WO2013071727A1

WO2013071727A1 - Anti-tumor traditional chinese medical composition

Info

Publication number: WO2013071727A1
Application number: PCT/CN2012/073008
Authority: WO
Inventors: 范圣刚; 刘鹏
Original assignee: Fan Shenggang; Liu Peng
Priority date: 2011-11-14
Filing date: 2012-03-26
Publication date: 2013-05-23
Also published as: CN102366464A; CN102366464B

Abstract

A anti-tumor traditional chinese medical composition comprising Radix Astragali 5-15 parts, Radix Ginseng 10-20 parts, Coleus Forskohlii 5-10 parts, Ganoderma 5-15 parts, Herba Scutellariae Barbatae 10-25 parts, Herba Hedyotidis Diffusae 5-25 parts, Pericarpium Citri Reticulatae 5-10 parts by weight. Said composition has a significant effect of inhibiting tumor，and it is suitable for treating various malignant cancerations including liver cancer, gastric cancer, renal cancer, esophagus cancer, lung cancer, leukemia, etc.

Description

Antitumor traditional Chinese medicine composition

Technical field

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition having anti-tumor effect.

Background technique

With the influence of various external environments such as ecological deterioration and social pressure, malignant tumors bring more and more troubles to people. Modern western medicine treats tumors with chemotherapy or radioactive therapy. While killing cancer cells, it also eliminates many normal cells of the human body, causing tremendous pain and psychological pressure on patients.

Summary of the invention

The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition which can suppress the killing of tumor cells and reduce the suffering of cancer patients. It utilizes traditional Chinese medicine and modern preparation techniques to overcome the defects of Western medicine in treating malignant tumors, inhibit the killing of tumor cells, reduce the suffering of cancer patients, and effectively prolong their survival time.

An anti-tumor traditional Chinese medicine composition, the raw material medicine in terms of parts by weight is:

Huang Wei: 5-15;

Ginseng: 10-20;

Coatseopsis sinensis flower: 5-10;

Ganoderma lucidum: 5-15;

Scutellaria barbata: 10-25;

White Snake Grass: 5-25;

Chenpi: 5-10.

The traditional Chinese medicine composition of the present invention, wherein the raw material medicine is preferably:

Huang Wei: 6-10;

Ginseng: 11-15;

Coleus forsythia: 6-9;

Ganoderma lucidum: 8-13;

Scutellaria barbata: 15-25;

White Snake Grass: 10-25;

Chenpi: 6-10.

The traditional Chinese medicine composition of the present invention, wherein the bulk drug is most preferably in terms of parts by weight:

Huang Wei: 8;

Ginseng: 12; Coleus chinensis: 6;

Ganoderma lucidum: 8;

Scutellaria bark: 16;

White Snake Grass: 16;

Chenpi: 6.

The traditional Chinese medicine composition of the present invention can be prepared into various intermediate dosage forms for clinical administration. For example, capsules, pills, tablets, powders, injections and/or oral solutions, and the like.

Among them, the most preferred capsule dosage form is convenient to take clinically, the absorption of the active ingredient of the medicine is fast, the storage time is long, and the production process is simple. A preferred preparation method comprises the following steps:

(1) accurately weighing each component, and placing it into a double high shear crusher to prepare a nanopowder;

(2) Transfer to ultrasonic mixer, ultrasonically mix for 30 minutes and then freeze to -18 °C;

(3) Mix evenly under the conditions of 2 ° C or lower;

(4) Prepared by aseptic filling capsule after 80 mesh sieve.

The above capsule dosage forms can be packaged in hard capsule No. 1, each containing about 430 mg of the contents. The method of administration is 3 times a day, 4 capsules each time. Take it after meals, usually 28 days for a course of treatment. It should be protected from light, stored at room temperature, and kept.

The traditional Chinese medicine composition and the traditional Chinese medicine preparation of the invention have the effects of inhibiting tumors by animal test and human clinical trial, and are suitable for the treatment of various malignant cancers including liver cancer, gastric cancer, kidney cancer, esophageal cancer, lung cancer and leukemia.

The traditional Chinese medicine composition of the present invention is a modern Chinese medicine designed according to the principles of Chinese medicine prescriptions of Jun, Chen, Zuo and Zhi. The efficacy of the drug substance used is as follows:

Astragalus, alias: Mianhuang, etc., English name: Milkvetch Root, Chinese medicine Latin name: RADIX ASTRAGALI; Astragalus has qi and solid table, diuretic toxin, pus discharge, sore muscles. Commonly used for qi deficiency and fatigue, eating less stool, qi sag, prolonged diarrhea and rectal prolapse, blood in the stool, scalp and spontaneous sweating, sputum is difficult to collapse, long-term ulceration, blood deficiency and sallowness, internal heat and thirst.

Ginseng, Alias: ginseng, garden ginseng, human title, blood ginseng, baby ginseng, etc., English name: Ginseng, Ginseng Root, Latin plant name: Panax ginseng CA Mey.; with great vitality, complex veins, spleen Yifei, Shengjinzhike, the effect of soothe the nerves. Indications: Injury, loss of food, fatigue, nausea, diarrhea, fecal diarrhea, vaginal convulsions, spontaneous sweating, convulsions, forgetfulness, dizziness, headache, impotence, frequent urination, thirst, uterine bleeding, slow children Surprising and long-lost, all the symptoms of qi and blood deficiency.

Coleus forskolin Briq. is a genus of the genus Coleoptera, belonging to about 90 species. It is produced in the subtropical region of the Eastern Hemisphere and is mainly distributed in India, Sri Lanka and Nepal. There are 6 species in China, mainly producing Sichuan, Fujian and Taiwan. It is known as the panacea in India. It is also known as sheath sulphate in ancient China. It is used in asthma, phlegm, blood pressure, antithrombotic, etc., and has been found to have been inhibited in the last two decades. The magical effect of the tumor. Ganoderma lucidum, Alias: Ganoderma lucidum, Hongzhi, Ganoderma lucidum, Ganoderma lucidum, Wannian, Ganoderma lucidum, English name: LucidGanoderma, Latin name: Ganoderma lucidum (Curtis: Fr.) P.Karst.; Basidiomycetes (Polyporaceae) Ganodelma fungus G. lucidum 'karst and G. japonicrn L loyd, the general name, has the effect of strengthening the body and so on. Ganoderma lucidum used as a medicine is Ganoderma lucidum and Zizhi, and its medicinal properties are sweet and flat. Heart, lung, liver, kidney. Indications of fatigue, cough, asthma, insomnia, indigestion, malignant tumors, etc.

Scutellaria barbata L., sylvestris sylvestris, sylvestris sylvestris, toothbrush grass, squarish sylvestris, sylvestris, English name: HERB ASCUTELLARIAEB ARB ATAE, Latin name: Portulaca grandiflora Hook.; Grass and roots. It is cool and tastes bitter. The function is to clear away heat and detoxify, promote blood circulation and remove blood stasis. Indications of snake bites, acne swelling and so on.

White Snake Grass, also known as Hedyotis diffusa, Hedyotis, Diloba, Bamboo Leaf, Snake Grass, Latin name: Hedyotis diffusa; is a plant of the genus Valeriana. Slightly bitter, sweet, cold. Into the stomach, large intestine, small intestine, bitter cold heat and detoxification, sweet and cold, clear and damp heat, have a strong detoxification and eliminate phlegm, swelling, sore throat, snake wounds.

Chenpi, alias: orange peel, expensive old, red skin, yellow orange peel, wide orange peel, new skin, orange peel, wide dried tangerine peel. It is the mature peel of the citrus plant orange and its cultivar. The cultivars are mainly Citrus reticulata 'Chachi' (Guang Chenpi), Dahongpai Citrus reticulata 'Dahongpao', Citrus reticulata 'Unshiu', Citrus reticulata 'TangerinaO with qi qi sag, acne appetite, dampness The effect of phlegm.

The invention has the main functional component of the genus Corydalis, supplemented by traditional Chinese medicines such as ganoderma lucidum, radix astragali, ginseng, scutellaria, and white snake grass, and has the effect of killing tumor cells, and has Fuzheng solid. The role of this, comprehensive conditioning. At the same time, the raw materials used are traditional Chinese medicine ingredients, and their dosages are within the scope of pharmacopoeia and national standards, and the side effects are small.

The raw materials and equipment required for the present invention are commercially available.

detailed description

To further illustrate the present invention, it will be specifically described in conjunction with the following examples:

The traditional Chinese medicine preparation of the present invention is preferably a capsule dosage form, and the preparation method comprises the following steps:

(1) accurately weigh each component and put it into a compound high shear crushing disperser (Shanghai Suwei Electromechanical Equipment Co., Ltd.) to prepare nano powder;

(3) Mix evenly under the conditions of 2 ° C or lower;

(4) Prepared by aseptic filling capsule after 80 mesh sieve. Example 1

The traditional Chinese medicine compound capsule prepared according to the above method, wherein the first step, the weight of each raw material medicine is as follows: Astragalus 8g, person Reference 12g, Coleus forsythiae 6g, Ganoderma Lucidum 8g, Scutellaria barbata 16g, White Snake Grass 6g, Tangerine 6g.

Example 2

The traditional Chinese medicine compound capsule prepared according to the above method, wherein the first step, the weight of each raw material medicine is as follows: astragalus 12g, ginseng 12g, hairy laryngeal flower 9g, ganoderma lucidum 12g, Scutellaria barbata 20g, white flower snake grass 6g, orange peel 6g.

Example 3

The traditional Chinese medicine compound capsule prepared according to the above method, wherein the first step, the weight of each raw material medicine is as follows: Astragalus 8g, ginseng 12g, Coleus chinensis 8g, Ganoderma lucidum 8g, Scutellaria bark 16g, White flower snake grass 12g, dried tangerine peel 6g.

Example 4

The traditional Chinese medicine compound capsule prepared according to the above method, wherein the first step, the weight of each raw material medicine is as follows: Astragalus 9g, ginseng 12g, Corydalis, 8g, Ganoderma lucidum 12g, Scutellaria bark 16g, White flower snake grass 12g, dried tangerine peel 6g.

Example 5

The traditional Chinese medicine compound capsule prepared according to the above method, wherein the first step, the weight of each raw material medicine is as follows: Astragalus 9g, ginseng 12g, Coleus forsythiae 6g, Ganoderma lucidum 10g, Scutellaria barbata 18g, White flower snake grass 12g, dried tangerine peel 6g.

Example 6

The traditional Chinese medicine compound capsule prepared according to the above method, wherein the first step, the weight of each raw material medicine is as follows: Astragalus 8g, ginseng 12g, Coleus forsythiae 9g, Ganoderma lucidum 12g, Scutellaria barbata 18g, White flower snake grass 10g, dried tangerine peel 6g. Test example:

1. Animal acute toxicology experiment:

The results of acute toxicology experiments with Kunming mice showed that the crude drug components of the samples of the first, tenfold, and 30-fold doses were administered to the mice for one month, and the three doses of the experimental group and the control group were There was no death; anatomical animal tissue observation showed that there were no significant differences in animal tissue morphology between the three groups of high, medium and low doses compared with the blank control group.

2, animal long-term toxicology experiment

SD rats were fed with SD rats and long-term toxicological experiments with the maximum dose of 35.4 times and 10 times the dose of the drug of the sample. The mice were incubated for three months, neither the experimental group nor the control group. Death occurred; anatomical animal tissue observation, there was no significant difference in animal tissue morphology between the experimental group and the blank control group.

3. Pharmacological experiments:

The present invention uses the conventional anti-tumor experimental method to study the crude drug constituents of the drugs of the present invention against osteosarcoma cells (UMR106, MG63), human promyelocytic leukemia cells (HL60, B4), human erythroleukemia cells (K562). Growth inhibition and cell morphology changes in mouse S180 sarcoma and human lung adenocarcinoma cells (PG), human nasopharyngeal carcinoma (CE), including growth curve, splitting index; optical microscopy, scanning electron microscopy and transmission Morphological changes observed under electron microscope Cell phenotype, subcellular structure and changes in cytoskeleton; effects of drugs on cancer cell cycle; effects on cell membrane fluidity and membrane potential measurement. The following experiments were also carried out using conventional anti-tumor experiments:

1. Anti-tumor experiment on animal transplanted tumor: anti-tumor experiment on transplanted tumor of mouse S180 sarcoma and mouse Ehrlich ascites cancer cells;

2. Anti-tumor experiments of human tumor transplanted nude mice: human promyelocytic leukemia cells (HL60, B4), human nasopharyngeal carcinoma (C E-2) cells, human colon cancer cells (CA-II), human gastric adenocarcinoma Anti-tumor experiments of cells (BGC-823) and human lung cancer cells (PG) transplanted into nude mice.

The above experiments all used retinoic acid as a positive control. The experimental results show that the anti-cancer rate of the traditional Chinese medicine composition provided by the present invention is between 31% and 70%, among which the effects on human promyelocytic leukemia, human gastric adenocarcinoma and human nasopharyngeal carcinoma. Preferably, the cancer suppression rate is between 60% and 70%.

4, clinical trials

Pre-clinical research based on animal testing: Under the strict supervision of doctors, guide volunteers to try.

1. Pre-clinical pre-clinical study for the treatment of human leukemia, according to the World Health Organization Classification of

Tumors. Pathology and Genetic of Tumors of Haematopoietic and Lymphoid Tissue (2008), "Diagnostic and Efficacy Standards for Hematological Diseases" (Zhang Zhinan, Editor-in-Chief, Science Press, 2008, Third Edition), we have carried out the following three aspects: Detection: (1) Physical examination with or without the following signs: fever, pale skin and mucous membranes, skin bleeding spots and ecchymoses, lymph nodes and hepatosplenomegaly, sternal tenderness. (2) Blood cell count and classification. (3) Bone marrow examination: morphology (including histochemistry). Twelve patients were enrolled, and the traditional Chinese medicine compound capsule of Example 1 contained about 430 mg of the contents per capsule. The method of administration is 3 times a day, 4 capsules each time. After taking a meal, taking 28 days as a course of treatment, after 3 courses of treatment, the improvement rate was 83.33%, and the effective rate was 58.33%. The results confirmed that the compound Chinese medicine of the present invention has an obvious effect on promyelocytic leukemia.

2. Pre-clinical study on the treatment of advanced gastric cancer in humans. According to the Ministry of Health's “Guidelines for the Diagnosis and Treatment of Gastric Cancer”, 26 patients were enrolled, and the traditional Chinese medicine compound capsule of Example 2 contained about 430 mg of each capsule. The method of administration is 3 times a day, 4 capsules each time. After taking a meal, taking 28 days as a course of treatment, after 4 courses of treatment, the improvement rate (PR) was 30.77%, the stable (SD) rate was 65.38%, and the deterioration (PD) rate was 3.85%. As a result, it was confirmed that the compound Chinese medicine of the present invention has a remarkable effect in improving the quality of life (e.g., tumor softening and atrophy, ascites disappearing, lymph node shrinking, appetite is increased, etc.).

3. Pre-clinical study of compound Chinese medicine for treating advanced renal cell carcinoma according to the present invention, according to the solid tumor efficacy evaluation standard (RECIST), 11 patients were enrolled, and the content of the traditional Chinese medicine compound capsule of Example 3 was about 430 mg per capsule. . The method of application is 3 times a day, 4 capsules each time. After taking a meal, taking 56 days as a course of treatment, after 3 courses of treatment, the improvement rate (PR) was 27.27%, the stable (SD) rate was 54.55%, and the deterioration (PD) rate was 18.18%.

Typical cases:

1. Wang, female, 78 years old, September 2010, the patient coughed up after a cold. When the family took their medical examination the next day, the CT examination issued There is a 3.5x4cm shadow in the lungs, diagnosed as lung cancer by Beihai Hospital of Yantai City. On April 30, 2011, the patient started taking the compound Chinese medicine described in Example 1 of the present invention, and after three courses of treatment, in January 2011, the family took it again for review, and the CT examination result showed that the lung shadow was reduced. The patient feels good about himself, increases his appetite more than before, and can do general housework.

2, Zeng Moumou, female, 54 years old, in November 2010, the National University of Singapore medical school diagnosed as breast cancer, after the removal of the left breast, Western medicine treatment effect is not obvious, and hair loss is serious, sleep is not good. Since June 2011, the compound Chinese medicine of the second embodiment of the present invention has been taken. After two courses of treatment, the patient is in good physical condition and no recurrence is observed. The state of mind is also refreshed, and the quality of sleep is greatly improved.

3. Yin Moumou, male, 69 years old, In August 2010, Qixia People's Hospital was diagnosed with advanced liver cancer and severe ascites. The patient was very painful. After consultation with a number of chief physicians, it was concluded that the patient's survival time would not exceed 2 months. Since September 2010, the compound Chinese medicine of the third embodiment of the present invention has been used. After 5 courses of treatment, the ascites is reduced and the pain is relieved, but it died in the hospital in February 2011. By taking the compound Chinese medicine of the present invention, the effective survival time of the patient is extended by about 3 months.

Industrial applicability

The anti-tumor traditional Chinese medicine composition provided by the invention can inhibit the killing of tumor cells and reduce the suffering of cancer patients. It is composed of the main functional components of Coleus formosanus, supplemented by traditional Chinese medicines such as Ganoderma lucidum, Astragalus, Ginseng, Scutellaria barbata, and White Snake Grass. The drug substance used is natural plant material, which is clinically long-term and has specific curative effect. The natural botanical raw material medicine has small toxic and side effects, and can be formulated into various forms of medicaments according to pharmacy, and the clinical treatment effect is remarkable.

Claims

Rights request

1. An anti-tumor traditional Chinese medicine composition, characterized in that: the raw material medicine is in terms of parts by weight:

Huang Wei: 5-15;

Ginseng: 10-20;

Coatseopsis sinensis flower: 5-10;

Ganoderma lucidum: 5-15;

Scutellaria barbata: 10-25;

White Snake Grass: 5-25;

Chenpi: 5-10.

The traditional Chinese medicine composition according to claim 1, wherein the raw material medicine is: xanthine: 6-10;

Ginseng: 11-15;

Coleus forsythia: 6-9;

Ganoderma lucidum: 8-13;

Scutellaria barbata: 15-25;

White Snake Grass: 10-25;

Chenpi: 6-10.

The traditional Chinese medicine composition according to claim 1, wherein the raw material medicine is: xanthine: 8;

Ginseng: 12;

Coleus chinensis: 6;

Ganoderma lucidum: 8;

Scutellaria bark: 16;

White Snake Grass: 6;

Chenpi: 6.

4. A traditional Chinese medicine preparation containing the traditional Chinese medicine composition according to any one of claims 1 to 3.

The traditional Chinese medicine preparation according to claim 4, wherein the preparation is a capsule, a pill, a tablet, a granule, and/or an oral solution.

6. The traditional Chinese medicine preparation according to claim 5, wherein the preparation is a capsule.

The method for preparing a traditional Chinese medicine preparation according to claim 6, characterized in that it comprises the following steps: (1) accurately weighing each component, and placing it into a double high shear crusher to prepare a nanopowder;

(3) Mix evenly under the conditions of 2 ° C or lower;

(4) Prepared by aseptic filling capsule after 80 mesh sieve.

The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 for the preparation of a medicament for treating a tumor disease.

9. The use of the traditional Chinese medicine preparation according to claim 4 for the preparation of a medicament for treating a tumor disease.

10. The use according to claim 8, wherein the tumor diseases include liver cancer, gastric cancer, kidney cancer, esophageal cancer, lung cancer, and leukemia.