Traditional Chinese medicine composition and preparation for treating obesity as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, and particularly provides a traditional Chinese medicine composition for treating obesity. Comprising 1-3 parts of a perilla extract, 1-3 parts of a reed rhizome extract, 5-10 parts of an ilex kudingcha extract, 0.1-1 part of a cape jasmine extract, 4-10 parts of a cassia seed extract, 1-3 parts of a white hyacinth bean extract, 2-5 parts of a roselle extract, 0.8-1.5 parts of an emblic leafflower fruit extract and 1-2 parts of a cranberry extract. The medicinal and edible composition not only has the dual functions of medicines and foods, but also acts on obesity in multiple ways of regulating metabolism, controlling appetite, improving inflammation and the like, so that the safety and effectiveness of treatment are ensured.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine compositions, and in particular to a Chinese medicine composition for treating obesity, a preparation thereof, and a preparation method and application thereof. Background Art

[0002] With the improvement of living standards, people's diet structure is increasingly developing in the direction of high calories, high fat and high sugar. Long-term intake of excessive high-fat food can easily lead to excessive fat synthesis in the human body, thus causing obesity. Obese people often face increased risks of cardiovascular disease, diabetes, hypertension, hyperlipidemia, fatty liver, bone and joint diseases, and even have a negative impact on mental health. Therefore, the treatment situation of obesity is not optimistic.

[0003] Western medicines for treating obesity include drugs that inhibit lipase, drugs that suppress appetite, and drugs that help reduce weight by increasing satiety and delaying gastric emptying. Currently, weight loss drugs on the market such as orlistat, amphetamine, and metformin do have good effects, but these Western medicines may cause diarrhea, increased fat excretion, headaches, insomnia, dry mouth, and many other adverse reactions, which will also discourage people from taking them. Therefore, finding an effective and safe method for weight loss and fat removal has become an urgent problem that people need to solve.

[0004] TCM believes that obesity is not just overweight, but also a pathological state and the result of a metabolic disorder. Obesity is mainly caused by spleen and stomach dysfunction, which leads to an imbalance in water metabolism in the body, forming pathological substances such as dampness, qi stagnation, phlegm and blood stasis, which in turn leads to poor internal functioning of the body and the formation of a state of fat accumulation. In addition, obesity is closely related to abnormal fat metabolism in the human body. The body lacks essential fatty acids and consumes too much saturated fatty acids, which leads to lipid metabolism disorders, excessive accumulation of fat in the body, and ultimately causes obesity. TCM generally uses a variety of methods such as medicated diet, acupuncture, cupping, and massage to treat obesity. The purpose is to regulate the spleen and stomach function, promote water metabolism in the body, eliminate pathological substances such as dampness, qi stagnation, phlegm and blood stasis, so as to achieve the effect of controlling fat accumulation in the body. In terms of preventing and treating obesity, traditional Chinese medicine has the characteristics of small side effects, reliable efficacy, flexible formulation, and emphasis on the overall regulation of human functions. For example, Chinese patent publication number CN118141876A discloses a tea composition based on Chinese medicinal materials that are both medicinal and edible and its application, which is mainly composed of the following raw materials in parts by weight: bitter gourd, lotus seeds, bitter melon, grass jelly, chrysanthemum, licorice, spinach seed, poria, lily, tangerine peel, cypress seed and gardenia; this technical solution uses a mixture of many herbs to improve and treat symptoms such as insomnia, memory loss, poor sleep, and dizziness, but this solution has not been dialectically analyzed from the perspective of traditional Chinese medicine theory, has not been targeted based on pathological mechanisms, and has not provided effective evidence of therapeutic effects.

[0005] However, the existing technologies for treating obesity and related problems with Chinese medicine compositions have problems such as complex formulas, unclear interactions between ingredients, insufficient safety for long-term use, and lack of symptom-type association. The main reasons include the complexity of formula design, insufficient research on ingredient interactions, lack of safety research, and neglect of individualized treatment of TCM syndromes. In addition, the existing technologies basically seek suitable combinations of compositions based on the combination of different Chinese medicines, but do not explore the extracts and / or active ingredients of the Chinese medicines that exert therapeutic effects, and the combination thereof from the perspective of exploring the therapeutic effects on obesity and related problems, which ultimately leads to insignificant weight loss effects or large side effects.

[0006] Therefore, on the basis of the existing Chinese medicine combinations, treatment based on different pathological mechanisms, further searching for extracts and / or active ingredients of Chinese medicine, and their combinations are important tasks for developing effective drug combinations for the treatment of obesity and related problems, so as to achieve more significant and more stable therapeutic effects. Summary of the invention

[0007] Since the treatment of obesity requires long-term conditioning, the medicine-food combination of the present invention has unique advantages and can be safely used for long-term conditioning of obesity. Compared with other traditional Chinese medicines, the medicine-food combination of the present invention not only has the dual functions of medicine and food, but also acts on obesity through multiple pathways such as regulating metabolism, controlling appetite, and improving inflammation, ensuring the safety and effectiveness of the treatment, and the treatment effect is more significant and more stable.

[0008] The embodiments of the present invention are achieved through the following technical solutions:

[0009] A Chinese medicine composition for treating obesity, comprising, by weight: 1-3 parts of perilla extract, 1-3 parts of reed root extract, 5-10 parts of iris extract, 0.1-1 parts of gardenia extract, 4-10 parts of cassia seed extract, 1-3 parts of white bean extract, 2-5 parts of roselle extract, 0.8-1.5 parts of emblica extract and 1-2 parts of cranberry extract.

[0010] Furthermore, in terms of weight, the composition includes: 2 parts of perilla extract, 2 parts of reed root extract, 8 parts of iris extract, 0.2 parts of gardenia extract, 8 parts of cassia seed extract, 1 part of white bean extract, 4 parts of roselle extract, 0.8 parts of emblica extract, and 2 parts of cranberry extract.

[0011] Furthermore, in terms of weight, the composition includes: 2 parts of perilla extract, 1 part of reed root extract, 5 parts of iris extract, 1 part of gardenia extract, 6 parts of cassia seed extract, 1 part of white bean extract, 5 parts of roselle extract, 1 part of emblica extract, and 2 parts of cranberry extract.

[0012] Furthermore, in terms of weight, the composition includes: 3 parts of perilla extract, 2 parts of reed root extract, 10 parts of iris extract, 0.5 parts of gardenia extract, 9 parts of cassia seed extract, 2 parts of white bean extract, 3 parts of roselle extract, 1.5 parts of emblica extract, and 1 part of cranberry extract.

[0013] Furthermore, the preparation method of the perilla extract is as follows: take 1 weight part of perilla, add 5-15 times the weight part of 50%-60% ethanol, reflux extraction at 60-80°C for 1-3 times, each time for 2 hours, filter, combine the filtrates, concentrate under reduced pressure to 1 / 4 of the original volume, let stand and settle at room temperature for 8 hours, filter, combine the filtrates, recover ethanol under reduced pressure, add water to dilute the concentrate, pass it through a macroporous resin column at a flow rate of 0.8-1mL / min, first elute with 6-10 times the column volume of deionized water, then elute with 8-15 times the column volume of 70% ethanol, collect the eluate, recover ethanol under reduced pressure and concentrate, and dry to obtain the perilla total flavonoid extract.

[0014] Further, the preparation method of the reed root extract is as follows: take 1 part by weight of the reed root, add 8-15 times the weight of water, ultrasonically extract twice, combine the filtrates, concentrate under reduced pressure to 1 / 2 of the original volume, add 1 / 4 volume of Sevag reagent (chloroform: n-butanol = 4:1), stir at high speed for 20 minutes, centrifuge at 5000r / min for 20 minutes, absorb the upper polysaccharide solution until there is no protein precipitation in the lower layer, add 1.5% powdered activated carbon, keep warm at 60°C for 1h, then centrifuge at high speed (10000rmp), and filter the supernatant. The decolorized solution is concentrated by rotary evaporation to about 1 / 2, 95% ethanol is added, the alcohol content is adjusted to 80%, and it is allowed to stand overnight, and then filtered, the filter residue is washed three times with acetone and anhydrous ethanol, and the filter residue is concentrated under reduced pressure and dried to obtain the total polysaccharide extract of the reed root.

[0015] Furthermore, the preparation method of Cassia seed extract is as follows: take 1 weight part of Cassia seed, add 5-10 times weight parts of 70% ethanol to soak the Cassia seed and then reflux extract twice, combine the filtrate, concentrate, and freeze-dry, add 60 times weight parts of 0.1 mol / L hydrochloric acid to the dried sample and reflux for 1 hour, then extract with chloroform 4 times, combine the chloroform solutions, recover the chloroform, and obtain the Cassia seed total anthraquinone extract.

[0016] Furthermore, the preparation method of white hyacinth bean extract is as follows: take 1 weight part of white hyacinth bean, grind it and pass it through an 80-mesh sieve, add 5-12 times the weight part of water, extract for 100 minutes at an ultrasonic power of 150W and a temperature of 50-60°C, centrifuge at 5000r / min for 15 minutes, extract the precipitate again according to the above process, combine the supernatant, filter with a 0.2μm microfiltration membrane to obtain a crude total polypeptide extract; the crude total polypeptide extract is subjected to organic membrane separation and purification, the ultrafiltration temperature is fixed at 30°C and the ultrafiltration pressure is fixed at 0.35MPa, the crude total polypeptide extract is separated by an ultrafiltration membrane with a cutoff molecular weight of 10kD in turn, the retentate is collected and concentrated under negative pressure and then freeze-dried to obtain the white hyacinth bean total polypeptide extract.

[0017] Furthermore, the preparation method of the roselle extract is as follows: taking 1 part by weight of roselle, adding 28 times by weight of water to soak the roselle, and then reflux extraction at 70-100°C for 1 to 3 times, each time for 1.5 hours, the filtrate is concentrated under reduced pressure to obtain a crude total organic acid extract, after centrifugation at 5000r / min and 4°C for 10 minutes, the supernatant is taken for reduced pressure distillation and vacuum drying, and the crude total organic acid powder is dried to obtain a crude total organic acid extract powder, using 3mg / mL crude total organic acid extract solution as the loading liquid, according to the loading liquid: resin = 25:1 (volume ratio) on the column, passing through a DM301 macroporous resin column at a flow rate of 0.8-1mL / min, eluting with 2-6 times the column volume of 90% ethanol, collecting the eluate, recovering the ethanol under reduced pressure and concentrating, and obtaining the roselle total organic acid extract.

[0018] Further, the preparation of the emblica extract: take 1 weight part of emblica, add 8 times weight parts of 70% ethanol, reflux twice at 70°C, each time for 1 to 2 hours, concentrate and dry the extract, adsorb it with D101 macroporous adsorption resin, elute with 4 times column volume of purified water at a volume flow rate of 1.5BV / h, discard the first 1.5BV of the eluate, collect 1.5 to 4BV of the eluate, concentrate and dry to obtain the emblica total phenolic extract.

[0019] Furthermore, the preparation method of cranberry extract is as follows: take 1 weight part of cranberry, add 8 times the weight part of 70% ethanol, reflux and extract twice at 70°C, each time for 1 to 2 hours, concentrate and dry the extract, adsorb it with D101 macroporous adsorption resin, elute with 4 times the column volume of purified water at a volume flow rate of 1.5BV / h, discard the first 1.5BV of the eluate, collect 1.5 to 4BV of the eluate, concentrate and dry it to obtain the cranberry total phenol extract.

[0020] Furthermore, the preparation method of the Aquilegia odorata extract is as follows: take 1 weight part of Aquilegia odorata, add 70% ethanol 10 to 12 times its weight, soak for 1 hour, reflux extraction at 70 to 80°C for 3 times, each time for 0.5 hour, and concentrate the filtrate under reduced pressure to a concentration of 10 to 14 mg / ml, adjust the pH value to 6.0-7.0, pass through a D101 macroporous adsorption resin column at a flow rate of 2BV / h, and elute with 4BV water, 4BV 30% ethanol, and 4BV 70% ethanol solution in sequence, and collect, concentrate, and dry to obtain the Aquilegia odorata total saponin extract.

[0021] Furthermore, the preparation method of gardenia extract is as follows: take 1 weight part of gardenia, add 70%-80% ethanol in an amount of 10-12 times its weight, reflux extraction at 70-80°C for 1-3 times, each time for 2 hours, and the filtrate is concentrated under reduced pressure to a concentration of 14.47 mg / ml, and passed through a D101 macroporous adsorption resin column at a flow rate of 2BV / h, firstly washed with 2BV of water to remove impurities, and then eluted with 3BV of 70%-80% ethanol aqueous solution and collected, concentrated, and dried to obtain the gardenia total saponin extract.

[0022] The present invention also provides a pharmaceutical preparation for treating obesity, comprising the above-mentioned Chinese medicine composition and pharmaceutically acceptable excipients.

[0023] Furthermore, the dosage form of the pharmaceutical preparation may be any one of a suspension, tablet, granule, hard capsule, pill or soft capsule.

[0024] Furthermore, the auxiliary materials include but are not limited to adhesives, such as sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, gelatin, chitosan, sodium hydroxybutyrate; diluents, such as starch, powdered sugar, dextrin, lactose, microcrystalline cellulose, mannitol; lubricants, such as polyethylene glycol, talc, magnesium stearate, micropowdered silica gel; disintegrants, such as dry starch, sodium carboxymethyl starch, low-substituted hydroxypropyl methylcellulose, cross-linked polyvinyl pyrrolidone, cross-linked carboxymethyl cellulose; absorption promoters, such as quaternary ammonium compounds; surfactants, such as hexadecane, sodium lauryl sulfate; excipients, such as lactose, starch, sucrose, dextrin, calcium carbonate, aluminum sulfate, magnesium oxide, magnesium stearate, sodium bicarbonate, glycerol, propylene glycol, polyethylene glycol, sorbitol, lanolin, vaseline, microcrystalline cellulose, beeswax, wood wax, liquid paraffin, resin, high-grade wax, pressure-sensitive adhesive, semi-synthetic fatty acid esters, etc.

[0025] The present invention also provides a method for preparing a suspension for treating obesity: after mixing various Chinese medicinal extracts, adding sodium carboxymethyl cellulose, and then adding distilled water and mixing evenly, the suspension is obtained.

[0026] The present invention also provides an application of the traditional Chinese medicine composition in preparing a medicine for treating obesity.

[0027] The technical solution of the embodiment of the present invention has at least the following advantages and beneficial effects:

[0028] The Chinese medicine composition of the present invention can simultaneously exert effects on different pathological mechanisms, such as lipid metabolism, suppressing appetite hormones, regulating fat cell differentiation, and the like, thereby achieving the effect of improving obesity in many aspects, such as being able to effectively treat fat deposition and obesity, especially in reducing body weight, adipose tissue weight, and serum indexes, and having significant and stable therapeutic effects. The Chinese medicine composition of the present invention is easy to use, has clear ingredients and pharmacological effects, and is highly safe. It not only conforms to the multi-target, multi-component, multi-pathway, and multi-mechanism treatment methods of traditional Chinese medicine, but also conforms to the development requirements of the modernization of traditional Chinese medicine, and can better meet the needs of clinical medication. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0030] Figure 1 The following are the comparison pictures of the appearance of mice in each group under different treatment conditions;

[0031] Figure 2 Comparison results of body weight changes of mice in each group under different treatment conditions from 1 to 5 weeks of treatment;

[0032] Figure 3 (A) The final body weight of mice in each group after 5 weeks of treatment under different treatment conditions; Figure 3 (B) is the comparison result of body weight difference of mice in each group after 5 weeks of treatment;

[0033] Figure 4 Comparison of fasting blood glucose (FBG) test results of mice in each group after 5 weeks of treatment under different treatment conditions;

[0034] Figure 5 The results of using the kit to detect the blood lipid levels in the serum of each group of mice, Figure 5 (A) is triglyceride (TG) content; Figure 5 (B) is the total cholesterol (TC) content; Figure 5 (C) is the high-density lipoprotein (HDL-C) content; Figure 5 (D) is the low-density lipoprotein (LDL-C) content;

[0035] Figure 6 The results of using ELISA to detect inflammatory factors in the serum of each group of mice; Figure 6(A) is the detection result of interleukin-6 (IL-6), Figure 6 (B) Detection results of tumor necrosis factor-α (TNF-α);

[0036] Figure 7 Comparison of adipose tissue weight and fat coefficient of mice in each group after 5 weeks of treatment under different treatment conditions;

[0037] Figure 8 HE staining and Oil Red O staining of liver tissue and HE staining of adipose tissue were performed to detect liver tissue damage and adipose tissue changes in each group of mice. DETAILED DESCRIPTION

[0038] In order to make the purpose, technical scheme and advantages of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially.

[0039] The following is a detailed description of a Chinese medicine composition, preparation, preparation method and application for treating obesity provided by an embodiment of the present invention.

[0040] A Chinese medicine composition for treating obesity, comprising, by weight: 1-3 parts of perilla extract, 1-3 parts of reed root extract, 5-10 parts of iris extract, 0.1-1 parts of gardenia extract, 4-10 parts of cassia seed extract, 1-3 parts of white bean extract, 2-5 parts of roselle extract, 0.8-1.5 parts of emblica extract and 1-2 parts of cranberry extract.

[0041] The present invention is guided by traditional Chinese medicine theory and combines relevant research results at home and abroad to treat from the aspects of removing dampness, promoting qi, and removing blood stasis. It has the therapeutic advantage of treating both the symptoms and the root causes. Therefore, the present invention uses Perilla as the main drug to promote qi and relieve stomach discomfort, harmonize the stomach and stop vomiting, and regulate spleen and stomach qi stagnation. This has a key conditioning effect on the fundamental causes of obesity - spleen and stomach disharmony, qi stagnation and other problems. The total flavonoids in Perilla can not only affect the formation and generation of fat cells, but also regulate lipid metabolism, thereby playing a key role in the weight loss process.

[0042] Cassia seed, reed root and white lentil are used as ministerial drugs, playing an important auxiliary role. Cassia seed, with its effects of clearing heat and promoting diuresis, moistening the intestines and promoting bowel movements, and lowering blood lipids, effectively enhances the effect of perilla. Its total anthraquinone components inhibit lipase activity and promote fat decomposition, thereby further enhancing the lipid-lowering and weight-loss effect of the overall prescription. Reed root can not only clear lung and stomach heat, but its total polysaccharide components have the function of regulating lipid metabolism, which is especially effective for patients with damp-heat constitution and lipid metabolism disorders. At the same time, it plays a role in balancing cold and heat in the overall formula, and is particularly suitable for obesity caused by internal heat. White lentil fundamentally improves the spleen and stomach function by strengthening the spleen and aiding digestion. Its total polypeptide components can inhibit α-amylase activity, regulate blood sugar and blood lipids, and reduce fat accumulation from the source. It is especially suitable for obese patients with weak spleen and stomach and heavy dampness.

[0043] Roselle, Phyllanthus emblica, cranberry, gardenia, and Kudingcha are used as adjuvants to further enrich the function of the formula. Roselle has the effects of clearing away heat and heat, lowering blood pressure and reducing lipids. Its total organic acid components can promote bile secretion, accelerate the dissolution of excess fat in the body, and promote metabolism. It is suitable for obese patients with damp-heat constitution. The total phenolic components in Phyllanthus emblica directly reduce fat accumulation in the body by inhibiting lipid production and promoting apoptosis of adipocytes, significantly reducing fat. At the same time, it can also help digestion and strengthen the stomach, and improve obesity caused by weak spleen and stomach. Cranberry has the effects of clearing heat and relieving stranguria, dissolving fat and reducing turbidity, and strengthening the spleen and replenishing qi. Its total phenolic components have the effect of inhibiting pancreatic lipase, thereby reducing fat absorption and helping to control body fat. It is an ideal choice for weight management after diet control. Gardenia, with its characteristics of clearing heat and dampness, cooling blood and dispersing blood stasis, effectively clears damp heat in the body and promotes blood circulation. The total saponin components can enhance the level of lipid metabolism, which is suitable for obesity caused by damp-heat or blood stasis constitution. Kuding tea has the functions of dispelling wind and heat, digesting food and reducing phlegm, and can clear away heat and toxins in the body. Its total saponin components can inhibit lipase activity, reduce fat production and accumulation, and are suitable for obesity caused by internal heat and phlegm.

[0044] In the formula, white lentils and reed roots also play the role of adjuvant drugs. They guide the drug power to concentrate on the spleen, lung, and stomach meridians, making the overall conditioning more effective. White lentils coordinate the efficacy of the whole formula to ensure that the spleen and stomach functions are fully improved; reed roots focus on clearing heat and reducing fire, guiding the drugs into the spleen and stomach meridians, and improving the overall treatment effect. The total ingredients of each drug interact with each other, further enhancing the synergistic effect of this formula in treating obesity, playing the role of regulating the spleen and stomach, clearing heat and dampness, and promoting qi and eliminating accumulation, playing a good role in weight loss and oil discharge.

[0045] In addition, the present invention predicts the effective targets of obesity and the Chinese medicine combination through the Chinese medicine system pharmacology formulation platform - TCMSP, and obtains the molecular mechanism synergistic effect information of each Chinese medicine and the Chinese medicine combination through KEGG pathway enrichment analysis, revealing that the synergistic effect of the Chinese medicine composition of the present invention is crucial to the therapeutic mechanism affecting obesity, and can target different pathological mechanisms, such as lipid metabolism, suppressing appetite hormones, regulating fat cell differentiation and other multiple mechanisms to work simultaneously, thereby achieving the effect of improving obesity in many aspects.

[0046] Example 1

[0047] This embodiment provides a suspension for treating obesity, which comprises, by weight: 2g of perilla extract, 2g of reed root extract, 8g of iris extract, 0.2g of gardenia extract, 8g of cassia seed extract, 1g of white lentil extract, 4g of roselle extract, 1.5g of emblica fruit, and 1.5g of cranberry extract;

[0048] The preparation method of the perilla extract is as follows: take 2g of perilla, add 20ml of 55% ethanol, reflux extract at 70°C for 3 times, each time for 2h, filter, combine the filtrates, concentrate under reduced pressure to 1 / 4 of the original volume, let stand and settle at room temperature for 8 hours, filter, combine the filtrates, recover ethanol under reduced pressure, add water to dilute the concentrate, pass it through a macroporous resin column at a flow rate of 1mL / min, first elute with 10 times the column volume of deionized water, then elute with 15 times the column volume of 70% ethanol, collect the eluate, recover ethanol under reduced pressure and concentrate, and dry to obtain the perilla total flavonoid extract.

[0049] Preparation of Phragmites australis extract: Take 2g Phragmites australis, add 20ml water and ultrasonically extract twice, combine the filtrates, concentrate under reduced pressure to 1 / 2 of the original volume, add 1 / 4 volume of Sevag reagent (chloroform: n-butanol = 4:1), stir at high speed for 20min, centrifuge at 5000r / min for 20min, absorb the upper polysaccharide solution until there is no protein precipitation in the lower layer, add 1.5% powdered activated carbon, keep at 60℃ for 1h for decolorization, then centrifuge at high speed (10000rmp), filter the supernatant. The decolorized solution is concentrated by rotary evaporation to about 1 / 2, add 95% ethanol, adjust the alcohol content to 80%, let stand overnight, filter by suction, wash the filter residue with acetone and anhydrous ethanol three times, concentrate the filter residue under reduced pressure and dry, and obtain the Phragmites australis total polysaccharide extract.

[0050] Preparation of Cassia seed extract: Take 8g of Cassia seed, add 65ml of 70% ethanol to soak the Cassia seed and then reflux extract twice, combine the filtrate, concentrate, and freeze-dry, add 60 times the weight of 0.1mol / L hydrochloric acid to the dried sample and reflux for 1h, then extract with chloroform 4 times, combine the chloroform solutions, recover the chloroform, and obtain the Cassia seed total anthraquinone extract.

[0051] Preparation of white lentil extract: 1g of white lentil was crushed and passed through an 80-mesh sieve, 10ml of water was added, and the mixture was extracted for 100min at an ultrasonic power of 150W and a temperature of 55°C, and then centrifuged at 5000r / min for 15min. The precipitate was extracted again according to the above process, and the supernatant was combined and filtered with a 0.2μm microfiltration membrane to obtain a crude total polypeptide extract. The crude total polypeptide extract was subjected to organic membrane separation and purification, and the ultrafiltration temperature was fixed at 30°C and the ultrafiltration pressure was fixed at 0.35MPa. The crude total polypeptide extract was separated by an ultrafiltration membrane with a molecular weight cutoff of 10kD in turn, and the retentate was collected and concentrated under negative pressure and then freeze-dried to obtain the total polypeptide extract of white lentil.

[0052] Preparation of roselle extract: Take 4g of roselle, add 28 times the weight of water to soak the roselle, then reflux extract at 85°C for 3 times, each time for 1.5h, and concentrate the filtrate under reduced pressure to obtain a crude total organic acid extract. After centrifugation at 5000r / min and 4°C for 10min, take the supernatant for reduced pressure distillation and vacuum drying to obtain a crude total organic acid powder. Use 3mg / mL crude total organic acid extract solution as the loading liquid, load the column according to the loading liquid: resin = 25:1 (volume ratio), pass through a DM301 macroporous resin column at a flow rate of 1mL / min, elute with 5 times the column volume of 90% ethanol, collect the eluate, recover the ethanol under reduced pressure and concentrate to obtain a roselle total organic acid extract.

[0053] Preparation of emblica extract: Take 1.5g of emblica, add 8 times the weight of 70% ethanol, reflux twice at 70°C, 2 hours each time, concentrate and dry the extract, adsorb it with D101 macroporous adsorption resin, elute with 4 times the column volume of purified water at a volume flow rate of 1.5BV / h, discard the first 1.5BV of the eluate, collect 3BV of the eluate, concentrate and dry to obtain the emblica total phenolic extract.

[0054] Preparation of cranberry extract: Take 1.5g of cranberry, add 8 times the weight of 70% ethanol, reflux and extract at 70°C twice, each time for 2 hours. After the extract is concentrated and dried, it is adsorbed on D101 macroporous adsorption resin, and eluted with 4 times the column volume of purified water at a volume flow rate of 1.5BV / h, the first 1.5BV of the eluate is discarded, and 3BV of the eluate is collected, concentrated, and dried to obtain the cranberry total phenol extract.

[0055] Preparation of the Aquilegia odorata extract: Take 8 g of Aquilegia odorata, add 70% ethanol (10 times its weight) and soak for 1 hour, reflux extraction at 75°C for 3 times, each time for 0.5 hour, and concentrate the filtrate under reduced pressure to a concentration of 10 mg / ml. The pH value is adjusted to 6.0, and passed through a D101 macroporous adsorption resin column at a flow rate of 2BV / h. Elution is performed with 4BV water, 4BV 30% ethanol, and 4BV 70% ethanol solution in sequence, and the extract is collected, concentrated, and dried to obtain the total saponin extract of Aquilegia odorata.

[0056] Preparation of Gardenia Extract: Take 0.2 g of Gardenia, add 75% ethanol at 10 times its weight, reflux extraction at 80°C for 3 times, each time for 2 hours, and concentrate the filtrate under reduced pressure to a concentration of 14.47 mg / ml. Pass the filtrate through a D101 macroporous adsorption resin column at a flow rate of 2BV / h, first wash with 2BV of water to remove impurities, then wash with 3BV of 80% ethanol aqueous solution and collect, concentrate and dry to obtain the Gardenia total saponin extract.

[0057] The preparation method of the above suspension is as follows: take the above Chinese medicine extracts according to the prescription, mix them, add 25g of sodium carboxymethyl cellulose, add distilled water and mix well to obtain the suspension.

[0058] Example 2

[0059] The difference between this embodiment and embodiment 1 is that the suspension provided in this embodiment includes: 2g of perilla extract, 1g of reed root extract, 5g of iris extract, 1g of gardenia extract, 6g of cassia seed extract, 1g of white bean extract, 5g of roselle extract, 1g of emblica extract, and 2g of cranberry extract.

[0060] Example 3

[0061] The difference between this embodiment and embodiment 1 is that the suspension provided in this embodiment includes: 3g of perilla extract, 2g of reed root extract, 10g of iris extract, 0.5g of gardenia extract, 9g of cassia seed extract, 2g of white bean extract, 3g of roselle extract, 1.5g of emblica extract, and 1g of cranberry extract.

[0062] Comparative Example 1

[0063] The difference between this comparative example and Example 3 is that the suspension provided in this comparative example includes: 0.5g of perilla extract, 2g of reed root extract, 15g of iris extract, 1.5g of gardenia extract, 8g of cassia seed extract, 1g of white bean extract, 1g of roselle extract, 2.5g of emblica extract, and 1g of cranberry extract.

[0064] Comparative Example 2

[0065] The difference between this comparative example and Example 3 is that the suspension provided in this comparative example does not contain the Kudingcha extract of Aquifoliaceae and the Gardenia extract.

[0066] Experimental Example 1

[0067] This experimental example is intended to evaluate the therapeutic effect of the Chinese medicine composition on obese mice induced by a high-fat diet, as follows:

[0068] To further verify the pharmacological effects of the present invention, the suspension of the present invention was used to conduct animal pharmacodynamic experiments to verify its effect on obesity in mice, with a focus on the effect on lipid-lowering and weight-loss effects in mice.

[0069] 1. Experimental Materials and Methods

[0070] 1.1 Experimental animals and groups

[0071] Experimental animals: Wild-type SPF male KM mice (6-8 weeks old) were purchased from Beijing Weitonglihua Experimental Animal Technology Co., Ltd. and raised at the Experimental Center of Northwest A&F University under standard breeding conditions, with an ambient temperature of (22±3)°C, humidity of (55±5)%, and light intensity of 12h / 12h day and night alternation. Mice were free to eat and drink.

[0072] Before the start of the experiment, all animals were adapted to the environment for one week.

[0073] According to the experimental needs, the experimental animals were divided into 8 groups, with 10 animals in each group: blank control group, model group, sample groups 1-5 (the samples used in each sample group later corresponded to the suspension samples obtained in Examples 1-3 and Comparative Examples 1-2, respectively), and positive drug control group.

[0074] 1.2 Obese mouse modeling and drug administration methods

[0075] The mice in the blank control group were given ordinary feed, and the mice in the other groups were given high-fat feed. When the body weight of the other groups exceeded that of the blank control group by 20%, it indicated that the model was successfully established.

[0076] Sample 1-5 group mice: before administration, take the above corresponding preparations and use carboxymethyl cellulose sodium (CMC-Na) solution to prepare the required drug concentration of 30 mg / ml solution. According to the body surface area conversion formula for human and mouse dosage, the dosage for mice is calculated to be 300 mg / kg / d by oral gavage;

[0077] Positive drug control group mice: Take the contents of Celecoxib orlistat capsules, grind them into powder, and prepare the required drug concentration of 5.406 mg / ml solution with sodium carboxymethyl cellulose (CMC-Na) solution. According to the body surface area conversion formula for human and mouse dosage, the dosage for mice is calculated to be 6 mg / kg / d by oral gavage;

[0078] In addition, the blank group and the model group were given the same volume of sodium carboxymethylcellulose (CMC-Na) solution.

[0079] During the experiment, mice were allowed to eat and drink freely, and their food intake was recorded every day. Their body weight and blood glucose were measured every 7 days. The drugs were administered for 5 consecutive weeks, and mice were killed after fasting for 12 hours.

[0080] 1.3 Metabolic index detection

[0081] Blood was collected from the eyeballs of mice and allowed to stand at room temperature for 2 hours. The blood was then centrifuged at 4°C and 5000 g for 10 minutes and then stored at 4°C for later use. The metabolic indicators in the serum of mice in different groups were then determined according to the official instructions of the kit.

[0082] Blood glucose level: fasting blood glucose (FBG);

[0083] Blood lipid levels: total triglyceride (TG), total cholesterol (TC), low-density lipoprotein (LDL-C), and high-density lipoprotein (HDL-C) levels.

[0084] 1.4 Detection of inflammatory factors

[0085] Inflammatory factor indicators: tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6).

[0086] 1.5 Adipose tissue weight and fat coefficient

[0087] Fat coefficient: Separate the white adipose tissue around the kidneys and epididymis of mice, weigh and calculate the fat coefficient:

[0088] Fat coefficient = m1 / m × 100%

[0089] Where: m1 is the mass of white adipose tissue around the kidneys and epididymis of the mouse, and m is the body mass of the mouse.

[0090] 1.6 HE and Oil Red O staining of liver tissue and HE staining of adipose tissue

[0091] After the mice were killed, the liver tissue was washed with saline, then fixed with 4% paraformaldehyde overnight, dehydrated, embedded, sectioned, and stained with hematoxylin and eosin (HE staining) and Oil Red O. The pathological changes of liver tissue were observed using an inverted fluorescence microscope (×400).

[0092] After the mice were killed, the adipose tissue was washed with physiological saline, then fixed with 4% paraformaldehyde overnight, dehydrated, embedded, sliced, and stained with hematoxylin and eosin (HE staining). The pathological changes of adipose tissue were observed using an inverted fluorescence microscope (×400).

[0093] 1.7 Results Analysis

[0094] The experimental results after treatment are shown in Figure 1-8 ; Different lowercase letters represent significant differences between the two groups (p<0.05), and the same letters represent no significant differences between the two groups.

[0095] 1. Weight comparison

[0096] Obesity is the excess amount of body fat tissue to a degree that may have a negative impact on health, usually manifested by increased body weight and an increase in fat tissue. Figure 1-2 The results showed that compared with the blank group mice, the body weight of the high-fat diet group mice after the modeling was completed (i.e., week 0 after treatment) was 20% higher than that of the blank group mice, indicating that the modeling was successful. Figure 1 and Figure 3 (A) The results show that after 5 weeks of treatment, the final body weight of mice in the model group increased by 27% compared with the blank group, which was significantly higher than the blank control group (P<0.05); compared with the model group, the body weight of mice in sample 1, sample 2, and sample 3 groups decreased by 15%, 13%, and 12%, respectively, with significant differences (P<0.05), which was equivalent to the positive drug control group (orlistat), while the body weight of mice in sample 4 and sample 5 groups did not change significantly, which can be clearly seen in the appearance. Figure 3 (B) is the difference in weight between the mice in each group after 5 weeks of treatment and before treatment. It can be seen that the final weight of the mice in sample 1, sample 2, sample 3 and orlistat group (positive drug control group) is lower than that before treatment. Studies have shown that drinking the suspension prepared by the Chinese medicine composition of the present invention has a significant synergistic effect of preventing weight gain and reducing weight on obesity caused by a high-fat diet.

[0097] 2. Metabolic Level-Blood Glucose Analysis

[0098] The changes in fasting blood glucose can reflect the changes in insulin sensitivity of mice; triglycerides can reflect the changes in lipid content in mouse plasma; the changes in total cholesterol, high-density lipoprotein, and low-density lipoprotein can reflect the degree of lipid metabolism disorder in mice. Figure 4 The results of fasting blood glucose content showed that compared with the blank group, the fasting blood glucose of mice in the model group increased significantly, indicating that a high-fat diet can cause blood glucose to increase; compared with the model group, the fasting blood glucose of sample 1, sample 2, and sample 3 groups decreased significantly (P<0.05), which was equivalent to the orlistat group (positive drug control group), while the difference between sample 4 and sample 5 groups and the model group was not significant. The above proves that a high-fat diet can increase the fasting blood glucose of mice, and drinking the suspension prepared by the Chinese medicine composition of the present invention has a synergistic effect on reducing fasting blood glucose.

[0099] in, Figure 5 The results of using the kit to detect blood lipid levels in mouse serum were obtained by Figure 5(A) triglyceride content, (B) total cholesterol content, (C) high-density lipoprotein content, (D) low-density lipoprotein content results show that compared with the blank group, the triglyceride, total cholesterol, and low-density lipoprotein in the serum of the model group mice were significantly increased (P<0.05), and the high-density lipoprotein was significantly reduced (P<0.05); compared with the model group, the triglyceride, total cholesterol, and low-density lipoprotein in the serum of the sample 1, sample 2, and sample 3 groups were significantly reduced (P<0.05), and the high-density lipoprotein was significantly increased (P<0.05), which was equivalent to the orlistat group (positive drug control group); while the effects of the sample 4 and sample 5 groups were not as obvious as those of the sample 1, sample 2, and sample 3 groups. The above proves that a high-fat diet can induce metabolic abnormalities, specifically increase triglycerides, total cholesterol, and low-density lipoprotein in serum, and reduce high-density lipoprotein, and drinking the suspension prepared by the Chinese medicine composition of the present invention can synergistically improve the above indicators.

[0100] 3. Inflammatory Factors

[0101] Inflammatory factors are one of the important indicators for evaluating the degree of obesity and related metabolic disorders in mice. In the obese state, adipose tissue will secrete a large amount of IL-6 and TNF-α, which will cause an inflammatory response in the body, thereby inhibiting the insulin signaling pathway and leading to increased insulin resistance. Figure 6 The results of (A) IL-6 content and (B) TNF-α content showed that compared with the blank group, the inflammatory indexes IL-6 and TNF-α content of the model group mice were significantly increased (P<0.05); compared with the model group, sample 1, sample 2, and sample 3 could significantly reduce the content of IL-6 and TNF-α (P<0.05); while the effects of sample 4, sample 5 and orlistat group (positive drug control group) were not as obvious as those of sample 1, sample 2, and sample 3. The above proves that a high-fat diet can cause an inflammatory reaction in mice, and drinking the suspension prepared by the Chinese medicine composition of the present invention has a synergistic effect on reducing the level of inflammation in the body.

[0102] 4. Fat Tissue Weight and Fat Index

[0103] Obese mice typically develop hyperplasia and enlargement of adipose tissue, as well as an increase in the number and size of fat cells. Figure 7 Comparison of adipose tissue weight and fat coefficient of mice in each group after 5 weeks of treatment under different treatment conditions. Figure 7(A) Perinephric, epididymal, subcutaneous inguinal and mesenteric fat tissue weight, (B) fat coefficient results show that compared with the blank group, the perinephric, epididymal, subcutaneous inguinal and mesenteric fat weight and fat coefficient (fat / body weight ratio) of the model group mice were significantly increased; compared with the model group, sample 1, sample 2, and sample 3 groups can significantly reduce the fat tissue weight and fat coefficient of high-fat mice, and the therapeutic effect is equivalent to the orlistat group (positive drug control group), while there is no significant difference between sample 4 and sample 5 groups. The above proves that a high-fat diet can increase the deposition of visceral fat, and drinking the suspension prepared by the Chinese medicine composition of the present invention has a synergistic effect on reducing abdominal obesity caused by visceral fat deposition.

[0104] 5. HE and Oil Red O staining of liver tissue and HE staining of adipose tissue

[0105] Figure 8 HE staining and oil red staining of liver tissue and HE staining of adipose tissue were performed to detect liver tissue damage and adipose tissue changes in each group of mice. Figure 8 As shown in the results of liver HE staining pathological sections, compared with the blank group, the obvious and bright round or polygonal fat vacuoles in the liver tissue of the model group mice increased significantly and became larger, and the structure of the hepatocytes was destroyed; compared with the model group, the liver HE staining sections of the mice in the sample 1, sample 2, and sample 3 groups showed no obvious fat vacuoles in the liver tissue, and the hepatocyte structure was intact and arranged neatly, which was equivalent to the orlistat group (positive drug control group). As shown in the results of liver oil red O staining pathological sections, compared with the blank group, the liver tissue sections of the model group mice showed a large amount of fat particles deposited, the hepatocytes showed obvious red or orange, and the fat accumulation increased; compared with the model group, the sample 1, sample 2, and sample 3 groups could reduce the content of fat droplets in the hepatocytes, and the effect was equivalent to the orlistat group (positive drug control group). The results of HE staining of adipose tissue pathological sections show that compared with the blank group, the adipose tissue volume of the model group mice increased significantly and was irregularly arranged; compared with the model group, samples 1, 2, and 3 can reduce the volume of adipocytes, and the morphology is relatively regular, and the effect is equivalent to the orlistat group (positive drug control group), while the improvement of liver and fat in samples 4 and 5 groups of mice is not as obvious as that in samples 1, 2, and 3. The above proves that a high-fat diet can lead to fat accumulation in the liver, fatty liver, and a significant increase in the volume of adipose tissue, and drinking the suspension prepared by the Chinese medicine composition of the present invention can improve the above symptoms, and has a synergistic effect on eliminating fat deposition in the liver and adipose tissue.

[0106] In summary, it is proved that through the experimental results of mouse body weight, mouse serum index detection, fat coefficient (adipose tissue weight), liver HE staining, and adipose tissue HE staining, it can be seen that the groups 1, 2, and 3 that drank the suspension made from the Chinese medicine composition of the present invention were far superior to the other groups in reducing mouse body weight, adipose tissue weight, and mouse serum indexes, indicating that the Chinese medicine composition of the present invention is effective in reducing mouse body weight, adipose tissue weight, and mouse serum indexes, and has a synergistic effect.

[0107] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating obesity, characterized in that: Calculated by weight, the composition includes: 1-3 parts of perilla extract, 1-3 parts of reed root extract, 5-10 parts of vaccinium myrtles extract, 0.1-1 parts of gardenia extract, 4-10 parts of cassia seed extract, 1-3 parts of white bean extract, 2-5 parts of roselle extract, 0.8-1.5 parts of emblica extract and 1-2 parts of cranberry extract.

2. The Chinese medicine composition for treating obesity according to claim 1, characterized in that: Calculated by weight, the composition includes: 2 parts of perilla extract, 2 parts of reed root extract, 8 parts of hollyhock tea extract, 0.2 parts of gardenia extract, 8 parts of cassia seed extract, 1 part of white bean extract, 4 parts of roselle extract, 0.8 parts of emblica extract and 2 parts of cranberry extract.

3. The Chinese medicine composition for treating obesity according to claim 1, characterized in that: Calculated by weight, the composition includes: 2 parts of perilla extract, 1 part of reed root extract, 5 parts of holly family kudingcha extract, 1 part of gardenia extract, 6 parts of cassia seed extract, 1 part of white bean extract, 5 parts of roselle extract, 1 part of emblica extract and 2 parts of cranberry extract.

4. The Chinese medicine composition for treating obesity according to claim 1, characterized in that: Calculated by weight, the composition includes: 3 parts of perilla extract, 2 parts of reed root extract, 10 parts of iris extract, 0.5 parts of gardenia extract, 9 parts of cassia seed extract, 2 parts of white bean extract, 3 parts of roselle extract, 1.5 parts of emblica extract and 1 part of cranberry extract.

5. A pharmaceutical preparation for treating obesity, characterized in that: The invention comprises the Chinese medicine composition according to any one of claims 1 to 4 and pharmaceutically acceptable excipients.

6. The pharmaceutical preparation for treating obesity according to claim 5, characterized in that: The dosage form of the pharmaceutical preparation is any one of suspension, tablet, granule, hard capsule, pill or soft capsule.

7. A method for preparing a pharmaceutical preparation for treating obesity according to claim 6, characterized in that: The preparation method of the suspension is as follows: after mixing various Chinese medicinal extracts, adding sodium carboxymethyl cellulose, and then adding distilled water to mix well, the suspension is obtained.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for treating obesity.

Images