New medical application of dyspepsia-resolving liver-nourishing preparation

Abstract

The invention relates to a new medical application of a stagnation-resolving and liver-nourishing preparation, belongs to the technical field of traditional Chinese medicines, and particularly relates to an effect of a traditional Chinese medicine composition in preparation of a medicine for treating weight loss, the traditional Chinese medicine composition is mainly prepared from hawthorn, rhizoma alismatis, oriental wormwood, rheum officinale, semen cassiae, herba cepbalanoplosis segeti, rhizoma atractylodis, rhizoma atractylodis macrocephalae, polyporus umbellatus, radix bupleuri and liquorice. All the medicines in the traditional Chinese medicine composition conform to the principle of compatibility of monarch, minister, assistant and guide, compatibility is scientific, clinical cases are considered, and pharmacodynamic tests show that the composition can remarkably reduce the weight, TC, TG and HDL-C of rats, promote fat metabolism and inhibit fat formation, meanwhile, the composition can adjust abnormal water metabolism caused by obesity, improve gastrointestinal hormone level disorder and improve the body immunity of the rats. The traditional Chinese medicine composition has obvious weight-losing and lipid-lowering effects, is low in toxic and side effects and good in safety, and has a wide market prospect.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition and a preparation method and new use thereof, and specifically relates to a preparation method and new use of a stagnation-relieving and liver-softening preparation. Background Art

[0002] Obesity has become one of the most serious public health challenges in the 21st century. By 2022, the number of obese people (BMI ≥ 30 kg / m 2 ) has exceeded 1 billion, accounting for 13% of the total population. This figure is projected to climb to 1.9 billion by 2035, representing 25% of the world's adult population. Data from 2020 shows that the overweight and obesity rate among Chinese adults has exceeded 50%. Even more worrying is the trend of obesity becoming prevalent at younger ages. In 2020, approximately 39 million children under the age of five were overweight or obese worldwide, with the prevalence of severe obesity reaching 1.96%-6.30%. Childhood obesity is significantly associated with cardiovascular disease, metabolic syndrome, and premature mortality in adulthood, a link confirmed by large-scale prospective studies.

[0003] Obesity, a global public health issue, presents pathological manifestations not limited to abnormal body fat accumulation but are often closely intertwined with numerous metabolic diseases. Clinical studies have shown that patients with obesity and fatty liver disease commonly experience symptoms such as liver pain, fatigue, and loss of appetite. Serological markers such as TC and TG are also significantly elevated, accompanied by abnormal increases in body mass index (BMI) and waist circumference (WC).

[0004] Chinese invention patent CN1191082C discloses a traditional Chinese medicine composition for treating fatty liver and its preparation method. The product "Huazhi Rougan Granules" prepared by this patent has now been approved for marketing. Huazhi Rougan Granules have a clear mechanism of action, treating both the liver and kidney, harmonizing the symptoms and the root causes, promoting dampness without damaging the yin, and activating blood circulation without damaging the blood, achieving the functions of clearing heat and dampness, detoxifying and removing turbidity, and removing blood stasis and softening the liver. It is clinically used for non-alcoholic simple fatty liver with damp-heat obstruction, mainly for clearing heat and dampness, removing turbidity and detoxifying, and removing blood stasis and softening the liver. No prior art has found any treatment related to obesity.

[0005] In this prescription, Artemisia capillaris and Cassia seed serve as the main ingredients, clearing heat and dampness, dispelling turbidity and detoxifying. Artemisia capillaris enters the liver and gallbladder meridians and is a specialized herb for clearing heat, detoxifying and dispelling dampness; Cassia seed enters the liver and kidney meridians and has the functions of clearing the liver, improving eyesight, and promoting diuresis and relieving constipation. Together, these two herbs achieve the functions of clearing the liver and detoxifying, dispelling dampness and turbidity, and serve as the main ingredients in this prescription.

[0006] Rhubarb, Alisma plantago-aquatica, Polyporus umbellatus, and Crataegus pinnatifida serve as the auxiliary herbs in this prescription, promoting blood circulation, dissolving stasis, and dissolving accumulation. Accumulation of damp-heat, disharmony in the meridians, and blood stasis, particularly in the liver meridian, are key factors in the development of fatty liver. Concerned that the main herbs are insufficient in dispersing dampness, dissolving stasis, and purging turbidity, rhubarb, a bitter and cold herb, is used to purge heat and toxicity, dissipate stagnation, dissipate blood stasis, and cleanse the intestines and stomach, creating a pathway for damp-heat to escape, allowing it to be expelled through the stool. Alisma plantago-aquatica and Polyporus umbellatus work together to promote diuresis, dissipate dampness, and dissipate heat. Alisma plantago-aquatica, with its sweet and cold properties, enters the kidney and bladder meridians, specifically promoting diuresis, dissipating dampness, and dissipating heat. Polyporus umbellatus, with its sweet, mild, and neutral properties, enters the spleen, kidney, and bladder meridians, making it a key diuretic and dampness-dissipating herb, promoting diuresis without damaging yin. Their combined use can promote the excretion of damp-heat through urination. Combined with rhubarb, it can dissipate damp-heat both frontally and rearward. Crataegus pinnatifida is excellent at digesting food, strengthening the spleen and stomach, promoting qi circulation, and dissipating blood stasis. This prescription can activate blood circulation, dissipate blood stasis, relieve stagnation and eliminate accumulation. When combined with rhubarb, its effect of removing blood stasis, unblocking meridians and relieving stagnation is even stronger.

[0007] Atractylodes, Atractylodes macrocephala, Tangerine peel, Bupleurum root, Trichosanthes root, Lycium barbarum, Ligustrum lucidum, Eclipta tenuifolia, and Cirsium sibiricum serve as adjuvants in the formula. Because Alisma orientale and Polyporus root are superior in dispelling dampness and dampness, but lack the ability to invigorate the spleen and transport dampness, Atractylodes and Atractylodes macrocephala are added to tonify the spleen and stomach, dispel dampness, and resolve turbidity. Tangerine peel is then added to regulate qi and balance the middle qi, drying out dampness and invigorating the spleen. These herbs are used together to complement the principal and auxiliary herbs in their heat-clearing, dampness-clearing, turbidity-clearing, and detoxifying effects. Bupleurum root not only regulates liver qi and regulates the liver, but also directs the full power of the formula directly to the affected area. Trichosanthes root is sweet, bitter, and cold, entering the lung, stomach, and large intestine meridians to dispel phlegm, relieve bowel movements, and soothe the liver. Lycium barbarum fruit is sweet and mild, nourishing the kidneys and replenishing essence, nourishing the liver, and improving eyesight. Ligustrum lucidum fruit is bitter, sweet, and mild, effectively tonifying the liver and kidneys, and strengthening the waist and knees. Eclipta prostrata is sweet, sour, and cool, also cooling blood, tonifying the kidneys, and tonifying yin. The combination of the three can nourish the kidneys and soften the liver, clear away heat and purge fire, and replenish the liver and clear the liver; small thistle is sweet and cool, and is a product that cools blood, removes blood stasis, detoxifies and eliminates dampness, and can assist the monarch and minister in clearing heat, removing dampness and eliminating phlegm.

[0008] Licorice harmonizes the other herbs, soothing the stomach and relieving urgency, and serves as the guiding herb in the formula. Furthermore, Bupleurum can guide the other herbs into the liver meridian, also serving as a guiding herb.

[0009] In summary, the prescription composition of the present invention is complete with monarch, minister, adjuvant and guiding ingredients. Although the medicinal flavors are many but not mixed, the compatibility is rigorous and orderly. The medicines complement each other, treat the liver and kidney at the same time, and harmonize the symptoms and the root cause. It clears away heat and dampness without damaging yin, and promotes blood circulation and removes blood stasis without damaging blood. It has the functions of clearing heat and dampness, detoxifying and removing turbidity, and removing blood stasis and softening the liver. When Huazhi Rougan Granules are used clinically to treat damp-heat obstruction syndrome of non-alcoholic fatty liver, in addition to significantly improving the core symptoms such as liver discomfort and fatigue, the patient population is generally accompanied by weight loss. After in-depth research, it was found that this weight loss effect is highly correlated with the pharmacology of the Huazhi Rougan Granules. The present invention is a new use of a Chinese medicine composition developed on the basis of Chinese invention patent CN1191082C, and specifically relates to the use of the Chinese medicine composition in the preparation of drugs for treating obesity. Summary of the Invention

[0010] The purpose of the present invention is to provide a new use of a traditional Chinese medicine composition, especially a liver-clearing and liver-softening preparation for preparing a drug for treating weight loss.

[0011] Specifically,

[0012] In some embodiments, the liver-tonifying and stagnation-relieving preparation comprises Artemisia capillaris, Cassia seed, Rhubarb, Polyporus umbellatus, Crataegus pinnatifida, Alisma orientalis, Trichosanthes kirilowii, Ligustrum lucidum fruit, Ecliptae macrocephala, Lycium barbarum fruit, Atractylodes lancea, Atractylodes macrocephala, Tangerine peel, Citrus aurantium, Bupleurum chinense, and Licorice root.

[0013] In some embodiments, the liver-clearing and liver-softening preparation is prepared from the following Chinese medicinal components in the following weight ratios:

[0014]

[0015]

[0016] In a more preferred embodiment, the liver-clearing and liver-softening preparation is made from the following Chinese medicinal components by weight:

[0017]

[0018] In some embodiments, the rhubarb is stewed rhubarb with wine, the cassia seed is stir-fried cassia seed, the white atractylodes is stir-fried with bran, the atractylodes is stir-fried with bran, the glossy privet fruit is steamed with wine, and the bupleurum is stir-fried with vinegar.

[0019] Another object of the present invention is to provide a use of the Huazhi Rougan preparation in the preparation of a medicament for treating reduction of visceral fat content and / or improvement of obesity-related metabolic homeostasis imbalance.

[0020] In some embodiments, the metabolic homeostasis imbalance includes obesity and metabolic imbalance.

[0021] Another object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition, wherein the Chinese medicine composition of the present invention is used as a raw material, and excipients are added to prepare a clinically acceptable dosage form.

[0022] In some embodiments, the clinically acceptable dosage form is granules, tablets, pills, capsules and microcapsules.

[0023] In a more preferred embodiment, the clinically acceptable dosage form is a granule.

[0024] A method for preparing the liver-clearing and liver-softening preparation of the present invention comprises:

[0025] A: Extract bupleurum root, wormwood, dried orange peel, thistle, and wolfberry fruit with ethanol at 50-80°C and concentrate under reduced pressure to a density of 1.10-1.15 g / cm 3 ;

[0026] B: Atractylodes macrocephala, Atractylodes lancea, Glycyrrhiza uralensis, Crataegus pinnatifida, Ligustrum lucidum, and Eclipta prostrata were enzymatically hydrolyzed with cellulase for 1-2 h, and then water extraction was performed, and the filtrate was collected by ultrafiltration;

[0027] C: Take Poria, Rhizoma Alismatis, and Rhizoma Trichosanthis, add 12 times the amount of water, extract at 100°C for 1-2 hours, precipitate with alcohol until the alcohol content is 50-80%, and take the supernatant;

[0028] D: Supercritical CO2 extraction of rhubarb and cassia seed to obtain fat-soluble extracts;

[0029] The concentrates of A, B and C are mixed and spray-dried, and then the extract of D is sprayed in and granulated.

[0030] In a more preferred embodiment, the preparation method is as follows: A: extract bupleurum, capillaris, tangerine peel, thistle, and wolfberry with 8 times the amount of 70% ethanol, reflux at 60 ° C for 2 times, and concentrate under reduced pressure for 1.5 hours each time to a density of 1.15g / cm 3 ;

[0031] B: Atractylodes macrocephala, Atractylodes lancea, Glycyrrhiza uralensis, Crataegus pinnatifida, Ligustrum lucidum, and Eclipta prostrata were enzymatically hydrolyzed with 0.5% cellulase at 50°C for 1 hour, then decocted twice with 10 times the amount of water for 1 hour each time, and the filtrate was collected by ultrafiltration;

[0032] C: Take Poria, Rhizoma Alismatis, and Rhizoma Trichosanthis, add 12 times the amount of water, extract at 100℃ for 1.5h, precipitate with alcohol until the alcohol content reaches 70%, and take the supernatant;

[0033] D: Rhubarb and Cassia seed, pressure 25MPa, temperature 45℃, supercritical CO2 extraction to obtain fat-soluble extract;

[0034] The concentrates of A, B and C were mixed and spray-dried with the inlet water temperature of 150°C, and the extract D was sprayed in and mixed to form granules.

[0035] Verified by efficacy tests: Rat experiments have verified that the Chinese medicine composition of the present application can reduce the weight of rats, significantly reduce the total cholesterol (TC) and triglycerides (TG) of model group rats, increase high-density lipoprotein (HDL-C), promote fat metabolism and inhibit fat formation, reduce the atherosclerosis index, and has a very high protection rate.

[0036] At the same time, the Chinese medicine composition of the present invention can also increase the plasma albumin content and reduce the serum aldosterone content, thereby regulating the abnormal water metabolism caused by obesity. The present invention can increase the levels of serum gastrin, plasma motilin and ghrelin, thereby improving gastrointestinal hormone level disorders and enhancing digestive function, that is, promoting the metabolism of body fat, reducing fat formation, and further reducing weight.

[0037] Clinical data show that the Chinese medicine composition of the present invention not only has the functions of clearing away heat and detoxifying, promoting dampness and reducing jaundice, but also has the pharmacodynamic effects of weight loss and lipid reduction. The Chinese medicine composition has comprehensive effects when used to treat obesity, and body weight, body fat percentage, visceral fat area and waist circumference are significantly reduced, and can be used for the treatment of obesity. Specific embodiments

[0038] Various exemplary embodiments of the present invention are now described in detail. This detailed description should not be considered as a limitation of the present invention, but should be understood as a more detailed description of certain aspects, features, and embodiments of the present invention. It should be understood that the terms used in the present invention are only for describing specific embodiments and are not intended to limit the present invention.

[0039] In addition, for numerical ranges in the present invention, it is understood that each intervening value between the upper and lower limits of the range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated value or intervening value in the stated range is also included in the present invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.

[0040] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention.

[0041] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0042] Example 1: A Chinese medicine composition for treating weight loss

[0043]

[0044]

[0045] Preparation process: A: Add 8 times the amount of 70% ethanol to bupleurum, wormwood, dried orange peel, thistle, and wolfberry, reflux at 60℃ for 2 times, each time for 1.5 hours and concentrate under reduced pressure to a density of 1.15g / cm 3; B: Add 0.5% cellulase to Atractylodes macrocephala, Atractylodes lancea, Licorice, Crataegus pinnatifida, Ligustrum lucidum, and Eclipta prostrata, enzymolysis at 50℃ for 1h, then add 10 times the amount of water and decoct twice, each time for 1h, and collect the filtrate by ultrafiltration; C: Take Poria cocos, Alisma orientalis, and Trichosanthes kirilowii, add 12 times the amount of water, extract at 100℃ for 1.5h, precipitate with alcohol to 70% alcohol content, and take the supernatant; D: Extract rhubarb and Cassia seed with supercritical CO2 at a pressure of 25MPa and a temperature of 45℃ to obtain a fat-soluble extract; Mix the concentrated solutions of A, B, and C and spray dry them with a water inlet temperature of 150℃, spray the extract D, add the remaining nanopowders of Atractylodes lancea and Lycium barbarum, and mix and granulate.

[0046] Example 2: A Chinese medicine composition for treating weight loss

[0047]

[0048] Preparation process: same as Example 1.

[0049] Example 3: A Chinese medicine composition for treating weight loss

[0050]

[0051] Comparative Example 1: A Chinese medicine composition for treating weight loss

[0052]

[0053] Preparation process: Grind licorice and thistle into fine powder under vacuum; crush oriental rhizome, glossy privet fruit, rhubarb and cassia seed, extract twice with 75% ethanol under reflux, combine the filtrates and set aside; crush bupleurum, atractylodes, atractylodes, wolfberry, tangerine peel and umbellate, add artemisia capillaris and boil to extract volatile oil inclusion compound, prepare inclusion compound of volatile oil with β-cyclodextrin, and set aside the residue and aqueous solution; boil the residue and aqueous solution with trichosanthes kirilowii, hawthorn and Eclipta prostrata twice with water to make a mixed decoction; combine the filtrate with the obtained decoction, The mixture was filtered and concentrated to a clear paste with a relative density of 1.03, ethanol was added to make the alcohol content 65%, and the mixture was allowed to stand for 15 hours. The mixture was filtered, the ethanol was recovered under reduced pressure and concentrated to a relative density of 1.23 to obtain a thick paste, vacuum dried at a temperature, and crushed through an 80-mesh sieve under a vacuum state to obtain a fine powder. The Huazhi Rougan extract was weighed and 1 / 10 weight part of sorbitol of the Huazhi Rougan extract was added, and an appropriate amount of 5% ethanol solution of sodium carboxymethyl cellulose was added to prepare a soft material, which was granulated and dried to obtain Huazhi Rougan granules.

[0054] Comparative Example 2: A Chinese medicine composition for treating weight loss

[0055]

[0056] Preparation process: same as Example 1.

[0057] Comparative Example 3: A Chinese medicine composition for treating weight loss

[0058]

[0059] Preparation process: A: Add 8 times the amount of 70% ethanol to bupleurum, wormwood, dried orange peel, thistle, and wolfberry, reflux at 60℃ for 2 times, each time for 1.5 hours and concentrate under reduced pressure to a density of 1.15g / cm 3 ; B: Add 0.5% cellulase to Atractylodes macrocephala, Atractylodes lancea, Licorice, Crataegus pinnatifida, Ligustrum lucidum, and Eclipta prostrata, enzymatically hydrolyze at 50℃ for 1h, then add 10 times the amount of water and decoct twice, each time for 1h, and collect the filtrate by ultrafiltration; C: Take Poria cocos, Alisma orientalis, and Trichosanthes kirilowii, add 12 times the amount of water, extract at 100℃ for 1.5h, precipitate with alcohol to 70% alcohol content, and take the supernatant; D: Extract rhubarb, pressure 25MPa, temperature 45℃, supercritical CO2 extraction to obtain a fat-soluble extract; Mix the concentrated solutions of A, B, and C, spray dry them, the water inlet temperature is 150℃, spray the extract D, add the remaining nanopowders of Atractylodes lancea and Lycium barbarum, and mix and granulate.

[0060] Comparative Example 4: A Chinese medicine composition for treating weight loss

[0061]

[0062] Preparation process: A: Add 8 times the amount of 70% ethanol to bupleurum, Lysimachia chinensis, dried tangerine peel, thistle, and wolfberry, and extract twice under reflux at 60℃, each time for 1.5 hours, and concentrate under reduced pressure to a density of 1.15g / cm 3 ; B: Add 0.5% cellulase to Atractylodes macrocephala, Atractylodes lancea, Licorice, Crataegus pinnatifida, Ligustrum lucidum, and Eclipta prostrata, enzymolysis at 50℃ for 1h, then add 10 times the amount of water and decoct twice, each time for 1h, and collect the filtrate by ultrafiltration; C: Take Poria cocos, Alisma orientalis, and Trichosanthes kirilowii, add 12 times the amount of water, extract at 100℃ for 1.5h, precipitate with alcohol to 70% alcohol content, and take the supernatant; D: Extract rhubarb and Cassia seed with supercritical CO2 at a pressure of 25MPa and a temperature of 45℃ to obtain a fat-soluble extract; Mix the concentrated solutions of A, B, and C and spray dry them with a water inlet temperature of 150℃, spray the extract D, add the remaining nanopowders of Atractylodes lancea and Lycium barbarum, and mix and granulate.

[0063] Comparative Example 5: A Chinese medicine composition for treating weight loss

[0064]

[0065] Preparation process: A: Add 8 times the amount of 70% ethanol to bupleurum, artemisia capillaris, dried orange peel, and wolfberry fruit, reflux and extract twice at 60℃, each time for 1.5 hours, and concentrate under reduced pressure to a density of 1.15g / cm 3; B: Add 0.5% cellulase to Atractylodes macrocephala, Atractylodes lancea, Licorice, Crataegus pinnatifida, and Ligustrum lucidum fruit, enzymatically hydrolyze at 50℃ for 1h, then add 10 times the amount of water and decoct twice, each time for 1h, and collect the filtrate by ultrafiltration; C: Take Alisma orientalis, add 12 times the amount of water, extract at 100℃ for 1.5h, precipitate with alcohol to 70% alcohol content, and take the supernatant; D: Extract rhubarb and Cassia seed with supercritical CO2 at a pressure of 25MPa and a temperature of 45℃ to obtain a fat-soluble extract; Mix the concentrated solutions of A, B, and C and spray dry them with a water inlet temperature of 150℃, spray the extract of D, add the remaining nanopowders of Atractylodes lancea and Lycium barbarum, and mix and granulate.

[0066] Comparative Example 6: A Chinese medicine composition for treating weight loss

[0067]

[0068] Preparation process: A: Add 8 times the amount of 70% ethanol to thistle, reflux at 60℃ for 2 times, and concentrate under reduced pressure to a density of 1.15g / cm 3 ; B: Add 0.5% cellulase to Atractylodes macrocephala, Atractylodes lancea, Licorice, Crataegus pinnatifida, Ligustrum lucidum, and Eclipta prostrata, enzymolysis at 50℃ for 1h, then add 10 times the amount of water and decoct twice, each time for 1h, and collect the filtrate by ultrafiltration; C: Take Poria cocos, Alisma orientalis, and Trichosanthes kirilowii, add 12 times the amount of water, extract at 100℃ for 1.5h, precipitate with alcohol to 70% alcohol content, and take the supernatant; D: Extract rhubarb and Cassia seed with supercritical CO2 at a pressure of 25MPa and a temperature of 45℃ to obtain a fat-soluble extract; Mix the concentrated solutions of A, B, and C and spray dry them with a water inlet temperature of 150℃, spray the extract D, add the remaining nanopowders of Atractylodes lancea and Lycium barbarum, and mix and granulate.

[0069] Comparative Example 7: A Chinese medicine composition for treating weight loss

[0070]

[0071]

[0072] Preparation process A: add 8 times the amount of 70% ethanol to bupleurum, wormwood, dried orange peel, thistle, and wolfberry, reflux and extract twice at 60℃, each time for 1.5 hours, and concentrate under reduced pressure to a density of 1.15g / cm 3 ; B: Add 0.5% cellulase to licorice and Eclipta prostrata, hydrolyze at 50℃ for 1h, then add 10 times the amount of water and boil twice, each time for 1h, and collect the filtrate by ultrafiltration; C: Take Poria, Alisma orientalis, and Trichosanthes kirilowii, add 12 times the amount of water, extract at 100℃ for 1.5h, precipitate with alcohol to the alcohol content of 70%, and take the supernatant; D: Extract rhubarb and cassia seed with supercritical CO2 at a pressure of 25MPa and a temperature of 45℃ to obtain a fat-soluble extract; Mix the concentrated solutions of A, B, and C and spray dry them with a water inlet temperature of 150℃, spray the extract of D, add the remaining nanopowders of Atractylodes lancea and Lycium barbarum, and mix and granulate.

[0073] Comparative Example 8: A Chinese medicine composition for treating weight loss

[0074]

[0075] Preparation process A: add 8 times the amount of 70% ethanol to bupleurum, wormwood, dried orange peel and thistle, extract twice under reflux at 60℃, and concentrate under reduced pressure for 1.5 hours each time to a density of 1.15g / cm 3 ; B: Add 0.5% cellulase to Atractylodes macrocephala, Atractylodes lancea, Licorice, and Crataegus pinnatifida, enzymatically hydrolyze at 50℃ for 1h, then add 10 times the amount of water and decoct twice, each time for 1h, and collect the filtrate by ultrafiltration; C: Take Poria cocos, Alisma orientalis, and Trichosanthes kirilowii, add 12 times the amount of water, extract at 100℃ for 1.5h, precipitate with alcohol to 70% alcohol content, and take the supernatant; D: Extract rhubarb and Cassia seed with supercritical CO2 at a pressure of 25MPa and a temperature of 45℃ to obtain a fat-soluble extract; Mix the concentrated solutions of A, B, and C and spray dry them with a water inlet temperature of 150℃, spray the extract of D, add the remaining nanopowders of Atractylodes lancea and Lycium barbarum, and mix and granulate.

[0076] Comparative Example 9: A Chinese medicine composition for treating weight loss

[0077]

[0078] Preparation process: A: Add 8 times the amount of 70% ethanol to bupleurum, wormwood, dried orange peel, thistle, and wolfberry, reflux at 60℃ for 2 times, each time for 1.5 hours, and concentrate under reduced pressure to a density of 1.15g / cm 3 ; B: Add 0.5% cellulase to Atractylodes macrocephala, Atractylodes lancea, Licorice, Crataegus pinnatifida, Ligustrum lucidum, and Eclipta prostrata, enzymolysis at 50℃ for 1h, then add 10 times the amount of water and decoct twice, each time for 1h, and collect the filtrate by ultrafiltration; C: Take Poria cocos and Trichosanthes kirilowii, add 12 times the amount of water, extract at 100℃ for 1.5h, precipitate with alcohol to 70% alcohol content, and take the supernatant; D: Extract Cassia seed with supercritical CO2 at a pressure of 25MPa and a temperature of 45℃ to obtain a fat-soluble extract; Mix the concentrated solutions of A, B, and C and spray dry them with a water inlet temperature of 150℃, spray the extract D, add the remaining nanopowders of Atractylodes lancea and Lycium barbarum, and mix and granulate.

[0079] Comparative Example 10: A Chinese medicine composition for treating weight loss

[0080] 12 parts of Astragalus, 12 parts of Stephania tetrandra, 12 parts of Atractylodes macrocephala, 12 parts of Ligusticum chuanxiong, 12 parts of processed Polygonum multiflorum, 25 parts of Alisma orientalis, 25 parts of raw Crataegus, 25 parts of Salvia miltiorrhiza, 25 parts of Artemisia capillaris, 25 parts of Horn of buffalo, 10 parts of Epimedium, 8 parts of raw Rhubarb, and 8 parts of dried tangerine peel.

[0081] Preparation process: All raw materials are dried, ground into powder, sterilized, and made into granules.

[0082] Comparative Example 11: A Chinese medicine composition for treating weight loss

[0083] 50g of Artemisia capillaris, 30g of Gardenia jasminoides, 30g of Poria cocos, 30g of Alisma orientalis, 30g of Bupleurum chinense, 30g of stir-fried white peony root, 30g of Citrus aurantium, 20g of Licorice root, 30g of Crataegus pinnatifida, 30g of Cassia seed, 30g of Lotus leaf, 30g of Zedoariae rhizome, and 30g of Pumice stone.

[0084] Preparation process: 1) weighing the raw material medicine according to the ratio, putting it into a casserole, adding clean water to soak the medicine surface by 3 cm, and soaking for 15 minutes; 2) first boiling the raw material medicine soaked in the clean water in the casserole with high heat, then decocting it with low heat for 20 minutes, filtering and taking the decoction for later use; 3) treating the filter residue remaining in step 2) according to the operating methods of steps 1) and 2) again, filtering and taking the decoction for later use; 4) mixing and concentrating the decoctions obtained in steps 2) and 3), and stirring them evenly to form a solution preparation of the Chinese medicine composition.

[0085] Comparative Example 12: A Chinese medicine composition for treating weight loss

[0086] Artemisia capillaris 40g, Polygonum multiflorum 20g, Rosa rugosa 30g, Polygonatum 30g, Raw hawthorn 15g, Salvia miltiorrhiza 20g, Rhubarb 10g, Panax notoginseng powder 5g, Alisma orientale 15g, Pueraria lobata 20g.

[0087] Preparation process: All raw materials are dried, ground into powder, sterilized, and made into granules.

[0088] Comparative Example 13: A Chinese medicine composition for treating weight loss

[0089] 70 parts of Radix Gentianae, 50 parts of Herba Lysimachiae, 30 parts of Herba Artemisiae Scopariae, 30 parts of Fructus Gardeniae, 40 parts of Radix Curcumae, 70 parts of Semen Cassiae, 20 parts of Rhizoma Alismatis, 50 parts of Lotus Leaf.

[0090] Preparation process: All raw materials are dried, ground into powder, sterilized, and made into granules.

[0091] 1. Weight loss effect of Huazhi Rougan granules on obese rats

[0092] Experimental Example 1 Effect of Huazhi Rougan Granules on Body Weight and Body Fat of Obese Rats

[0093] 1 Materials and Methods

[0094] 1.1 Experimental animals and feeding

[0095] 120 male SPF rats, weighing 180-200 g, license number: SYXK(Lu)20230023, were purchased from Lunan Pharmaceutical Group Co., Ltd. The animals were housed in separate cages in a dedicated laboratory and acclimatized for one week before the experiment. The animals were exposed to natural light and had free access to food and water. The room temperature was controlled at 25°C ± 0.2°C.

[0096] Ordinary feed: provided by Beijing Keao Xieli Feed Co., Ltd.

[0097] High-fat feed: ordinary feed 55%, casein 17%, sucrose 10%, lard 16%, salt 1%, yeast powder 1%.

[0098] 1.2 Experimental drugs

[0099] Huazhi Rougan Granules, provided by Shandong Xinshidai Pharmaceutical Co., Ltd., with the batch number Z20090077, were prepared with 0.5% sodium carboxymethylcellulose to the required concentration during the experiment. Orlistat Capsules, specification: 0.12g, produced by Shandong Xinshidai Pharmaceutical Co., Ltd., with the batch number H20143119, were prepared with 0.5% sodium carboxymethylcellulose solution to 3g / L before use. -1 Oral administration of 60mg.kg- 1 .d -1 , each group of the comparative example was prepared with 0.5% sodium carboxymethyl cellulose to the required concentration.

[0100] 1.3 Test methods

[0101] 1.3.1 Grouping and Dosing

[0102] Ten rats were randomly selected as the blank group and given ordinary feed, and the remaining 110 rats were fed with a high-fat feed for 45 consecutive days. After eliminating the obesity-insensitive rats, the remaining rats were randomly divided into the model group, the positive drug orlistat group (0.048 g / kg / d) (hereinafter referred to as the OLST group), the low-dose group of Huazhi Rougan Granules (1.8 g / kg / d) (hereinafter referred to as HZRG-L), the medium-dose group of Huazhi Rougan Granules (3.6 g / kg / d) (hereinafter referred to as HZRG-M) and the high-dose group of Huazhi Rougan Granules combination (7.2 g / kg / d) (hereinafter referred to as HZRG-H). For comparative examples 1, 2, 6, 7, 9, and 11, the gavage volume was 1 mL / 100 g, and the gavage was performed once a day. The blank group and the model group were gavaged with an equal amount of normal saline for 8 consecutive weeks, and the body weight of each group was recorded every week.

[0103] 1.3.2 Measurement indicators

[0104] Body weight was recorded weekly. One hour after the last administration, the rats were anesthetized with 1% sodium pentobarbital, and the perinephric fat and perinephric fat were removed and weighed to calculate the fat / body ratio.

[0105] 1.4 Statistical Results

[0106] The data were processed using SPSS 22.0 statistical software. The experimental results are presented as mean ± standard deviation. The data were expressed in the form of , and the differences among the groups were compared using one-way analysis of variance. P < 0.05 indicated that the differences were statistically significant.

[0107] 2. Experimental Results

[0108] 2.1 Body mass changes

[0109] Table 1 Changes in body weight of rats in each group

[0110]

[0111]

[0112] Compared with the model group, @P<0.05, @@P<0.01; compared with the orlistat group, # P<0.5, ## P<0.01; compared with the low-dose group of Huazhi Rougan Granule, ^ P<0.5, ^^ P<0.01.

[0113] Table 2 Changes in body fat content and fat / body ratio of rats in each group

[0114] Group Perididymal fat (g) Perididymal fat / body ratio (%) Perinephric fat (g) Perinephric fat / body ratio (%) Blank group 9.27±2.69 1.85±0.57 4.17±1.75 0.82±0.17 Model Group 26.85±7.15 3.76±0.86 8.49±1.60 1.42±0.15 OLST group 18.62±1.75@@ 2.95±1.03@@ 5.95±0.86@@ 1.01±0.19@@ HZRG-L group 17.57±1.59@@ 2.85±0.78@@ 5.75±1.22@@ 0.98±0.12@@ HZRG-M group 16.94±1.58@@ 2.62±0.92@@ <![CDATA[5.22±1.15@@ # ]]> <![CDATA[0.88±0.13@@ # ]]> HZRG-H group <![CDATA[15.21±2.09@@ # ]]> <![CDATA[2.54±0.73@@ # ]]> <![CDATA[5.07±1.55@@ # ]]> <![CDATA[0.83±0.28 ## ]]> Comparative Example 1 <![CDATA[23.69±2.37 #^^ ]]> <![CDATA[3.35±0.90 ##^^ ]]> <![CDATA[7.95±1.35 ##^^ ]]> <![CDATA[1.29±0.22 #^^ ]]> Comparative Example 2 <![CDATA[22.29±2.24@ #^ ]]> <![CDATA[3.18±0.78@ ^ ]]> <![CDATA[7.51±1.57 ##^^ ]]> <![CDATA[1.35±0.23 #^^ ]]> Comparative Example 6 21.59±1.58@ <![CDATA[3.20±0.81@ ^ ]]> <![CDATA[7.18±2.06@ ##^^ ]]> 1.12±0.16@ Comparative Example 7 <![CDATA[23.55±1.87 #^^ ]]> <![CDATA[3.39±0.75 ##^^ ]]> <![CDATA[6.95±1.42@ ##^^ ]]> <![CDATA[1.22±0.19 ^ ]]> Comparative Example 9 20.76±1.69@ <![CDATA[3.37±0.65 ##^^ ]]> <![CDATA[7.29±1.29@ ##^^ ]]> <![CDATA[1.31±0.22 #^ ]]> Comparative Example 11 <![CDATA[22.57±1.52@ #^ ]]> <![CDATA[3.28±1.02 #^ ]]> <![CDATA[7.35±1.64@ ##^^ ]]> <![CDATA[1.36±0.24 #^^ ]]>

[0115] Compared with the model group, @P<0.5, @@P<0.01; compared with the orlistat group, # P<0.5, ## P<0.01; compared with the low-dose group of Huazhi Rougan Granule, ^ P<0.5, ^^ P<0.01.

[0116] It can be seen from Tables 1 and 2 that compared with the model group, the orlistat capsule group and the Huazhi Rougan dose groups can significantly reduce the body weight, epididymal and perirenal fat content of obese rats, and the effect of Huazhi Rougan granules is better than that of the orlistat capsule group and the control group, indicating that the Chinese medicine composition of the present application can reduce the body weight of rats, promote fat metabolism and inhibit fat formation.

[0117] Experimental Example 2 Effect of Huazhi Rougan Granules on Blood Glucose and Blood Lipid Levels in Obese Rats

[0118] 1 Materials and Methods

[0119] 1.1 Experimental animals and feeding

[0120] 110 SPF-grade healthy male rats, weighing 180 g to 200 g, were obtained under license number SYXK(Lu)20230023 and were purchased from Lunan Pharmaceutical Group Co., Ltd. The animals were housed in separate cages in a dedicated laboratory and acclimated for one week before the experiment. The animals were exposed to natural light and had free access to food and water. The room temperature was controlled at 25°C ± 0.2°C.

[0121] Ordinary feed: provided by Beijing Keao Xieli Feed Co., Ltd.

[0122] High-fat feed: ordinary feed 55%, casein 17%, sucrose 10%, lard 16%, salt 1%, yeast powder 1%.

[0123] 1.2 Experimental drugs

[0124] Huazhi Rougan Granules, provided by Shandong Xinshidai Pharmaceutical Co., Ltd., with the batch number Z20090077, were prepared with 0.5% sodium carboxymethylcellulose to the required concentration during the experiment. Orlistat Capsules, specification: 0.12g, produced by Shandong Xinshidai Pharmaceutical Co., Ltd., with the batch number H20143119, were prepared with 0.5% sodium carboxymethylcellulose solution to 3g / L before use. -1 Oral administration of 60mg.kg- 1 .d -1 , each group of the comparative example was prepared with 0.5% sodium carboxymethyl cellulose to the required concentration.

[0125] 1.3 Test methods

[0126] 1.3.1 Grouping and Dosing

[0127] Ten rats were randomly selected as the blank group and given ordinary feed, and the remaining 100 rats were fed with a high-fat feed for 45 consecutive days. After eliminating the obesity-insensitive rats, the remaining rats were randomly divided into the model group, the positive drug orlistat group (0.048 g / kg / d) (hereinafter referred to as the OLST group), the low-dose group of Huazhi Rougan Granules (1.8 g / kg / d) (hereinafter referred to as HZRG-L), the medium-dose group of Huazhi Rougan Granules (3.6 g / kg / d) (hereinafter referred to as HZRG-M) and the high-dose group of Huazhi Rougan Granules combination (7.2 g / kg / d) (hereinafter referred to as HZRG-H). For the comparative examples 3, 4, 5, 8, and 10, the gavage volume was 1 mL / 100 g, and the gavage was performed once a day. The blank group and the model group were gavaged with an equal amount of normal saline for 8 consecutive weeks, and the body weight of each group was recorded every week.

[0128] 1.3.2 Measurement indicators

[0129] (1) After the last administration, the rats in each group were fasted for 24 hours, and blood was collected from the eye sockets. The serum was separated and the absorbance values ​​of triglyceride (TG), total cholesterol (TC) and high-density lipoprotein-cholesterol (HDL-C) in the blood samples at a wavelength of 500-600 nm were measured using an ultraviolet spectrophotometer according to the instructions of the biochemical kit. The concentrations of these three substances in the sample (mmol / L) were calculated according to the following calculation formula: CT = (AT × CS) / AS, where CT is the sample concentration, AT is the sample absorbance value, CS is the standard concentration, and AS is the standard absorbance value. The atherosclerosis index and protection rate of the Chinese herbal composition of the present invention were calculated. The calculation formula of the atherosclerosis index (AI) is:

[0130] Where TC is serum total cholesterol content, HDL is serum high-density lipoprotein content;

[0131] The calculation formula of protection rate (%) is as follows:

[0132] (2) The spleen, stomach, and small intestine tissues were collected and frozen in liquid nitrogen. The serum gastrin, plasma motilin, and ghrelin levels were detected by enzyme-linked immunosorbent assay.

[0133] (3) Radioimmunoassay was used to detect plasma albumin and serum aldosterone levels

[0134] 1.4 Statistical Results

[0135] The data were processed using SPSS 22.0 statistical software. The experimental results are presented as mean ± standard deviation. The data were expressed in the form of , and the differences among the groups were compared using one-way analysis of variance. P < 0.05 indicated that the differences were statistically significant.

[0136] 2. Experimental Results

[0137] 2.1 Effects on serum TC, TG and blood lipid concentrations

[0138] Table 3 Changes in blood lipid concentrations in each group

[0139] Group TC (mmol / L) TG (mmol / L) HDL-C (mmol / L) Blank group 2.47±0.25 0.98±0.11 1.83±0.31 Model Group 2.93±0.22 1.64±0.19 0.97±0.09 OLST group 2.41±0.23@ 1.26±0.13@ 1.51±0.12 HZRG-L group 2.31±0.12@@ 1.13±0.09@@ 1.66±0.24 HZRG-M group <![CDATA[2.12±0.16@@ # ]]> <![CDATA[1.06±0.20@@ # ]]> <![CDATA[1.74±0.3 # ]]> HZRG-H group <![CDATA[2.07±0.18@@ ## ]]> <![CDATA[1.02±0.23@@ # ]]> <![CDATA[1.86±0.32 ## ]]> Comparative Example 3 2.46±0.21@ <![CDATA[1.53±0.11 #^ ]]> <![CDATA[1.16±0.18 ^ ]]> Comparative Example 4 <![CDATA[2.53±0.17 ^ ]]> 1.44±0.17 <![CDATA[1.08±0.26 ^^ <!-- 10 -->]]> Comparative Example 5 2.42±0.33@ 1.35±0.21 <![CDATA[1.26±0.15 #^ ]]> Comparative Example 8 2.57±0.30 1.42±0.25 1.35±0.24 Comparative Example 10 <![CDATA[2.62±0.26 #^ ]]> <![CDATA[1.46±0.23 #^ ]]> <![CDATA[1.21±0.20 ^^ ]]>

[0140] Compared with the model group, @P<0.05, @@P<0.01; compared with the orlistat group, # P<0.5, ## P<0.01; compared with the low-dose group of Huazhi Rougan Granule, ^ P<0.05, ^^ P<0.01.

[0141] As shown in Table 3, compared with the blank group, the total cholesterol (TC), triglycerides (TG) and high-density lipoprotein (HDL-C) of the model group rats decreased, and the differences were statistically significant (P < 0.05, P < 0.01), which is consistent with the manifestation of obesity, blood lipids, and metabolic imbalance. Compared with the model group, orlistat capsules can significantly reduce TC and TG, and increase HDL-C (P < 0.05). All dose groups of Huazhi Rougan granules can significantly reduce the total cholesterol (TC) and triglycerides (TG) of the model group rats, and the effect is better than that of the orlistat group and the control group (P < 0.05). As the concentration of Huazhi Rougan granules increases, the high-density lipoprotein (HDL-C) in the rat serum increases. Compared with the model group, the difference is significant, and the effect is also better than that of the control group. This shows that the present invention has the effect of promoting lipid metabolism, thereby playing a lipid-lowering role.

[0142] Table 4 Atherosclerosis index of each group

[0143] Group Atherosclerosis Index Protection rate (%) Blank group 0.35 - Model Group 1.92 - OLST group 0.48 75.09 HZRG-L group 0.45 76.47 HZRG-M group 0.22 88.63 HZRG-H group 0.22 88.52 Comparative Example 3 0.68 64.33 Comparative Example 4 0.71 63.05 Comparative Example 5 0.92 52.05 Comparative Example 8 0.90 52.93 Comparative Example 10 0.86 55.30

[0144] Compared with the model group, each dose group of Huazhi Rougan Granule could significantly reduce the atherosclerosis index, and the protection rate was as high as 88.52%, indicating that the Chinese medicine composition of the present invention has the effect of lowering blood lipids.

[0145] 2.2 Effects on plasma protein and serum aldosterone levels

[0146] Table 5 Effects of the present invention on water metabolism in rats

[0147] Group Albumin (g / L) Aldosterone (ng / mL) Blank group 53.32±2.23 0.76±0.10 Model Group 37.09±1.61 1.52±0.22 OLST group 50.33±2.61@@ 0.92±0.32@@ HZRG-L group 53.30±2.22@@ <![CDATA[0.77±0.28@@ # ]]> HZRG-M group 54.49±3.27@@ <![CDATA[0.73±0.17@@ ## ]]> HZRG-H group <![CDATA[56.81±2.31@@ # ]]> <![CDATA[0.71±0.23@@ ## ]]> Comparative Example 3 <![CDATA[45.28±2.51@ #^ ]]> <![CDATA[0.96±0.19@@ ^ ]]> Comparative Example 4 <![CDATA[46.32±3.13@ ^^ ]]> <![CDATA[1.06±0.12@ ^^ ]]> Comparative Example 5 <![CDATA[43.67±3.35 #^ ]]> <![CDATA[1.12±0.22@ ##^^ <!-- 11 -->]]> Comparative Example 8 <![CDATA[44.23±3.12 #^^ ]]> <![CDATA[1.17±0.16@ ##^^ ]]> Comparative Example 10 <![CDATA[45.39±2.18@ ^ ]]> <![CDATA[1.25±0.11 ##^^ ]]>

[0148] Compared with the model group, @P<0.05, @@P<0.01; compared with the orlistat group, # P<0.5, ## P<0.01; compared with the low-dose group of Huazhi Rougan Granule, ^ P<0.05, ^^ P<0.01.

[0149] When water and dampness accumulate inside the body and form phlegm, which overflows into the tissues, it manifests as edema, which is consistent with the abnormal water metabolism caused by modern obesity. As shown in Table 5, compared with the model group, each experimental group was able to increase plasma albumin content and reduce serum aldosterone content; among them, each dose group of Orlistat Capsules and Huazhi Rougan Granules was able to significantly increase plasma albumin content (P < 0.05) and reduce serum aldosterone content (P < 0.05), with better effects than the control groups. The high-dose group of Huazhi Rougan Granules was more effective than the Orlistat Capsules group. This shows that the Chinese medicine composition of the present invention can improve abnormal water metabolism, can treat abnormal water metabolism caused by modern obesity, and further achieve the effect of weight loss.

[0150] 2.3 Effects on gastrointestinal hormones

[0151] Table 6 Effects on gastrointestinal hormones in rats of each group

[0152] Group Gastrin (mmol / L) Motilin (mmol / L) Ghrelin (mmol / L) Blank group 55.25±8.25 443.37±25.38 2.51±0.44 Model Group 33.35±7.53 310.34±23.57 1.21±0.35 OLST group 44.25±8.09@@ 400.25±30.35@@ 2.03±0.35@@ HZRG-L group <![CDATA[51.37±7.43@@ # ]]> <![CDATA[434.37±32.41@@ # ]]> 2.22±0.21@@ HZRG-M group <![CDATA[50.45±7.11@@ # ]]> <![CDATA[436.58±21.54@@ # ]]> <![CDATA[2.44±0.11@@ # ]]> HZRG-H group <![CDATA[52.89±5.84@@ ## ]]> <![CDATA[447.32±34.58@@ ## ]]> <![CDATA[2.53±0.38@@ ## ]]> Comparative Example 3 <![CDATA[38.38±8.34@@ #^^ ]]> <![CDATA[335.44±23.88@ ##^^ ]]> <![CDATA[1.83±0.32@@ ^ ]]> Comparative Example 4 <![CDATA[37.52±5.25@ #^^ ]]> <![CDATA[371.42±31.41@@ #^^ ]]> <![CDATA[1.47±0.23@ ##^^ ]]> Comparative Example 5 <![CDATA[40.35±7.23@@ ^^ ]]> <![CDATA[356.21±35.22@ #^^ ]]> <![CDATA[1.72±0.56@@ ^^ ]]> Comparative Example 8 <![CDATA[37.11±9.52@@ #^^ ]]> <![CDATA[362.98±20.25@@ #^^ ]]> <![CDATA[1.63±0.39@ #^^ ]]> Comparative Example 10 <![CDATA[38.59±8.4@ #^^ ]]> <![CDATA[352.11±19.17@ #^^ ]]> <![CDATA[1.56±0.41@ ##^^ ]]>

[0153] Compared with the model group, @P<0.05, @@P<0.01; compared with the orlistat group, # P<0.5, ## P<0.01; compared with the low-dose group of Huazhi Rougan Granule, ^ P<0.05, ^^ P<0.01.

[0154] The abnormal digestion, absorption and transport of nutrients by the gastrointestinal tract are consistent with the functional abnormalities of the digestive system caused by modern obesity. As shown in Table 6, compared with the model group, the orlistat capsule group and the Huazhi Rougan granule group can significantly increase the levels of serum gastrin, plasma motilin and ghrelin (P < 0.05), which is better than the control group, and the effect of the medium and high dose groups is better than that of the orlistat capsule group. This shows that the Chinese medicine composition of the present application can improve gastrointestinal hormone level disorders, enhance digestive function, and has the effect of reducing weight.

[0155] 2. Clinical Data

[0156] 1 General Information

[0157] 1.1 Sample

[0158] A total of 120 obese patients aged 18-60 years (①age 18-60 years; ②BMI ≥ 28 kg / m 2 or waist circumference ≥90cm for men / ≥85cm for women; ③ Patients who met the TCM criteria of damp-heat obstruction (main symptoms: obesity, abdominal distension, dry mouth, bitter taste, red tongue with yellow greasy coating) were randomly divided into 4 groups, 30 cases in each group.

[0159] Exclusion criteria: secondary obesity, severe heart, liver, and kidney diseases, pregnancy, and use of diet pills in the past 3 months.

[0160] 1.2 Intervention measures

[0161] Experimental group: Huazhi Rougan granules;

[0162] Positive control group: orlistat capsules;

[0163] Comparative Example Group: Granules prepared in Comparative Examples 12 and 13;

[0164] All groups simultaneously implemented a low-fat diet (daily calorie deficit 500kcal) and moderate-intensity exercise such as brisk walking for 150 minutes per week. 1.3 Evaluation and indicators: weight, visceral fat area, waist circumference

[0165] 2. Results

[0166] Table 7 Changes in body weight, visceral fat area, and waist circumference in each group

[0167] index Weight loss (kg) Decreased body fat percentage (%) <![CDATA[Visceral fat area (cm 2 )]]> Waist circumference reduction (cm) Huazhi Rougan Granule Group 4.4±1.5 5.8±2.1 -22.7±5.8 6.5±1.6 Orlistat group 3.1±1.2 4.1±1.8 -15.2±3.7 3.1±1.2 Comparative Example 12 2.5±1.1 4.2±0.7 -14.3±3.2 2.9±0.9 Comparative Example 13 2.2±0.8 3.9±0.9 -12.1±2.6 3.3±1.3

[0168] These results demonstrate that the Huazhi Rougan Granule group significantly outperformed the orlistat and control groups in terms of weight loss, lower body fat percentage, reduced visceral fat, and reduced waist circumference, demonstrating a positive improvement in obesity (particularly visceral fat accumulation). While traditional Chinese medicine for weight loss may be slow to take effect and require a long treatment course, its advantages include not only controlling weight, preventing and treating complications and symptoms of obesity, minimizing toxic side effects, preventing rebound effects, and improving quality of life, but more importantly, regulating physical fitness, ultimately preventing illness.

Claims

1. Use of a Huazhi Rougan preparation in the preparation of a medicament for weight loss, characterized in that: The stagnation-relieving and liver-softening preparation is mainly prepared from Artemisia capillaris, cassia seed, rhubarb, Poria cocos, hawthorn, oriental rhizome, trichosanthes root, glossy privet fruit, Ecliptae macrocephala, wolfberry fruit, atractylodes, white atractylodes, tangerine peel, thistle, bupleurum and liquorice.

2. The use according to claim 1, characterized in that The liver-clearing and liver-softening preparation is made from the following Chinese medicinal ingredients in the following weight ratios:

3. The use according to claim 2, characterized in that The liver-clearing and liver-softening preparation is made from the following Chinese medicinal ingredients by weight:

4. The use according to claim 1, wherein Rhubarb is stewed with wine, Cassia seed is stir-fried Cassia seed, Atractylodes is stir-fried with bran, Atractylodes is stir-fried with bran, Ligustrum lucidum is steamed with wine, and Bupleurum is roasted with vinegar.

5. The use according to claim 1, characterized in that The weight loss includes reducing visceral fat content and / or improving obesity-related metabolic homeostasis imbalance.

6. The use according to claim 5, characterized in that The metabolic homeostasis imbalance includes obesity and comprehensive metabolic imbalance.

7. The use according to claim 1, characterized in that The Huazhirougan preparation is prepared into a clinically acceptable dosage form after adding excipients. Preferably, the clinically acceptable dosage form is granules, tablets, pills, capsules and microcapsules; further preferably, the clinically acceptable dosage form is granules.

8. The use according to claim 1, characterized in that The liver-clearing and liver-softening preparation is prepared by the following steps: A: Extract bupleurum root, wormwood, dried orange peel, thistle, and wolfberry fruit with ethanol at 50-80°C and concentrate under reduced pressure to a density of 1.10-1.15 g / cm 3 ; B: Atractylodes macrocephala, Atractylodes lancea, Glycyrrhiza uralensis, Crataegus pinnatifida, Ligustrum lucidum, and Eclipta prostrata were enzymatically hydrolyzed with cellulase for 1-2 h, and then water extraction was performed, and the filtrate was collected by ultrafiltration; C: Take Poria, Rhizoma Alismatis, and Rhizoma Trichosanthis, add 12 times the amount of water, extract at 100°C for 1-2 hours, precipitate with alcohol until the alcohol content is 50-80%, and take the supernatant; D: Supercritical CO2 extraction of rhubarb and cassia seed to obtain fat-soluble extracts; The concentrates of A, B and C are mixed and spray-dried, and then the extract of D is sprayed in and granulated.

9. The use according to claim 8, characterized in that The liver-clearing and liver-softening preparation is prepared by the following steps: A: Extract radix bupleuri, artemisia capillaris, dried tangerine peel, thistle, and wolfberry fruit with 8 times the volume of 70% ethanol, reflux at 60°C for 2 times, each time for 1.5 hours, and concentrate under reduced pressure to a density of 1.15 g / cm 3 ; B: Atractylodes macrocephala, Atractylodes lancea, Glycyrrhiza uralensis, Crataegus pinnatifida, Ligustrum lucidum, and Eclipta prostrata were enzymatically hydrolyzed with 0.5% cellulase at 50°C for 1 hour, then decocted twice with 10 times the amount of water for 1 hour each time, and the filtrate was collected by ultrafiltration; C: Take Poria, Rhizoma Alismatis, and Rhizoma Trichosanthis, add 12 times the amount of water, extract at 100℃ for 1.5h, precipitate with alcohol until the alcohol content reaches 70%, and take the supernatant; D: Rhubarb and Cassia seed, pressure 25MPa, temperature 45℃, supercritical CO2 extraction to obtain fat-soluble extract; The concentrates of A, B and C were mixed and spray-dried with the inlet water temperature of 150°C, and the extract D was sprayed in and mixed to form granules.

10. The use according to any one of claims 1 to 9, characterized in that The Huazhi Rougan preparation is Huazhi Rougan granules.

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