Traditional Chinese medicine composition for treating spleen deficiency and phlegm-dampness type metabolic syndrome as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating spleen deficiency and phlegm-dampness type metabolic syndrome. The invention also provides a traditional Chinese medicine extract and a preparation method thereof. The invention further provides a traditional Chinese medicine preparation. The invention further provides application of the traditional Chinese medicine composition, the traditional Chinese medicine extract or the traditional Chinese medicine preparation in preparation of a medicine for treating the spleen-deficiency phlegm-dampness type metabolic syndrome. According to the traditional Chinese medicine composition for treating the spleen-deficiency and phlegm-dampness type metabolic syndrome and the preparation method and application of the traditional Chinese medicine composition, the effects of invigorating the spleen, replenishing qi, reducing phlegm and clearing damp can be achieved, the effect of improving glucose metabolism is achieved, the effect of improving lipid metabolism is achieved, the purpose of treating both symptoms and root causes is achieved, and the remarkable curative effect on the spleen-deficiency and phlegm-dampness type metabolic syndrome is achieved.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for treating spleen deficiency and phlegm-dampness type metabolic syndrome, and a preparation method and application thereof. Background Art

[0002] Metabolic syndrome (MS) is a clinical syndrome characterized by multiple metabolic risk factors, including obesity, dysglycemia, dyslipidemia, and elevated blood pressure. Its pathological characteristics are characterized by the interaction of metabolic risk factors, and it is one of the core risk factors for cardiovascular disease. MS is common in patients with acute myocardial infarction. The prevalence of MS in my country is 33.9%, making it a public health issue threatening the health of residents. From a modern medical perspective, the root cause of MS is insulin resistance, making improving insulin resistance a key component of effective prevention and treatment of metabolic syndrome. However, existing Western medicine treatments often target a single component, making long-term use prone to adverse reactions.

[0003] Traditional Chinese Medicine (TCM) offers unique advantages by regulating metabolism holistically through multiple targets. MS falls under the TCM categories of "diabetes" and "phlegm and dampness," with underlying deficiency and superficial excess. The "Routine Guidelines for Diagnosis and Treatment of Traditional Chinese Medicine" categorizes metabolic syndrome into spleen deficiency and phlegm-dampness syndrome, heart and spleen deficiency syndrome, and spleen and kidney deficiency syndrome. Studies have shown that spleen deficiency and phlegm-dampness syndrome predominate among MS patients, accounting for 27.6%. Given its underlying pathogenesis of "spleen deficiency and phlegm-dampness as superficial symptoms," treatment must balance strengthening the spleen and replenishing Qi with resolving phlegm and dampness. Therefore, further research and exploration is necessary. Summary of the Invention

[0004] In view of the shortcomings of the prior art described above, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating metabolic syndrome of spleen deficiency and phlegm-dampness type, as well as its preparation method and use. The composition has a rigorous formula and scientific compatibility, can take into account both strengthening the spleen and replenishing qi and resolving phlegm and dampness, has a significant therapeutic effect on MS of spleen deficiency and phlegm-dampness type, and is more suitable for comprehensive intervention in the complex pathological links of MS.

[0005] To achieve the above-mentioned and other related purposes, the present invention provides a first aspect of a Chinese medicine composition for treating metabolic syndrome of spleen deficiency and phlegm-dampness type, comprising the following raw material components in parts by weight:

[0006] 5-30 parts by weight of Astragalus root;

[0007] 10-30 parts by weight of Ganoderma lucidum;

[0008] 1-20 parts by weight of Ligustrum lucidum fruit;

[0009] 10-30 parts by weight of black plum;

[0010] 1-20 parts by weight of Typhae Pollen;

[0011] 1-20 parts by weight of raw hawthorn;

[0012] 1-20 parts by weight of Rhizoma Alismatis;

[0013] 1-20 parts by weight of lotus leaves.

[0014] The second aspect of the present invention provides a traditional Chinese medicine extract, which is obtained by extracting the traditional Chinese medicine composition described in the first aspect of the present invention as a raw material.

[0015] The third aspect of the present invention provides a method for preparing the above-mentioned Chinese medicine extract, comprising: mixing the various raw material components of the Chinese medicine composition described in the first aspect of the present invention according to a proportion, and extracting the obtained mixture by decoction.

[0016] The fourth aspect of the present invention provides a traditional Chinese medicine preparation comprising a therapeutically effective amount of the traditional Chinese medicine composition provided by the first aspect of the present invention, or a therapeutically effective amount of the traditional Chinese medicine extract provided by the second aspect of the present invention, and one or more conventional pharmaceutically acceptable excipients.

[0017] The fifth aspect of the present invention provides the use of the traditional Chinese medicine composition provided by the first aspect of the present invention, the traditional Chinese medicine extract provided by the second aspect of the present invention, or the traditional Chinese medicine preparation provided by the fourth aspect of the present invention in the preparation of a medicament for treating metabolic syndrome of spleen deficiency and phlegm-dampness type.

[0018] As described above, the present invention provides a traditional Chinese medicine composition for treating metabolic syndrome of spleen deficiency and phlegm-dampness type, as well as its preparation method and use. Based on the TCM understanding of the pathogenesis of "spleen deficiency as the root cause and phlegm-dampness as the symptoms", by introducing drugs such as pollen typhae, raw hawthorn, rhizome of Alisma orientalis, and lotus leaf, it not only has the effect of improving sugar metabolism, but also has the effect of improving lipid metabolism, achieving the purpose of "treating both the symptoms and the root cause", and can have significant therapeutic effects on metabolic syndrome (MS), especially MS of spleen deficiency and phlegm-dampness type, and is more suitable for comprehensive intervention in the complex pathological links of MS.

[0019] Because MS falls under the categories of "diabetes," "phlegm and dampness," and "aggregate syndrome" in Traditional Chinese Medicine, the underlying deficiency is characterized by both underlying deficiency and superficial excess. The underlying deficiency is often qi and yin deficiency, while the superficial excess is primarily characterized by turbid phlegm, blood stasis, and heat stagnation, often affecting the liver, spleen, and kidney. Experiments conducted by the present invention demonstrate that the prepared Chinese medicine composition exhibits unique and innovative advantages in improving comprehensive metabolic indicators in patients with spleen deficiency and phlegm dampness-type MS, particularly in regulating lipid metabolism disorders and central obesity. It can more effectively improve multi-component abnormalities in MS patients and significantly increase the reversal rate in patients with spleen deficiency and phlegm dampness-type MS.

[0020] This study innovatively quantifies the diagnostic criteria for MS into an actionable reversal rate metric, transcending the limitations of previous studies that were limited to evaluating a single metabolic component. This study confirms the unique value of the Traditional Chinese Medicine (TCM) formulary approach of "treating both the symptoms and the root cause" in the management of MS patients, providing new insights into the integration of TCM's holistic approach with Western medicine's syndromic approach. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 The figure shows the number of cases in which each component in the two groups met the diagnostic requirements for MS after treatment, where TG is triglyceride and HDL-G is high-density lipoprotein cholesterol. DETAILED DESCRIPTION

[0022] Before further describing the specific embodiments of the present invention, it should be understood that the scope of the present invention is not limited to the specific embodiments described below. It should also be understood that the terminology used in the examples is intended to describe specific embodiments and is not intended to limit the scope of the present invention. The experimental procedures in the following examples, where specific conditions are not specified, were generally performed under conventional conditions or according to the conditions recommended by the respective manufacturers.

[0023] The first aspect of the present invention provides a traditional Chinese medicine composition for treating metabolic syndrome of spleen deficiency and phlegm-dampness type, comprising the following raw materials in parts by weight:

[0024] 5-30 parts by weight of Astragalus root; specifically 5-10 parts, 10-20 parts, 20-30 parts;

[0025] 10-30 parts by weight of Ganoderma lucidum; specifically 10-15 parts, 15-25 parts, 25-30 parts;

[0026] 1-20 parts by weight of Ligustrum lucidum fruit; specifically 1-5 parts, 5-15 parts, 15-20 parts;

[0027] 10-30 parts by weight of black plums; specifically 10-15 parts, 15-25 parts, 25-30 parts;

[0028] 1-20 parts by weight of Typhae Pollen; specifically 1-5 parts, 5-15 parts, 15-20 parts;

[0029] 1-20 parts by weight of raw hawthorn; specifically 1-5 parts, 5-15 parts, 15-20 parts;

[0030] 1-20 parts by weight of Rhizoma Alismatis; specifically 1-5 parts, 5-15 parts, 15-20 parts;

[0031] 1-20 parts by weight of lotus leaves; specifically 1-5 parts, 5-15 parts, 15-20 parts.

[0032] In the present invention, the astragalus is the dried root of the leguminous plant Astragalus mongolica or Astragalus membranaceus, which has the effects of replenishing qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting fluid and nourishing blood, relieving stagnation and relieving numbness, expelling toxins and draining pus, and healing sores and promoting tissue regeneration.

[0033] In the present invention, the Ganoderma lucidum is the dried fruiting body of Ganoderma lucidum or Ganoderma rubrum of the Polyporaceae family, and has the effects of replenishing qi, calming the mind, relieving cough and relieving asthma.

[0034] In the present invention, the Ligustrum lucidum fruit is the dried mature fruit of Ligustrum lucidum of the Oleaceae family, and has the effects of nourishing the liver and kidney, clearing away deficiency-heat, improving eyesight, etc.

[0035] In the present invention, the black plum is the dried nearly mature fruit of the rose family plant plum, which has the effects of astringing the lungs, astringing the intestines, promoting the production of body fluids, and calming ascaris.

[0036] In the present invention, the cattail pollen is the dried pollen of Typha aquatica, Typha orientalis or plants of the same genus of the Typhaceae family, and has the effects of astringing and stopping bleeding, promoting blood circulation and removing blood stasis, and promoting diuresis and relieving stranguria.

[0037] In the present invention, the raw hawthorn is hawthorn, which is the dried mature fruit of the plant Shanlihong or Crataegus pinnatifida of the Rosaceae family, and has the effects of promoting digestion and strengthening the stomach, promoting qi and dispersing blood stasis, and clearing turbidity and reducing lipids.

[0038] In the present invention, the Rhizoma Alismatis is the dried tuber of the plant Rhizoma Alismatis of the family Alismataceae, which has the effects of promoting diuresis and dispelling dampness, relieving heat, clearing turbidity and reducing lipids.

[0039] In the present invention, the lotus leaf is the leaf of the plant Nelumbo nucifera of the Nymphaeaceae family, which has the effects of clearing away heat and dampness, promoting the generation of clear yang, cooling blood and stopping bleeding.

[0040] The Chinese medicine composition for treating metabolic syndrome of spleen deficiency and phlegm dampness type of the present invention fully follows the principle of syndrome differentiation and treatment of traditional Chinese medicine. Among them, astragalus is sweet in taste and warm in nature. It is used as the monarch, which can tonify the middle and replenish qi, strengthen the spleen and distribute essence, and promote qi transformation, so as to achieve the effect of "treating the disease must seek the root"; Ganoderma lucidum can cultivate the innate root to help astragalus replenish qi, and enter the liver meridian and can also soothe the liver; the two medicines are both monarch medicines, the liver and spleen are in harmony, replenishing qi without stagnating qi, and when the qi mechanism is restored, dampness and turbidity will be transformed. Alisma and raw hawthorn are both ministerial medicines, which can eliminate dampness and resolve phlegm; among them, Alisma is diuretic and eliminates dampness, clears the water channels of the three burners, and makes the evil have a way out, and forms a tonifying and purging effect with the monarch medicine, tonifying the spleen without promoting dampness, and removing dampness without hurting the body; using raw hawthorn as the minister can not only take advantage of its function of removing turbidity and lowering fat, but also because it can digest food and resolve accumulation, reduce the burden on the spleen, and strengthen the monarch medicine's qi-tonifying effect. Black plum, Ligustrum lucidum fruit, and Pollen Typhae serve as adjuvants. Black plum has a sour flavor, which enters the liver, soothing liver qi and aiding Ganoderma lucidum in relieving the danger of liver wood overtaking spleen earth. Ligustrum lucidum fruit has a mild medicinal effect. The "Shennong Bencao Jing" states, "Ligustrum lucidum fruit nourishes the middle, calms the five internal organs, and nourishes the spirit..." It also nourishes the liver and kidneys, counteracting the warming and drying nature of the entire formula. Pollen Typhae can clear the upper and lower parts of the blood, promote blood circulation, and stop bleeding. Together with the main herb, Astragalus membranaceus, it fosters a synergistic effect between qi and blood, preventing pathogenic factors from spreading from qi to the blood. Lotus leaf serves as an adjuvant, carrying all the herbs into the spleen and stomach meridians. Its light, clearing, and ascending properties help Astragalus membranaceus elevate spleen yang. It also works with Alisma orientalis to raise the clear and lower the turbid, restoring qi in the middle burner. The eight herbs, when used together, exert a synergistic therapeutic effect.

[0041] The overall combination of the formula embodies the characteristics of "tonifying without stagnation, eliminating without damaging the body". The synergistic effect of its multiple components can simultaneously intervene in the two major pathological links of insulin resistance and lipid metabolism disorders, providing a certain basis for the practical application of TCM's "holistic view" in Western medicine's "syndrome".

[0042] In a preferred embodiment of the present invention, the Chinese medicine composition comprises the following raw material components in parts by weight:

[0043] 10-20 parts of Astragalus; for example, 10 parts, 15 parts, 20 parts, preferably 15 parts;

[0044] 15-25 parts of Ganoderma lucidum; for example, 15 parts, 20 parts, 25 parts, preferably 20 parts;

[0045] 5-15 parts of Ligustrum lucidum fruit, for example, 5 parts, 10 parts, 15 parts, preferably 10 parts;

[0046] 15-25 parts of black plums; for example, 15 parts, 20 parts, 25 parts, preferably 20 parts;

[0047] 5-15 parts of Typhae Pollen; for example, 5 parts, 10 parts, 15 parts, preferably 10 parts;

[0048] 5-15 parts of raw hawthorn, for example, 5 parts, 10 parts, 15 parts, preferably 10 parts;

[0049] 5-15 parts of Rhizoma Alismatis; for example, 5 parts, 10 parts, 15 parts, preferably 10 parts;

[0050] 5-15 parts of lotus leaves; for example, 5 parts, 10 parts, 15 parts, preferably 10 parts.

[0051] The second aspect of the present invention provides a traditional Chinese medicine extract, which is obtained by extracting the traditional Chinese medicine composition described in the first aspect of the present invention as a raw material.

[0052] The third aspect of the present invention provides a method for preparing the above-mentioned Chinese medicine extract, comprising: mixing the various raw material components of the Chinese medicine composition described in the first aspect of the present invention according to a proportion, and extracting the obtained mixture by decoction.

[0053] In a preferred embodiment of the present invention, the water-adding decoction method comprises: adding water to the mixture at least once for decoction, evaporating the mixture, and filtering the mixture to provide the Chinese herbal medicine extract.

[0054] In a further preferred embodiment of the present invention, the ratio of the mass (g) of the mixture added to the volume (mL) of water added each time is 30-190:350-450, specifically 30-65:350-450, 65-145:350-450, 145-190:350-450, further such as 65-145:350, 65-145:400, 65-145:450, preferably 105:400.

[0055] In a further preferred embodiment of the present invention, the water is added 1-3 times, preferably 2 times.

[0056] In a further preferred embodiment of the present invention, the decocting step is to boiling.

[0057] In a further preferred embodiment of the present invention, the time for decocting each time with water is 10-45 minutes, specifically 10-15 minutes, 15-25 minutes, or 25-45 minutes.

[0058] In a further preferred embodiment of the present invention, when the water is added twice, the time for boiling for the first time is 20-25 minutes, and the time for boiling for the second time is 15-20 minutes.

[0059] In a further preferred embodiment of the present invention, the ratio of the volume of the juice extracted after evaporation to the volume of water added each time is 1:1.8-2.2, preferably 1:2.

[0060] In a further preferred embodiment of the present invention, the filtration is a conventional filtration method, such as filter mesh filtration, filter cloth filtration, etc., which is mainly used to remove impurities and requires that no drug residue remains.

[0061] The fourth aspect of the present invention provides a traditional Chinese medicine preparation comprising a therapeutically effective amount of the traditional Chinese medicine composition provided by the first aspect of the present invention, or a therapeutically effective amount of the traditional Chinese medicine extract provided by the second aspect of the present invention, and one or more conventional pharmaceutically acceptable excipients.

[0062] Pharmaceutically acceptable excipients include, but are not limited to, pharmaceutically acceptable carriers, diluents, fillers, binders, disintegrants, lubricants, suspending agents, adhesives, sweeteners, flavoring agents, preservatives, and other excipients. Therapeutically inert inorganic or organic carriers known to those skilled in the art include, but are not limited to, lactose, corn starch or its derivatives, talc, vegetable oils, waxes, fats, polyols such as polyethylene glycol, water, sucrose, ethanol, glycerol, and the like, as well as various preservatives, lubricants, dispersants, and flavoring agents. Moisturizers, antioxidants, sweeteners, colorants, stabilizers, salts, buffers, and the like may also be added to enhance the stability of the formulation or to improve the activity or bioavailability of the formulation, as needed.

[0063] In a preferred embodiment of the present invention, the dosage form of the Chinese medicine preparation includes but is not limited to tablets, capsules, pills, syrups, granules, powders, ointments, pellets, suspensions or emulsions.

[0064] The above-mentioned various dosage forms of Chinese medicine preparations can be prepared by conventional methods. The Chinese medicine preparations of the present invention can also be used together with other therapeutic agents.

[0065] The therapeutically effective amount in the present invention is calculated based on the total weight of the raw medicinal materials. The specific dosage should also take into account factors such as the route of administration and the patient's health status, which are all within the skills of skilled physicians.

[0066] The fifth aspect of the present invention provides the use of the traditional Chinese medicine composition provided by the first aspect of the present invention, the traditional Chinese medicine extract provided by the second aspect of the present invention, or the traditional Chinese medicine preparation provided by the fourth aspect of the present invention in the preparation of a medicament for treating metabolic syndrome of spleen deficiency and phlegm-dampness type.

[0067] The aforementioned metabolic syndrome of spleen deficiency and phlegm-dampness is a comorbid condition characterized by obesity, hyperglycemia (impaired glucose regulation or diabetes), hypertension, and dyslipidemia (hypertriglyceridemia and / or low HDL-C). It is characterized by the combination of interrelated metabolic risk factors in the same individual. The specific diagnostic criteria for symptoms in Western medicine and Traditional Chinese Medicine (TCM) are provided in Section 1.2 of Test Example 1.

[0068] The present invention is further described below with reference to specific examples. It should be understood that these examples are only used to illustrate the present invention and are not used to limit the scope of protection of the present invention.

[0069] The following describes the embodiments of the present invention through specific examples. Those skilled in the art will readily understand the other advantages and benefits of the present invention from the disclosure herein. The present invention may also be implemented or applied through various other specific embodiments, and the details in this specification may be modified or altered based on different viewpoints and applications without departing from the spirit of the present invention.

[0070] When numerical ranges are given in the examples, it should be understood that, unless otherwise specified herein, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art.

[0071] Unless otherwise specified, the production processes, experimental methods or detection methods involved in the embodiments and comparative examples of the present invention are conventional methods in the prior art, and their names and / or abbreviations are conventional names in the field and are very clear and unambiguous in the relevant fields of use. Those skilled in the art can understand the conventional process steps based on the names and apply the corresponding equipment to implement them according to conventional conditions or the conditions recommended by the manufacturer.

[0072] The various instruments, equipment, raw materials, or reagents used in the examples of the present invention are not particularly limited in their sources and are all conventional products that can be purchased through regular commercial channels or prepared according to conventional methods well known to those skilled in the art. Unless otherwise specified, the sources of cells, animals, and drugs involved in the examples of the present invention are all commercially available.

[0073] Example 1

[0074] The raw material components of the traditional Chinese medicine composition for treating metabolic syndrome of spleen deficiency and phlegm-dampness type were taken, namely: 15g of Astragalus, 20g of Ganoderma lucidum, 10g of Ligustrum lucidum, 20g of Prunus mume, 10g of Pollen Typhae, 10g of Crataegus pinnatifida, 10g of Alisma orientalis, and 10g of lotus leaf, to obtain traditional Chinese medicine composition sample 1#.

[0075] Example 2

[0076] The raw material components of the traditional Chinese medicine composition for treating metabolic syndrome of spleen deficiency and phlegm-dampness type were taken, namely: 10g of Astragalus, 25g of Ganoderma lucidum, 5g of Ligustrum lucidum, 25g of Prunus mume, 5g of Pollen Typhae, 15g of Crataegus pinnatifida, 5g of Alisma orientalis, and 15g of lotus leaf, to obtain traditional Chinese medicine composition sample 2#.

[0077] Example 3

[0078] The raw material components of the traditional Chinese medicine composition for treating metabolic syndrome of spleen deficiency and phlegm-dampness type were taken, namely: 20g of Astragalus, 15g of Ganoderma lucidum, 15g of Ligustrum lucidum, 15g of Prunus mume, 15g of Pollen Typhae, 5g of Crataegus pinnatifida, 15g of Alisma orientalis, and 5g of lotus leaf, to obtain traditional Chinese medicine composition sample 3#.

[0079] Example 4

[0080] The raw material components of the traditional Chinese medicine composition for treating metabolic syndrome of spleen deficiency and phlegm-dampness type were taken, namely: 12g of Astragalus, 22g of Ganoderma lucidum, 8g of Ligustrum lucidum, 22g of Prunus mume, 8g of Pollen Typhae, 12g of Crataegus pinnatifida, 8g of Alisma orientalis, and 12g of lotus leaf, to obtain traditional Chinese medicine composition sample 4#.

[0081] Example 5

[0082] The raw material components of the traditional Chinese medicine composition for treating metabolic syndrome of spleen deficiency and phlegm-dampness type were taken, namely: 18g of astragalus, 18g of ganoderma lucidum, 22g of glossy privet fruit, 8g of black plum, 12g of pollen cattail, 8g of raw hawthorn, 12g of oriental rhizome, and 8g of lotus leaf, to obtain traditional Chinese medicine composition sample 5#.

[0083] Example 6

[0084] The Chinese medicine composition sample 1# of Example 1 was mixed according to the ratio, and the effective ingredients were extracted by decoction. That is, the mixture was added with water twice and decocted to boiling, each time adding 400 ml of water. The first decoction time was 23 minutes, and the second decoction time was 18 minutes. After evaporation, 200 ml of juice was taken and filtered to obtain the Chinese medicine extract sample 1*.

[0085] Example 7

[0086] The Chinese medicine composition sample 2# of Example 2 was mixed according to the ratio, and the effective ingredients were extracted by the water decoction method, that is, the mixture was added with water twice and decocted to boiling, 420 ml of water was added each time, the first decoction time was 20 minutes, and the second decoction time was 20 minutes. After evaporation, 200 ml of juice was taken and filtered to obtain the Chinese medicine extract sample 2*.

[0087] Example 8

[0088] The Chinese medicine composition sample 3# of Example 3 was mixed according to the ratio, and the effective ingredients were extracted by the water decoction method, that is, the mixture was added with water three times and decocted to boiling, 380 ml of water was added each time, the first decoction time was 25 minutes, and the second decoction time was 15 minutes. After evaporation, 200 ml of juice was taken and filtered to obtain the Chinese medicine extract sample 3*.

[0089] Test Example 1

[0090] 1. Case selection

[0091] 1.1 Patient Condition

[0092] A total of 120 patients with metabolic syndrome of spleen deficiency and phlegm-dampness type who were admitted to the Nanxiang Town community in Jiading District, Shanghai from March 2022 to March 2024 were enrolled. SAS software was used to generate random numbers, and the subjects were divided into an intervention group and a control group according to a randomized ranking scheme, with 60 cases in each group. There were 24 males and 36 females in the control group; their ages ranged from 46 to 70 years, with an average age of (59.90±6.53) years; their disease duration ranged from 0 to 12 years, with an average disease duration of (6.35±3.61) years. There were 27 males and 33 females in the intervention group; their ages ranged from 50 to 70 years, with an average age of (59.58±5.94) years; their disease duration ranged from 1 to 12 years, with an average disease duration of (7.05±3.29) years. Gender of the two groups of patients (χ 2 There were no significant differences between the two groups (P > 0.05) in age (t = 0.307, P = 0.580), age (t = 0.278, P = 0.782), or disease duration (t = -1.111, P = 0.269). The differences were not statistically significant, and the baseline characteristics were well-balanced and comparable. No subjects withdrew from the trial. The study was approved by the Medical Ethics Committee of the Nanxiang Town Community Health Service Center in Jiading District, Shanghai. All patients were informed of the study and signed informed consent.

[0093] 1.2 Diagnostic criteria

[0094] (1) Western medicine diagnostic criteria:

[0095] The guidelines for the prevention and treatment of type 2 diabetes in China (2017 edition) were formulated with reference to the Chinese Medical Association Diabetes Branch: (1) Abdominal obesity (i.e., central obesity): waist circumference ≥90 cm for men and ≥85 cm for women; (2) fasting plasma glucose (FPG) ≥6.1 mmol / L or 2-hour post-glycemic plasma glucose (2hPG) ≥7.8 mmol / L and / or patients diagnosed with diabetes and receiving treatment; (3) blood pressure (BP) ≥130 / 85 mmHg and / or patients diagnosed with hypertension and receiving treatment; (4) triglycerides (TG) ≥1.70 mmol / L; (5) high-density lipoprotein cholesterol (HDL-C) <1.04 mmol / L. Patients who meet three or more of the above criteria are diagnosed.

[0096] (2) Diagnostic criteria for TCM syndrome types: Combined with clinical practice and referring to the diagnostic criteria of the "Routine Diagnosis and Treatment of Traditional Chinese Medicine":

[0097] Spleen deficiency and phlegm-dampness syndrome: Symptoms include abdominal distension, weight gain, shortness of breath, laziness, fatigue, uncomfortable bowel movements, dizziness, palpitations, thick and greasy tongue coating, and a stringy or slippery pulse.

[0098] 1.3 Inclusion criteria

[0099] (1) Meet the diagnostic criteria of Western medicine; (2) Meet the diagnostic criteria of TCM syndrome type; (3) The original treatment plan has not been adjusted within 3 months before enrollment; (4) The subject has given informed consent and signed the informed consent form.

[0100] 1.4 Exclusion criteria

[0101] (1) Severe cardiovascular, hepatic, renal, or ocular complications; (2) Acute complications of diabetes (such as ketoacidosis, hyperosmolar coma, etc.) within the past three months; (3) Stress reactions such as trauma and infection; (4) Combined malignant tumors, tuberculosis, or blood system diseases; (5) History of mental disorders; (6) Long-term use of glucocorticoids; (7) Severe hepatic and renal dysfunction; (8) Pregnant or lactating women; (9) Patients with type 1 diabetes.

[0102] 2. Intervention methods

[0103] (1) Basic intervention: On the basis of maintaining the original treatment plan, health education and related indicator monitoring are carried out.

[0104] (2) Intervention group drug treatment: On the basis of basic treatment, the Chinese herbal extract sample 1* prepared in Example 6 was given, one dose per day, warm and taken on an empty stomach in the morning and evening.

[0105] (3) Control group drug treatment: The following components were administered: 15 g of Astragalus membranaceus, 20 g of Ganoderma lucidum, 10 g of Ligustrum lucidum fruit, and 20 g of Prunus mume. The components were mixed and prepared according to the water decoction extraction conditions described in Example 6 to obtain Chinese herbal medicine extract control sample 1. In addition to the basic treatment, Chinese herbal medicine extract control sample 1 was administered once daily, taken warm on an empty stomach in the morning and evening.

[0106] (4) Treatment course: One course of treatment for both the control group and the intervention group was 12 weeks.

[0107] 3. Observation indicators

[0108] 3.1 Traditional Chinese Medicine Symptom Score

[0109] The TCM symptom scores of the two groups were evaluated with reference to the "Routine Diagnosis and Treatment of Traditional Chinese Medicine" and the "Guiding Principles for Clinical Research of New Chinese Medicines". See Table 1 for details.

[0110] Table 1 TCM symptom scores and evaluation criteria (points)

[0111]

[0112] 3.2 Evaluation of TCM efficacy The TCM symptom score reduction rate was calculated using the nimodipine method with reference to the Guiding Principles for Clinical Research of New Chinese Medicines: [(score before treatment - score after treatment) ÷ score before treatment] × 100%.

[0113] (1) Clinical recovery: symptoms and signs disappear or nearly disappear, with a score reduction of >95%;

[0114] (2) Markedly effective: symptoms are significantly alleviated, with a score reduction of ≥70%;

[0115] (3) Effective: partial relief of symptoms, with a score reduction of ≥30%;

[0116] (4) Ineffective: Symptoms remain unchanged or worsen, and the score decreases by less than 30%.

[0117] 3.3MS component indicators

[0118] 3.3.1 Indicators involved in the five components of the MS diagnostic criteria: (1) waist circumference (WC); (2) glucose metabolism indicators: fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2hPG); (3) blood pressure indicators: systolic blood pressure (SBP), diastolic blood pressure (DBP); (4) triglycerides (TG); (5) high-density lipoprotein cholesterol (HDL-C).

[0119] 3.3.2 Metabolic syndrome reversal rate

[0120] Reversal rate = number of people who no longer meet the diagnosis of metabolic syndrome after treatment / number of people who meet the diagnosis of metabolic syndrome before treatment.

[0121] 3.3.3MS group number:

[0122] The MS diagnostic criteria include 5 components, and the changes in the number of components that meet the MS diagnostic criteria in MS patients before and after treatment were observed.

[0123] 3.3.4 Number of cases meeting the diagnostic requirements for MS for each component:

[0124] The changes in the number of people meeting the five components of MS diagnosis were compared before and after treatment.

[0125] 4. Statistical methods

[0126] SPSS 18.0 statistical software was used for statistical analysis. Mann-Whitney U test was used for rank data, t test was used for measurement data, and χ test was used for constituent ratio. 2 test.

[0127] 5. Results

[0128] 5.1 Traditional Chinese Medicine Symptom Score

[0129] After the treatment, independent sample t-tests showed that the intervention group had significantly lower total scores and scores for abdominal distension, perceived weight gain, constipation, and dizziness compared to the control group (P < 0.01). There were no significant differences in the scores for shortness of breath, laziness, fatigue, and palpitations between the intervention and control groups (P > 0.05). Paired sample t-tests showed that the scores for each item were significantly lower in both the control and intervention groups after treatment (P < 0.01). The results are shown in Table 2. As shown in Table 2, the intervention group improved various symptoms in patients with spleen deficiency and phlegm-dampness-type MS, particularly for perceived weight gain, constipation, and dizziness, which were more pronounced than in the control group.

[0130] Table 2 TCM symptom scores of the two groups before and after treatment (points)

[0131]

[0132]

[0133] Note: Compared with the control group, a P<0.01; compared with the group before treatment, b P<0.01.

[0134] 5.2 Evaluation of the efficacy of traditional Chinese medicine

[0135] After the treatment course, Mann-Whitney U test showed that 25 patients in the intervention group showed significant efficacy, 35 patients showed effective efficacy, and 0 patients showed no efficacy. In the control group, 2 patients showed significant efficacy, 57 patients showed effective efficacy, and 1 patient showed no efficacy. The intervention group had a significantly better efficacy than the control group (P < 0.01). The results are shown in Table 3. As shown in Table 3, the TCM efficacy of the intervention group in treating patients with spleen deficiency and phlegm-dampness-type MS was superior to that of the control group.

[0136] Table 3 TCM efficacy of the two groups before and after treatment [cases (%)]

[0137]

[0138] Note: Compared with the control group, a P<0.01.

[0139] 5.3MS component indicators

[0140] After the treatment, independent sample t-tests showed that WC, 2hPG, SBP, and TG in the intervention group improved more significantly than those in the control group, with statistically significant differences (P < 0.05). There were no statistically significant differences in FPG, DBP, and HDL-C between the intervention and control groups (P > 0.05). Paired sample t-tests showed that WC, FPG, 2hPG, SBP, DBP, and TG in the intervention group decreased significantly compared with those before treatment, with statistically significant differences (P < 0.01), while HDL-C did not change significantly, with no statistically significant differences (P > 0.05). In the control group, WC, FPG, 2hPG, SBP, and TG decreased significantly compared with those before treatment, with statistically significant differences (P < 0.01), but DBP and HDL-C did not change significantly, with no statistically significant differences (P > 0.05). The results are shown in Table 4. As shown in Table 4, the intervention group can improve the WC, FPG, 2hPPG, SBP, DBP, and TG of patients with spleen deficiency and phlegm-dampness type MS, especially the improvement effects of WC, 2hPPG, SBP, and TG are more obvious than those in the control group.

[0141] Table 4 Comparison of MS component indicators between the two groups before and after treatment

[0142]

[0143] Note: Compared with the control group, a P<0.05; compared with the group before treatment, b P<0.01.

[0144] 5.4 Metabolic syndrome reversal rate

[0145] After the treatment, 52 cases in the control group were still in line with the diagnosis of MS, with a reversal rate of 13.33%; 30 cases in the intervention group were still in line with the diagnosis of MS, with a reversal rate of 50.00%. 2 The analysis showed that the difference between the two groups was statistically significant (P < 0.01), as shown in Table 5. As shown in Table 5, 50% of the patients with spleen deficiency and phlegm dampness type MS no longer met the diagnostic criteria for MS (i.e., reversed) after intervention in the intervention group, which was better than the control group.

[0146] Table 5 Comparison of the number of cases diagnosed with MS and the reversal rate between the two groups before and after treatment (cases, %)

[0147]

[0148] Note: Compared with the control group, aP<0.01.

[0149] 5.5MS group number

[0150] After the treatment, 2The Mann-Whitney U test showed that the number of patients with group scores of 3, 2, and 1 in the intervention group was significantly different from that in the control group (P < 0.05). The Mann-Whitney U test showed that both the control and intervention groups had a statistically significant decrease in MS group scores (P < 0.01). The results are shown in Table 6. As shown in Table 6, the MS group scores of patients with spleen deficiency and phlegm-dampness-type MS decreased after treatment in the intervention group, with a significant decrease compared to the control group. This result only reflects the overall downward trend in group scores after treatment. The specific increase in the number of patients meeting the target in each group is further demonstrated in Table 7 through in-depth data analysis.

[0151] Table 6 Comparison of group numbers before and after treatment in the two groups (cases)

[0152]

[0153] Note: Compared with the control group, aP<0.05, aaP<0.01; compared with this group before treatment, bP<0.01.

[0154] 5.6 Number of cases meeting the diagnostic requirements for MS for each component

[0155] After the treatment, 2 Test, the number of waist circumference and TG components in the intervention group that met the diagnosis of MS was less than that in the control group, and the difference was statistically significant (P < 0.01); the number of HDL-C, blood pressure, and blood sugar components that met the diagnosis of MS was not statistically significant compared with the control group (P > 0.05). The number of TG components in the intervention group that met the diagnosis of MS was less than that before treatment, and the difference was statistically significant (P < 0.01); the other components had no statistically significant differences compared with before treatment (P > 0.05). The number of waist circumference components, TG components, and HDL-C components in the treatment group that met the diagnosis of MS was less than that before treatment, and the difference was statistically significant (P < 0.01); the other components had no statistically significant differences compared with before treatment (P > 0.05). The results are shown in Table 7, Figure 1 From Table 7, Figure 1 It can be seen that after the intervention, the number of patients with spleen deficiency and phlegm dampness-type MS who met the diagnostic requirements for waist circumference, TG, and HDL-C components decreased, that is, the number of people who met the standards increased. In particular, the improvement in waist circumference and TG components was better than that in the control group. Figure 1 The number of cases that meet the diagnostic requirements of MS in each component is reduced = the number of cases that meet the diagnostic requirements of MS before treatment - the number of cases that meet the diagnostic requirements of MS after treatment.

[0156] Table 7 Comparison of the number of cases meeting the diagnostic requirements of MS in each component between the two groups before and after treatment (cases)

[0157]

[0158] Note: Compared with the control group, aP<0.01; compared with this group before treatment, bP<0.05, bbP<0.01.

[0159] 6. Conclusion

[0160] The above experimental results show that the number of patients with 1-2 components after treatment in the intervention group increased significantly compared to the control group, demonstrating the overall metabolic regulation advantages of this traditional Chinese medicine composition. This "quantitative change to qualitative change" transformation is also fully reflected in the significant increase in the reversal rate of MS. This traditional Chinese medicine composition not only improves glucose metabolism but also regulates lipid metabolism.

[0161] Specifically, through the synergistic effects of drugs, the core pathogenesis of phlegm-dampness stagnation is directly addressed. For example, raw hawthorn can regulate Tbx21 and Gata3 factors, thereby affecting the differentiation of Th1 and Th2 cells and improving TC, TG, HDL-C, and LDL-C levels. The triterpenoids in Alisma can lower total cholesterol levels by inhibiting the activity of 3-hydroxy-3-methylglycosyl-CoA reductase. The nuciferine component in lotus leaves can regulate lipid metabolism through multi-level interactions with lipids, cells, and proteins.

[0162] In the above test case, the total score of TCM symptoms and the scores of abdominal distension, perceived weight gain, uncomfortable bowel movements, and dizziness in the intervention group were significantly lower than those in the control group. The TG level in the intervention group was further reduced compared with the control group, and the waist circumference improved more significantly. Figure 1 The intervention group significantly outperformed the control group in improving comprehensive metabolic indicators in patients with spleen deficiency and phlegm-dampness-type MS, particularly in regulating lipid metabolism disorders and central obesity. This suggests that the modified herbal formula synergistically reduces visceral fat accumulation through multiple pathways, consistent with the mechanism of lipid metabolism regulation observed in clinical studies using natural herbal formulas.

[0163] The intervention group strengthened its ability to resolve phlegm and address the symptoms. Hawthorn's inhibitory effect on α-glucosidase can delay carbohydrate absorption, explaining the lack of difference in fasting blood glucose between the two groups in this study, but the more significant improvement in blood glucose two hours after a meal in the intervention group. This combination of "treating both the symptoms and the root cause" specifically addresses the critical issue of excessive postprandial metabolic load in patients with spleen deficiency and phlegm-dampness syndrome.

[0164] The intervention group was given drugs that promote blood circulation and dredge collaterals to assist in metabolic regulation, reflecting the concept of preventing disease before it occurs in traditional Chinese medicine. Pollen pollen improves blood rheology by regulating blood lipid metabolism and has a protective effect on vascular endothelial damage.

[16] Total flavonoids from Pollen Typhae can inhibit fatty acid-induced insulin resistance. The reduction in systolic blood pressure in the intervention group was significantly greater than that in the control group, possibly due to the antihypertensive effects of flavonoids and quercetin in Pollen Typhae.

[0165] The intervention group showed no statistically significant difference in HDL-C improvement, which may be related to the shorter observation period and the gradual nature of TCM lipid-lowering. However, analysis of the HDL-C component revealed that significantly fewer patients in the intervention group met the diagnostic criteria for MS after treatment compared to before treatment. This discrepancy stems primarily from the fact that the diagnostic criteria for MS define HDL-C as <1.04 mmol / L. While this improvement did not reach statistical significance, it may have allowed some patients to move from below the critical value to the normal range, thus escaping the MS diagnosis.

[0166] Furthermore, while both groups showed improvement in blood sugar and blood pressure after treatment (Table 4), the number of individuals meeting the MS diagnosis criteria for both blood pressure and blood sugar components in Table 7 did not decrease significantly after treatment. This is because the diagnostic criteria include patients with a history of hypertension and diabetes as meeting these criteria. For example, even if a patient's blood sugar and blood pressure return to normal, if they have been diagnosed with hypertension or diabetes, they will still be included in the corresponding MS diagnosis components in Table 7.

[0167] As can be seen in test case 1, the intervention group had a better therapeutic effect than the control group (P < 0.01). The intervention group showed more significant improvements in the total score of TCM symptoms and abdominal distension, perceived weight gain, constipation, and dizziness (P < 0.01). The MS reversal rate in the intervention group was higher than that in the control group (P < 0.01). The number of cases with group scores of 3, 2, and 1 in the intervention group was significantly different from that in the control group (P < 0.05). The number of people in the intervention group who met the MS diagnosis in waist circumference and TG components was lower than that in the control group (P < 0.01). The intervention group also showed more significant improvements in WC, 2hPG, SBP, and TG (P < 0.05).

[0168] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form or substance. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention. Any equivalent changes, modifications and evolutions made by technicians familiar with this profession without departing from the spirit and scope of the present invention by using the technical content disclosed above are all equivalent embodiments of the present invention; at the same time, any equivalent changes, modifications and evolutions made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition comprising the following raw materials, in parts by weight: 5-30 parts by weight of Astragalus root; 10-30 parts by weight of Ganoderma lucidum; 1-20 parts by weight of Ligustrum lucidum fruit; 10-30 parts by weight of black plum; 1-20 parts by weight of Typhae Pollen; 1-20 parts by weight of raw hawthorn; 1-20 parts by weight of Rhizoma Alismatis; 1-20 parts by weight of lotus leaves.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition comprises the following raw materials in parts by weight: 10-20 parts of Astragalus; 15-25 servings of Ganoderma lucidum; 5-15 parts of Ligustrum lucidum fruit; 15-25 servings of black plums; 5-15 parts of Typhae Pollen; 5-15 servings of raw hawthorn; 5-15 parts of Alisma orientalis; 5-15 lotus leaves.

3. A Chinese medicine extract, obtained by extracting the Chinese medicine composition according to any one of claims 1-2 as raw material.

4. A method for preparing a Chinese medicine extract, comprising: The raw material components of the Chinese medicine composition according to any one of claims 1-2 are mixed according to the proportion, and the obtained mixture is extracted by decoction.

5. The method for preparing the Chinese herbal extract according to claim 4, wherein The water-adding decoction method comprises: adding water to the mixture at least once for decoction, evaporating the mixture, and filtering the mixture to provide the Chinese medicine extract.

6. The method for preparing the Chinese herbal medicine extract according to claim 5, wherein The ratio of the mass of the mixture added to the volume of water added each time is 30-190:350-450, g / mL; and / or the ratio of the volume of the juice taken after evaporation to the volume of water added each time is 1:1.8-2.

2.

7. The method for preparing the Chinese herbal medicine extract according to claim 5, wherein Includes any one or more of the following conditions: 1) The water is added 1-3 times; 2) boiling; 3) The time for decocting each time by adding water is 10-45 minutes.

8. The method for preparing the Chinese herbal medicine extract according to claim 7, wherein: When the water is added twice, the first boiling time is 20-25 minutes, and the second boiling time is 15-20 minutes.

9. A traditional Chinese medicine preparation comprising a therapeutically effective amount of the traditional Chinese medicine composition according to any one of claims 1-2, or a therapeutically effective amount of the traditional Chinese medicine extract according to claim 3, and one or more conventional pharmaceutically acceptable excipients.

10. Use of the Chinese medicine composition according to any one of claims 1-2, the Chinese medicine extract according to claim 3, or the Chinese medicine preparation according to claim 9 in the preparation of a medicament for treating metabolic syndrome of spleen deficiency and phlegm-dampness type.

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