Traditional Chinese medicine extract preparation for treating AIDS

Abstract

The invention relates to a preparation method of a traditional Chinese medicine for treating AIDS. The traditional Chinese medicine is prepared from ginseng, astragalus membranaceus, venenum bufonis, cantharides and a paris polyphylla extract. Comprising ginsenoside, astragalus polysaccharide, venenum bufonin, cantharidimide, polyphyllin and the like.

Description

[0001] The purpose of the present invention is to overcome the shortcomings of the background technology and provide a pharmaceutical composition for treating AIDS.

[0002] The present invention is achieved through the following technical solutions:

[0003] The composition and weight proportion of the raw material of a pharmaceutical composition for treating AIDS of the present invention are as follows:

[0004] Ginsenoside 10-25 parts by weight Methylcanthamide 2-10 parts by weight Toad venom 2-8 parts by weight Paris saponin 8-15 parts by weight Astragaloside 20-30 parts by weight

[0005] The pharmaceutical composition for treating AIDS of the present invention can be prepared into tablets, capsules and dripping pills by conventional pharmaceutics methods.

[0006] The present invention discloses a pharmaceutical composition for treating AIDS, characterized in that it is used for treating AIDS.

[0007] The pharmaceutical composition provided by the present invention can inhibit splenomegaly caused by FLV when taken orally. The spleen is the main target organ of the virus, and the size of the spleen enlargement of mice infected with FLV can quantitatively reflect the amount of virus. Therefore, the spleen index is an intuitive and reliable indicator of whether the drug can inhibit the virus. The spleen is rich in lymphocytes and macrophages, both of which are involved in the humoral immune response. Therefore, in the experiment, the pharmaceutical composition can inhibit splenomegaly, indicating that it not only has an anti-FLV effect in the body, but also may have the effect of improving humoral immune function. From the experimental results of immunological indicators, the pharmaceutical composition has a good up-regulation effect on cellular immunity, especially when the body's immune function is low due to retrovirus, which is particularly significant, indicating that the pharmaceutical composition can enhance the body's cellular immune function and inhibit the immunodeficiency caused by FLV, and is a better immunomodulator. DETAILED DESCRIPTION

[0008] The following is a further description of a pharmaceutical composition for treating AIDS through specific experimental examples and embodiments, but is not limited to the present invention.

[0009] Example 1: Pharmaceutical composition for treating AIDS

[0010] The composition and weight proportions of the raw materials of the pharmaceutical composition for treating AIDS are as follows:

[0011] 10 parts by weight of ginsenosides 2 parts by weight of methylcantharidin 8 parts by weight of toad venom 15 parts by weight of paridis saponins 20 parts by weight of astragaloside

[0012] Example 2: A pharmaceutical composition for treating AIDS.

[0013] The composition and weight proportions of the raw materials of the pharmaceutical composition for treating AIDS are as follows:

[0014] Ginsenoside 5 parts by weight Methylcantharidin 2 parts by weight Toad venom 8 parts by weight Paris saponin 8 parts by weight Astragaloside 18 parts by weight.

[0015] Example 3: Pharmaceutical composition for treating AIDS

[0016] The composition and weight proportions of the raw materials of the pharmaceutical composition for treating AIDS are as follows:

[0017] Ginsenoside 15 parts by weight Methylcantharidin 6 parts by weight Toad venom 6 parts by weight Paris saponin 15 parts by weight Astragaloside 20 parts by weight

[0018] Example 4: Pharmaceutical composition for treating AIDS

[0019] The composition and weight proportions of the raw materials of the pharmaceutical composition for treating AIDS are as follows:

[0020] Ginsenoside 15 parts by weight Methylcantharidin 10 parts by weight Toad venom 8 parts by weight Paris saponin 15 parts by weight Astragaloside 20 parts by weight

[0021] Example 5: Preparation of tablets

[0022] Take 150 g of the composition of Example 1, add 75 g of starch, mix well, granulate, dry, add 20 g of microcrystalline cellulose and 2.5 g of magnesium stearate, mix well, and press into 1000 tablets to obtain tablets of the composition of the present invention.

[0023] Example 6: Preparation of capsules

[0024] Take 165 g of the composition of Example 2, add 65 g of starch, mix well, granulate, dry, granulate, add appropriate amount of magnesium stearate, mix well, and fill 1000 capsules to obtain capsules of the composition of the present invention.

[0025] Example 7: Preparation of Dropping Pills

[0026] Weigh 200 g of polyethylene glycol 6000 and heat it in a water bath (80° C.) to melt, add 50 g of the composition of Example 3, stir well, use liquid paraffin as a coolant, place in a glass tube (4*80 cm), the cooling temperature is 10° C., the inner and outer diameters of the dropping port are 7.0 / 2.0 (mm / mm), the dropping port is 2 cm from the liquid surface, and the dropping rate is 50 drops per minute as the optimal condition. Use cotton cloth to absorb the condensing agent on the surface of the dropping pills to obtain the dropping pills of the composition of the present invention.

[0027] Experimental Example 1: Therapeutic effect of the drug composition on AIDS mice

[0028] 1. Materials and Methods

[0029] Drugs: The pharmaceutical composition of Example 1, the pharmaceutical composition of Example 2, the pharmaceutical composition of Example 3, and the pharmaceutical composition of Example 4, with batch numbers: 202111010, 202111011, 20211012, and 20211013, respectively. During the test, they were dissolved in 30 g / L dimethyl sulfoxide (DMSO) and then diluted with distilled water to the required concentration; the positive control drug zidovudine (AZT) was produced by Xiamen Pharmaceutical Factory with batch number 090907.

[0030] Animals: 50 SPF BALB / C mice, female, weight 13-15 g, provided by Henan Experimental Animal Center.

[0031] Virus strain: Friend Leukemia virus (FLV) was obtained from the American Typical Culture Centre (ATCC). After passage through mice to enhance virulence, the virus was made into a 100 g / L spleen suspension and stored at -70°C for future use.

[0032] Main reagents: PE / Cy5 anti-mouse CD3e monoclonal double-labeled antibody; PE / Cy5 Mouse IgG1, K Isotype Ctrl isotype control; FITC anti-mouse CD4 / PE anti-mouse CD8a monoclonal single-labeled antibody; FITC Mouse IgG1, K Isotype Ctrl / PEMouse IgG1, K Isotype Ctrl isotype control, all of which are products of Biolegend, USA.

[0033] The viral infection dose (ID 50 ) Titration: Intraperitoneal injection of FLV to prepare 0.1g / L spleen suspension, collect spleen suspension and calculate ID according to literature method 50 , the experiment was carried out with 60 times ID 50 This is the experimental concentration for the mouse AIDS model.

[0034] Inhibitory effect of the drug composition on FLV-induced splenomegaly in mice: 70 mice were divided into a normal group, a model group, an Example 1 drug composition group, an Example 2 drug composition group, an Example 3 drug composition group, an Example 4 drug composition group, and an AZT group, with 10 mice in each group; except the normal group, all mice were infected by intraperitoneal injection of FLV. The normal group and the model group were gavaged with distilled water 0.2 mL / mouse every day. The dosage of the pharmaceutical composition group of Example 1, the pharmaceutical composition group of Example 2, the pharmaceutical composition group of Example 3, and the pharmaceutical composition group of Example 4 was 20 mg / kg, and the dosage of the AZT group was 100 mg / kg. All of them were prepared into 2 mL solution with distilled water. The mice were gavaged 1 day after the virus attack, 0.2 mL / mouse, once / d, and continuously administered for 21 days. After 21 days of administration, the mice were killed, and the spleen index and spleen index inhibition rate of the mice were calculated. The spleen index (mass ratio) ω spleen = m spleen (mg) / m body (g), p spleen index inhibition = (ω average, model group - ω average, drug administration group) / ω average, model group × 100%. The obtained experimental data were analyzed using statistical software SPSS 10.0, and the comparison between each group was performed using single-factor analysis of variance (LSD).

[0035] Blood examination: remove the eyeball and draw blood with anticoagulation, and count the red blood cells (RBC) and white blood cells (WBC) using an automatic blood cell counter.

[0036] Effect on cellular immune function: Determination of mouse thymus index (mass ratio), ω thymus = m thymus (mg) / m body (g);

[0037] Peripheral blood T cell subset levels were detected by flow cytometry to measure the levels of CD3+, CD4+, CD8+, and CD4+ / CD8+ T lymphocyte subsets in the peripheral blood of BALB / C mice.

[0038] 2. Results

[0039] 2.1 Comparison of the inhibitory effects of each group on FLV-induced splenomegaly in mice

[0040] The spleen index of each drug composition group was significantly different from that of the model group (P < 0.05), indicating that the drug composition had an inhibitory effect on FLV-induced splenomegaly in mice, with inhibition rates of 78.45%, 73.56%, 67.54% and 65.80%, respectively.

[0042] ①: P<0.05, ②: P<0.01, compared with the normal control group; ③: P<0.05, ④: P<0.01, compared with the model group (the same below).

[0043] 2.2 Comparison of cellular immune function among groups

[0044] The thymus glands of each drug combination group were well protected. No obvious atrophy was observed, and the decrease of thymus index caused by viral infection was antagonized, showing a good immune protection effect. Peripheral blood T lymphocyte analysis (TLC) showed that each drug combination could significantly increase the levels of CD3+, CD4+, and CD8+ T lymphocytes in peripheral blood, and could adjust the

[0045] The CD4+ / CD8+ ratio tends to be normal.

[0047] The results of this experiment show that oral administration of each pharmaceutical composition of the present invention can inhibit splenomegaly caused by FLV. The spleen is the main target organ of the virus, and the size of the spleen enlargement in FLV-infected mice can quantitatively reflect the amount of virus. Therefore, the spleen index is an intuitive and reliable indicator of whether the drug can inhibit the virus. The spleen is rich in lymphocytes and macrophages, both of which are involved in humoral immune responses. Therefore, in the experiment, the pharmaceutical composition can inhibit splenomegaly, indicating that it not only has an anti-FLV effect in vivo, but also may have the effect of improving humoral immune function. From the experimental results of immunological indicators, the pharmaceutical composition has a good up-regulating effect on cellular immunity, especially when the body's immune function is low due to retroviruses. It is particularly significant, indicating that each pharmaceutical composition can enhance the body's cellular immune function and inhibit the immune deficiency caused by FLV, and is a better immunomodulator.

[0048] The composition and weight proportions of the raw materials of the pharmaceutical composition for treating AIDS are as follows:

[0049] 10 parts by weight of ginsenosides 2 parts by weight of methylcantharidin 8 parts by weight of toad venom 15 parts by weight of paridis saponins 20 parts by weight of astragaloside

[0050] Example 2: Pharmaceutical composition for treating AIDS

[0051] The composition and weight proportions of the raw materials of the pharmaceutical composition for treating AIDS are as follows:

[0052] Ginsenoside 5 parts by weight Methylcantharidin 2 parts by weight Toad venom 8 parts by weight Paris saponin 8 parts by weight Astragaloside 18 parts by weight.

[0053] Example 3: Pharmaceutical composition for treating AIDS

[0054] The composition and weight proportions of the raw materials of the pharmaceutical composition for treating AIDS are as follows:

[0055] Ginsenoside 15 parts by weight Methylcantharidin 6 parts by weight Toad venom 6 parts by weight Paris saponin 15 parts by weight Astragaloside 20 parts by weight

[0056] Example 4: Pharmaceutical composition for treating AIDS

[0057] The composition and weight proportions of the raw materials of the pharmaceutical composition for treating AIDS are as follows:

[0058] Ginsenoside 15 parts by weight Methylcantharidin 10 parts by weight Toad venom 8 parts by weight Paris saponin 15 parts by weight Astragaloside 20 parts by weight

[0059] Example 5: Preparation of tablets

[0060] Take 150 g of the composition of Example 1, add 75 g of starch, mix well, granulate, dry, add 20 g of microcrystalline cellulose and 2.5 g of magnesium stearate, mix well, and press into 1000 tablets to obtain tablets of the composition of the present invention.

[0061] Example 6: Preparation of capsules

[0062] Take 165 g of the composition of Example 2, add 65 g of starch, mix well, granulate, dry, granulate, add appropriate amount of magnesium stearate, mix well, and fill 1000 capsules to obtain capsules of the composition of the present invention.

[0063] Example 7: Preparation of pills.

Claims

1. A new Chinese medicine extract combination preparation for treating AIDS, which is prepared in accordance with the provisions of the Pharmacopoeia of the People's Republic of China on Chinese medicine pieces, and in accordance with strict processing technology and scientific extraction methods. They are: 10-25% ginsenoside, 2-10% alpha-cantharidin, 2-8% paridis saponin, 8-15% astragaloside, 20-30% micro-fine cellulose and hard magnesium are mixed evenly to make capsule preparation, each capsule is 0.5g, that is, the capsule of the preparation.

2. The preparation according to claim 1, Features The main medicines are: ginsenoside 10g, grade A cantharidin 4g, toadflax 6g, paridis saponin 15g, astragaloside 15g.

3. The preparation according to claim 1, wherein the Chinese medicine extract composition of the preparation is put into human oral capsules that meet national standards, and each capsule is 0.5g.

4. According to claim 1, the preparation is made into an oral liquid. After the drugs are prepared according to the weight percentage of the drugs required for each preparation of the preparation, the preparation is processed according to the national technical requirements for making Chinese medicine oral liquids to make the oral liquid of the preparation.

5. The preparation capsule according to claim 1 is made into an injection by preparing the combination of Chinese medicinal extracts of the preparation. The weight of the medicine selected for preparing the preparation capsule each time is mixed according to the percentage, and the injection is made according to the relevant national technical requirements for making injections.

6. The capsule of the preparation according to claim 1 is made into tablets, and the powder of the capsule of the preparation is added into a tablet press.