CN114588195B - Preparation and application of compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumor - Google Patents

Preparation and application of compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumor Download PDF

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CN114588195B
CN114588195B CN202210420664.8A CN202210420664A CN114588195B CN 114588195 B CN114588195 B CN 114588195B CN 202210420664 A CN202210420664 A CN 202210420664A CN 114588195 B CN114588195 B CN 114588195B
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chinese medicine
traditional chinese
medicine composition
tumor immunity
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CN114588195A (en
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刘彩刚
杨永亮
刘贺
牛楠
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Dalian University of Technology
Shengjing Hospital of China Medical University
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Shengjing Hospital of China Medical University
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Abstract

The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors, and a preparation method and application thereof. The composite material consists of the following raw materials in parts by weight: 5-15 parts of lucid ganoderma, 15-25 parts of astragalus, 5-15 parts of ginseng, 5-15 parts of stir-fried bighead atractylodes rhizome, 5-15 parts of poria cocos, 5-15 parts of Chinese angelica, 5-15 parts of radix sophorae flavescentis and 5-15 parts of honey-fried licorice root. The compound traditional Chinese medicine composition provided by the invention has the effects of tonifying and strengthening the spleen, replenishing qi and enriching blood, detoxifying and resolving masses, regulating tumor immunity, resisting tumors and the like, can regulate and control tumor immunity check point proteins, has a killing effect on various tumor cells, can regulate the proportion of a plurality of T lymphocyte sub-populations, causes remarkable increase of immunocompetence cells, enhances the immune function and treats tumors.

Description

Preparation and application of compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumor
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a compound traditional Chinese medicine composition preparation for regulating tumor immunity and resisting tumors.
Background
Cancer is a serious disease that is seriously threatening the life and health of humans. According to world health organization statistics, 996 tens of thousands of cancer deaths worldwide in 2020, of which nearly 300 tens of thousands occur in china. Clinically, the treatment of tumors mainly depends on chemoradiotherapy. For example, chemotherapy has great toxicity, and can kill autoimmune cells such as leucocytes and lymphocytes while killing tumor cells, so that autoimmune functions of patients are destroyed, and serious adverse reactions are generated. On the other hand, tumor-targeted drugs act against specific targets, but are very limited in use and high in treatment cost due to the different genotypes of each patient. Tumor immunity is the most advanced tumor treatment method in recent years, and a method for killing tumor cells by stimulating an autoimmune system is proposed, and a Nobel medical prize was obtained in 2018 in tumor immunity research. In order to avoid the immune system, the tumor cells use immune checkpoint proteins such as PD-L1, CTLA-4 and the like to shut down the defensive activity of the immune T cells, so that the tumor cells avoid the attack of the immune system. Tumor immunotherapy kills tumor cells by modulating immune checkpoint proteins, thereby stimulating and directing the immune system. Our research team also developed the first tumor immune target database and the tumor immune knowledge graph platform CKTTD worldwide in 2020, and the global annual access usage amount was more than 3000 times, which promoted the development of tumor immunotherapy and related tumor immune drugs.
The traditional Chinese medicine has unique advantages in the aspect of treating tumors, and the natural medicine represented by the traditional Chinese medicine has the characteristics of small toxic and side effects, multiple action targets, good tolerance and the like. The theory of traditional Chinese medicine emphasizes dialectical treatment, on one hand, the deficiency of the human body is compensated, and the immune function of the patient is regulated and controlled from the whole system; on the other hand, detoxification and resolving hard mass are used for treating tumors, so that the unification of treatment and conditioning is emphasized, the whole body state of a patient is improved, and the emphasis is placed on tumor treatment. The traditional Chinese medicine composition for anti-tumor treatment has larger dosage at present, and no related report of the traditional Chinese medicine composition for regulating tumor immunity check point protein and improving tumor immunity exists.
The compound traditional Chinese medicine combined preparation is discovered in tumor immunity research and combines clinical practice, has small dosage and scientific and reasonable proportion, can effectively inhibit tumor immunity check point targets and improve tumor immunity of patients, promote the whole immune function of the patients and stimulate immune systems to kill tumor cells, reduce toxic and side effects brought by conventional treatment methods such as radiotherapy and chemotherapy, regulate and control the tumor immunity as a whole, detoxify and dissipate stagnation to treat tumors, and can obviously improve and improve the life quality of tumor patients and effectively prolong the survival time of the patients.
Disclosure of Invention
Aiming at the problems, the invention provides a compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors, and the other aim of the invention is to provide a preparation method of the compound traditional Chinese medicine composition and application of the compound traditional Chinese medicine composition in preparation of medicines for regulating tumor immunity and resisting tumors.
In order to achieve the above purpose, the present invention provides the following technical solutions.
The invention provides a compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors, which is characterized by comprising the following traditional Chinese medicine raw materials in parts by weight: 5-15 parts of lucid ganoderma, 15-25 parts of astragalus, 5-15 parts of ginseng, 5-15 parts of stir-fried bighead atractylodes rhizome, 5-15 parts of poria cocos, 5-15 parts of Chinese angelica, 5-15 parts of radix sophorae flavescentis and 5-15 parts of honey-fried licorice root.
Further, the traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials in parts by weight: 10 parts of lucid ganoderma, 25 parts of astragalus membranaceus, 8 parts of ginseng, 10 parts of stir-fried bighead atractylodes rhizome, 15 parts of poria cocos, 10 parts of Chinese angelica, 8 parts of radix sophorae flavescentis and 8 parts of honey-fried licorice root.
Further, the traditional Chinese medicine composition also comprises a pharmaceutically acceptable carrier and/or excipient.
Still further, the pharmaceutically acceptable carrier and/or excipient comprises one or more of liposome, microcrystalline cellulose, sodium carboxymethyl starch, sodium carboxymethyl cellulose, polyethylene glycol, polyvinyl alcohol, acrylic polymers, glycerol, propylene glycol, sorbitol, beta-cyclodextrin, tween-80, lactose, starch, you Jite S-100, you Jite L-100, sodium alginate, pectin, dextrin.
Further, the traditional Chinese medicine composition is in the forms of granules, capsules, oral liquid, tablets, pills, paste, decoction, injection and microcapsules.
The invention also provides a preparation method of the compound traditional Chinese medicine composition extract for regulating tumor immunity and resisting tumor, which comprises any one of the following steps:
a: decocting the Chinese medicinal materials in 5-12 times of water, filtering, concentrating the filtrate to obtain extract;
b: reflux extracting the prescription Chinese medicine with 50-90% ethanol water solution, filtering, concentrating the filtrate to obtain extract;
c: decocting the prescription Chinese medicine with 5-12 times of water, and filtering; reflux extracting the residue with 50-90% ethanol water solution, filtering, mixing filtrates, and concentrating to obtain extract.
Further, the dosage of the ethanol aqueous solution in the reflux extraction operation of the ethanol aqueous solution in the step B is 8-10 times of the weight of the medicinal materials.
Further, the compound traditional Chinese medicine composition is applied to preparation of medicines for regulating tumor immunity and resisting tumors.
Further, the tumor includes lung cancer, breast cancer, colon cancer, pancreatic cancer, esophageal cancer, osteosarcoma, renal cancer, cervical cancer, head and neck cancer, multiple myeloma, brain tumor, prostate cancer, melanoma, gastric cancer, liver cancer, glioma, leukemia, and lymphoma.
Preferably, the tumor is preferably lung cancer, breast cancer, colon cancer, lymphoma or melanoma.
The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumor has the following efficacy.
Ganoderma, wen Weidan, has effects of invigorating qi and blood, tonifying heart qi, tranquilizing mind, regulating immunity, resisting oxidation, and resisting tumor.
Astragalus root, wen Weigan, which has the effects of invigorating qi, elevating yang, inducing diuresis, relieving edema, expelling toxin, expelling pus, promoting salivation, nourishing blood, resisting tumor and enhancing immunity, has the effect of invigorating spleen and lung meridian.
Ginseng radix, wen Weigan, has effects of invigorating qi and blood, promoting salivation, tranquilizing mind, resisting tumor and enhancing immunity, and can be used for treating heart, lung, spleen and kidney meridian.
Stir-baked Bai Zhu, with the property Wen Weigan, enters spleen and stomach meridians, and has the effects of strengthening spleen and tonifying qi, resisting oxidation and tumors and enhancing immunity.
Poria cocos has the effects of inducing diuresis, strengthening spleen, calming heart, activating immunity and resisting tumor, and is sweet in nature and taste, and enters heart, lung and spleen meridians.
Angelica sinensis, radix Angelicae sinensis, wen Weigan, has effects of tonifying blood, promoting blood circulation, loosening bowel to relieve constipation, enhancing immunity, resisting oxidation and resisting tumor.
Kuh-seng, bitter in property and cold in taste, enters heart, liver and stomach meridians, and has the effects of clearing heat and removing toxicity, killing parasites and promoting urination, and activating immunity and resisting tumors.
Honey-fried licorice root, radix Glycyrrhizae Preparata, property Wen Weigan, enters heart, lung, stomach and spleen meridians, and has the effects of invigorating spleen, regulating stomach, tonifying qi, restoring pulse and enhancing immunity.
The medicines are combined based on the theory of monarch, minister, assistant and guide in the traditional Chinese medicine, are reasonably configured and mutually compatible. In the invention, ginseng and astragalus root are used for reinforcing primordial qi and strengthening healthy energy as principal drugs in the prescription; the ganoderma lucidum, the bighead atractylodes rhizome and the poria cocos are used for assisting the monarch drugs to tonify qi. Because tangible qi cannot be produced rapidly and occurs in intangible qi, the emphasis is on replenishing qi to produce blood, which is taken as a ministerial drug. Taking angelica sinensis to nourish blood, harmonize blood and relieve pain; kuh-seng and licorice root, radix Sophorae Flavescentis and licorice root, radix Glycyrrhizae Praeparata are used as adjuvant drugs for detoxification and pain relief. Licorice root, radix Glycyrrhizae can be used in combination with other drugs to regulate the quality of the product. Quan Fang it has effects in invigorating qi, nourishing blood, strengthening body resistance, consolidating constitution, and removing toxic substances, resolving hard mass, eliminating pathogenic factors, and treating symptoms. The eight herbs are combined to play the roles of tonifying qi, nourishing blood, removing toxicity and resolving masses.
Compared with the prior art, the invention has the beneficial effects.
1. According to the theory of traditional Chinese medicine, the invention combines the forefront research result of tumor immunity, adopts the principle of dialectical treatment and systemic regulation to carry out traditional Chinese medicine formula screening, and the provided compound traditional Chinese medicine composition with the functions of regulating tumor immunity and resisting tumor can inhibit key tumor immunity check point targets, inhibit tumor cell growth and promote tumor cell apoptosis, and has killing effect on various types of tumor cells.
2. Experimental results show that the compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors has the effects of regulating yin and yang, strengthening body resistance and banking up root, simultaneously regulating tumor immunity, regulating various tumor immunity-related targets and cytokines, activating human immune mechanisms to kill tumor cells, playing the role of treating tumors by a multi-target system, reducing pain of cancer patients, obviously improving the survival quality of the patients and prolonging the survival time. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumor provided by the invention has high safety and low toxic and side effects.
3. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumor provided by the invention can be prepared into various dosage forms by utilizing pharmaceutical carriers/excipients and the like, and is convenient for patients to take. In addition, the compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumor provided by the invention has scientific and reasonable proportion, small dosage, quick play of medicine effect and stable preparation process, and is suitable for industrial mass production.
Detailed Description
The following further detailed description of the present invention is provided in connection with the accompanying drawings that are provided solely for the purpose of illustrating the invention and are not intended to limit the scope of the invention.
Example 1.
The preparation method comprises the steps of taking the raw materials in parts by weight, taking 15 g of lucid ganoderma, 25 g of astragalus, 15 g of ginseng, 15 g of stir-fried bighead atractylodes rhizome, 15 g of poria cocos, 15 g of Chinese angelica, 15 g of kuh-seng and 15 g of honey-fried licorice root. Adding water (1560 mL) 12 times of the weight of the compound traditional Chinese medicine, decocting for 3 times, each time for 2 hours, naturally filtering with 120 mesh stainless steel net, loading the concentrate on macroporous adsorption resin column, eluting, concentrating under reduced pressure to obtain extract with relative density of 1.20-1.30, vacuum drying, pulverizing into fine powder at low temperature, adding diluent lactose and corn starch, mixing uniformly, and making into enteric capsule. (lot number: T001).
Example 2.
Taking the raw materials in parts by weight, taking 10g of lucid ganoderma, 20 g of astragalus, 10g of ginseng, 10g of stir-fried bighead atractylodes rhizome, 10g of poria cocos, 10g of Chinese angelica, 10g of kuh-seng and 10g of honey-fried licorice root. Adding water 10 times of the compound Chinese medicine, namely 900mL of water, decocting for 3 times, extracting for 2 hours each time, naturally filtering by a stainless steel net with 120 meshes, loading the concentrate on a macroporous adsorption resin column, eluting, concentrating under reduced pressure to obtain extract with the relative density of 1.20-1.30, vacuum drying, superfine grinding at low temperature to obtain fine powder, adding microcrystalline cellulose and sodium carboxymethyl starch, adding magnesium stearate as lubricant, mixing uniformly, tabletting, and preparing into tablets. (lot number: T002).
Example 3.
Taking the raw materials in parts by weight, 5g of lucid ganoderma, 15 g of astragalus, 5g of ginseng, 5g of stir-fried bighead atractylodes rhizome, 5g of poria cocos, 5g of Chinese angelica, 5g of kuh-seng and 5g of honey-fried licorice root. Reflux extracting with 400mL ethanol solution (8 times 70% ethanol solution) for 3 times (2 hr each time), filtering with 120 mesh stainless steel net, purifying with macroporous adsorbent resin column, eluting, concentrating under reduced pressure to obtain extract with relative density of 1.20-1.30, vacuum drying, superfine pulverizing at low temperature to obtain fine powder, adding excipient such as acrylic polymer and polyethylene glycol, and binder, and making into dripping pill. (lot number: T003).
Example 4.
Taking the raw materials in parts by weight, 5g of lucid ganoderma, 15 g of astragalus, 5g of ginseng, 5g of stir-fried bighead atractylodes rhizome, 5g of poria cocos, 5g of Chinese angelica, 5g of kuh-seng and 5g of honey-fried licorice root. Adding water (400 mL) according to the weight of the compound traditional Chinese medicine, decocting with water (8 times) and water (400 mL), naturally filtering with 120 mesh stainless steel mesh, reflux extracting the residue with 10 times of 50% ethanol (500 mL), naturally filtering with 120 mesh stainless steel mesh, mixing filtrates, purifying with macroporous adsorbent resin column, eluting, concentrating under reduced pressure to obtain extract with relative density of 1.20-1.30, vacuum drying, pulverizing into fine powder at low temperature, and adding excipient such as glycerol and sorbitol to obtain oral compound traditional Chinese medicine ointment. (lot number: T004).
Example 5.
Taking the raw materials in parts by weight, 10g of lucid ganoderma, 25 g of astragalus, 8 g of ginseng, 10g of stir-fried bighead atractylodes rhizome, 15 g of poria cocos, 10g of Chinese angelica, 8 g of kuh-seng and 8 g of honey-fried licorice root. Reflux extracting with 10 times of 90% ethanol solution (940 mL ethanol solution) for 3 times (2 hr each time), filtering with 120 mesh stainless steel net, purifying with macroporous adsorbent resin column, concentrating under reduced pressure to obtain extract with relative density of 1.20-1.30, vacuum drying, superfine pulverizing at low temperature to obtain fine powder, adding sodium alginate, xylooligosaccharide and pectin, microencapsulating, and spray drying to obtain microcapsule. (lot number: T005).
Example 6.
Taking the raw materials in parts by weight, 10g of lucid ganoderma, 25 g of astragalus, 8 g of ginseng, 10g of stir-fried bighead atractylodes rhizome, 15 g of poria cocos, 10g of Chinese angelica, 8 g of kuh-seng and 8 g of honey-fried licorice root. Adding water 10 times of the weight of the compound traditional Chinese medicine, namely 940mL of water, decocting, naturally filtering by a 120-mesh stainless steel net, adding 752mL of 50% ethanol with 8 times of the weight of the dregs, naturally filtering by the 120-mesh stainless steel net, combining the filtrate, loading the concentrate on a macroporous adsorption resin column, and eluting to obtain a concentrated solution. And (3) placing the concentrated solution into a liquid preparation tank, slowly adding a benzoic acid ethanol solution and a sorbic acid ethanol solution into the concentrated solution of the traditional Chinese medicine, and simultaneously adding a flavoring agent to prepare the oral liquid of the compound traditional Chinese medicine. (lot number: T006).
Example 7.
Taking the raw materials in parts by weight, 10g of lucid ganoderma, 25 g of astragalus, 8 g of ginseng, 10g of stir-fried bighead atractylodes rhizome, 15 g of poria cocos, 10g of Chinese angelica, 8 g of kuh-seng and 8 g of honey-fried licorice root. Adding 940mL of water 10 times the weight of the compound traditional Chinese medicine, naturally filtering by a 120-mesh stainless steel net, adding 940mL of 70% ethanol 10 times the weight of the residue, carrying out reflux extraction for 3 times, carrying out natural filtration by a 120-mesh stainless steel net each time for 2 hours, merging filtrate, loading the concentrate on a macroporous adsorption resin column, eluting, further concentrating under reduced pressure to obtain an extract with the relative density of 1.20-1.30, carrying out vacuum drying, carrying out low-temperature superfine grinding to obtain fine powder, adding dextrin, and spraying to obtain the granule of the compound traditional Chinese medicine. (lot number: T007).
Example 8.
The compound traditional Chinese medicine composition prepared by the embodiment of the invention is subjected to an in vitro anti-tumor experiment by using an MTT method. The compound traditional Chinese medicine formula product is prepared into mother liquor after dissolving by using buffer solution, and the tumor cells are selected from human breast cancer cell strain MCF-7, lung cancer cell strain A-549, colon cancer cell strain HCT-116, melanoma cell strain B16F10 and lymphoma cell strain U2932. Digesting and counting tumor cells with pancreatin to obtain 6' -10 concentration 4 Cell suspensions were added to each mL and 96-well plates (6' -10 per well) 3 Individual cells). The drug was diluted to the different concentration gradients required and the inhibition profile was determined.
。
Example 9.
The inhibition activity of the compound traditional Chinese medicine composition prepared by the embodiment of the invention on the interaction of tumor immunity check point protein PD-L1/PD-1 is detected by using a kit, so that the regulation effect of the compound traditional Chinese medicine composition on tumor immunity is detected. Tumor immune escape isA fundamental feature of malignancy. When the tumor cells are combined with proteins such as PD-L1 and the like on the surfaces of cytotoxic T lymphocytes, the T lymphocytes can relieve immune monitoring and immune-mediated killing of the tumor cells, namely an immune escape mechanism. The PD-L1 kit (Cisbio PD-1/PD-L1 binding assay kit) containing Anti-tag1-Eu, anti-tag2-XL665, detection buffer and other reagents was purchased, and the positive drug was BMS-1018. Preparing a buffer solution with a certain concentration gradient from the traditional Chinese medicine composition preparation by using DMSO, uniformly mixing, and adding into a 2 mL-96-hole white ELISA plate. PD-L1 and PD-1 proteins are diluted by buffer solution, then added into a hole of a 4 mL-96 hole white enzyme-labeled plate, after incubation for 15 minutes, anti-tag1-Eu, anti-tag2-XL665 and detection buffer solution are added, after incubation for 2 hours at room temperature, fluorescence signals of 665nm and 620nm are detected by using a Tecan Infinite F200 enzyme-labeled instrument, the inhibition rate of PD-L1/PD-1 binding is calculated according to a fluorescence proportion value, and IC is calculated 50 And evaluating the regulation effect of the compound traditional Chinese medicine composition on tumor immunity.
。
Example 10.
The in vivo anti-tumor experiment is carried out on the traditional Chinese medicine composition prepared by the embodiment of the invention by using a nude mouse animal model. The compound Chinese medicinal composition product is prepared from batch number T006 in the example by preparing mother liquor with buffer solution, and selecting human breast cancer cell strain MCF-7. 30 female nude mice (BALB/c-nu/nu) of 5 to 6 weeks of age were selected. Formulated in serum-free medium to 2X 10 6 100. Mu.L of the cell suspension was injected under the right anterior axillary fat pad of each nude mouse, and tumor growth was observed periodically. After 5 days of tumor implantation, 30 animals were randomly divided into 3 groups of 10 animals each, and were given gastric lavage doses of: blank group (0.9% physiological saline), treatment group 1 (5 g/kg of Chinese medicinal composition), treatment group 2 (10 g/kg of Chinese medicinal composition), and comparative example group (10 g/kg of Chinese patent medicine Jin Kehuai ear granule for treating tumor in clinical use) once daily for 4 weeks, and the time is observedAnd (5) observing the growth condition of the tumor. After 4 weeks, animals were sacrificed and tumor tissues were weighed. The results are shown in Table 2. The results show that the compound traditional Chinese medicine composition has a better treatment effect on a tumor animal model, and the tumor inhibition rate is superior to that of the traditional Chinese patent medicine Jin Kehuai ear particles for treating tumor in clinical common use of a control group under the same dosage.
。
Example 11.
The compound traditional Chinese medicine formula product provided by the invention is subjected to acute toxicity and safety test by carrying out oral administration experiments on animals. Within 24 hours, compound traditional Chinese medicine compound product solutions (T001-T007 group products, dose: 2000 mg/kg) were intragastrically administered to 6-week-old male SD rats (n=10 per group). As a result, animals were observed within one week after dosing, and no abnormalities in general status, weight change, food consumption, or histopathology were observed in any of the product test groups. From the results, the nontoxic dosage of the compound traditional Chinese medicine formula product is more than 2000 mg/kg. Experimental results show that the compound traditional Chinese medicine formula product has low toxic and side effects and good oral safety.
Example 12.
Clinical trial research is carried out to evaluate the tumor immunoregulation and anti-tumor effect of the compound traditional Chinese medicine formula product. A total of 100 patients with stage II-III breast cancer were enrolled using an open, randomized control design. The subject is 18-75 years old, and the stage of the tumor accords with the pathological tissue of the standard of the 8 th edition of the AJCC classification manual of common tumors and accords with the new adjuvant therapy indication, and is the invasive breast cancer of stage II-III. If one of the following conditions exists, the clinical trial study cannot be participated: 1. other drug clinical trials were enrolled within 4 weeks prior to group entry; 2. intolerance or poor compliance with traditional Chinese medicine; 3. other malignant tumors appear within 5 years before; stage iv breast cancer; 5. bilateral breast cancer or inflammatory breast cancer; 6. serious heart, liver and kidney and the like are important to organ dysfunction. Subjects entered the trial period after signing informed consent, enrolled patients were enrolledThe random assignment was made to test and control groups of 50 cases each. The test group took the compound traditional Chinese medicine formula product (product batch number T007 in the examples) twice daily, 10 g/bag each time. Every 3 weeks is 1 cycle, totaling 6 cycles. The treatment effect is evaluated by rechecking color ultrasound every period, and the treatment effect of the tumor is evaluated by MRI every 2 periods. The peripheral blood detection immune indexes are collected every 2 periods, the number and the proportion of each immune cell subgroup in the peripheral blood are detected by utilizing a flow cytometry, and the treatment effect of the compound traditional Chinese medicine formula product is evaluated. According to tumor immune theory, T lymphocyte subpopulations play an important role in human tumor immune response, wherein CD3 + The cell population is total T lymphocytes, and compared with healthy people, CD3 of tumor patients + The proportion of cell population will show a decrease; CD4 + The cell subset is helper T cells, and compared with healthy people, CD4 of tumor patients + The proportion of cell subsets will show a decrease; CD8 + The cell subset is T-suppressor cell subset, has negative regulation effect on tumor immunity, and compared with healthy people, CD8 of tumor patients + The proportion of cell subsets will exhibit an increase; CD4 + /CD8 + The ratio shows the state of human immune function, compared with healthy people, CD4 of tumor patients + /CD8 + The ratio will show a decrease, indicating a decrease in immune function and a poor prognosis.
。
The result shows that compared with the control group, the CD3 of the patients in the compound traditional Chinese medicine formula treatment group + Increased total T lymphocyte fraction, CD4 + Increased proportion of helper T cell subpopulations and CD8 + Cell subpopulations decreased in proportion, CD4 + /CD8 + The proportion is obviously increased, which indicates that the compound traditional Chinese medicine formula treatment can cause the obvious increase of immunocompetence cells of organisms, effectively regulate tumor immunity, strengthen the immune function of the organisms and treat tumors.

Claims (9)

1. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumor is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 5-15 parts of lucid ganoderma, 15-25 parts of astragalus membranaceus, 5-15 parts of ginseng, 5-15 parts of fried bighead atractylodes rhizome, 5-15 parts of poria cocos, 5-15 parts of Chinese angelica, 5-15 parts of radix sophorae flavescentis and 5-15 parts of honey-fried licorice root; the tumor is lung cancer, breast cancer, colon cancer, lymph cancer, and melanoma.
2. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors according to claim 1, which is characterized by being prepared from the following traditional Chinese medicine raw materials in parts by weight: 10 parts of lucid ganoderma, 25 parts of astragalus membranaceus, 8 parts of ginseng, 10 parts of stir-fried bighead atractylodes rhizome, 15 parts of poria cocos, 10 parts of Chinese angelica, 8 parts of radix sophorae flavescentis and 8 parts of honey-fried licorice root.
3. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors according to claim 1, wherein the traditional Chinese medicine composition further comprises a pharmaceutically acceptable carrier and/or excipient.
4. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumor according to claim 3, wherein the pharmaceutically acceptable carrier and/or excipient comprises one or more of liposome, microcrystalline cellulose, sodium carboxymethyl starch, sodium carboxymethyl cellulose, polyethylene glycol, polyvinyl alcohol, acrylic polymers, glycerol, propylene glycol, sorbitol, beta-cyclodextrin, tween-80, lactose, starch, sodium alginate, pectin and dextrin.
5. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors according to claim 1, wherein the dosage forms of the traditional Chinese medicine composition are granules, capsules, oral liquid, tablets, pills, ointment, decoction, injection and microcapsules.
6. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors according to claim 1, wherein the preparation method of the extract of the traditional Chinese medicine composition specifically comprises the following steps:
decocting the Chinese medicinal materials in 5-12 times of water, filtering, and concentrating the filtrate to obtain extract.
7. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors according to claim 1, wherein the preparation method of the extract of the traditional Chinese medicine composition specifically comprises the following steps:
reflux extracting the prescription Chinese medicine with 50-90% ethanol water solution, filtering, concentrating the filtrate to obtain extract; the dosage of the ethanol aqueous solution is 8-10 times of the weight of the medicinal materials.
8. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors according to claim 1, wherein the preparation method of the extract of the traditional Chinese medicine composition specifically comprises the following steps:
decocting the prescription Chinese medicine with 5-12 times of water, and filtering; reflux extracting the residue with 50-90% ethanol water solution, filtering, mixing filtrates, and concentrating to obtain extract.
9. The use of the compound Chinese medicinal composition according to claim 1 in preparing medicines for regulating tumor immunity and resisting tumors, wherein the tumors are lung cancer, breast cancer, colon cancer, lymphoma and melanoma.
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CN107198709A (en) * 2016-03-16 2017-09-26 天津正中科技有限公司 A kind of compound ginseng Ganoderma Lucidum Spore Powder Capsule
CN112352884A (en) * 2020-09-24 2021-02-12 杭州径心农业科技有限公司 Traditional Chinese medicine additive for chicken and application thereof

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