Traditional Chinese medicine formula for treating gastric cancer as well as preparation method and application of traditional Chinese medicine formula

Abstract

The invention discloses a traditional Chinese medicine formula for treating gastric cancer as well as a preparation method and application thereof. The formula is prepared from the following components in parts by weight: monarch drugs: 38-90 parts of tripterygium wilfordii alkaloid, 38-90 parts of tripterygium hypoglaucum alkaloid, 28-85 parts of chamaejasmine, 28-85 parts of gelsemium elegans alkaloid and 28-85 parts of xanthoxylin; ministerial and adjuvant drugs: 16 to 80 parts of ganoderan, 16 to 80 parts of pinellia ternate sitosterol, 16 to 80 parts of radix rehmanniae praeparata catalpol, 16 to 80 parts of amomum cardamomum volatile oil, 16 to 80 parts of piper cubeba element, 16 to 80 parts of dendrobine, 16 to 80 parts of alpinia katsumadai volatile oil, 16 to 80 parts of panax notoginseng ginsenoside, 16 to 80 parts of linalool, 16 to 80 parts of caulis spatholobi element, 16 to 80 parts of cassia seed element, 16 to 80 parts of bergamot alcohol, 16 to 80 parts of cistanche deserticola, 16 to 80 parts of fructus forsythiae alkaloid and 16 to 80 parts of mulberry inorganic salt; 16 to 80 parts of total flavonoids of sea-buckthorn; and 100 parts of water. Wherein the ratio of the total parts by weight of the monarch drugs to the total parts by weight of the ministerial and adjuvant drugs is 1: (1.5-5.0). The traditional Chinese medicine formula for treating gastric cancer provided by the invention has the advantages of obvious curative effect, multi-target synergistic effect, high safety and controllable toxicity, and can improve the living quality of patients.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine formula, in particular to a traditional Chinese medicine formula for treating gastric cancer and a preparation method and application thereof. BACKGROUND

[0002] Gastric cancer is a malignant tumor with high incidence and mortality worldwide. Current mainstream treatments such as surgery, radiotherapy and chemotherapy have certain efficacy, but are often accompanied by serious side effects, reducing the quality of life of patients, and have limited effect on patients in the advanced stage, and are prone to drug resistance.

[0003] Traditional Chinese medicine has shown unique advantages of multi-target, overall regulation and less side effects in the adjuvant therapy of tumors. However, some existing anti-tumor traditional Chinese medicine compounds have problems such as complex components, unstable efficacy and no obvious effect on advanced gastric cancer.

[0004] More difficultly, traditional Chinese medicines such as Tripterygium wilfordii and Gelsemium elegans have been proven to have strong anti-tumor activity, but due to their inherent strong toxic side effects (such as hepatotoxicity and neurotoxicity), they have been greatly restricted in clinical application. At present, there is a lack of a mature traditional Chinese medicine formula that can systematically control its toxicity and safely and effectively apply it to the treatment of gastric cancer. SUMMARY

[0005] In view of the above technical deficiencies, the purpose of the present application is to provide a traditional Chinese medicine formula for treating gastric cancer and a preparation method thereof to solve the problems mentioned in the background art.

[0006] To solve the above technical problems, the present application adopts the following technical scheme: the present application provides a traditional Chinese medicine formula for treating gastric cancer, which is made of the following components by weight: Monarch drug: Tripterygium wilfordii alkaloids 38-90 parts, Kunming mountain tetranychus alkaloids 38-90 parts, wolf poison 28-85 parts, Gelsemium elegans Hu Man Teng alkaloids 28-85 parts, Zanthoxylum bungeanum 28-85 parts; Minister and assistant drug: Ganoderma lucidum polysaccharide 16-80 parts, Pinellia ternate stigmasterol 16-80 parts, Radix Rehmanniae Preparata Catechin 16-80 parts, White cardamom volatile oil 16-80 parts, Amomum villosum volatile oil 16-80 parts, Dendrobium alkaloid 16-80 parts, Kaempferia galanga volatile oil 16-80 parts, Panax notoginseng saponin 16-80 parts, Agarwood alcohol 16-80 parts, Spatholobus suberectus 16-80 parts, Cassia seed 16-80 parts, Bergamot alcohol 16-80 parts, Cistanche 16-80 parts, Forsythia fruit inorganic salt 16-80 parts, Hippophae rhamnoides total flavonoids 16-80 parts; and, water 100 parts; The ratio of the total weight parts of the monarch drug to the total weight parts of the minister and assistant drug is 1:(1.5 ~ 5.0).

[0007] Preferably, it further comprises one or more of folic acid 0.4-0.8 parts, vitamin B group 0.05-0.08 parts, copper sulfate 2-10 parts, zinc sulfate 10-16 parts, manganese sulfate 5-10 parts, and mother's milk 2-8 parts.

[0008] Preferably, the vitamin B group comprises vitamin B1, B2, B6, and B12.

[0009] Preferably, it comprises the following components in parts by weight: water 100 parts, tripterygium alkaloids 38 parts, Kunming mountain tigress alkaloids 38 parts, wolf poison 28 parts, hook Hu Man Fengjia alkaloids 28 parts, Zanthoxylum 28 parts; Ganoderma lucidum polysaccharide 16 parts, pinellia tuberifera sterol 16 parts, radix rehmanniae 16 parts, white cardamom volatile oil 16 parts, amomum costatum 16 parts, dendrobium alkaloid 16 parts, piper nigrum volatile oil 16 parts, panax notoginseng saponin 16 parts, linalool 16 parts, Spatholobus suberosus 16 parts, cassia seed 16 parts, bergamot alcohol 16 parts, cistanche 16 parts, forsythia alkaloids 16 parts, mulberry inorganic salt 16 parts, total flavonoids of Hippophae 16 parts; folic acid 0.4 parts, vitamin B group 0.05 parts, copper sulfate 2 parts, zinc sulfate 10 parts, manganese sulfate 5 parts, and mother's milk 2 parts.

[0010] Preferably, it comprises the following components in parts by weight: water 100 parts, tripterygium alkaloids 90 parts, Kunming mountain tigress alkaloids 90 parts, wolf poison 85 parts, hook Hu Man Fengjia alkaloids 85 parts, Zanthoxylum 85 parts; Ganoderma lucidum polysaccharide 80 parts, pinellia tuberifera sterol 80 parts, radix rehmanniae 80 parts, white cardamom volatile oil 80 parts, amomum costatum 80 parts, dendrobium alkaloid 80 parts, piper nigrum volatile oil 80 parts, panax notoginseng saponin 80 parts, linalool 80 parts, Spatholobus suberosus 80 parts, cassia seed 80 parts, bergamot alcohol 80 parts, cistanche 80 parts, forsythia alkaloids 80 parts, mulberry inorganic salt 80 parts, total flavonoids of Hippophae 80 parts; folic acid 0.8 parts, vitamin B group 0.08 parts, copper sulfate 10 parts, zinc sulfate 16 parts, manganese sulfate 10 parts, and mother's milk 8 parts.

[0011] Preferably, it comprises the following components in parts by weight: water 100 parts, tripterygium alkaloids 64 parts, Kunming mountain tigress alkaloids 64 parts, wolf poison 56.5 parts, hook Hu Man Fengjia alkaloids 56.5 parts, Zanthoxylum 56.5 parts; Ganoderma lucidum polysaccharide 48 parts, pinellia tuberifera sterol 48 parts, radix rehmanniae 48 parts, white cardamom volatile oil 48 parts, amomum costatum 48 parts, dendrobium alkaloid 48 parts, piper nigrum volatile oil 48 parts, panax notoginseng saponin 48 parts, linalool 48 parts, Spatholobus suberosus 48 parts, cassia seed 48 parts, bergamot alcohol 48 parts, cistanche 48 parts, forsythia alkaloids 48 parts, mulberry inorganic salt 48 parts, total flavonoids of Hippophae 48 parts; folic acid 0.6 parts, vitamin B group 0.065 parts, copper sulfate 6 parts, zinc sulfate 13 parts, manganese sulfate 7.5 parts, and mother's milk 5 parts.

[0012] The application provides a preparation method of a traditional Chinese medicine formula for treating stomach cancer. (1) each component is weighed by weight parts; (2) leigongteng alkaloids, kunming mountain tetracentron alkaloids, wolf poison, hook-wan tetracentron alkaloids, zanthoxylum piperitum and water are mixed, heated to 50-60 DEG C, stirred for 30-60 minutes; (3) ganoderma lucidum polysaccharide, pinellia ternata stigmasterol, radix rehmanniae procyanidins, white cardamom volatile oil, amomum xanthicola, dendrobium alkaloids, piper nigrum volatile oil, panax notoginseng saponins, agarwood alcohol, kaempferia rotunda, cassia senna, bergamot alcohol, cistanche, forsythia alkaloids, morus inorganic salt, hippophae rhamnoides total flavonoids, continue stirring for 20-40 minutes; (4) folic acid, vitamin B, copper sulfate, zinc sulfate, manganese sulfate, food mother, stirring until completely dissolved; (5) filtration, sterilization, and dispensing are obtained.

[0013] The traditional Chinese medicine formula for treating stomach cancer provided by the application is applied to preparation of stomach cancer treating drugs.

[0014] The details of each component of the application are as follows: Leigongteng alkaloids are the extract of the dried roots, stems and leaves of the Celastraceae plant Tripterygium wilfordii, which is composed of six components, i.e., triptolide, wilfordine, jineol, chong-alkaloid, furan fenchol and leitengsu; Kunming mountain tetracentron alkaloids contain three effective components, i.e., celadocine, leipinol methyl ether and b-sitosterol, and the kunming mountain tetracentron alkaloids are the dried root extract of the Celastraceae plant Tetracentron sinense; Wolf poison is the extract of the Daphne genus plant, which is a liquid, slurry or powder with a specific gravity of 15-17 extracted by using an organic solvent or a cooking method, and the wolf poison is new wolf poison A, new wolf poison B or wolf poison dry powder extracted from the Daphne genus plant; Hook-wan tetracentron alkaloids are the extract of the perennial evergreen vine plant of the tetracentron genus in the Loganiaceae family, which contains the toxic effective component tetracentron alkaloids, and is a liquid, slurry or powder with a specific gravity of 15-17 extracted by using an organic solvent or a cooking method; Zanthoxylum piperitum is the fruit extract of the Rutaceae plant Zanthoxylum bungeanum, which contains zanthoxylum piperitum and small pepper amide, and is a liquid, slurry or powder with a specific gravity of 15-17 extracted by using an organic solvent or a cooking method; Ganoderma lucidum polysaccharide is the dried fruiting body extract of the Polyporaceae fungus Ganoderma lucidum or Ganoderma sinense, which is composed of three components, i.e., ganoderma lucidum polysaccharide, L-mannitol and glycerol; Pinellia ternata stigmasterol is the tuber extract of the Araceae plant Pinellia ternata, which contains stigmasterol components; Raddeanin, extract of Radix Rehmanniae Preparata, contains Raddeanin; White pepper volatile oil, composed of a-pinene, caryophyllene, a-terpineol, limonene, and sinensene, is the extract of dried mature fruit of Amomum xanthioides or Amomum compactum; Murrayo Koenigii, the extract of fruit of Litsea cubeba, contains Murrayo Koenigii; Dendrobium alkaloid, composed of three components, i.e., Dendrobium alkaloid, Dendrobium stellatum alkaloid, and Dendrobium subalkaloid, is the extract of dried stem of Dendrobium candidum; Piperlongum volatile oil, containing eucalyptol, linalool, camphor, and acetyl camphor ester, is the extract of dried nearly mature seed of Piper longum; Panax notoginseng saponin, the extract of root of Panax notoginseng, contains Panax notoginseng saponin; Linalool, the extract of wood containing resin of Aquilaria sinensis, contains Linalool; Millettia pinnata, the extract of stem of Millettia pinnata, contains Millettia pinnata; Semen Cassiae, the extract of dried mature seed of Cassia obtusifolia, contains Cassia obtusifolia; Fingered citron, the extract of fruit of Citrus medica, contains Fingered citron; Cistanche, the extract of succulent stem of Cistanche tubulosa, contains vitamins and minerals; Forsythia alkaloid, the extract of dried whole plant of Forsythia suspense, contains alkaloid; Sangshen inorganic salt, the extract of dried fruiting branch of Morus alba, contains inorganic salt; Sarcococca total flavonoids, the extract of fruit of Hippophae rhamnoides, contains total flavonoids.

[0015] The present application has the following advantages: Compared with the prior art, the traditional Chinese medicine formula for treating gastric cancer and the preparation method thereof provided by the present application have the technical effects of synergistic effect, toxicity reduction, and side effect control. 1. Curative effect is accurate and remarkable, multi-target synergistic effect: the application defines the core anti-tumor active ingredients such as tripterygium alkaloids, kunming mountain tetrodotoxin, and hook-wan huamantou base as "jun medicine", and combines with a large number of "chenshaoyi" such as ganoderma polysaccharide, panax notoginseng saponin, and hippophae total flavonoids, to form a treatment system that attaches equal importance to "expelling evil" and "supporting health", as shown in test examples 1 and 2, the formula shows a significant effect of inhibiting the proliferation of gastric cancer cells and tumor growth in vitro and in vivo, and the curative effect is significantly better than that of the commercial control drug, and is equivalent to the effect of the standard chemotherapy drug.

[0016] 2. High safety, controllable toxicity: Control example 3 proves that if the jun medicine (tripterygium alkaloids, hook-wan huamantou base) is removed, the drug effect is greatly lost (IC50 increases by about 5 times, and the tumor inhibition rate decreases to 13.3%), proving that the jun medicine is the core of the curative effect.

[0017] Control example 4 proves that if the key chenshaoyi (ganoderma polysaccharide, panax notoginseng saponin, and hippophae total flavonoids) is removed, the toxicity of the formula is significantly increased (animal weight loss, clinical adverse reaction rate increases to 20%), and the curative effect is reduced.

[0018] Therefore, it is fully proved that the formula provided by the application controls the toxicity within a safe range while ensuring strong curative effect.

[0019] 3. Overall regulation, improving the quality of life of patients: The chenshaoyi ingredients (such as ganoderma polysaccharide, panax notoginseng saponin) and auxiliary materials (vitamin B and trace elements) in the prescription can effectively improve the common symptoms of cancer patients such as weakness, fatigue, and loss of appetite. As shown in the clinical results of test example 3, the patients taking the formula of the application not only have a high disease control rate (DCR), but also have a significantly improved physical condition (KPS score) compared with the chemotherapy group, realizing the unity of curative effect and quality of life. DETAILED DESCRIPTION

[0020] The technical solutions in the embodiments of the application will be clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the application, not all the embodiments. Based on the embodiments in the application, all other embodiments obtained by those skilled in the art without creative labor belong to the protection scope of the application.

[0021] The jun medicine mentioned in the application refers to the drug that plays a major therapeutic role against the main disease or main symptoms in the prescription. In the composition, the jun medicine is tripterygium alkaloids, kunming mountain tetrodotoxin, wolf poison, hook-wan huamantou base, and zanthoxylum, which jointly play a core anti-tumor (expelling evil) role.

[0022] Ministerial drugs: there are two meanings, one is to assist the monarch drug to strengthen the therapeutic effect; the second is to eliminate or slow down the toxicity or intensity of the monarch drug. In the composition, the ministerial drugs include but are not limited to ganoderma polysaccharide, notoginseng saponin, etc., which jointly play the role of strengthening body resistance and reducing toxicity.

[0023] In the present application, the 'total weight parts of the monarch drug' refers to the sum of the weight parts of all the components of the monarch drug in the formula; the 'total weight parts of the ministerial drugs' refers to the sum of the weight parts of all the components of the ministerial drugs in the formula. The ratio is calculated based on the sum.

[0024] Example 1 Take the following weight parts of ingredients: water 100 parts, tripterygium alkaloids 38 parts, radix sinicae alkaloids 38 parts, wolf toxin 28 parts, gelsemium humile alkaloids 28 parts, zanthoxylum alkaloids 28 parts; ganoderma polysaccharide 16 parts, pinellia sterols 16 parts, radix rehmanniae 16 parts, amomum villosum volatile oil 16 parts, amomum costatum 16 parts, dendrobium alkaloids 16 parts, piper nigrum volatile oil 16 parts, notoginseng saponin 16 parts, linalool 16 parts, morindae radix 16 parts, cassia seed 16 parts, bergamot alcohol 16 parts, cistanche 16 parts, forsythia alkaloids 16 parts, morus inorganic salt 16 parts, total flavonoids of hippophae 16 parts; folic acid 0.4 parts, vitamin B group 0.05 parts, copper sulfate 2 parts, zinc sulfate 10 parts, manganese sulfate 5 parts, food mother 2 parts.

[0025] The preparation method comprises the following steps: (1) Take each component according to the above weight parts; (2) Mix the monarch drug components (tripterygium alkaloids, radix sinicae alkaloids, wolf toxin, gelsemium humile alkaloids, zanthoxylum alkaloids) with water, heat to 55℃, and stir for 45 minutes; (3) Add the ministerial drug components (ganoderma polysaccharide, pinellia sterols, radix rehmanniae, amomum villosum volatile oil, amomum costatum, dendrobium alkaloids, piper nigrum volatile oil, notoginseng saponin, linalool, morindae radix, cassia seed, bergamot alcohol, cistanche, forsythia alkaloids, morus inorganic salt, total flavonoids of hippophae), continue to stir for 30 minutes; (4) Add folic acid, vitamin B group, copper sulfate, zinc sulfate, manganese sulfate, food mother, and stir until completely dissolved; (5) Filter the obtained medicinal liquid, sterilize, and then divide and pack to obtain the traditional Chinese medicine liquid preparation for treating stomach cancer.

[0026] Example 2 Take the following weight parts of ingredients: water 100 parts, tripterygium alkaloids 90 parts, radix sinicae alkaloids 90 parts, wolf toxin 85 parts, gelsemium humile alkaloids 85 parts, zanthoxylum alkaloids 85 parts; Ganoderma lucidum polysaccharide 80 parts, Pinellia ternate sterol 80 parts, Alisma orientalis radix alder- manulin 80 parts, White cardamom volatile oil 80 parts, Amomum villosum 80 parts, Dendrobium alkaloid 80 parts, Galangal volatile oil 80 parts, Panax notoginseng ginsenoside 80 parts, Agarwood alcohol 80 parts, Spatholobus suberectus 80 parts, Cassia seed element 80 parts, Bergamot alcohol 80 parts, Cistanche 80 parts, Forsythia alkaloid 80 parts, Morus inorganic salt 80 parts, Hippophae rhamnoides total flavonoids 80 parts; Folic acid 0.8 parts, vitamin B group 0.08 parts, copper sulfate 10 parts, zinc sulfate 16 parts, manganese sulfate 10 parts, food mother 8 parts.

[0027] The preparation method is the same as that of Example 1.

[0028] Example 3 The following ingredients are weighed: water 100 parts, tripterygium alkaloids 64 parts, Kunming mountain tangerine alkaloids 64 parts, wolf poison 56.5 parts, Gelsemium elegans alkaloids 56.5 parts, Zanthoxylum bungeanum 56.5 parts; Ganoderma lucidum polysaccharide 48 parts, Pinellia ternate sterol 48 parts, Alisma orientalis radix alder- manulin 48 parts, White cardamom volatile oil 48 parts, Amomum villosum 48 parts, Dendrobium alkaloid 48 parts, Galangal volatile oil 48 parts, Panax notoginseng ginsenoside 48 parts, Agarwood alcohol 48 parts, Spatholobus suberectus 48 parts, Cassia seed element 48 parts, Bergamot alcohol 48 parts, Cistanche 48 parts, Forsythia alkaloid 48 parts, Morus inorganic salt 48 parts, Hippophae rhamnoides total flavonoids 48 parts; Folic acid 0.6 parts, vitamin B group 0.065 parts, copper sulfate 6 parts, zinc sulfate 13 parts, manganese sulfate 7.5 parts, food mother 5 parts.

[0029] The preparation method is the same as that of Example 1.

[0030] Control Example 1 (commercially available Chinese medicine control 1) The patient took the commercially available anticancer Chinese medicine "Kang'ai Ping Pill" (Guojia Zhunzi Z46020009) according to the recommended dose and method of use in the instructions.

[0031] Control Example 2 (commercially available Chinese medicine control 2) The patient took the commercially available anticancer Chinese medicine "Fufang Tianxian Capsule" (Guojia Zhunzi Z10880008) according to the recommended dose and method of use in the instructions.

[0032] Control Example 3 The formula does not contain tripterygium alkaloids and Gelsemium elegans alkaloids, two key but toxic anticancer ingredients, and the rest of the components and the amount are exactly the same as Example 3.

[0033] Control Example 4 The formula does not contain Ganoderma lucidum polysaccharide, Panax notoginseng ginsenoside, and Hippophae rhamnoides total flavonoids, three key tonifying and tonifying ingredients, and the rest of the components and the amount are exactly the same as Example 3.

[0034] Test Example Test Example 1: In vitro anti-gastric cancer cell activity test Objective: To evaluate the proliferation inhibition effect of the formula of the present application on different human gastric cancer cell lines.

[0035] Method: Cell lines: Human gastric cancer cell lines MKN-45, AGS, SGC-7901; Grouping: Example 1-3 groups, control example 1-4 groups, 5-FU positive control group, blank control group; Concentration gradient: 0, 12.5, 25, 50, 100, 200 μg / mL; Culture time: 24h, 48h, 72h; Detection method: CCK-8 method; Data processing: Calculate IC50 value, and use SPSS 22.0 for statistical analysis; The results are shown in the following table: Table 1 IC50 values of different formulas on gastric cancer cell lines (μg / mL, X ± SD) Table 1 Conclusion: The three examples of the present application all show significant proliferation inhibition effect on three kinds of gastric cancer cell lines, and the IC50 value is significantly lower than that of each control group, and the cytotoxicity to normal gastric mucosa is much lower than that of 5-FU.

[0036] Test Example 2: In vivo pharmacodynamic test of animals Objective: To verify the anti-gastric cancer effect of the formula of the present application in animals.

[0037] Method: Animals: BALB / c nude mice, half male and half female, 6-8 weeks old, body weight 18-22g; Model: MKN-45 cell subcutaneous tumor model; Grouping: normal control group, model control group, example 1-3 group, control example 1-4 group, 5-FU group, 12 in each group; Dosing: Gavage, 0.1 mL / 10g, once a day, for 28 consecutive days; Observation index: Tumor volume, body weight, survival status; End of experiment: Sacrifice the animals, take the tumor and weigh it, and calculate the tumor inhibition rate; The results are shown in the following table: Table 2 Comparison of tumor growth of animals in each group (X ± SD) Table 2 Note: **P < 0.01 vs model group; ##P < 0.01 vs example group; Conclusion: The formula of the present application can significantly inhibit tumor growth, and the tumor inhibition rate is comparable to that of 5-FU, but the body weight change shows that its toxicity is significantly lower than that of 5-FU.

[0038] Test Example 3: Observation of clinical efficacy Objective: To observe the clinical efficacy and safety of the formula of the present application in the treatment of gastric cancer.

[0039] Method: Research object: Patients with stage II-III gastric cancer confirmed by pathology; Sample size: 30 cases in each group, a total of 270 cases; Grouping: Example groups 1-3, control groups 1-4, and standard chemotherapy group; Treatment cycle: 3 months; Evaluation index: Objective remission rate, disease control rate, quality of life score, and adverse reactions; The results are shown in Table 3: Table 3 Evaluation of clinical efficacy and safety Table 3 Conclusion: The formula of the present application significantly reduces treatment-related adverse reactions while maintaining high efficacy, and improves the quality of life of patients.

[0040] The safety of the formula is also verified Effect Example 1: Long-term toxicity test Objective: To evaluate the toxicity of repeated administration of the formula of the present application.

[0041] Method: Animals: SD rats, half male and half female, 20 in each group; Dose: 1, 3, and 5 times of the clinical equivalent dose; Administration cycle: 90 days, with a recovery period of 30 days; Observation index: Body weight, food intake, hematology, blood biochemistry, organ coefficient, and histopathology; The results are shown in Table 4: Table 4 Changes in main indicators of long-term toxicity test Table 4 Conclusion: No significant toxicity was observed at 1 times the clinical dose, and only reversible liver enzyme elevation occurred at 5 times the dose. The formula of the present application has high safety at the set clinical dose, and the main potential risk is that long-term over-dose use may cause mild and reversible effects on the liver, while the kidney and hematopoietic system show good safety.

[0042] Example 2: Allergy test Objective: To evaluate the sensitization of the formula of the present application.

[0043] Methods: Guinea pig maximization test: 30 guinea pigs, divided into example group, positive control group, negative control group; Human patch test: 60 healthy volunteers; Observation index: skin reaction score, allergy incidence; The results are shown in Table 5: Table 5 Results of allergy test Table 5 Conclusion: The formula of the present application shows no sensitization in animal and human tests.

[0044] Example 3: Genetic toxicity test Objective: To evaluate the genetic toxicity of the formula of the present application.

[0045] Methods: Ames test: 5 strains, with and without S9; Micronucleus test: ICR mice, 10 in each group; Chromosome aberration test: CHL cells; The results are shown in Table 6: Table 6 Results of genetic toxicity test Table 6 Conclusion: The results of the three genetic toxicity tests are negative, indicating that the formula of the present application has no genetic toxicity.

[0046] Typical cases Case 1 Mr. Chen, born in 1945, was diagnosed with advanced gastric cancer in May 2018. Under the doctor's advice, the patient voluntarily tried oral liquid of the present application (Example 1) as an adjuvant therapy. After three months of review, imaging examination showed that the gastric lesion was stable compared with the previous one, the tumor marker level decreased, and the patient's pain, loss of appetite and other symptoms improved, and the quality of life improved. Regular follow-up later, the condition remained stable.

[0047] Case 2 Ms. Liu, 40 years old, was diagnosed with advanced gastric cancer in 2010. Due to personal reasons, she did not undergo radiotherapy and chemotherapy, and chose to take oral liquid of the present application (Example 2). After 6 months of treatment, hospital review showed that the gastric tumor had not progressed, some indicators had improved, and the physical function and mental state had improved compared with before treatment.

[0048] Case 3 Patient Mr. Qian, 45 years old, diagnosed with advanced gastric cancer in 2016. On the basis of conventional supportive treatment, the drug solution of the application (Example 3) was added. After 3 months of review, CT evaluation showed stable lesions and no new lesions, and the patient felt good.

[0049] Case Four Patient Ms. Kang, 50 years old, diagnosed with advanced gastric cancer in 2002. The patient orally took the drug solution of the application (Example 1) for 6 months. Regular monitoring during the period showed that the disease was effectively controlled, the symptoms were relieved, and the survival time with tumor was prolonged.

[0050] Case Five Patient Mr. Shui, 35 years old, diagnosed with advanced gastric cancer in 2003. The patient took the drug solution of the application (Example 2) for 6 months. The review showed that the growth rate of the tumor was inhibited, and the related clinical symptoms were relieved.

[0051] Case Six Patient Mr. Xu, 50 years old, diagnosed with advanced gastric cancer in 2001. The patient took the drug solution of the application (Example 3) for 7 months. Follow-up physical examination showed that the disease was stable and did not deteriorate rapidly, and the quality of life was maintained.

[0052] In summary: the traditional Chinese medicine formula provided by the application has been proved by a large number of experiments to have significant anti-gastric cancer activity, and by scientific compatibility, the side effects of toxic ingredients are reduced, the safety of drug use is improved while the efficacy is ensured.

[0053] Obviously, those skilled in the art can make various modifications and variations to the present application without departing from the spirit and scope of the present application. Thus, if these modifications and variations of the present application fall within the scope of the claims of the present application and their equivalents, the present application also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine formula for treating gastric cancer, characterized in that, It is made from the following components in parts by weight: Principal ingredients: Tripterygium wilfordii alkaloids 38-90 parts, Malus kunmingensis alkaloids 38-90 parts, Euphorbia fischeriana 28-85 parts, Gelsemium elegans alkaloids 28-85 parts, Zanthoxylum bungeanum 28-85 parts; Assistant ingredients: 16-80 parts of Ganoderma lucidum polysaccharide, 16-80 parts of Pinellia ternata sitosterol, 16-80 parts of Rehmannia glutinosa volatile oil, 16-80 parts of cardamom volatile oil, 16-80 parts of Piper cubeba alkaloid, 16-80 parts of Alpinia officinarum volatile oil, 16-80 parts of Panax notoginseng saponins, 16-80 parts of Aquilaria sinensis volatile oil ... The ratio of the total weight of the principal drug to the total weight of the adjuvant drugs is 1:(1.5 ~ 5.0).

2. The traditional Chinese medicine formula for treating gastric cancer as described in claim 1, characterized in that, It also includes the following components by weight: folic acid 0.4-0.8 parts, B vitamins 0.05-0.08 parts, copper sulfate 2-10 parts, zinc sulfate 10-16 parts, manganese sulfate 5-10 parts, and glutenin 2-8 parts.

3. The traditional Chinese medicine formula for treating gastric cancer as described in claim 2, characterized in that, The B vitamins include vitamins B1, B2, B6, and B12.

4. The traditional Chinese medicine formula for treating gastric cancer as described in claim 2, characterized in that, The product comprises the following components by weight: 100 parts water, 38 parts Tripterygium wilfordii alkaloids, 38 parts Malus kunmingensis alkaloids, 28 parts Euphorbia fischeriana, 28 parts Gelsemium elegans alkaloids, 28 parts Zanthoxylum bungeanum polysaccharides, 16 parts Pinellia ternata sitosterol, 16 parts Rehmannia glutinosa volatile oil, 16 parts Amomum villosum volatile oil, 16 parts Piper cubeba alkaloids, 16 parts Dendrobium nobile alkaloids, 16 parts Amomum villosum volatile oil, 16 parts Panax notoginseng saponins, 16 parts Aquilaria sinensis volatile oil, 16 parts Spatholobus suberectus volatile oil, 16 parts Cassia tora volatile oil, 16 parts Citrus aurantium volatile oil, 16 parts Cistanche deserticola volatile oil, 16 parts Forsythia suspensa alkaloids, 16 parts Morus alba inorganic salts, 16 parts Hippophae rhamnoides total flavonoids; 0.4 parts folic acid, 0.05 parts B vitamins, 2 parts copper sulfate, 10 parts zinc sulfate, 5 parts manganese sulfate, and 2 parts glutenin.

5. A traditional Chinese medicine formula for treating gastric cancer as described in claim 2, characterized in that, The product comprises the following components by weight: 100 parts water, 90 parts Tripterygium wilfordii alkaloids, 90 parts Malus kunmingensis alkaloids, 85 parts Euphorbia fischeriana, 85 parts Gelsemium elegans alkaloids, 85 parts Zanthoxylum bungeanum polysaccharides, 80 parts Pinellia ternata sitosterol, 80 parts Rehmannia glutinosa volatile oil, 80 parts Amomum villosum volatile oil, 80 parts Piper cubeba alkaloids, 80 parts Dendrobium nobile alkaloids, 80 parts Amomum villosum volatile oil, 80 parts Panax notoginseng saponins, 80 parts Aquilaria sinensis volatile oil, 80 parts Spatholobus suberectin, 80 parts Cassia tora alkaloids, 80 parts Citrus medica volatile oil, 80 parts Cistanche deserticola alkaloids, 80 parts Forsythia suspensa alkaloids, 80 parts Morus alba inorganic salts, 80 parts Hippophae rhamnoides total flavonoids; 0.8 parts folic acid, 0.08 parts B vitamins, 10 parts copper sulfate, 16 parts zinc sulfate, 10 parts manganese sulfate, and 8 parts Glutamic acid.

6. A traditional Chinese medicine formula for treating gastric cancer as described in claim 2, characterized in that, The composition includes the following components by weight: 100 parts water, 64 parts Tripterygium wilfordii alkaloids, 64 parts Malus kunmingensis alkaloids, 56.5 parts Euphorbia fischeriana alkaloids, 56.5 parts Gynostemma pentaphyllum polysaccharides, 48 ​​parts Pinellia ternata sitosterol, 48 parts Rehmannia glutinosa volatile oil, 48 parts Amomum villosum volatile oil, 48 parts Piper cubeba alkaloids, 48 ​​parts Dendrobium nobile alkaloids, 48 ​​parts Amomum villosum volatile oil, 48 parts Panax notoginseng saponins, 48 ​​parts Aquilaria sinensis volatile oil, 48 parts Spatholobus suberectin, 48 parts Cassia tora alkaloids, 48 ​​parts Citrus medica volatile oil, 48 parts Cistanche deserticola alkaloids, 48 ​​parts Morus alba inorganic salts, 48 ​​parts Hippophae rhamnoides total flavonoids; 0.6 parts folic acid, 0.065 parts B vitamins, 6 parts copper sulfate, 13 parts zinc sulfate, 7.5 parts manganese sulfate, and 5 parts glutenin.

7. The method for preparing a traditional Chinese medicine formula for treating gastric cancer as described in claim 2, characterized in that, Includes the following steps: (1) Weigh each component according to its weight parts; (2) Mix Tripterygium wilfordii alkaloids, Malus kunmingensis alkaloids, Euphorbia fischeriana alkaloids, Gelsemium elegans alkaloids, Zanthoxylum bungeanum alkaloids and water, heat to 50-60℃ and stir for 30-60 minutes; (3) Add Ganoderma lucidum polysaccharide, Pinellia ternata sterol, Rehmannia glutinosa flavonoids, Amomum villosum volatile oil, Piper cubeba alkaloid, Dendrobium nobile alkaloid, Amomum villosum volatile oil, Panax notoginseng saponins, Aquilaria sinensis alcohol, Spatholobus suberectin, Cassia tora alkaloid, Citrus medica alcohol, Cistanche deserticola, Forsythia suspensa alkaloid, Morus alba inorganic salt, and Hippophae rhamnoides total flavonoids, and continue stirring for 20-40 minutes; (4) Add folic acid, B vitamins, copper sulfate, zinc sulfate, manganese sulfate, and digestive enzymes, and stir until completely dissolved; (5) Filter, sterilize, and repackage to obtain the product.

8. A traditional Chinese medicine formula for treating gastric cancer as described in any one of claims 1-6, characterized in that, It is used in the preparation of drugs for treating gastric cancer.

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