Pharmaceutical composition for treating or preventing gallbladder cancer

Abstract

The invention provides a pharmaceutical composition for treating or preventing gallbladder cancer, which comprises the following main components: EGCG: a catechin compound extracted from green tea, the purity of which is greater than or equal to 95%; the ginsenoside Rg3 is extracted from araliaceae plant ginseng, and the purity is greater than or equal to 98%; capsaicin is extracted from red pepper, and the purity is greater than or equal to 90%; the auxiliary components comprise L-ascorbic acid, alpha-tocopherol and curcumin, the curcumin is extracted from turmeric, and the purity of the curcumin is larger than or equal to 95%; the main components and the auxiliary components in the pharmaceutical composition are proportioned as follows: an oral preparation: 20-40 mg / kg of EGCG (epigallocatechin gallate), 10-30 mg / kg of ginsenoside Rg3, 1-5 mg / kg of capsaicin, 50-100 mg / kg of L-ascorbic acid, 20-50 mg / kg of alpha-tocopherol and 10-20 mg / kg of curcumin; the invention discloses a pharmaceutical composition for treating or preventing gallbladder cancer, which is prepared from the following raw materials: 10-20 mg / kg of EGCG, 5-15 mg / kg of ginsenoside Rg3, 0.5-2 mg / kg of capsaicin, and DSPE-PEG2000 as a carrier material, the pharmaceutical composition for treating or preventing gallbladder cancer, provided by the invention, remarkably improves the anti-tumor effect through a multi-way and multi-target action mechanism, and provides a new thought and method for treating gallbladder cancer.

Description

Technical Field

[0001] The present invention belongs to the technical field of gallbladder cancer, and in particular relates to a pharmaceutical composition for treating or preventing gallbladder cancer. Background Art

[0002] Gallbladder cancer is an extremely aggressive malignant tumor. Due to its unclear early symptoms, it is often in the late stage when diagnosed, which makes treatment difficult and the prognosis poor. The incidence of gallbladder cancer is on the rise worldwide, especially in Asia and South America. According to the Global Cancer Observatory, the number of new cases and deaths from gallbladder cancer is increasing each year, posing a serious threat to public health. The high mortality rate of gallbladder cancer is mainly attributed to the difficulty in early diagnosis and the lack of effective treatment. Most patients have already developed local infiltration or distant metastasis at the time of diagnosis and have lost the opportunity for surgical treatment. Traditional chemotherapy and radiotherapy methods have limited effects on gallbladder cancer and have large side effects, and the quality of life and survival rate of patients cannot be effectively improved.

[0003] In response to the urgent need for the treatment of gallbladder cancer, the present invention aims to develop a new pharmaceutical composition to improve the therapeutic effect of gallbladder cancer, reduce side effects, and improve the quality of life and survival rate of patients. The pharmaceutical composition is based on the latest cancer research and can effectively inhibit the proliferation and metastasis of gallbladder cancer cells through the synergistic effect of multiple active ingredients, while enhancing the patient's immune function, providing a new solution for the treatment of gallbladder cancer. Summary of the invention

[0004] The present invention provides a pharmaceutical composition for treating or preventing gallbladder cancer, which solves the problems in the prior art.

[0005] The technical solution of the present invention is achieved as follows: a pharmaceutical composition for the treatment or prevention of gallbladder cancer, the main components of the pharmaceutical composition include:

[0006] EGCG: catechins extracted from green tea, purity ≥ 95%;

[0007] Ginsenoside Rg3: extracted from ginseng of the Araliaceae family, with a purity of ≥98%;

[0008] Capsaicin: extracted from red pepper, purity ≥ 90%;

[0009] It also includes auxiliary ingredients: L-ascorbic acid, α-tocopherol and curcumin, wherein curcumin is extracted from turmeric with a purity of ≥95%;

[0010] The ratio of main ingredients to auxiliary ingredients in the pharmaceutical composition:

[0011] Oral preparation: EGCG 20-40mg / kg, ginsenoside Rg3 10-30mg / kg, capsaicin 1-5mg / kg, L-ascorbic acid 50-100mg / kg, α-tocopherol 20-50mg / kg, curcumin 10-20mg / kg;

[0012] Injection: EGCG 10-20mg / kg, ginsenoside Rg35-15mg / kg, capsaicin 0.5-2mg / kg, supplemented with DSPE-PEG2000 as carrier material.

[0013] As a preferred embodiment of a pharmaceutical composition for the treatment or prevention of gallbladder cancer, the stability test of the pharmaceutical composition is as follows: the oral preparation and the injection are stored at 25°C±2°C and 60%±10% relative humidity for 12 months, and samples are taken to analyze the degradation rate of the active ingredients.

[0014] As a preferred embodiment of a pharmaceutical composition for the treatment or prevention of gallbladder cancer, the stability test of the pharmaceutical composition is accelerated: the oral preparation and the injection are stored at 40°C±2°C and 75%±5% relative humidity for 6 months, during which time samples are taken at the end of the 1st, 2nd, 3rd and 6th month respectively.

[0015] As a preferred embodiment of a pharmaceutical composition for treating or preventing gallbladder cancer, the oral preparation in the pharmaceutical composition is taken once a day for four consecutive weeks.

[0016] As a preferred embodiment of a pharmaceutical composition for treating or preventing gallbladder cancer, the injection in the pharmaceutical composition is administered once a week for four consecutive weeks.

[0017] After adopting the above technical scheme, the beneficial effect of the present invention is that the pharmaceutical composition can significantly inhibit the growth and spread of gallbladder cancer cells. In in vitro experiments, the survival rate of gallbladder cancer cells treated with the pharmaceutical composition was significantly reduced, the cell cycle was blocked in the G0 / G1 phase, and the apoptosis rate was significantly increased. In in vivo experiments, the tumor volume and weight of mice treated with the pharmaceutical composition were significantly smaller than those of the control group, and the survival period was significantly prolonged. In addition, the pharmaceutical composition also significantly enhanced the immune function of mice and inhibited the formation of tumor blood vessels.

[0018] The drug combination significantly improves the anti-tumor effect through a multi-pathway and multi-target mechanism of action, providing new ideas and methods for the treatment of gallbladder cancer. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0020] Figure 1 is a curve chart of the cell survival rate in an in vitro experiment of the present invention;

[0021] Figure 2 It is a curve diagram of the cell survival rate in the in vivo experiment of the present invention. DETAILED DESCRIPTION

[0022] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0023] Example 1

[0024] A pharmaceutical composition for treating or preventing gallbladder cancer, the main components of the pharmaceutical composition comprising:

[0025] EGCG: catechin compound extracted from green tea, purity ≥ 95%, mechanism of action: targeted inhibition of EGFR phosphorylation, blocking downstream PI3K / Akt and Ras / Raf / MEK / ERK pathways, inhibiting tumor cell proliferation, inducing cell cycle arrest and mitochondria-dependent apoptosis, inhibiting MMP-2 / 9 expression, and reducing tumor cell invasion ability;

[0026] Ginsenoside Rg3: extracted from ginseng of the Araliaceae family, with a purity of ≥98%. Mechanism of action: regulates the expression of tumor cell cycle proteins, such as Cyclin D1, inhibits proliferation, promotes tumor cell apoptosis, enhances the activity of NK cells and macrophages, and improves immune function;

[0027] It also includes auxiliary ingredients: L-ascorbic acid, α-tocopherol and curcumin. Curcumin is extracted from turmeric with a purity of ≥95%. L-ascorbic acid has the effect of enhancing the stability of EGCG, preventing oxidative degradation, and synergistic antioxidant effects. α-tocopherol has the effect of protecting cell membranes, enhancing drug bioavailability, regulating immune cell activity, and inhibiting the immunosuppression of MDSCs in the tumor microenvironment. Curcumin can inhibit the Wnt / β-catenin pathway, reverse tumor cell EMT, enhance the permeability of other ingredients, and improve the efficacy.

[0028] The ratio of main ingredients to auxiliary ingredients in the pharmaceutical composition:

[0029] Oral preparation: EGCG 20mg / kg, ginsenoside Rg310mg / kg, L-ascorbic acid 50mg / kg, α-tocopherol 20mg / kg, curcumin 10mg / kg;

[0030] Injection: EGCG 10mg / kg, ginsenoside Rg35mg / kg, supplemented with DSPE-PEG2000 as carrier material.

[0031] Among them, the stability test of the drug composition: the oral preparation and the injection are stored at 25℃±2℃ and relative humidity 60%±10% for 12 months, and the degradation rate of the active ingredients is analyzed by sampling.

[0032] Accelerated test in the stability test of pharmaceutical compositions: oral preparations and injections are stored at 40°C ± 2°C and 75% ± 5% relative humidity for 6 months. During this period, samples are taken at the end of the 1st, 2nd, 3rd and 6th month respectively.

[0033] The oral preparation in the pharmaceutical composition is taken once daily for four consecutive weeks.

[0034] The injection of the pharmaceutical composition is administered once a week for four consecutive weeks.

[0035] Example 2

[0036] A pharmaceutical composition for treating or preventing gallbladder cancer, the main components of the pharmaceutical composition comprising:

[0037] EGCG: catechins extracted from green tea, purity ≥ 95%;

[0038] Ginsenoside Rg3: extracted from ginseng of the Araliaceae family, with a purity of ≥98%;

[0039] Capsaicin: extracted from red peppers, with a purity of ≥90%. Mechanism of action: through activation of TRPV1 receptors, it induces calcium overload in tumor cells, triggers apoptosis, regulates the NF-κB pathway, and inhibits the release of tumor-related inflammatory factors. If capsaicin causes gastrointestinal discomfort, it can be relieved by adjusting the dosage;

[0040] It also includes auxiliary ingredients: L-ascorbic acid, α-tocopherol and curcumin, wherein curcumin is extracted from turmeric with a purity of ≥95%;

[0041] The ratio of main ingredients to auxiliary ingredients in the pharmaceutical composition:

[0042] Oral preparation: EGCG 30mg / kg, ginsenoside Rg315mg / kg, capsaicin 2mg / kg, L-ascorbic acid 100mg / kg, α-tocopherol 50mg / kg, curcumin 20mg / kg;

[0043] Injection: EGCG 20mg / kg, ginsenoside Rg310mg / kg, capsaicin 2mg / kg, supplemented with DSPE-PEG2000 as carrier material.

[0044] The pharmaceutical composition can significantly inhibit the growth and spread of gallbladder cancer cells. In in vitro experiments, the survival rate of gallbladder cancer cells treated with the pharmaceutical composition was significantly reduced, the cell cycle was blocked in the G0 / G1 phase, and the apoptosis rate was significantly increased. In in vivo experiments, the tumor volume and weight of mice treated with the pharmaceutical composition were significantly smaller than those of the control group, and the survival period was significantly prolonged. In addition, the pharmaceutical composition also significantly enhanced the immune function of mice and inhibited the formation of tumor blood vessels.

[0045] The drug combination significantly improves the anti-tumor effect through a multi-pathway and multi-target mechanism of action, providing new ideas and methods for the treatment of gallbladder cancer.

[0046] The pharmaceutical composition for treating or preventing gallbladder cancer provided by the present invention brings new ideas for the treatment or prevention of gallbladder cancer and opens up a new application field of the pharmaceutical composition. The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention, and these improvements and supplements should also be regarded as the scope of protection of the present invention.

[0047] The present invention provides a pharmaceutical composition for the treatment or prevention of gallbladder cancer. The above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A pharmaceutical composition for treating or preventing gallbladder cancer, characterized in that: The main ingredients of the pharmaceutical composition include: EGCG: catechins extracted from green tea, purity ≥ 95%; Ginsenoside Rg3: extracted from ginseng of the Araliaceae family, with a purity of ≥98%; Capsaicin: extracted from red pepper, purity ≥ 90%; It also includes auxiliary ingredients: L-ascorbic acid, α-tocopherol and curcumin, wherein curcumin is extracted from turmeric with a purity of ≥95%; The ratio of main ingredients to auxiliary ingredients in the pharmaceutical composition: Oral preparation: EGCG 20-40 mg / kg, ginsenoside Rg3 10-30 mg / kg, capsaicin 1-5 mg / kg, L-ascorbic acid 50-100 mg / kg, α-tocopherol 20-50 mg / kg, curcumin 10-20 mg / kg; Injection: EGCG 10-20mg / kg, ginsenoside Rg35-15mg / kg, capsaicin 0.5-2mg / kg, supplemented with DSPE-PEG2000 as carrier material.

2. A pharmaceutical composition for treating or preventing gallbladder cancer according to claim 1, characterized in that: The stability test of the pharmaceutical composition: the oral preparation and the injection are stored at 25°C ± 2°C and a relative humidity of 60% ± 10% for 12 months, and samples are taken to analyze the degradation rate of the active ingredients.

3. A pharmaceutical composition for treating or preventing gallbladder cancer according to claim 2, characterized in that: Accelerated test in the stability test of the pharmaceutical composition: oral preparations and injections are stored at 40°C ± 2°C and 75% ± 5% relative humidity for 6 months. During this period, samples are taken at the end of the 1st, 2nd, 3rd and 6th month respectively.

4. A pharmaceutical composition for treating or preventing gallbladder cancer according to claim 1, characterized in that: The oral preparation in the pharmaceutical composition is taken once a day for four consecutive weeks.

5. A pharmaceutical composition for treating or preventing gallbladder cancer according to claim 1, characterized in that: The injection described in the pharmaceutical composition is administered once a week for four consecutive weeks.

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