Lipid-lowering and liver-protecting Tibetan medicine composition as well as preparation method and application thereof

Abstract

The invention provides a Tibetan medicine composition for lowering lipid and protecting liver. The Tibetan medicine composition is prepared from the following components in parts by weight: 9-16 parts of fried dracocephalum tanguticum, 6-10 parts of fructus cassiae fistulae and 3-8 parts of calyx. The invention also provides a preparation method and application thereof. Compared with the prior art, the Tibetan medicine composition has the advantages that three Tibetan medicines with the effect of clearing liver heat are screened according to the symptom relation between liver heat and liver diseases and in combination with the basis of early-stage research and are subjected to formula compatibility, the Tibetan medicine composition for lowering lipid and protecting liver is further provided, and by multi-angle research on the preparation process and pharmacodynamics of the Tibetan medicine composition, the effect of lowering lipid and protecting liver is achieved. It is verified that the composition can significantly adjust abnormal liver functions and blood lipid indexes in serum of metabolism-related fatty liver model rats and improve pathological changes such as fatty degeneration and inflammation of liver tissue.

Description

Technical Field

[0001] The present application relates to the technical field of pharmaceutical compositions, and in particular to a lipid-lowering and liver-protecting Tibetan medicine composition and a preparation method and application thereof. Background Art

[0002] With the development of economy and the improvement of people's living standards, various types of liver diseases (especially metabolic liver diseases) are on the rise year by year, with the characteristics of widespread incidence and high mortality rate; hyperlipidemia is also a common and frequent metabolic disease, an important risk factor for cardiovascular and cerebrovascular diseases, common in middle-aged and elderly people; both seriously affect the health of the global population. At present, there is a shortage of relevant preventive and therapeutic drugs, mainly hormones and immunosuppressants. Although they can alleviate the symptoms of the disease to a certain extent, they have the defects of strong dependence and large side effects. Tibetan medicine is welcomed by patients for its unique compatibility and unique efficacy, but Tibetan medicine for lipid-lowering and liver protection is not included in the Chinese pharmacopoeia and there is no marketed variety. Summary of the invention

[0003] In view of the above-mentioned technical limitations, the present application proposes a lipid-lowering and liver-protecting Tibetan medicine composition and its preparation method and application; it overcomes the deficiencies and defects mentioned in the background technology.

[0004] To achieve the above objectives, this application adopts the following technical solutions: The invention of the present application is to provide a lipid-lowering and liver-protecting Tibetan medicine composition, which is prepared from the following components in parts by weight: 9-16 parts of stir-fried Ganqinglan, 6-10 parts of sausage fruit, and 3-8 parts of Luodi.

[0005] Optionally, in the above-mentioned Tibetan medicine composition, the weight ratio of the stir-fried Ganqinglan, sausage fruit and lotus root is 5:3:2 (15 parts, 9 parts, 6 parts).

[0006] The second invention of the present application is to provide a method for preparing a Tibetan medicine composition, comprising the following steps: S1. Take the stir-fried Ganqinglan in a formula amount, add sodium hydroxide to shake and extract, filter, take the supernatant, adjust the pH to neutral; add ethanol to precipitate, let stand and then centrifuge to obtain the precipitate, and freeze-dry to obtain the stir-fried Ganqinglan extract; S2, respectively taking the formula amount of sausage fruit and rhubarb, adding distilled water to decoct and extract, filtering, and concentrating the filtrate to obtain a sausage fruit-rhubarb mixed extract; S3, mixing the stir-fried Ganqinglan extract obtained in step S1 and the sausage fruit-lotus mixed extract obtained in step S2 evenly to obtain the Tibetan medicine composition.

[0007] Optionally, in the above-mentioned preparation method, in step S1, the preparation method of stir-fried Ganqinglan is: take raw Ganqinglan, cut into sections, and stir-fry over low heat; the stir-frying is divided into two stages, the first stage adopts the method of stir-frying and pressing, and takes out the leaves after they are stir-fried until they are slightly yellow, and the second stage stir-fryes the stems until they are yellow, fragrant, and have a crisp sound when broken, and then mixes them with the leaves after taking them out to dissipate heat to obtain the stir-fried Ganqinglan.

[0008] Optionally, in the above-mentioned preparation method, in step S1, the concentration of sodium hydroxide is 5-7%, the extraction is shaken twice, the shaking temperature is 68-72°C, the solid-liquid ratio of stir-fried Ganqinglan and sodium hydroxide is 1: (14-16) g / ml; acetic acid is used to adjust the pH value; the final concentration of alcohol precipitation is 78-82%; the standing time of alcohol precipitation is 12-18h; the centrifugal speed is 3000-4000rpm, and the centrifugal time is 4-6min.

[0009] Optionally, in the above preparation method, in step S2, the solid-liquid ratio of the sausage fruit-loti extracted by decoction with distilled water to water is 1: (14-16) g / ml, the number of extractions is 2-3 times, and the extraction time is 55-65 min.

[0010] The third invention point of the present application is to provide the use of the Tibetan medicine composition or the Tibetan medicine composition prepared by the preparation method in the preparation of lipid-lowering and liver-protecting preparations.

[0011] The fourth invention point of the present application is to provide a lipid-lowering and liver-protecting preparation, comprising the Tibetan medicine composition or the Tibetan medicine composition prepared by the preparation method and pharmaceutically acceptable excipients.

[0012] Optionally, the above-mentioned preparation has a dosage form including oral solution, tablet, pill, capsule, granule, powder, injection or suspension.

[0013] The dosage of this lipid-lowering and liver-protecting preparation is: oral, 10 mL at a time, twice a day.

[0014] Ganqinglan is the main drug, which can clear liver heat. Because of its bitter and heavy taste, it can hurt the vitality, so it is fried and harmonized; sausage fruit is a good medicine for purging liver toxins, which can purge heat and attack the lower part, soothe the liver and protect the liver, and is the assistant drug; Luodi is sweet and bitter, and tastes sweet after digestion, which can clear liver fire and promote blood circulation, and is also an adjuvant. The three drugs are combined, the bitter taste is sweet, and they mainly enter the liver, playing the role of "clearing liver heat, purging blood toxins, regulating the three factors, and harmonizing qi and blood".

[0015] Compared with the prior art, this application has the following advantages: Based on the relationship between "liver heat" and liver disease, and combined with previous research foundations, this application screened out three Tibetan medicines with the effect of "clearing liver heat" and formulated them into a prescription, and then proposed a Tibetan medicine composition for lowering blood lipids and protecting the liver. Through multi-angle research on its preparation process and pharmacodynamics, it was verified that this composition can significantly adjust the abnormal liver function and blood lipid indicators in the serum of metabolic liver disease model rats, and improve pathological changes such as fatty degeneration and inflammation of liver tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 The results of serum biochemical index detection in the blank group, model group and drug-treated group in one embodiment of the present application are shown (compared with the blank group, *P<0.05, **P<0.01; compared with the model group, # P<0.05, ## P<0.01).

[0017] Figure 2 Shown is a graph of liver tissue pathology observation results of the blank group, model group and drug-treated group in one embodiment of the present application.

[0018] Figure 3 The figure shows the comparison results of serum biochemical indexes of rats in the blank group, model group, drug combination group, and drug single group in one embodiment of the present application (compared with the blank group, *P<0.05, **P<0.01; compared with the model group, # P<0.05, ## P<0.01). DETAILED DESCRIPTION

[0019] In order to make the purpose, technical solution and advantages of the present application more clear, the present application is further described in detail below. However, it should be understood that the description here is only used to explain the present application and is not used to limit the scope of the present application.

[0020] Unless otherwise defined, all technical terms and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present application, and the terms used herein in the specification of the present application are only for the purpose of describing specific embodiments and are not intended to limit the present application. The reagents and instruments used herein are all commercially available, and the characterization means involved can refer to the relevant descriptions in the prior art, which will not be repeated herein.

[0021] In order to further understand the present application, the present application is further described in detail below in conjunction with the best embodiment.

[0022] Ganqingqinglan is included in the "Drug Standard of the Ministry of Health of the People's Republic of China" (WS3-BC-0023-95). It comes from the dried aerial parts of Dracocephalum tanguticum Maxim. of the Lamiaceae plant, after impurities are removed and dried in the shade.

[0023] Sausage fruit is included in the "Drug Standard of the Ministry of Health of the People's Republic of China" (WS3-BC-0109-95). It comes from the dried mature fruit of the leguminous plant Cassia fistula L., which is dried in the sun.

[0024] Lloydia serotina (listed in the Quality Standards of Local Medicinal Materials of the Tibet Autonomous Region Food and Drug Administration, XZ-BC-0086-2012) is derived from the dried aerial parts of the Liliaceae plant Lloydia serotina (L.) Reichb., after removing impurities and air-drying.

[0025] Example 1 The Tibetan medicine composition for reducing blood lipid and protecting liver is prepared from the following components: 9g of stir-fried sweet potato, 6g of sausage fruit and 3g of lodi.

[0026] The preparation method of the Tibetan medicine composition comprises the following steps: S1. Take the stir-fried Ganqinglan in a certain amount, add sodium hydroxide to shake and extract, filter, take the supernatant, adjust the pH to neutral; add ethanol to precipitate, let stand and then centrifuge to obtain the precipitate, freeze-dry to obtain the stir-fried Ganqinglan extract; the concentration of sodium hydroxide is 5%, shake extraction is performed twice, the shaking temperature is 68°C, and the material-liquid ratio of stir-fried Ganqinglan to sodium hydroxide is 1:14g / ml; acetic acid is used to adjust the pH value; the final concentration of alcohol precipitation is 78%; the standing time is 14h; the centrifugal speed is 3000rpm, and the centrifugal time is 4min; the preparation method of stir-fried Ganqinglan is: take the raw Ganqinglan, cut it into sections, heat the container over medium heat, and stir-fry it over low heat; the stir-frying is divided into two stages, the first stage adopts the method of stir-frying and pressing, and the leaves are taken out after being stir-fried until they are slightly yellow, and the second stage is to stir-fry the stems until they are yellow, fragrant, and crisp when broken, and then mix them with the leaves after taking them out to dissipate heat, so as to obtain the stir-fried Ganqinglan; S2, respectively taking the formula amount of sausage fruit and rhubarb, adding distilled water to decoct and extract, filtering, and concentrating the filtrate to obtain a sausage fruit-rhubarb mixed extract; the solid-liquid ratio of sausage fruit-rhubarb extracted by decoction with distilled water to water is 1:14 g / ml, the number of extractions is 2, and the extraction time is 55 min; S3, mixing the stir-fried Ganqinglan extract obtained in step S1 and the sausage fruit-lotus mixed extract obtained in step S2 evenly to obtain the Tibetan medicine composition.

[0027] The Tibetan medicine composition or the Tibetan medicine composition prepared according to the preparation method can be used to prepare lipid-lowering and liver-protecting preparations.

[0028] The lipid-lowering and liver-protecting preparation comprises a Tibetan medicine composition or a Tibetan medicine composition prepared by the preparation method and pharmaceutically acceptable auxiliary materials.

[0029] The dosage forms of the preparation include oral solution, tablet, pill, capsule, granule, powder, injection or suspension.

[0030] Example 2 The Tibetan medicine composition for reducing blood lipid and protecting liver is prepared from the following components: 16g of stir-fried sweet potato, 10g of sausage fruit and 8g of lodi.

[0031] The preparation method of the Tibetan medicine composition comprises the following steps: S1. Take the stir-fried Ganqinglan in a certain amount, add sodium hydroxide to shake and extract, filter, take the supernatant, adjust the pH to neutral; add ethanol to precipitate, let stand and then centrifuge to obtain the precipitate, freeze-dry to obtain the stir-fried Ganqinglan extract; the concentration of sodium hydroxide is 6%, shake extraction is performed twice, the shaking temperature is 72°C, and the material-liquid ratio of stir-fried Ganqinglan to sodium hydroxide is 1:16 g / ml; acetic acid is used to adjust the pH value; the final concentration of alcohol precipitation is 82%; the alcohol precipitation is allowed to stand for 18h; the centrifugal speed is 4000rpm, and the centrifugal time is 6min; the preparation method of stir-fried Ganqinglan is: take the raw Ganqinglan, cut it into sections, and stir-fry it over low heat; the stir-frying is divided into two stages, the first stage adopts the method of stir-frying and pressing, and the leaves are taken out after being stir-fried until they are slightly yellow, and the second stage stir-fryes the stems until they are yellow, fragrant, and have a crisp sound when broken, and then mixes with the leaves after taking them out to dissipate heat, thus obtaining the stir-fried Ganqinglan; S2, respectively taking the formula amount of sausage fruit and rhubarb, adding distilled water to decoct and extract, filtering, and concentrating the filtrate to obtain a sausage fruit-rhubarb mixed extract; the solid-liquid ratio of sausage fruit-rhubarb extracted by decoction with distilled water to water is 1:16 g / ml, the number of extractions is 3, and the extraction time is 65 min; S3, mixing the stir-fried Ganqinglan extract obtained in step S1 and the sausage fruit-lotus mixed extract obtained in step S2 evenly to obtain the Tibetan medicine composition.

[0032] Example 3 The Tibetan medicine composition for reducing blood lipid and protecting liver is prepared from the following components: 15g of stir-fried sweet potato, 9g of sausage fruit and 6g of lodi.

[0033] The preparation method of the Tibetan medicine composition comprises the following steps: S1. Take the stir-fried Ganqinglan in the formula amount, add sodium hydroxide to shake and extract, filter, take the supernatant, adjust the pH to neutral; add ethanol to precipitate, let stand and then centrifuge to obtain the precipitate, freeze-dry to obtain the stir-fried Ganqinglan extract; the concentration of sodium hydroxide is 7%, shake and extract twice, the shaking temperature is 70°C, and the material-liquid ratio of stir-fried Ganqinglan to sodium hydroxide is 1:15 g / ml; acetic acid is used to adjust the pH value; the final concentration of alcohol precipitation is 80%; the standing time is 12h; the centrifugal speed is 3500rpm, and the centrifugal time is 5min; the preparation method of stir-fried Gan Qinglan is: take the raw Gan Qinglan, cut it into sections, and stir-fry it with slow fire; the stir-frying is divided into two stages, the first stage adopts the method of stir-frying and pressing, and the leaves are taken out after being stir-fried until they are slightly yellow, and the second stage stir-fryes the stems until they are yellow, have fragrance, and have a crisp sound when broken, and then mix them with the leaves after taking them out, and dissipate heat to obtain the stir-fried Gan Qinglan; the power range of medium fire is: 600-1000W; the power range of slow fire is: 100-200W; S2, respectively taking the formula amount of sausage fruit and rhubarb, adding distilled water to decoct and extract, filtering, and concentrating the filtrate to obtain a sausage fruit-rhubarb mixed extract; the solid-liquid ratio of sausage fruit-rhubarb extracted by decoction with distilled water to water is 1:15 g / ml, the number of extractions is 2, and the extraction time is 60min; S3, mixing the stir-fried Ganqinglan extract obtained in step S1 and the sausage fruit-lotus mixed extract obtained in step S2 evenly to obtain the Tibetan medicine composition.

[0034] Example 4 Evaluation of lipid-lowering and liver-protecting effects: Establishment of metabolic-related fatty liver rat model: Sixty SPF SD male rats were randomly divided into a blank group, a model group, a combination group (administered with the Tibetan medicine combination prepared according to the ratio and method of Example 3) and each single drug group (the single drug was three drugs in the combination with the same total amount of drugs and the same preparation method as in Example 3) according to body weight after adaptive feeding for 1 week, with 10 rats in each group.

[0035] The rats in the blank group were fed with ordinary feed, and the rats in the model group and the drug group were fed with MCD (methionine choline deficient feed) for 8 consecutive weeks. At the same time, the rats in the drug group were given each drug by gavage (ig) (the dosage was 3.125g / kg in terms of crude drug), and the dosage was calculated according to the original crude drug amount of the combination (30g), the amount of medicinal materials in each formula (30g) and the equivalent amount of rat and human surface area; the blank group and the model group were given the same volume of distilled water ig.

[0036] The lipid-lowering and liver-protecting effects of the Tibetan medicine composition were evaluated by detecting the levels of serum liver injury indicators (AST, ALT, ADH) and blood lipid indicators (TC, TG, HDL-C, LDL-C) combined with pathological observation of liver tissue.

[0037] Depend on Figure 1 The results showed that compared with the model group, drug intervention could adjust the abnormalities of various biochemical indicators in serum to varying degrees; Figure 2 The results showed that the drug-treated group could significantly improve the pathological damage of liver tissue (manifested as structural disorder, lipid accumulation and inflammatory response).

[0038] In order to prove the compatibility effect of each drug in the present application, a comparative experiment on the efficacy of each prescription and formula on a metabolic-related fatty liver rat model was also conducted, wherein the dosage of each prescription was 30g. Figure 3 As shown, the medicinal materials in each prescription can adjust the abnormalities of various biochemical indicators in serum to varying degrees; especially the drug combination group is better than the group using each drug alone, and the difference in indicators is significant.

[0039] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present application should be included in the protection scope of the present application.

Claims

1. A lipid-lowering and liver-protecting Tibetan medicine composition, characterized in that: The invention is prepared from the following components in parts by weight: 9-16 parts of stir-fried sweet and sour green orchid, 6-10 parts of sausage fruit and 3-8 parts of lodi.

2. The Tibetan medicine composition according to claim 1, characterized in that: The weight ratio of the stir-fried sweet potato, sausage fruit and loli is 5:3:

2.

3. The method for preparing the Tibetan medicine composition according to claim 1 or 2, characterized in that: The following steps are involved: S1. Take the stir-fried Ganqinglan in the formula amount, add sodium hydroxide to shake and extract, filter, take the supernatant, and adjust the pH to neutral; Add ethanol to precipitate, let stand and then centrifuge to obtain the precipitate, and freeze-dry to obtain the stir-fried Ganqinglan extract; S2, respectively taking the formula amount of sausage fruit and rhubarb, adding distilled water to decoct and extract, filtering, and concentrating the filtrate to obtain a sausage fruit-rhubarb mixed extract; S3, mixing the stir-fried Ganqinglan extract obtained in step S1 and the sausage fruit-lotus mixed extract obtained in step S2 evenly to obtain the Tibetan medicine composition.

4. The preparation method according to claim 3, characterized in that: In the step S1, the preparation method of stir-fried Gan Qinglan is: take raw Gan Qinglan, cut into sections, and stir-fry over low heat; the stir-frying is divided into two stages, the first stage adopts the method of stir-frying and pressing, and takes out the leaves after they are stir-fried until they are slightly yellow, and the second stage stir-fryes the stems until they are yellow, fragrant, and have a crisp sound when broken, and then mixes them with the leaves after taking them out and dissipates heat to obtain the stir-fried Gan Qinglan.

5. The preparation method according to claim 3, characterized in that: In the step S1, the concentration of sodium hydroxide is 5-7%, the extraction is performed by shaking for 2 times, the shaking temperature is 68-72°C, the material-liquid ratio of stir-fried Ganqinglan and sodium hydroxide is 1:(14-16); acetic acid is used to adjust the pH value; the final concentration of alcohol precipitation is 78-82%; the standing time of alcohol precipitation is 12-18h; the centrifugal speed is 3000-4000rpm, and the centrifugal time is 4-6min.

6. The preparation method according to claim 3, characterized in that: In the step S2, the solid-liquid ratio of the sausage fruit-loti extracted by decoction with distilled water to water is 1:(14-16), the number of extractions is 2-3 times, and the extraction time is 55-65 minutes.

7. Use of the Tibetan medicine composition according to claim 1 or 2 or the Tibetan medicine composition prepared by the preparation method according to any one of claims 3 to 6 in the preparation of lipid-lowering and liver-protecting preparations.

8. A lipid-lowering and liver-protecting preparation, characterized in that: The invention comprises the Tibetan medicine composition according to claim 1 or 2 or the Tibetan medicine composition prepared by the preparation method according to any one of claims 3 to 6 and pharmaceutically acceptable excipients.

9. The preparation according to claim 8, characterized in that The dosage form of the preparation includes oral solution, tablet, pill, capsule, granule, powder, injection or suspension.

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