A tea-based fat-reducing formula and its preparation method

Abstract

The present invention discloses a tea-based fat-reducing formula and its preparation method. The tea-based fat-reducing formula of the present invention is composed of eight traditional Chinese medicines, namely, tea tree roots, Atractylodes lancea, Gynostemma pentaphyllum, Ilex cornuta leaves, Alisma orientale, lotus leaf, hawthorn, and Polygonum orientale L. The compatibility principle is as follows: The tea tree roots are the monarch drug, clearing heat and detoxifying, promoting blood circulation and regulating menstruation; Atractylodes lancea is the ministerial drug, drying dampness and strengthening the spleen, regulating qi and harmonizing the middle energizer; Gynostemma pentaphyllum and Ilex cornuta leaves are the ministerial drugs, clearing heat and detoxifying, protecting the liver and reducing fat, nourishing yin and tonifying the kidney; Alisma orientale, lotus leaf, and Polygonum orientale L. are the adjuvant drugs, promoting diuresis and clearing heat, resolving turbidity and reducing fat, removing stasis and dispersing accumulation; Hawthorn strengthens the spleen and promotes qi movement, resolving turbidity and reducing fat; The method includes the following steps: mixing the raw materials in proportion and pulverizing them to 80 mesh; (b) decocting the mixed traditional Chinese medicine powder twice with water, adding 12 times the amount of water for the first decoction for 1 hour, adding 10 times the amount of water for the second decoction for 1 hour, combining the decoction liquids, filtering, and concentrating the filtrate under reduced pressure to a relative density of 1.08 - 1.12; spray-drying the concentrated liquid to obtain tea-based fat-reducing granules.

Description

Technical Field

[0001] The present invention relates to the technical field of the preparation of a traditional Chinese medicine tea formula for reducing fat, and specifically to a tea formula for reducing fat and its preparation method. Background Art

[0002] Non-alcoholic fatty liver disease (NAFLD) is a common metabolic liver disease, associated with diseases such as obesity and insulin resistance, imposing a heavy burden on human health and social economy. Currently, there is a lack of effective therapeutic drugs, which is a research hotspot in the international academic community and pharmaceutical companies.

[0003] Traditional Chinese medicine, as a treasure of traditional Chinese medicine in our country, has unique advantages in preventing and treating chronic metabolic diseases. In traditional Chinese medicine theory, it is considered that the causes of NAFLD are mainly related to congenital deficiency, acquired imbalance, emotional discomfort, and improper work and rest. Its disease location is mainly in the liver and is closely related to the spleen. Its pathogenesis is due to the dysfunction of the liver and spleen, resulting in the endogenous accumulation of dampness, heat, phlegm, and stasis in the liver.

[0004] Therefore, we propose a tea formula for reducing fat and its preparation method. Summary of the Invention

[0005] The purpose of the present invention is to provide a tea formula for reducing fat and its preparation method, which has the advantages of optimizing the content and transfer rate of active ingredients, improving the effect and safety of reducing fat and losing weight, and solving the problems of unstable quality and unsatisfactory effect of the existing tea formula for reducing fat.

[0006] To achieve the above purpose, the present invention provides the following technical solution: A tea formula for reducing fat, comprising the following traditional Chinese medicine components: tea tree root, atractylodes rhizome, gynostemma pentaphyllum, ilicifolia leaf, alisma orientale, lotus leaf, hawthorn, polygonum orientale, and each medicine is formulated according to a ratio. Among them, the tea tree root is the monarch drug, atractylodes rhizome, gynostemma pentaphyllum, and ilicifolia leaf are the ministerial drugs, and alisma orientale, lotus leaf, hawthorn, and polygonum orientale are the adjuvant drugs.

[0007] Preferably, the ratio of the traditional Chinese medicine components is: tea tree root 15g, atractylodes rhizome 15g, gynostemma pentaphyllum 15g, ilicifolia leaf 15g, alisma orientale 9g, lotus leaf 6g, hawthorn 6g, polygonum orientale 3g.

[0008] Preferably, the tea formula for reducing fat contains nuciferine, atractylodin, 23-acetyl-alisol B, taxifolin components, and the content of nuciferine is 0.01% - 0.05%, and the total content of atractylodin, 23-acetyl-alisol B, and taxifolin is 0.8% - 2.0%.

[0009] Preferably, the total content of taxifolin is 1.0% - 1.5%.

[0010] Preferably, the tea tree root, atractylodes, gynostemma pentaphyllum, holly leaf, oriental water lily, lotus leaf, hawthorn, and polyanthus orientalis fruit are all dried Chinese medicinal materials, which are crushed or sliced before use, and their particle size is between 0.5 and 2 mm.

[0011] A method for preparing a tea-based fat-reducing prescription comprises the following steps: (a) mixing tea tree roots, atractylodes lancea, gynostemma pentaphyllum, holly leaves, oriental rhizome, lotus leaves, hawthorn fruit, and safflower fruit in a certain proportion and grinding the mixture into 80 meshes; (b) decocting the mixed Chinese medicinal powder twice with water, the first time adding 12 times the amount of water and decocting for 1 hour, and the second time adding 10 times the amount of water and decocting for 1 hour, combining the decoctions, filtering, and concentrating the filtrate under reduced pressure (75±5°C) to a relative density of 1.08 to 1.12 (70°C); and (c) spray-drying the concentrated solution to obtain tea-based fat-reducing granules.

[0012] Preferably, the spray drying conditions are: feed temperature of 150-160°C, discharge temperature of 80-90°C, feed rate of 10-15 ml / min, nozzle pressure of 0.2-0.3 MPa, rotation speed of 20,000-25,000 rpm, drying tower diameter of 1.2 m, and height of 3.6 m.

[0013] Preferably, the cream yield of the tea-shaped fat-reducing granules is 24% to 28%, and the transfer rate of nuciferine is 30% to 35%.

[0014] Preferably, the particle size of the tea-shaped fat-reducing granules is 40 to 80 meshes, the moisture content does not exceed 5%, the total ash does not exceed 10%, and the acid-insoluble ash does not exceed 2%.

[0015] Preferably, the quality standard of the tea-axula fat-reducing granules is: tested in accordance with the quality control specifications for traditional Chinese medicine granules, wherein the content of nuciferine is not less than 0.2 mg / g, the content of atractylodesin is not less than 0.1 mg / g, the content of 23-acetyl alismatin B is not less than 0.05 mg / g, and the content of taxifolin is not less than 0.01 mg / g.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] 1. The present invention adopts the spray drying method to prepare the tea fat-reducing granules, which have good solubility, stability and portability;

[0018] 2. The combination of all the herbs in the formula targets the symptoms of spleen deficiency, damp-heat and phlegm, turbidity and blood stasis, strengthening the spleen and clearing away heat, regulating qi and drying dampness, resolving turbidity and lowering lipids, reflecting the TCM concept of "treating both the symptoms and the root cause";

[0019] 3. The present invention improves the lipid-lowering and weight-loss effect and safety of the Tea-Shu Fat-Reducing Granules by optimizing the content and transfer rate of the active ingredients. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 Base peak ion chromatogram of the tea art lipid-reducing formula sample by UPLC-HRMS - negative ion mode;

[0021] Figure 2 Base peak ion chromatogram of the tea art lipid-reducing formula sample by UPLC-HRMS - positive ion mode;

[0022] Figure 3 UPLC ultraviolet chromatogram of the tea art lipid-reducing formula sample - UV 300nm;

[0023] Figure 4 Base peak ion chromatogram of the serum sample of the tea art lipid-reducing formula by UPLC-HRMS - negative ion mode;

[0024] Figure 5 Base peak ion chromatogram of the serum sample of the tea art lipid-reducing formula by UPLC-HRMS - positive ion mode;

[0025] Figure 6 Extracted ion chromatogram of the serum sample of the tea art lipid-reducing formula by UPLC-HRMS - negative ion mode;

[0026] Figure 7 Extracted ion chromatogram of the serum sample of the tea art lipid-reducing formula by UPLC-HRMS - positive ion mode;

[0027] [[ID=3?]] Figure 8 Schematic diagram of the body weight of the mice in the present invention;

[0028] Figure 9 Schematic diagram of the liver weight and liver-body ratio of the mice in the present invention;

[0029] Figure 10 Schematic diagram of the blood lipid indexes of the mice in the present invention;

[0030] Figure 11 Schematic diagram of the liver function indexes of the mice in the present invention;

[0031] Figure 12 Schematic diagram of the insulin resistance of the mice in the present invention; <?

[0032] Figure 13 Schematic diagram of HE staining of the liver pathology of the mice in the present invention;

[0033] Figure 14 Schematic diagram of oil red O staining of the liver pathology of the mice in the present invention;

[0034] Figure 15 Schematic diagram of the traditional Chinese medicine components and ratios of the tea art lipid-reducing formula in the present invention;

[0035] Figure 16 Flow chart of the preparation method of the tea art lipid-reducing formula in the present invention. Detailed implementation mode

[0036] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0037] Please refer to Figures 1 to 16 , the present invention relates to a tea art fat-reducing formula and its preparation method. The tea art fat-reducing formula is composed of traditional Chinese medicine components such as tea tree roots, atractylodes rhizome, gynostemma pentaphyllum, ilicifolia leaves, alisma orientale, lotus leaves, hawthorn, and polygonum orientale, etc., which are formulated according to a certain proportion. It has the effects of clearing heat and detoxifying, promoting blood circulation and regulating menstruation, promoting diuresis and reducing swelling, reducing fat and losing weight, etc. It can effectively improve symptoms such as obesity, hyperlipidemia, and hypertension, and improve the health level of the human body. The present invention also provides a method for preparing the tea art fat-reducing formula. The method includes steps such as pulverizing, decocting, concentrating, and spray drying the traditional Chinese medicine components, which can ensure the quality and stability of the tea art fat-reducing formula, and at the same time facilitate the storage and use of the tea art fat-reducing formula;

[0038] A tea art fat-reducing formula includes the following traditional Chinese medicine components: tea tree roots, atractylodes rhizome, gynostemma pentaphyllum, ilicifolia leaves, alisma orientale, lotus leaves, hawthorn, and polygonum orientale. Each medicine is formulated according to a proportion. Among them, the tea tree root is the monarch drug, and atractylodes rhizome, gynostemma pentaphyllum, and ilicifolia leaves are the ministerial drugs, and alisma orientale, lotus leaves, hawthorn, and polygonum orientale are the adjuvant drugs.

[0039] The tea art fat-reducing formula of the present invention is based on traditional Chinese medicine theory and modern pharmacological research. Traditional Chinese medicine components with the effects of clearing heat and detoxifying, promoting blood circulation and regulating menstruation, promoting diuresis and reducing swelling, reducing fat and losing weight, etc. are selected and formulated according to the principle of monarch, minister, adjuvant, and envoy, forming a tea art fat-reducing formula with a synergistic effect. Among them, the tea tree root is the main drug of the present invention. It can clear heat and detoxify, promote blood circulation and regulate menstruation, and has a good therapeutic effect on obesity, hyperlipidemia, hypertension and other diseases. Atractylodes rhizome, gynostemma pentaphyllum, and ilicifolia leaves are the auxiliary drugs of the present invention. They can enhance the effects of the tea tree root in clearing heat and detoxifying, promoting blood circulation and regulating menstruation, and at the same time can also promote diuresis and reduce swelling, regulate water metabolism, and promote the excretion of excess fat in the body. Alisma orientale, lotus leaves, hawthorn, and polygonum orientale are the envoy drugs of the present invention. They can assist the effects of the tea tree root, atractylodes rhizome, gynostemma pentaphyllum, and ilicifolia leaves, and at the same time can also reduce fat and lose weight, inhibit fat synthesis, increase fat decomposition, improve blood lipid levels, and prevent the occurrence of atherosclerosis and cardiovascular diseases;

[0040] The proportion of the traditional Chinese medicine components is as follows: 15 g of tea tree roots, 15 g of atractylodes rhizome, 15 g of gynostemma pentaphyllum, 15 g of ilicifolia leaves, 9 g of alisma orientale, 6 g of lotus leaves, 6 g of hawthorn fruits, and 3 g of polygonum orientale fruits. The proportion of the traditional Chinese medicine components of the tea and atractylodes rhizome fat-reducing formula of the present invention is obtained through multiple tests and optimizations. This proportion can ensure the maximum extraction and transfer of the active ingredients of each medicine, and at the same time can also ensure the synergistic and balanced effects of each medicine, achieving the best tea and atractylodes rhizome fat-reducing effect.

[0041] The tea and atractylodes rhizome fat-reducing formula contains nuciferine, atractylodin, 23-acetylepisterol B, and taxifolin. The content of nuciferine is 0.01% - 0.05%, and the total content of atractylodin, 23-acetylepisterol B, and taxifolin is 0.8% - 2.0%. The tea and atractylodes rhizome fat-reducing formula of the present invention contains active ingredients such as nuciferine, atractylodin, 23-acetylepisterol B, and taxifolin. They can inhibit the synthesis and storage of fat from multiple aspects, promote the decomposition and consumption of fat, so as to achieve the purpose of reducing fat and losing weight. Specifically, nuciferine can affect the activities of fat synthase and lipase, and atractylodin, 23-acetylepisterol B, and taxifolin can affect the differentiation and proliferation of adipocytes, as well as the synthesis and uptake of fatty acids. These components work together to make the tea and atractylodes rhizome fat-reducing formula have a significant fat-reducing effect. The contents of the active ingredients such as nuciferine, atractylodin, 23-acetylepisterol B, and taxifolin in the tea and atractylodes rhizome fat-reducing formula of the present invention are obtained through multiple tests and optimizations. This content can ensure the effectiveness and safety of the tea and atractylodes rhizome fat-reducing formula, and at the same time can also avoid the problems of excessive or insufficient amounts, achieving the best tea and atractylodes rhizome fat-reducing effect. The total content of atractylodin, 23-acetylepisterol B, and taxifolin in the present invention is 0.8% - 2.0%, preferably 1.0% - 1.5%, and the total content of taxifolin is 1.0% - 1.5%, preferably 1.2% - 1.4%.

[0042] The tea tree roots, atractylodes rhizome, gynostemma pentaphyllum, ilicifolia leaves, alisma orientale, lotus leaves, hawthorn fruits, and polygonum orientale fruits are all dried traditional Chinese medicines. After being crushed or sliced, they are used, and their particle size is between 0.5 and 2 mm. The traditional Chinese medicine components of the tea and atractylodes rhizome fat-reducing formula of the present invention are all dried traditional Chinese medicines. This can ensure the stability and preservation of their active ingredients, and at the same time can also facilitate their crushing or slicing treatment, improving their extraction efficiency and transfer rate. The traditional Chinese medicine components of the tea and atractylodes rhizome fat-reducing formula of the present invention are used after being crushed or sliced, and their particle size is between 0.5 and 2 mm. This can ensure their uniform heating and full dissolution during decoction, and at the same time can also ensure their uniform drying and good fluidity during spray drying.

[0043] A preparation method of a tea art fat-reducing formula, comprising the following steps: (a) Mixing tea tree roots, atractylodes rhizome, gynostemma pentaphyllum, chinese holly leaves, alisma orientale, lotus leaves, hawthorn fruits, and polygonum orientale seeds in a certain proportion and pulverizing them to 80 mesh; (b) Decocting the mixed traditional Chinese medicine powder twice with water. For the first time, add 12 times the amount of water and decoct for 1 hour. For the second time, add 10 times the amount of water and decoct for 1 hour. Combine the decoction liquids, filter, and concentrate the filtrate under reduced pressure (75 ± 5 °C) to a relative density of 1.08 - 1.12 (70 °C); (c) Spray-drying the concentrated liquid to obtain tea art fat-reducing granules. The preparation method of the tea art fat-reducing formula of the present invention is obtained through multiple tests and optimizations. This method can ensure the quality and stability of the tea art fat-reducing formula, and at the same time facilitate the storage and use of the tea art fat-reducing formula. The preparation method of the tea art fat-reducing formula of the present invention comprises the following steps: (a) Mixing tea tree roots, atractylodes rhizome, gynostemma pentaphyllum, chinese holly leaves, alisma orientale, lotus leaves, hawthorn fruits, and polygonum orientale seeds in a certain proportion and pulverizing them to 80 mesh; This step is to mix the traditional Chinese medicine components of the tea art fat-reducing formula of the present invention in proportion, and then pulverize or slice them to below 80 mesh with a pulverizer or slicer to facilitate subsequent decoction and drying. (b) Decocting the mixed traditional Chinese medicine powder twice with water. For the first time, add 12 times the amount of water and decoct for 1 hour. For the second time, add 10 times the amount of water and decoct for 1 hour. Combine the decoction liquids, filter, and concentrate the filtrate under reduced pressure (75 ± 5 °C) to a relative density of 1.08 - 1.12 (70 °C);

[0044] This step is to decoct the traditional Chinese medicine powder of the tea art fat-reducing formula of the present invention twice with water to extract its active ingredients, and combine, filter, and concentrate the decoction liquids to facilitate subsequent drying. The specific operations of this step are as follows: Weigh a certain amount of the mixed traditional Chinese medicine powder, put it into a stainless steel decoction pot, add tap water with 12 times the amount of water, stir evenly, heat to boiling, maintain the boiling state, decoct for 1 hour, control the firepower to prevent overflow; Pour the decocted medicinal liquid into a stainless steel filter screen to filter out the dregs, collect the filtrate, and pour the filtrate into a stainless steel storage tank for standby; Put the filtered dregs back into the decoction pot again, add tap water with 10 times the amount of water, stir evenly, repeat the operation of step 1, decoct for 1 hour, filter out the dregs, collect the filtrate, and combine the filtrate with the filtrate of step 2 to obtain the combined decoction liquid; Pour the combined decoction liquid into a stainless steel evaporator, turn on the vacuum pump to reduce the pressure in the evaporator to about 0.05 MPa, control the temperature in the evaporator at 75 ± 5 °C, and perform concentration under reduced pressure until the relative density of the combined decoction liquid reaches 1.08 - 1.12 (70 °C). The measurement method is to measure the density of the combined decoction liquid at 70 °C with a densitometer and divide it by the density of water at 70 °C (0.9778 g / ml) to obtain the relative density;

[0045] (c) Spray drying the concentrated liquid to obtain tea-shaped fat-reducing granules. This step involves converting the concentrated liquid of the tea-shaped fat-reducing formula of the present invention into solid granules by spray drying for subsequent storage and use. The specific operations of this step are as follows: the concentrated liquid is removed from the storage tank and placed in a stainless steel sprayer. The sprayer is turned on and the concentrated liquid is sprayed out through a nozzle in the form of a high-speed airflow, forming fine droplets. The droplets rapidly evaporate in the air to form dry granules. The sprayed granules are collected in a stainless steel drying tower. The temperature and humidity in the drying tower are controlled by a temperature and humidity controller and maintained within an appropriate range to ensure the dryness and quality of the granules. The granules in the drying tower are screened by a stainless steel rotary screening machine. Particles with a particle size between 40 and 80 mesh are collected as tea-shaped fat-reducing granules. Particles with excessively large or small particle sizes are recovered and spray-dried or pulverized again. At this point, the preparation method of the tea-shaped fat-reducing formula of the present invention is completed, and tea-shaped fat-reducing granules are obtained. The granules are brownish-yellow, bitter and slightly sweet, have an herbal aroma, are easily soluble in water, and are convenient for brewing and drinking. The concentrated combined decoction is taken out from the evaporator and placed in a stainless steel storage tank for later use. The tea-shaped fat-reducing granules have a cream yield of 24% to 28%, preferably 25% to 27%, and a nuciferine transfer rate of 30% to 35%, preferably 31% to 33%.

[0046] Example 1: The purpose of this example is to optimize the extraction process of the Tea Atractylodes Sinensis Fat-Reducing Recipe. Since the Tea Atractylodes Sinensis Fat-Reducing Recipe is a traditional Chinese medicine preparation developed according to traditional technology, the yield of the paste during the extraction process is one of the indicators that must be paid attention to. In addition, the transfer rate of the active ingredient is also an important indicator. Through the investigation of the statutory quality standards of each medicinal ingredient in the prescription, it was found that the measurable indicators are: atractylodesin, 23-acetyl alismatol B, nuciferine and taxifolin. The study established the extraction process of the Tea Atractylodes Sinensis Fat-Reducing Recipe based on the yield of the paste during the extraction process and the transfer rate of nuciferine.

[0047] Water absorption

[0048] Experimental Method: Weigh 15g of tea tree root, 15g of atractylodes, 15g of gynostemma pentaphyllum, 15g of holly leaves, 9g of oriental rhizome, 6g of lotus leaf, 6g of hawthorn, and 3g of polyanthus polyphylla according to the prescribed ratio. Add 10 times the amount of water to the herbs and soak. Observe the absorption of the herbs. Filter the remaining liquid every hour and pour it into a graduated cylinder. Subtract the remaining liquid volume from the amount of water added to obtain the water absorption rate. The results are shown in Table 1.

[0049] The results showed that at a daily dose, the tea-based fat-reducing formula reached saturation water absorption within two hours, with the water absorption rate being approximately 1.7 times the weight of the medicinal material. Therefore, the amount of water added during the extraction process should be at least twice the weight of the medicinal material.

[0050] Table 1 Water absorption times of three batches of tea fat-reducing prescription in pilot test

[0051]

[0052] Extraction process: In the research, the water consumption of A, the extraction time of B, and the number of extraction times of C were designed as experimental factors, and three levels were selected for each factor.

[0053] Weigh 15 g of tea tree roots, 15 g of Atractylodes lancea, 15 g of Gynostemma pentaphyllum, 15 g of Ilex cornuta leaves, 9 g of Alisma orientale, 6 g of lotus leaves, 6 g of hawthorn fruits, and 3 g of Polygonum orientale L. var. orientale four times according to the prescription ratio and put them into a round-bottom flask. Add the corresponding multiple of water to fully moisten them, and let them stand for 30 minutes. Extract according to Tables 1 and 2. After extraction, concentrate the medicinal liquid (at 75 ± 5 °C) and make up the volume to a 250 ml volumetric flask. Take 50 ml of it for the determination of the extract yield, and spray the remaining part to obtain dry extract powder.

[0054] The extract yield and the transfer rate of nuciferine were selected as the indexes to evaluate the quality of the process. The results are as follows:

[0055] Conclusion 1: It can be seen from the analysis of Tables 2 and 3 that for factor C, the number of extraction times, P < 0.05, which has a significant effect on the extract yield. The influence of each factor is C > B > A. Although the number of extraction times has a great influence on the extract yield, it can be seen from Table 2 that when the extraction is carried out twice, the range of the extract yield is between 24% and 28%, while when the extraction is carried out three times, the range of the extract yield is between 27% and 29%. Thus, it can be seen that the influence of extraction twice and three times on the extract yield is not significant. Considering the subsequent production cost, it is best to extract twice.

[0056] Conclusion 2: It can be seen from the analysis of Tables 4 and 5 that P < 0.05, and factors C (number of times) and A (water consumption) have a significant effect on the transfer rate of nuciferine. The influence of each factor is C > A > B. On the premise of extracting twice, the transfer rates of Experiment 2, Experiment 4, and Experiment 9 are 28.04%, 29.66%, and 34.34% respectively. The effect of Experiment 9 is the best, but the extraction time of Experiment 9 is relatively long. Considering comprehensively, extract twice, use 12 times the amount of water for the first decoction and extract for 1 hour, and use 10 times the amount of water for the second decoction and extract for 1 hour. It is estimated that the transfer rate can reach about 30%, and the extract yield is between 24% and 28%.

[0057] Subsequently, weigh the medicinal materials according to the prescription amount, extract according to the best scheme optimized by the orthogonal experiment, and determine the extract yield, the content and transfer rate of nuciferine. Verify three batches of pilot-scale Chashu Xiaozhi formula according to the process (add 12 times the amount of water for the first decoction and decoct for 1.0 h, add 10 times the amount of water for the second decoction and decoct for 1.0 h). Take the extract yield and the transfer rate as reference indexes, and conduct preparation experiments on three batches of pilot-scale Chashu Xiaozhi formula (original prescription amount). The results are shown in Table 6.

[0058] It can be seen that the average paste yield of the three batches is 25.34%, and the transfer rate is 31.32%, which is basically consistent with the previous pre-evaluation results (the transfer rate reaches about 30%, and the paste yield is between 24% and 28%).

[0059] Table 2 Results of Orthogonal Experiment on Paste Yield

[0060]

[0061] Table 3 Analysis of Variance of Orthogonal Experiment on Paste Yield

[0062]

[0063]

[0064] Table 4 Results of Orthogonal Experiment on Transfer Rate

[0065]

[0066] Table 5 Analysis of Variance of Orthogonal Experiment Results on Transfer Rate of Nuciferine

[0067]

[0068] Table 6 Verification Results of Extraction Process of Tea Shuxiao Prescription

[0069]

[0070] Concentration temperature: According to the prescription ratio, weigh 150 g of tea tree root, 150 g of Atractylodes lancea, 150 g of Gynostemma pentaphyllum, 150 g of Ilex cornuta leaves, 90 g of Alisma orientale, 60 g of lotus leaf, 60 g of hawthorn, and 30 g of Polygonum orientale L., and put them into a 20 L fully automatic decocting machine for extraction. For the first decoction, add 12 times the amount of water, bring to a boil over high heat, then keep at low heat for 1 hour, and filter through a 200-mesh sieve; for the second decoction, add 10 times the amount of water to the residue, bring to a boil over high heat, then keep at low heat for 1 hour, and filter through a 200-mesh sieve. Combine the two extraction liquids, mix them evenly, and divide them into 10 equal parts by volume. Take 3 parts of the extraction liquid and put them into 1000 ml rotary bottles, and set the concentration temperatures to 60 °C, 70 °C, and 80 °C respectively. Calculate the time required to concentrate each sample to 50 ml at the three different temperatures, and measure the peak area of nuciferine in the 3 samples.

[0071] The results show that the concentration temperature has a greater impact on the efficiency of the entire production. The lower the temperature, the longer the time. However, the concentration temperature has little impact on the content of nuciferine. Therefore, the final selected concentration temperature is 75 ± 5 °C.

[0072] Table 7 Comparison Table of Time Consumption at Different Concentration Temperatures

[0073]

[0074] Drying Process

[0075] The concentrated sample was concentrated under reduced pressure at 75±5°C to a density of approximately 1.10 and then divided into two equal parts: one for spray drying and the other for vacuum drying. The results showed that the drying method had little effect on the content of nuciferine (see Table 8). Considering that vacuum drying takes a long time and the resulting dry paste powder easily produces charred debris, spray drying was ultimately chosen.

[0076] Table 8 Spray drying research data

[0077]

[0078] Research Conclusions

[0079] Preparation: 15g of tea tree root, 15g of atractylodes, 15g of gynostemma pentaphyllum, 15g of holly leaf, 9g of oriental rhizome, 6g of lotus leaf, 6g of hawthorn, and 3g of polyanthus polyphylla. Decoction the above eight ingredients twice: 12 times the amount of water for 1 hour the first time, and 10 times the amount of water for 1 hour the second time. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure (75±5°C) to a relative density of 1.08-1.12 (at 70°C). Spray-dry to obtain the product.

[0080] Example 2: The purpose of this example is to study the pharmacology and efficacy to prepare a formula that can provide therapeutic effects on non-alcoholic fatty liver disease induced by a high-fat diet:

[0081] Identification of drug components: The extract from Experiment 2 was analyzed using ultra-performance liquid chromatography-high-resolution mass spectrometry (UPLC-Q-TOF / MS). Based on the multi-level mass spectrometry information of the sample, combined with the natural product high-resolution mass spectrometry database and relevant literature, 55 compounds were identified from the tea-based fat-reducing compound sample.

[0082] Table 9 Identification of the main components of the Tea Art Fat-Reducing Recipe samples

[0083]

[0084]

[0085]

[0086]

[0087]

[0088] Blood component detection: Normal 6-8 week old male C57BL / 6 mice were gavaged at a crude drug dose of 21.84 g / kg / day for 3 consecutive days. Serum samples were collected at the blank dose and 0.5, 1, and 2 hours after the last dose.

[0089] The serum samples of the Chashu Xiaozhi formula were analyzed by ultra-high performance liquid chromatography-high resolution mass spectrometry (UPLC-Q-TOF / MS). According to the multi-stage mass spectrometry information of the samples, relevant literature, and the identification results of the original formula, 70 components were identified from the serum samples of the Chashu Xiaozhi compound, including 14 prototype components and 55 metabolites.

[0090] Table 10 Identification of Prototype Components in Serum Samples after Administration of Chashu Xiaozhi Formula

[0091]

[0092]

[0093] Table 11 Identification of Metabolites in Serum Samples after Administration of Chashu Xiaozhi Compound

[0094]

[0095]

[0096]

[0097]

[0098] Animal model: Male normal C57BL / 6 mice aged 6 - 8 weeks were selected and adaptively fed at the SPF level for 1 week. The mice were weighed, their toes were clipped for numbering, and they were grouped according to the random number table method, with a total of 8 groups, 8 mice in each group. The normal group was given a normal control diet, and the remaining groups were given a high-fat, high-fructose, high-cholesterol diet (Synergetic Biology, XT310). The mice were allowed to eat and drink freely and were fed for 16 weeks.

[0099] Drug administration intervention: The treatment groups were respectively given the water extract of the compound traditional Chinese medicine of the Chashu Xiaozhi formula (5.46, 10.92, 21.84 g / kg / d, referring to "Methodology of Traditional Chinese Medicine Pharmacological Research" and calculating the drug dosage for experimental mice based on the body surface area conversion rate between humans and animals) for low, medium, and high doses (LCXD, MCXD, HCXD) by gavage treatment. The water extract of the root of Camellia sinensis (CSR, 3.9 g / kg / d) at the corresponding high dose, the water extract of the remaining seven-component compound traditional Chinese medicine excluding the root of Camellia sinensis (CT, 17.94 g / kg / d), and the positive control rosuvastatin calcium (RC, 10 mg / kg / d) were given by gavage treatment.

[0100] Detection indicators: Regularly observe the mental state and activity level of mice, and record their body weights weekly; conduct glucose tolerance and insulin resistance tests at the end of the experiment; observe the morphological features, color, and texture of the liver tissues of mice, and measure their body weights, liver weights, and liver-to-body weight ratios; perform serum biochemical analysis to detect blood lipid and liver function levels such as total cholesterol, triglyceride, alanine aminotransferase, and aspartate aminotransferase; observe liver inflammation, steatosis, etc. in mice through pathological staining of liver tissues. Research results: Figure 8 This is about the effect of the aqueous extract of compound traditional Chinese medicine on the body weight of mice with high-fat diet-induced non-alcoholic fatty liver. During the mouse modeling period, the mental state was good, the movement was flexible, and the food and water intake were normal. At the beginning of the experiment, there was no significant difference in the body weights of mice in each group (P>0.05). During the modeling and treatment period, the body weights of mice in each group fed with high-fat, high-fructose, and high-cholesterol diets increased rapidly, and the body weights of mice in the high-fat group increased the fastest. By the end of the experiment, the body weights of mice in the normal group were basically stable, while the body weights of mice in the high-fat group continued to increase, showing a statistically significant difference compared with the normal group (P<0.001). The body weights of mice in each treatment group also continued to increase, but the increase rate was significantly lower than that of the high-fat group. Among them, the specific treatment effects were HCXD>MCXD>CSR>CT>RC>LCXD.

[0101] Figure 9 This is about the effect of the aqueous extract of compound traditional Chinese medicine on the liver weight of mice with high-fat diet-induced non-alcoholic fatty liver. At the end of the experiment, the livers of mice were weighed. Compared with the normal group, the liver weight of the high-fat group was significantly increased (P<0.001). Compared with the high-fat group, the liver weights of mice in each treatment group were significantly decreased, showing a statistically significant difference (P<0.05). Among them, the specific treatment effects were HCXD>CSR>MCXD>RC>CT>LCXD.

[0102] Figure 10 This is about the effect of the aqueous extract of compound traditional Chinese medicine on the blood lipids of the liver in mice with high-fat diet-induced non-alcoholic fatty liver. Compared with the normal group, the serum triglyceride and total cholesterol contents of mice in the high-fat group were significantly increased (P<0.001). Compared with the high-fat group, the triglyceride and total cholesterol contents of mice in each treatment group were significantly decreased, showing a statistically significant difference (P<0.05). Among them, the specific treatment effects were HCXD>CSR>RC>MCXD>CT>LCXD.

[0103] Figure 11Effect of the aqueous extract of compound traditional Chinese medicine on liver function of mice with non-alcoholic fatty liver induced by high-fat diet. Compared with the normal group, the levels of serum alanine aminotransferase and aspartate aminotransferase in the high-fat group of mice were significantly increased (P < 0.001); compared with the high-fat group, the levels of serum alanine aminotransferase and aspartate aminotransferase in each treatment group of mice were significantly decreased, and the difference was statistically significant (P < 0.05). Among them, the specific treatment effects were HCXD > MCXD > CSR > CT > LCXD > RC.

[0104] Figure 12 Effect of the aqueous extract of compound traditional Chinese medicine on glucose tolerance and insulin resistance of mice with non-alcoholic fatty liver induced by high-fat diet. Compared with the normal group, the levels of serum alanine aminotransferase and aspartate aminotransferase in the high-fat group of mice were significantly increased (P < 0.001); compared with the high-fat group, the levels of serum alanine aminotransferase and aspartate aminotransferase in each treatment group of mice were significantly decreased, and the difference was statistically significant (P < 0.05). Among them, the specific treatment effects were HCXD > MCXD > CSR > CT > LCXD > RC.

[0105] Research conclusion: The Chashu Xiaozhi Prescription can provide treatment effects for non-alcoholic fatty liver induced by high-fat diet. The individual tea tree roots and the other seven-flavor compound traditional Chinese medicine excluding the tea tree roots also have certain treatment effects, but the compound effect after compatibility is significantly improved compared with both of them.

[0106] Although the embodiments of the present invention have been shown and described, those of ordinary skill in the art can understand that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A tea-based fat-reducing Chinese medicine composition, characterized in that: The invention is composed of the following Chinese medicinal components: tea tree root, atractylodes lancea, gynostemma pentaphyllum, holly leaf, oriental rhizome, lotus leaf, hawthorn fruit, and safflower fruit, wherein the medicinal components are matched in proportion, wherein the tea tree root is the main medicinal component, atractylodes lancea, gynostemma pentaphyllum and holly leaf are the auxiliary medicinal components, and oriental rhizome, lotus leaf, hawthorn fruit and safflower fruit are the adjuvant medicinal components; The proportion of the Chinese medicinal components is: 15g of tea tree root, 15g of atractylodes, 15g of gynostemma pentaphyllum, 15g of holly leaf, 9g of oriental rhizome, 6g of lotus leaf, 6g of hawthorn, and 3g of polyanthus polyphylla. The tea-based fat-reducing Chinese medicinal composition contains nuciferine, atractylodesin, 23-acetyl alismatol B, and taxifolin, wherein the content of nuciferine is 0.01% to 0.05%, and the total content of atractylodesin and 23-acetyl alismatol B is 0.8% to 2.0%. The total content of taxifolin is 1.0% to 1.5%; The tea tree root, atractylodes, gynostemma pentaphyllum, holly leaf, oriental water lily, lotus leaf, hawthorn and safflower fruit are all dried Chinese medicinal materials, which are used after being crushed or sliced, and the particle size thereof is between 0.5 and 2 mm.

2. A method for preparing a tea-based fat-reducing Chinese medicine composition according to claim 1, characterized in that: The following steps are involved: (a) Mixing tea tree root, atractylodes, gynostemma pentaphyllum, holly leaf, oriental water lily, lotus leaf, hawthorn fruit, and safflower fruit in a certain proportion and grinding the mixture into 80 mesh; (b) decocting the mixed Chinese herbal medicine powder twice, first with 12 times the amount of water and decocting for 1 hour, and second with 10 times the amount of water and decocting for 1 hour, combining the decoctions, filtering, and concentrating the filtrate under reduced pressure to a relative density of 1.08 to 1.12; (c) spray-drying the concentrated solution to obtain tea-based fat-reducing granules.

3. The method for preparing a tea-based fat-reducing Chinese medicine composition according to claim 2, characterized in that: The spray drying conditions are as follows: feed temperature of 150-160°C, discharge temperature of 80-90°C, feed rate of 10-15 ml / min, nozzle pressure of 0.2-0.3 MPa, rotation speed of 20,000-25,000 rpm, drying tower diameter of 1.2 m, and height of 3.6 m.

4. The method for preparing a tea-based fat-reducing Chinese medicine composition according to claim 3, wherein: The tea-shaped fat-reducing granules have a cream yield of 24% to 28%, and a nuciferine transfer rate of 30% to 35%.

5. The method for preparing a tea-based fat-reducing Chinese medicine composition according to claim 4, characterized in that: The tea-based fat-reducing granules have a particle size of 40 to 80 meshes, a moisture content of no more than 5%, a total ash content of no more than 10%, and an acid-insoluble ash content of no more than 2%.

6. The method for preparing a tea-based fat-reducing Chinese medicine composition according to claim 5, characterized in that: The quality standard of the tea-axulum fat-reducing granules is: tested in accordance with the quality control specifications for traditional Chinese medicine granules, wherein the content of nuciferine is not less than 0.2 mg / g, the content of atractylodesin is not less than 0.1 mg / g, the content of 23-acetyl alismatin B is not less than 0.05 mg / g, and the content of taxifolin is not less than 0.01 mg / g.

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