Traditional Chinese medicine preparation, preparation method thereof and application of traditional Chinese medicine preparation in blood glucose reduction and lipid reduction

Abstract

The invention discloses a traditional Chinese medicine preparation as well as a preparation method and application thereof in reducing blood sugar and blood fat. The traditional Chinese medicine preparation disclosed by the invention not only has relatively good inhibition capability on glycometabolism related enzymes including alpha-amylase and alpha-glucosidase, but also has relatively high inhibition capability on pancreatic lipase and cholesterol esterase for digesting fat, and the inhibition capability is superior to that of various reported single medicinal and edible substance extracts; the inhibition capability of the Erchen decoction is superior to that of a classic prescription Erchen decoction and an Erchen decoction food-grade basic prescription (except the traditional Chinese medicine rhizoma pinellinae The capacity of inhibiting sugar and lipid-related digestive enzymes and the capacity of regulating blood sugar and lipid disorder of the traditional Chinese medicine preparation are superior to the regulating effect of first-line Chinese patent medicine lipid-lowering granules, and the regulating effect of the traditional Chinese medicine preparation has no significant difference (p is less than 0.05) with the regulating effect of a classic prescription Erchen decoction.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine preparation and a preparation method thereof, and application in reducing blood sugar and blood lipids. Background Art

[0002] In recent years, obesity has evolved into a global epidemic and a major health challenge. As a chronic, recurrent and progressive disease, obesity is a risk factor for a variety of chronic metabolic diseases, including type 2 diabetes and hypercholesterolemia. Currently, traditional treatment drugs are often accompanied by a variety of side effects, including inducing gastrointestinal diseases.

[0003] Epidemiological studies have shown that bad dietary habits are the main cause of obesity and complications, especially excessive intake of high-energy-density foods such as high-fat or high-sugar foods. The main carbohydrate digestive enzymes in the human digestive system are α-amylase and α-glucosidase. Among them, α-amylase is widely distributed in saliva and pancreas, acting on starch, indiscriminately cutting α-1,4-glycosidic bonds, breaking it down into oligosaccharides such as maltose and glucose, and then α-glucosidase releases glucose by hydrolyzing glucosidic bonds, which is absorbed in the small intestine for energy. Inhibiting the enzymatic activity of α-amylase and α-glucosidase and inhibiting the body's decomposition of starch carbohydrates is an important means to slow down or reduce the production and storage of carbohydrates. The digestion and absorption of fat in the digestive system is mainly completed by lipase, among which pancreatic lipase is the main lipase involved in digestion secreted by the pancreas. Inhibiting the activity of pancreatic lipase will block the metabolic pathways of 50% to 70% of dietary lipids in the small intestine, thereby blocking the excessive absorption and storage of exogenous fat by the human body, achieving the effect of effectively controlling blood lipids and liver fat.

[0004] Erchen Decoction is a classic Chinese prescription for treating phlegm-dampness syndrome. It is mainly composed of Pinellia ternata, Tangerine Peel, Poria cocos, Roasted Licorice, Ginger and Black Plum. Pinellia ternata is pungent and warm in nature and enters the spleen, stomach and lung meridians, and has the effects of drying dampness and resolving phlegm, lowering adverse qi and harmonizing the stomach; Tangerine peel is bitter, pungent and warm in nature and enters the lung and spleen meridians, and has the effects of regulating the ascending and descending of spleen and lung qi and regulating qi and regulating the middle; Poria cocos is sweet, light and flat in nature and enters the heart, lung, spleen and kidney meridians, and has the effects of penetrating dampness and promoting diuresis, concentrating the heart and calming the mind; Licorice is sweet and flat in nature and enters the heart, lung, spleen and stomach meridians, and has the effects of replenishing qi and tonifying the middle, relieving acute pain, removing phlegm and relieving cough; Ginger is pungent and warm in nature and enters the lung, stomach and spleen meridians, and has the effects of releasing dampness, dispelling cold, stopping vomiting and removing phlegm. Plum is sour and neutral in nature, and enters the liver, spleen, lung, and large intestine meridians. It has the effects of astringing the lungs, astringing the intestines, promoting the production of body fluids, and calming ascaris. The combination of various herbs has the effects of drying dampness and resolving phlegm, regulating qi and harmonizing the middle. Modern medicine has proven that Erchen Decoction has the potential to treat obesity-related diseases, including fatty liver, hyperlipidemia, and atherosclerosis.

[0005] However, the Chinese Pinellia ternata in Erchen Decoction is a traditional Chinese medicine, which requires syndrome differentiation and treatment and is taken under the guidance of a doctor, which greatly limits the application of this prescription in daily weight loss and lipid reduction. As the main medicine in Erchen Decoction, how to reasonably and scientifically replace the Chinese Pinellia ternata with the Chinese Pinellia ternata on the basis of traditional Chinese medicine formula is a huge challenge. Summary of the invention

[0006] Purpose of the invention: The technical problem to be solved by the present invention is to provide a Chinese medicine preparation. The Chinese medicine preparation prepared by the present invention can alleviate the blood sugar and blood lipid disorders caused by simple obesity. In view of the problems that the existing drugs have single enzyme inhibition and large side effects, a Chinese medicine preparation prepared from a medicine-food homologous composition is further proposed, which can alleviate the blood sugar and lipid disorders caused by simple obesity by inhibiting the activities of multiple sugar and lipid digestive enzymes, including α-amylase, α-glucosidase, pancreatic lipase and cholesterol esterase.

[0007] The technical problem that the present invention needs to solve is to provide a method for preparing a traditional Chinese medicine preparation.

[0008] The technical problem that the present invention also solves is to provide the application of the traditional Chinese medicine preparation in reducing blood sugar and reducing blood lipid.

[0009] Technical solution: In order to solve the above technical problems, the present invention provides a traditional Chinese medicine preparation, which is made of the following components by weight: 6-12 parts of lotus leaves, 6-12 parts of platycodon, 6-12 parts of tangerine peel, 4-8 parts of poria, 2-5 parts of red beans, 2-4 parts of alkyl oxyphylla, 2-5 parts of licorice, 2-5 parts of ginger, and 0.5-2 parts of black plum.

[0010] Among them, as a preferred embodiment, the Chinese medicine preparation comprises the following components by weight: 6-9 parts of lotus leaves, 6-9 parts of platycodon, 6-9 parts of tangerine peel, 6-8 parts of poria, 2-5 parts of red beans, 2-4 parts of alkyl oxyphylla, 2-5 parts of licorice, 2-5 parts of ginger, and 1-2 parts of ebony.

[0011] Among them, as a preferred embodiment, the Chinese medicine preparation comprises the following components by weight: 9 parts of lotus leaves, 6 parts of platycodon, 6 parts of tangerine peel, 6 parts of poria, 2 parts of red beans, 2 parts of alkyl oxyphylla, 3 parts of licorice, 3 parts of ginger, and 1 part of ebony.

[0012] Among them, as a preferred embodiment, the Chinese medicine preparation comprises the following components by weight: 9 parts of lotus leaves, 9 parts of platycodon, 6 parts of tangerine peel, 6 parts of poria, 2 parts of red bean, 2 parts of alkyl oxyphylla, 3 parts of licorice, 3 parts of ginger, and 1 part of ebony.

[0013] Among them, as a preferred embodiment, the Chinese medicine preparation comprises the following components by weight: 6 parts of lotus leaves, 6 parts of platycodon, 9 parts of tangerine peel, 9 parts of poria, 2 parts of red bean, 2 parts of alkyl oxyphylla, 3 parts of licorice, 3 parts of ginger, and 1 part of ebony.

[0014] The present invention also includes a method for preparing the Chinese medicine preparation, comprising the following steps:

[0015] 1) Weigh lotus leaf, platycodon grandiflorum, tangerine peel, poria, red bean, alpinia oxyphylla, licorice, ginger, and ebony according to the above mass parts, put them into a traditional Chinese medicine grinder, grind them thoroughly, and sieve the powder;

[0016] 2) Soaking the mixture treated in step 1) in water at room temperature, extracting, filtering or centrifuging to obtain an extract, and then sterilizing or disinfecting it for later use.

[0017] Wherein, in step 1), the powder is passed through a 60-80 mesh sieve.

[0018] Wherein, the weight ratio of the material to the liquid in step 2) is 1:10 to 1:20.

[0019] Wherein, the soaking time in step 2) is 20 min to 40 min.

[0020] Wherein, in step 2), the extraction temperature is 65° C.-85° C., and the extraction time is 0.5-3 h.

[0021] The present invention also includes the use of the traditional Chinese medicine preparation in the preparation of hypoglycemic and / or lipid-lowering drugs or foods.

[0022] The food includes but is not limited to herbal beverages. The herbal beverage prepared by the present invention has the ability to inhibit sugar and fat related digestive enzymes.

[0023] The scientific basis of the Chinese medicine preparation of the present invention is as follows:

[0024] (1) Theoretical basis of traditional Chinese medicine:

[0025] ①Replacement basis: Lotus leaf is bitter and flat, and it belongs to the heart, liver, spleen, gallbladder, and lung meridians. It has the effects of clearing away heat and dampness, promoting the smoothness of yang, and stopping blood lipids. Platycodon grandiflorum is bitter and pungent, flat, and belongs to the lung meridian. It has the effects of clearing the lungs, relieving throat, removing phlegm, and expelling pus. In addition, red beans are sweet and sour, flat in nature, and belong to the heart and small intestine meridians. It has the effects of promoting diuresis and reducing swelling, detoxifying and expelling pus. Alpinia oxyphylla is pungent and warm in nature. It belongs to the spleen and kidney meridians. It has the effect of warming the spleen, stomach, and kidneys. The combination of the four has the effects of removing phlegm and dampness, warming the spleen and promoting diuresis, and can better replace French Pinellia from the perspective of the science of traditional Chinese medicine prescriptions.

[0026] ② Basis of prescription: This prescription is based on Erchen Decoction, but without Pinellia, and with Platycodon grandiflorum, lotus leaf, red bean and Alpinia oxyphylla. It has the functions of drying dampness and strengthening the spleen, promoting qi and lowering turbidity. Tangerine peel in the prescription is bitter, pungent and warm, good at drying dampness, strengthening the spleen and resolving phlegm, regulating qi and removing stagnation, and is the main medicine; Poria cocos and red bean are sweet and mild, sweet enters the spleen and can strengthen the spleen and benefit the stomach, and mild penetration can promote dampness and move downward; Platycodon grandiflorum is bitter, pungent and mild, bitter can dry dampness, and pungent can move upward to clear the lungs and eliminate phlegm. The three help tangerine peel to promote dampness and eliminate phlegm, and are collectively the ministerial medicines; lotus leaf eliminates dampness, awakens the spleen and raises clearness, ginger harmonizes the stomach and reduces adverse reactions, eliminates phlegm and stops vomiting, black plum is sour and astringes lung qi, and protects stomach yin, and Alpinia oxyphylla is pungent and warm.

[0027] It warms the spleen, stomach and kidneys, and is also an adjuvant. Roasted licorice is an adjuvant, strengthening the spleen and harmonizing the middle, and coordinating all the medicines.

[0028] (2) Theoretical basis of modern food nutrition, function, medicine, etc.

[0029] French Pinellia mainly contains alkaloids, organic acids, polysaccharides and other ingredients, which have antitussive and expectorant, sedative, anti-tumor, anti-inflammatory and other pharmacological effects. Lotus leaf is rich in alkaloids and has the effect of lowering blood lipids and regulating metabolic syndrome. Platycodon grandiflorum is rich in saponins, flavonoids and organic acids, which have the effects of clearing the lungs and removing phlegm and strong anti-inflammatory and antioxidant effects. Adzuki beans are rich in saponins, flavonoids and organic acids, and have strong antioxidant capacity. Alpinia oxyphylla is rich in a variety of terpenoid compounds and polysaccharides, which have anti-inflammatory, antioxidant and immune-regulating effects. The combination of the four can effectively replace French Pinellia in terms of ingredients, functions and medical theory.

[0030] Beneficial effects:

[0031] 1. The present invention uses lotus leaf, tangerine peel, platycodon, poria and other medicinal and edible homologues as raw materials, and obtains a Chinese medicine liquid that can effectively inhibit the activity of sugar and fat related digestive enzymes through processes such as powdering and extraction. In vitro experiments show that the Chinese medicine liquid not only has a good inhibitory ability for sugar metabolism related enzymes including α-amylase and α-glucosidase, but also has a high inhibitory ability for pancreatic lipase and cholesterol esterase that digest fat, and the inhibitory ability is better than the inhibitory ability of a variety of reported single medicinal and edible homologues extracts, and is better than the inhibitory ability of the classic prescription Erchen Decoction and the food-grade basic prescription of Erchen Decoction (removing the Chinese medicine method Pinellia). In vivo experiments show that the Chinese herbal liquid also has a good inhibitory ability on the sugar and lipid-related enzyme activities in the intestines of obese rats. After consumption, it can reduce the levels of total cholesterol (TC), total triglycerides (TG), high-density lipoprotein (HDL-C), low-density lipoprotein (LDL-C), blood sugar (GLU) in serum, and TC and TG in the liver; the total sugar and lipid in the rat feces are significantly increased. The Chinese herbal liquid can effectively reduce the digestion and absorption of energy substances in rats and effectively reduce the blood sugar and blood lipid disorders caused by obesity. Animal experiments show that the ability of this Chinese herbal liquid to inhibit sugar and lipid-related digestive enzymes and regulate blood sugar and blood lipid disorders is better than the regulatory effect of the first-line Chinese patent medicine Jiangzhiling Granules, and there is no significant difference in the regulatory effect with the classic prescription Erchen Decoction (p < 0.05).

[0032] 2. The best Chinese herbal liquid prepared by the present invention has the ability to inhibit the activities of α-amylase, α-glucosidase, pancreatic lipase and cholesterol esterase in vitro, and the inhibition rates are as high as 64.34%, 86.53%, 93.19% and 84.10%, respectively. Compared with the control group classic prescription Erchen Decoction, the inhibition rates are increased by 1.13 times, 1.21 times, 1.19 times and 1.27 times, respectively; the semi-inhibitory concentration (semi-inhibitory concentration, IC50) of the best Chinese herbal liquid prepared by the present invention for α-amylase, α-glucosidase, pancreatic lipase and cholesterol esterase are 5.04 mg / mL, 2.83 mg / mL, 1.80 mg / mL and 4.17 mg / mL, respectively. Compared with Erchen Decoction, the IC50 values ​​are reduced by 22.58%, 27.81%, 47.37% and 18.87%, respectively.

[0033] 3. The best Chinese medicine liquid prepared by the present invention has the ability to reduce the activity of α-amylase, α-glucosidase and pancreatic lipase in the intestine of rats. After taking the Chinese medicine liquid, the activity of α-amylase in rats decreased from 83.95U / mg prot to 60.00U / mg prot, α-glucosidase decreased from 228.81U / mg prot to 190.20U / mg prot, and pancreatic lipase decreased from 5090.93U / g prot to 2887.84U / g prot, compared with the positive control group Erchen Decoction, there was no significant difference. In addition, the Chinese medicine liquid prepared by the present invention also has the ability to reduce high levels of blood sugar, blood lipids and liver fat caused by a high-fat diet. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 The α-glucosidase inhibition ability and dosage curve fitting diagram of formula 1, formula 2 and formula 3;

[0035] Figure 2 The α-amylase inhibition ability and dosage curve fitting diagram of formula 1, formula 2 and formula 3;

[0036] Figure 3 The pancreatic lipase inhibition ability and dosage curve fitting diagram of formula 1, formula 2 and formula 3;

[0037] Figure 4 The cholesterol esterase inhibition ability and dosage curve fitting diagram of formula 1, formula 2 and formula 3;

[0038] Figure 5 It is the activity of lipase, α-amylase and α-glucosidase in rat intestine;

[0039] Figure 6 It is the content of total sugar, total cholesterol and total triglyceride in rat feces;

[0040] Figure 7 is the rat body weight and food effect ratio;

[0041] Figure 8 The total cholesterol, total triglyceride, high-density lipoprotein, low-density lipoprotein and blood glucose levels in the rats' blood;

[0042] Fig. 9 Total cholesterol and total triglyceride levels in rat liver. DETAILED DESCRIPTION

[0043] The present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0044] The present invention finds through comparative studies that the traditional Chinese medicine preparation has a better effect of inhibiting digestive enzyme activity in vitro, and uses animal experiments to study the digestive enzyme inhibitory effect and weight loss and lipid-lowering effect of the traditional Chinese medicine preparation of the present invention in obese rats.

[0045] The present invention first uses Erchen Decoction as a positive control and food-grade Erchen Decoction without Pinellia tuber as a basic control to determine the ability of the Chinese medicine preparation to inhibit digestive enzymes in vitro. The present invention carries out substitution schemes of 1, 2, 4 or more medicinal and edible homologues. The inhibitory effect of substitution schemes of more than 4 ingredients decreases significantly, so only the results of substitution schemes of 1, 2 and 4 medicinal and edible homologues are shown.

[0046] Then, rats were fed with a high-fat diet for 4 weeks to establish a simple obesity rat model induced by a high-fat diet, and Jiangzhiling tablets (National Medicine Standard Z50020125) for treating hyperlipidemia were used as positive control 1, the original recipe of Erchen Decoction was used as positive control 2, and the food-grade basic recipe of Erchen Decoction was used as control 3. The Chinese medicine preparation of the present invention and Jiangzhiling tablets were gavaged for 4 weeks, and the activities of α-amylase, α-glucosidase and pancreatic lipase in the duodenal chyme of rats were determined, and fresh feces of rats were collected to determine the energy content therein. The weight changes and dietary intake of rats were recorded, TG, TC, HDL-C and LDL-C in rat serum were determined, and the TC and TG levels of liver homogenate were determined to evaluate its weight loss and lipid-lowering effects.

[0047] Preparation of Chinese medicine preparations with different ratios in Examples 1 to 3 and Comparative Examples 1 to 10

[0048] Different Chinese medicine preparations were prepared according to the formulas and mass ratios shown in Table 1.

[0049] Table 1

[0050]

[0051]

[0052] In 1500kg of deionized water, add 100kg of the above 15 groups of edible and medicinal powder mixtures while stirring, mix well, soak at room temperature with stirring for 30min, heat to 85℃ and extract for 1h, then centrifuge the extracted mixture (4500rpm, 20min) to obtain an extract, treat it with sterilization or sterilization methods such as 135℃ / 5S, 95℃ / 15min, and cool it for use to obtain a Chinese medicine liquid.

[0053] Example 4 Determination of in vitro digestive enzyme inhibition ability

[0054] (1) Inhibition of α-amylase

[0055] 50 μL of the Chinese medicine liquid of Examples 1 to 3 and Comparative Examples 1 to 10 and 50 μL of 3 U / mL α-amylase aqueous solution were added to a 1.5 mL centrifuge tube, incubated at 37°C for 10 min, and 50 μL of 5 mg / mL soluble starch solution was added and incubated for 10 min. Then, the enzyme was inactivated in a 90°C water bath for 1 min, 100 μL of DNS reagent solution (containing 5.31 mol / L potassium sodium tartrate, 96 mmol / L 3,5 dinitrosalicylic acid and 2 mol / L sodium hydroxide) was added to the above solution, and the mixture was placed in a 90°C water bath for 10 min, and finally the mixture was diluted with 900 μL of distilled water. 200 μL of the dilution was taken to detect its absorbance at 540 nm.

[0056] α-amylase inhibition rate % = 1-(A sample -A blank ) / (A test -A control )

[0057] A sample Indicates the absorbance of the sample (traditional Chinese medicine liquid + enzyme + soluble starch); A blank is the blank absorbance (traditional Chinese medicine liquid + enzyme + 50μL distilled water); A test To test absorbance (traditional Chinese medicine liquid + soluble starch + 50μL distilled water); A control is the model absorbance (enzyme + 100 μL distilled water). The inhibitory capacity of α-amylase of the sample diluted 10 times is shown in the following table.

[0058] The in vitro α-amylase inhibition ability of the Chinese medicine liquid after dilution 10 times is shown in Table 2. As shown in Table 2, the Chinese medicine liquid prepared in Example 2 reached 60.04%, the Chinese medicine liquid prepared in Example 3 reached 63.45%, and the Chinese medicine liquid prepared in Example 1 reached the highest 64.34%. Compared with the original recipe of Erchen Decoction, the inhibition ability was significantly improved to 1.13 times (p < 0.05), and compared with the food-grade basic recipe, it was significantly improved by 1.17 times, and had a more outstanding ability to inhibit α-amylase activity in vitro.

[0059] Table 2 Summary of the in vitro α-amylase inhibition ability of various Chinese medicine preparations

[0060]

[0061]

[0062] Determine the α-amylase inhibition rate of Erchen Decoction original recipe, Erchen Decoction food-grade basic recipe and Erchen Decoction alternative recipe at different concentrations, and draw the dose-α-amylase inhibition rate curve Figure 1, and its IC50 value was determined. The results are shown in Table 3. The inhibitory ability of the Chinese medicine liquid prepared in Example 1 was significantly improved compared with the original prescription and the basic prescription (p < 0.05), and the IC50 value was reduced to 5.04 ± 0.31 mg / mL.

[0063] Table 3 Comparison of IC50 values ​​of different Chinese medicine preparations for inhibiting α-amylase

[0064]

[0065] (2) Inhibition of α-glucosidase

[0066] 50 μL of the Chinese medicine liquid of Examples 1 to 3 and Comparative Examples 1 to 10 and 50 μL of α-glucosidase (PBS, pH 6.8, 0.1 mol / L) at a concentration of 3.38 U / mL were incubated at 37° C. for 10 min, and 50 μL of 2.5 mmol / L 4-nitrobenzene-α-D-pyranoglucoside (pNPG) was incubated at 37° C. for 20 min. 80 μL of Na2CO3 at a concentration of 0.2 mol / L was added to the mixture to terminate the reaction. The absorbance of the mixture was measured at 405 nm.

[0067] α-glucosidase inhibition rate % = 1-(A sample -A blank ) / (A test -A control )

[0068] A sample Indicates the absorbance of the sample (traditional Chinese medicine liquid + enzyme + pNPG); A blank is the blank absorbance (traditional Chinese medicine liquid + enzyme + 20μL PBS); A test To test absorbance (enzyme + pNPG + 20 μL distilled water); A control It is the model absorbance (enzyme+20μL PBS+20μL distilled water).

[0069] The in vitro α-glucosidase inhibition ability of the Chinese medicine liquid after dilution 10 times is measured as shown in Table 4. The inhibition ability of the Chinese medicine liquid (Formula 3) prepared in Example 1 is as high as 86.53%, which is significantly higher than the other groups (p < 0.05) compared with the original formula of Erchen Decoction, and is 1.21 times higher than the food-grade basic formula of Erchen Decoction. Therefore, the Chinese medicine liquid prepared by the present invention has a more prominent in vitro α-glucosidase inhibition ability.

[0070] Table 4 List of in vitro α-glucosidase inhibition abilities of various Chinese medicine preparations

[0071]

[0072] Determine the α-glucosidase inhibition rate of the original Erchen Decoction, the food-grade basic Erchen Decoction, and the Erchen Decoction substitute at different concentrations, and draw the dose-α-glucosidase inhibition rate curve Figure 2 The IC50 value was determined and the results are shown in Table 5. The IC50 value of the herbal beverage reached 2.83 mg / mL, which was significantly lower than that of the basic formula (p < 0.05).

[0073] Table 5 Comparison of IC50 values ​​of different Chinese medicine preparations for inhibiting α-glucosidase

[0074]

[0075] (3) Inhibition of pancreatic lipase

[0076] 50 μL of the Chinese medicine liquid of Examples 1 to 3 and Comparative Examples 1 to 10 and 50 μL of pancreatic lipase solution were added to a 96-well plate, incubated at 37° C. for 10 min, then 50 μL of 2 mg / mL pNPB was added and incubated for another 20 min, and the absorbance was detected at 405 nm.

[0077] Inhibition rate (%) = 1-(A sample -A blank ) / (A test -A control )

[0078] A sample is the absorbance of the sample after reaction (traditional Chinese medicine liquid + pancreatic lipase + pNPB); A blank is the blank absorbance (traditional Chinese medicine liquid + buffer + pNPB); A test To test absorbance (distilled water + pancreatic lipase + pNPB);

[0079] A control To control absorbance (distilled water + buffer + pNPB).

[0080] The inhibitory ability of the Chinese medicine liquid after dilution 10 times of in vitro pancreatic lipase is shown in Table 6. The inhibition rate of the Chinese medicine liquid (Formula 3) prepared in Example 1 of the present invention is as high as 93.19%, which is 1.19 times higher than that of the original formula of Erchen Decoction, and 1.13 times higher than that of the food-grade basic formula of Erchen Decoction, and has a high inhibitory ability.

[0081] Table 6 In vitro pancreatic lipase inhibition ability of various Chinese medicine preparations

[0082]

[0083] Determine the pancreatic lipase inhibition rate of Erchen Decoction original recipe, Erchen Decoction food-grade basic recipe and Erchen Decoction alternative recipe at different concentrations, and draw the curve of dose and pancreatic lipase inhibition rate Figure 3 The IC50 value was determined, and the results are shown in Table 7. The IC50 value of the prepared Chinese medicine liquid (Formula 3) of Example 1 was significantly lower than that of the original Erchen Decoction and the food-grade basic formula (p < 0.05), reaching 1.80 mg / mL.

[0084] Table 7 Comparison of IC50 values ​​of pancreatic lipase inhibition rate of Chinese medicine preparations with different formulas

[0085]

[0086]

[0087] (4) Cholesterol esterase inhibition

[0088] 50 μL of the Chinese medicine liquid of Examples 1 to 3 and Comparative Examples 1 to 10 and 50 μL of pNPB solution were mixed and incubated at 37° C. for 10 min. Then 50 μL of 0.163 U / mL cholesterol esterase was added and incubated at 37° C. for 20 min. The absorbance of the above mixture was detected at 405 nm.

[0089] Inhibition rate (%) = 1-(A sample -A blank ) / (A test -A control )

[0090] A sample is the absorbance of the sample after reaction (traditional Chinese medicine liquid + cholesterol esterase + pNPB); A blank is the blank absorbance (traditional Chinese medicine liquid + buffer + pNPB); A test To test absorbance (distilled water + cholesterol esterase

[0091] +pNPB); A control To control absorbance (distilled water + buffer + pNPB).

[0092] The in vitro cholesterol esterase inhibition ability of the Chinese herbal liquid of the present invention after dilution 10 times is measured as shown in the following table. The Chinese herbal liquid (formula 3) prepared in Example 1 of the present invention has an inhibition rate of up to 84.10% on cholesterol esterase, which is significantly higher than the other groups except for formula 6 and formula 13. Compared with the original formula of Erchen Decoction, the Chinese herbal liquid prepared in Example 1 of the present invention is increased to 1.27 times, and compared with the food-grade basic formula of Erchen Decoction, the Chinese herbal liquid prepared in Example 1 of the present invention is increased to 1.73 times, which shows that this herbal beverage has a more prominent cholesterol esterase inhibition ability.

[0093] Table 8 In vitro inhibition of cholesterol esterase by various Chinese medicine preparations

[0094]

[0095]

[0096] Determine the pancreatic lipase inhibition rate of Erchen Decoction original recipe, Erchen Decoction food-grade basic recipe and Erchen Decoction alternative recipe at different concentrations, and draw the dose-pancreatic lipase inhibition rate curve Figure 4 , and its IC50 value was determined, and the results are shown in Table 9. The IC50 value of the Chinese medicine liquid agent (Formula 3) of Example 1 of the present invention is significantly lower than that of the food-grade basic formula (p < 0.05), and has a higher cholesterol inhibition effect.

[0097] Table 9 Comparison of IC50 values ​​of cholesterol esterase inhibition rate of Chinese medicine preparations with different formulas

[0098]

[0099] The above in vitro results show that the Chinese medicine liquid preparation of Example 1 has a more prominent in vitro glycolipid digestive enzyme inhibitory effect in vitro and has the potential to reduce weight and reduce blood lipids.

[0100] Example 5 Determination of Glucose and Lipid Digestive Enzyme Inhibition and Lipid-Lowering Efficacy in Mice

[0101] (1) Preparation of the positive control group intragastric solution: Take 5 Jiangzhiling granules, crush them and dissolve them in 32 mL of normal saline. Prepare and use immediately.

[0102] (2) Animal grouping and simple obesity rat modeling

[0103] Twenty-five healthy SPF Wistar male rats aged 4-5 weeks were selected. The laboratory adopts 12h light and dark rotation lighting, has good ventilation and sanitary conditions, room temperature is 22±2℃, and humidity is 60±5%. Before the formal administration, the experimental rats were fed with environmental adaptation common feed (20% flour, 10% rice flour, 20% corn, 26% drum skin, 20% bean feed, 2% fish meal, 2% bone meal) for 1 week, during which the mice were free to eat standard diet and drink water.

[0104] Then, the 25 rats were divided into 5 groups. There was no significant difference in the average body weight among the groups (p>0.05). The blank group continued to be fed with ordinary feed, and the other groups were fed with high-fat feed (78.80% high-fat feed, 10% lard, 10% egg yolk powder, 1% cholesterol, 0.2% bile salt). After 4 weeks of modeling, the positive control group and the experimental group were given Jiangzhiling granules (dose of 392 mg / kg / d), the traditional Chinese medicine liquid Hechen Decoction (HCT) of formula 3, the classic prescription Erchen Decoction, and the blank group and the model group were given normal saline for gavage, and the gavage dose was 1 mL / 100 g·d -1 The intervention time was 4 weeks. The groups and treatments are shown in Table 10.

[0105] Table 10 Animal experiment groups

[0106]

[0107] (3) Digestive enzyme inhibition

[0108] Lipase, α-amylase and α-glucosidase secreted by the pancreas are responsible for the digestion of carbohydrates and lipids in the intestine. Inhibiting their activity will effectively block the digestion and absorption of carbohydrates and lipids, thereby achieving the effect of reducing energy intake. The chyme of the rat duodenum was prepared into a homogenate and the activity of α-amylase, α-glucosidase and lipase was measured. The results are as follows Figure 5 As shown. Figure 5 It can be seen that after feeding with a high-fat diet, the digestive enzyme activity in the intestine of the model group increased significantly (p < 0.05). After 4 weeks of intervention, the α-amylase, α-glucosidase and pancreatic lipase in the HCT group decreased significantly compared with the model group (p < 0.05). The α-amylase decreased from 83.95 ± 1.43 U / mg prot to 60.00 ± 0.36 U / mg prot, and there was no significant difference compared with the positive control group ECT. α-glucosidase 228.81 ± 10.60 U / mg prot decreased to 190.20 ± 7.39 U / mg prot, and there was no significant difference compared with the positive control group ECT. Pancreatic lipase 5090.93 ± 126.31 U / g prot decreased to 2887.84 ± 294.72 U / g prot, and there was no significant difference compared with the positive control group ECT. This shows that the Chinese medicine liquid of the present invention has the function of inhibiting glycolipid digestive enzymes.

[0109] (4) Energy content of rat feces

[0110] Feces of rats were collected within 12 hours, dried at 60°C to constant weight, accurately weighed, and dissolved in water at a mass ratio of 1:10. The total sugar content was determined using the phenol-sulfuric acid method, and the TC and TG contents in the feces were determined using the Nanjing Jiancheng kit. The results were as follows: Figure 6As shown. The results showed that 4 weeks of high-fat diet significantly increased the TC and TG content in the feces of the model group (p < 0.05), while there was no significant difference in total sugar content (p > 0.05). However, after 4 weeks of HCT intervention, the total sugar, TC and TG content in the feces were significantly increased (p < 0.05), which was consistent with the enzyme activity results. High inhibition of enzyme activity resulted in the indigestion of sugars and lipids and their direct excretion from the body. This shows that HCT can inhibit the digestion and absorption of energy substances carbohydrates and lipids by inhibiting the activity of sugar and lipid digestion enzymes.

[0111] (5) Body weight and food effect ratio of rats

[0112] The rats were weighed weekly, and the weight change trend was plotted. The rats' food intake was recorded every day. The food effect ratio = weight gain (mg) / food intake (g). The results of weight and food effect ratio of different groups are shown in the figure. Figure 7 As shown. Figure 7 The results of ab showed that after high-fat diet feeding, the weight gain rate of rats accelerated, reaching 393.70±15.41g in the eighth week, which was significantly higher than 330.49±18.95g in the blank group (p<0.05). However, after 4 weeks of intervention with liquid Chinese medicine HCT, the weight gain slowed down, reaching 350.42±7.80g in the eighth week, which was significantly lower than that in the model group (p<0.05).

[0113] 0.05), and there was no significant difference with the positive control group JZLKL and ECT (p>0.05), which showed that HCT had a significant weight loss effect. Figure 7 c It can be seen that the effect ratio of high-fat diet is significantly higher than that of the blank group (p < 0.05) because more lipid substances are added. After intervention, its food effect ratio decreased significantly (p < 0.05), from 176.02 ± 6.77 mg / g to 110.34 ± 4.94 mg / g, and the effect was significantly better than that of the positive control groups JZLKL and ECT (p < 0.05).

[0114] (6) Rat blood biochemical analysis

[0115] At the end of the experiment, all rats were fasted for 12 hours. After ether anesthesia, the eyeballs were immediately removed to collect blood. The collected blood was incubated in a 37°C incubator for 30 minutes and centrifuged at 3500 rpm and 4°C for 10 minutes to separate the serum. The levels of TG, TC, HDL-C and LDL-C were analyzed by Hitachi 7020 fully automatic biochemical analyzer. The results are as follows Figure 8 As shown. Figure 8From ab, we can see that the TC and TG contents in the model group were significantly higher than those in the blank group (p < 0.05). After 4 weeks of HCT intervention, the TC and TG values ​​were significantly reduced (p < 0.05), from 2.42 ± 0.06 mmol / L and 2.59 ± 0.01 mmol / L to 2.14 ± 0.09 mmol / L and 1.29 ± 0.13 mmol / L, respectively. There was no significant difference with the positive control group. In addition, HCT intervention also significantly improved HDL-C and LDL-C (p < 0.05). HDL-C increased from the original 0.48 ± 0.05 mmol / L to 0.63 ± 0.07, and LDL-C decreased from 0.47 ± 0.04 mmol / L to 0.31 ± 0.03 mmol / L. There was no significant difference with the positive control group. This shows that HCT has a good effect in lowering blood lipids. In addition, Figure 8 It can be seen that HCT intervention can significantly reduce blood sugar content (p < 0.05), from 8.15mmol / L to 6.07mmol / L. There is no significant difference with the positive control group. This shows that HCT has a good effect in lowering blood sugar.

[0116] (7) Liver fat level

[0117] In an ice water bath, the liver tissue was homogenized in a 0.9% sodium chloride solution (1:9, w / v), and then centrifuged at 3500 rpm for 15 min, and the supernatant was taken for use. TG and TC were analyzed by Hitachi 7020 fully automatic biochemical analyzer. The results were as follows: Fig. 9 As shown. As can be seen from the figure, the liver fat level in the model group was significantly higher than that in the blank group (p < 0.05), which indicates that high-fat diet feeding leads to lipid accumulation in the rat liver. After 4 weeks of HCT intervention, the TC and TG values ​​were significantly lower than those in the model group (p < 0.05), among which TC decreased from 3.30 ± 0.16 mmol / L to 2.08 ± 0.18 mmol / L, and TG decreased from 14.08 ± 0.61 mmol / L to 12.16 ± 0.69 mmol / L. There was no significant difference with the positive control group. This shows that the Chinese medicine liquid of the present invention has a good lipid-lowering effect.

Claims

1. A Chinese medicine preparation, characterized in that: The Chinese medicine preparation comprises the following components by weight: 6-12 parts of lotus leaves, 6-12 parts of platycodon grandiflorum, 6-12 parts of tangerine peel, 4-8 parts of tuckahoe, 2-5 parts of red bean, 2-4 parts of oxyphylla, 2-5 parts of liquorice, 2-5 parts of ginger and 0.5-2 parts of black plum.

2. The Chinese medicine preparation according to claim 1, characterized in that: The Chinese medicine preparation comprises the following components by weight: 6-9 parts of lotus leaves, 6-9 parts of platycodon grandiflorum, 6-9 parts of tangerine peel, 6-8 parts of poria cocos, 2-5 parts of red beans, 2-4 parts of oxyphylla, 2-5 parts of liquorice, 2-5 parts of ginger, and 1-2 parts of black plum.

3. The Chinese medicine preparation according to claim 1, characterized in that: The Chinese medicine preparation comprises the following components by weight: 9 parts of lotus leaves, 6 parts of platycodon grandiflorum, 6 parts of tangerine peel, 6 parts of poria cocos, 2 parts of red beans, 2 parts of alkyl oxyphylla seeds, 3 parts of liquorice, 3 parts of ginger and 1 part of black plum.

4. The method for preparing the Chinese medicine preparation according to any one of claims 1 to 3, characterized in that: The following steps are involved: 1) Weigh lotus leaves, platycodon grandiflorum, tangerine peel, poria cocos, red bean, alpinia oxyphylla, licorice, ginger, and ebony according to the above mass parts, put them into a traditional Chinese medicine grinder, grind them thoroughly, and sieve the powder; 2) Soaking the mixture treated in step 1) in water at room temperature, extracting, filtering or centrifuging to obtain an extract, and then sterilizing or disinfecting it for later use.

5. The method for preparing the Chinese medicine preparation according to claim 4, characterized in that: Step 1) The powder is passed through a 60-80 mesh sieve.

6. The method for preparing the Chinese medicine preparation according to claim 4, characterized in that: The weight ratio of the material to the liquid in step 2) is 1:10 to 1:

20.

7. The method for preparing the Chinese medicine preparation according to claim 4, characterized in that: The soaking time in step 2) is 20 min to 40 min.

8. The method for preparing the Chinese medicine preparation according to claim 4, characterized in that: In step 2), the extraction temperature is 65°C-85°C, and the extraction time is 0.5-3 h.

9. Use of the Chinese medicine preparation according to any one of claims 1 to 3 in the preparation of hypoglycemic and / or lipid-lowering drugs or foods.

10. The use according to claim 9, characterized in that: The food includes beverages.

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