Traditional Chinese medicine composition with effects of tonifying spleen, removing dampness and reducing weight and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition with effects of tonifying spleen, removing dampness and reducing weight, which is prepared from the following raw material medicines in parts by weight: 5-10 parts of lotus leaf, 3-6 parts of poria cocos, 3-6 parts of bighead atractylodes rhizome, 2-4 parts of chrysanthemum, 2-4 parts of raw hawthorn, 3-6 parts of cassia seed, 2-4 parts of medicated leaven, 3-6 parts of rhizoma alismatis and 1-2 parts of folium sennae. The traditional Chinese medicine composition adopts common traditional Chinese medicinal materials as raw materials, is scientific in formula, has the effects of invigorating the spleen, replenishing qi, removing dampness, removing stagnation and the like, can comprehensively improve obesity conditions of obese patients, including body weight index, obesity degree and waistline, can be used for treating simple obesity patients, is exact in medicine effect, safe and reliable, treats both symptoms and root causes, and has no toxic or side effect. The method has the advantages of high efficiency, low toxicity, safety, no obvious side reaction and the like.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and specifically, to a traditional Chinese medicine composition with the functions of strengthening the spleen, removing dampness and reducing weight and its application. Background Art

[0002] Obesity is a chronic and complex metabolic disease that seriously threatens human health. Its harm has far exceeded the individual level and has become a public health problem that cannot be ignored globally. Data shows that obesity not only significantly reduces the overall health level of humans, but also seriously affects the quality of life, increases the disease burden and medical costs. Currently, the number of overweight (BMI≥24 kg / m²) or obese (BMI≥28 kg / m²) adults globally has reached as high as 2.2 billion, accounting for 42.3% of the global total population. According to predictions, this figure may further climb to 3.3 billion by 2035, accounting for 54.2% of the global total population. It is worth noting that the obesity problem in children and adolescents is also showing a rapid growth trend. Model predictions show that the obesity rate among children and adolescents globally will increase significantly between 2020 and 2035. Among them, the obesity rate of boys is expected to increase from 10% to 20%, and that of girls will increase from 8% to 18%. This trend indicates that obesity has become an important threat to global health and may impose a continuous and profound burden on the public health system in the coming decades.

[0003] As a complex metabolic disorder, the occurrence and development of obesity are the result of the interaction of multiple factors such as genes, biology, environment, behavior, social culture and economy. A large number of studies have shown that obesity is closely related to a variety of chronic diseases and mental diseases, and can trigger a series of pathophysiological changes such as insulin resistance, lipid metabolism disorders, and chronic low-grade inflammation, and cause serious damage to multiple organ systems of the human body. Obesity is considered an important risk factor for cardiovascular diseases (such as hypertension, atherosclerosis, etc.), type 2 diabetes, metabolic syndrome, and various cancers (such as colorectal cancer, breast cancer, pancreatic cancer, etc.). In addition, obesity is also closely related to respiratory diseases (such as obstructive sleep apnea syndrome), skeletal muscle diseases (such as osteoarthritis), reproductive system diseases (such as polycystic ovary syndrome), digestive system diseases (such as fatty liver disease), etc. At the same time, obesity may also lead to intestinal microecological imbalance, sleep disorders, mobility difficulties, and significantly increase the risk of mental problems such as depression and anxiety, seriously affecting individual health and social functions.

[0004] At present, the treatment of obesity in modern medicine mainly includes diet control, exercise intervention, drug treatment, and surgical treatment. However, there are many limitations in the actual application of these intervention measures. Diet control and exercise intervention are often difficult to adhere to in the long term, and the curative effects vary due to individual differences; drug treatment may be accompanied by obvious side effects, and some drugs are addictive; surgical treatment is limited in its scope of application due to its invasiveness and high cost, and patients may still experience weight rebound due to insufficient lifestyle changes after surgery. Therefore, a single modern medical treatment method is still difficult to meet the actual needs of obese patients.

[0005] Traditional Chinese medicine has a long history of understanding obesity. Its theoretical system classifies obesity into categories such as "obese people with excessive phlegm" and "obese people with excessive fat", and believes that the occurrence of obesity is closely related to the imbalance of yin and yang, the imbalance of qi and blood, and the disorder of zang-fu organ functions. The treatment of obesity with traditional Chinese medicine takes the overall concept and syndrome differentiation and treatment as the core, starting from adjusting the balance of yin and yang, restoring the smooth flow of qi and blood, and improving the functions of zang-fu organs, and achieving the dynamic balance within the body through the combination of tonifying and regulating, strengthening the healthy qi and eliminating pathogenic factors, so as to achieve the purpose of reducing obesity symptoms and improving the health status. The treatment of traditional Chinese medicine has unique advantages such as high safety, no dependence, and individualized treatment, and is especially suitable for long-term management and the treatment of chronic diseases. In recent years, with the continuous deepening of the modern research of traditional Chinese medicine, a large number of clinical studies and experimental studies have confirmed the significant curative effect of traditional Chinese medicine in the treatment of obesity. For example, traditional Chinese medicine plays a therapeutic role through multiple pathways such as regulating lipid metabolism, improving insulin sensitivity, and relieving chronic inflammation, providing strong support for the comprehensive treatment of obesity.

[0006] In short, the treatment of obesity with traditional Chinese medicine has unique advantages in theory and practice. Combining with the research methods of modern medicine will further promote the precise and individualized development of obesity treatment. Strengthening the mechanism research and clinical application exploration of traditional Chinese medicine in the field of obesity treatment will provide new ideas and solutions for dealing with this global public health problem. Summary of the Invention

[0007] The purpose of the present invention is to provide a traditional Chinese medicine composition with the functions of strengthening the spleen, removing dampness, and reducing weight and its application.

[0008] Based on the long-term work in traditional Chinese medicine treatment research, the inventor of the present invention obtained an oral traditional Chinese medicine composition with the functions of strengthening the spleen, removing dampness, and reducing weight through repeated practice, and verified the therapeutic effect of the oral traditional Chinese medicine composition with the functions of strengthening the spleen, removing dampness, and reducing weight on obese patients through clinical trials. The traditional Chinese medicine composition is a traditional Chinese medicine product, which has the characteristics of safety, effectiveness, and no dependence compared with western medicine.

[0009] In the first aspect of the present invention, there is provided a traditional Chinese medicine composition with the functions of strengthening the spleen, eliminating dampness and reducing weight, which is composed of the following raw materials in parts by weight: 5 - 10 parts of lotus leaf, 3 - 6 parts of poria cocos, 3 - 6 parts of atractylodes macrocephala, 2 - 4 parts of chrysanthemum, 2 - 4 parts of raw hawthorn, 3 - 6 parts of cassia seed, 2 - 4 parts of medicated leaven, 3 - 6 parts of alisma orientale, and 1 - 2 parts of senna leaf.

[0010] Further, the traditional Chinese medicine composition with the functions of strengthening the spleen, eliminating dampness and reducing weight is composed of the following raw materials in parts by weight: 5 - 6 parts of lotus leaf, 3 - 4 parts of poria cocos, 3 - 4 parts of atractylodes macrocephala, 2 - 3 parts of chrysanthemum, 2 - 3 parts of raw hawthorn, 3 - 4 parts of cassia seed, 2 - 3 parts of medicated leaven, 3 - 4 parts of alisma orientale, and 1 - 2 parts of senna leaf.

[0011] Still further, the traditional Chinese medicine composition with the functions of strengthening the spleen, eliminating dampness and reducing weight is composed of the following raw materials in parts by weight: 5 parts of lotus leaf, 3 parts of poria cocos, 3 parts of atractylodes macrocephala, 2 parts of chrysanthemum, 2 parts of raw hawthorn, 3 parts of cassia seed, 2 parts of medicated leaven, 3 parts of alisma orientale, and 1 part of senna leaf.

[0012] In the second aspect of the present invention, there is provided an application of the above - mentioned traditional Chinese medicine composition in the preparation of a drug for strengthening the spleen, eliminating dampness and reducing weight.

[0013] In the third aspect of the present invention, there is provided an application of the above - mentioned traditional Chinese medicine composition in the preparation of a drug for treating obesity.

[0014] Further, the obesity is simple obesity.

[0015] In the fourth aspect of the present invention, there is provided a pharmaceutical preparation with the above - mentioned traditional Chinese medicine composition having the functions of strengthening the spleen, eliminating dampness and reducing weight as the active ingredient, and the pharmaceutical preparation is a tea preparation.

[0016] Further, the pharmaceutical preparation is taken orally after being steeped in water, divided into two doses in the morning and evening, and taken continuously for 4 weeks as one course of treatment.

[0017] In the fifth aspect of the present invention, there is provided an application of the above - mentioned pharmaceutical preparation in the preparation of a drug for strengthening the spleen, eliminating dampness and reducing weight.

[0018] In the sixth aspect of the present invention, there is provided an application of the above - mentioned pharmaceutical preparation in the preparation of a drug for treating obesity.

[0019] In the traditional Chinese medicine composition of the present invention having the functions of strengthening the spleen, eliminating dampness and reducing weight, poria cocos and atractylodes macrocephala strengthen the spleen and replenish qi, promote diuresis and eliminate dampness, and together serve as the monarch drugs; lotus leaf clears heat and resolves dampness, promotes diuresis and reduces lipid, chrysanthemum clears heat and detoxifies, cassia seed clears heat and improves eyesight, moistens the intestines and promotes defecation. Alisma orientale promotes diuresis and eliminates dampness, reduces turbidity and lipid, and together serve as the minister drugs. Hawthorn promotes digestion and strengthens the stomach, promotes qi movement and dispels stasis, reduces turbidity and lipid, and medicated leaven strengthens the spleen and promotes appetite, resolves dampness and reduces phlegm, and together serve as the assistant drugs; senna leaf purges heat and promotes qi movement, promotes defecation and promotes diuresis, and serves as the guiding drug. All the drugs work together to achieve the efficacy of "strengthening the spleen and replenishing qi, eliminating dampness and promoting qi movement".

[0020] The advantages of the present invention are as follows:

[0021] 1. The traditional Chinese medicine composition of the present invention uses common traditional Chinese medicinal materials as raw materials, has a scientific formula, and has the effects of strengthening the spleen and replenishing qi, removing dampness and promoting qi movement, etc. It can be used to treat patients with simple obesity, with remarkable curative effects and good safety. The retrospective case analysis of the pharmaceutical composition of the present invention shows that the traditional Chinese medicine composition of the present invention can comprehensively improve the obesity condition of obese patients, including improving body mass index, obesity degree and waist circumference, and is clinically safe. The traditional Chinese medicine composition of the present invention has definite curative effects, is safe and reliable, treats both the symptoms and the root cause, and has the advantages of high efficiency, low toxicity, safety and no obvious side effects.

[0022] 2. The traditional Chinese medicine composition of the present invention is a traditional Chinese medicine product, and has the characteristics of safety, effectiveness and no dependence compared with western medicines. Specific Embodiments

[0023] The following provides a detailed description of the specific embodiments of the present invention in conjunction with the embodiments.

[0024] Example 1: The traditional Chinese medicine composition of the present invention

[0025] 5 parts of lotus leaf, 3 parts of poria cocos, 3 parts of atractylodes macrocephala, 2 parts of chrysanthemum, 2 parts of raw hawthorn, 3 parts of cassia seed, 2 parts of medicated leaven, 3 parts of alisma orientale, 1 part of senna leaf.

[0026] Example 2: The traditional Chinese medicine composition of the present invention

[0027] 6 parts of lotus leaf, 4 parts of poria cocos, 4 parts of atractylodes macrocephala, 3 parts of chrysanthemum, 3 parts of raw hawthorn, 4 parts of cassia seed, 3 parts of medicated leaven, 4 parts of alisma orientale, 2 parts of senna leaf.

[0028] Example 3: The traditional Chinese medicine composition of the present invention

[0029] 8 parts of lotus leaf, 5 parts of poria cocos, 5 parts of atractylodes macrocephala, 4 parts of chrysanthemum, 4 parts of raw hawthorn, 5 parts of cassia seed, 4 parts of medicated leaven, 5 parts of alisma orientale, 1 part of senna leaf.

[0030] Example 4: The traditional Chinese medicine composition of the present invention

[0031] 10 parts of lotus leaf, 6 parts of poria cocos, 6 parts of atractylodes macrocephala, 4 parts of chrysanthemum, 4 parts of raw hawthorn, 6 parts of cassia seed, 4 parts of medicated leaven, 6 parts of alisma orientale, 2 parts of senna leaf.

[0032] Example 5: The preparation of the traditional Chinese medicine composition of the present invention

[0033] 5 g of lotus leaf, 3 g of poria cocos, 3 g of atractylodes macrocephala, 2 g of chrysanthemum, 2 g of raw hawthorn, 3 g of cassia seed, 2 g of medicated leaven, 3 g of alisma orientale, 1 g of senna leaf, soaked in 300 ml of water and taken orally, divided into two doses in the morning and evening.

[0034] Example 6: Therapeutic effect of the traditional Chinese medicine composition of the present invention on obese patients

[0035] 1. Clinical data

[0036] 1.1 General information

[0037] From October 2023 to October 2024, a total of 80 obese patients were included in this study. All of them were from the outpatient department of acupuncture and moxibustion in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine. Obese patients who met the inclusion criteria and exclusion criteria were randomly divided into a control group and a treatment group using a random number table, with 40 cases in each group. During the random grouping process, the generation of the random number table, the inclusion of subjects, and the evaluation of the scale were independently completed by different researchers. During the trial, 5 cases dropped out from the treatment group, and 35 cases were completed; 5 cases dropped out from the control group, and 35 cases were completed. Finally, a total of 70 cases were included in the statistical analysis. There were no statistically significant differences in the general information of the two groups of patients (all P>0.05), and they were comparable, as shown in Table 1.

[0038] Table 1 Comparison of general information of two groups of obese patients

[0039]

[0040] 1.2 Diagnostic criteria

[0041] Refer to the diagnostic criteria for obesity in Asian regions by WHO and the International Obesity Task Force in 2000:

[0042] (1) Body mass index (BMI): One of the important indicators for diagnosing obesity, and its calculation formula is: body weight / height 2 (kg / m 2 ) The specific classification is shown in Table 2:

[0043] Table 2 BMI classification standard table Physical condition

[0044]

[0045] (2) Obesity degree (%): The calculation formula is (actual weight - standard weight) / standard weight × 100%. The specific degree classification is shown in Table 3:

[0046] Table 3 Obesity degree classification

[0047]

[0048] (3) Waist circumference (cm): As a simple obesity measurement index, its measurement standard is the diameter line between the midpoints of the anterior superior iliac spines and the lower edge of the twelfth rib. For men, ≥90 cm, and for women, ≥80 cm can be considered obese.

[0049] 1.3 Inclusion criteria

[0050] 1) Meeting the diagnostic criteria for obesity in the WHO;

[0051] 2) Patients aged between 18 and 65 years old;

[0052] 3) Not having undergone other weight loss therapies such as oral medications or surgeries in the past two months;

[0053] 4) Having clear consciousness, voluntarily participating in this study, and signing the informed consent form.

[0054] 1.4 Exclusion criteria

[0055] 1) Patients with severe heart, liver, and kidney function impairments, blood and respiratory system diseases, and severe mental illnesses;

[0056] 2) Patients with infectious diseases such as liver diseases and AIDS, and those with severe trauma who have not recovered;

[0057] 3) Patients with severe digestive system diseases and severe malnutrition.

[0058] 4) Pregnant or lactating women.

[0059] 5) Secondary obesity caused by other diseases (such as neurological diseases, etc.).

[0060] 1.5 Criterion for exclusion and dropout

[0061] 1) Those who terminate treatment due to adverse reactions;

[0062] 2) Cases that are lost during clinical treatment and follow-up;

[0063] 3) Cases with poor compliance during the treatment process;

[0064] 4) Receiving other obesity-related interventions during the treatment process.

[0065] 2. Treatment plan

[0066] 2.1 Control group: A weight management prescription is given, including a diet prescription and an exercise prescription. The diet prescription for each patient is an individualized diet plan, which includes not only a nutritional recipe but also recommended water intake and nutritional supplements, and is formulated by a nutritionist according to the specific conditions of the patient's height, weight, physical activity level, etc. In addition to strictly implementing the diet prescription, the patient also needs to implement the exercise prescription. The content of the exercise prescription includes 150 - 300 minutes of moderate-to-low-intensity aerobic exercise per week, such as jogging, brisk walking, swimming, cycling, etc. Four weeks is a treatment course.

[0067] 2.2 Treatment group: On the basis of the treatment of the control group, the Chinese medicine composition provided by the present invention was given to the treatment group for oral administration as a water-soaked tea (5 g of lotus leaf, 3 g of poria cocos, 3 g of atractylodes macrocephala, 2 g of chrysanthemum, 2 g of raw hawthorn, 3 g of cassia seed, 2 g of medicated leaven, 3 g of alisma orientale, 1 g of senna leaf, prepared by the Chinese medicine pharmacy of the Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine). Each bag contains 24 g. One bag was taken daily, soaked in 300 ml of water and taken orally, divided into two doses in the morning and evening, and continuously taken for 4 weeks as one course of treatment.

[0068] 3. Efficacy observation

[0069] 3.1 Observation indicators

[0070] 3.1.1 Primary outcome indicators

[0071] (1) Body mass index (BMI): It is an index used to evaluate whether an individual's weight is within a healthy range relative to their height. The calculation formula is: weight / height 2 (kg / m 2 ) It was evaluated once before and after treatment respectively.

[0072] 3.1.2 Secondary outcome indicators

[0073] (1) Waist circumference: To evaluate the degree of obesity. The person being measured stands, with feet separated by about 25 to 30 cm. The measurement position should be at the midpoint of the line connecting the anterior superior iliac spine and the lower edge of the 12th rib (usually about 1 - 2 cm above the navel).

[0074] Use a non-elastic soft ruler with a minimum scale of 1 mm. Wrap the soft ruler horizontally around the waist, close to the skin but without pressing. The measurement should be taken after normal exhalation. The measured value should be accurate to 1 mm, and the average value should be taken after measuring 3 times. It was evaluated once before and after treatment respectively.

[0075] 3.2 Efficacy criteria

[0076] Refer to the obesity efficacy evaluation criteria formulated by the Third National Obesity Academic Conference, as shown in Table 4 specifically:

[0077] Table 4 Degree of decline of each index Obesity degree

[0078]

[0079] 3.3 Statistical methods

[0080] SPSS 26.0 statistical software was used for statistical analysis. Measurement data conforming to the normal distribution were expressed as mean ± standard deviation, and the t-test was used for comparison. Count data were expressed as cases and rates, and the chi-square test was used for comparison. A P < 0.05 indicates that the difference is statistically significant.

[0081] 3.4 Treatment results

[0082] (1) Comparison of BMI values between two groups of patients

[0083] Before treatment, there was no statistically significant difference in BMI values between the control group and the treatment group (P > 0.05); after treatment, the BMI values of both the control group and the treatment group decreased, and the difference between the two groups was statistically significant (P < 0.05); when comparing the BMI values of the control group before and after treatment, the difference was statistically significant (P < 0.05), and when comparing the BMI values of the treatment group before and after treatment, the difference was statistically significant (P < 0.05) (see Table 5).

[0084] Table 5 Comparison of BMI values between two groups of patients before and after treatment ( ±s)

[0085]

[0086] (2) Comparison of waist circumferences between two groups of patients

[0087] Before treatment, there was no statistically significant difference in waist circumferences between the control group and the treatment group (P > 0.05); after treatment, the waist circumferences of both the control group and the treatment group decreased, and the difference between the two groups was statistically significant (P < 0.05); when comparing the waist circumferences of the control group before and after treatment, the difference was statistically significant (P < 0.05), and when comparing the waist circumferences of the treatment group before and after treatment, the difference was statistically significant (P < 0.05) (see Table 6).

[0088] Table 6 Waist circumferences of two groups of patients before and after treatment ( ±s)

[0089]

[0090] (3) Analysis of the clinical efficacy of two groups of patients

[0091] In the treatment group, there were 13 cases of marked efficacy, 18 cases of effective, and 4 cases of ineffective, with an effective rate of 88.57%. In the control group, there were 8 cases of marked efficacy, 13 cases of effective, and 12 cases of ineffective, with an effective rate of 57.14%. Using test, the results showed that = 8.10, P < 0.05, and the difference was statistically significant (see Table 7).

[0092] Table 7 Comparison of treatment effective rates between two groups

[0093]

[0094] Based on the summary of the experimental data, the traditional Chinese medicine composition provided by the present invention with the functions of strengthening the spleen, dispelling dampness, and reducing weight can significantly reduce the degree of obesity, decrease its BMI value, obesity degree, and waist circumference, and the effective rate for treating obesity can reach 88.57%.

[0095] The preferred embodiments of the present invention have been specifically described above. However, the present invention is not limited to the described embodiments. Those skilled in the art can still make various equivalent modifications or substitutions without departing from the spirit of the present invention, and these equivalent modifications or substitutions are all included within the scope defined by the claims of this application.

Claims

1. A traditional Chinese medicine composition with the functions of strengthening the spleen, removing dampness and reducing weight, characterized in that It is composed of the following raw medicinal materials in parts by weight: 5 - 10 parts of lotus leaf, 3 - 6 parts of poria cocos, 3 - 6 parts of atractylodes macrocephala, 2 - 4 parts of chrysanthemum, 2 - 4 parts of raw hawthorn, 3 - 6 parts of cassia seed, 2 - 4 parts of medicated leaven, 3 - 6 parts of alisma orientale, 1 - 2 parts of senna leaf.

2. The traditional Chinese medicine composition with the functions of strengthening the spleen, removing dampness and reducing weight according to claim 1, wherein, It is composed of the following raw medicinal materials in parts by weight: 5 - 6 parts of lotus leaf, 3 - 4 parts of poria cocos, 3 - 4 parts of atractylodes macrocephala, 2 - 3 parts of chrysanthemum, 2 - 3 parts of raw hawthorn, 3 - 4 parts of cassia seed, 2 - 3 parts of medicated leaven, 3 - 4 parts of alisma orientale, 1 - 2 parts of senna leaf.

3. The traditional Chinese medicine composition with the functions of invigorating the spleen, removing dampness and reducing weight according to claim 1, wherein, It is composed of the following raw medicinal materials in parts by weight: 5 parts of lotus leaf, 3 parts of poria cocos, 3 parts of atractylodes macrocephala, 2 parts of chrysanthemum, 2 parts of raw hawthorn, 3 parts of cassia seed, 2 parts of medicated leaven, 3 parts of alisma orientale, 1 part of senna leaf.

4. A pharmaceutical preparation with the traditional Chinese medicine composition having the functions of strengthening the spleen, removing dampness and reducing weight as described in any one of claims 1-3 as the active ingredient, characterized in that, The pharmaceutical preparation is a tea preparation.

5. Use of a traditional Chinese medicine composition as described in any one of claims 1 - 3 in the preparation of a drug for strengthening the spleen, dispelling dampness and reducing weight.

6. Use of a traditional Chinese medicine composition as described in any one of claims 1 - 3 in the preparation of a drug for treating obesity.

7. Use of the pharmaceutical preparation as described in claim 4 in the preparation of a drug for strengthening the spleen, dispelling dampness and reducing weight.

8. Use of the pharmaceutical preparation as described in claim 4 in the preparation of a drug for treating obesity.

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