Yinling qudshizhongyaowu composition, preparation method and application thereof

Abstract

The application belongs to the field of traditional Chinese medicines, and particularly relates to a Yincheng Qushi traditional Chinese medicine composition, a preparation method thereof and application. The Yincheng Qushi traditional Chinese medicine composition comprises the following raw medicinal materials in parts by mass: 30-60 parts of Poria cocos, 10-30 parts of Atractylodes, 10-30 parts of Polyporus, 10-30 parts of Ramulus Cinnamomi, 5-10 parts of dried ginger, 10-30 parts of licorice, 10-30 parts of Artemisia, and 10-30 parts of North Adenophora. Clinical tests show that the Yincheng Qushi traditional Chinese medicine composition can effectively reduce the BMI of a wetness syndrome population, effectively improve the wetness syndrome level, obviously reduce the waist circumference and hip circumference, and has a certain weight loss trend, can significantly down-regulate the triglyceride level and up-regulate the high-density lipoprotein cholesterol level, can obviously reduce the systolic pressure and diastolic pressure level, and has good safety. Therefore, the Yincheng Qushi traditional Chinese medicine composition has good therapeutic effect on the wetness syndrome metabolic syndrome.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for dispelling dampness using Yinling, its preparation method, and its application. Background Technology

[0002] Metabolic syndrome (MetS) is a combination of metabolically interrelated risk factors that directly contribute to the development of cardiovascular diseases such as atherosclerotic cardiovascular disease, ischemic stroke, and type 2 diabetes. With the improvement of modern living standards, the incidence of metabolic syndrome is showing a continuous upward trend globally.

[0003] Western medicine treatment primarily involves intervening in different metabolic abnormalities using various medications such as hypoglycemic agents, antihypertensive drugs, and lipid-lowering drugs. Long-term use of Western medicine may lead to adverse reactions such as gastrointestinal discomfort and liver and kidney damage. Furthermore, due to the coexistence of multiple abnormal factors, patients with metabolic syndrome often need to take multiple medications simultaneously, which can easily cause drug interactions, potentially threatening their health and impacting their quality of life.

[0004] Traditional Chinese medicine (TCM), based on a holistic approach and individualized diagnosis and treatment, plays a vital role in the diagnosis and treatment of metabolic syndrome. It offers advantages such as precision, individualization, and fewer adverse reactions, demonstrating promising application prospects. Currently, various TCM formulas are used clinically to treat metabolic syndrome, such as Tianqi Jiangtang Capsules, Er Chen Tang combined with Tao Hong Si Wu Tang, Yi Tang Kang, Wen Pi Fu Zheng Tang, Jiangtang Wan, Tang Zhi Ping, Jiangtang Tiao Zhi Fang, Da Huang Huang Lian Xie Xin Tang, He Ye Jiang Zhi Tang, Chai Hu San Ren Tang, and Yang Yin Jiang Ya Capsules. These TCM formulas primarily target metabolic syndrome patterns associated with Yin deficiency, Qi deficiency, excess heat, Qi stagnation, or blood stasis. However, their effectiveness in treating the more common dampness-type metabolic syndrome is limited. Therefore, it is necessary to develop a TCM composition that can effectively treat dampness-type metabolic syndrome to meet clinical needs. Summary of the Invention

[0005] The first objective of this invention is to provide a traditional Chinese medicine composition for dispelling dampness, the second objective of this invention is to provide a method for preparing the traditional Chinese medicine composition, and the third objective of this invention is to provide the application of the traditional Chinese medicine composition.

[0006] According to a first aspect of the present invention, a traditional Chinese medicine composition for dispelling dampness is provided, the effective components of which include the following raw materials in parts by weight: 30-60 parts of Poria cocos, 10-30 parts of Atractylodes macrocephala, 10-30 parts of Polyporus umbellatus, 10-30 parts of Cinnamomum cassia, 5-10 parts of dried ginger, 10-30 parts of Glycyrrhiza uralensis, 10-30 parts of Artemisia capillaris, and 10-30 parts of Adenophora stricta.

[0007] This invention posits that dampness-induced metabolic syndrome arises from the prolonged internal accumulation of dampness and turbidity due to spleen and stomach deficiency. Insufficient congenital endowment or inadequate postnatal care damages the spleen and stomach, disrupting their qi transformation and reducing the transport and transformation of nutrients, leading to their accumulation in the body as phlegm, dampness, and turbid heat. When this phlegm flows into the blood vessels, it manifests as elevated blood sugar, blood lipids, and uric acid; when it accumulates in the middle jiao (middle burner), it results in abdominal and gluteal obesity; when it stagnates in the liver and gallbladder, it commonly causes fatty liver; and when liver qi is obstructed, it can lead to liver yang hyperactivity and elevated blood pressure.

[0008] The formula heavily utilizes Poria cocos as the principal ingredient. Poria cocos is sweet, bland, and neutral in nature, strengthening the spleen, promoting diuresis, and eliminating dampness. Combined with the adjuvant ingredient Cinnamomum cassia, which is pungent and warm, it opens the bladder and bowels to aid in the transformation of qi and the elimination of dampness. Atractylodes macrocephala is used as an assistant ingredient. Atractylodes macrocephala is sweet, bitter, and warm in nature, strengthening the middle jiao and assisting the principal ingredient Poria cocos in enhancing its dampness-eliminating power, thus eliminating the source of dampness. Polyporus umbellatus is also used as an assistant ingredient. Polyporus umbellatus is sweet, bland, and neutral in nature, eliminating dampness and promoting diuresis, assisting the principal ingredient Poria cocos in eliminating dampness without harming the true yin. Dried ginger is used as an assistant ingredient. Dried ginger is pungent and hot, strengthening the spleen, warming the middle jiao, and eliminating dampness. Artemisia capillaris is used as an adjuvant ingredient. Artemisia capillaris is bitter, pungent, and slightly cold, clearing heat and eliminating dampness, and restraining the warming and drying properties of the above herbs. Adenophora stricta is used as an adjuvant ingredient. Adenophora stricta is sweet, bitter, and slightly cold; its sweetness nourishes yin, promotes qi circulation, and moistens dryness, preventing excessive dampness elimination from damaging yin fluids. Licorice is used as the guiding ingredient. Licorice is sweet and neutral in nature, strengthening the spleen, clearing heat, promoting diuresis, and harmonizing the effects of the other herbs. The formula works synergistically to strengthen the spleen, promote diuresis and eliminate dampness, warm the middle jiao and benefit the stomach, and also eliminate damp-heat.

[0009] The raw materials for this invention are sourced as follows:

[0010] Poria: The dried sclerotium of the fungus Poriacocos (Schw.) Wolf, belonging to the genus Poria in the family Polyporaceae.

[0011] Atractylodes macrocephala Koidz: The rhizome of Atractylodes macrocephala Koidz, a plant belonging to the genus Atractylodes in the family Asteraceae.

[0012] Zhu Ling: The dried sclerotium of the fungus Polyporus umbellatus (Pers) Fr., belonging to the genus Polyporus of the family Polyporaceae.

[0013] Cinnamon twig: The tender branch of Cinnamomum cassia Presl, a plant belonging to the genus Cinnamomum in the family Lauraceae.

[0014] Dried ginger: The dried rhizome of Zingiber officinale Rosc., a plant belonging to the genus Zingiber in the family Zingiberaceae.

[0015] Licorice: The dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., plants belonging to the genus Glycyrrhiza in the legume family.

[0016] Artemisia capillaris: The dried aerial parts of Artemisia scoparza Waldst. et Kit. or Artemisia capillaris Thunb., plants belonging to the genus Artemisia in the family Asteraceae.

[0017] North American ginseng: The root of *Glehnia littoralis* F.Schmidtex Miq., a plant belonging to the genus *Glehnia* in the family Apiaceae.

[0018] In some embodiments, the active ingredients include the following raw materials in parts by weight: 48 parts Poria cocos, 18 parts Atractylodes macrocephala, 12 parts Polyporus umbellatus, 12 parts Cinnamomum cassia, 8 parts dried ginger, 12 parts Glycyrrhiza uralensis, 15 parts Artemisia capillaris, and 12 parts Adenophora stricta.

[0019] In some implementations, pharmaceutically acceptable excipients may also be added.

[0020] In some embodiments, the excipient is at least one selected from the following: sustained-release agent, excipient, filler, binder, wetting agent, disintegrant, absorption promoter, adsorbent carrier, surfactant, and lubricant.

[0021] In some embodiments, the dosage form of the traditional Chinese medicine composition is granules, decoction, paste, powder, tablet, pill or capsule.

[0022] According to a second aspect of the present invention, a method for preparing the above-mentioned Yinling dehumidifying traditional Chinese medicine composition is provided. When the dosage form of the traditional Chinese medicine composition is granules, the preparation method includes the following steps:

[0023] (1) The above raw materials are decocted twice with water. For the first decoction, add water equivalent to 10 times the total mass of the raw materials, heat to boiling, and maintain a gentle boil for 1.5 hours. After separation, the first decoction and the dregs are obtained. For the second decoction, take the dregs obtained after the first decoction, add water equivalent to 8 times the total mass of the raw materials, heat to boiling, and maintain a gentle boil for 1.0 hour. After separation, the second decoction and the dregs are obtained. Combine the first decoction and the second decoction to obtain a combined decoction.

[0024] (2) The combined decoction was concentrated under reduced pressure to obtain a clear extract;

[0025] (3) Add excipients to the obtained ointment, dissolve and mix well, sieve, and then spray dry to collect the powder and obtain dry ointment powder. The spray drying process parameters are: air inlet temperature 165-195℃, air outlet temperature 80-105℃.

[0026] (4) Sift the obtained dry extract powder, mix it evenly, and obtain the extraction intermediate;

[0027] (5) The obtained extraction intermediate is granulated into 12-40 mesh particles by dry granulation.

[0028] In some embodiments, in step (2), the combined decoction is concentrated under reduced pressure to a specific gravity of 1.08-1.10 at 65±5℃ to obtain a clear extract.

[0029] According to a third aspect of the present invention, the above-mentioned Yinling dehumidifying traditional Chinese medicine composition is provided for use in the preparation of a medicament for treating metabolic syndrome.

[0030] According to a fourth aspect of the present invention, the above-mentioned Yinling dehumidifying traditional Chinese medicine composition is provided for use in the preparation of a medicament for treating dampness-induced metabolic syndrome.

[0031] The beneficial effects of this invention include:

[0032] (1) Clinical trials have shown that the Yinling dehumidifying traditional Chinese medicine composition of the present invention can effectively reduce BMI in people with dampness-induced metabolic syndrome and effectively improve the level of dampness. It also has a significant effect on reducing waist circumference (WC) and hip circumference (HC), resulting in a certain downward trend in weight. Its regulation of blood lipids mainly involves downregulating triglyceride (TG) levels and upregulating high-density lipoprotein cholesterol (HDL-C) levels, and can significantly reduce systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels. Regarding safety, no serious adverse events have been reported that are clearly related to the Yinling dehumidifying traditional Chinese medicine composition of the present invention, indicating that the Yinling dehumidifying traditional Chinese medicine composition of the present invention is safe. Therefore, the Yinling dehumidifying traditional Chinese medicine composition of the present invention has a good therapeutic effect on dampness-induced metabolic syndrome.

[0033] (2) The Yinling Dampness-Clearing Chinese Medicine Composition of the present invention strengthens the spleen, promotes diuresis and eliminates dampness, warms the middle and benefits the stomach, and also eliminates damp heat. It is mainly used to treat metabolic syndrome caused by dampness obstructing the middle, spleen and stomach deficiency and cold, resulting in the middle jiao not functioning properly, dampness spreading, and damp heat. Detailed Implementation

[0034] The present invention will be further described in detail below with reference to specific embodiments, but the implementation of the present invention is not limited thereto. The materials involved in the following embodiments are all commercially available.

[0035] Example 1

[0036] The preparation method of Yinling dampness-removing granules in this embodiment includes the following steps:

[0037] (1) Weigh out 48g of Poria cocos, 18g of Atractylodes macrocephala, 12g of Polyporus umbellatus, 12g of Cinnamomum cassia, 8g of Zingiber officinale, 12g of Glycyrrhiza uralensis, 15g of Artemisia capillaris, and 12g of Adenophora stricta.

[0038] (2) Add water to the above raw materials and decoct twice. For the first decoction, add water equivalent to 10 times the total mass of the raw materials, heat to boiling, and keep simmering for 1.5 hours. After separation, obtain the first decoction and the dregs. For the second decoction, take the dregs obtained after the first decoction, add water equivalent to 8 times the total mass of the raw materials, heat to boiling, and keep simmering for 1.0 hour. After separation, obtain the second decoction and the dregs. Combine the first decoction and the second decoction to obtain the combined decoction.

[0039] (3) The combined decoction was concentrated under reduced pressure to a specific gravity of 1.09 (65±5℃) to obtain a clear extract.

[0040] (4) Add 6.85g of excipient maltodextrin MD15 to the obtained paste, dissolve and mix well, pass through a 100-mesh sieve, and then spray dry, collect the powder in time to obtain dry paste powder. The spray drying process parameters are: air inlet temperature 180℃, air outlet temperature 90℃.

[0041] (5) The obtained dry powder is sieved and mixed evenly to obtain the extraction intermediate.

[0042] (6) The obtained extraction intermediate was granulated into 40-mesh particles by dry granulation and packaged in blank aluminum foil bags with inkjet printing. Each bag contains 5.2g. When taking the medicine, take 3 bags at a time, twice a day.

[0043] Example 2

[0044] The preparation method of Yinling Dehumidifying Granules in this embodiment is similar to that in Example 1. The difference is that in step (1), 30g of Poria cocos, 15g of Atractylodes macrocephala, 10g of Polyporus umbellatus, 10g of Cinnamomum cassia, 5g of Zingiber officinale, 10g of Glycyrrhiza uralensis, 10g of Artemisia capillaris, and 10g of Adenophora stricta are weighed.

[0045] Example 3

[0046] The preparation method of Yinling Dehumidifying Granules in this embodiment is similar to that in Example 1. The difference is that in step (1), 45g of Poria cocos, 20g of Atractylodes macrocephala, 15g of Polyporus umbellatus, 15g of Cinnamomum cassia, 10g of Zingiber officinale, 15g of Glycyrrhiza uralensis, 20g of Artemisia capillaris, and 15g of Adenophora stricta are weighed.

[0047] Example 4

[0048] The preparation method of Yinling Dehumidifying Granules in this embodiment is similar to that in Example 1. The difference is that in step (1), 60g of Poria cocos, 30g of Atractylodes macrocephala, 20g of Polyporus umbellatus, 20g of Cinnamomum cassia, 10g of Zingiber officinale, 20g of Glycyrrhiza uralensis, 20g of Artemisia capillaris, and 20g of Adenophora stricta are weighed.

[0049] To demonstrate the therapeutic effect of the Yinling dehumidifying traditional Chinese medicine composition of the present invention on metabolic syndrome (MetS), the following clinical trials were conducted.

[0050] I. Research Design

[0051] Randomized, double-blind, placebo-controlled study.

[0052] II. Diagnostic and Inclusion / Exclusion Criteria

[0053] 1. Diagnostic criteria for metabolic syndrome

[0054] Refer to the diagnosis of MetS in the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2017 Edition)":

[0055] (1) Abdominal obesity (i.e. central obesity): WC ≥90cm for men and ≥85cm for women.

[0056] (2) Hyperglycemia: FPG ≥ 6.1 mmol / L or blood glucose ≥ 7.8 mmol / L 2 hours after glucose load and / or those who have been diagnosed with diabetes and are under treatment.

[0057] (3) Hypertension: Blood pressure ≥130 / 85 mmHg and / or those who have been diagnosed with hypertension and are receiving treatment.

[0058] (4) Fasting TG ≥ 1.70 mmol / L.

[0059] (5) Fasting HDL-C < 1.04 mmol / L.

[0060] A diagnosis can be made if three or more of the above criteria are met.

[0061] 2. Diagnostic criteria for dampness syndrome

[0062] Referencing the typical diagnostic criteria for dampness syndrome in the "Diagnostic Criteria for Dampness Syndrome in Traditional Chinese Medicine V2.0" published by the China Association of Traditional Chinese Medicine:

[0063] Typical Dampness Syndrome Diagnostic Criteria: A diagnosis of typical dampness syndrome can be made if any one of the following conditions is met:

[0064] (1) It has 1 type of specific indicator + 2 sensitivity indicators;

[0065] (2) Possesses two types of specific indicators;

[0066] (3) It has 4 sensitivity indicators.

[0067] The specific and sensitivity indicators of dampness syndrome are shown in Table 1:

[0068] Table 1. Specific and Sensitivity Indicators for Dampness Syndrome

[0069]

[0070]

[0071] Note 1: Specificity indicators are measured in "classes"; sensitivity indicators are measured in "items".

[0072] Note 2: The severity grading of the indicators can be found in the "Information Collection Form for Core Symptoms of Dampness Syndrome in Traditional Chinese Medicine" in the published group standard;

[0073] Note 3: For the diagnostic criteria for dampness syndrome, if any one of the specific indicators of the same category meets the severity of moderate or severe, it can be determined that the specific indicator of that category is present; for the diagnostic criteria for typical dampness syndrome, if any one or multiple specific indicators of the same category are present, they are counted as one category of specific indicators.

[0074] 3. Inclusion criteria

[0075] (1) Ages 18-75;

[0076] (2) Those who meet the typical diagnostic criteria for dampness syndrome;

[0077] (3) Those who meet the diagnostic criteria for metabolic syndrome;

[0078] (4) Those who voluntarily participate in this research project and sign an informed consent form.

[0079] 4. Exclusion criteria

[0080] (1) Patients with secondary abnormalities in blood glucose, blood lipids and blood pressure caused by diseases such as nephrotic syndrome, hypothyroidism, renal failure, liver disease, systemic lupus erythematosus, myeloma, glycogen storage disease, lipoatrophy, acute porphyria and polycystic ovary syndrome;

[0081] (2) Patients with abnormal blood glucose and lipid levels caused by drugs (phenothiazines, beta-blockers, corticosteroids, etc.);

[0082] (3) Patients whose blood pressure SBP is still ≥180 mmHg or DBP is still ≥110 mmHg after treatment;

[0083] (4) Patients whose fasting plasma glucose (FPG) remains ≥11.1 mmol / L after drug treatment;

[0084] (5) Patients whose blood lipids, after oral medication treatment, have TC ≥ 6.22 mmol / L, LDL-C ≥ 4.92 mmol / L, or TG ≥ 3.39 mmol / L;

[0085] (6) Patients with malignant tumors, severe heart disease, hematological diseases, cerebrovascular accidents, severe trauma or major surgery;

[0086] (7) Individuals with allergic constitutions or who may be allergic to this drug;

[0087] (8) Pregnant or breastfeeding women, or women who plan to become pregnant during the trial or whose spouses plan to become pregnant;

[0088] (9) Others who cannot cooperate in the long term.

[0089] III. Intervention Plan

[0090] 1. Basic intervention measures

[0091] The basic treatment that the subjects received before participating in the trial will not be changed. That is, if the subjects have received routine modern medical treatment before participating in the trial, including oral lipid-lowering, blood pressure-lowering, and blood sugar-controlling drugs, their previous treatment plan will remain unchanged. If the subjects have not received regular treatment and their blood lipids, blood pressure, and blood sugar are within a safe range (i.e., not within the range specified by the exclusion criteria), then routine Western medicine treatment will not be given.

[0092] 2. Group intervention measures

[0093] (1) The experimental group was given oral administration of Yinling Qushi Granules prepared in Example 1, 3 small packets (5.2g / packet) at a time, i.e., 15.6g / time. The Chinese medicine granules were dissolved in 200-300mL of boiling water, stirred evenly, and taken warm, twice a day, after breakfast and lunch. Yinling Qushi Granules were prepared by Jiangyin Tianjiang Pharmaceutical Co., Ltd.

[0094] (2) The control group was given oral placebo granules at the same dosage and frequency as the experimental group, namely, 3 small packets (5.2g / packet, 15.6g / dose) each time. The granules were dissolved in 200-300mL of boiling water, stirred well, and taken warm, twice a day, after breakfast and lunch. The main components of the placebo were starch, dextrin, caramel coloring, and lemon yellow pigment. The outer packaging was completely identical to that of Yinling Qushi Granules. The appearance, color, smell, and taste of the placebo granules were basically the same as those of Yinling Qushi Granules, and the two were indistinguishable. The placebo granules were also prepared by Jiangyin Tianjiang Pharmaceutical Co., Ltd.

[0095] 3. Intervention cycle

[0096] The intervention period for both groups was 12 consecutive weeks.

[0097] IV. Evaluation Indicators

[0098] Assessments were conducted at baseline (0w), 4 weeks ± 5 days after intervention (4w), and 12 weeks ± 7 days after intervention (12w).

[0099] 1. Main therapeutic indicators

[0100] Body Mass Index (BMI).

[0101] 2. Secondary therapeutic indicators

[0102] (1) Dampness syndrome level: Dampness syndrome scale score.

[0103] (2) Other body shape related indicators: weight, waist circumference (WC), hip circumference (HC).

[0104] (3) Lipid metabolism: triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C).

[0105] (4) Blood pressure: systolic blood pressure (SBP), diastolic blood pressure (DBP).

[0106] (5) Glucose metabolism: fasting blood glucose (FBG), glycated hemoglobin (HbA1c), etc.

[0107] 3. Safety indicators

[0108] Safety evaluation includes laboratory indicators (complete blood count, liver and kidney function, urinalysis), electrocardiogram examination, and adverse event status.

[0109] V. Statistical Methods

[0110] SPSS software was used for statistical analysis, and the PPS dataset was used for efficacy evaluation.

[0111] For repeated measures (i.e., more than 2 tests), if the data follows a normal distribution, analysis of variance for repeated measures data is used; if it does not follow a normal distribution, analysis using a generalized estimating equation is used. P < 0.05 indicates a significant difference.

[0112] VI. Research Results

[0113] A total of 108 subjects were included, with 54 in the experimental group and 54 in the control group. Seven subjects dropped out of the experimental group and six subjects dropped out of the control group. Finally, 95 subjects were included in the analysis, including 47 in the experimental group and 48 in the control group.

[0114] 1. Baseline data

[0115] The comparison results of age data between the two groups of subjects are shown in Table 2, the gender distribution is shown in Table 3, and the baseline comparison results of the outcome indicators are shown in Table 4.

[0116] Table 2 Comparison of age data between the two groups

[0117]

[0118] Table 3. Gender distribution in the two groups

[0119]

[0120]

[0121] Table 4. Baseline comparison of outcome indicators between the two groups ( / M(P25 ~P 75 ))

[0122] Weight(kg) 78.20(68.80～88.00) 75.10(70.38～85.78) -0.231 0.818 <![CDATA[BMI(kg / m 2 )]]> 28.45±3.03 28.37±3.13 0.123 0.903 WC(cm) 96.88±7.45 96.65±6.90 0.157 0.876 HC(cm) 103.05±0.625 101.98±7.77 0.740 0.461 TG (mmol / L) 2.30(2.04～2.83) 2.37(2.15～3.45) -1.050 0.294 TC (mmol / L) 5.41(4.70～6.35) 5.29(5.00～6.17) -0.261 0.794 HDL-C (mmol / L) 1.06(0.94～1.34) 1.16(0.98～1.29) -0.584 0.559 LDL-C (mmol / L) 3.80±1.21 3.60±1.01 0.923 0.358 FBG (mmol / L) 5.32(5.06～6.24) 5.30(5.05～6.19) -0.119 0.905 HbA1c (%) 5.90(5.60～6.30) 5.75(5.53～6.25) -1.565 0.118 SBP (mmHg) 139.00(130.00～147.00) 138.00(127.00～142.00) -1.505 0.132 DBP (mmHg) 85.96±11.48 84.48±10.14 0.666 0.507 Dampness syndrome score (points) 46.74±14.78 51.33±12.171 -1.654 0.102

[0123] As can be seen from Table 2-4, the age, gender, and outcome indicators of the two groups of subjects before the intervention were evenly distributed and comparable.

[0124] 2. Key Outcome Indicators

[0125] The comparison results of the two groups of BMI are shown in Table 5:

[0126] Table 5 Comparison of BMI between the two groups (kg / m²) 2 , )

[0127] experimental group 47 28.45±3.03 28.45±2.89 28.28±2.95 -0.166 0.027 control group 48 28.37±3.13 28.45±3.33 28.40±3.32 0.096 0.095 Between-group differences - 0.08 -0.003 -0.113 - - F - 0.015 <0.001 0.031 - - <![CDATA[Partial η 2 > - <0.001 <0.001 <0.001 - - <![CDATA[P 组间 ]]> - 0.903 0.996 0.861 - -

[0128] As shown in Table 5, the BMI of the experimental group decreased significantly after intervention compared to baseline (P = 0.027), while the BMI of the control group did not change significantly before and after intervention. This indicates that the Yinling dehumidifying traditional Chinese medicine composition of the present invention can effectively reduce the BMI of people with dampness syndrome (MetS).

[0129] 3. Secondary outcome indicators

[0130] (1) Dampness syndrome scoring

[0131] The comparison results of the two groups of dampness syndrome level scores are shown in Table 6:

[0132] Table 6 Comparison of dampness syndrome level scores between the two groups (points, )

[0133]

[0134]

[0135] As shown in Table 6, the dampness syndrome scores of both groups decreased significantly after intervention (P<0.001), with the experimental group showing a more significant improvement and a statistically significant difference between the groups (P<0.001). This indicates that the dampness syndrome levels of both groups improved, and that Yinling Qushi Granules were more effective in improving the dampness syndrome scores of the MetS population.

[0136] (2)Weight

[0137] The results of the weight comparison between the two groups are shown in Table 7:

[0138] Table 7 Comparison of body weight between the two groups (kg, M (P)) 25 ~P 75 ))

[0139]

[0140] As shown in Table 7, the weight of the experimental group decreased after the intervention compared to baseline (P > 0.05), while the weight of the control group did not change significantly before and after the intervention. This indicates that the Yinling dehumidifying Chinese herbal composition of the present invention can induce a downward trend in the weight of individuals with dampness-related MetS syndrome after intervention.

[0141] (3) Waist and hip circumference

[0142] The comparison results of waist circumference (WC) and hip circumference (HC) for the two groups are shown in Table 8:

[0143] Table 8 Comparison of WC and HC between the two groups (cm, M (P)) 25 ~P 75 ))

[0144]

[0145] As shown in Table 8, the difference in waist circumference between the two groups at 12 weeks was statistically significant (P = 0.017); the difference in waist circumference before and after intervention in the experimental group was statistically significant (P < 0.001), while the difference in waist circumference before and after intervention in the control group was not statistically significant (P = 0.693). This indicates that the Yinling dehumidifying traditional Chinese medicine composition of the present invention can effectively reduce waist circumference in people with dampness syndrome (MetS).

[0146] Table 8 also shows that at 12 weeks, the hip circumference in the experimental group was lower than at 0 weeks, and the difference in hip circumference before and after the intervention was statistically significant (P = 0.004). In contrast, the hip circumference in the control group showed an increasing trend after the intervention, but the difference between the two groups was not statistically significant. This indicates that the Yinling dehumidifying traditional Chinese medicine composition of the present invention can effectively reduce hip circumference in individuals with dampness-induced MetS.

[0147] (4) Triglycerides

[0148] The comparison results of triglycerides (TG) in the two groups are shown in Table 9:

[0149] Table 9 Comparison of TG between the two groups (mmol / L, M (P)) 25 ~P 75 ))

[0150]

[0151] As shown in Table 9, the difference in TG between the two groups after intervention was statistically significant (P < 0.05). 组间 =0.049). This suggests that the Yinling dampness-removing traditional Chinese medicine composition, compared with the placebo, has a better regulatory effect on TG in the MetS population with dampness syndrome.

[0152] (5) High-density lipoprotein cholesterol, low-density lipoprotein cholesterol and total cholesterol

[0153] The comparison results of high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total cholesterol (TC) in the two groups are shown in Table 10:

[0154] Table 10 Comparison of HDL-C, LDL-C, and TC between the two groups (mmol / L) )

[0155]

[0156] As shown in Table 10, the difference in HDL-C before and after intervention in the experimental group was statistically significant (P = 0.014), indicating that HDL-C significantly increased after intervention with Yinling Qushi Granules. This suggests that the Yinling Qushi Chinese medicine composition can effectively improve HDL-C levels in individuals with dampness-related MetS. In contrast, HDL-C significantly decreased in the control group after 12 weeks of placebo intervention, with a statistically significant difference (P = 0.026).

[0157] Table 10 also shows that there were no significant changes in LDL-C and TC levels before and after the intervention in both groups, indicating that these two indicators did not improve significantly after the intervention.

[0158] (6) Blood pressure

[0159] The comparison results of the two groups of systolic blood pressure (SBP) are shown in Table 11:

[0160] Table 11 Comparison of SBP between the two groups (mmHg, M (P)) 25 ~P 75 ))

[0161]

[0162] As shown in Table 11, the difference in SBP between the two groups at 12 weeks was statistically significant (P = 0.032); the difference in SBP before and after intervention in the experimental group was statistically significant (P < 0.001), while the difference in SBP before and after intervention in the control group was not statistically significant (P = 0.347). This suggests that the Yinling dehumidifying traditional Chinese medicine composition of the present invention can effectively reduce the SBP level in people with dampness syndrome and MetS.

[0163] The comparison results of the two groups of diastolic blood pressure (DBP) are shown in Table 12:

[0164] Table 12 Comparison of DBP between the two groups (mmHg, )

[0165] experimental group 47 85.96±11.48 80.91±9.40 81.36±9.33 -4.596 <![CDATA[<0.001 * ]]> control group 48 84.48±10.14 82.94±12.15 84.02±8.81 -0.458 1.000 Between-group differences - 1.478 -2.023 -2.659 - - F - 1.348 2.500 6.214 - - <![CDATA[Partial η 2 > - <0.001 <0.001 <0.001 - - <![CDATA[P 组间 ]]> - 0.247 0.115 <![CDATA[0.013 * ]]> - -

[0166] As shown in Table 12, the difference in DBP between the two groups at 12 weeks was statistically significant (P = 0.013 < 0.05); the difference in DBP before and after intervention in the experimental group was statistically significant (P < 0.001), while the difference in DBP before and after intervention in the control group was not statistically significant (P > 0.05). This suggests that the Yinling dehumidifying traditional Chinese medicine composition of the present invention can effectively reduce the DBP level in people with dampness syndrome and MetS.

[0167] (7) Fasting blood glucose and glycated hemoglobin

[0168] The comparison results of fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) between the two groups are shown in Table 13:

[0169] Table 13 Comparison of FBG and HbA1c between the two groups (M (P) 25 ~P 75 ))

[0170]

[0171]

[0172] As can be seen from Table 13, there were no significant changes in FBG and HbA1c levels before and after the intervention in both groups, indicating that these two indicators did not improve significantly after the intervention.

[0173] 4. Safety evaluation

[0174] Safety evaluation included laboratory indicators (complete blood count, liver and kidney function, urinalysis), electrocardiogram (ECG), and adverse events. A safety analysis set was used, including all patients (13 dropouts), totaling 108 cases, with 54 in the experimental group and 54 in the control group. During the 12-week treatment period, no significant abnormalities were observed in blood count, liver function (AST, ALT), kidney function (creatinine, urea), urinalysis, or ECG results in either group. A total of 15 subjects experienced adverse events during the trial, including 6 in the experimental group (12.77%) and 9 in the control group (18.75%). One serious adverse event occurred in the experimental group, involving subject number 18, who was found to have a 4mm liver mass during a physical examination on day 16 of the intervention. The patient was diagnosed with early-stage liver cancer, underwent further surgery, and was in good general condition. The event was determined to be unrelated to the investigational drug, primarily due to the short duration of treatment and the insidious nature of liver cancer development. The remaining 14 adverse events were all transient, resolved spontaneously or after symptomatic treatment, and did not affect daily work and life. Considering factors such as the fact that the trial was conducted during the peak of influenza season, it was determined that 2 of them may be related to the investigational drug (hemorrhoid bleeding and eczema) and were expected adverse events. The main reason is that the investigational drug contains warm-natured Chinese medicines such as cinnamon twig, which may be too warm and dry for people with a pre-existing damp-heat constitution. The remaining 12 cases may or may not be related to the investigational drug.

[0175] Therefore, there have been no reports of serious adverse events related to Yinling Qushi Granules, and no liver or kidney damage occurred in the subjects after intervention, indicating that Yinling Qushi Granules are safe.

[0176] 5. Conclusion

[0177] Clinical trial results show that the Yinling dehumidifying traditional Chinese medicine composition of the present invention can effectively reduce BMI in people with dampness-induced metabolic syndrome and effectively improve the level of dampness. It also has a significant effect on reducing waist circumference (WC) and hip circumference (HC), resulting in a certain weight loss trend. Its regulation of blood lipids mainly involves downregulating triglyceride (TG) levels and upregulating high-density lipoprotein cholesterol (HDL-C) levels, and can significantly reduce systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels. Regarding safety, no serious adverse events clearly associated with the Yinling dehumidifying traditional Chinese medicine composition of the present invention have been reported, indicating that the Yinling dehumidifying traditional Chinese medicine composition of the present invention is safe. Therefore, the Yinling dehumidifying traditional Chinese medicine composition of the present invention has a good therapeutic effect on dampness-induced metabolic syndrome.

[0178] The above descriptions are merely some embodiments of the present invention. Those skilled in the art can make various modifications and improvements without departing from the inventive concept of the present invention, and these all fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for dispelling dampness using Yinling herbs, characterized in that, It is made from the following raw materials in parts by weight: Poria cocos 30-60 parts, Atractylodes macrocephala 10-30 parts, Polyporus umbellatus 10-30 parts, Cinnamomum cassia 10-30 parts, Zingiber officinale 5-10 parts, Glycyrrhiza uralensis 10-30 parts, Artemisia capillaris 10-30 parts, and Adenophora stricta 10-30 parts.

2. The Yinling dehumidifying traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Poria cocos 48 parts, Atractylodes macrocephala 18 parts, Polyporus umbellatus 12 parts, Cinnamomum cassia 12 parts, Zingiber officinale 8 parts, Glycyrrhiza uralensis 12 parts, Artemisia capillaris 15 parts, and Adenophora stricta 12 parts.

3. The Yinling dehumidifying traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Pharmaceutically acceptable excipients can also be added.

4. The Yinling Dampness-Clearing Traditional Chinese Medicine Composition according to claim 3, characterized in that, The excipients are at least one of the following: filler, binder, wetting agent, disintegrant, absorption promoter, and lubricant.

5. The Yinling dehumidifying traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The dosage form of the traditional Chinese medicine composition is granules, decoction, paste, powder, tablet, pill or capsule.

6. The method for preparing the Yinling dehumidifying traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, When the dosage form of the traditional Chinese medicine composition is granules, its preparation method includes the following steps: (1) The above raw materials are decocted twice with water. For the first decoction, add water equivalent to 10 times the total mass of the raw materials, heat to boiling, and keep simmering for 1.5 hours. After separation, the first decoction and the dregs are obtained. For the second decoction, take the dregs obtained after the first decoction, add water equivalent to 8 times the total mass of the raw materials, heat to boiling, and keep simmering for 1.0 hour. After separation, the second decoction and the dregs are obtained. Combine the first decoction and the second decoction to obtain the combined decoction. (2) The combined decoction was concentrated under reduced pressure to obtain a clear extract; (3) Add excipients to the obtained ointment, dissolve and mix well, sieve, and then spray dry to collect the powder and obtain dry ointment powder. The spray drying process parameters are: air inlet temperature 165-195℃, air outlet temperature 80-105℃. (4) Sift the obtained dry extract powder, mix it evenly, and obtain the extraction intermediate; (5) The obtained extraction intermediate is granulated into 12-40 mesh particles by dry granulation.

7. The preparation method according to claim 6, characterized in that, In step (2), the combined decoction is concentrated under reduced pressure to a specific gravity of 1.08-1.10 at 65±5℃ to obtain a clear extract.

8. The use of the Yinling dehumidifying traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament for treating dampness-induced metabolic syndrome.

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