Traditional Chinese medicine compound composition for secondary prevention of atherosclerosis and preparation method thereof

Abstract

The invention belongs to a traditional Chinese medicine compound composition for secondary prevention of atherosclerosis and a preparation method of the traditional Chinese medicine compound composition. The traditional Chinese medicine compound composition has the effects of promoting diuresis, tonifying spleen, reducing phlegm and eliminating turbidity. The health-care tea comprises the following components in parts by mass: 20-40 parts of lotus leaves, 20-40 parts of corn stigma, 10-30 parts of poria cocos, 10-30 parts of dried orange peel, 10-30 parts of haws, 5-20 parts of flatstem milkvetch seeds and 5-20 parts of cassia seeds. The extract prepared from the mixture by a specific method is prepared into a tea bag or extract, so that risk factors of atherosclerotic cardiovascular diseases of atherosclerotic patients in the middle and lower reaches of Yangtze River can be effectively reduced, and the tea bag or extract has a remarkable prevention effect on occurrence of the cardiovascular and cerebrovascular diseases of the atherosclerotic patients in the area. And a new thought and a new method of traditional Chinese medicine supplementary treatment are provided for atherosclerosis patients with aspirin and statins intolerance or obvious side effects.

Description

Technical Field

[0001] The invention relates to the technical field of Chinese medicinal compound compositions, and more particularly to a Chinese medicinal compound composition for treating secondary prevention of atherosclerosis and a preparation method thereof. Technical Background

[0002] Atherosclerosis (As) is a common chronic inflammatory vascular disease that destroys the vascular endothelial structure in segments and forms atherosclerotic plaques, which eventually leads to an increase in the incidence of coronary heart disease, stroke, and major adverse cardiovascular events (MACE), and is the main cause of death and disability in humans. According to the data from the "China Cardiovascular Report 2017", the current number of AS patients in my country is estimated to be 290 million, including 13 million strokes and 11 million coronary heart disease, which is the leading cause of death among Chinese residents. However, as an economically developed and rich medical resource reserve and distribution region in the middle and lower reaches of the Yangtze River, the incidence of AS-related cardiovascular and cerebrovascular diseases ranks among the highest in my country. This data is still rising with the aging of the local population and changes in dietary structure, which will be a huge challenge that my country needs to face in the process of realizing the Healthy China strategy. my country's "Expert Consensus on the Prevention and Treatment of Atherosclerosis with Traditional Chinese and Western Medicine" (2021 Edition) emphasizes the primary position of anti-plate and lipid regulation. However, according to real-world research data, bleeding events and gastrointestinal reactions caused by antiplatelet therapy, and abnormal liver function and myalgia caused by statins limit their application in clinical treatment and are the main reasons for poor compliance and even drug discontinuation in the secondary prevention of AS patients.

[0003] Secondary prevention is to prevent the preclinical or early clinical changes of the disease through early detection and diagnosis of the disease and appropriate treatment. It can detect and treat the disease at an early stage, avoid or reduce the occurrence of complications, sequelae and disability, or shorten the time of disability. Secondary prevention of atherosclerosis (As) is the management of risk factors for atherosclerotic cardiovascular disease (ASCVD) after atherosclerotic plaques have been formed, which is similar to the idea of ​​"preventing changes after the disease is already ill" in traditional Chinese medicine. "Suwen·Yin Yang Ying Xiang Da Lun" says: "The east produces wind", "the south produces heat", "the west produces dryness", "the north produces cold", and "the center produces dampness". It can be seen that the differences in climate in different places will also lead to differences in the occurrence of diseases. The middle and lower reaches of the Yangtze River are hot and rainy in summer and autumn, and cold and humid in winter and spring, so patients in this area are prone to long-term immersion in exogenous dampness. At the same time, humid climate is not only a meteorological condition, but also affects the lifestyle and living conditions of local people. Most of the middle and lower reaches of the Yangtze River are located along the coast or adjacent to lakes. Local residents consume more fish, shrimp and meat, resulting in excessive cholesterol and purine intake. Moreover, the winter in this region is colder and longer than that in the southern coastal areas, and the means of keeping warm are limited, making outdoor sports inconvenient. In addition, the elderly people's awareness of disease prevention, treatment and health care is still relatively weak, which objectively creates favorable conditions for the invasion of external dampness and the breeding of internal dampness. "Dampness is the source of all diseases." The elderly and weak have insufficient positive energy and cannot resist dampness externally. In addition, overeating fatty and greasy foods can easily generate dampness internally, making this region a "severely affected area" for cardiovascular and cerebrovascular diseases. Studies have shown that long-term exposure to a humid environment will cause varying degrees of mitochondrial ultrastructural damage, which will in turn reduce the activity of Na+-K+-ATPase and reduce energy metabolism efficiency. By analogy, the "Qi" in traditional Chinese medicine is similar to the function of mitochondria. Long-term internal and external accumulation of dampness can lead to abnormal mitochondrial energy metabolism and the inability to produce "Qi", resulting in qi blockage, stagnation of body fluids, accumulation of dampness to produce phlegm, phlegm blocking the blood vessels, and poor meridians, which will form visible AS lesions. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine compound composition for the secondary prevention of atherosclerosis and a preparation method thereof, which has the effect of reducing the risk factors of atherosclerotic cardiovascular disease in patients with atherosclerosis in the middle and lower reaches of the Yangtze River, preventing the occurrence of cardiovascular and cerebrovascular diseases in such patients, and has the effects of promoting dampness and strengthening the spleen, and resolving phlegm and turbidity. To achieve the above purpose, the technical scheme of the present invention is as follows:

[0005] A Chinese medicinal compound composition for treating secondary prevention of atherosclerosis, comprising the following components in parts by mass:

[0006] 20-40 parts of lotus leaves, 20-40 parts of corn silk, 10-30 parts of Poria cocos, 10-30 parts of dried tangerine peel, 10-30 parts of hawthorn, 5-20 parts of Astragalus membranaceus seeds, and 5-20 parts of Cassia seeds.

[0007] Furthermore, a Chinese medicinal compound composition for treating secondary prevention of atherosclerosis comprises the following ingredients:

[0008] 25-30 parts of lotus leaves, 25-30 parts of corn silk, 15-20 parts of Poria cocos, 15-20 parts of dried tangerine peel, 15-20 parts of hawthorn, 5-10 parts of Astragalus membranaceus seeds, and 5-10 parts of Cassia seed.

[0009] A method for preparing a tea bag of a Chinese medicinal compound composition for secondary prevention of atherosclerosis comprises the following steps: taking lotus leaves, corn silk, poria, tangerine peel, hawthorn, astragalus, and cassia seed according to the above mass fractions, crushing and mixing them into a tea bag.

[0010] A method for preparing a Chinese medicine compound extract for treating secondary prevention of atherosclerosis comprises the following steps:

[0011] According to the above-mentioned mass fractions, lotus leaf, corn silk, Poria cocos, tangerine peel, hawthorn, Astragalus membranaceus seed, and Cassia seed are added with 5 times the weight volume of water, decocted twice, each time for 2 hours, the decoctions are combined, filtered, 80% volume concentration of ethanol is added, allowed to stand, filtered, the filtrate is recovered and concentrated at 60°C to a relative density of 1.36 to obtain an extract.

[0012] The beneficial effects of the present invention are:

[0013] The present invention discloses a Chinese medicine compound composition for secondary prevention and auxiliary treatment of atherosclerosis. The disease belongs to the syndrome of deficiency and excess, deficiency is the root of the disease, phlegm, dampness and blood stasis are the symptoms of the disease, deficiency can produce excess, excess can cause deficiency, and the transformation of deficiency and excess forms a vicious cycle. In addition, the disorder of qi, blood and body fluids, and dysfunction of viscera finally show the pathogenesis of a complicated pathological state. The prescription is composed of lotus leaf, corn silk, Poria cocos, tangerine peel, hawthorn, Astragalus membranaceus, and Cassia seed. The lotus leaf in the prescription is fragrant and light in quality, floating and dispersing, and has the functions of supplementing spleen yang, promoting dampness and resolving phlegm; corn silk is light in taste and flat in nature, mainly promoting dampness and reducing swelling, and the two are the main drugs in the prescription. Modern pharmacological studies have shown that lotus leaf extract has lipid-lowering, anti-oxidation and antihypertensive effects, and corn silk extract also has certain curative effects in anti-platelet, antihypertensive and uric acid-lowering aspects. Poria cocos promotes water, strengthens the spleen and penetrates dampness, and further consolidates the function of the main drug to eliminate dampness, and is the minister drug in the prescription. Tangerine peel regulates qi and strengthens the spleen, dries dampness and resolves phlegm, hawthorn helps digestion and strengthens the stomach, and promotes qi and disperses blood stasis. The two are adjuvants. Cassia seed clears heat and moistens the intestines, and Astragalus membranaceus is neither dry nor strong, but is sweet, warm, and astringent. The two are astringent and astringent. The whole prescription is used together to achieve the functions of removing dampness and strengthening the spleen, resolving phlegm and eliminating turbidity. This prescription can effectively reduce the risk factors of atherosclerotic cardiovascular disease in patients with atherosclerosis in the middle and lower reaches of the Yangtze River, and has a significant preventive effect on the occurrence of cardiovascular and cerebrovascular diseases in patients with AS in this area. At the same time, the Chinese medicine paste and Chinese medicine tea bags prepared by this prescription are easy to carry and not easy to volatilize, which is convenient for long-term storage. Specific implementation plan

[0014] The present invention is used for secondary prevention and auxiliary treatment of patients with atherosclerosis with spleen deficiency and dampness excess syndrome. The clinical manifestations of patients with this disease are fatigue, loose stools, abdominal distension, poor appetite, nausea and vomiting. X-ray, ultrasound and arteriography reveal vascular stenosis or dilation lesions.

[0015] The present invention provides a Chinese medicinal compound composition for treating secondary prevention of atherosclerosis, which is composed of the following components in parts by mass:

[0016] 20-40 parts of lotus leaves, 20-40 parts of corn silk, 10-30 parts of Poria cocos, 10-30 parts of dried tangerine peel, 10-30 parts of hawthorn, 5-20 parts of Astragalus membranaceus seeds, and 5-20 parts of Cassia seeds.

[0017] Furthermore, a Chinese medicinal compound composition for treating secondary prevention of atherosclerosis comprises the following ingredients:

[0018] 25-30 parts of lotus leaves, 25-30 parts of corn silk, 15-20 parts of Poria cocos, 15-20 parts of dried tangerine peel, 15-20 parts of hawthorn, 5-10 parts of Astragalus membranaceus seeds, and 5-10 parts of Cassia seed.

[0019] The preparation method of the above-mentioned Chinese medicine compound composition for treating secondary prevention of atherosclerosis comprises the following steps:

[0020] According to the above-mentioned mass fractions, lotus leaf, corn silk, Poria cocos, tangerine peel, hawthorn, Astragalus membranaceus seed, and Cassia seed are added with 5 times the weight volume of water, decocted twice, each time for 2 hours, the decoctions are combined, filtered, 80% volume concentration of ethanol is added, allowed to stand, filtered, the filtrate is recovered and concentrated at 60°C to a relative density of 1.36 to obtain an extract.

[0021] The clinical effect of the Chinese herbal compound composition for secondary prevention of atherosclerosis of the present invention is illustrated below through clinical trial examples.

[0022] Clinical data:

[0023] Research subjects: From September 2022 to September 2023, 60 patients with inpatient atherosclerosis in the Department of Cardiology, Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine were selected. Inclusion criteria: The diagnosis was in accordance with the diagnostic criteria for atherosclerosis in the "Expert Consensus on the Prevention and Treatment of Atherosclerosis by Traditional Chinese and Western Medicine (2021 Edition)". The patients were randomly divided into a treatment group and a control group, with 30 cases in each group. The control group was treated with conventional Western medicine (atorvastatin 20 mg 1 / day, aspirin 100 mg 1 / day), and the Chinese medicine group was treated with the Chinese medicine compound composition of the present invention on the basis of conventional Western medicine treatment. The treatment course for both groups was 8 weeks. After the treatment, the changes in blood lipids, blood sugar, uric acid, TCM syndrome scores, and safety indicators of the two groups were statistically compared and analyzed to evaluate their efficacy and safety. There was no significant statistical difference in age, gender, and underlying diseases between the two groups of patients (P>0.05).

[0024] Inclusion criteria: (1) Those who meet the Western medical diagnostic criteria for atherosclerosis; (2) Those who meet the TCM syndrome of spleen deficiency and dampness excess; (3) Aged 18-75 years old, regardless of gender; (4) Voluntary participation and signing of the informed consent form.

[0025] Exclusion criteria: (1) patients with severe cardiovascular and cerebrovascular events within the past 6 months; (2) patients with severe liver and kidney damage; (3) pregnant or lactating women and those with allergic constitution or previous allergies to multiple drugs, or those who are allergic to the ingredients in the study drugs.

[0026] result

[0027] 1. Safety indicators

[0028] There was no significant statistical difference in liver and kidney function between the Chinese medicine group and the control group after treatment (P>0.05), and there was no significant statistical difference in liver and kidney function between the Chinese medicine group and before and after treatment (P>0.05). The results show that the present invention has no significant effect on the liver and kidney function of patients. See Table 1 and Table 2.

[0029] Table 1 Safety observation indexes of patients in the two groups after treatment

[0030]

[0031] Table 2 Safety indicators of patients in the Chinese medicine group before and after treatment

[0032]

[0033] 2. Efficacy indicators

[0034] After treatment, the low-density lipoprotein, triglyceride, uric acid, 2-hour postprandial blood glucose, BMI, and TCM syndrome score of the TCM group were significantly lower than those of the control group (P < 0.05). The TCM syndrome score of the TCM group was significantly lower than that of the control group (P < 0.05). See Table 3, Table 4, and Table 5.

[0035] Table 3 Efficacy indexes of the two groups of patients after treatment (1)

[0036]

[0037] Table 4 Efficacy indexes of the two groups of patients after treatment (2)

[0038]

[0039] Table 5 Efficacy indicators of patients in the treatment group before and after treatment

[0040]

[0041]

[0042] 3. Overall comparison of clinical efficacy of TCM syndromes between the two groups of patients

[0043] The clinical efficacy level was evaluated according to the TCM syndrome scores of the two groups of patients and compared using the chi-square test. It was finally found that the clinical efficacy of TCM syndrome in the TCM group was significantly better than that in the control group (P < 0.05). See Table 6 for details.

[0044] Table 6 Clinical efficacy of TCM syndromes in two groups of patients

[0045]

[0046] Typical medical cases

[0047] Case 1: Zhang, male, 61 years old. Date of first visit: January 16, 2023. Main complaint: fatigue and dizziness for 1 month. The patient has been feeling fatigued and weak for the past month, with occasional dizziness, a sense of fullness after meals, and 2-3 bowel movements per day, which are watery and unformed. Color Doppler ultrasound of the neck vessels in the outpatient clinic showed: atherosclerosis of the internal carotid artery. Triglycerides 3.39mmol / l. Because the patient had a history of chronic renal insufficiency and refused to take Liping's lipid-lowering treatment, the triglyceride level was 1.17mmol / l after taking this Chinese medicine compound decoction for 2 months. The patient's fatigue, dizziness, and fullness after meals were significantly reduced, and the symptoms of loose stools disappeared.

[0048] Case 2: Xu, female, 46 years old. Date of first visit: December 25, 2022. Chief complaint: dizziness for more than 2 months. The patient has had dizziness and discomfort in the past 2 months, mostly after eating greasy food, accompanied by nausea and vomiting. A cranial CT scan at the outpatient clinic showed: mild cerebral ischemia. Triglycerides were 3.58mmol / l. After taking one tablet of Liping orally daily for 1 month, the triglycerides were 2.52mmol / l during a recheck. The symptoms of dizziness and nausea did not improve significantly, and the liver function test was higher than before taking the medicine. I stopped taking Liping and changed to this Chinese medicine compound decoction. After taking it for 4 weeks, the triglycerides were 1.18mmol / l. The patient's dizziness and nausea symptoms were significantly alleviated, and the liver function test returned to normal. Conclusion

[0049] With the increasing awareness of preventive health care and the deepening of people's understanding of traditional Chinese medicine, the use of traditional Chinese medicine "ancient" prescriptions to "treat" modern diseases has become a trend of reform in the Chinese medicine industry. This prescription adheres to the method of "preventing changes after the disease occurs" and follows the principle of "adapting to the time, place and person". It accurately locates patients with spleen deficiency and dampness-excess type atherosclerosis in the middle and lower reaches of the Yangtze River, abandons the traditional "blood circulation and stasis" treatment method, and takes a different approach to use the "dampness-removing and spleen-strengthening" theory to treat atherosclerosis for secondary prevention. The effective ingredients of this prescription are concentrated using modern technology. The Chinese medicine paste made is easy to carry, simple to take, and has significant effects. It will interpret a new method of secondary prevention of atherosclerosis in Chinese medicine, produce great social and economic benefits, and lead the Chinese medicine industry into the next generation.

Claims

1. A Chinese medicinal compound composition for the secondary prevention of atherosclerosis, comprising the following components by mass: 20-40 parts of lotus leaves, 20-40 parts of corn silk, 10-30 parts of Poria cocos, 10-30 parts of dried tangerine peel, 10-30 parts of hawthorn, 5-20 parts of Astragalus membranaceus seeds, and 5-20 parts of Cassia seeds.

2. A Chinese medicinal compound composition for treating secondary prevention of atherosclerosis according to claim 1, characterized in that: 25-30 parts of lotus leaves, 25-30 parts of corn silk, 15-20 parts of Poria cocos, 15-20 parts of dried tangerine peel, 15-20 parts of hawthorn, 5-10 parts of Astragalus membranaceus seeds, and 5-10 parts of Cassia seed.

3. A method for preparing a Chinese medicine compound composition for treating secondary prevention of atherosclerosis as claimed in claim 1 or 2, wherein the specific steps are to take the raw materials lotus leaf, corn silk, Poria cocos, tangerine peel, hawthorn, Astragalus complanatus, and Cassia seed according to the above-mentioned mass fractions, and then grind and mix them into tea bags.

4. A method for preparing a Chinese medicinal compound composition for treating secondary prevention of atherosclerosis as claimed in claim 1 or 2, comprising the following steps: According to the above-mentioned mass fractions, lotus leaf, corn silk, Poria cocos, tangerine peel, hawthorn, Astragalus membranaceus seed, and Cassia seed are added with 5 times the weight volume of water, decocted twice, each time for 2 hours, the decoctions are combined, filtered, 80% volume concentration of ethanol is added, allowed to stand, filtered, the filtrate is recovered and concentrated at 60°C to a relative density of 1.36 to obtain an extract.

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