CN100434112C - Pure Chinese medicine for treating hyperplasia of mammary glands and preparing method - Google Patents

Abstract

The present invention relates to a pure traditional Chinese medicine for treating cyclomastopathy diseases and a preparation method thereof, and the medicine is prepared from bupleurum root, angelica, red sage root, milkvetch root, corydalis tuber, frankincense, white peony alba, szechwan chinaberry fruit, liquorice, cowherb seed, common prism tuber and Chinese honeylocust spine. The raw material is extracted by ethanol after being prepared into extractum according to a certain proportion, and then the mixture is added with sucrose to be prepared into granules. The medicine of the present invention is a pure traditional Chinese medicine, has the advantages of good treatment effect and less side effect, and is superior to homogeneous traditional Chinese medicines and western medicines. The treatment effect of 1280 cases of patients summarizes that the total effective rate reaches 97%, the effective rate is close to 100% when the time of medicine administration is prolonged according to integral clinical data.

Description

The pure Chinese medicine medicine and the preparation method of treatment disease of hyperplasia of mammary glands glands

Technical field

The present invention relates to a kind of pure Chinese medicine medicine and preparation method for the treatment of disease of hyperplasia of mammary glands glands, specifically a kind of have the treatment medicine of cyclomastopathy and the adjuvant drug and a preparation method of breast carcinoma.

Background technology

(hyperplasia disease of breast HDB), is a kind of commonly encountered diseases, the frequently-occurring disease that influences women of child-bearing age's health to cyclomastopathy.Use of the generaI investigation of infrared breast examination instrument over past ten years according to us, find that about 80% all suffer from this disease to some extent among the women more than 30 years old tens thousand of adult females.Cyclomastopathy is characteristics with mammary gland glandular epithelium and proliferation of fibrous tissue on the histology, forms and epithelial metaplasia with cyst sometimes.Found that according to our breast biopsy of nearly thousand examples the case of breast carcinoma usually has the background pathological changes of cyclomastopathy.On pathology, it is considered as a kind of precancerous lesion, the particularly the sort of easier generation canceration of person that has the dysplasia, canceration rate is about 10%.In recent years, China's main cities breast cancer incidence has risen 37%.Therefore the active treatment cyclomastopathy is the important method of preventing and treating breast carcinoma.Doctor trained in Western medicine does not still have this sick ideal medicament of treatment, is mainly symptomatic treatment but up to the present.Though tamoxifen has certain curative effect, because of toxic and side effects is big, the report that has the carcinoma of endometrium of making to increase again so all there is certain restriction the time of crowd, dosage and the medication used, is difficult to adhere to use.And Chinese medicine is having one's own knack aspect the treatment HDB, as Chinese medicine RUHE SANJIE PIAN commonly used at present, the treatment cyclomastopathy is just had certain curative effect, and toxic and side effects is also less.

Summary of the invention

Technical problem to be solved by this invention provides a kind of pure Chinese medicine medicine and preparation method for the treatment of disease of hyperplasia of mammary glands glands, we are according to the genesis mechanism of cyclomastopathy, in conjunction with the achievement in research of modern Chinese medicine and Traditional Chinese medical theory, prescription, make " the soothing the liver granule of Zhong Jing Radix Bupleuri (ZCS); be used for the treatment of disease of hyperplasia of mammary glands glands, curative effect is good; Studies have shown that the mechanism of action, site of action, medicinal effects and the medicinal scope thereof of Chinese medicine ZCS, be clinical treatment HDB and the foundation that science is provided according to the different drug dose of various disease application, also going abroad for this medicine lays a solid foundation.This medicine is during clinical practice, and effect is better than Chinese medicine of the same race, is better than similar Western medicine, and side effect is little and lack.

Medicine of the present invention is formed (component by weight) by following raw material components:

Radix Bupleuri 5-15 Radix Angelicae Sinensis 5-17 Radix Salviae Miltiorrhizae 5-20 Radix Astragali 5-15 Rhizoma Corydalis 5-15

Olibanum 5-15 Radix Paeoniae Alba 5-16 Fructus Toosendan 5-12 Radix Glycyrrhizae 5-9 Semen Vaccariae 5-15

Rhizoma sparganic 5-20 Spina Gleditsiae 5-20.

The present invention can make any any clinical pharmaceutical preparation that is applicable to by existing process of Chinese medicine preparation, comprises solid preparation (granule, tablet, capsule), liquid preparation (syrup, mixture) etc., and route of administration adopts oral.

Preparation method of the present invention is: by the 4-5 of above-mentioned prescription medical material total amount extraordinarily decocting boil 2 times, gradation filters, collecting decoction, be concentrated into the extractum of relative density 1.18-1.20 (70 ℃), precipitate 24 hours, precipitation part with behind the ethanol extraction with sucrose, make granule, packing.

Raw material of the present invention is all on sale in market.

Through the research of many decades, the mechanism of the function of discovery ZCS and treatment mastopathy is as follows:

1, in the research of using micro whole blood lymphocyte culture method, finds that ZCS can obviously improve people's lymphocytic conversion ratio, also promptly improve the immunologic function of human body, in the concentration range that test is provided with, with the reduction of concentration, its facilitation to LTR but constantly strengthens.

2,, behind the ZCS therapeutic intervention, find that ZCS suppresses the hypertrophy of laboratory animal breast duct epithelium by duplicating the HDB animal model; Can make outgrowth epithelial tissue generation degenerative change and atresia; By animal experiment, observational study ZCS to histiocytic acute and chronic toxic action with to the influence of serology liver, renal function, the result does not find the abnormal change of any organ-tissue morphology regulating liver-QI, renal function.

3, use the research of MTT colorimetry, find that ZCS and the interior beta-carotene that may contain thereof have tangible toxic action to breast carcinoma MCF-7 cell strain in vitro, its onset mechanism has gone out that direct killing effect is outer, its mutation, resisting mitosis effect also can cause the DNA chain interruption, disturbs genetic transcription and produces antitumaous effect.Therefore, ZCS not only can be used as the medicine of treatment HDB, also can be used as the adjuvant drug of breast carcinoma.

4, by the indirect paired observation before and after the human body HDB treatment, one of mechanism of finding ZCS treatment HDB is its hypertrophy that can suppress breast duct epithelium and lobule; Can also make outgrowth epithelial tissue generation degenerative change, even atresia, the purpose that gives protection against cancer has been played on the canceration basis of having eliminated breast carcinoma; That uses the MP53 gene proteins discovers that the positive expression of MP53 is 39.39% at the HDB matched group, and treatment group MP53 positive expression 9.09%, and expression intensity weakens.

5, use spectrophotography, measure the absorption value of variable concentrations β-C standard substance and ZCS sample, found that the ZCS sample is behind chloroform extraction, the curve that same β-C standard substance basically identical is arranged at the wavelength place of 450nm, show that ZCS contains β-C and β-C class material, one of the anti-hypertrophy of ZCS, anticancer mechanism play a role by β-C.

6, using thin layer chromatography finishes to the qualitative investigation of the effective ingredient ferulic acid among the ZCS.

The present invention is further described.

The present invention carries out clinical verification in part hospital, under unified clinical indexes, people up to ten thousand is treated, and 1280 more complete routine patients of clinical data therapeutic effect is summarized as follows:

Curative effect judging standard: formulate with reference to standard and documents and materials that China Association of Traditional Chinese Medicine formulates.

1. clinical cure: lump dissipates, pain disappears, stop to treat 3 months not the recidivist be clinical cure.

2. produce effects: lump disappears over half, and mammary gland pain disappears and is produce effects.

Lump disappear not enough half, mammary gland pain alleviates to effectively.

4. lump no change person is invalid.

Treat mastopathy 1280 examples by visible the present invention in the table, after the treatment of 4 courses of treatment finishes, clinical cure 396 examples, produce effects 349 examples, effective 498 examples, total effective rate reaches 97% (1243/1280).

The clinical efficacy result of study is as follows:

1. medicine ZCS total effective rate of the present invention reaches 97%, and effect is fast, good effect, short treating period, obviously is better than similar RUPIXIAO of curative effect and RUHE SANJIE PIAN (its total effective rate is 73%).

2. in the Histological research of animal HDB model, medicine of the present invention is compared with the similar Western medicine tamoxifen of curative effect, and ZCS treatment group II level is 2 examples, and tamoxifen group II level is 4 examples (the 0-III level classification method of HDB, the 0-I level is normal range), prove that the curative effect of ZCS is better than tamoxifen.

3. in the morphology, the breast duct epithelium of tamoxifen treatment group is multiformity to be changed, and focal epithelial hyperplasia and low papillary hyperplasia are obvious than the ZCS group, and the epithelial cell atrophic changes difficulty and sees.

4. one of dosage form of the present invention is a granule, and route of administration all belongs to oral.

5. other dosage form of the present invention such as syrup, powder, mixture etc. have identical clinical efficacy.

The specific embodiment

The invention will be further described below in conjunction with embodiment

Embodiment 1:

Radix Bupleuri 5 Radix Angelicae Sinensis 5 Radix Salviae Miltiorrhizaes 5 Radixs Astragali 5 Rhizoma Corydalis 5 Olibanums 5

The Radix Paeoniae Alba 5 Fructus Toosendan Radix Glycyrrhizaes 5 Semen Vaccariae 5

Rhizoma sparganic 5 Spina Gleditsiaes 5

Production method is as follows: the qualified decoction pieces of above-mentioned prescription drug is added 4-5 water doubly, decoct 2 times, gradation filters, collecting decoction is concentrated into the extractum of relative density 1.18-1.20 (70 ℃), precipitates 24 hours, precipitation part with behind the ethanol extraction with sucrose, make granule, packing.

Embodiment 2:

Radix Bupleuri 15 Radix Angelicae Sinensis 17 Radix Salviae Miltiorrhizaes 20 Radixs Astragali 15 Rhizoma Corydalis 15 Olibanums 15

The Radix Paeoniae Alba 16 Fructus Toosendans 12 Radix Glycyrrhizaes 9 Semen Vaccariae 15 rhizoma sparganic 20 Spina Gleditsiaes

20

Production method is as follows: with the compositions of above-mentioned prescription, put into tablet machine, tabletting promptly.

Embodiment 3:

Radix Bupleuri 10 Radix Angelicae Sinensis 11 Radix Salviae Miltiorrhizaes 10 Radixs Astragali 10 Rhizoma Corydalis 8

Olibanum 10 Radix Paeoniae Albas 8 Fructus Toosendans 8 Radix Glycyrrhizaes 7 Semen Vaccariae 10

Rhizoma sparganic 10 Spina Gleditsiaes 8

Production method is as follows: the qualified decoction pieces of above-mentioned prescription drug is added 4-5 water doubly, decocts 2 times, gradation filters, and collecting decoction is concentrated into the extractum of relative density 1.18-1.20 (70 ℃), and adding Mel or syrup make syrup.

Claims (2)

1. pure Chinese medicine medicine for the treatment of disease of hyperplasia of mammary glands glands, it is made up of following weight parts proportion raw material component:

Radix Bupleuri 5-15 Radix Angelicae Sinensis 5-17 Radix Salviae Miltiorrhizae 5-20 Radix Astragali 5-15 Rhizoma Corydalis 5-15

Olibanum 5-15 Radix Paeoniae Alba 5-16 Fructus Toosendan 5-12 Radix Glycyrrhizae 5-9 Semen Vaccariae 5-15

Rhizoma sparganic 5-20 Spina Gleditsiae 5-20.

2. preparation method for the treatment of the pure Chinese medicine medicine of disease of hyperplasia of mammary glands glands, following weight parts proportion raw material component is mixed:

Radix Bupleuri 5-15 Radix Angelicae Sinensis 5-17 Radix Salviae Miltiorrhizae 5-20 Radix Astragali 5-15 Rhizoma Corydalis 5-15

Olibanum 5-15 Radix Paeoniae Alba 5-16 Fructus Toosendan 5-12 Radix Glycyrrhizae 5-9 Semen Vaccariae 5-15

Rhizoma sparganic 5-20 Spina Gleditsiae 5-20;

Boil 2 times by medical material total amount 4-5 decocting doubly, gradation filters, and collecting decoction is concentrated into the extractum of relative density 1.18-1.20, precipitate 24 hours, precipitation partly with behind the ethanol extraction with sucrose, make granule, packing.