CN114588195A - 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 PDFInfo
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Abstract
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors, and a preparation method and application thereof. The composition is prepared from the following 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 angelica sinensis, 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 reinforcing and eliminating, tonifying qi and enriching blood, detoxifying and resolving masses, regulating tumor immunity, resisting tumors and the like, can regulate and control tumor immunity check point protein, has a killing effect on various tumor cells, can regulate the proportion of a plurality of T lymphocyte subsets, causes the remarkable increase of immunocompetent cells, enhances the immune function, and has the effect of treating tumors.
Description
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 seriously threatens human life and health. According to the statistics of the world health organization, 996 ten thousand worldwide cancer deaths occur in 2020, and nearly 300 ten thousand of them occur in China. The clinical treatment of tumors mainly depends on chemoradiotherapy. Taking chemotherapy as an example, the chemotherapy drugs have high toxicity, and can kill autoimmune cells such as leucocytes and lymphocytes while killing tumor cells, so that the autoimmune function of a patient is damaged, and serious adverse reactions are generated. On the other hand, tumor-targeted drugs act on specific targets, but because of the difference in genotype of each patient, the use of the drugs is greatly limited, and the treatment cost is high. Tumor immunity is the leading tumor treatment method in recent years, a method for killing tumor cells by stimulating an autoimmune system is proposed, and the tumor immunity research obtains a Nobel medical prize in 2018. In order for tumor cells to evade the immune system, immune checkpoint proteins such as PD-L1, CTLA-4, etc. are used to turn off the defense activity of immune T cells, thereby evading the tumor cells from the attack of the immune system. Tumor immunotherapy kills tumor cells by modulating immune checkpoint proteins, which in turn stimulate and direct the immune system. The first tumor immune target database and a tumor immune knowledge map platform CKTTD worldwide are developed by our research team in 2020, the usage amount is visited more than 3000 times in the whole year, and the development of tumor immunotherapy and related tumor immune drugs is promoted.
The traditional Chinese medicine has unique advantages in the aspect of treating tumors, and natural medicines represented by the traditional Chinese medicine have 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 traditional Chinese medicine can tonify deficiency of human body and regulate and control the immune function of patients on the whole system; on the other hand, detoxication and stagnation elimination are used for treating tumors, focus on the unification of treatment and conditioning, improve the general state of patients, and are increasingly emphasized in the aspect of tumor treatment. At present, the traditional Chinese medicine composition for anti-tumor treatment has a large dosage, and relevant reports of the traditional Chinese medicine composition for regulating and controlling tumor immunity check point proteins and improving tumor immunity do not exist.
The compound traditional Chinese medicine composition preparation is discovered in tumor immunity research by combining with clinical practice, has small dosage and scientific and reasonable proportion, can effectively inhibit tumor immunity check point targets and improve the tumor immunity of patients, promotes the overall immune function of the patients, stimulates the immune system to kill tumor cells, reduces toxic and side effects brought by conventional treatment methods such as radiotherapy, chemotherapy and the like, treats tumors by detoxifying and resolving masses while regulating and controlling the tumor immunity integrally, can obviously improve and improve the life quality of tumor patients, and effectively prolongs the life cycle 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 invention also aims to provide a preparation method of the compound traditional Chinese medicine composition and application of the compound traditional Chinese medicine composition in preparing medicines for regulating tumor immunity and resisting tumors.
In order to achieve the above object, 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 membranaceus, 5-15 parts of ginseng, 5-15 parts of fried bighead atractylodes rhizome, 5-15 parts of poria cocos, 5-15 parts of angelica sinensis, 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 fried bighead atractylodes rhizome, 15 parts of poria cocos, 10 parts of angelica sinensis, 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.
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, acrylate polymer, glycerol, propylene glycol, sorbitol, beta-cyclodextrin, tween-80, lactose, starch, euchelite S-100, euchelite L-100, sodium alginate, pectin and dextrin.
Furthermore, the dosage form of the traditional Chinese medicine composition is 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 tumors, which comprises any step of:
a: decocting the Chinese medicinal materials in water 5-12 times, filtering, and concentrating the filtrate to obtain extract;
b: reflux extracting the Chinese medicinal materials with 50-90% ethanol water solution, filtering, and concentrating the filtrate to obtain extract;
c: decocting the Chinese medicinal materials in water 5-12 times, 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 water solution in the B reflux extraction operation is 8-10 times of the weight of the medicinal materials.
Furthermore, the compound traditional Chinese medicine composition is applied to preparing 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 lung cancer, breast cancer, colon cancer, lymph cancer or melanoma.
The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors provided by the invention has the following bulk drug effects.
Ganoderma has warm nature and light taste, and has effects of invigorating qi and blood, benefiting heart qi, tranquilizing mind, regulating immunity, resisting oxidation, and resisting tumor.
The astragalus membranaceus is warm in nature and sweet in taste, enters spleen and lung channels, and has the effects of tonifying qi, invigorating yang, inducing diuresis to alleviate edema, expelling toxin and pus, promoting fluid production, nourishing blood, resisting tumors and improving immunity.
Ginseng, warm in nature and sweet in taste, enters heart, lung, spleen and kidney meridians, and has the effects of invigorating qi and blood, promoting the production of body fluid, tranquilizing mind, resisting tumor and improving immunity.
The fried bighead atractylodes rhizome is warm in nature and sweet in taste, enters spleen and stomach channels, and has the effects of tonifying spleen and qi, resisting oxidation, resisting tumors and improving immunity.
Poria cocos, being neutral in nature and sweet in taste, enters heart, lung and spleen channels, and has the effects of promoting diuresis, strengthening spleen, calming heart, activating immunity and resisting tumors.
The angelica sinensis is warm in nature and sweet in taste, enters liver, heart and spleen channels, and has the effects of enriching blood and activating blood, relaxing bowel, improving immune function, resisting oxidation and resisting tumors.
The lightyellow sophora root is cold in nature and bitter in taste, enters heart, liver and stomach channels, and has the effects of clearing away heat and toxic materials, killing insects, promoting urination, activating immunity and resisting tumors.
Prepared licorice has warm property and sweet taste, enters heart, lung, stomach and spleen channels, and has the effects of tonifying spleen and stomach, tonifying qi and recovering pulse and enhancing immunity.
The medicines are combined according to the 'monarch, minister, assistant and guide' theory of the traditional Chinese medicine, are reasonably configured and are mutually compatible. In the invention, ginseng and astragalus root which can greatly tonify primordial qi and strengthen healthy qi are used as monarch drugs in the formula; ganoderma lucidum, rhizoma Atractylodis Macrocephalae and Poria are used to assist the monarch drugs in invigorating qi. Since tangible qi can not grow fast and is originated from intangible qi, the emphasis is on invigorating qi and blood, which are used as ministerial drugs. Collecting radix Angelicae sinensis for nourishing blood, regulating blood circulation, and relieving pain; ku Shen and gan Cao are used as adjuvant drugs for removing toxicity and alleviating pain. Licorice root, radix Glycyrrhizae can regulate and harmonize the other ingredients, and is also used as a guiding drug. The whole formula mainly tonifies qi and nourishes blood, strengthens body resistance to consolidate the constitution, and is assisted with the detoxification and nodulation dispersion of the lightyellow sophora root and the liquorice to eliminate pathogenic factors to treat the symptoms. The eight medicines are combined together to play the effects of benefiting qi, nourishing blood, detoxifying and dissipating stagnation.
Compared with the prior art, the invention has the beneficial effects.
1. According to the traditional Chinese medicine theory, the invention combines the most advanced research result of tumor immunity, and adopts the principle of dialectical treatment and whole body regulation to carry out traditional Chinese medicine formula screening, so that 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, has the functions of inhibiting tumor cell growth and promoting tumor cell apoptosis, and has a 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 consolidating foundation, simultaneously regulates the tumor immunity function, regulates various tumor immunity related targets and cytokines, activates a human immunity mechanism to kill tumor cells, plays a role in treating tumors by a multi-target system, can reduce the pain of cancer patients, obviously improves the life quality of the patients and prolongs the life cycle of the patients. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors 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 tumors provided by the invention is scientific and reasonable in proportion, small in dosage, stable in preparation process and suitable for industrial large-scale production, and can quickly exert the drug effect.
Detailed Description
The present invention is described in further detail below with reference to specific embodiments, which are provided only for illustrating the present invention and not for limiting the scope of the present invention.
Example 1.
The raw materials are taken according to the parts by weight, 15 g of lucid ganoderma, 25 g of astragalus, 15 g of ginseng, 15 g of fried bighead atractylodes rhizome, 15 g of tuckahoe, 15 g of angelica, 15 g of sophora flavescens and 15 g of honey-fried licorice root are taken. Adding water 12 times the weight of the compound traditional Chinese medicine, namely 1560mL, decocting together, extracting for 3 times, each time for 2 hours, naturally filtering through a 120-mesh stainless steel net, passing the concentrate through a macroporous adsorption resin column, eluting, then further concentrating under reduced pressure to obtain an extract with the relative density of 1.20-1.30, drying in vacuum, carrying out superfine grinding at low temperature to obtain fine powder, adding a diluent, namely lactose and corn starch, mixing uniformly, and filling into enteric capsules to prepare the capsules of the compound traditional Chinese medicine. (batch number: T001).
Example 2.
The raw materials are taken according to the parts by weight, 10g of lucid ganoderma, 20 g of astragalus, 10g of ginseng, 10g of fried bighead atractylodes rhizome, 10g of tuckahoe, 10g of angelica, 10g of sophora flavescens and 10g of honey-fried licorice root are taken. Adding 10 times of water (900 mL) by weight of the compound Chinese medicine, decocting, extracting for 3 times, each time for 2 hours, naturally filtering with 120-mesh stainless steel net, passing the concentrate through macroporous adsorbent resin column, eluting, concentrating under reduced pressure to obtain extract with relative density of 1.20-1.30, vacuum drying, micronizing at low temperature to obtain fine powder, adding microcrystalline cellulose and sodium carboxymethyl starch, adding magnesium stearate as lubricant, mixing, and tabletting. (batch No. T002).
Example 3.
The raw materials are taken according to the parts by weight, 5g of lucid ganoderma, 15 g of astragalus, 5g of ginseng, 5g of fried bighead atractylodes rhizome, 5g of tuckahoe, 5g of angelica, 5g of sophora flavescens and 5g of honey-fried licorice root are taken. Adding 70% ethanol solution 8 times the weight of the compound Chinese medicinal materials, i.e. 400mL ethanol solution, reflux extracting for 3 times, each time for 2 hours, naturally filtering with 120 mesh stainless steel net, passing the concentrate through macroporous adsorbent resin column, eluting, concentrating under reduced pressure to obtain extract with relative density of 1.20-1.30, vacuum drying, micronizing at low temperature to obtain fine powder, adding excipient such as acrylate polymer, polyethylene glycol, etc., and binder, and making into dripping pill by melting method. (batch No. T003).
Example 4.
The raw materials are taken according to the parts by weight, 5g of lucid ganoderma, 15 g of astragalus, 5g of ginseng, 5g of fried bighead atractylodes rhizome, 5g of tuckahoe, 5g of angelica, 5g of sophora flavescens and 5g of honey-fried licorice root are taken. Adding water 8 times the weight of the compound traditional Chinese medicine, namely 400mL of water, decocting together, naturally filtering through a 120-mesh stainless steel net, adding 50% ethanol 500mL of 10 times the weight of the medicine residues, refluxing and extracting, naturally filtering through the 120-mesh stainless steel net, combining the filtrate, passing the concentrate through a macroporous adsorption resin column, further concentrating under reduced pressure after elution to obtain an extract with the relative density of 1.20-1.30, drying in vacuum, carrying out low-temperature superfine grinding to obtain fine powder, and adding excipients such as glycerol, sorbitol and the like to prepare the compound traditional Chinese medicine paste for oral administration. (batch No. T004).
Example 5.
The raw materials are taken according to the parts by weight, 10g of lucid ganoderma, 25 g of astragalus, 8 g of ginseng, 10 parts of fried bighead atractylodes rhizome, 15 g of tuckahoe, 10g of angelica, 8 g of sophora flavescens and 8 g of honey-fried licorice root. Adding 90% ethanol solution (940 mL) 10 times the weight of the compound Chinese medicine, reflux-extracting for 3 times, each time for 2 hr, naturally filtering with 120 mesh stainless steel net, loading the concentrate into macroporous adsorbent resin column, eluting, concentrating under reduced pressure to obtain extract with relative density of 1.20-1.30, vacuum drying, micronizing at low temperature to obtain fine powder, adding sodium alginate, xylooligosaccharide and pectin, microencapsulating, embedding, and spray drying to obtain microcapsule. (batch No. T005).
Example 6.
The raw materials are taken according to the parts by weight, 10g of lucid ganoderma, 25 g of astragalus, 8 g of ginseng, 10 parts of fried bighead atractylodes rhizome, 15 g of tuckahoe, 10g of angelica, 8 g of sophora flavescens and 8 g of honey-fried licorice root. Adding 10 times of water (940 mL) by weight of the compound traditional Chinese medicine, decocting, naturally filtering with 120-mesh stainless steel net, adding 752mL of 50% ethanol 8 times of the weight of the medicine residue, reflux-extracting, naturally filtering with 120-mesh stainless steel net, combining the filtrates, loading the concentrate on a macroporous adsorption resin column, and eluting to obtain the concentrate. 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 traditional Chinese medicine concentrated solution, and simultaneously adding a flavoring agent to prepare the oral liquid of the compound traditional Chinese medicine. (batch No. T006).
Example 7.
The raw materials are taken according to the parts by weight, 10g of lucid ganoderma, 25 g of astragalus, 8 g of ginseng, 10 parts of fried bighead atractylodes rhizome, 15 g of tuckahoe, 10g of angelica, 8 g of sophora flavescens and 8 g of honey-fried licorice root. Adding water 10 times the weight of the compound traditional Chinese medicine, namely 940mL of water, decocting together, naturally filtering through a 120-mesh stainless steel net, adding 70% ethanol 940mL of 10 times the weight of the medicine residues, refluxing and extracting, extracting for 3 times, 2 hours each time, naturally filtering through the 120-mesh stainless steel net, combining the filtrate, passing the concentrate through a macroporous adsorption resin column, eluting, further concentrating under reduced pressure to obtain an extract with the relative density of 1.20-1.30, drying in vacuum, carrying out superfine grinding at low temperature to obtain fine powder, adding dextrin, and spraying to obtain the compound traditional Chinese medicine granule. (batch No. T007).
Example 8.
The compound traditional Chinese medicine composition prepared by the embodiment of the invention is subjected to in vitro anti-tumor experiment by using an MTT method. The compound traditional Chinese medicine formula product is prepared by the above embodiments, and is dissolved by using a buffer solution to prepare a mother solution, and the tumor cells are selected from a human breast cancer cell line MCF-7, a lung cancer cell line A-549, a colon cancer cell line HCT-116, a melanoma cell line B16F10 and a lymphoma cell line U2932. Digesting tumor cells with pancreatin, and countingMaking into 6' 104Per/mL of cell suspension and added to 96-well plates (6' -10 per well)3One cell). The drug was diluted to the different concentration gradients required and the inhibition curves were determined.
Example 9.
The kit is used for detecting the inhibitory activity of the compound traditional Chinese medicine composition prepared by the embodiment of the invention on the interaction of tumor immunity checkpoint protein PD-L1/PD-1, thereby detecting the regulating effect of the compound traditional Chinese medicine composition on tumor immunity. Tumor immune escape is an essential feature of malignant tumors. The tumor cell surface high-expression immune check point such as PD-L1 and other proteins, when combined with the cytotoxic T lymphocyte surface PD-1 and other proteins, can lead the T lymphocyte to relieve the immune surveillance and immune-mediated killing of the tumor cell, namely an immune escape mechanism. PD-L1 kit (PD-1/PD-L1 binding assay kit, Cisbio) was purchased, and contained Anti-tag1-Eu, Anti-tag2-XL665, and detection buffer, and BMS-1018 as a positive drug. The traditional Chinese medicine composition preparation is prepared into a buffer solution with a certain concentration gradient by DMSO, and the buffer solution is added into a 96-hole white enzyme label plate after being uniformly mixed with 2 mL. Diluting PD-L1 and PD-1 protein with buffer solution, adding into a 96-well white enzyme label plate well with 4mL, incubating for 15 minutes, adding Anti-tag1-Eu, Anti-tag2-XL665 and detection buffer solution, incubating for 2 hours at room temperature, detecting 665nm and 620nm fluorescence signals with a Tecan Infinite F200 microplate reader, calculating the inhibition rate of PD-L1/PD-1 combination according to the fluorescence ratio value, and calculating IC50And evaluating the regulation effect of the compound traditional Chinese medicine composition on tumor immunity.
Example 10.
The traditional Chinese medicine composition prepared by the embodiment of the invention is subjected to an in vivo anti-tumor experiment by using a nude mouse animal model.The compound traditional Chinese medicine formula product is selected from the product batch number T006 in the embodiment, a mother solution is prepared by using a buffer solution, and a human breast cancer cell strain MCF-7 is selected. 30 female nude mice (BALB/c-nu/nu) with the age of 5-6 weeks were selected. Prepared into 2 x 10 by serum-free medium6mu.L of the cell suspension was injected 100. mu.L of the above cell suspension 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 administered by gavage, which were: blank group (0.9% physiological saline), treatment group 1 (5 g/kg traditional Chinese medicine composition), treatment group 2 (10 g/kg traditional Chinese medicine composition), comparative example group (10 g/kg clinical common tumor treatment Chinese patent medicine kui-choi ear granule), once a day, lasting for 4 weeks, and regularly observing the tumor growth condition. After 4 weeks, the animals were sacrificed and tumor tissue was weighed. The results are shown in Table 2. The results show that the compound traditional Chinese medicine composition has better treatment effect on tumor animal models, and the tumor inhibition rate is better than that of the clinical common tumor treatment Chinese patent medicine kui-shen-chui-shi particles of a control group under the same dosage.
Example 11.
The compound traditional Chinese medicine formula product is subjected to acute toxicity and safety tests by carrying out oral administration experiments on animals. The compound traditional Chinese medicine formula product solution (T001-T007 group product, dose: 2000 mg/kg) is administered to 6-week-old male SD rats (n =10 per group) by gavage within 24 hours. As a result, the animals were observed within one week after the administration, and no abnormality in general state, body weight change, food consumption or histopathology was observed in any of the product test groups. According to the results, the non-toxic dosage of the compound traditional Chinese medicine formula product is more than 2000 mg/kg. The experimental result shows that the compound traditional Chinese medicine formula product has very low toxic and side effects and good oral safety.
Example 12.
The compound traditional Chinese medicine formula product of the invention is evaluated through clinical trial researchThe product has effects in regulating tumor immunity and resisting tumor. A total of 100 patients with stage II-III breast cancer were enrolled using an open, randomized control design. The patients are 18-75 years old, and the invasive breast cancer in II-III stage is confirmed by the pathological histology that the tumor stage meets the 8 th standard of the AJCC classification manual of common tumors and meets the new adjuvant therapy indication. Clinical trial studies cannot be performed unless one of the following conditions is present: 1. other medicine clinical tests are participated in within 4 weeks before group entry; 2. intolerance to traditional Chinese medicines or poor compliance; 3. other malignant tumors appear within 5 years; stage IV breast cancer; 5. bilateral breast cancer or inflammatory breast cancer; 6. severe dysfunction of the vital organs such as heart, liver and kidney. Subjects entered the trial period after signing an informed consent form, and the enrolled patients were randomly assigned to the trial and control groups of 50 patients each. The test group took the compound traditional Chinese medicine formula product (batch number T007 in the example) twice a day, 10 g/bag each time. Every 3 weeks for 1 cycle for a total of 6 cycles. Color ultrasonography was reviewed every cycle to evaluate the treatment efficacy, and MRI was added every 2 cycles to evaluate the tumor efficacy. Collecting peripheral blood every 2 cycles to detect immunity index, detecting the number and proportion of each immune cell subgroup of peripheral blood by flow cytometry, and evaluating the treatment effect of the compound traditional Chinese medicine formula product. According to the theory of tumor immunity, T lymphocyte subset plays an important role in human tumor immune response, wherein CD3+The cell population is total T lymphocytes, and compared with healthy population, CD3 of tumor patients+The proportion of the cell population will be reduced; CD4+The cell subset is helper T cell, and compared with healthy population, 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 has CD8 of tumor patients compared with healthy population+The proportion of cell subsets will appear to rise; CD4+/CD8+The ratio shows the state of the immune function of the human body, compared to healthy population, CD4 of tumor patients+/CD8+The proportion will show to decline, indicate immune function decline, prognosis worsen.
The results show that compared with the control group, the CD3 of the patients in the compound traditional Chinese medicine formula treatment group is+Increased proportion of total T lymphocytes, CD4+Increased proportion of helper T cell subsets, CD8+The proportion of cell subsets, CD4, decreased+/CD8+The proportion is obviously increased, which indicates that the compound traditional Chinese medicine formula treatment can cause the obvious increase of immunocompetent cells of the organism, effectively adjust the tumor immunity, enhance the immune function of the organism and treat the tumor.
Claims (10)
1. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors 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 membranaceus, 5-15 parts of ginseng, 5-15 parts of fried bighead atractylodes rhizome, 5-15 parts of poria cocos, 5-15 parts of angelica sinensis, 5-15 parts of radix sophorae flavescentis and 5-15 parts of honey-fried licorice root.
2. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumors according to claim 1, is characterized by comprising 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 fried bighead atractylodes rhizome, 15 parts of poria cocos, 10 parts of angelica sinensis, 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 tumor according to any one of claims 1-2, 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, acrylate polymer, glycerol, propylene glycol, sorbitol, beta-cyclodextrin, tween-80, lactose, starch, Ewing 'S-100, Ewing' S L-100, sodium alginate, pectin, and dextrin.
5. The compound traditional Chinese medicine composition for regulating tumor immunity and resisting tumor according to any one of claims 1-2, wherein the dosage form of the traditional Chinese medicine composition is granules, capsules, oral liquid, tablets, pills, paste, decoction, injection and microcapsules.
6. The preparation method of the compound traditional Chinese medicine composition extract for regulating tumor immunity and resisting tumors according to any one of claims 1 to 5, which is characterized by comprising any one of the following steps:
a: decocting the Chinese medicinal materials in water 5-12 times, filtering, and concentrating the filtrate to obtain extract;
b: reflux extracting the Chinese medicinal materials with 50-90% ethanol water solution, filtering, and concentrating the filtrate to obtain extract;
c: decocting the Chinese medicinal materials in water 5-12 times, and filtering; reflux extracting the residue with 50-90% ethanol water solution, filtering, mixing filtrates, and concentrating to obtain extract.
7. The preparation method according to claim 6, wherein the amount of the ethanol aqueous solution used in the ethanol aqueous solution reflux extraction operation in B is 8-10 times of the weight of the medicinal materials.
8. The use of the compound Chinese medicinal composition according to any one of claims 1-5 in the preparation of medicaments for regulating tumor immunity and resisting tumors.
9. The use of claim 8, wherein the tumor comprises 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.
10. Use according to claim 8, wherein the tumor is preferably lung cancer, breast cancer, colon cancer, lymphoma, melanoma.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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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| Publication number | Priority date | Publication date | Assignee | Title |
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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 |
Non-Patent Citations (1)
| Title |
|---|
| 计小清等: "四君子汤合当归补血汤提高化疗荷瘤小鼠免疫功能的实验研究", 《中药材》 * |
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