Application of purple bud tea in preparation of medicine for improving metabolic disorder

Abstract

The invention discloses an application of purple bud tea in preparation of a medicine for improving metabolic disorders, belongs to the technical field of traditional Chinese medicines, and particularly relates to an application of purple bud tea, an extract of purple bud tea or a pharmaceutical composition of purple bud tea in preparation of a medicine for improving metabolic disorders. The purple bud tea extract disclosed by the invention can improve uric acid level rise caused by metabolic disorder, and has good prevention and treatment effects on metabolic disorder caused by sugar, fat and uric acid level rise caused by high-fat and high-sugar diet.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and relates to the application of purple bud tea in preparing a drug for improving metabolic disorders, and specifically relates to the application of purple bud tea, an extract thereof or a pharmaceutical composition thereof in preparing a drug for improving metabolic disorders. Background Art

[0002] In modern society, long-term intake of a high-fat and high-fructose diet (HFFD) has become a common phenomenon. This dietary pattern is closely related to metabolic abnormalities such as obesity, insulin resistance, and metabolic syndrome, and significantly increases the risk of diseases such as hyperglycemia, hyperlipidemia, hyperuricemia, and non-alcoholic fatty liver disease. HFFD causes obesity and metabolic disorders by leading to energy metabolism imbalance, liver and muscle fat accumulation, chronic inflammation, and other mechanisms, and aggravates insulin resistance and lipid metabolism disorders. In addition, high fructose intake increases uric acid production, leading to hyperuricemia, and forms a vicious cycle of two-way influence with insulin resistance, further promoting the development of metabolic diseases. These metabolic abnormalities put tremendous pressure on individual health and global medical resources.

[0003] Purple bud tea is a unique tea named after its purple buds. Its color mainly comes from the rich anthocyanins in the leaves of the tea plant, which give purple bud tea its unique appearance and potential health benefits. Unlike traditional green tea and black tea, purple bud tea not only has a unique flavor in taste, but also attracts widespread attention for its powerful antioxidant activity. Studies in recent years have shown that purple bud tea has significant health effects in lowering blood sugar and blood lipids, giving it a broad application prospect in the fields of food, health products and medicine.

[0004] No research has been found on the effect of purple bud tea in lowering uric acid. Summary of the invention

[0005] The purpose of the present invention is to provide the use of purple bud tea in the preparation of a drug for improving metabolic disorders; in particular, the use of purple bud tea, its extract or its pharmaceutical composition in the preparation of a drug for improving metabolic disorders. The purple bud tea extract of the present invention can improve the elevated uric acid level caused by metabolic disorders, and has a good preventive and therapeutic effect on metabolic disorders caused by elevated sugar, fat and uric acid levels due to a high-fat and high-sugar diet.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] In a first aspect, the present invention provides the use of purple bud tea, an extract thereof or a pharmaceutical composition thereof in the preparation of a drug for improving metabolic disorders.

[0008] The metabolic disorders described in the present invention are associated with abnormal uric acid levels, including elevated uric acid levels and uric acid levels combined with glucose metabolism disorders, lipid metabolism disorders, and elevated uric acid levels.

[0009] In a second aspect, the present invention provides the use of purple bud tea, an extract thereof or a pharmaceutical composition thereof in the preparation of a uric acid-lowering drug.

[0010] In a third aspect, the present invention provides the use of purple bud tea, an extract thereof or a pharmaceutical composition thereof in the preparation of a drug for improving renal function.

[0011] The improvement described in the present invention is: reducing the elevated uric acid level and urea nitrogen level induced by high fat and high sugar.

[0012] The purple bud tea involved in the present invention is raw Pu'er purple bud tea which has not been ripened.

[0013] The extract involved in the present invention is an extract of purple bud tea. In some embodiments, the extract is a water extract and / or an alcohol extract of purple bud tea.

[0014] In some embodiments, the method for preparing the extract comprises the following steps:

[0015] (1) extracting purple bud tea with solvent at least once, separating the solid and liquid, and combining the filtrate;

[0016] (2) Concentrating and drying the combined filtrate from step (1) to obtain a purple bud tea extract.

[0017] Preferably, the amount of the solvent added in step (1) is 3-15 times the weight of the purple bud tea; more preferably 6-12 times; and even more preferably 8-10 times.

[0018] Preferably, the solvent in step (1) is water or alcohol.

[0019] Further preferably, when the solvent is water, the extraction temperature is 90-100°C; when the solvent is alcohol, the extraction temperature is 70-90°C.

[0020] More preferably, the volume fraction of the alcohol is 50-95%, and the alcohol is methanol and / or ethanol.

[0021] Preferably, the solid-liquid separation in step (1) includes filtration, centrifugation and filter pressing, and more preferably filtration.

[0022] Preferably, the concentration in step (2) is reduced pressure concentration, and more preferably, the concentration temperature is 50-75°C, and even more preferably 55-70°C.

[0023] Preferably, the drying in step (2) is freeze drying and / or spray drying.

[0024] The pharmaceutical composition of the present invention comprises purple bud tea or its extract as the only active ingredient and pharmaceutically acceptable auxiliary materials.

[0025] In some embodiments, the pharmaceutical composition is in the form of tea bags, tablets, pills, granules, powders, mixtures, syrups or oral solutions.

[0026] In some embodiments, the pharmaceutical composition comprises a second active ingredient, which acts together with purple bud tea or its extract to improve metabolic disorders. The second active ingredient comprises at least one of a glucose-lowering drug, a lipid-lowering drug and other uric acid-lowering drugs.

[0027] The pharmaceutical composition of the present invention is purple bud tea or its extract and the second active ingredient directly mixed together or combined together after being packaged separately.

[0028] The beneficial effects of the present invention are:

[0029] (1) Experiments have shown that the purple bud tea extract of the present invention can reduce the level of uric acid in the blood and inhibit the increase of urea nitrogen, an indicator of renal function induced by high fat and high sugar, and has the effect of improving renal function.

[0030] (2) The purple bud tea extract of the present invention can reduce blood sugar, blood lipid and uric acid levels, and has a good preventive and therapeutic effect on metabolic disorders caused by high-fat and high-sugar diets with elevated sugar, lipid and uric acid levels.

[0031] (3) The present invention discloses for the first time the new use of purple bud tea extract in lowering uric acid, thus broadening the application field of purple bud tea. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 To investigate the effects of a high-fat, high-fructose diet on serum triglyceride levels in rats and the improving effect of purple bud tea.

[0033] Figure 2 Effects of high-fat and high-fructose diet on serum cholesterol levels in rats and the improving effect of purple bud tea

[0034] Figure 3 To investigate the effects of a high-fat, high-fructose diet on blood glucose levels in rats and the improving effect of purple bud tea.

[0035] In the figure, different letters indicate significant differences among the groups, P < 0.05. DETAILED DESCRIPTION

[0036] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0037] Before further describing the specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terms used in the examples of the present invention are for describing specific embodiments rather than for limiting the scope of protection of the present invention.

[0038] When the embodiment gives a numerical range, it should be understood that, unless otherwise specified in the present invention, the two endpoints of each numerical range and any numerical value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those of ordinary skill in the art to which the present invention belongs.

[0039] The present invention does not limit the sources of the raw materials used. Unless otherwise specified, the raw materials used in the present invention are common commercial products in the technical field.

[0040] The "pharmaceutical composition" described in the present invention comprises purple bud tea or its extract and pharmaceutically acceptable excipients. In a specific embodiment, the purple bud tea or its extract described in the present invention is provided in the pharmaceutical composition in an effective amount (e.g., a therapeutically effective amount).

[0041] The "pharmaceutically acceptable" ingredients described in the present invention are substances that are suitable for humans and / or animals without excessive adverse side effects (such as toxicity, irritation and allergic reactions), that is, substances with a reasonable benefit / risk ratio. The "pharmaceutically acceptable excipients" include starch, dextrin, sucrose, milk powder, sweeteners, mannitol, lactose, cellulose and its derivatives, calcium carbonate, cyclodextrin, β-cyclodextrin, phospholipid materials, magnesium stearate, talc or flavors.

[0042] The "pharmaceutical composition" described in the present invention can be prepared by any method known in pharmacy. Generally speaking, these preparation methods include associating the purple bud tea or its extract (i.e., the only active ingredient) with a carrier or excipient and / or one or more other auxiliary ingredients, and then if necessary and / or desired, shaping and / or packaging the product into a desired single dose or multiple dose unit.

[0043] The pharmaceutical composition of the present invention can be prepared according to known methods, such as the methods described in the general rules for preparation of the Chinese Pharmacopoeia 2020, the Japanese Pharmacopoeia 16, the United States Pharmacopoeia and the European Pharmacopoeia 9. Depending on the dosage form, the pharmaceutical composition of the present invention can be appropriately administered to a patient.

[0044] The sole active ingredient, pharmaceutically acceptable excipient in the "pharmaceutical composition" described herein will vary depending on the identity, size and / or condition of the subject being treated and further on the route of administration of the composition. The pharmaceutical composition may contain between 0.1% and 100% (w / w) of the first active ingredient.

[0045] The "pharmaceutical composition" described in the present invention may also optionally contain other therapeutic ingredients for use in combination, especially those additional therapeutic ingredients disclosed herein, such as "hypoglycemic drugs, lipid-lowering drugs and other uric acid-lowering drugs" (i.e., the second active ingredient), wherein the second active ingredient is a chemical drug, a traditional Chinese medicine or a Chinese patent medicine preparation.

[0046] "Treatment" as used herein, unless otherwise indicated, means reversing, alleviating, inhibiting the progression of, or preventing the condition or disorder or one or more symptoms of such condition or disorder to which the term applies, unless otherwise indicated. The term "treat" as used herein refers to the act of treating, as "treat" is defined immediately above.

[0047] The "effective amount" described in the present invention refers to an amount sufficient to induce a desired biological response. The effective amount of the active ingredient of the present invention may vary depending on factors such as the desired biological endpoint, the pharmacokinetics of the compound, the condition being treated, the mode of administration, and the age and health of the subject. In certain embodiments, the effective amount is a therapeutically effective amount. The effective amount is the amount of the only active ingredient described in the present invention in a single dose. In certain embodiments, the effective amount is the combined amount of the only active ingredient described in the present invention in multiple doses.

[0048] The "therapeutically effective amount" described in the present invention is an amount sufficient to provide a therapeutic benefit in the treatment of a disorder or sufficient to delay or minimize one or more symptoms associated with the disorder. The therapeutically effective amount of purple bud tea, its extract means the amount of the therapeutic agent alone or in combination with other therapies to provide a therapeutic benefit in the treatment of the disorder. The term "therapeutically effective amount" can encompass an amount that improves overall therapy, reduces or avoids symptoms, signs or causes of a disorder, and / or enhances the therapeutic efficacy of another therapeutic agent. In certain embodiments, a therapeutically effective amount is an amount sufficient to treat any disease or disorder described.

[0049] Example 1 Preparation of Purple Tea Water Extract

[0050] (1) Accurately weigh 10 g of purple bud tea (purchased from Jianghu Yanyi (Guangdong) Trading Co., Ltd.), add distilled water 10 times the weight of the medicinal material, heat to boiling in a round-bottom flask, extract at boiling state and start timing for 1.5 h. After 1.5 h, remove the round-bottom flask and collect filtrate 1;

[0051] (2) Add 8 times the amount of distilled water as the medicinal material to the residue and continue to extract for 1.5 hours with the same parameters as above. After the extraction is completed, filter and collect filtrate 2, and combine filtrate 1 and filtrate 2;

[0052] (3) The combined filtrate was evaporated with a rotary evaporator at a speed of 40 and a temperature of 70 degrees Celsius to remove the water in the extract, and finally a purple bud tea extract with a crude drug concentration of 1.6 g / ml was obtained.

[0053] Example 2 Preparation of Purple Tea Alcohol Extract

[0054] (1) Accurately weigh 10 g of purple bud tea (purchased from Jianghu Yanyi (Guangdong) Trading Co., Ltd.), add 85% ethanol 10 times the weight of the medicinal material, heat to 80±2°C in a round-bottom flask, extract for 1.5 h, remove the round-bottom flask after 1.5 h, and collect the filtrate 1;

[0055] (2) Add 85% ethanol 8 times the weight of the medicinal material to the residue and continue to extract for 1.5 hours with the same parameters as above. After the extraction is completed, filter, collect filtrate 2, and combine filtrate 1 and filtrate 2;

[0056] (3) The combined filtrate was evaporated by rotary evaporation at a speed of 40 and a temperature of 70 degrees Celsius to remove the solvent of the extract, and finally a purple bud tea extract with a crude drug concentration of 1.6 g / ml was obtained.

[0057] Example 3: Evaluation of blood sugar, blood lipid and uric acid lowering effects

[0058] 1. Experimental Materials

[0059] 1.1 Experimental animals

[0060] Adult male SD rats of SPF grade, weighing 180±20 g, were purchased from Guangzhou Yancheng Biotechnology Co., Ltd., with the animal production license number: SYXK(Yue)2022-0125. After 7 days of adaptive feeding, they entered the experimental period.

[0061] 1.2 Experimental drugs

[0062] Water extract of purple bud tea, ethanol extract of purple bud tea, normal saline, and anthocyanin (CAS No.: 4852-22-6, purity 95%).

[0063] 1.3 Experimental reagents

[0064] Glucose (Glu) test kit, uric acid (UA) test kit (enzymatic colorimetric method), total cholesterol (TC) assay kit, and triglyceride (TG) assay kit were all purchased from Nanjing Jiancheng Bioengineering Institute.

[0065] 1.4 Experimental instruments

[0066] Multifunctional microplate reader (model: SpectraMax), purchased from Molecular Device.

[0067] 2. Experimental methods

[0068] After 7 days of adaptive feeding, SPF-grade adult male SD rats were randomly divided into 5 groups, namely blank control group (CON), high-fat and high-sugar model group (MOD), drug control group (QY), water extract administration group (SY), and ethanol extract administration group (CY), with 8 rats in each group.

[0069] Except for the blank control group fed with normal feed and given normal drinking water, the other groups were given 45% high-fat feed (15 kg of lard, 12.5 kg of casein, 1.2 kg of cholesterol, 1.3 kg of calcium hydrogen phosphate, 0.5 kg of stone powder, and 0.2 kg of sodium cholate), 12% fructose syrup, and 43% normal feed.

[0070] The blank control group and the high-fat and high-sugar model group were given normal saline by gavage every day; the water extract group was given the water extract of purple bud tea by gavage once a day, with the administration dose of 1.05 g / kg / d (converted according to the normal human tea-drinking amount of 10 g / d); the ethanol extract group was given the ethanol extract of purple bud tea by gavage once a day, with the administration dose of 1.05 g / kg / d, and the drug control group was given anthocyanin by gavage once a day, with the administration dose of 0.5 g / kg. The continuous modeling and drug administration lasted for 8 weeks.

[0071] After the last administration of the test substance, the rats were anesthetized, and blood was taken from the carotid artery. After centrifugation at 3000 rpm for 10 min, the supernatant was taken for the detection of blood glucose, blood lipids, uric acid, and creatinine; the plasma was taken for the detection of urea nitrogen level.

[0072] 3. Experimental results

[0073] Figure 1 To investigate the effects of a high-fat, high-fructose diet on serum triglyceride levels in rats and the improving effect of purple bud tea. Figure 1 The results showed that the serum triglyceride level of rats in the high-fat and high-sugar model group was significantly increased, which was significantly different from that in the blank control group (P<0.05), indicating that a high-fat and high-sugar diet can increase the triglyceride level in serum.

[0074] Compared with the high-fat and high-sugar model group, the serum triglyceride levels of rats in the drug control group, water extract group and alcohol extract group were significantly reduced (P<0.05), indicating that anthocyanins and purple bud tea water extract and alcohol extract can improve the increased triglyceride levels caused by a high-fat and high-sugar diet.

[0075] Figure 2 To investigate the effect of high-fat and high-fructose diet on serum cholesterol levels in rats and the improving effect of purple bud tea. Figure 2 The results showed that the serum cholesterol level of rats in the high-fat and high-sugar model group was significantly increased, which was significantly different from that in the blank control group (P<0.05), indicating that a high-fat and high-sugar diet can increase the cholesterol level in serum.

[0076] Compared with the high-fat and high-sugar model group, the serum cholesterol levels of rats in the drug control group, water extract group and alcohol extract group were significantly reduced (P<0.05), indicating that the water extract and alcohol extract of anthocyanins and purple bud tea can improve the increased cholesterol levels caused by a high-fat and high-sugar diet.

[0077] Figure 3 To investigate the effects of a high-fat, high-fructose diet on blood glucose levels in rats and the improving effect of purple bud tea. Figure 3 The results showed that the blood glucose level of rats in the high-fat and high-sugar model group was significantly increased, which was significantly different from that in the blank control group (P<0.05), indicating that a high-fat and high-sugar diet can increase blood glucose levels.

[0078] Compared with the high-fat and high-sugar model group, the blood glucose levels of rats in the drug control group, water extract group and alcohol extract group were significantly reduced (P<0.05), indicating that the water extract and alcohol extract of anthocyanins and purple bud tea can improve the increased blood glucose levels caused by a high-fat and high-sugar diet.

[0079] Table 1 Effects of high-fat and high-fructose diet on serum uric acid levels in rats and the improvement effect of purple bud tea (Mean±SD)

[0080]

[0081] Note: Different letters indicate significant differences among the groups, P < 0.05.

[0082] Table 1 shows that the serum uric acid level of rats in the high-fat and high-sugar model group was significantly increased, which was significantly different from that in the blank control group (P<0.05).

[0083] It is worth noting that the serum uric acid level of rats in the water extract group and alcohol extract group of purple bud tea intervention was significantly lower than that in the high-fat and high-sugar model group (P<0.05), indicating that the water extract and alcohol extract of purple bud tea can reduce uric acid levels and improve the elevated uric acid level caused by a high-fat and high-sugar diet. The serum uric acid level of rats in the drug control group of anthocyanin intervention was lower than that in the high-fat and high-sugar model group, but no significant difference was shown (P>0.05), indicating that anthocyanin has limited regulatory effect on uric acid levels caused by a high-fat and high-sugar diet and has no improvement effect.

[0084] Table 2 Effects of high-fat and high-fructose diet on serum creatinine levels in rats and the improvement effect of purple bud tea (Mean±SD)

[0085]

[0086] Table 2 shows that the serum creatinine level of rats in the high-fat and high-sugar model group was increased, but there was no significant difference compared with the blank control group (P>0.05), and the serum creatinine levels of rats in each group were similar, indicating that the high-fat and high-sugar diet pattern and the intervention of purple bud tea had limited effects on creatinine levels.

[0087] Table 3 Effects of high-fat and high-fructose diet on plasma urea nitrogen levels in rats and the improvement effect of purple bud tea (Mean±SD)

[0088]

[0089]

[0090] Note: Different letters indicate significant differences among the groups, P < 0.05.

[0091] Table 3 shows that the serum urea nitrogen level of rats in the high-fat and high-sugar model group was significantly increased, which was significantly different from that in the blank control group (P<0.05), indicating that a high-fat and high-sugar diet may have a negative impact on renal function.

[0092] The serum urea nitrogen level of rats in the water extract group and alcohol extract group treated with purple bud tea was significantly lower than that in the high-fat and high-sugar model group (P<0.05), indicating that the water extract and alcohol extract of purple bud tea can reduce the urea nitrogen level and improve the elevated urea nitrogen level caused by a high-fat and high-sugar diet. The serum urea nitrogen level of rats in the drug control group treated with anthocyanin was lower than that in the high-fat and high-sugar model group, but no significant difference was shown (P>0.05), indicating that anthocyanin has limited regulatory effect on the elevated urea nitrogen level caused by a high-fat and high-sugar diet and has no improvement effect.

[0093] The above is a further description of the present invention in conjunction with specific embodiments, but these embodiments are merely exemplary and do not constitute any limitation on the scope of the present invention. It should be understood by those skilled in the art that the details and forms of the technical solution of the present invention may be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the scope of protection of the present invention.

Claims

1. Use of purple bud tea, its extract or its pharmaceutical composition in the preparation of drugs for improving metabolic disorders.

2. The use according to claim 1, characterized in that: The metabolic disorder is associated with abnormal uric acid levels.

3. Use of purple bud tea, its extract or its pharmaceutical composition in the preparation of uric acid-lowering drugs.

4. Use of purple bud tea, its extract or its pharmaceutical composition in the preparation of drugs for improving renal function.

5. The use according to claim 4, characterized in that: The improvement is: reducing the increase in uric acid levels and urea nitrogen levels induced by high fat and high sugar.

6. The use according to any one of claims 1 to 5, characterized in that: The extract is a water extract and / or an alcohol extract of purple bud tea.

7. The use according to claim 6, characterized in that: The preparation method of the extract comprises the following steps: (1) extracting purple bud tea with solvent at least once, separating the solid and liquid, and combining the filtrate; (2) concentrating and drying the combined filtrate from step (1) to obtain a purple bud tea extract; The solvent in step (1) is water or alcohol.

8. The use according to claim 6, characterized in that: The pharmaceutical composition comprises purple bud tea or its extract and pharmaceutically acceptable excipients.

9. A pharmaceutical composition, characterized in that Contains purple bud tea or an extract thereof.

10. The pharmaceutical composition according to claim 9, characterized in that The dosage form of the pharmaceutical composition is tea bag, tablet, pill, granule, powder, mixture, syrup or oral liquid.

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