Traditional Chinese medicine compositions with lipid-lowering and intestinal flora-regulating effects, preparation methods and applications

Abstract

This invention discloses a traditional Chinese medicine composition, preparation method, and application with lipid-lowering and intestinal flora-regulating effects, belonging to the field of traditional Chinese medicine technology. The raw material components are: 10-20 parts mulberry leaf, 10-20 parts immature bitter orange, 10-20 parts plantain, 8-15 parts lotus leaf, 8-16 parts medicated leaven, and 8-15 parts poria cocos. Based on the etiology and pathogenesis of obesity, this invention adopts a formula based on the principles of eliminating dampness and phlegm, lowering lipids and clearing turbidity. In addition to changing the obese phenotype, it focuses on balancing the body's internal organs and blood, strengthening the spleen and replenishing qi, resolving phlegm and eliminating dampness, supplemented by promoting qi circulation and digestion, lowering lipids and eliminating phlegm, thereby regulating the body's overall function, accelerating the decomposition of excess fat, and achieving the goal of weight loss by lowering lipids and regulating intestinal flora. Pharmacological experiments have shown that oral administration significantly improves weight gain and liver lipid accumulation induced by a high-fat diet in rats, resulting in clearer liver cord structure, denser cell arrangement, reduced lipid vacuolation and ballooning degeneration, and altering the composition and function of the intestinal microbiota.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine composition, preparation method and application that has the effects of lowering lipids and regulating intestinal flora. Background Technology

[0002] Obesity is a chronic metabolic disease characterized by a body fat percentage exceeding 20% ​​of ideal body weight. It is primarily caused by an imbalance between energy intake and expenditure, leading to excessive lipid accumulation. Typical symptoms include a large body size, abnormal lipid accumulation in the abdomen, buttocks, and thighs, fatigue, lethargy, shortness of breath, and reluctance to speak, often accompanied by dyslipidemia. It is closely related to various chronic diseases such as type 2 diabetes, hypertension, coronary heart disease, non-alcoholic fatty liver disease, and osteoarthritis. The main pathogenesis of obesity is phlegm-dampness obstruction, and its development is often associated with a preference for rich, fatty, and greasy foods, a sedentary lifestyle, and impaired spleen function. In recent decades, the global incidence of obesity has been rising, becoming a serious problem affecting people's quality of life. The prevention and treatment of obesity has become an important public health issue.

[0003] Treatment of obesity involves a multidisciplinary approach, including drug intervention, surgical treatment, and lifestyle modifications. Currently, weight-loss drugs have a narrow spectrum of action, and long-term use can lead to serious side effects such as anorexia, insomnia, and abnormal liver and kidney function. Surgery has many contraindications and carries postoperative risks; dietary changes are slow and difficult to maintain; and methods such as liposuction used in beauty centers lack medical basis and are difficult to standardize and promote in the medical field, resulting in a lack of safe and effective prevention and intervention strategies in clinical practice. For many years, researchers have been dedicated to developing safe, effective weight-loss drugs with minimal side effects. Traditional Chinese medicine, as a natural herbal plant with few side effects, holds great promise for developing anti-obesity drugs.

[0004] Traditional Chinese medicine's understanding of obesity can be traced back to the *Huangdi Neijing* (Yellow Emperor's Inner Classic), which describes obesity as follows: "Those with firm flesh and full skin are obese. Those with loose flesh and loose skin are greasy. Greasy people have abundant qi and loose skin, thus they can protrude their abdomen and droop their pancreas. Fat people have a smaller body." "Fat people" and "greasy people" are the earliest descriptions of obesity in traditional Chinese medicine. From a TCM perspective, excessive phlegm and dampness are the main pathological basis of obesity. In the early stages of obesity, obese patients have an increased appetite, and the body's qi transformation function is enhanced or normal. Over time, excessive fat accumulates in the body, generating a large amount of phlegm and dampness. This phlegm and dampness obstructs the flow of qi, thus affecting the spleen and stomach function. Furthermore, long-term irregular eating habits inevitably lead to food stagnation, damaging the spleen and stomach. Once the spleen and stomach are damaged, the body's qi transformation function weakens, further aggravating the internal generation of phlegm and dampness, thus forming a vicious cycle. Excessive accumulation of phlegm and dampness in the body is difficult to metabolize, leading to obesity.

[0005] Traditional Chinese medicine (TCM) has the advantage of holistic treatment in the prevention and treatment of obesity, addressing both the symptoms and the root cause, and is economical, safe, and less prone to rebound. In-depth exploration of the mechanism of action of TCM in treating obesity is of great significance for the clinical prevention and treatment of obesity.

[0006] Based on this, the present invention provides a traditional Chinese medicine composition, preparation method and application with lipid-lowering and intestinal flora-regulating effects, and explores the therapeutic characteristics and advantages of traditional Chinese medicine in the prevention and treatment of obesity. Summary of the Invention

[0007] Based on the etiology and pathogenesis of obesity, this invention adopts a treatment formula based on the principles of eliminating dampness and phlegm, reducing lipids and clearing turbidity. In addition to changing the obese phenotype, it focuses on the balance of qi and blood in the body's internal organs, strengthens the spleen and replenishes qi, eliminates phlegm and dampness, and is supplemented by promoting qi circulation and digestion, reducing lipids and clearing phlegm, thereby regulating the overall function of the body, accelerating the decomposition of excess fat in the body, and achieving the purpose of reducing lipids and regulating intestinal flora for weight loss. Based on this purpose, this invention was completed.

[0008] To achieve these objectives and other advantages of the present invention, the present invention provides a traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects, which is composed of the following raw material components in parts by weight: 10-20 parts of mulberry leaf, 10-20 parts of immature bitter orange, 10-20 parts of plantain, 8-15 parts of lotus leaf, 8-16 parts of medicated leaven, and 8-15 parts of poria cocos.

[0009] Preferably, the traditional Chinese medicine composition having the effects of lowering lipids and regulating intestinal flora consists of the following raw material components: 15 parts mulberry leaf, 10 parts immature bitter orange, 10 parts plantain, 10 parts lotus leaf, 8 parts medicated leaven, and 8 parts poria cocos.

[0010] Preferably, the traditional Chinese medicine composition having the effects of lowering lipids and regulating intestinal flora consists of the following raw material components: 10 parts mulberry leaf, 10 parts immature bitter orange, 10 parts plantain, 10 parts lotus leaf, 8 parts medicated leaven, and 8 parts poria cocos.

[0011] Preferably, the traditional Chinese medicine composition having the effects of lowering lipids and regulating intestinal flora consists of the following raw material components: 20 parts mulberry leaf, 10 parts immature bitter orange, 10 parts plantain, 10 parts lotus leaf, 8 parts medicated leaven, and 8 parts poria cocos.

[0012] Preferably, the traditional Chinese medicine composition having the effects of lowering lipids and regulating intestinal flora consists of the following raw material components: 20 parts of mulberry leaf, 20 parts of immature bitter orange, 20 parts of plantain, 15 parts of lotus leaf, 16 parts of medicated leaven, and 16 parts of poria cocos.

[0013] Preferably, the traditional Chinese medicine composition having the effects of lowering lipids and regulating intestinal flora consists of the following raw material components: 20 parts mulberry leaf, 15 parts immature bitter orange, 15 parts plantain, 11 parts lotus leaf, 12 parts medicated leaven, and 12 parts poria cocos.

[0014] Preferably, the dosage form of the traditional Chinese medicine composition having the effects of lowering lipids and regulating intestinal flora is pills or decoction.

[0015] A method for preparing a pill form of a traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects, using any raw material component and obtaining it through the following steps:

[0016] (1) Weigh out the mulberry leaves, immature bitter orange, plantain, lotus leaves, medicated leaven, and poria according to the dosage, wash them clean, and dry them;

[0017] (2) Pulverize the dried medicinal materials and pass them through a 50-200 mesh sieve to obtain fine powder. Mix the fine powder evenly and set aside.

[0018] (3) Sterilize the mixed medicinal powder for 20-40 minutes at 100℃-120℃.

[0019] (4) Add refined honey to the sterilized medicinal powder. The ratio of medicinal powder to honey is 10:1 to 3:1. The temperature of adding honey is 70℃ to 100℃. During this period, kneading, bumping and turning are carried out to gradually increase the size of the pellets into spherical small particles with a diameter of 1.0 to 5.0 mm, and make the surface of the pellets dense, smooth and uniform in color.

[0020] (5) Dry the prepared pellets at a temperature of 60℃~90℃.

[0021] (6) The pills are screened to remove those that are too large, too small, or irregular, so that the pills are of uniform size.

[0022] (7) After screening the pellets, put them into packaging bottles for packaging and affix labels.

[0023] A method for preparing a decoction of a traditional Chinese medicine composition having lipid-lowering and intestinal flora-regulating effects, comprising:

[0024] 1) Weigh out the mulberry leaves, immature bitter orange, plantain, lotus leaves, medicated leaven, and poria according to the dosage, wash them clean, and dry them;

[0025] 2) First decoction with 8 to 12 times the amount of pure water for 1 to 2 hours, then decoction with 4 to 8 times the amount of pure water for 0.5 to 1.5 hours. Combine the two extracts and concentrate them to obtain the Chinese medicine liquid.

[0026] The application of the traditional Chinese medicine composition or the pills or decoction prepared by the preparation method described above in the preparation of lipid-lowering and intestinal flora-regulating drugs.

[0027] The present invention has at least the following beneficial effects:

[0028] 1. Mulberry leaves are sweet, bitter, and cold in nature, and enter the lung and liver meridians. They have the effects of dispersing wind-heat, moistening the lung and relieving dryness, calming the liver and improving eyesight, and cooling blood to stop bleeding, and are applicable to reducing blood sugar, blood lipids, and anti-inflammatory effects. Immature bitter orange is bitter, pungent, sour, slightly cold in nature, and enters the spleen and stomach meridians. It has the effects of breaking qi to eliminate accumulation and resolving phlegm and dissipating stagnation, and is applicable to internal retention of accumulation, fullness and distending pain, and qi stagnation and phlegm obstruction. Plantain herb is sweet and cold in nature, and enters the liver, kidney, and bladder meridians, and has the effects of clearing heat and promoting diuresis, and promoting urination and relieving stranguria, and is applicable to oliguria with edema, diarrhea, and red and painful eyes. Lotus leaf enters the liver, spleen, and stomach meridians, and has the effects of clearing heat and relieving summer heat, ascending the clear yang, and cooling blood to stop bleeding, and is used for summer heat and vexation with thirst, summer dampness and diarrhea, spleen deficiency diarrhea, dizziness, hematemesis due to blood heat, hematochezia, and metrorrhagia and metrostaxis. Medicated leaven: It enters the spleen and stomach meridians, invigorates the spleen and harmonizes the stomach, promotes digestion and regulates the middle, and treats food stagnation, chest stuffiness and abdominal distension. Poria cocos is sweet, light, and neutral in nature, and enters the heart, spleen, lung, and kidney meridians, and has the effects of promoting diuresis to eliminate dampness, benefiting the spleen and stomach and protecting the kidney, and calming the mind and promoting fluid production. The combination of the above-mentioned herbs together plays the effects of strengthening the spleen and eliminating dampness, reducing lipid and resolving turbidity, and achieves the weight loss purpose of reducing lipid and regulating intestinal flora. According to the etiology and pathogenesis of obesity, the present invention uses immature bitter orange, Poria cocos, and mulberry leaves, etc. to formulate a prescription based on the principle of eliminating dampness and resolving phlegm, reducing lipid and resolving turbidity. In addition to changing the obesity phenotype, it pays more attention to the balance of qi and blood in the zang-fu organs of the body, strengthening the spleen and replenishing qi, eliminating phlegm and dampness, supplemented by promoting qi and promoting digestion, reducing lipid and eliminating phlegm, clearing heat and promoting diuresis, so as to regulate the overall function of the body, accelerate the decomposition of excess fat in the body, and achieve the weight loss purpose of reducing lipid and regulating intestinal flora.

[0029] 2. The preparation methods of the pills and decoctions of the present invention have simple technological steps and are easy to operate, and have broad application prospects.

[0030] 3. After the traditional Chinese medicine composition with the effects of reducing lipid and regulating intestinal flora of the present invention is decocted and prepared into a traditional Chinese medicine liquid (weight loss and lipid reduction decoction - SZBC), through pharmacological experimental verification, oral administration of SZBC can significantly improve the weight gain and liver lipid accumulation induced by high-fat diet in rats; after oral administration of SZBC, the hepatic cords of the rat model are clear, the cells are arranged densely, and lipid vacuoles and ballooning degeneration are reduced; oral administration of SZBC changes the composition and function of the intestinal microbiota. At the phylum level, compared with the NC group, the HFD group feeding significantly reduced the abundance of Bacteroidetes (P<0.01), increased the abundances of Firmicutes and Actinobacteria, and at the same time reduced the Firmicutes / Bacteroidetes ratio (P<0.01). Among the genus-level characteristics, Turicibacter and Barnesiera bacteria in rats treated with SZBC were significantly increased (P<0.05), while the abundances of beneficial bacteria Lactobacillus and Prevotella were increased, and the abundance of harmful bacteria Romboutsia was reduced. At the family level, SZBC increased the number of SCFAs-producing bacteria.

[0031] Other advantages, objectives, and features of the present invention will be partially reflected by the following description, and will also be understood by those skilled in the art through the research and practice of the present invention. Attached Figure Description

[0032] Figure 1 Images show H&E staining (×20) of rat liver tissue, Oil Red O staining (×10) and H&E staining (×20) of perirenal fat in this invention.

[0033] Figure 2 The effects of the traditional Chinese medicine composition of the present invention on the structure and abundance of the intestinal microbiota (phylum, genus, family level);

[0034] Figure 3 This refers to the Firmicutes / Bacteroidetes ratio of the present invention.

[0035] Figure 4 The linear discriminant analysis (LDA) scores of this invention showed differences in bacterial abundance, representing bacteria that play important roles in the NC, HFD, and HFD+SZBC-L groups. Detailed Implementation

[0036] The present invention will be further described in detail below with reference to embodiments, so that those skilled in the art can implement it based on the description.

[0037] Example 1

[0038] A traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects is made from the following traditional Chinese medicinal materials in parts by weight: 15 parts mulberry leaves, 10 parts immature bitter orange, 10 parts plantain, 10 parts lotus leaves, 8 parts medicated leaven, and 8 parts poria cocos.

[0039] Example 2

[0040] A traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects is made from the following traditional Chinese medicinal materials in parts by weight: 10 parts mulberry leaves, 10 parts immature bitter orange, 10 parts plantain, 10 parts lotus leaves, 8 parts medicated leaven, and 8 parts poria cocos.

[0041] Example 3

[0042] A traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects is made from the following traditional Chinese medicinal materials in parts by weight: 20 parts mulberry leaves, 10 parts immature bitter orange, 10 parts plantain, 10 parts lotus leaves, 8 parts medicated leaven, and 8 parts poria cocos.

[0043] Example 4

[0044] A traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects is made from the following traditional Chinese medicinal materials in parts by weight: 20 parts mulberry leaves, 20 parts immature bitter orange, 20 parts plantain, 15 parts lotus leaves, 16 parts medicated leaven, and 16 parts poria cocos.

[0045] Example 5

[0046] A traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects is made from the following traditional Chinese medicinal materials in parts by weight: 20 parts mulberry leaves, 15 parts immature bitter orange, 15 parts plantain, 11 parts lotus leaves, 12 parts medicated leaven, and 12 parts poria cocos.

[0047] Example 6

[0048] A traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects is made from the following traditional Chinese medicinal materials in parts by weight: 15 parts mulberry leaf, 15 parts immature bitter orange, 15 parts plantain, 11 parts lotus leaf, 12 parts medicated leaven, and 12 parts poria cocos.

[0049] Example 7

[0050] A traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects is made from the following traditional Chinese medicinal materials in parts by weight: 10 parts mulberry leaves, 15 parts immature bitter orange, 15 parts plantain, 11 parts lotus leaves, 12 parts medicated leaven, and 12 parts poria cocos.

[0051] Example 8

[0052] A method for preparing a traditional Chinese medicine pill with lipid-lowering and intestinal flora-regulating effects, using the medicinal materials from any one of the formulas in Examples 1-7, including:

[0053] (1) Weigh out the Chinese medicinal materials mulberry leaves, immature bitter orange, plantain, lotus leaves, medicated leaven, and poria according to the dosage, wash the Chinese medicinal materials clean, and dry them;

[0054] (2) Pulverize the dried Chinese medicinal materials and pass them through a 100-mesh sieve to obtain fine powder. Mix the fine powder evenly and set aside.

[0055] (3) Sterilize the mixed medicinal powder for 30 minutes at 100°C.

[0056] (4) Add refined honey to the sterilized medicinal powder. The ratio of medicinal powder to honey is 7:1, and the honey temperature is 80℃. During this process, kneading, banging, and turning are carried out to gradually increase the size of the pellets into spherical pellets with a diameter of 2.0 to 4.0 mm, and to make the surface of the pellets dense, smooth, and uniform in color.

[0057] (5) The prepared pellets are dried by microwave or far-infrared drying at a temperature of 80°C.

[0058] (6) Put the pellets from step (5) into a screening device such as a vibrating screen or a drum screen for screening to remove excessively large, small and irregular pellets so that the finished product is uniform in size.

[0059] (7) After screening the pellets, put them into packaging bottles for packaging and affix labels.

[0060] Pharmacological experiments

[0061] 1. Study on the effects of a traditional Chinese medicine composition with lipid-lowering and gut microbiota-regulating effects on obese rats.

[0062] (1) Experimental drug: The weight loss and lipid-lowering decoction (SZBC) was prepared in the laboratory. The Chinese medicinal materials used were the Chinese herbal composition of the present invention, which has the effects of lowering lipids and regulating intestinal flora. The preparation method was as follows: 15 parts of mulberry leaves, 10 parts of immature bitter orange, 10 parts of plantain, 10 parts of lotus leaves, 8 parts of medicated leaven, and 8 parts of poria cocos were weighed. The first decoction was made with 10 times the amount of pure water for 1.5 hours, and the second decoction was made with 6 times the amount of pure water for 1 hour. The extracts from the two decoctions were combined, concentrated, and prepared into Chinese herbal liquids of different concentrations (0.3736 g / ml, 0.7472 g / ml, and 1.4944 g / ml) for administration (hereinafter referred to as weight loss and lipid-lowering decoction SZBC).

[0063] The following breakdown methods are used for comparison:

[0064] Prescription 1: 10 parts of immature bitter orange, 15 parts of mulberry leaf, 8 parts of medicated leaven, and 10 parts of plantain;

[0065] Prescription 2: 10 parts of immature bitter orange, 15 parts of mulberry leaf, 8 parts of medicated leaven, and 10 parts of lotus leaf;

[0066] Prescription 3: 10 parts of immature bitter orange, 15 parts of mulberry leaf, and 8 parts of poria cocos;

[0067] Formula 4: Poria cocos 8 parts, Plantago asiatica 10 parts, Nelumbo nucifera leaf 10 parts;

[0068] Formula 5: 8 parts Poria cocos and 15 parts mulberry leaves.

[0069] The above-mentioned decoction preparation method involves first decocting with 10 times the amount of pure water for 1.5 hours, and then decocting with 6 times the amount of pure water for 1 hour. The extracts from the two decoctions are combined, concentrated, and prepared into the corresponding decoction (concentration 0.3736g / ml) for administration.

[0070] (2) Main reagents: Orlistat (Shandong New Era Pharmaceutical Co., Ltd., National Drug Approval Number H20143119); Total cholesterol (TC) (A111-1-1), Triglycerides (TG) (A110-1-1), Low-density lipoprotein cholesterol (LDL-C) (A113-1-1), High-density lipoprotein cholesterol (HDL-C) (A112-1-1) (Nanjing Chengjian Bioengineering Research Institute). The main antibodies include p-ACC1 antibody (AF3421), ACC1 antibody (AF6421), FAS antibody (AF5342), CPT-1 antibody (DF12004), CYP7A1 antibody (DF2612), ABCA1 antibody (DF8233), goat anti-rabbit IgG (H+L)HRP (#S0001), goat anti-mouse IgG (H+L)HRP (#S0002) (Qinke Biotechnology Co., Ltd.); CD36 antibody (18836-1-AP) (Wuhan Sanying Biotechnology Co., Ltd.); β-Actin (GB12001) (Beijing Solarbio Technology Co., Ltd.).

[0071] (3) Experimental animals and grouping: SD rats, male, several, weighing 160 - 200 g, purchased from Hunan Slack Jingda Experimental Animal Co., Ltd., license number SCXK(Xiang)2019 - 0004, certificate number NO.430727221100046417. All animal experiments were approved by the Medical Ethics Society of Guangxi University of Chinese Medicine, approval number DW20211208 - 256. The animals were housed under SPF conditions with a standard 12 - hour light - dark cycle, temperature 22.2°C, and relative humidity 60.5%. After 1 week of adaptive feeding, all rats were randomly divided into a normal diet group (NC) (7 rats), fed with ordinary feed; an obesity model group (≥70 rats), fed with a high - fat diet for 14 weeks, with free access to food and water to establish an obesity animal model. Subsequently, 70 obese rats with a body weight exceeding 20% of the average body weight of the NC group were randomly divided into 10 groups. High - fat diet (HFD) group, SZBC low - dose (HFD + SZBC - L) group (0.3736 g / ml), SZBC medium - dose (HFD + SZBC - M) group (0.7472 g / ml), SZBC high - dose (HFD + SZBC - H) group (1.4944 g / ml), orlistat (HFD + P) group (4.48 mg / ml), decoction formula 1 (HFD + D1) group (0.3736 g / ml), decoction formula 2 (HFD + D2) group (0.3736 g / ml), decoction formula 3 (HFD + D3) group (0.3736 g / ml), decoction formula 4 (HFD + D4) group (0.3736 g / ml), decoction formula 5 (HFD + D5) group (0.3736 g / ml), with 7 rats in each group. Rats in the NC group and HFD group were gavaged with normal saline, rats in the SZBC group were gavaged with SZBC solution, rats in the HFD + P group were gavaged with orlistat suspension, and rats in the decoction formula groups were gavaged with decoction formula traditional Chinese medicine solution. The gavage dose for each group was 0.5 ml / 100 g. Once a day for 30 consecutive days, the body weight was recorded weekly. On the last day of the intervention, fresh and uncontaminated fecal samples were collected. The rats were anesthetized with sodium phenobarbital (50 mg / kg), and blood was taken from the abdominal aorta. Fresh liver tissue and adipose tissue of the rats were collected for subsequent analysis.

[0072] 2. Experimental observations: Each group was continuously gavaged with drugs for 6 weeks, and the blank group and the model group were given the same volume of normal saline. Each index was continuously recorded. The observed indexes are as follows:

[0073] Apparent indexes: Observe and record the body weights of the NC group, HFD group, HFD + SZBC - L group, HFD + SZBC - M group, HFD + SZBC - H group, HFD + SZBC - P group, HFD + D1 group, HFD + D2 group, HFD + D3 group, HFD + D4 group, and HFD + D5 group.

[0074] Biochemical analysis: Following the instructions provided with the kit, the levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) in rat liver were measured.

[0075] Histopathological analysis: Perirenal fat and liver tissue were fixed in 4% paraformaldehyde and then embedded in paraffin. Perirenal fat and liver sections were stained with hematoxylin and eosin (H&E) according to standard procedures. Additionally, 10 μm liver sections were stained with Oil Red O. Hepatic fat accumulation and adipocyte morphological changes were analyzed under a microscope.

[0076] Gut microbiota analysis: Fecal DNA was extracted using a fecal DNA isolation kit, and 30 ng of genomic DNA samples were collected. Polymerase chain reaction (PCR) was used to amplify the bacterial 16S rRNA gene at a reaction volume of 30 μl. The PCR amplification products were purified and dissolved in elution buffer using Agencourt AMPure XP magnetic beads to establish the database. The fragment range and concentration of the library were detected using an Agilent 2100 bioanalyzer. Libraries meeting the insert size criteria were selected, and finally, sequencing was performed on the Illumina HiSe platform. Data were clustered into OTUs, and species and association analyses were performed based on the OTUs and annotation results.

[0077] 3. Experimental Results

[0078] (1) In high-fat diet-induced obese rats, oral administration of SZBC (Slimming and Lipid-Lowering Decoction) improved body weight and liver fat accumulation:

[0079] Table 1. Body weight of each group after 1 week of adaptive feeding, 14 weeks of high-fat diet feeding, and 6 weeks of continuous gavage administration.

[0080]

[0081]

[0082] Table 2 Liver weight of each group

[0083]

[0084] Table 3 Fat weight of each group

[0085]

[0086] Table 4. Liver biochemical analysis results

[0087]

[0088]

[0089] As shown in Tables 1-3 above, at the end of the 14-week high-fat diet feeding period, the mean body weight of the HFD group was 732.36±95.24g, while that of the NC group was 527.10±36.11g. After 6 weeks of treatment with SZBC, compared with the HFD group, the mean body weight, fat weight, and liver weight of the HFD+SZBC-L group, HFD+SZBC-M group, and HFD+SZBC-H group were significantly reduced, and the effects were better than those of the split-treatment groups.

[0090] As shown in Table 4, the data from the HFD, HFD+SZBC-L, HFD+SZBC-M, and HFD+SZBC-H groups indicate that SZBC treatment significantly reduced the levels of TC, TG, and LDL-C in rat liver tissue and increased HDL levels, suggesting that oral SZBC can improve HFD-induced weight gain and hepatic lipid accumulation. Compared to the HFD group, the HFD+D1, HFD+D2, HFD+D3, HFD+D4, and HFD+D5 groups also showed some effects, but not as significant as the SZBC treatment.

[0091] (2) This invention further investigated the effects of the weight-loss and lipid-lowering decoction on liver and perirenal adipose tissue in a high-fat diet obese rat model: H&E staining of liver tissue showed that after SZBC treatment, the liver cord structure was clear, cells were densely arranged, and lipid vacuolation and ballooning degeneration were reduced. Oil Red O staining showed a reduction in the area of ​​fat accumulation in the liver tissue of rats in the SZBC group. Furthermore, H&E staining of perirenal adipose tissue showed that after SZBC intervention, adipocyte size decreased, and the cells exhibited a more defined capsule and regular cell arrangement. Results are as follows: Figure 1 As shown.

[0092] (3) In rats induced by a high-fat diet, oral administration of the weight-loss and lipid-lowering decoction altered the composition and function of the gut microbiota: To investigate whether the weight-loss effect of SZBC was related to the gut microbiota, we sequenced the 16S rDNA of fecal bacteria from rats. According to the results in Table 1 above, the weight loss of obese rats in the HFD+SZBC-L group was more significant. Therefore, the HFD+SZBC-L group was selected for further study in this invention. At the phylum level, compared with the NC group, the HFD group significantly reduced the abundance of Bacteroides (P<0.01), increased the abundance of Firmicutes and Actinobacteria, and decreased the Firmicutes / Bacteroides ratio (P<0.01), as shown in the results. Figure 2 and Figure 3 Among the genus-level characteristics, the abundance of Turicibacter and Barnesiera bacteria was significantly increased in SZBC-treated rats (P<0.05), while the abundance of beneficial bacteria Lactobacillus and Prevotella increased, and the abundance of harmful bacteria Romboutsia decreased. The results are as follows: Figure 2 As shown in Table 5 below. At the family level, SZBC increased the number of SCFA-producing bacteria, including Lactobacillus, Prevotelaceae, and Veillonellaceae, with Prevotelaceae showing significant enrichment (P<0.01), as shown in Table 5 below. Figure 2 Linear discriminant analysis (LEfSe) results showed that Ruminococcaceae was the most significantly different in the NC group, Aerococcaceae was the most strongly correlated with the HFD group, and Bacteroidetes and Barnesiella were the most representative bacteria in the SZBC group. Figure 4 .

[0093] Table 5. Species richness at the genus level (x±s, n=3)

[0094]

[0095] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects, characterized in that, It is composed of the following raw material components in parts by weight: 10-20 parts mulberry leaves, 10-20 parts immature bitter orange, 10-20 parts plantain, 8-15 parts lotus leaves, 8-16 parts medicated leaven, and 8-15 parts poria cocos.

2. The traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects as described in claim 1, characterized in that, It is composed of the following raw materials: 15 parts mulberry leaves, 10 parts immature bitter orange, 10 parts plantain, 10 parts lotus leaves, 8 parts medicated leaven, and 8 parts poria cocos.

3. The traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects as described in claim 1, characterized in that, It is composed of the following raw materials: 10 parts mulberry leaves, 10 parts immature bitter orange, 10 parts plantain, 10 parts lotus leaves, 8 parts medicated leaven, and 8 parts poria cocos.

4. The traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects as described in claim 1, characterized in that, It is composed of the following raw materials: 20 parts mulberry leaves, 10 parts immature bitter orange, 10 parts plantain, 10 parts lotus leaves, 8 parts medicated leaven, and 8 parts poria cocos.

5. The traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects as described in claim 1, characterized in that, It is composed of the following raw materials: 20 parts mulberry leaves, 15 parts immature bitter orange, 15 parts plantain, 11 parts lotus leaves, 12 parts medicated leaven, and 12 parts poria cocos.

6. The traditional Chinese medicine composition with lipid-lowering and intestinal flora-regulating effects as described in any one of claims 1 to 5, characterized in that, Its dosage form is either pills or decoction.

7. A method for preparing pills of a traditional Chinese medicine composition having lipid-lowering and intestinal flora-regulating effects, characterized in that, The product is prepared using any of the raw material components according to claims 1 to 5, and through the following steps: 1) Weigh out the mulberry leaves, immature bitter orange, plantain, lotus leaves, medicated leaven, and poria according to the dosage, wash them clean, and dry them; 2) Crush the dried medicinal materials and pass them through a 50-200 mesh sieve to obtain fine powder. Mix the fine powder evenly and set aside. 3) Sterilize the evenly mixed fine powder of medicinal materials for 20-40 minutes at a temperature of 100℃-120℃. 4) After sterilization, the fine powder of the medicinal materials is added to refined honey. The ratio of medicinal powder to honey is 10:1 to 3:1, and the temperature of adding honey is 70℃ to 100℃. During this process, kneading, banging, and turning are carried out to gradually increase the size of the pellets into spherical particles with a diameter of 1.0 to 5.0 mm, and to make the surface of the pellets dense, smooth, and uniform in color. 5) Dry the prepared pellets at a temperature controlled between 60℃ and 90℃; 6) Screen the pills to remove those that are too large, too small, or irregular in size, so that the pills are of uniform size.

8. A method for preparing a decoction of a traditional Chinese medicine composition having lipid-lowering and intestinal flora-regulating effects, characterized in that, The product comprises any one of the raw material components according to claims 1 to 5, including: 1) Weigh out the mulberry leaves, immature bitter orange, plantain, lotus leaves, medicated leaven, and poria according to the dosage, wash them clean, and dry them; 2) The above raw materials are decocted for 1 to 2 hours with 8 to 12 times the amount of pure water for the first time, and 0.5 to 1.5 hours with 4 to 8 times the amount of pure water for the second time. The extracts from the two decoctions are combined and concentrated to obtain the Chinese medicine liquid.

9. The application of any traditional Chinese medicine composition according to claims 1 to 5 or a pill or decoction prepared by the preparation method according to claims 7 or 8 in the preparation of a drug with any or multiple effects of lowering lipids or reducing weight.

10. The application according to claim 9, characterized in that, The drug is used to lower lipids or reduce weight by regulating the gut microbiota.

Images