Weight-losing traditional Chinese medicine composition and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a weight-losing traditional Chinese medicine composition and a preparation method thereof. According to the invention, microcos paniculata, hawthorn, lotus leaf, immature bitter orange, magnolia officinalis, radish seed, dried orange peel, fortune eupatorium herb, oriental waterplantain rhizome, cassia seed and other raw materials are adopted, decoction is carried out, lactococcus lactis subsp. Lactis CICC 6242 and Lactobacillus reuteri CICC 6121 are fermented according to a ratio of 0.4-0.8: 1, ginger protease and snail protease are adopted for combined enzymolysis, 15-25 wt% ethanol is adopted for extraction, and the extract is prepared through freeze drying. The composition is endowed with excellent lipid-lowering and weight-losing effects.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and particularly relates to a weight-loss traditional Chinese medicine composition and a preparation method thereof. Background Art

[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 triglycerides; the factors causing obesity lie in excessive food intake or changes in body metabolism, resulting in excessive accumulation of body fat, excessive weight gain, and causing pathological and physiological changes or latent conditions in the human body.

[0003] Currently, common weight-loss methods include: aerobic exercise, liposuction surgery, diet regulation, and drug control, etc. Among them, aerobic exercise takes a long time and requires continuous exercise to produce certain effects. Although liposuction surgery is efficient, it has a great impact on human health. Although diet regulation is gentle and healthy, the regulation speed is slow and it is easy to rebound. Drug control has the characteristics of fast speed and short time consumption, but different drug controls have different effects and side effects, etc.

[0004] Therefore, it is necessary to provide an effective weight-loss drug with low side effects, which is a technical problem that needs to be solved currently. Summary of the Invention

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

[0006] The present invention provides a preparation method of a weight-loss traditional Chinese medicine composition, comprising the following steps:

[0007] Step 1: Prepare raw materials: Microcos paniculata leaves, hawthorn, lotus leaf, bitter orange, magnolia officinalis, radish seed, tangerine peel, eupatorium fortunei, alisma orientale, and cassia seed;

[0008] Step 2: Mix all the raw materials in Step 1, pulverize to obtain a pulverized product, add water, boil and then cool to obtain a cooled material;

[0009] Step 3: Add a carbon source and a nitrogen source for fermentation to the cooled material, mix, then inoculate with a fermenting bacterium, perform anaerobic fermentation, and sterilize to obtain a fermented product;

[0010] Step 4: Add a complex enzyme to the fermented product for enzymatic hydrolysis, inactivate the enzyme to obtain an enzymatically hydrolyzed product;

[0011] Step 5: Add ethanol to the enzymatically hydrolyzed product, adjust the ethanol concentration, heat and stir to obtain an extract;

[0012] Step 6: Filter, concentrate, and dry the extract to obtain the weight-loss traditional Chinese medicine composition.

[0013] Preferably, in step 1, prepare raw materials by mass parts: 1-4 parts of Microcos paniculata leaves, 1-5 parts of hawthorn, 1-5 parts of lotus leaf, 2-6 parts of Fructus aurantii Immaturus, 0.5-4 parts of Magnolia officinalis, 0.4-3.5 parts of Semen raphani, 0.3-3 parts of dried tangerine peel, 0.3-4 parts of Eupatorium fortunei Turcz., 2-6 parts of Alisma orientale and 1-4 parts of Cassia obtusifolia.

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

[0015] Preferably, in step 2, cool to 20-40 °C.

[0016] Preferably, in step 3, the addition amounts of the carbon source and the nitrogen source are 1-5% and 0.001-0.1% of the mass of the cooled material.

[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 water, ammonium salt, peptone, urea, and protein powder.

[0019] Preferably, in step 3, the fermenting bacteria are composed of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121 in a bacterial quantity ratio of 0.4-0.8:1.

[0020] Preferably, in step 3, the total dosage of the fermenting bacteria is 8×10 9 -4×10 10 cfu / g of the cooled material.

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

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

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

[0024] Preferably, in step 4, the enzymatic hydrolysis temperature is 35-60 °C 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 °C and the time is 3-10 hours.

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

[0028] Preferably, in step 6, it is dried until the water content is lower than 5 wt%.

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

[0030] The present invention also provides a drug, comprising the said traditional Chinese medicine composition and adjuvants.

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

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

[0033] The present invention also provides a preparation method of a drug, comprising the step of mixing the traditional Chinese medicine composition and adjuvants.

[0034] Advantages of the present invention:

[0035] The present invention uses Microcos paniculata, Hawthorn Fruit, Lotus Leaf, Immature Bitter Orange, Magnolia officinalis, Radish Seed, Tangerine Peel, Eupatorium fortunei, Alisma orientale, and Cassia obtusifolia. After decocting, Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121 are fermented in a ratio of 0.4 - 0.8:1, then combined enzymatic hydrolysis is carried out using ginger protease and snail protease, and then extraction is carried out with 15 - 25 wt% ethanol, endowing the composition with excellent lipid-lowering and weight-loss effects.

[0036] The composition prepared by the present invention has the efficacy of significantly reducing the contents of total cholesterol (TC), triglyceride (TG), and low-density lipoprotein (LDL-C) and increasing the content of high-density lipoprotein (HDL-C).

[0037] Compared with other fermenting bacteria, using the specific fermenting bacteria Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121 in the present invention can enrich the types and contents of active ingredients of the product, making the composition have better effects.

[0038] When preparing the composition of the present invention, a specific combination of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121 is used, generating a mutually promoting fermentation relationship, making the lipid-lowering effect of the composition significantly improved.

[0039] In the preparation system of the present invention, fermentation is carried out with a ratio of 0.4 - 0.8:1 of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121, which can make the lipid-lowering performance of the composition better.

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

[0041] The present invention uses the form of ethanol extraction at 15-25 wt%, compared with using high-concentration ethanol or water extraction, which can make the composition better reduce the contents of total cholesterol (TC), triglyceride (TG), and low-density lipoprotein (LDL-C), and improve the content of high-density lipoprotein (HDL-C), endowing the composition with a better lipid-lowering effect.

[0042] The composition of the present invention can effectively inhibit the excessive increase in body weight and has a good weight loss effect. Detailed implementation manners

[0043] The following will elaborate on the present invention in combination with the detailed implementation manners, and various effects of the present invention will be presented more clearly therefrom. Those skilled in the art should understand that these detailed implementation manners are used to illustrate the present invention rather than limit the present invention.

[0044] The present invention provides a preparation method of a weight loss traditional Chinese medicine composition, comprising the following steps:

[0045] Step 1: Prepare raw materials: Microcos paniculata leaves, hawthorn, lotus leaf, immature bitter orange, magnolia bark, radish seed, dried tangerine peel, eupatorium fortunei, oriental water plantain rhizome, and cassia seed;

[0046] Step 2: Mix all the raw materials in Step 1, pulverize to obtain a pulverized product, add water, boil, and then cool to obtain a cooled material;

[0047] Step 3: Add a carbon source and a nitrogen source for fermentation to the cooled material, mix, then inoculate with a fermenting bacterium, perform anaerobic fermentation, and sterilize to obtain a fermented product;

[0048] Step 4: Add a composite enzyme to the fermented product for enzymatic hydrolysis, inactivate the enzyme to obtain an enzymatically hydrolyzed product;

[0049] Step 5: Add ethanol to the enzymatically hydrolyzed product, adjust the ethanol concentration, heat and stir to obtain an extract;

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

[0051] Preferably, in Step 1, prepare the raw materials according to parts by mass: 1-4 parts of Microcos paniculata leaves, 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 eupatorium fortunei, 2-6 parts of oriental water plantain rhizome, 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 product.

[0053] Preferably, in Step 2, cool to 20-40 °C.

[0054] Preferably, in step 3, the addition amounts of the carbon source and the nitrogen source are 1-5% and 0.001-0.1% of the mass of the cooled material.

[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 water, ammonium salt, peptone, urea, and protein powder.

[0057] Preferably, in step 3, the fermenting bacteria are composed of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121 in a bacterial number ratio of 0.4-0.8:1.

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

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

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

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

[0062] Preferably, in step 4, the enzymatic hydrolysis temperature is 35-60°C 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°C and the time is 3-10 hours.

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

[0066] Preferably, in step 6, it is dried to a water content of less than 5 wt%.

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

[0068] The present invention also provides a medicine, comprising the said traditional Chinese medicine composition and adjuvants.

[0069] Preferably, the adjuvant includes at least one of a solvent, a diluent, a filler, a sustained-release agent, a binder, and a lubricant.

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

[0071] The present invention also provides a preparation method of a medicine, which includes the step of mixing the traditional Chinese medicine composition with an adjuvant.

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

[0073] I. Preparation of the composition

[0074] 1. Composition I

[0075] Step 1: Prepare raw materials: Prepare raw materials according to parts by mass: 1.5 parts of Microcos paniculata leaves, 3 parts of hawthorn, 4 parts of lotus leaf, 4.5 parts of immature bitter orange, 2.8 parts of Magnolia officinalis, 3 parts of radish seed, 2.2 parts of dried tangerine peel, 1.8 parts of Eupatorium fortunei Turcz., 3.7 parts of Alisma orientale, and 2.4 parts of Cassia obtusifolia;

[0076] Step 2: Mix all the raw materials in Step 1, crush them to a particle size below 60 mesh to obtain a crushed material, add water 13.5 times the mass of the crushed material, boil and then cool to 25°C to obtain a cooled material;

[0077] Step 3: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) for fermentation to the cooled material according to the mass of the cooled material, mix, and then inoculate a fermentation bacterium composed of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121 with a bacterial quantity ratio of 0.6:1 (the total inoculation amount of the fermentation bacterium is 1.20×10 10 cfu / g of the cooled material), ferment under anaerobic conditions at a temperature of 32.5°C and stir at 60 rpm for 150 hours, and sterilize to obtain a fermented product;

[0078] Step 4: Add a complex enzyme (the complex enzyme is composed of zingibain and snail protease, and the dosages of zingibain and snail protease are 450 u / g of the fermented product and 500 u / g of the fermented product respectively) to the fermented product, carry out enzymatic hydrolysis at a temperature of 45°C and a stirring speed of 70 rpm for 5.2 hours, and inactivate the enzyme to obtain an enzymolyzed product;

[0079] Step 5: Add ethanol to the enzymolyzed product, adjust the ethanol concentration to 20 wt%, heat at a temperature of 42°C and stir at a speed of 80 rpm for 6.5 hours to obtain an 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 mass of the extract, and then freeze-dry at -47 °C until the water content is 1.72 wt% to obtain the weight-loss traditional Chinese medicine composition.

[0081] 2. Composition II

[0082] Step 1: Prepare raw materials: Prepare raw materials according to parts by mass: 1.3 parts of Microcos paniculata leaves, 2.1 parts of hawthorn, 1.8 parts of lotus leaf, 5.5 parts of Fructus aurantii Immaturus, 1 part of Magnolia officinalis, 2.5 parts of Raphanus sativus seeds, 1.5 parts of dried tangerine peel, 3.7 parts of Eupatorium fortunei Turcz., 2.4 parts of Alisma orientale (Sam.) Juzep. and 3.3 parts of Cassia obtusifolia L.

[0083] Step 2: Mix all the raw materials in Step 1, crush them to a particle size below 60 mesh to obtain a crushed product, add 15 times the mass of water of the crushed product, boil and then cool to 25 °C to obtain a cooled material.

[0084] Step 3: Add 2.62% glucose (carbon source) and 0.045% sodium dihydrogen phosphate (nitrogen source) for fermentation to the cooled material according to the mass of the cooled material, mix them, and then inoculate with a fermentation bacterium composed of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121 with a bacterial number ratio of 0.4:1 (the total inoculation amount of the fermentation bacterium is 1.25×10 10 cfu / g of the cooled material), and ferment under anaerobic conditions at a temperature of 33 °C and 60 rpm with stirring for 142 hours, and then sterilize to obtain a fermented product.

[0085] Step 4: Add a complex enzyme to the fermented product (the complex enzyme is composed of zingibain and snail protease, and the dosages of zingibain and snail protease are 350 u / g of the fermented product and 620 u / g of the fermented product respectively), and carry out enzymatic hydrolysis at a temperature of 47 °C and a stirring speed of 70 rpm for 5.5 hours, and then inactivate the enzyme to obtain an enzymolyzed product.

[0086] Step 5: Add ethanol to the enzymolyzed product, adjust the ethanol concentration to 15.5 wt%, heat at a temperature of 45 °C and stir at a speed of 80 rpm for 5.3 hours to obtain an extract.

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

[0088] 3. Composition III

[0089] The difference from Composition I lies in Step 3. Step 3 is as follows: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) for fermentation to the cooled material, based on the mass of the cooled material. Mix them, and then inoculate the fermenting bacterium Lactiplantibacillus plantarum CICC 21796 (the total inoculation amount of the fermenting bacterium is 1.20×10 10 cfu / g of the cooled material), and ferment under anaerobic conditions at a temperature of 32.5 °C with stirring at 60 rpm for 150 hours, and then sterilize to obtain the fermented product. The others are the same as those of Composition I.

[0090] 4. Composition IV

[0091] The difference from Composition I lies in Step 3. Step 3 is as follows: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) for fermentation to the cooled material, based on the mass of the cooled material. Mix them, and then inoculate the fermenting bacterium Lactococcus lactis subsp. lactis CICC 6242 (the total inoculation amount of the fermenting bacterium is 1.20×10 10 cfu / g of the cooled material), and ferment under anaerobic conditions at a temperature of 32.5 °C with stirring at 60 rpm for 150 hours, and then sterilize to obtain the fermented product. The others are the same as those of Composition I.

[0092] 5. Composition V

[0093] The difference from Composition I lies in Step 3. Step 3 is as follows: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) for fermentation to the cooled material, based on the mass of the cooled material. Mix them, and then inoculate the fermenting bacterium Limosilactobacillus reuteri CICC 6121 (the total inoculation amount of the fermenting bacterium is 1.20×10 10 cfu / g of the cooled material), and ferment under anaerobic conditions at a temperature of 32.5 °C with stirring at 60 rpm for 150 hours, and then sterilize to obtain the fermented product. The others are the same as those of Composition I.

[0094] 6. Composition VI

[0095] The difference from Composition I lies in Step 3. Step 3 is as follows: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) for fermentation to the cooled material, based on the mass of the cooled material. Mix them, and then inoculate the fermenting bacterium composed of Lactococcus lactis subsp. lactis CICC 6242 and Limosilactobacillus reuteri CICC 6121 with a bacterial number ratio of 0.08:1 (the total inoculation amount of the fermenting bacterium is 1.20×10 10 cfu / g of the cooled material), and ferment under anaerobic conditions at a temperature of 32.5 °C with stirring at 60 rpm for 150 hours, and then sterilize to obtain the fermented product. The others are the same as those of Composition I.

[0096] 7. Composition VII

[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) for fermentation to the cooled material, based on the mass of the cooled material. Mix them, and then inoculate with a fermentation bacterium composed of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121 in a bacterial quantity ratio of 2:1 (the total inoculation amount of the fermentation bacterium is 1.20×10 10 cfu / g of the cooled material), and ferment under anaerobic conditions at a temperature of 32.5°C with stirring at 60 rpm for 150 hours, then sterilize to obtain a fermented product. The others are the same as those of Composition 1.

[0098] 8. Composition 8

[0099] The difference from Composition 1 lies in Step 4. Step 4 is as follows: Add bromelain to the fermented product, with the dosage of bromelain being 950 u / g of the fermented product, and carry out enzymatic hydrolysis for 5.2 hours under stirring conditions at a temperature of 45°C and a rotation speed of 70 rpm, then inactivate the enzyme to obtain an enzymatically hydrolyzed product. The others are the same as those of Composition 1.

[0100] 9. Composition 9

[0101] The difference from Composition 1 lies in Step 4. Step 5 is as follows: Add ethanol to the enzymatically hydrolyzed product, adjust the ethanol concentration to 45 wt%, heat at a temperature of 42°C with stirring at a rotation speed of 80 rpm for 6.5 hours to obtain an extract. The others are the same as those of Composition 1.

[0102] 10. Composition 10

[0103] Step 1: Prepare raw materials: Prepare raw materials according to parts by mass: 1.5 parts of Microcos paniculata leaves, 3 parts of hawthorn, 4 parts of lotus leaf, 4.5 parts of immature bitter orange, 2.8 parts of Magnolia officinalis, 3 parts of radish seed, 2.2 parts of tangerine peel, 1.8 parts of Eupatorium fortunei, 3.7 parts of Alisma orientale, and 2.4 parts of Cassia obtusifolia;

[0104] Step 2: Mix all the raw materials in Step 1, crush them to a particle size below 60 mesh to obtain a crushed product, add water 13.5 times the mass of the crushed product, boil and then cool to 25°C to obtain a cooled material;

[0105] Step 3: Add 2.84% glucose (carbon source) and 0.04% sodium dihydrogen phosphate (nitrogen source) for fermentation to the cooled material, based on the mass of the cooled material. Mix them, and then inoculate with a fermentation bacterium composed of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121 in a bacterial quantity ratio of 0.6:1 (the total inoculation amount of the fermentation bacterium is 1.20×10 10(cfu / g cooled material), ferment at 32.5 °C under anaerobic conditions with stirring at 60 rpm for 150 hours, and sterilize to obtain a fermented product;

[0106] Step 4: Add a complex enzyme (the complex enzyme is composed of ginger protease and snail protease, and the dosages of ginger protease and snail protease are 450 u / g fermented product and 500 u / g fermented product respectively) to the fermented product, and carry out enzymatic hydrolysis for 5.2 hours under the conditions of stirring at a temperature of 45 °C and a rotation speed of 70 rpm, and inactivate the enzyme to obtain an enzymolyzed product;

[0107] Step 5: Filter the enzymolyzed product, 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 a water content of 1.72 wt% to obtain a weight-loss traditional Chinese medicine composition.

[0108] II. Experimental tests of the composition

[0109] Perform performance tests on the above composition, and the specific test process is as follows.

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

[0111] Feed the mice adaptively for 3 days. Then randomly divide the mice into groups according to their body weights, with 10 mice in each group. The groups are the blank group, the model group, and groups one to ten of the composition, a total of 12 groups. Feed the blank group with 10% low-fat feed, and feed the model group and groups one to ten of the composition with high-fat feed. Each group is fed for 2 months; during the above 2-month feeding period, groups one to ten of the composition are respectively gavaged with the compositions of groups one to ten of the composition, and the gavage dose is 80 mg composition / kg mouse. The composition is diluted with physiological saline into a solution, and the volume of the gavage solution is 0.2 mL / 10 g mouse, and the gavage is carried out once a day, while the blank group and the model group are gavaged with an equal amount of physiological saline; each group of mice drinks water and sleeps adaptively during the experiment.

[0112] After the gavage experiment, sacrifice the mice, take blood and collect serum.

[0113] 1. Use the kit to test the contents of the indicators total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL-C), and high-density lipoprotein (HDL-C) in the serum. The results are shown in Table 1.

[0114] Table 1: Contents of serum indicators

[0115]

[0116]

[0117] According to the average values of each group in Table 1, calculate the reduction amounts of total cholesterol (TC), triglyceride (TG), and low-density lipoprotein (LDL-C) in each group compared with the model group, as well as the increase amount of high-density lipoprotein (HDL-C). The results are shown in Table 2.

[0118] Table 2: Variation values of each group compared with the model group

[0119]

[0120]

[0121] Combined with the test results in Tables 1-2, it can be seen that the composition prepared by the present invention has the efficacy of significantly reducing the contents of total cholesterol (TC), triglyceride (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] The present invention uses Microcos paniculata leaves, Hawthorn Fruit, Folium Nelumbinis, Immature Bitter Orange, Cortex Magnoliae Officinalis, Semen Raphani, Pericarpium Citri Reticulatae, Herba Eupatorii, Alisma orientale, and Cassia Seed. After decocting, Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC 6121 are fermented in a ratio of 0.4-0.8:1, then combined enzymatic hydrolysis is carried out using ginger protease and snail protease, and then extraction is carried out with 15-25 wt% ethanol, endowing the composition with excellent lipid-lowering effects.

[0123] Combined with the tests of Composition 1 and 3, it can be seen that compared with other fermenting bacteria, using the specific fermenting bacteria Lactococcus lactis subsp. lactis CICC6242 and Lactobacillus mucosae CICC 6121 of the present invention can enrich the types and contents of active ingredients of the product, making the composition have better effects.

[0124] Combined with the test results of Composition 1 and 4, 5, it can be seen that when the dosage of the fermenting bacteria remains unchanged, the effect of combined fermentation of the two is better; it can be seen that the specific combination of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus mucosae CICC6121 used in the present invention produces a mutually promoting fermentation relationship, significantly improving the lipid-lowering effect of the composition.

[0125] Combined with the test results of Composition 1 and 5, 6, it can be seen that in the preparation system of the present invention, when changing the ratio of the fermenting bacteria combination, the obtained Composition 1 has better effects, indicating that the fermentation ratio of 0.4-0.8:1 used in the present invention can make the lipid-lowering performance of the composition better.

[0126] Combined with the test results of Composition 1 and Composition 8, it can be seen that compared with other enzymes for enzymatic hydrolysis, the combined enzymatic hydrolysis of zingibain and snail protease in the present invention can significantly improve the lipid-lowering effect of the composition.

[0127] Combined with the test results of Composition 1, Composition 9, and Composition 10, it can be seen that in the present invention, using 15 - 25wt% ethanol extraction can achieve better effects in reducing the contents of total cholesterol (TC), triglyceride (TG), and low-density lipoprotein (LDL-C) and increasing the content of high-density lipoprotein (HDL-C) compared with using high-concentration ethanol or water extraction, endowing the composition with a better lipid-lowering effect.

[0128] 2. Before and after the gavage experiment, measure the body weights (g) of the mice in the blank group, model group, and Compositions 1 to 2, conduct statistics, and calculate the body weight increments (g) of the mice in each group. The results are shown in Table 3.

[0129] Table 3: Body weight changes in each group

[0130] Test / g Body weight before experiment Body weight after experiment Body weight increment 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 1 25.16±0.81 33.54±1.17 8.38 Composition 2 23.01±1.12 31.55±1.27 8.54

[0131] Combined with the test in Table 3, it can be seen that the composition of the present invention can effectively inhibit the excessive increase in body weight and has a good weight loss effect.

[0132] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and its equivalent technologies, the present invention also intends to include these modifications and variations.

Claims

1. A method for preparing a weight loss Chinese medicine composition, characterized in that: The steps include: Step 1: Prepare the ingredients: buza leaves, hawthorn, lotus leaves, immature bitter orange, magnolia bark, radish seeds, tangerine peel, perilla, oriental water plantain and cassia seed; Step 2: Mix all the raw materials in step 1, crush them to obtain a crushed material, add water to boil, and then cool to obtain a cooled material; Step 3: adding a carbon source and a nitrogen source for fermentation to the cooled material, mixing, then inoculating fermentation bacteria, performing anaerobic fermentation, and sterilizing to obtain a fermentation product; Step 4: adding a complex enzyme to the fermented product for enzymolysis, inactivating the enzyme, and obtaining an enzymolysis product; Step 5: adding ethanol to the enzymatic hydrolysate, adjusting the ethanol concentration, heating and stirring to obtain an extract; Step 6: Filter, concentrate and dry the extract to obtain a weight loss Chinese medicine composition.

2. The preparation method according to claim 1, characterized in that: In step 1, prepare the raw materials according to the mass parts: 1-4 parts of Buza leaves, 1-5 parts of hawthorn, 1-5 parts of lotus leaves, 2-6 parts of Citrus aurantium, 0.5-4 parts of Magnolia officinalis, 0.4-3.5 parts of radish seeds, 0.3-3 parts of tangerine peel, 0.3-4 parts of Cyperus rotundus, 2-6 parts of Alisma orientalis and 1-4 parts of Cassia seed.

3. 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 crushed material; and / or, cooling 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; and / or, the carbon source comprises at least one of glucose, fructose, galactose, sucrose, lactose, and maltose; And / or, the nitrogen source includes at least one of nitrate, ammonia water, ammonium salt, peptone, urea, and protein powder.

4. The preparation method according to claim 1, characterized in that: In step 3, the fermentation bacteria are composed of Lactococcus lactis subsp. lactis CICC 6242 and Lactobacillus reuteri CICC 6121 at a bacterial count ratio of 0.4-0.8:1; And / or, the total amount of fermentation bacteria is 8×10 9 -4×10 10 cfu / g cooling material; And / or, the fermentation temperature is 25-45°C and the fermentation time is 120-180 hours.

5. The preparation method according to claim 1, characterized in that: In step 4, the complex enzyme is composed of ginger protease and snail protease; and / or, the dosage of ginger protease and snail protease is 300-650u / g fermentation product and 320-700u / g fermentation product, respectively; And / or, the enzymolysis temperature is 35-60°C and the time is 2.5-6 hours.

6. The preparation method according to claim 1, characterized in that: In step 5, the ethanol concentration is 15-25wt%; And / or, the heating and stirring temperature is 35-60° C. and the time is 3-10 hours.

7. The preparation method according to claim 1, characterized in that: In step 6, the extract is concentrated to 10-20% by mass; and / or, drying to a moisture content of less than 5 wt%.

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

9. A drug, characterized in that The invention comprises the Chinese medicine composition as claimed in claim 8 and auxiliary materials.

10. The drug according to claim, characterized in that The auxiliary material includes at least one of a solvent, a diluent, a filler, a sustained-release agent, a binder, and a lubricant.

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