Traditional Chinese medicine composition for treating insulin resistance of obese children and preparation method

Abstract

The invention provides a traditional Chinese medicine composition for treating insulin resistance of obese children and a preparation method, and belongs to the technical field of traditional Chinese medicines. According to the traditional Chinese medicine composition, divaricate saposhnikovia roots and wrinkled gianthyssop herbs are used as monarch drugs, fructus gardeniae praeparatus is used as a ministerial drug, rhizoma coptidis and pericarpium citri reticulatae are used as adjuvant drugs, liquorice is used as a conductant drug, rhizoma nardostachyos and bitter herbs are used together, lifting and descending are combined, the effects of purging spleen and stomach fire, clearing damp and heat, eliminating dampness and reducing phlegm and regulating qi activity of the spleen and the stomach are achieved together, middle-jiao fire is cleared, qi activity is regulated, and therefore insulin sensitivity is improved, insulin resistance is improved, and toxic and side effects are reduced. And the physiological characteristic of delicate spleen and stomach of children is considered. When the traditional Chinese medicine composition is used for obese mice, the weight of the obese mice can be effectively reduced, glycolipid metabolism can be optimized, glucose tolerance and insulin resistance can be improved, the pathological morphology of epididymal adipose tissue can be reversed, the diversity of intestinal microbiota of the obese mice with insulin resistance can be increased, and the abundance of beneficial bacteria can be improved.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for treating insulin resistance of obese children and a preparation method. BACKGROUND

[0003] Insulin resistance is a decrease in the physiological effect of insulin in the body, and its causes mainly include genetic factors, environmental factors, increased hormone secretion and other diseases. Insulin resistance patients have no specific symptoms, but are often accompanied by diseases such as obesity, atherosclerosis and abnormal blood coagulation function, and are the pathological basis and key link of obesity and related complications, directly leading to metabolic abnormalities and causing serious harm such as cardiovascular diseases, type 2 diabetes and non-alcoholic fatty liver, which further aggravates the process of obesity and forms a vicious cycle.

[0004] Childhood insulin resistance is mainly caused by improper diet, obesity, high blood sugar, destruction of islet cells, hypothyroidism and the like. At present, the treatment of childhood insulin resistance caused by improper diet and obesity mainly focuses on adjusting diet, enhancing exercise and reducing weight, but has a long onset period and poor effect. SUMMARY

[0005] The application aims to provide a traditional Chinese medicine composition for treating insulin resistance of obese children and a preparation method, so as to solve the problem of poor treatment effect of insulin resistance of obese children.

[0006] To achieve the above-mentioned purpose, the application adopts the following technical solutions. In a first aspect, the application provides a traditional Chinese medicine composition for treating insulin resistance of obese children, which comprises, by mass, 10-15g of fuzi, 10-15g of huoxiang, 6-10g of jiaozicao, 5-8g of huanglian, 10-15g of chenpi and 5-8g of shengangcao.

[0007] In a second aspect, the application provides a preparation method of a granule for treating insulin resistance of obese children, which comprises the following steps. Fuzi, huoxiang and chenpi are added to ethanol, heated and extracted to obtain volatile oil and dregs; Beta-cyclodextrin is added to the volatile oil, stirred and coated, and then distilled and dried to obtain volatile oil inclusion compound and distillation liquid; The dregs, jiaozicao, huanglian and shengangcao are added to water and decocted twice, the decoction liquid of the two times is combined with the distillation liquid, and then concentrated, dried and pulverized to form fine powder; The fine powder, the volatile oil, soluble starch and stevioside are mixed, dried and prepared to obtain granules.

[0008] In a third aspect, the application provides a Chinese medicine composition for treating insulin resistance in obese children.

[0009] The application has the following beneficial effects: The Chinese medicine composition in the application takes Radix Saposhnikoviae and Agastache rugosa as monarch drugs, Fructus Gardeniae praeparatus as a minister drug, Rhizoma Coptidis and Pericarpium Citri Reticulatae as auxiliary drugs, and Radix Glycyrrhizae as an assistant drug. The whole prescription uses bitter and sweet drugs together, and combines ascending and descending, to jointly achieve the effects of purging the spleen and stomach latent fire, clearing damp heat, removing dampness and phlegm, and regulating the qi movement of the spleen and stomach, so that the latent fire in the middle jiao is cleared and the qi movement is regulated, thereby improving the insulin sensitivity and insulin resistance, and taking into account the physiological characteristics of the tender spleen and stomach in children. When the Chinese medicine composition in the application is used for obese mice, it can effectively reduce the body weight of the obese mice, optimize the sugar and lipid metabolism, improve the glucose tolerance and insulin resistance, reverse the pathological morphology of epididymal adipose tissue, increase the intestinal microbial community diversity of obese insulin resistance mice, and improve the abundance of beneficial bacteria. BRIEF DESCRIPTION OF DRAWINGS

[0010] Figure 1 Fig. 1 is a graph of the body weight changes of mice in each group, wherein a is the body weight change trend in 0-8 weeks of administration, and b is the comparison of the body weight of mice in each group after the treatment; Figure 2 Fig. 2 is a graph of the fasting blood glucose, fasting insulin and HOMA-IR level detection of mice in each group, wherein a-c are the fasting blood glucose, fasting insulin and HOMA-IR, respectively; Figure 3 Fig. 3 is a graph of the TC, TG, HDL-C and LDL-C content detection in the serum of mice in each group, wherein a-d are TC, TG, HDL-C and LDL-C, respectively; Figure 4 Fig. 4 is a graph of the blood glucose changes of mice in each group during the OGTT experiment, wherein a is the blood glucose change trend in 0-120 minutes after oral glucose, and b is the comparison of the area under the OGTT curve of mice in each group; Figure 5 Fig. 5 is a graph of the blood glucose changes of mice in each group during the ITT experiment, wherein a is the blood glucose change trend in 0-120 minutes after insulin injection, and b is the comparison of the area under the ITT curve of mice in each group; Figure 6 Fig. 6 is a HE staining graph of the epididymal adipose tissue of mice in each group; Figure 7 Fig. 7 is an Alpha diversity analysis curve of the 16S rRNA sequencing of mice in each group, wherein a is a sparse curve graph, and b is a species abundance rank curve graph; Figure 8 Fig. 8 is an Alpha diversity index graph of the 16S rRNA sequencing of mice in each group, wherein a-f are the comparison of the community diversity index at different levels of door, class, order, family, genus and species of mice in each group, respectively. Figure 9 Graphlan phylogenetic trees of 16S rRNA sequencing of mice in each group are used to reflect the abundance of mouse gut microbiota at different levels of phylum, class, order, family, genus, and species. Figure 10 A heatmap showing the genus-level species composition of the gut microbiota in each group of mice. Detailed Implementation

[0011] This application provides a traditional Chinese medicine composition for treating insulin resistance in obese children, comprising, by weight: 10-15g of Saposhnikovia divaricata, 10-15g of Pogostemon cablin, 6-10g of Gardenia jasminoides (roasted), 5-8g of Coptis chinensis, 10-15g of Citrus reticulata peel, and 5-8g of Glycyrrhiza uralensis (raw).

[0012] The principal herbs are: Saposhnikovia divaricata, which is pungent and sweet, and has an ascending and dispersing nature, capable of dispersing latent fire in the spleen and stomach, and has the effect of "lightening the body with prolonged use"; and Pogostemon cablin, which is pungent and warm, capable of resolving dampness, invigorating the spleen, dispelling foulness, and harmonizing the middle jiao. In this application, Saposhnikovia divaricata and Pogostemon cablin are used together as the principal herbs, which address both the dampness on the body surface and the dampness in the spleen and stomach, and work together to produce the effects of dispelling dampness and turbidity and regulating qi.

[0013] Assistant herb: Roasted gardenia fruit is bitter and cold in nature. It can clear heat from the triple burner, guide heat downwards, and has the effects of purging fire, relieving irritability, clearing heat, and promoting diuresis. As an assistant herb, roasted gardenia fruit can assist the principal herb in clearing heat and damp-heat in the spleen and stomach, and also cool the blood and promote diuresis.

[0014] Adjuvant herbs: Coptis chinensis is cold in nature and bitter in taste, and is good at clearing damp-heat in the spleen and stomach. It can enter the heart and liver meridians, clearing fire in the heart and liver, and has the effects of relieving summer heat, damp heat, and stagnant heat. Tangerine peel is bitter in taste, and has the effects of drying dampness and resolving phlegm, as well as strengthening the spleen, tonifying deficiency and purging excess. In this application, Coptis chinensis and tangerine peel are used together as adjuvant herbs. Coptis chinensis and charred gardenia jasminoides work together to enhance the heat-clearing effect and relieve metabolic disorders caused by damp-heat. Tangerine peel not only assists the principal herbs in resolving phlegm and dampness, but also moderates the bitter and cold nature of Coptis chinensis and charred gardenia jasminoides, avoiding damage to the delicate spleen and stomach of children. The two work together to produce the effects of clearing heat and drying dampness, regulating qi and resolving phlegm, and improving the digestive function of the spleen and stomach.

[0015] Guiding herb: Licorice root is sweet and neutral in nature, capable of clearing heat, harmonizing the middle jiao, relieving spasms and pain, thus serving as the guiding herb. Furthermore, licorice root harmonizes the bitter-cold and warm-drying properties of the entire formula, preventing damage to the spleen; it also invigorates qi and nourishes the middle jiao, while also supporting the child's vital energy, providing functional support for improving insulin resistance.

[0016] This formula combines sweet and bitter flavors, with ascending and descending properties, to effectively purge latent heat in the spleen and stomach, clear damp-heat, eliminate dampness and phlegm, and regulate the Qi mechanism of the spleen and stomach. This clears latent heat in the middle Jiao and regulates Qi, thereby improving insulin sensitivity and reducing insulin resistance, while also taking into account the delicate physiological characteristics of children's spleen and stomach. This invention is primarily used to treat obesity-related insulin resistance with stomach heat and dampness obstruction, such as obesity, abdominal distension, excessive hunger, lethargy, thirst, halitosis, chest tightness, sweating upon exertion, irritability or drowsiness, dirty face, possibly accompanied by nausea and vomiting, yellow urine, dry or sticky stools, red tongue, enlarged tongue body, or teeth marks on the edges, yellow and greasy or slightly yellow tongue coating, and slippery and rapid or slippery pulse, etc.

[0017] A preferred traditional Chinese medicine composition for treating insulin resistance in obese children includes, by weight: 12g of Saposhnikovia divaricata, 12g of Pogostemon cablin, 9g of Gardenia jasminoides (roasted), 6g of Coptis chinensis, 12g of Citrus reticulata peel, and 6g of Glycyrrhiza uralensis (raw).

[0018] The dosage form of the traditional Chinese medicine composition in the embodiments of this application is granules, tablets, capsules or decoction.

[0019] When the dosage form of the traditional Chinese medicine composition is granules, the method for preparing the granules includes: S01: Add Saposhnikovia divaricata, Pogostemon cablin, and Citrus reticulata peel to an ethanol solution, heat and extract to obtain volatile oil and residue.

[0020] Saposhnikovia divaricata, patchouli, and tangerine peel are added to ethanol, with the ethanol level covering them by 1-3 cm. The mixture is then heated at 40-60℃ to extract the volatile oil components from the saposhnikovia divaricata, patchouli, and tangerine peel into the ethanol, forming volatile oil and medicinal residue.

[0021] S02: Add β-cyclodextrin to the volatile oil, stir to encapsulate, and then distill and dry at 50-60℃ to obtain the volatile oil inclusion complex and distillate. The mass of β-cyclodextrin added is 10-15% of the volume of the volatile oil.

[0022] S03: Add the dregs, charred gardenia, coptis, and raw licorice to water, ensuring the water level covers the herbs. Decoct twice, 1 hour each time. After decoction, combine the two decoctions and distillate, and concentrate to a relative density of 1.3-1.35 at 60°C to obtain a thick paste. Dry the thick paste under reduced pressure and pulverize it to form a fine powder. The reduced pressure drying is performed using conventional methods and process conditions in this field.

[0023] S04: The prepared fine powder, volatile oil, soluble starch, and steviol glycosides are mixed and dried at 50-60℃ to prepare granules. The soluble starch and steviol glycosides are added at 2-5% of the mass of the fine powder, respectively.

[0024] In addition, when the dosage form of the traditional Chinese medicine composition is tablets, the fine powder, volatile oil, soluble starch, and steviol glycosides are mixed and compressed into tablets. When the dosage form of the traditional Chinese medicine composition is capsules, the granules are filled into capsule shells. When the dosage form of the traditional Chinese medicine composition is a decoction, the decoction is obtained by combining the decoction liquid and the distillate from two separate decoctions.

[0025] This application also provides an application of the above-mentioned traditional Chinese medicine composition, namely, its application in the preparation of a drug for treating insulin resistance in obese children.

[0026] The technical solution of the present invention will be further explained and described below through specific embodiments.

[0027] Example 1 This application provides a traditional Chinese medicine composition for treating insulin resistance in obese children. The composition comprises, by weight: 12g of Saposhnikovia divaricata, 12g of Pogostemon cablin, 9g of Gardenia jasminoides (roasted), 6g of Coptis chinensis, 12g of Citrus reticulata peel, and 6g of Glycyrrhiza uralensis.

[0028] The traditional Chinese medicine composition in this application embodiment is a granule, and the preparation method of the granule includes: S101: Add Saposhnikovia divaricata, Pogostemon cablin, and Citrus reticulata peel to ethanol, wherein the amount of ethanol added is 2 cm above the Saposhnikovia divaricata, Pogostemon cablin, and Citrus reticulata peel. Heat the mixture at 50°C to extract the volatile oil and the residue.

[0029] S102: Add 15% by volume of β-cyclodextrin to the volatile oil, stir to encapsulate, and then distill and dry at 60°C to obtain the volatile oil inclusion complex and distillate.

[0030] S103: Add the dregs, charred gardenia, coptis, and raw licorice to water and decoct twice, 1 hour each time. After decoction, combine the two decoctions and distillate, and concentrate to a relative density of 1.3-1.35 at 60℃ to obtain a thick paste. Dry the thick paste under reduced pressure and pulverize it to form a fine powder.

[0031] S104: After mixing the prepared fine powder and volatile oil, add soluble starch and steviol glycosides at 5% and 4% of the weight of the fine powder, respectively. After mixing, dry at 50-60℃ to prepare granules.

[0032] Example 2 This application provides a traditional Chinese medicine composition for treating insulin resistance in obese children. The composition comprises, by weight: 10g of Saposhnikovia divaricata, 15g of Pogostemon cablin, 6g of Gardenia jasminoides (roasted), 5g of Coptis chinensis, 15g of Citrus reticulata peel, and 7g of Glycyrrhiza uralensis.

[0033] This application also provides a method for preparing a traditional Chinese medicine composition for treating insulin resistance in obese children, which is the same as in Example 1.

[0034] Example 3 This application provides a traditional Chinese medicine composition for treating insulin resistance in obese children. The composition comprises, by weight: 13g of Saposhnikovia divaricata, 10g of Pogostemon cablin, 8g of Gardenia jasminoides (roasted), 8g of Coptis chinensis, 10g of Citrus reticulata peel, and 8g of Glycyrrhiza uralensis (raw).

[0035] This application also provides a method for preparing a traditional Chinese medicine composition for treating insulin resistance in obese children, which is the same as in Example 1.

[0036] Example 4 This application provides a traditional Chinese medicine composition for treating insulin resistance in obese children. The composition comprises, by weight: 15g of Saposhnikovia divaricata, 11g of Pogostemon cablin, 10g of Gardenia jasminoides (roasted), 7g of Coptis chinensis, 15g of Citrus reticulata peel, and 8g of Glycyrrhiza uralensis.

[0037] This application also provides a method for preparing a traditional Chinese medicine composition for treating insulin resistance in obese children, which is the same as in Example 1.

[0038] To verify that the traditional Chinese medicine composition provided in this application has the effect of treating insulin resistance in obese children, animal experiments were conducted using 5-week-old, SPF-grade, C57BL / 6J male mice as experimental subjects. The specific details are as follows: 1. Animal grouping and modeling Sixty 5-week-old, SPF-grade, C57BL / 6J male mice were housed in an SPF-grade animal room with an ambient temperature of 25±1℃ and a relative humidity of 50±10%, under alternating light and dark conditions for 12 hours each. After one week of acclimatization, the mice were randomly divided into a control group (n=10) and a model group (n=50) using a random number table. All mice were housed in separate cages of 5. The control group was fed a standard diet, while the model group was fed a high-fat diet. The standard diet contained 3.44 kcal / g of total calories, comprising 12.95% fat, 24.02% protein, and 63.03% carbohydrates. The high-fat diet contained 5.26 kcal / g of total calories, comprising 60% fat, 20% protein, and 20% carbohydrates. After 12 weeks of continuous feeding, the animals were fasted for 12 hours but allowed free water. Fasting weight was measured, and fasting blood glucose and fasting insulin were measured by collecting blood from the tail tip. HOMA-IR (Homeostasis Model Assessment of Insulin Resistance Index) was calculated to determine whether the IR model was successfully constructed.

[0039] 2. Model Evaluation Criteria The obesity model was considered successfully established if the body weight of the model group exceeded the average body weight of the control group by 20%. The insulin resistance model was considered successfully established if the HOMA-IR of the model group was significantly higher than that of the control group (P < 0.05). When both of these criteria were met, the obese insulin resistance mouse model was considered successfully established.

[0040] 3. Administration Obese mice with irritable bowel syndrome (IR) were randomly divided into a model group, a metformin group, a low-dose group (XHS-L group), a medium-dose group (XHS-M group), and a high-dose group (XHS-H group) using a random number table method, and continued to be fed a high-fat diet. The metformin group was administered metformin by gavage at a dose of 200 mg / kg / day; the low-dose, medium-dose, and high-dose groups were all administered the traditional Chinese medicine composition from Example 1 by gavage at doses of 8.6 g / kg / day, 17.1 g / kg / day, and 34.2 g / kg / day, respectively; the normal and model groups, fed a normal diet, were administered physiological saline by gavage at the same volume as the metformin group. All groups were administered the medication once daily for 8 weeks.

[0041] 4. Testing 4.1 Weight Measurement During the continuous gavage feeding for 8 weeks, the fasting body weight of mice in each group was measured every two weeks to obtain the attached... Figure 1 From the appendix Figure 1 As can be seen, with the extension of feeding time, the body weight of mice in the model group and low-dose group gradually increased, while the body weight of mice in the metformin group, medium-dose group, and high-dose group gradually decreased, tending to the body weight of mice in the normal group. This indicates that the traditional Chinese medicine composition provided in this application can effectively reduce the body weight of obese mice, and the efficacy of high-dose administration is the same as that of the Western medicine metformin.

[0042] 4.2. Detection of fasting blood glucose, fasting insulin, and HOMA-IR levels At the end of week 8 after drug administration, fasting blood glucose levels in each group of mice were measured using a rapid blood glucose meter and disposable blood glucose test strips. Fasting insulin levels in each group of mice were measured using a mouse insulin ELISA kit, and HOMA-IR was calculated. Figure 2 .

[0043] From the appendix Figure 2 (a) As can be seen, compared with the model group mice, the fasting blood glucose levels of the metformin group, low-dose group, medium-dose group, and high-dose group mice were all reduced, and the fasting blood glucose levels of the metformin group and high-dose group mice were close to those of the normal group mice. This indicates that the traditional Chinese medicine composition provided in the embodiments of this application can effectively reduce the fasting blood glucose of obese mice, and the efficacy of high-dose administration is the same as that of the Western medicine metformin.

[0044] From the appendix Figure 2(b) Appendix Figure 2 (c) As can be seen, compared with the model group mice, the fasting insulin and HOMA-IR levels of the metformin group, low-dose group, medium-dose group, and high-dose group mice were all reduced, and the fasting insulin and HOMA-IR levels of the high-dose group mice were significantly lower than those of the metformin group mice, and tended to be similar to those of the normal group mice. This indicates that the traditional Chinese medicine composition provided in the embodiments of this application can effectively reduce the fasting insulin and HOMA-IR levels of obese mice, and the efficacy of high-dose administration is superior to that of the Western medicine metformin.

[0045] 4.3 Detection of serum TC, TG, HDL-C and LDL-C levels At the end of the 8th week after drug administration, mice in each group were anesthetized by isoflurane inhalation after fasting for 12 hours. Blood was collected from the orbital venous plexus of the mice, placed in sterile EP tubes, and allowed to stand at room temperature for 4 hours to coagulate. The tubes were then centrifuged at 3000 r / min for 20 minutes, and the supernatant serum was stored in a -80℃ freezer for later use.

[0046] The levels of TC (total cholesterol), TG (triglycerides), LDL-C (low-density lipoprotein cholesterol), and HDL-C (high-density lipoprotein cholesterol) in the upper serum of mice in each group were measured using a total cholesterol assay kit, a triglyceride assay kit, a low-density lipoprotein cholesterol assay kit, and a high-density lipoprotein cholesterol (HDL-C) assay kit, respectively. The results were then obtained. Figure 3 .

[0047] From the appendix Figure 3 (a) As can be seen, compared with the model group mice, the TC content of the metformin group, low-dose group, medium-dose group and high-dose group mice were reduced, and the TC content of the metformin group mice was higher than that of the low-dose group, medium-dose group and high-dose group mice. This indicates that the traditional Chinese medicine composition provided in the embodiments of this application can effectively reduce the TC content of obese mice, and the effect is better than that of the Western medicine metformin.

[0048] From the appendix Figure 3 (b) As can be seen, compared with the model group mice, the TG content of the metformin group, low-dose group, medium-dose group and high-dose group mice was reduced, and the TG content of the metformin group, medium-dose group and high-dose group mice tended to be similar to that of the normal group mice. This indicates that the traditional Chinese medicine composition provided in the embodiments of this application can effectively reduce the TG content of obese mice.

[0049] From the appendix Figure 3(c) As can be seen, compared with the model group mice, the HDL-C levels of mice in the metformin group, low-dose group, medium-dose group, and high-dose group were increased, and the HDL-C levels of mice in the metformin group were lower than those in the medium-dose group and high-dose group. This indicates that the traditional Chinese medicine composition provided in the embodiments of this application can effectively increase the HDL-C levels of obese mice.

[0050] From the appendix Figure 3 (d) As can be seen, compared with the model group mice, the LDL-C content of the metformin group, low-dose group, medium-dose group and high-dose group mice was reduced, and the LDL-C content of the metformin group, medium-dose group and high-dose group mice tended to be similar to that of the normal group mice. This indicates that the traditional Chinese medicine composition provided in the embodiments of this application can effectively reduce the LDL-C content of obese mice.

[0051] 4.4 OGTT and ITT Measurements At the end of week 8 after drug administration, mice in each group underwent oral glucose tolerance test (OGTT) and insulin tolerance test (ITT), and their AUC was assessed to obtain the results. Figure 4 , 5 The OGTT and ITT testing methods employ existing conventional methods.

[0052] From the appendix Figure 4 As can be seen, the blood glucose levels of mice in each group first increased and then decreased over time. Thirty minutes after oral glucose administration, compared to the model group, the blood glucose levels of mice in the metformin group, low-dose group, medium-dose group, and high-dose group were significantly lower. This indicates that the traditional Chinese medicine composition provided in this application can effectively improve glucose tolerance in obese mice.

[0053] From the appendix Figure 5 As can be seen, the blood glucose levels of mice in each group first decreased and then increased over time. Compared to the model group, the blood glucose trends in the metformin group, low-dose group, medium-dose group, and high-dose group were similar to those in the normal group, and tended to be similar to those in the normal group. This indicates that the traditional Chinese medicine composition provided in this application can effectively improve insulin resistance in obese mice.

[0054] 4.5 HE staining of adipose tissue At the end of week 8 after drug administration, blood was collected from mice in each group, and the mice were euthanized by cervical dislocation. The mice were placed on a surgical table, fixed in a supine position, and their abdominal cavities were disinfected with alcohol swabs. The abdominal cavities were then opened using sterile surgical instruments, and the epididymal adipose tissue and liver were harvested. Fascia and other impurities were removed, and the bloodstains were washed with pre-cooled physiological saline. After washing, the surface moisture was blotted dry with filter paper, and the weight was recorded. Liver and epididymal adipose tissue were harvested from the same location. A portion was preserved in 4% paraformaldehyde fixative, while the remainder was rapidly aliquoted on ice, then flash-frozen in liquid nitrogen and stored at -80°C. The pathological morphology of the epididymal adipose tissue in each group of mice was examined using routine HE staining experiments. Figure 6 .

[0055] From the appendix Figure 6 As can be seen, the adipocytes in the normal group mice were regularly morphologically regular and tightly arranged, with no obvious inflammatory cell infiltration. In contrast, some adipocytes in the model group showed pathological dilation and irregular shapes, with a large number of newly formed adipocytes aggregated, and cell membrane rupture in some areas, suggesting visceral fat accumulation. After treatment with low-dose, medium-dose, and high-dose groups, all treatment groups showed varying degrees of reduction in fatty degeneration. This indicates that the traditional Chinese medicine composition provided in this application can effectively improve the pathological morphology of epididymal adipose tissue in obese mice.

[0056] 4.6 Intestinal flora assay On the day of drug administration, intestinal contents of mice in each group were collected using sterile EP tubes. 16S rRNA sequencing technology was used to analyze the composition and differences in the intestinal flora of each group. Figures 7-10 .

[0057] From the appendix Figure 7 As can be seen, the dilution curves of the three groups are all relatively flat, indicating that the amount of sequencing data is reasonable and sufficient to cover all groups. At the same time, the Rank-Aundance curves show that the horizontal span of each dose group is large and the vertical smoothness is high, indicating that the species richness and uniformity of the gut microbiota of the mice in this group are better.

[0058] From the appendix Figure 8 Appendix Figure 9 It is evident that the community diversity index and species abundance of mice in each dosage group were significantly better than those in the model group at different levels of phylum, class, order, family, genus, and species.

[0059] From the appendix Figure 10 It is evident that, at the genus level, the distribution of gut microbiota in mice of each dose group was significantly different from that in the normal group and significantly improved compared to the model group.

[0060] As can be seen from the above, the traditional Chinese medicine composition provided in this application can increase the diversity of the gut microbiota in obese mice and increase the abundance of beneficial bacteria.

[0061] Clinical Cases Example 1 Mr. Li, male, 13 years old, visited the clinic on February 23, 2025. At the initial visit, his height was 158.7cm and his weight was 68.2kg. Examination revealed that he was obese due to damp-heat syndrome of the spleen and stomach. The prescription included: Saposhnikovia divaricata 12g, Pogostemon cablin 15g, Gardenia jasminoides 6g, Coptis chinensis 6g, Citrus reticulata 15g, and Glycyrrhiza uralensis 6g. After taking the medicine for 4 months, he visited the clinic on June 15, 2025, and his height was 160.4cm and his weight was 63.8kg.

[0062] Example 2 Mr. Zhang, male, 10 years old, visited the clinic on August 25, 2023. At the initial visit, his height was 150.8cm, weight was 68.6kg, and fasting insulin was 394.90pmol / L. Examination revealed he was obese due to spleen and stomach damp-heat syndrome. The prescription included: Saposhnikovia divaricata 12g, Pogostemon cablin 15g, Gardenia jasminoides (roasted) 6g, Coptis chinensis 6g, Citrus reticulata peel 12g, and Glycyrrhiza uralensis (raw) 6g. After taking the medicine for 4 months, at the clinic visit on December 15, 2023, his height was 152.8cm, weight was 62.7kg, and fasting insulin was 33.1uu / mL.

[0063] In summary, the traditional Chinese medicine composition provided in this application can effectively reduce the body weight of obese mice, optimize glucose and lipid metabolism, improve glucose tolerance and insulin resistance, reverse the pathological morphology of epididymal adipose tissue, increase the diversity of gut microbiota in obese insulin-resistant mice, and enhance the abundance of beneficial bacteria. This is because the traditional Chinese medicine composition regulates the gut microbiota to alleviate pathological changes in white adipose tissue morphology and correct glucose and lipid metabolism disorders, thereby exerting anti-obesity and insulin resistance-improving effects.

[0064] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A traditional Chinese medicine composition for treating insulin resistance in obese children, characterized in that, According to quality, it includes: 10-15g of Saposhnikovia divaricata, 10-15g of Pogostemon cablin, 6-10g of charred Gardenia jasminoides, 5-8g of Coptis chinensis, 10-15g of Citrus reticulata peel, and 5-8g of raw Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition for treating insulin resistance in obese children according to claim 1, characterized in that, According to quality, it includes: 12g of Saposhnikovia divaricata, 12g of Pogostemon cablin, 9g of Gardenia jasminoides (roasted), 6g of Coptis chinensis, 12g of Citrus reticulata peel, and 6g of Glycyrrhiza uralensis (raw).

3. The traditional Chinese medicine composition for treating insulin resistance in obese children according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is granules, tablets, capsules, or decoction.

4. The traditional Chinese medicine composition for treating insulin resistance in obese children according to claim 3, characterized in that, The method for preparing the particles includes: Saposhnikovia divaricata, patchouli, and tangerine peel were added to ethanol and heated for extraction to obtain volatile oil and residue. β-cyclodextrin was added to the volatile oil, stirred to form an inclusion complex, and then distilled and dried to obtain the volatile oil inclusion complex and the distillate. The dregs, charred gardenia, coptis and raw licorice are added to water and decocted twice. The decoctions from the two decoctions are combined with the distillate, and then concentrated, dried and pulverized to form a fine powder. The fine powder, volatile oil, soluble starch, and steviol glycosides are mixed and then dried to prepare granules.

5. The traditional Chinese medicine composition for treating insulin resistance in obese children according to claim 4, characterized in that, The distillation and drying temperature is 50-60℃.

6. The traditional Chinese medicine composition for treating insulin resistance in obese children according to claim 4, characterized in that, The amount of ethanol added is such that it covers the Saposhnikovia divaricata, Patchouli, and Citrus reticulata by 1-3 cm, and the mass of β-cyclodextrin added is 10-15% of the volume of the volatile oil.

7. The traditional Chinese medicine composition for treating insulin resistance in obese children according to claim 4, characterized in that, The boiling time was 1 hour for both simmerings.

8. The traditional Chinese medicine composition for treating insulin resistance in obese children according to claim 4, characterized in that, The relative density when concentrated to 60°C is 1.3-1.

35.

9. The traditional Chinese medicine composition for treating insulin resistance in obese children according to claim 4, characterized in that, The amount of soluble starch and steviol glycoside added is 2-5% and 2-5% of the mass of the fine powder, respectively.

10. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating insulin resistance in obese children.

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