Application of a Chinese medicine composition in the preparation of a medicine having anti-hepatitis B virus effect

Abstract

The present invention relates to the technical field of traditional Chinese medicine, and specifically discloses the use of a traditional Chinese medicine composition in the preparation of a drug with an anti-hepatitis B virus effect. The traditional Chinese medicine composition comprises the following traditional Chinese medicine raw materials: Sargentodon spatholobus, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice. Studies have shown that the traditional Chinese medicine composition prepared with 7 medicinal materials such as Sargentodon spatholobus, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice as raw materials has an anti-hepatitis B virus effect; the composition has a small number of raw materials, only 7 raw materials are needed, and there is no need to use a large number of traditional Chinese medicine raw material combinations, which has important application value.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to application of a traditional Chinese medicine composition in preparing a medicine having an anti-hepatitis B virus effect. Background Art

[0002] Hepatitis B specifically refers to chronic hepatitis B, which is caused by infection with the hepatitis B virus (HBV). Its early symptoms include fatigue, dizziness, loss of appetite, etc., and later symptoms may include liver palms, spider nevi, hepatosplenomegaly, etc.

[0003] At present, the main treatment for hepatitis B is antiviral treatment; commonly used antiviral drugs include nucleotide antiviral drugs and interferon antiviral drugs, including emtricitabine, tenofovir, interferon, pegylated interferon, etc. Traditional Chinese medicine is a traditional Chinese medicine, which also plays an important role in the treatment of antiviral, anti-tumor and other diseases. Therefore, it is of great application value to develop a drug with anti-hepatitis B virus using traditional Chinese medicine as raw materials. Summary of the invention

[0004] In order to overcome at least one of the technical problems existing in the prior art, the present invention provides an application of a traditional Chinese medicine composition in the preparation of a drug having an anti-hepatitis B virus effect.

[0005] The technical solution of the present invention is as follows:

[0006] The present invention firstly provides a traditional Chinese medicine composition, which comprises the following traditional Chinese medicine raw materials: Sargentodon sphaerocephala, Paris polyphylla, Taraxacum mongolicum, Patrinia sphaerocephala, Indigo naturalis, Phellodendron amurense and Licorice.

[0007] The invention provides a new Chinese medicine composition prepared with seven medicinal materials, namely, Sargentodoxae, Paris polyphylla, Taraxacum mongolicum, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice as raw materials; studies have shown that the composition has an anti-hepatitis B virus effect.

[0008] Preferably, the Chinese medicine composition comprises the following Chinese medicine raw materials in parts by weight:

[0009] 1-30 parts of Sargentodon grandiflora; 1-30 parts of Paris polyphylla; 1-30 parts of Taraxacum herb; 1-30 parts of Patrinia scabra; 1-30 parts of Indigo naturalis; 1-30 parts of Phellodendron chinense; 1-30 parts of Licorice root.

[0010] Further preferably, the Chinese medicine composition comprises the following Chinese medicine raw materials in parts by weight:

[0011] 20-30 parts of Sargentodon grandiflora; 20-30 parts of Paris polyphylla; 10-20 parts of Taraxacum herb; 10-20 parts of Patrinia scabra; 5-10 parts of Indigo naturalis; 5-10 parts of Phellodendron chinense; 1-5 parts of Licorice root.

[0012] Most preferably, the Chinese medicine composition comprises the following Chinese medicine raw materials in parts by weight:

[0013] 25 parts of Sargentophyllae; 25 parts of Paris polyphyllae; 15 parts of Herba Taraxaci; 15 parts of Herba Patriniae; 8 parts of Indigo naturalis; 8 parts of Cortex Phellodendri; 4 parts of Radix Glycyrrhizae.

[0014] The inventors found in the study that in the process of preparing a Chinese medicine composition using 7 medicinal materials such as Sargentodoxae, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron chinense and Licorice as raw materials, the weight ratio of each Chinese medicine raw material component has an important influence on the anti-HBV effect of the prepared Chinese medicine composition. The study showed that the Chinese medicine composition prepared by Sargentodoxae, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron chinense and Licorice in the above weight ratio has a much higher anti-HBV effect than the Chinese medicine composition prepared in other weight ratios.

[0015] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, which comprises the following steps:

[0016] Mix and grind the Chinese medicinal materials, such as Sargentophyllum, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice, to obtain Chinese medicinal raw material powder;

[0017] The Chinese medicine raw material powder is heated and extracted with a solvent, filtered after the extraction is completed, and the extract is taken, and the extract is concentrated and dried to obtain the Chinese medicine composition.

[0018] Preferably, the dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:6~20L;

[0019] Preferably, the dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:12L.

[0020] Preferably, the solvent used is ethanol aqueous solution.

[0021] Preferably, the ethanol aqueous solution refers to an ethanol aqueous solution with an ethanol volume fraction of 70%.

[0022] Preferably, the solvent consists of isopropanol and ethyl acetate.

[0023] Preferably, the volume ratio of isopropanol to ethyl acetate is 1-3:1-3.

[0024] Most preferably, the volume ratio of isopropanol to ethyl acetate is 1:1.

[0025] The inventors found in the study that in the process of preparing a Chinese medicine composition using 7 medicinal materials such as Sargentodoxae, Paris, Taraxacum, Patrinia, Indigo, Phellodendron and Licorice as raw materials, the selection of the extraction solvent plays an important role in the anti-HBV effect of the prepared Chinese medicine composition. The study showed that the Chinese medicine composition obtained by extracting Sargentodoxae, Paris, Taraxacum, Patrinia, Indigo, Phellodendron and Licorice with a solvent composed of isopropanol and ethyl acetate has a much higher anti-HBV effect than the Chinese medicine composition extracted with ethanol aqueous solution.

[0026] Moreover, only the traditional Chinese medicine composition obtained by extraction with a solvent composed of isopropanol and ethyl acetate can have a significantly higher anti-hepatitis B virus effect than the traditional Chinese medicine composition obtained by extraction with an ethanol-water solution; while the traditional Chinese medicine composition obtained by extraction with a single isopropanol or ethyl acetate, or a combination of other solvents, cannot have a significantly higher anti-hepatitis B virus effect than the traditional Chinese medicine composition obtained by extraction with an ethanol-water solution.

[0027] Preferably, the heating extraction specifically refers to heating reflux extraction at 70-80° C. for 1-3 hours.

[0028] Most preferably, the heating extraction specifically refers to heating reflux extraction at 75°C for 2h.

[0029] The present invention also provides an application of the Chinese medicine composition in preparing a medicine having an anti-hepatitis B virus effect.

[0030] Preferably, the dosage form of the drug is decoction, pill, powder, granule, tablet or capsule.

[0031] Beneficial effects: The present invention provides a new Chinese medicine composition. Studies have shown that the composition of Sargentophyllum spatholobi,

[0032] A traditional Chinese medicine composition prepared with seven medicinal materials, namely, Paris polyphylla, Taraxacum mongolicum, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice as raw materials, has anti-hepatitis B virus effect; the composition only needs seven raw materials and does not require the use of a large number of traditional Chinese medicine raw material combinations, and has important application value. DETAILED DESCRIPTION

[0033] The present invention is further explained below in conjunction with specific examples, but the examples do not limit the present invention in any form.

[0034] Example 1 Preparation of Chinese medicine composition

[0035] The Chinese medicinal raw materials are composed of 15 parts of Sargentophylla, 15 parts of Paris polyphylla, 25 parts of Taraxacum herb, 25 parts of Patrinia scabra, 8 parts of Indigo naturalis, 8 parts of Phellodendron amurense and 4 parts of Licorice.

[0036] Preparation method:

[0037] (1) Mix the Chinese medicinal materials of Sargentodon spatholobi, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice root according to the above weight proportions, grind them through a 100-mesh sieve to obtain Chinese medicinal raw material powder;

[0038] (2) extracting the Chinese medicine raw material powder with a solvent by heating and refluxing for 2 hours, filtering after the extraction, taking the extract, and concentrating and drying the extract to obtain the Chinese medicine composition;

[0039] The dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:12L; the solvent is an ethanol aqueous solution with a volume fraction of 70%.

[0040] Example 2 Preparation of Chinese medicine composition

[0041] The Chinese medicinal raw materials are composed of 8 parts of Sargentophylla, 8 parts of Paris polyphylla, 15 parts of Taraxacum herb, 15 parts of Patrinia scabra, 25 parts of Indigo naturalis, 25 parts of Phellodendron amurense and 4 parts of Licorice.

[0042] Preparation method:

[0043] (1) Mix the Chinese medicinal materials of Sargentodon spatholobi, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice root according to the above weight proportions, grind them through a 100-mesh sieve to obtain Chinese medicinal raw material powder;

[0044] (2) extracting the Chinese medicine raw material powder with a solvent by heating and refluxing for 2 hours, filtering after the extraction, taking the extract, and concentrating and drying the extract to obtain the Chinese medicine composition;

[0045] The dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:12L; the solvent is an ethanol aqueous solution with a volume fraction of 70%.

[0046] Example 3 Preparation of Chinese medicine composition

[0047] The Chinese medicinal raw materials are composed of 25 parts of Sargentodon grandiflora, 25 parts of Paris polyphylla, 15 parts of Taraxacum herb, 15 parts of Patrinia scabra, 8 parts of Indigo naturalis, 8 parts of Phellodendron amurense and 4 parts of Licorice.

[0048] Preparation method:

[0049] (1) Mix the Chinese medicinal materials of Sargentodon spatholobi, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice root according to the above weight proportions, grind them through a 100-mesh sieve to obtain Chinese medicinal raw material powder;

[0050] (2) extracting the Chinese medicine raw material powder with a solvent by heating and refluxing for 2 hours, filtering after the extraction, taking the extract, and concentrating and drying the extract to obtain the Chinese medicine composition;

[0051] The dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:12L; the solvent is an ethanol aqueous solution with a volume fraction of 70%.

[0052] Example 4 Preparation of Chinese medicine composition

[0053] The Chinese medicinal raw materials are composed of 25 parts of Sargentodon grandiflora, 25 parts of Paris polyphylla, 15 parts of Taraxacum herb, 15 parts of Patrinia scabra, 8 parts of Indigo naturalis, 8 parts of Phellodendron amurense and 4 parts of Licorice.

[0054] Preparation method:

[0055] (1) Mix the Chinese medicinal materials of Sargentodon spatholobi, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice root according to the above weight proportions, grind them through a 100-mesh sieve to obtain Chinese medicinal raw material powder;

[0056] (2) extracting the Chinese medicine raw material powder with a solvent by heating and refluxing for 2 hours, filtering after the extraction, taking the extract, and concentrating and drying the extract to obtain the Chinese medicine composition;

[0057] The dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:12L; the solvent is composed of isopropanol and ethyl acetate in a volume ratio of 1:1.

[0058] Example 5 Preparation of Chinese medicine composition

[0059] The Chinese medicinal raw materials are composed of 25 parts of Sargentodon grandiflora, 25 parts of Paris polyphylla, 15 parts of Taraxacum herb, 15 parts of Patrinia scabra, 8 parts of Indigo naturalis, 8 parts of Phellodendron amurense and 4 parts of Licorice.

[0060] Preparation method:

[0061] (1) Mix the Chinese medicinal materials of Sargentodon spatholobi, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice root according to the above weight proportions, grind them through a 100-mesh sieve to obtain Chinese medicinal raw material powder;

[0062] (2) extracting the Chinese medicine raw material powder with a solvent by heating and refluxing for 2 hours, filtering after the extraction, taking the extract, and concentrating and drying the extract to obtain the Chinese medicine composition;

[0063] The dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:12L; and the solvent is isopropanol.

[0064] Example 6 Preparation of Chinese medicine composition

[0065] The Chinese medicinal raw materials are composed of 25 parts of Sargentodon grandiflora, 25 parts of Paris polyphylla, 15 parts of Taraxacum herb, 15 parts of Patrinia scabra, 8 parts of Indigo naturalis, 8 parts of Phellodendron amurense and 4 parts of Licorice.

[0066] Preparation method:

[0067] (1) Mix the Chinese medicinal materials of Sargentodon spatholobi, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice root according to the above weight proportions, grind them through a 100-mesh sieve to obtain Chinese medicinal raw material powder;

[0068] (2) extracting the Chinese medicine raw material powder with a solvent by heating and refluxing for 2 hours, filtering after the extraction, taking the extract, and concentrating and drying the extract to obtain the Chinese medicine composition;

[0069] The dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:12L; and the solvent is ethyl acetate.

[0070] Example 7 Preparation of Chinese medicine composition

[0071] The Chinese medicinal raw materials are composed of 25 parts of Sargentodon grandiflora, 25 parts of Paris polyphylla, 15 parts of Taraxacum herb, 15 parts of Patrinia scabra, 8 parts of Indigo naturalis, 8 parts of Phellodendron amurense and 4 parts of Licorice.

[0072] Preparation method:

[0073] (1) Mix the Chinese medicinal materials of Sargentodon spatholobi, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice root according to the above weight proportions, grind them through a 100-mesh sieve to obtain Chinese medicinal raw material powder;

[0074] (2) extracting the Chinese medicine raw material powder with a solvent by heating and refluxing for 2 hours, filtering after the extraction, taking the extract, and concentrating and drying the extract to obtain the Chinese medicine composition;

[0075] The dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:12L; the solvent is composed of isopropanol and ether in a volume ratio of 1:1.

[0076] Example 8 Preparation of Chinese medicine composition

[0077] The Chinese medicinal raw materials are composed of 25 parts of Sargentodon grandiflora, 25 parts of Paris polyphylla, 15 parts of Taraxacum herb, 15 parts of Patrinia scabra, 8 parts of Indigo naturalis, 8 parts of Phellodendron amurense and 4 parts of Licorice.

[0078] Preparation method:

[0079] (1) Mix the Chinese medicinal materials of Sargentodon spatholobi, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice root according to the above weight proportions, grind them through a 100-mesh sieve to obtain Chinese medicinal raw material powder;

[0080] (2) extracting the Chinese medicine raw material powder with a solvent by heating and refluxing for 2 hours, filtering after the extraction, taking the extract, and concentrating and drying the extract to obtain the Chinese medicine composition;

[0081] The dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:12L; the solvent is composed of dichloromethane and ethyl acetate in a volume ratio of 1:1. Example

[0082] Hep G2.2.15 cells (human liver cancer cells expressing HBV virus) were taken and 10×10 5 The concentration of 50 μg / mL was inoculated in a 96-well plate containing DMEM culture medium, and then cultured in a 5% CO2 incubator at 37°C for 24 h. After the culture, the culture medium of the experimental group was replaced with DMEM culture medium containing 200 μg / mL of the sample to be tested; the DMEM culture medium containing 200 μg / mL of the sample to be tested was replaced every 3 days; the blank control group was replaced with DMEM culture medium without the sample to be tested; 5 parallel wells were set for each group; after continuous culture for 9 days, the supernatant was taken, and the HBsAg and HBeAg contents were detected by ELISA kits; the inhibition rates of HBsAg and HBeAg were calculated, and the test results are shown in Table 1.

[0083] The samples to be tested are the Chinese medicine composition prepared in Examples 1 to 8 and the positive control drug lamivudine.

[0084] Table 1. Experimental results of the Chinese medicine composition of the present invention against hepatitis B virus

[0085]

[0086] From the experimental results in Table 1, it can be seen that the Chinese medicine compositions prepared in Examples 1 to 3 show different inhibition rates on HBsAg and HBeAg; this shows that the Chinese medicine compositions prepared with 7 medicinal materials such as Sargentodoxae, Paris, Taraxacum, Patrinia, Indigo, Phellodendron and Licorice as raw materials have a certain anti-HBV effect. However, the magnitude of its antiviral effect is closely related to the weight ratio of 7 medicinal materials such as Sargentodoxae, Paris, Taraxacum, Patrinia, Indigo, Phellodendron and Licorice; among them, the inhibition rate of HBsAg and HBeAg prepared in Example 3 is significantly higher than that of the positive control drug lamivudine. This shows that in the process of preparing Chinese medicine compositions with 7 medicinal materials such as Sargentodoxae, Paris, Taraxacum, Patrinia, Indigo, Phellodendron and Licorice as raw materials, the weight ratio of each Chinese medicine raw material component has an important influence on the anti-HBV effect of the prepared Chinese medicine composition. Studies have shown that the Chinese medicine composition prepared under the weight ratio of Example 3 has a significantly higher anti-hepatitis B virus effect than the Chinese medicine composition prepared under other weight ratios; it is also significantly higher than the positive control drug lamivudine; it has an excellent anti-hepatitis B virus effect; while the Chinese medicine compositions prepared under other weight ratios have less anti-hepatitis B virus effects than the positive control drug lamivudine, and are not significantly higher than the positive control drug.

[0087] It can be seen from the experimental results in Table 1 that the Chinese medicine composition prepared in Example 4 has a much higher inhibition rate on HBsAg and HBeAg than the Chinese medicine composition prepared in Example 3; and it is also much higher than the positive control drug lamivudine. This shows that in the process of preparing a Chinese medicine composition using 7 medicinal materials such as Sargassum ulmoides, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron chinense and Licorice as raw materials, the selection of the extraction solvent has an important influence on the anti-hepatitis B virus effect of the prepared Chinese medicine composition. The above experiments show that the Chinese medicine composition obtained by extracting with Sargassum ulmoides, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron chinense and Licorice as raw materials and using a solvent composed of isopropanol and ethyl acetate has a much higher anti-hepatitis B virus effect than the Chinese medicine composition obtained by conventional extraction with ethanol aqueous solution; it has a very excellent anti-hepatitis B virus effect.

[0088] It can be seen from the experimental results in Table 1 that the inhibition rate of HBsAg and HBeAg of the Chinese medicine compositions prepared in Examples 5 and 6 is much lower than that of the Chinese medicine composition prepared in Example 3 than that of the Chinese medicine composition prepared in Example 4; this indicates that the Chinese medicine composition obtained by extraction with a solvent composed of isopropanol and ethyl acetate can synergistically improve the anti-hepatitis B virus effect of the Chinese medicine composition.

[0089] It can be seen from the experimental results in Table 1 that the inhibition rates of HBsAg and HBeAg of the Chinese medicine compositions prepared in Examples 5 to 8 are much higher than those of the Chinese medicine composition prepared in Example 3, which is much lower than that of the Chinese medicine composition prepared in Example 4. This shows that only the Chinese medicine composition extracted with a solvent consisting of isopropanol and ethyl acetate can have a significantly higher anti-hepatitis B virus effect than the Chinese medicine composition extracted with a conventional ethanol-water solution; while the Chinese medicine composition extracted with a single isopropanol or ethyl acetate, or with a combination of other solvents, cannot have a significantly higher anti-hepatitis B virus effect than the Chinese medicine composition extracted with a conventional ethanol-water solution.

Claims

1. A Chinese medicine composition, characterized in that: Made from the following Chinese medicinal materials in parts by weight: 1~30 parts of Sargentodon grandiflora; 1~30 parts of Paris polyphylla; 1~30 parts of Taraxacum officinale; 1~30 parts of Patrinia scabra; 1~30 parts of Indigo naturalis; 1~30 parts of Phellodendron chinense; 1~30 parts of Licorice root; The preparation method of the Chinese medicine composition comprises the following steps: Mix and grind the Chinese medicinal materials, such as Sargentophyllum, Paris polyphylla, Taraxacum officinale, Patrinia scabra, Indigo naturalis, Phellodendron amurense and Licorice, to obtain Chinese medicinal raw material powder; The Chinese medicine raw material powder is heated and extracted with a solvent, filtered after the extraction, and the extract is taken, and the extract is concentrated and dried to obtain the Chinese medicine composition; The dosage ratio of the Chinese medicine raw material powder to the solvent is 1kg:6~20L; the heating extraction specifically refers to heating reflux extraction at 70~80°C for 1~3h; The solvent consists of isopropanol and ethyl acetate; wherein the volume ratio of isopropanol to ethyl acetate is 1-3:1-3.

2. The Chinese medicine composition according to claim 1, characterized in that: Made from the following Chinese medicinal materials in parts by weight: 20-30 parts of Sargentodon grandiflora; 20-30 parts of Paris polyphylla; 10-20 parts of Taraxacum herb; 10-20 parts of Patrinia scabra; 5-10 parts of Indigo naturalis; 5-10 parts of Phellodendron chinense; 1-5 parts of Licorice root.

3. The Chinese medicine composition according to claim 1, characterized in that Made from the following Chinese medicinal materials in parts by weight: 25 parts of Sargentophyllae; 25 parts of Paris polyphyllae; 15 parts of Herba Taraxaci; 15 parts of Herba Patriniae; 8 parts of Indigo naturalis; 8 parts of Cortex Phellodendri; 4 parts of Radix Glycyrrhizae.

4. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament having an anti-hepatitis B virus effect.

5. The use according to claim 4, characterized in that: The dosage form of the medicine is decoction, pill, powder, granule, tablet or capsule.

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