A weight-reducing traditional Chinese medicine composition and a preparation method thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine, in particular to a kind of slimming traditional Chinese medicine composition and preparation method thereof.The present application uses the raw materials such as Buzha Leaf, hawthorn, lotus leaf, immature fruit of Chinese citron, magnolia officinalis, raphanus sativus, dried orange peel, pellitory, alisma orientalis and cassia obtusifolia, after decoction, lactic acid lactobacillus lactis CICC 6242 and royi mucous lactobacillus CICC 6121 are fermented with 0.4-0.8:1 ratio, then combined enzymolysis is carried out using ginger protease and snail protease, and then 15-25wt% ethanol is used for extraction, and the composition is endowed with excellent lipid-lowering and weight loss effect.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a weight loss traditional Chinese medicine composition and a preparation method thereof. BACKGROUND

[0002] Obesity refers to a certain degree of obvious overweight and excessive fat layer, which is a state caused by excessive accumulation of body fat, especially triglyceride; the factors causing obesity are excessive food intake or changes in body metabolism, which leads to excessive accumulation of body fat and causes excessive weight gain and pathological and physiological changes or latency in human body.

[0003] The common weight loss methods at present include aerobic exercise, liposuction surgery, diet conditioning and drug control, etc. Among them, aerobic exercise takes a long time and needs to be exercised to produce a certain effect. Although liposuction surgery is efficient, it has a great impact on human health. Although diet conditioning is mild and healthy, it is slow to regulate and easy to rebound. Drug control has the characteristics of fast speed and short time consumption, but different drug control has different effects and side effects.

[0004] Therefore, it is necessary to provide an effective and low side effect weight loss drug, which is a technical problem to be solved at present. SUMMARY

[0005] In view of the above technical problems, the present application provides a technical solution, which includes a weight loss traditional Chinese medicine composition and a preparation method thereof.

[0006] The present application provides a preparation method of a weight loss traditional Chinese medicine composition, which comprises the following steps:

[0007] Step 1: preparing raw materials: buzhayeye, hawthorn, lotus leaf, citron fruit, magnolia officinalis, raphanus sativus, dried tangerine or orange peel, pellitory, alisma and cassia seed;

[0008] Step 2: mixing all the raw materials of step 1, crushing to obtain a crushed material, boiling with water and cooling to obtain a cooled material;

[0009] Step 3: adding a carbon source and a nitrogen source for fermentation in the cooled material, mixing, then inoculating a fermentation bacteria, anaerobic fermentation, sterilization, to obtain a fermentation product;

[0010] Step 4: adding a complex enzyme to the fermentation product for enzymolysis, enzyme inactivation, to obtain an enzymolysis product;

[0011] Step 5: adding ethanol to the enzymolysis product, adjusting the ethanol concentration, heating and stirring to obtain a leaching product;

[0012] Step 6: filtering, concentrating and drying the leaching product to obtain a weight loss traditional Chinese medicine composition.

[0013] Preferably, in step 1, the raw materials are prepared according to the following parts by weight: 1-4 parts of Buzha leaf, 1-5 parts of hawthorn, 1-5 parts of lotus leaf, 2-6 parts of immature bitter orange, 0.5-4 parts of magnolia bark, 0.4-3.5 parts of radish seed, 0.3-3 parts of dried tangerine peel, 0.3-4 parts of agastache, 2-6 parts of alisma and 1-4 parts of cassia seed.

[0014] Preferably, in step 2, the amount of water added is 5-50 times the mass of the pulverized material.

[0015] Preferably, in step 2, the temperature is cooled to 20-40°C.

[0016] Preferably, in step 3, the amount of carbon source and nitrogen source added is 1-5% and 0.001-0.1% of the mass of the cooling material, respectively.

[0017] Preferably, in step 3, the carbon source includes at least one of glucose, fructose, galactose, sucrose, lactose, and maltose.

[0018] Preferably, in step 3, the nitrogen source includes at least one of nitrate, ammonia, ammonium salt, peptone, urea, and protein powder.

[0019] Preferably, in step 3, the fermentation bacteria consist of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus reuteri CICC 6121 in a bacterial count ratio of 0.4-0.8:1.

[0020] Preferably, in step 3, the total amount of fermentation bacteria used is 8 × 10⁻⁶. 9 -4×10 10 cfu / g of cooled material.

[0021] Preferably, in step 3, the fermentation temperature is 25-45℃ and the time is 120-180 hours.

[0022] Preferably, in step 4, the complex enzyme is composed of ginger protease and snail protease.

[0023] Preferably, in step 4, the amounts of ginger protease and snail protease are 300-650 u / g fermentation product and 320-700 u / g fermentation product, respectively.

[0024] Preferably, in step 4, the enzymatic hydrolysis temperature is 35-60℃ and the time is 2.5-6 hours.

[0025] Preferably, in step 5, the ethanol concentration is 15-25 wt%.

[0026] Preferably, in step 5, the heating and stirring temperature is 35-60℃, and the time is 3-10 hours.

[0027] Preferably, in step 6, the extract is concentrated to 10-20% of its mass.

[0028] Preferably, in step 6, the product is dried until the moisture content is less than 5 wt%.

[0029] The present invention also provides a weight-loss traditional Chinese medicine composition prepared according to the preparation method described above.

[0030] The present invention also provides a medicine comprising the aforementioned traditional Chinese medicine composition and excipients.

[0031] Preferably, the excipients include at least one of solvent, diluent, filler, slow-release agent, binder, and lubricant.

[0032] Preferably, the amount of the traditional Chinese medicine composition in the drug is 0.1-40%.

[0033] The present invention also provides a method for preparing a drug, including the step of mixing a traditional Chinese medicine composition with excipients.

[0034] The beneficial effects of this invention are:

[0035] This invention uses *Broussonetia papyrifera* leaves, hawthorn, lotus leaves, immature bitter orange, magnolia bark, radish seeds, dried tangerine peel, *Eupatorium fortunei*, *Alisma plantago-aquatica*, and cassia seeds. After decoction, *Lactococcus lactis* subsp. *lactococcus* CICC 6242 and *Lactobacillus reuteri* CICC 6121 are fermented at a ratio of 0.4-0.8:1. Then, ginger protease and snail protease are used for combined enzymatic hydrolysis, followed by extraction with 15-25 wt% ethanol, giving the composition excellent lipid-lowering and weight-loss effects.

[0036] The composition prepared by this invention has the effect of significantly reducing the levels of total cholesterol (TC), triglycerides (TG), and low-density lipoprotein (LDL-C) and increasing the levels of high-density lipoprotein (HDL-C).

[0037] Compared with other fermentation bacteria, the specific fermentation strains of this invention, Lactococcus lactis subsp. CICC 6242 and Lactobacillus reuteri CICC6121, can enrich the types and contents of active ingredients in the product, resulting in better effects of the composition.

[0038] In preparing the composition, the present invention uses a specific combination of Lactococcus lactis subsp. CICC 6242 and Lactobacillus reuteri CICC 6121 to generate a mutually promoting fermentation relationship, which significantly enhances the lipid-lowering effect of the composition.

[0039] In the preparation system of this invention, fermentation is carried out using a ratio of 0.4-0.8:1 for Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus reuteri CICC 6121, which can improve the lipid-lowering performance of the composition.

[0040] The present invention uses ginger protease and snail protease in combination for enzymatic hydrolysis, which can significantly improve the lipid-lowering effect of the composition compared with other enzymes.

[0041] This invention uses 15-25 wt% ethanol extraction, which, compared to extraction with high concentrations of ethanol or water, allows the composition to better reduce total cholesterol (TC), triglycerides (TG), and low-density lipoprotein (LDL-C) levels while increasing high-density lipoprotein (HDL-C) levels, thus giving the composition a better lipid-lowering effect.

[0042] The composition of the present invention can effectively inhibit excessive weight gain and has a good weight loss effect. Detailed Implementation

[0043] The present invention will be described below with reference to specific embodiments, thereby making the various effects of the invention clearer. Those skilled in the art should understand that these specific embodiments are for illustrative purposes only and not for limiting the invention.

[0044] This invention provides a method for preparing a traditional Chinese medicine composition for weight loss, comprising the following steps:

[0045] Step 1: Prepare the ingredients: Buzha leaves, hawthorn, lotus leaves, immature bitter orange, magnolia bark, radish seeds, dried tangerine peel, agastache, alisma, and cassia seeds;

[0046] Step 2: Mix all the raw materials from Step 1, crush them to obtain pulverized material, add water, boil, and then cool to obtain cooled material;

[0047] Step 3: Add carbon and nitrogen sources for fermentation to the cooled material, mix, then inoculate with fermentation bacteria, anaerobic ferment, sterilize, and obtain fermented product;

[0048] Step 4: Add a compound enzyme to the fermentation product for enzymatic hydrolysis and enzyme inactivation to obtain the hydrolysate;

[0049] Step 5: Add ethanol to the enzymatic hydrolysate, adjust the ethanol concentration, heat and stir to obtain the extract;

[0050] Step 6: Filter the extract, concentrate and dry it to obtain the weight loss Chinese medicine composition.

[0051] Preferably, in step 1, the raw materials are prepared according to the following parts by weight: 1-4 parts of Buzha leaf, 1-5 parts of hawthorn, 1-5 parts of lotus leaf, 2-6 parts of immature bitter orange, 0.5-4 parts of magnolia bark, 0.4-3.5 parts of radish seed, 0.3-3 parts of dried tangerine peel, 0.3-4 parts of agastache, 2-6 parts of alisma and 1-4 parts of cassia seed.

[0052] Preferably, in step 2, the amount of water added is 5-50 times the mass of the pulverized material.

[0053] Preferably, in step 2, the temperature is cooled to 20-40°C.

[0054] Preferably, in step 3, the amount of carbon source and nitrogen source added is 1-5% and 0.001-0.1% of the mass of the cooling material, respectively.

[0055] Preferably, in step 3, the carbon source includes at least one of glucose, fructose, galactose, sucrose, lactose, and maltose.

[0056] Preferably, in step 3, the nitrogen source includes at least one of nitrate, ammonia, ammonium salt, peptone, urea, and protein powder.

[0057] Preferably, in step 3, the fermentation bacteria consist of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus reuteri CICC 6121 in a bacterial count ratio of 0.4-0.8:1.

[0058] Preferably, in step 3, the total amount of fermentation bacteria used is 8 × 10⁻⁶. 9 -4×10 10 cfu / g of cooled material.

[0059] Preferably, in step 3, the fermentation temperature is 25-45℃ and the time is 120-180 hours.

[0060] Preferably, in step 4, the complex enzyme is composed of ginger protease and snail protease.

[0061] Preferably, in step 4, the amounts of ginger protease and snail protease are 300-650 u / g fermentation product and 320-700 u / g fermentation product, respectively.

[0062] Preferably, in step 4, the enzymatic hydrolysis temperature is 35-60℃ and the time is 2.5-6 hours.

[0063] Preferably, in step 5, the ethanol concentration is 15-25 wt%.

[0064] Preferably, in step 5, the heating and stirring temperature is 35-60℃, and the time is 3-10 hours.

[0065] Preferably, in step 6, the extract is concentrated to 10-20% of its mass.

[0066] Preferably, in step 6, the product is dried until the moisture content is less than 5 wt%.

[0067] The present invention also provides a weight-loss traditional Chinese medicine composition prepared according to the preparation method described above.

[0068] The present invention also provides a medicine comprising the aforementioned traditional Chinese medicine composition and excipients.

[0069] Preferably, the excipients include at least one of solvent, diluent, filler, slow-release agent, binder, and lubricant.

[0070] Preferably, the amount of the traditional Chinese medicine composition in the drug is 0.1-40%.

[0071] The present invention also provides a method for preparing a drug, including the step of mixing a traditional Chinese medicine composition with excipients.

[0072] Unless otherwise specified, the raw materials used in this invention are obtained from commercially available raw materials by ordinary means.

[0073] I. Preparation of the Composition

[0074] 1. Composition One

[0075] Step 1: Prepare the ingredients: Prepare the ingredients according to the following weight parts: 1.5 parts of Buzha leaf, 3 parts of hawthorn, 4 parts of lotus leaf, 4.5 parts of immature bitter orange, 2.8 parts of magnolia bark, 3 parts of radish seed, 2.2 parts of dried tangerine peel, 1.8 parts of agastache, 3.7 parts of alisma and 2.4 parts of cassia seed;

[0076] Step 2: Mix all the raw materials from Step 1, pulverize them until the particle size is less than 60 mesh, and add 13.5 times the weight of the pulverized material with water. Boil the mixture and then cool it to 25°C to obtain the cooled material.

[0077] Step 3: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) to the cooled material, relative to the mass of the cooled material, mix, and then inoculate with a fermentation culture consisting of Lactococcus lactis subsp. CICC 6242 and Lactobacillus reuteri CICC 6121 at a ratio of 0.6:1 (total inoculum size 1.20 × 10⁻⁶). 10 The material (cfu / g cooled material) was fermented anaerobically at 32.5℃ with stirring at 60 rpm for 150 hours, then sterilized to obtain the fermented product.

[0078] Step 4: Add a compound enzyme (composed of ginger protease and snail protease, with ginger protease and snail protease dosages of 450u / g fermentation product and 500u / g fermentation product, respectively) to the fermentation product, and carry out enzymatic hydrolysis for 5.2 hours at 45℃ and 70rpm stirring speed to inactivate the enzyme and obtain the enzymatic hydrolysate;

[0079] Step 5: Add ethanol to the enzymatic hydrolysate to adjust the ethanol concentration to 20wt%, heat at 42℃ and stir at 80rpm for 6.5 hours to obtain the extract;

[0080] Step 6: Filter the extract, concentrate the filtrate under reduced pressure at 0.001 MPa and 60°C to 15.4% of the extract mass, and freeze-dry at -47°C to 1.72 wt% of water content to obtain the weight-loss traditional Chinese medicine composition.

[0081] 2. Composition Two

[0082] Step 1: Prepare the ingredients: Prepare the ingredients according to the following weight parts: 1.3 parts of Buzha leaf, 2.1 parts of hawthorn, 1.8 parts of lotus leaf, 5.5 parts of immature bitter orange, 1 part of magnolia bark, 2.5 parts of radish seed, 1.5 parts of dried tangerine peel, 3.7 parts of agastache, 2.4 parts of alisma and 3.3 parts of cassia seed;

[0083] Step 2: Mix all the raw materials from Step 1, pulverize them until the particle size is less than 60 mesh, and add 15 times the weight of water to the pulverized material. Boil the mixture and then cool it to 25°C to obtain the cooled material.

[0084] Step 3: Add 2.62% glucose (carbon source) and 0.045% sodium dihydrogen phosphate (nitrogen source) to the cooled material, relative to the mass of the cooled material, mix, and then inoculate with a fermentation culture composed of *Lactococcus lactis* subsp. *lactococcus* 6242 and *Lactobacillus reuteri* 6121 at a ratio of 0.4:1 (total inoculum size 1.25 × 10⁻⁶). 10 The material (cfu / g cooled material) was fermented at 33℃ under anaerobic conditions with stirring at 60 rpm for 142 hours, and then sterilized to obtain the fermented product.

[0085] Step 4: Add a compound enzyme (composed of ginger protease and snail protease, with ginger protease and snail protease dosages of 350u / g fermentation product and 620u / g fermentation product, respectively) to the fermentation product, and carry out enzymatic hydrolysis for 5.5 hours at a temperature of 47℃ and a stirring speed of 70rpm to inactivate the enzyme and obtain the enzymatic hydrolysate.

[0086] Step 5: Add ethanol to the enzymatic hydrolysate to adjust the ethanol concentration to 15.5 wt%, heat at 45°C and stir at 80 rpm for 5.3 hours to obtain the extract;

[0087] Step 6: Filter the extract, concentrate the filtrate under reduced pressure at 0.001 MPa and 60°C until the extract mass is 14.7%, freeze-dry at -45°C until the water content is 1.69 wt%, and obtain the weight loss traditional Chinese medicine composition.

[0088] 3. Composition Three

[0089] The difference from Composition 1 lies in step 3. Step 3 is as follows: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) relative to the mass of the cooled material to the cooled material, mix, and then inoculate with the fermentation bacteria *Lactobacillus plantarum* CICC 21796 (total inoculum size 1.20 × 10⁻⁶). 10 The mixture (cfu / g cooled material) was fermented anaerobically at 32.5℃ with stirring at 60 rpm for 150 hours, then sterilized to obtain the fermented product. Everything else was the same as in Composition 1.

[0090] 4. Composition Four

[0091] The difference from Composition 1 lies in step 3. Step 3 is as follows: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) relative to the mass of the cooled material to the cooling material, mix, and then inoculate with the fermentation bacteria *Lactococcus lactis* subsp. *lactococcus* CICC 6242 (total inoculum size 1.20 × 10⁻⁶). 10 The mixture (cfu / g cooled material) was fermented anaerobically at 32.5℃ with stirring at 60 rpm for 150 hours, then sterilized to obtain the fermented product. Everything else was the same as in Composition 1.

[0092] 5. Composition Five

[0093] The difference from Composition 1 lies in step 3. Step 3 is as follows: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) to the cooled material, relative to the mass of the cooled material, mix, and then inoculate with the fermentation bacteria *Lactobacillus reuteri* CICC 6121 (total inoculum size 1.20 × 10⁻⁶). 10 The mixture (cfu / g cooled material) was fermented anaerobically at 32.5℃ with stirring at 60 rpm for 150 hours, then sterilized to obtain the fermented product. Everything else was the same as in Composition 1.

[0094] 6. Composition Six

[0095] The difference from Composition 1 lies in step 3. Step 3 is as follows: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) relative to the mass of the cooled material to the cooling material, mix, and then inoculate with a fermentation culture composed of Lactococcus lactis subsp. CICC 6242 and Lactobacillus reuteri CICC 6121 at a ratio of 0.08:1 (total inoculum of 1.20 × 10⁻⁶). 10 The mixture (cfu / g cooled material) was fermented anaerobically at 32.5℃ with stirring at 60 rpm for 150 hours, then sterilized to obtain the fermented product. Everything else was the same as in Composition 1.

[0096] 7. Composition Seven

[0097] The difference from Composition 1 lies in step 3. Step 3 is as follows: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) relative to the mass of the cooled material for fermentation to the cooled material, mix, and then inoculate with a fermentation culture composed of Lactococcus lactis subsp. CICC 6242 and Lactobacillus reuteri CICC 6121 in a 2:1 ratio (total inoculum of 1.20 × 10⁻⁶). 10 The mixture (cfu / g cooled material) was fermented anaerobically at 32.5℃ with stirring at 60 rpm for 150 hours, then sterilized to obtain the fermented product. Everything else was the same as in Composition 1.

[0098] 8. Composition Eight

[0099] The difference between this composition and Composition 1 lies in step 4. Step 4 involves adding bromelain to the fermentation product at a dosage of 950 u / g of fermentation product, and then performing enzymatic hydrolysis for 5.2 hours at 45°C and 70 rpm with stirring. The enzyme is then inactivated to obtain the hydrolysate. Everything else is the same as in Composition 1.

[0100] 9. Composition Nine

[0101] The difference between this composition and Composition 1 lies in step 4. Step 5 is as follows: Ethanol is added to the enzymatic hydrolysate to adjust the ethanol concentration to 45 wt%, and the mixture is heated at 42°C and stirred at 80 rpm for 6.5 hours to obtain the extract. All other steps are the same as in Composition 1.

[0102] 10. Composition Ten

[0103] Step 1: Prepare the ingredients: Prepare the ingredients according to the following weight parts: 1.5 parts of Buzha leaf, 3 parts of hawthorn, 4 parts of lotus leaf, 4.5 parts of immature bitter orange, 2.8 parts of magnolia bark, 3 parts of radish seed, 2.2 parts of dried tangerine peel, 1.8 parts of agastache, 3.7 parts of alisma and 2.4 parts of cassia seed;

[0104] Step 2: Mix all the raw materials from Step 1, pulverize them until the particle size is less than 60 mesh, and add 13.5 times the weight of the pulverized material with water. Boil the mixture and then cool it to 25°C to obtain the cooled material.

[0105] Step 3: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) to the cooled material, relative to the mass of the cooled material, mix, and then inoculate with a fermentation culture consisting of Lactococcus lactis subsp. CICC 6242 and Lactobacillus reuteri CICC 6121 at a ratio of 0.6:1 (total inoculum size 1.20 × 10⁻⁶). 10The material (cfu / g cooled material) was fermented anaerobically at 32.5℃ with stirring at 60 rpm for 150 hours, then sterilized to obtain the fermented product.

[0106] Step 4: Add a compound enzyme (composed of ginger protease and snail protease, with ginger protease and snail protease dosages of 450u / g fermentation product and 500u / g fermentation product, respectively) to the fermentation product, and carry out enzymatic hydrolysis for 5.2 hours at 45℃ and 70rpm stirring speed to inactivate the enzyme and obtain the enzymatic hydrolysate;

[0107] Step 5: Filter the enzymatic hydrolysate, concentrate the filtrate under reduced pressure at 0.001 MPa and 60°C until the extract mass is 15.4%, and freeze-dry at -47°C until the water content is 1.72 wt% to obtain the weight loss traditional Chinese medicine composition.

[0108] II. Experimental Testing of the Composition

[0109] The above composition was subjected to performance testing, and the specific testing process is as follows.

[0110] Materials preparation: SPF grade C57BL / 6J male mice weighing 22±2g, total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), high-density lipoprotein (HDL-C) kits, high-fat diet (D12492), and 10% low-fat diet (D12450B low-fat diet).

[0111] Mice were acclimatized for 3 days. Then, the mice were randomly divided into 12 groups (n=10 per group) according to their weight: a control group, a model group, and groups containing compositions one through ten. The control group was fed a 10% low-fat diet, while the model group and groups containing compositions one through ten were fed a high-fat diet. All groups were fed for 2 months. During these 2 months, groups containing compositions one through ten were administered each via gavage at a dose of 80 mg / kg of the composition, diluted with physiological saline. The gavage solution volume was 0.2 mL / 10g of mouse, administered once daily. The control group and model group were administered the same amount of physiological saline. Mice in all groups were allowed to drink water and sleep during the experiment.

[0112] After the gavage experiment, the mice were euthanized, and blood and serum were collected.

[0113] 1. The levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), and high-density lipoprotein (HDL-C) in serum were tested using a kit. The results are shown in Table 1.

[0114] Table 1: Serum Indicator Levels

[0115]

[0116]

[0117] Based on the average values ​​of each group in Table 1, the reduction in total cholesterol (TC), triglycerides (TG), and low-density lipoprotein (LDL-C), and the increase in high-density lipoprotein (HDL-C) in each group compared to the model group were calculated. The results are shown in Table 2.

[0118] Table 2: Changes in each group compared to the model group

[0119]

[0120]

[0121] Based on the test results in Table 1-2, it can be seen that the composition prepared in this invention has the effect of significantly reducing the content of total cholesterol (TC), triglycerides (TG), and low-density lipoprotein (LDL-C) and increasing the content of high-density lipoprotein (HDL-C), and has a good lipid-lowering effect.

[0122] This invention uses *Broussonetia papyrifera* leaves, hawthorn, lotus leaves, immature bitter orange, magnolia bark, radish seeds, dried tangerine peel, *Eupatorium fortunei*, *Alisma plantago-aquatica*, and cassia seeds. After decoction, *Lactococcus lactis* subsp. *lactococcus* 6242 and *Lactobacillus reuteri* 6121 are fermented in a ratio of 0.4-0.8:1. Then, ginger protease and snail protease are used for combined enzymatic hydrolysis, followed by extraction with 15-25 wt% ethanol, giving the composition excellent lipid-lowering effects.

[0123] The tests of Composition 1 and Composition 3 show that, compared with other fermentation bacteria, the specific fermentation strains of this invention, Lactococcus lactis subsp. CICC6242 and Lactobacillus reuteri CICC6121, can enrich the types and contents of active ingredients in the product, resulting in better effects of the composition.

[0124] Based on the test results of compositions one, four, and five, it can be seen that, while keeping the amount of fermenting bacteria constant, the combined fermentation of the two is more effective. It is evident that the specific combination of Lactococcus lactis subsp. CICC 6242 and Lactobacillus reuteri CICC6121 in this invention produces a mutually promoting fermentation relationship, which significantly enhances the lipid-lowering effect of the composition.

[0125] Based on the test results of compositions one, five, and six, it can be seen that in the preparation system of the present invention, when the ratio of fermentation bacteria is changed, composition one has a better effect, indicating that the fermentation of the present invention using a ratio of 0.4-0.8:1 can make the composition have better lipid-lowering performance.

[0126] Based on the test results of Compositions I and II, it can be seen that the combined enzymatic hydrolysis of ginger protease and snail protease used in this invention can significantly improve the lipid-lowering effect of the composition compared with enzymatic hydrolysis using other enzymes.

[0127] Based on the test results of Compositions 1, 9, and 10, it can be seen that the present invention uses 15-25wt% ethanol extraction, which, compared with extraction using high concentrations of ethanol or water, can make the composition more effective in reducing total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C) and increasing high-density lipoprotein (HDL-C) content, thus giving the composition a better lipid-lowering effect.

[0128] 2. Before and after the gavage experiment, the body weight (g) of mice in the blank group, model group and combinations one to two was measured, and the weight gain (g) of each group was calculated. The results are shown in Table 3.

[0129] Table 3: Weight Changes in Each Group

[0130] Test / g Pre-experiment weight Post-experiment weight Weight gain Blank group 24.32±0.92 29.15±1.21 4.83 Model group 23.94±1.03 36.69±1.09 12.75 Composition one 25.16±0.81 33.54±1.17 8.38 Composition two 23.01±1.12 31.55±1.27 8.54

[0131] As shown in Table 3, the composition of the present invention can effectively inhibit excessive weight gain and has a good weight loss effect.

[0132] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A method for preparing a traditional Chinese medicine composition for weight loss, characterized in that, Includes the following steps: Step 1: Prepare the ingredients: Buzha leaves, hawthorn, lotus leaves, immature bitter orange, magnolia bark, radish seeds, dried tangerine peel, agastache, alisma, and cassia seeds; Step 2: Mix all the raw materials from Step 1, crush them to obtain pulverized material, add water, boil, and then cool to obtain cooled material; Step 3: Add carbon and nitrogen sources for fermentation to the cooled material, mix, then inoculate with fermentation bacteria, anaerobic ferment, sterilize, and obtain fermented product; Step 4: Add a compound enzyme to the fermentation product for enzymatic hydrolysis and enzyme inactivation to obtain the hydrolysate; Step 5: Add ethanol to the enzymatic hydrolysate, adjust the ethanol concentration, heat and stir to obtain the extract; Step 6: Filter the extract, concentrate, and dry to obtain a weight-loss traditional Chinese medicine composition; In step 3, the fermentation bacteria consist of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus reuteri CICC 6121 in a bacterial count ratio of 0.4-0.8:1; In step 4, the complex enzyme consists of ginger protease and snail protease; In step 1, prepare the raw materials according to the following weight parts: 1-4 parts of Buzha leaf, 1-5 parts of hawthorn, 1-5 parts of lotus leaf, 2-6 parts of immature bitter orange, 0.5-4 parts of magnolia bark, 0.4-3.5 parts of radish seed, 0.3-3 parts of dried tangerine peel, 0.3-4 parts of agastache, 2-6 parts of alisma and 1-4 parts of cassia seed.

2. The preparation method according to claim 1, characterized in that, In step 2, the amount of water added is 5-50 times the mass of the pulverized material; And / or, cool to 20-40°C; And / or, in step 3, the amount of carbon source and nitrogen source added is 1-5% and 0.001-0.1% of the mass of the cooling material, respectively; And / or, the carbon source includes at least one of glucose, fructose, galactose, sucrose, lactose, and maltose; And / or, the nitrogen source includes at least one of nitrates, ammonia, ammonium salts, peptone, urea, and protein powder.

3. The preparation method according to claim 1, characterized in that, The total amount of fermentation bacteria used is 8×10 9 -4×10 10 CFU / g of cooled material; And / or, the fermentation temperature is 25-45℃, and the time is 120-180 hours.

4. The preparation method according to claim 1, characterized in that, The dosages of ginger protease and snail protease were 300-650 u / g fermented product and 320-700 u / g fermented product, respectively; And / or, the enzymatic hydrolysis temperature is 35-60℃, and the time is 2.5-6 hours.

5. The preparation method according to claim 1, characterized in that, In step 5, the ethanol concentration is 15-25 wt%; And / or, heat and stir at a temperature of 35-60℃ for 3-10 hours.

6. The preparation method according to claim 1, characterized in that, In step 6, the extract is concentrated to 10-20% of its mass. And / or, dry to a moisture content of less than 5 wt%.

7. A weight-loss traditional Chinese medicine composition prepared by the preparation method according to any one of claims 1-6.

8. A drug, characterized in that, It includes the traditional Chinese medicine composition as described in claim 7 and excipients.

9. The medicament according to claim 8, characterized in that, The excipients include at least one of solvents, fillers, slow-release agents, binders, and lubricants.

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