteria
With reference to " traditional Chinese medical science inside and outside Gynecology & Pediatrics Dept. disease diagnosis criterion of therapeutical effect ": the bar rope or the lamellar that 1) have the one or both sides breast to occur single or a plurality ofly differing in size clinically, form differ thicken lump, and the axillary lymph knot is little; 2) breast often has twinge or distending pain, occurs or increases the weight of with a couple of days before the menstruation, and the back pain of passing through obviously alleviates or disappears, and lump dwindles; 3) pain is everlasting and is increased the weight of when unhappy or tired, sometimes to shoulder back or oxter radiation; 4) scanning of mammary gland near infrared ray helps diagnosis, carries out histopathological examination in case of necessity, gets rid of other breast lesions.
Therapeutic Method
The treatment group gives the embodiment of the invention 1 medicament capsule, and three times on the one, each 3～4,30 days is a course of treatment, totally 2 courses of treatment.The matched group newborn eliminating stagnation capsule that disappears, oral, one time 3～4,3 times on the one, 30 days is a course of treatment.Two groups of cases all inactive all other medicines in therapeutic process.
Curative effect determinate standard (according to the standard determination curative effect of Society of Surgery of All-China Association of Traditional Chinese Medicine breast disease special topic group formulation)
Clinical cure: lump disappears, and mastalgia disappears.Do not recur in 3 months after the drug withdrawal.
Produce effects: the lump maximum gauge dwindles more than 1/2, and mastalgia disappears.
Effectively: the lump maximum gauge dwindles less than 1/2, and mastalgia alleviates or lump dwindles more than 1/2, and mastalgia alleviates not obvious.
Invalid: lump does not dwindle, or increases hardening on the contrary, or simple mastalgia is alleviated and lump does not dwindle.
Therapeutic effect is seen table 9.
Can know that by last table medication therapy groups 50 routine patient's clinical cure 19 examples of the present invention account for 38.0%; Produce effects 21 examples account for 42.0%, and effective 8 examples account for 16.0%, and invalid 2 examples account for 4.0%, total effective rate 96.0%, and matched group 40 routine patient's clinical cure 8 examples account for 20.0%; Produce effects 13 examples account for 32.5%, and effective 12 examples account for 30.0%, and invalid 7 examples account for 17.5%, and total effective rate 82.5% explains that medicine of the present invention has significant curative effect to cyclomastopathy, and curative effect is superior to matched group.
Claims (5)
1. medicine that is used to treat cyclomastopathy is prepared by the crude drug of following parts by weight:
Pericarpium Citri Reticulatae Viride 6～30 Rhizoma Cyperis 6～20 Radix Bupleuri 6～20 Radix Paeoniae Albas 6～30
Radix Salviae Miltiorrhizae 10～30 Semen Vaccariae 10～30 Bulbus Fritillariae Uninbracteataes 6～30 Spica Prunellaes 10～30
Radix Notoginseng 1～15.
2. claim 1 is used to treat the method for preparing of the medicine of cyclomastopathy, is to prepare according to following steps:
1) Radix Salviae Miltiorrhizae of the Radix Notoginseng of said parts by weight, said parts by weight and the part of Bulbus Fritillariae Uninbracteatae are ground into fine powder;
2) get Pericarpium Citri Reticulatae Viride, Rhizoma Cyperi, Radix Bupleuri, the Radix Paeoniae Alba, Semen Vaccariae, the Spica Prunellae of said parts by weight, mix with the Radix Salviae Miltiorrhizae and the Bulbus Fritillariae Uninbracteatae of residuals weight umber, decocte with water three times, collecting decoction filters, and filtrating is condensed into concentrated solution;
3) said fine powder is added in the said concentrated solution, stir, low-temperature reduced-pressure is dry, pulverizes, and obtains the active component of medicine.
3. the method for preparing that is used to treat the medicine of cyclomastopathy according to claim 2 is characterized in that being used to be ground into the part Radix Salviae Miltiorrhizae of fine powder and the consumption of Bulbus Fritillariae Uninbracteatae is respectively the Bulbus Fritillariae Uninbracteatae of the Radix Salviae Miltiorrhizae and 1/5～1/2 parts by weight of 1/5～1/3 parts by weight.
4. the method for preparing that is used to treat the medicine of cyclomastopathy according to claim 2 is characterized in that each amount of water is 8～10 times of weight of medicine, decocts 1～2h at every turn.
5. the method for preparing that is used to treat the medicine of cyclomastopathy according to claim 2 is characterized in that it is 1.10～1.30 concentrated solution that described filtrating is concentrated into 80 ℃ of relative densities.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN111562324A (en) * | 2020-05-20 | 2020-08-21 | 山东步长神州制药有限公司 | Method for detecting content of multiple index components of medicinal preparation |
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| CN116327831A (en) * | 2023-03-03 | 2023-06-27 | 谷医堂(湖南)健康科技有限公司 | A Chinese medicinal composition with effect of resisting hyperplasia of mammary glands |
| CN116327831B (en) * | 2023-03-03 | 2023-09-15 | 谷医堂(湖南)健康科技有限公司 | A Chinese medicinal composition with effect of resisting hyperplasia of mammary glands |
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