A traditional Chinese medicine composition, its preparation method and application in preparing a drug with the function of treating and / or preventing gout

Abstract

The present invention relates to the technical field of traditional Chinese medicine, and specifically discloses a traditional Chinese medicine composition, a preparation method thereof, and an application thereof in the preparation of a drug having the function of treating and / or preventing gout. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials: Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata Blanco, and Pueraria lobata. Research shows that the traditional Chinese medicine composition has the effect of reducing uric acid. Therefore, further using the traditional Chinese medicine composition of the present invention as an active ingredient in the preparation of a drug having the function of treating and / or preventing gout has important application value.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition, a preparation method thereof, and an application thereof in the preparation of a drug having a therapeutic and / or prophylactic effect on gout. Background Art

[0002] Gout is a common and complex type of arthritis. The main manifestations of gout are symptoms such as pain, edema, redness and inflammation in the joints. After the 1980s, with the improvement of the economic living standards, the dietary structure and living habits have changed, resulting in an increasing trend in the incidence of gout year by year.

[0003] Since the cause of gout is closely related to hyperuricemia, when there is too much uric acid in the blood, uric acid crystals will accumulate in the joints, body fluids and tissues in the body, thus causing gout. Therefore, reducing the content of blood uric acid is one of the research directions for developing drugs for gout. Therefore, providing a traditional Chinese medicine composition with uric acid-lowering effect has important application value for the treatment or prevention of gout. Summary of the Invention

[0004] In order to overcome at least one technical problem existing in the prior art, the present invention provides a traditional Chinese medicine composition, a preparation method thereof, and an application thereof in the preparation of a drug having a therapeutic and / or prophylactic effect on gout.

[0005] The above technical problems to be solved by the present invention are realized by adopting the following technical solutions:

[0006] The present invention first provides a traditional Chinese medicine composition, which is made from the following traditional Chinese medicine raw materials: Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata Blanco, and Pueraria lobata.

[0007] Preferably, the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials in parts by weight:

[0008] Smilax glabra 10 - 15 parts; Cichorium intybus 10 - 15 parts; Paeonia lactiflora 8 - 12 parts; Citrus reticulata Blanco 5 - 10 parts; Pueraria lobata 3 - 6 parts.

[0009] The present invention provides a brand-new traditional Chinese medicine composition prepared from Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata Blanco, and Pueraria lobata as raw materials; research shows that the traditional Chinese medicine composition has an uric acid-lowering effect.

[0010] Most preferably, the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials in parts by weight:

[0011] Smilax glabra 12 parts; Cichorium intybus 12 parts; Paeonia lactiflora 10 parts; Citrus reticulata Blanco 8 parts; Pueraria lobata 5 parts.

[0012] Preferably, the traditional Chinese medicine raw materials further include Imperata cylindrica and Gentiana macrophylla.

[0013] In further research, the inventor found that in traditional Chinese medicine raw materials such as Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata, and Pueraria lobata, the addition of Imperata cylindrica and Gentiana macrophylla to prepare a traditional Chinese medicine composition significantly improved its uric acid-lowering effect compared to the traditional Chinese medicine composition prepared from Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata, and Pueraria lobata as raw materials.

[0014] Preferably, the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials in parts by weight:

[0015] Smilax glabra 10 - 15 parts; Cichorium intybus 10 - 15 parts; Paeonia lactiflora 8 - 12 parts; Citrus reticulata 5 - 10 parts; Pueraria lobata 3 - 6 parts; Imperata cylindrica 5 - 10 parts; Gentiana macrophylla 3 - 6 parts.

[0016] Most preferably, the traditional Chinese medicine composition is made from the following traditional Chinese medicine raw materials in parts by weight:

[0017] Smilax glabra 12 parts; Cichorium intybus 12 parts; Paeonia lactiflora 10 parts; Citrus reticulata 8 parts; Pueraria lobata 5 parts; Imperata cylindrica 8 parts; Gentiana macrophylla 5 parts.

[0018] The present invention also provides a preparation method of the above traditional Chinese medicine composition, which comprises the following steps:

[0019] Mix the traditional Chinese medicine raw materials and then crush them, followed by extraction with a solvent. After the extraction is completed, separate the extract, concentrate and dry the extract to obtain a traditional Chinese medicine solvent extract; take the traditional Chinese medicine solvent extract to obtain the traditional Chinese medicine composition.

[0020] Preferably, the solvent is an ethanol aqueous solution with a volume fraction of 30 - 60%.

[0021] Most preferably, the solvent is an ethanol aqueous solution with a volume fraction of 50%.

[0022] Preferably, the dosage ratio of the traditional Chinese medicine raw materials to the solvent is 1 kg: 8 - 15 L.

[0023] Most preferably, the dosage ratio of the traditional Chinese medicine raw materials to the solvent is 1 kg: 10 L.

[0024] Preferably, the extraction is heating reflux extraction, and the extraction time is 1.5 - 3 h.

[0025] Preferably, the preparation method of the traditional Chinese medicine composition further comprises the following steps: Take the traditional Chinese medicine solvent extract and load it onto a macroporous resin column. First, elute and remove impurities with an ethanol aqueous solution with a volume fraction of 6 - 9%; then elute with an ethanol aqueous solution with a volume fraction of 21 - 24%, collect the eluate eluted by the ethanol aqueous solution with a volume fraction of 21 - 24%, and concentrate and dry it to obtain the traditional Chinese medicine composition.

[0026] Most preferably, the preparation method of the traditional Chinese medicine composition further comprises the following steps: taking the extract of the traditional Chinese medicine in a solvent and subjecting it to a macroporous resin column, first eluting and removing impurities with an aqueous ethanol solution with a volume fraction of 8%; then eluting with an aqueous ethanol solution with a volume fraction of 23%, collecting the eluate eluted by the aqueous ethanol solution with a volume fraction of 23%, and concentrating and drying to obtain the traditional Chinese medicine composition.

[0027] In further research, the inventors found that the preparation method of the traditional Chinese medicine composition is very crucial; the traditional Chinese medicine composition prepared by further eluting the extract of the traditional Chinese medicine in a solvent under the elution conditions of the macroporous resin column of the present invention has a much higher uric acid-lowering effect than the extract of the traditional Chinese medicine in a solvent prepared without the elution conditions of the macroporous column of the present invention.

[0028] Here, the inventors need to explain that the elution conditions of the macroporous resin column of the present invention are very crucial; only when the extract of the traditional Chinese medicine in a solvent is further prepared into a traditional Chinese medicine composition through the elution conditions of the macroporous resin column of the present invention, can its uric acid-lowering effect be further significantly improved compared with the extract of the traditional Chinese medicine in a solvent prepared without the elution conditions of the macroporous column of the present invention; while the traditional Chinese medicine composition prepared by other elution conditions of the macroporous resin column cannot be further significantly improved in its uric acid-lowering effect compared with the extract of the traditional Chinese medicine in a solvent prepared without the elution conditions of the macroporous column of the present invention.

[0029] The present invention also provides an application of the above traditional Chinese medicine composition in the preparation of a drug having a uric acid-lowering effect.

[0030] The present invention also provides an application of the above traditional Chinese medicine composition in the preparation of a drug having a therapeutic and / or prophylactic effect on gout.

[0031] Beneficial effects: The present invention provides a novel traditional Chinese medicine composition prepared from Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata Blanco and Pueraria lobata as raw materials; research shows that the traditional Chinese medicine composition has a uric acid-lowering effect. Therefore, further using the traditional Chinese medicine composition of the present invention as an active ingredient in the preparation of a drug having a therapeutic and / or prophylactic effect on gout has important application value. Detailed implementation manners

[0032] The following combines specific embodiments to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present invention.

[0033] Example 1 Preparation of the traditional Chinese medicine composition

[0034] The weight parts composition of the traditional Chinese medicine: 12 parts of Smilax glabra Roxb.; 12 parts of Cichorium intybus L.; 10 parts of Paeonia lactiflora Pall.; 8 parts of Citrus reticulata Blanco; 5 parts of Pueraria lobata (Willd.) Ohwi.

[0035] Preparation method: Mix the traditional Chinese medicine raw materials in the above weight parts, crush them and pass through an 80-mesh sieve, then heat with a solvent to 78 °C for reflux extraction for 2 h. After the extraction is completed, separate the extract, concentrate and dry the extract to obtain the traditional Chinese medicine solvent extract; wherein, the solvent is an ethanol aqueous solution with a volume fraction of 50%; the ratio of the total weight of the traditional Chinese medicine raw materials to the amount of the solvent used is 1 kg: 10 L;

[0036] Take the obtained traditional Chinese medicine solvent extract to obtain the traditional Chinese medicine composition.

[0037] Example 2 Preparation of the traditional Chinese medicine composition

[0038] The weight parts composition of the traditional Chinese medicine: 12 parts of Smilax glabra Roxb.; 12 parts of Cichorium intybus L.; 10 parts of Paeonia lactiflora Pall.; 8 parts of Citrus reticulata Blanco; 5 parts of Pueraria lobata (Willd.) Ohwi.; 8 parts of Imperata cylindrica Beauv.; 5 parts of Gentiana macrophylla Pall.

[0039] Preparation method: Mix the traditional Chinese medicine raw materials in the above weight parts, crush them and pass through an 80-mesh sieve, then heat with a solvent to 78 °C for reflux extraction for 2 h. After the extraction is completed, separate the extract, concentrate and dry the extract to obtain the traditional Chinese medicine solvent extract; wherein, the solvent is an ethanol aqueous solution with a volume fraction of 50%; the ratio of the total weight of the traditional Chinese medicine raw materials to the amount of the solvent used is 1 kg: 10 L;

[0040] Take the obtained traditional Chinese medicine solvent extract to obtain the traditional Chinese medicine composition.

[0041] Example 3 Preparation of the traditional Chinese medicine composition

[0042] The weight parts composition of the traditional Chinese medicine: 12 parts of Smilax glabra Roxb.; 12 parts of Cichorium intybus L.; 10 parts of Paeonia lactiflora Pall.; 8 parts of Citrus reticulata Blanco; 5 parts of Pueraria lobata (Willd.) Ohwi.; 8 parts of Imperata cylindrica Beauv.; 5 parts of Gentiana macrophylla Pall.

[0043] Preparation method:

[0044] (1) Mix the traditional Chinese medicine raw materials in the above weight parts, crush them and pass through an 80-mesh sieve, then heat with a solvent to 78 °C for reflux extraction for 2 h. After the extraction is completed, separate the extract, concentrate and dry the extract to obtain the traditional Chinese medicine solvent extract; the solvent is an ethanol aqueous solution with a volume fraction of 50%; the ratio of the total weight of the traditional Chinese medicine raw materials to the amount of the solvent used is 1 kg: 10 L.

[0045] (2) Load the traditional Chinese medicine solvent extract onto a D101 macroporous resin column, first elute and remove impurities with 5 column volumes of an ethanol aqueous solution with a volume fraction of 8%; then elute with 5 column volumes of an ethanol aqueous solution with a volume fraction of 23%, collect the eluate eluted by the ethanol aqueous solution with a volume fraction of 23%, and concentrate and dry it to obtain the traditional Chinese medicine composition.

[0046] Comparative Example 1 Preparation of Traditional Chinese Medicine Composition

[0047] The weight parts of traditional Chinese medicine components: 12 parts of Smilax glabra Roxb.; 12 parts of Cichorium intybus L.; 10 parts of Paeonia lactiflora Pall.; 8 parts of Citrus reticulata Blanco; 5 parts of Pueraria lobata (Willd.) Ohwi; 8 parts of Imperata cylindrica Beauv..

[0048] Preparation method: the same as that of Example 2

[0049] The difference between Comparative Example 1 and Example 2 is that in Comparative Example 1, Imperata cylindrica Beauv. is further added only to traditional Chinese medicine raw materials such as Smilax glabra Roxb., Cichorium intybus L., Paeonia lactiflora Pall., Citrus reticulata Blanco and Pueraria lobata (Willd.) Ohwi. While in Example 2, Imperata cylindrica Beauv. and Gentiana macrophylla Pall. are further added to traditional Chinese medicine raw materials such as Smilax glabra Roxb., Cichorium intybus L., Paeonia lactiflora Pall., Citrus reticulata Blanco and Pueraria lobata (Willd.) Ohwi.

[0050] Comparative Example 2 Preparation of Traditional Chinese Medicine Composition

[0051] The weight parts of traditional Chinese medicine components: 12 parts of Smilax glabra Roxb.; 12 parts of Cichorium intybus L.; 10 parts of Paeonia lactiflora Pall.; 8 parts of Citrus reticulata Blanco; 5 parts of Pueraria lobata (Willd.) Ohwi; 5 parts of Gentiana macrophylla Pall..

[0052] Preparation method: the same as that of Example 2

[0053] The difference between Comparative Example 2 and Example 2 is that in Comparative Example 2, Gentiana macrophylla Pall. is further added only to traditional Chinese medicine raw materials such as Smilax glabra Roxb., Cichorium intybus L., Paeonia lactiflora Pall., Citrus reticulata Blanco and Pueraria lobata (Willd.) Ohwi. While in Example 2, Imperata cylindrica Beauv. and Gentiana macrophylla Pall. are further added to traditional Chinese medicine raw materials such as Smilax glabra Roxb., Cichorium intybus L., Paeonia lactiflora Pall., Citrus reticulata Blanco and Pueraria lobata (Willd.) Ohwi.

[0054] Comparative Example 3 Preparation of Traditional Chinese Medicine Composition

[0055] The weight parts of traditional Chinese medicine components: 12 parts of Smilax glabra Roxb.; 12 parts of Cichorium intybus L.; 10 parts of Paeonia lactiflora Pall.; 8 parts of Citrus reticulata Blanco; 5 parts of Pueraria lobata (Willd.) Ohwi; 8 parts of Imperata cylindrica Beauv.; 5 parts of Gentiana macrophylla Pall..

[0056] Preparation method:

[0057] (1) Take the above-mentioned weight parts of traditional Chinese medicine raw materials, mix and pulverize them through an 80-mesh sieve, then heat them with a solvent to 78 °C and reflux for 2 h. After the extraction is completed, separate the extract, and concentrate and dry the extract to obtain a traditional Chinese medicine solvent extract; the solvent is an ethanol aqueous solution with a volume fraction of 50%; the ratio of the total weight of the traditional Chinese medicine raw materials to the amount of the solvent used is 1 kg:10 L.

[0058] (2) Take the traditional Chinese medicine solvent extract and load it onto a D101 macroporous resin column. First, elute and remove impurities with an ethanol aqueous solution with a volume fraction of 15% for 5 times the column volume; then elute with an ethanol aqueous solution with a volume fraction of 30% for 5 times the column volume, collect the eluate eluted by the ethanol aqueous solution with a volume fraction of 30%, and concentrate and dry it to obtain the traditional Chinese medicine composition.

[0059] The difference between Comparative Example 3 and Example 3 lies in the different elution conditions of the macroporous resin column.

[0060] Preparation of the Traditional Chinese Medicine Composition in Comparative Example 4

[0061] The composition of the traditional Chinese medicine in parts by weight: 12 parts of Smilax glabra Roxb.; 12 parts of Cichorium intybus L.; 10 parts of Paeonia lactiflora Pall.; 8 parts of Citrus reticulata Blanco; 5 parts of Pueraria lobata (Willd.) Ohwi; 8 parts of Imperata cylindrica Beauv.; 5 parts of Gentiana macrophylla Pall.

[0062] Preparation method:

[0063] (1) Take the above-mentioned traditional Chinese medicine raw materials in parts by weight, mix and pulverize them through an 80-mesh sieve, then heat them with a solvent to 78 °C and reflux for 2 h. After the extraction is completed, separate the extract, concentrate and dry the extract to obtain the traditional Chinese medicine solvent extract; the solvent is an ethanol aqueous solution with a volume fraction of 50%; the ratio of the total weight of the traditional Chinese medicine raw materials to the amount of the solvent used is 1 kg: 10 L.

[0064] (2) Take the traditional Chinese medicine solvent extract and load it onto a D101 macroporous resin column. First, elute and remove impurities with an ethanol aqueous solution with a volume fraction of 30% at 5 times the column volume; then elute with an ethanol aqueous solution with a volume fraction of 60% at 5 times the column volume, collect the eluate eluted by the ethanol aqueous solution with a volume fraction of 60%, and concentrate and dry it to obtain the traditional Chinese medicine composition.

[0065] The difference between Comparative Example 4 and Example 3 lies in the different elution conditions of the macroporous resin column.

[0066] Experimental Example 1 Uric Acid Lowering Experiment

[0067] Select Balb / c mice with a body weight of 25 ± 2 g, randomly divide them into 9 groups, with 12 mice in each group, namely the normal control group, the model group and experimental groups 1-7; among them, in experimental groups 1-7, the traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-4 are respectively intragastrically administered to the mice at a dose of 100 mg / kg per day; the traditional Chinese medicine composition is suspended with normal saline; the normal control group and the model group are intragastrically administered an equal amount of normal saline every day; continuously intragastrically administer for 7 days; after intragastric administration on the 7th day, in experimental groups 1-7 and the model group, the mice are respectively intraperitoneally injected with potassium oxonate (dose: 500 mg / kg). One hour after the injection of potassium oxonate, blood is taken from the veins of each group of mice, and the uric acid (UA) content of each group of mice is detected; the experimental results are shown in Table 1.

[0068] Table 1. Experimental Results of Uric Acid Lowering by the Traditional Chinese Medicine Composition of the Invention

[0069]

[0070] It can be seen from the experimental results in Table 1 that the UA content of the mice in the model group is much higher than that in the normal control group; this indicates that the hyperuricemia mouse model is successfully constructed.

[0071] As can be seen from the experimental results in Table 1, the UA content of the mice in Experimental Group 1 was significantly lower than that in the model group; this indicates that: the novel traditional Chinese medicine composition prepared from Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata, and Pueraria lobata as raw materials has the effect of reducing uric acid.

[0072] As can be seen from the experimental results in Table 1, the UA content of the mice in Experimental Group 2 was further significantly lower than that in Experimental Group 1; this indicates that: among the traditional Chinese medicine raw materials such as Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata, and Pueraria lobata, the traditional Chinese medicine composition prepared by further adding Imperata cylindrica and Gentiana macrophylla has a significantly improved uric acid reducing effect compared with the traditional Chinese medicine composition prepared from Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata, and Pueraria lobata as raw materials.

[0073] As can be seen from the experimental results in Table 1, compared with Experimental Group 1, the UA content of the mice in Experimental Groups 4 and 5 decreased, but not significantly; this indicates that: among the traditional Chinese medicine raw materials such as Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata, and Pueraria lobata, the traditional Chinese medicine composition prepared by further adding Imperata cylindrica and Gentiana macrophylla simultaneously can significantly improve its uric acid reducing effect compared with the traditional Chinese medicine composition prepared from Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata, and Pueraria lobata as raw materials; the traditional Chinese medicine composition prepared by adding only Imperata cylindrica or only Gentiana macrophylla cannot significantly improve its uric acid reducing effect compared with the traditional Chinese medicine composition prepared from Smilax glabra, Cichorium intybus, Paeonia lactiflora, Citrus reticulata, and Pueraria lobata as raw materials.

[0074] As can be seen from the experimental results in Table 1, the UA content of the mice in Experimental Group 3 was further significantly lower than that in Experimental Group 2; this indicates that: the preparation method of the traditional Chinese medicine composition is very crucial; based on the above-mentioned traditional Chinese medicine solvent extract, the traditional Chinese medicine composition prepared by further eluting with the macroporous resin column under the conditions of the present invention has a further significantly higher uric acid reducing effect than the traditional Chinese medicine solvent extract not prepared by the macroporous column elution conditions of the present invention; thus, the prepared traditional Chinese medicine composition has an excellent uric acid reducing effect.

[0075] As can be seen from the experimental results in Table 1, the UA content of the mice in Experimental Group 6 decreased compared with that in Experimental Group 2, but the decrease was not significant; the UA content of the mice in Experimental Group 7 increased instead of decreasing compared with that in Experimental Group 2. This shows that: the elution conditions of the macroporous resin column of the present invention are very crucial; only the traditional Chinese medicine composition prepared by further eluting the traditional Chinese medicine solvent extract through the elution conditions of the macroporous resin column of the present invention can significantly improve its uric acid-lowering effect compared with the traditional Chinese medicine solvent extract not prepared by the elution conditions of the macroporous resin column of the present invention; while the traditional Chinese medicine composition prepared by other elution conditions of the macroporous resin column cannot significantly improve its uric acid-lowering effect compared with the traditional Chinese medicine solvent extract not prepared by the elution conditions of the macroporous resin column of the present invention.

[0076] For those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and the present invention can be implemented in other specific forms without departing from the spirit or basic characteristics of the present invention. Therefore, from any point of view, the embodiments should be regarded as exemplary and non-limiting. The scope of the present invention is defined by the appended claims rather than the above description. Therefore, all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present invention.

[0077] In addition, it should be understood that although this specification is described according to embodiments, not every embodiment only contains an independent technical solution. This narrative way of the specification is only for clarity. Those skilled in the art should regard the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A traditional Chinese medicine composition, characterized in that, It is made from the following Chinese herbal medicine raw materials in parts by weight: Smilax glabra Roxb. 10 - 15 parts; Cichorium intybus L. 10 - 15 parts; Paeonia lactiflora Pall. 8 - 12 parts; Pericarpium Citri Reticulatae 5 - 10 parts; Pueraria lobata (Willd.) Ohwi 3 - 6 parts; Imperata cylindrica Beauv. 5 - 10 parts; Gentiana macrophylla Pall. 3 - 6 parts.

2. The traditional Chinese medicine composition according to claim 1, wherein It is made from the following Chinese herbal medicine raw materials in parts by weight: Smilax glabra Roxb. 12 parts; Cichorium intybus L. 12 parts; Paeonia lactiflora Pall. 10 parts; Pericarpium Citri Reticulatae 8 parts; Pueraria lobata (Willd.) Ohwi 5 parts; Imperata cylindrica Beauv. 8 parts; Gentiana macrophylla Pall. 5 parts.

3. The preparation method of the traditional Chinese medicine composition according to any one of claims 1 to 2, characterized in that, It comprises the following steps: Take the Chinese herbal medicine raw materials, mix and pulverize them, then extract with a solvent. After the extraction is completed, separate the extract, and concentrate and dry the extract to obtain a Chinese herbal medicine solvent extract; Take the Chinese herbal medicine solvent extract to obtain the said Chinese herbal medicine composition.

4. The preparation method of the traditional Chinese medicine composition according to claim 3, characterized in that, The said solvent is an ethanol aqueous solution with a volume fraction of 30 - 60%.

5. Use of the Chinese herbal medicine composition according to any one of claims 1 - 2 in the preparation of a drug having the effect of reducing uric acid.

6. Use of the Chinese herbal medicine composition according to any one of claims 1 - 2 in the preparation of a drug having the effect of treating and / or preventing gout.

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