A kind of high ester catechin capsule for the treatment of breast carcinoma and preparation method thereof
Technical field
The present invention relates to a kind of capsule for the treatment of breast carcinoma, specifically refer to be the capsule that primary raw material is made, the invention still further relates to this capsular preparation method with high ester catechin, Fructus Trichosanthis.
Technical background
Breast carcinoma is the major malignant tumor of harm WomanHealth, and the whole world has more than 100 ten thousand women to suffer from breast carcinoma every year approximately.There is significant difference in breast cancer incidence all over the world, the sickness rate of China's women with breast cancer is compared lower with world developed country, but occur tangible ascendant trend in recent years, the morbidity problem of China's women with breast cancer is on the rise, and accounts for the front two of women's malignant tumor.The cause of disease of breast carcinoma it be unclear that at present, by basis and clinical research, massive epidemiology investigation, analysis, known many factors can influence developing of breast carcinoma, research comparatively extensively and profoundly be endocrine, heredity and viral three kinds of paathogenic factors, also the someone thinks that the breast carcinoma morbidity is relevant closely with life style, diet, nutrition, calorie, obesity etc.Western medical treatment is first-selected with the excision at present, while combination with radiotherapeutic, chemotherapy, incretotherapy and immunotherapy etc., but the whole bag of tricks all has its limitation.Breast carcinoma is early on the books in the successive dynasties of traditional Chinese medical science document, is called as " nodule in the breast ", " stone carbuncle ", " newborn painful abdominal mass ", " mastocarcinoma " or the like respectively, and modern more unified traditional Chinese medical science title is " breast carcinoma ".Traditional Chinese medical herbal treatment breast carcinoma has its special advantages, utilizes the advantage of differentiation of tcm, and the medicine of taking to adjust cancer patient's whole body internal organs, QI and blood, meridians, imbalance of YIN and YANG takes orally, reaches the purpose of treatment disease.At present, be used for the treatment of the Chinese medicine preparation of breast carcinoma, by ten number flavor Chinese medicine preparations, not only medicine variety is many, and the preparation process complexity mostly.Catechins is the main component in the tea polyphenols, account for about 70% of tea polyphenols total amount, catechin is mainly by catechin (C), epicatechin (EC), epigallo catechin (EGC), L-Epicatechin gallate (ECG), epigallocatechin gallate (EGCG) (EGCG) is formed.Wherein EGCG removes free radical, a kind of catechin that oxidation resistance is the strongest in the tea polyphenols, have obvious antioxidation activity, anticancer, Antiradiation injury effect, influence cell generation cycle, regulating cell apoptogene, promote the proteic expression of p53 to strengthen, thus the apoptosis of inducing tumor cell.Fructus Trichosanthis is a Cucurbitaceae herbaceous perennial vine plant, and the traditional Chinese medical science is thought functions such as Fructus Trichosanthis has heat clearing away, lung moistening, reduces phlegm, eliminating stagnation, laxation, cure mainly phlegm-heat cough, the thoracic obstruction, blocked-up chest, consumptive lung disease hemoptysis, quench one's thirst, jaundice, constipation, carbuncle from the beginning of etc.Experimental results show that in recent years the Fructus Trichosanthis extract has antitumor action, can also improve the killing activity of NK cell, cell death inducing, enhance immunity, Profilin matter synthetic.
Summary of the invention
The purpose of this invention is to provide capsule of a kind of effective treatment breast carcinoma and preparation method thereof, this capsule administration kind is few, preparation technology is simple, is main component with the high ester catechin and the Fructus Trichosanthis extract of tool anti-tumor activity, adds that acceptable auxiliary is prepared from the pharmaceutics.
Composition of the present invention and proportioning are: high ester catechin 20%~60%, and Fructus Trichosanthis 40%~80%, optimum ratio are high ester catechin 25%~50%, Fructus Trichosanthis 50%~75%, best proportioning is a high ester catechin 35%, Fructus Trichosanthis 65%.
Acceptable auxiliary can be a kind of in starch, methylcellulose, ethyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, sucrose, the gelatin etc. on the pharmaceutics of the present invention.
Preparation process of the present invention can be:
A. get Fructus Trichosanthis and pulverize, added 4~6 times of volume of ethanol reflux, extract, 2~4 hours, filter, ethanol extract is standby;
B. ethanol is reclaimed in the ethanol extract distilling under reduced pressure of Fructus Trichosanthis among the step a, to 1/3~1/4 of former extracting liquid volume;
C. rest solution cooling in distillation back among the step b adds adjuvant, high ester catechin, and mixing is made soft material, crosses 14 order nylon mesh and granulates, and is dried to moisture below 3% in 65~70 ℃, and dried granules is loaded in the capsulae vacuus, promptly.
Above-mentioned high ester catechin contains in catechin monomers (C), epicatechin (EC), epigallo catechin (EGC), L-Epicatechin gallate (ECG), the epigallocatechin gallate (EGCG) (EGCG) one or more.Used concentration of ethanol is 45%~65% among the step a, preferred 60%.
The present invention can effectively suppress growth of tumor, inducing apoptosis of tumour cell, and take safety, toxic and side effects is little, is used for the treatment or the auxiliary treatment of breast carcinoma, takes medicine once a 300~900mg in 1~2 day.
The specific embodiment
Embodiment 1:
Get Fructus Trichosanthis 160g and pulverize, 65% alcohol reflux of 6 times of volumes of adding 4 hours filters, the ethanol extract distilling under reduced pressure, reclaim ethanol, to 1/4 of former extracting liquid volume, cooling, add sucrose 15g, high ester catechin 40g, mixing is made soft material, crosses 14 order nylon mesh and granulates, and is dried to moisture below 3% in 65~70 ℃, dried granules is loaded in the capsulae vacuus, promptly.
Embodiment 2:
Get Fructus Trichosanthis 80g and pulverize, 45% alcohol reflux of 4 times of volumes of adding 2 hours filters, the ethanol extract distilling under reduced pressure, reclaim ethanol, to 1/3 of former extracting liquid volume, cooling, add methylcellulose 15g, high ester catechin 120g, mixing is made soft material, crosses 14 order nylon mesh and granulates, and is dried to moisture below 3% in 65~70 ℃, dried granules is loaded in the capsulae vacuus, promptly.
Embodiment 3:
Get Fructus Trichosanthis 130g and pulverize, 60% alcohol reflux of 5 times of volumes of adding 3 hours filters, the ethanol extract distilling under reduced pressure, reclaim ethanol, to 1/4 of former extracting liquid volume, cooling, add starch 10g, high ester catechin 70g, mixing is made soft material, crosses 14 order nylon mesh and granulates, and is dried to moisture below 3% in 65~70 ℃, dried granules is loaded in the capsulae vacuus, promptly.
Embodiment 4:
The TM40 cell of trophophase of taking the logarithm is made into 1 * 10 after with trypsinization
7Individual/the ml single cell suspension, BALB/C mice (female, 18~20g) thoracic wall, 5~6 intercostal subcutaneous vaccination tumor cell suspension 0.1ml observe the tumor growth situation, inoculate a week after, subcutaneous visible lump confirms to set up the model success.Get 40 of breast cancer model mices, be divided into 4 groups immediately, every group 10, be respectively blank group (starch), the high, medium and low dosage group of high ester catechin capsule (press embodiment 3 prescriptions and preparation method preparation, calculate by high ester catechin and be respectively 6mg/kg by dosage, 12mg/kg, 24mg/kg), the next day, be administered once, successive administration 21 days.In the 21st day, mice is put to death, peel off tumor tissues and weigh, calculate tumor control rate.Tumor control rate=(the average tumor of the average tumor weight-administration of matched group group is heavy)/average tumor of matched group is heavy.The results are shown in Table one, can find out that by the result the present invention has significant inhibitory effect to breast cancer tumour.
Table one high ester catechin capsule is to BALB/C mice tumor control rate (x ± s)
Group |
Number of animals |
Tumor weight (g) |
Tumor control rate |
Dosage group high ester catechin capsule low dose group in the blank group high ester catechin capsule high dose group high ester catechin capsule |
10 10 10 10 |
4.38±1.73 1.15±0.84
* 1.42±1.02
* 2.11±1.15
* |
0 73.74% 67.58% 51.83% |
Compare with the blank group,
*P<0.01