LIVER-PROTECTIVE COMPOSITION

Abstract

The present invention relates to the technical field of traditional Chinese medicines, and in particular to a liver-protective composition and a method for its preparation. The liver-protective composition contains, by weight: 10 to 25 parts of Bulbus Fritillariae Cirrhosae, 5 to 15 parts of Fructus Forsythiae, 5 to 13 parts of Turmeric, 2 to 8 parts of Ginseng, 2 to 8 parts of Hovenia dulcis Thunb., and a flavoring agent, wherein the flavoring agent comprises red dates. The present invention relates to a purely traditional Chinese medicine that is easy to prepare and convenient to take, has beneficial effects in protecting and nourishing the liver, and also exhibits an effect in alleviating the effects of alcohol.

Description

TECHNICAL AREA

[0001] The present invention relates to the technical field of traditional Chinese medicines and in particular to a liver-protective composition and a method for its manufacture. GENERAL STATE OF THE ART

[0002] The liver is a multi-functional metabolic organ. It can detoxify various metabolic products, regulate glycogen storage, synthesize plasma proteins, produce hormones, and generate biochemical substances to facilitate the metabolism of toxic substances. Patients with liver disease may experience problems with digestion, coagulation, blood sugar, immunity, lipid metabolism, and more. Fat malabsorption can cause symptoms such as indigestion, deficiencies in fat-soluble vitamins, gallstones, intolerance to fatty foods, alcohol intolerance, abdominal distension, and nausea.

[0003] Regarding the causes of liver disease, viral and parasitic infections are the primary causes in Africa and Asia. However, in Europe and the United States, alcoholism is a leading cause of liver disease, while the rate of viral hepatitis infections is steadily increasing.

[0004] Although an increasing number of patients are currently suffering from liver diseases, there is still a lack of medications to treat or protect the liver. Therefore, medical professionals anticipate research into drugs for the effective treatment or protection of the liver.

[0005] Against this background, the present invention is proposed. SUMMARY

[0006] The first object of the present invention relates to a liver-protecting composition comprising, in parts by weight: 10 to 25 parts Bulbus Fritillariae Cirrhosae, 5 to 15 parts Fructus forsythiae, 5 to 13 parts Turmeric, 2 to 8 parts Ginseng, 2 to 8 parts Hovenia dulcis Thunb. and a flavoring agent, wherein The flavoring agent contains red dates.

[0007] The combination of the aforementioned ingredients not only achieves good efficacy but also avoids obvious toxic effects and side effects. This combination effectively creates a significant synergistic effect, resulting in beneficial liver protection and support.

[0008] In some embodiments, the liver-protecting composition includes, by weight: 12 to 23 parts Bulbus Fritillariae Cirrhosae, 7 to 13 parts Fructus forsythiae, 7 to 10 parts Turmeric, 4 to 6 parts Ginseng and 4 to 6 parts Hovenia dulcis Thunb.

[0009] In some embodiments, the liver-protecting composition includes, by weight: 17 parts Bulbus Fritillariae Cirrhosae, 10 parts Fructus forsythiae, 9 parts turmeric, 5 parts ginseng and 5 parts Hovenia dulcis Thunb.

[0010] In some embodiments, the Fructus forsythiae is roasted Fructus forsythiae.

[0011] In some embodiments, the liver-protecting composition also includes a pharmaceutically acceptable excipient.

[0012] In some embodiments, a dosage form of the liver-protective composition includes a pill, a powder, an ointment, a tablet, a granule (electuary), a lozenge, a capsule, an aqueous agent or a tincture.

[0013] A preferred dosage form is the aqueous solution or the tincture.

[0014] The aqueous remedy is an aqueous solution of a traditional Chinese medicine composition. The medicine is uniformly dispersed in water in the form of ions or molecules. The concentration of the remedy is determined by the water solubility of the original medicine, which is usually its maximum solubility; the remedy is then diluted with water before use. To ensure complete release of the active ingredients from the medicine, the aqueous remedy can be prepared by decocting the medicine in hot water or by other methods, and the decoction can be performed once, twice, or several times.

[0015] The tincture is a clear liquid formulation prepared by leaching or dissolving the drug in ethanol at a specific concentration, and it can also be prepared by diluting the drug with a liquid extract. The tincture is taken orally or applied topically. Preparation of the tincture requires no heating, the tincture contains relatively pure ingredients with a high concentration of active substances, and the tincture is administered in precise doses, is rapidly absorbed, and is suitable for preparing formulations containing volatile or heat-labile ingredients. Preferably, the tincture according to the invention is an orally administered tincture.

[0016] The present invention also provides a method for producing the aforementioned liver-protective composition.

[0017] First, a simple composition is prepared. A further object of the present invention is to provide a method for preparing the aforementioned liver-protective composition, comprising the step of grinding and mixing the ingredients.

[0018] Secondly, a more elaborate manufacturing process is provided, which includes the following steps: (a) Decoction or brewing of the ingredients with water to obtain a decoction solution, or extraction using an aqueous ethanol solution to obtain an extract solution; and (b) Preparing the decocted solution or the extract solution into a desired dosage form.

[0019] In some embodiments, the method for producing the liver-protecting composition includes the following: Grinding of Bulbus Fritillariae Cirrhosae and Fructus forsythiae, adding water to a obtained mixture, decocting the obtained mixture twice for 1 to 2 hours each time, filtering a decocted solution and combining the filtrates to form the first filtrate; Crushing and mixing turmeric, ginseng and Hovenia dulcis Thunb., adding 60 to 80 percent ethanol two to four times for reflux extraction, combining the extracts and filtering the extracts to obtain the second filtrate; and Combining the first and second filtrates, allowing the resulting mixture to stand for 2 to 3 days, skimming off a supernatant, recovering the ethanol from the supernatant under reduced pressure, and adding the flavoring agent. The present invention relates to a purely traditional Chinese medicine that is easy to prepare and convenient to take, has beneficial effects in protecting and nourishing the liver, and also has an effect in alleviating the effects of alcohol. DETAILED DESCRIPTION

[0020] Detailed reference is made to embodiments of the present invention, and one or more examples are described below. Each example serves to illustrate, not to limit, the present invention. Indeed, a person skilled in the art can make various modifications and changes to the present invention without altering its scope or essence. For example, features illustrated or described as part of one embodiment can be used in another embodiment to create yet another embodiment.

[0021] Unless otherwise specified, all terms (including technical and scientific terms) used in the disclosure of the present invention have the same meaning as they would be generally understood by a person skilled in the art in the field to which the present invention belongs. For better understanding of instructions within the scope of the present invention, the following definitions are used. The terms used in this document in the description of the present invention serve only to describe certain embodiments and are not intended to limit the present invention.

[0022] The terms “comprise”, “include” and “contain” used in the present invention are synonymous and are inclusive or non-limiting and do not exclude further unmentioned parts, elements or process steps.

[0023] In the present invention, a value range defined by endpoints includes all values, fractions, and the aforementioned endpoints that fall within this range. A concentration value according to the invention can fluctuate within a specific range. For example, the concentration value can fluctuate within a corresponding accuracy range. For instance, an accuracy range of 2% allows fluctuations within a range of ±0.1%. For a larger value, or a value that does not require fine control, a larger fluctuation is also permissible. For example, an accuracy range of 100 mM can allow fluctuations within a range of ±1%, ±2%, ±5%, etc. The molecular weight may fluctuate by ±10%.

[0024] In the present invention, descriptions such as "several" and "different" refer to two or more than two, unless otherwise specified.

[0025] In the present invention, technical features in non-limiting descriptions include limiting technical solutions that are composed of the listed features, and also include non-limiting technical solutions that include the listed features.

[0026] In the present invention, “preferred”, “better”, “preferably” and “suitable” are intended to describe only embodiments or examples with better effects and are not to be interpreted as limiting the scope of protection of the present invention.

[0027] The embodiments of the present invention are described in more detail below with reference to examples. It is understood that these examples serve only to illustrate the present invention and are not intended to limit its scope of protection. In the following examples, for a test method for which no specific condition is given, reference is preferably made to the instructions provided in the present invention, a test manual, a conventional condition in the prior art, another test method known in the prior art, or a condition recommended by a manufacturer.

[0028] In the following examples, a measurement parameter related to an ingredient may exhibit a slight deviation within a weighing accuracy range, unless otherwise specified. For temperature and time parameters, an acceptable deviation is permissible due to the accuracy of the measuring instrument or the operational accuracy. Example 1

[0029] Weighing: 10 g Bulbus Fritillariae Cirrhosae, 15 g Fructus forsythiae, 5 g turmeric, 8 g ginseng, 2 g Hovenia dulcis Thunb. and 13 g of red dates.

[0030] Preparation: Bulbus Fritillariae Cirrhosae and Fructus forsythiae were ground, water was added to the resulting mixture, the resulting mixture was decocted twice for 1 hour each time, a decocted solution was filtered, and the filtrates were combined to obtain the first filtrate;

[0031] Turmeric, ginseng, and Hovenia dulcis Thunb. were ground and mixed, 80% ethanol was added twice for reflux extraction, and the extracts were combined and filtered to obtain the second filtrate; and The first filtrate and the second filtrate were combined and left to stand for 2 days, a supernatant was drawn off, ethanol was recovered from the supernatant under reduced pressure, and red dates were added. Example 2

[0032] Weighing: 25 g Bulbus Fritillariae Cirrhosae, 5 g Fructus forsythiae, 13 g turmeric, 2 g ginseng, 8 g Hovenia dulcis Thunb. and 5 g of red dates.

[0033] Preparation: Bulbus Fritillariae Cirrhosae and Fructus forsythiae were ground, water was added to the resulting mixture, the resulting mixture was decocted twice for 2 hours each time, a decocted solution was filtered, and the filtrates were combined to obtain the first filtrate;

[0034] Turmeric, ginseng, and Hovenia dulcis Thunb. were ground and mixed, 60% ethanol was added four times for reflux extraction, and the extracts were combined and filtered to obtain the second filtrate; and The first filtrate and the second filtrate were combined and left to stand for 3 days, a supernatant was drawn off, ethanol was recovered from the supernatant under reduced pressure, and red dates were added. Example 3

[0035] Weigh: 12 parts Bulbus Fritillariae Cirrhosae, 13 parts Fructus forsythiae, 7 parts Turmeric, 6 parts Ginseng, 4 parts Hovenia dulcis Thunb. and 10 parts red dates.

[0036] Preparation: Bulbus Fritillariae Cirrhosae and Fructus forsythiae were ground, water was added to the resulting mixture, the resulting mixture was decocted twice for 1 to 2 hours each time, a decocted solution was filtered, and the filtrates were combined to obtain the first filtrate;

[0037] Crushing and mixing turmeric, ginseng and Hovenia dulcis Thunb., adding 60 to 80 percent ethanol two to four times for reflux extraction, combining the extracts and filtering the extracts to obtain the second filtrate; and the first filtrate and the second filtrate were combined and left to stand for 2 to 3 days, a supernatant was drawn off, ethanol was recovered from the supernatant under reduced pressure, and red dates were added. Example 4

[0038] Weighing: 17 g Bulbus Fritillariae Cirrhosae, 10 g Fructus forsythiae, 9 g turmeric, 5 g ginseng, 5 g Hovenia dulcis Thunb. and 9 g of red dates.

[0039] Preparation: Bulbus Fritillariae Cirrhosae and Fructus forsythiae were ground, water was added to the resulting mixture, the resulting mixture was decocted twice for 2 hours each time, a decocted solution was filtered, and the filtrates were combined to obtain the first filtrate;

[0040] Turmeric, ginseng, and Hovenia dulcis Thunb. were ground and mixed, 70% ethanol was added three times for reflux extraction, and the extracts were combined and filtered to obtain the second filtrate; and The first filtrate and the second filtrate were combined and left to stand for 3 days, a supernatant was drawn off, ethanol was recovered from the supernatant under reduced pressure, and red dates were added. Test example

[0041] The formulation prepared in Example 4 was used for a test on mice with acute liver damage caused by CCl4: Sixty mice were randomly divided into four groups of 15 mice each. Administration to each group was performed via a gastric tube. An empty group and a modeling group received clean water, a test group received the formulation prepared in Example 4, and a positive group, intended to serve as a control group, was administered an effective dose of Sunflower Liver-Protecting tablets. A dose was calculated for the mice according to the Chinese Pharmacopoeia. The dose for the positive group was 560 mg / kg, and the dose for the test group was 420 mg / kg. In the present invention, olive oil was used to prepare a 1% CCl4 solution. This solution was injected intraperitoneally at a rate of 10 ml / kg body weight into each mouse separately to create a model. Only the empty group did not require modeling.One week after intragastric administration, mice in the CCl4 modeling group, the test group, and the positive group received further intraperitoneal injections, this time of which the 0.1% CCl4 oil solution was injected to create the model. Within 18 hours, blood samples were then taken from each mouse via orbital blood sampling, and liver function indicators (AST and ALT) were assessed using conventional methods. The results are shown in Table 1. Table 1 group Number of animals OLD (E / l) AST (E / l) Empty group 10 37,2±7,4** 30,6±4,33** Modeling group 10 397,5+81,6 141,6±32,7 Test group 10 154,2±29,8** 82,90±10,75** Positive group 10 234,55±52,01** 98,73±12,93**

[0042] Note: *P<0.05 and **P<0.01 compared to the modeling group.

[0043] The foregoing results show that the drug according to the invention was able to significantly reduce the activity of ALT, and there was a difference of large significance (P< 0.01) compared to the modeling group; and The samples were able to reduce ALT activity at all three dosages, and there was a significant difference (P < 0.01) between the three dosage groups and the modeling group. The test results show that the sample had a significant protective effect against liver damage and a significant hepatoprotective effect.

[0044] The foregoing embodiments describe only a few examples of the present invention. The descriptions are relatively detailed and specific, but they cannot be interpreted as limiting the scope of the present invention. It should be noted that a person skilled in the art could also make several variations and improvements without departing from the concept of the present invention. These variations and improvements all fall within the scope of protection of the present invention.

Claims

[1] Liver-protecting composition, comprising in parts by weight: 10 to 25 parts Bulbus Fritillariae Cirrhosae, 5 to 15 parts Fructus forsythiae, 5 to 13 parts Turmeric, 2 to 8 parts Ginseng, 2 to 8 parts Hovenia dulcis Thunb. and a flavoring agent, wherein The flavoring agent includes red dates. [2] Liver-protecting composition according to claim 1, comprising in parts by weight: 12 to 23 parts Bulbus Fritillariae Cirrhosae, 7 to 13 parts Fructus forsythiae, 7 to 10 parts Turmeric, 4 to 6 parts Ginseng and 4 to 6 parts Hovenia dulcis Thunb. [3] Liver-protecting composition according to claim 2, comprising in parts by weight: 17 parts Bulbus Fritillariae Cirrhosae, 10 parts Fructus forsythiae, 9 parts turmeric, 5 parts ginseng and 5 parts Hovenia dulcis Thunb. [4] Liver-protecting composition according to any one of claims 1 to 3, wherein the Fructus forsythiae is roasted Fructus forsythiae. [5] Liver-protecting composition according to claim 4, further comprising a pharmaceutically acceptable excipient. [6] Liver-protecting composition according to claim 4, wherein a dosage form comprises a pill, a powder, an ointment, a tablet, a granule (electuary), a lozenge, a capsule, an aqueous agent or a tincture. [7] Method for producing the liver-protecting composition according to any one of claims 1 to 6, comprising the following step: grinding and mixing the ingredients. [8] Method for producing the liver-protecting composition according to any one of claims 1 to 6, comprising the following step: (a) Decoction or brewing of the ingredients with water to obtain a decoction solution, or extraction using an aqueous ethanol solution to obtain an extract solution; and (b) Preparing the decocted solution or the extract solution into a desired dosage form. [9] Method for producing the liver-protecting composition according to claim 8, comprising the following: Grinding of Bulbus Fritillariae Cirrhosae and Fructus forsythiae, adding water to the resulting mixture, decocting the mixture twice for 1 to 2 hours each time, filtering a decocted solution and combining the filtrates to obtain the first filtrate; crushing and mixing of turmeric, ginseng, and Hovenia dulcis Thunb., adding 60 to 80% ethanol two to four times for reflux extraction, combining the extracts and filtering the extracts to obtain the second filtrate; and combining the first and second filtrates, allowing the resulting mixture to stand for 2 to 3 days, drawing off a supernatant, recovering the ethanol from the supernatant under reduced pressure, and adding the flavoring agent.