Anti-tumor traditional Chinese medicine composition

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to an anti-tumor traditional Chinese medicine composition. The traditional Chinese medicine composition comprises the pleurotus eryngii mycelium polypeptide and the cistanche polysaccharide, through the synergistic effect, the growth of tumors can be inhibited, the hepatotoxicity can be relieved, and a safer and more effective treatment method is provided for treatment of tumor and hepatotoxic diseases.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for anti-tumor. Background Art

[0002] Tumor is a major challenge in the current medical field, and hepatotoxic diseases are also a common clinical problem. The limitations of traditional treatment methods have prompted people to actively seek new treatment approaches. Pleurotus eryngii mycelium polypeptide (PEMP) is a bioactive polypeptide extracted from Pleurotus eryngii mycelium. It is rich in amino acids and has antioxidant, anti-tumor and immune activities. It has been studied and shown potential in antioxidant, anti-inflammatory, anti-tumor and immunomodulatory effects. Cistanche tubulosa polysaccharides (CDPS) are derived from the plant Cistanche tubulosa, usually extracted from its rhizome part.

[0003] The mechanism of action of PEMP is concentration-dependent. At a concentration of 0.05 to 2 mg / mL, it inhibits the proliferation of cancer cells, but promotes the proliferation of macrophages, the secretion of tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) by releasing NO and H 2 O 2 Cistanche tubulosa polysaccharides limit its growth and spread by inducing apoptosis of cancer cells. And Cistanche tubulosa polysaccharides can enhance the recognition and attack of cancer cells by the immune system, promote the activation of immune cells, inhibit angiogenesis, and prevent tumor cells from growing and spreading.

[0004] The synergistic mechanism of action between Pleurotus eryngii mycelium polypeptide and Cistanche tubulosa polysaccharides is the key point of the drug combination. When Pleurotus eryngii mycelium polypeptide and Cistanche tubulosa polysaccharides are used in combination, their synergistic effect significantly enhances the therapeutic effect. Pleurotus eryngii mycelium polypeptide can reduce the infection and inflammation around the tumor through its antibacterial effect, thus creating favorable conditions for the anti-tumor effect of Cistanche tubulosa polysaccharides. Cistanche tubulosa polysaccharides further improve the therapeutic effect on tumors by reducing toxicity and promoting the activation of the immune system. At present, there is no report on the combined use of Pleurotus eryngii mycelium polypeptide and Cistanche tubulosa polysaccharides in the treatment of tumors. Summary of the Invention

[0005] The purpose of the present invention is to provide a safer and more effective treatment method for the treatment of tumors and hepatotoxic diseases. The traditional Chinese medicine composition of the present invention, through synergistic effects, can not only inhibit the growth of tumors, but also reduce liver toxicity, and has a certain effect on hepatotoxic diseases, including alcoholic hepatitis, fatty liver, and liver fibrosis.

[0006] Specifically, the present invention is achieved through the following technical solutions:

[0007] The present invention provides a traditional Chinese medicine composition for anti-tumor.

[0008] Furthermore, the traditional Chinese medicine composition comprises pleurotus eryngii mycelium polypeptide and cistanche deserticola polysaccharide.

[0009] Furthermore, the traditional Chinese medicine composition is used for treating tumors and liver toxicity diseases.

[0010] Furthermore, the preparation method of the traditional Chinese medicine composition comprises the following steps:

[0011] (1) Extract polypeptide from pleurotus eryngii and purify it to obtain pleurotus eryngii mycelium polypeptide;

[0012] (2) Ultrasonically extract polysaccharide from cistanche deserticola and purify it to obtain cistanche deserticola polysaccharide;

[0013] (3) Mix pleurotus eryngii mycelium polypeptide and cistanche deserticola polysaccharide according to a mass ratio of 1:10 to 10:1.

[0014] Furthermore, the preparations made from the traditional Chinese medicine composition, such as tablets, granules, and suspensions.

[0015] Compared with the prior art, the beneficial effects of the present invention are mainly reflected in:

[0016] The pleurotus eryngii mycelium polypeptide and cistanche deserticola polysaccharide in the traditional Chinese medicine composition of the present invention are natural plant extracts, which have a synergistic effect on inhibiting tumor growth, can reduce the occurrence of adverse reactions, improve the tolerance and safety of treatment, and provide a new treatment plan for tumor patients that can not only effectively inhibit tumor growth but also reduce the burden on the liver and lower drug toxicity. The traditional Chinese medicine composition of the present invention has low toxicity and high safety, and is suitable for long-term use and large-scale production. Description of the Drawings

[0017] Figure 1 : Chart of the change in tumor volume (PEMP:CDPS is 6:14) in CDX model mice of human hepatocellular carcinoma cell line (HepG-2).

[0018] Figure 2 : Chart of the change in body weight (PEMP:CDPS is 6:14) in CDX model mice of human hepatocellular carcinoma cell line HepG-2.

[0019] Figure 3 : Chart of the combined effect in tumor growth inhibition (PEMP:CDPS is 6:14) in CDX model mice of human hepatocellular carcinoma cell line HepG-2. Detailed Embodiments

[0020] The present invention will be further described in detail below with reference to specific examples, but the protection scope of the present invention is not limited thereto:

[0021] "g" represents the unit of weight "gram"; "mL" represents the unit of volume "milliliter"; "r / min" represents the rotational speed; "℃" represents the temperature "degree Celsius"; "min" represents the unit of time "minute"; "h" represents the unit of time "hour"; "mg / mL" represents the mass concentration "milligram per milliliter"; "mg / kg / day" represents the dosage unit "milligram per kilogram per day".

[0022] 1. Preparation of Traditional Chinese Medicine Composition

[0023] Example 1

[0024] The obtained Pleurotus eryngii mycelium polypeptide and Cistanche deserticola polysaccharide were mixed evenly according to a mass ratio of 3:17 to prepare Drug Combination 1.

[0025] Extraction of Pleurotus eryngii mycelium polypeptide: The Pleurotus eryngii mycelium was cultured, extracted, and purified to obtain Pleurotus eryngii mycelium polypeptide. The specific operation was as described in the article by Sun Yanan (Research on the Isolation, Purification and Biological Activity of Pleurotus eryngii Mycelium Polypeptide [D]. Shandong: Qingdao Agricultural University, 2017).

[0026] Extraction of Cistanche deserticola polysaccharide: High-quality Cistanche deserticola was selected and subjected to steps such as washing, drying, pulverizing, extracting, concentrating, and purifying to obtain Cistanche deserticola polysaccharide. The specific operation was as described in the article by Yan Jiajing (Biomedicine & Pharmacotherapy, 162 (2023) 114719).

[0027] The preparation methods of Examples 2 - 6 and Comparative Examples 1 - 2 were the same as those of Example 1, except for the ratio between the polypeptide and the polysaccharide, as shown in Table 1.

[0028] Table 1 Formulation compositions of Examples 1 - 6 and Comparative Examples 1 - 2

[0029]

[0030] A combined effect test was conducted using CDX model mice (n = 27) of the human hepatocellular carcinoma cell line HepG-2. As the test substances, PEMP and CDPS used were both purchased from Shaanxi Hongtai Biotechnology Co., Ltd. The mice were assigned to each group in such a way that the average tumor volume (TV) of each group was equal, and the day when this grouping (n = 9) was carried out was set as Day 1.

[0031] 2. In Vivo Animal Experiments

[0032] Test Example 1

[0033] The mice in Example 1 were gavaged at a dose of 500 mg / kg / day once every night for 40 days. On the 41st day, all the mice were weighed, and blood and liver tissues were collected and the indicators were measured.

[0034] Test Example 2

[0035] The mice in Example 2 were gavaged at a dose of 500 mg / kg / day once every night for 40 days. On the 41st day, all the mice were weighed, and blood and liver tissues were collected and the indicators were measured.

[0036] Test Example 3

[0037] The mice in Example 3 were gavaged at a dose of 500 mg / kg / day once every night for 40 days. On the 41st day, all the mice were weighed, and blood and liver tissues were collected and the indicators were measured.

[0038] Test Example 4

[0039] The mice in Example 4 were gavaged at a dose of 500 mg / kg / day once every night for 40 days. On the 41st day, all the mice were weighed, and blood and liver tissues were collected and the indicators were measured.

[0040] Test Example 5

[0041] The mice in Example 5 were gavaged at a dose of 500 mg / kg / day once every night for 40 days. On the 41st day, all the mice were weighed, and blood and liver tissues were collected and the indicators were measured.

[0042] Control Example 1

[0043] The test solution of the PEMP single group was prepared into 500 mg / kg / day for gavage once every night for 40 days. On the 41st day, all the mice were weighed, and blood and liver tissues were collected and the indicators were measured.

[0044] Control Example 2

[0045] The test solution of the CDPS single group was prepared into 500 mg / kg / day for gavage once every night for 40 days. On the 41st day, all the mice were weighed, and blood and liver tissues were collected and the indicators were measured.

[0046] Blank group

[0047] Three mice in the blank group were gavaged with 0.9% physiological saline at a dose of 0.1 mL / 10 g.bw once every night for 40 days. On the 41st day, all the mice were weighed, and blood and liver tissues were collected and the indicators were measured.

[0048] Positive control group

[0049] As a control experiment, silybin was selected as the control drug. The test solution of the silybin alone group was prepared into 40 mg / kg / day for gavage, once every night for 40 days. On the 41st day, all mice were weighed, blood and liver tissues were collected and the indicators were measured.

[0050] In this experiment, the dosage of silybin was set using the maximum tolerated dose (MTD) of each drug. For anti-tumor agents, the dosage showing the maximum efficacy is very close to the dosage at which toxicity is found. In order to evaluate the maximum anti-tumor effect of the agent using an animal model, it is generally evaluated near the MTD. In this experimental example, the definition of MTD is almost the same as that of the dosage at which the maximum effect is exerted.

[0051] As an index of anti-tumor effect, the TV on the 41st day (day41) was measured in each drug administration group, and the relative tumor volume (relative tumor volume: RTV) and liver index relative to the 1st day were calculated, thereby evaluating the anti-tumor effect.

[0052] Judging from the obtained results, the effect of Example 2 is the best, and the data in the chart are all for Drug Combination 2, PEMP:CDPS = 6:14.

[0053] It can be seen from the above that the drug combination of this anti-tumor agent, by scientifically proportioning the two natural plant extracts of Pleurotus eryngii mycelium polypeptide and Cistanche deserticola polysaccharide, achieves a remarkable synergistic effect in inhibiting tumor growth and reducing liver toxicity. This composition not only demonstrates a multi-target and multi-path anti-tumor mechanism, effectively enhancing the body's immune function, but also significantly reduces the damage of traditional anti-tumor treatments to the liver and promotes the repair and protection of the liver.

Claims

1. An anti-tumor Chinese medicine composition, characterized in that: The traditional Chinese medicine composition comprises Pleurotus eryngii mycelium polypeptide and Cistanche deserticola polysaccharide.

2. An anti-tumor Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is used for treating tumors and hepatotoxic diseases.

3. An anti-tumor Chinese medicine composition according to claim 1 or 2, characterized in that: The preparation method of the Chinese medicine composition comprises the following steps: (1) extracting polypeptides from Pleurotus eryngii and purifying them to obtain Pleurotus eryngii mycelium polypeptides; (2) extracting polysaccharides from Cistanche deserticola by ultrasonic method, and purifying the polysaccharides to obtain Cistanche deserticola polysaccharides; (3) Mix the Pleurotus eryngii mycelium polypeptide and the Cistanche deserticola polysaccharide in a mass ratio of 1:10 to 10:

1.

4. An anti-tumor Chinese medicine composition according to claims 1-3, characterized in that: The preparations made from the Chinese medicine composition include tablets, granules and suspensions.

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