Traditional Chinese medicine composition for treating hyperlipemia

Abstract

The invention relates to a traditional Chinese medicine composition for treating hyperlipemia, which can effectively solve the medication problem of hyperlipemia. The traditional Chinese medicine composition is prepared from, by weight, 15-25 g of lotus leaves, 13-23 g of rhizoma alismatis, 6-12 g of flos carthami, 6-12 g of peach kernels, 4-8 g of poria cocos, 4-8 g of rhizoma atractylodis macrocephalae, 4-8 g of agastache rugosus, 4-8 g of herba eupatorii, 8-16 g of pinellia ternate, 8-16 g of gynostemma pentaphyllum, 8-16 g of semen cassiae, 6-12 g of ligusticum wallichii and 4-8 g of scutellaria baicalensis. The traditional Chinese medicine composition for treating hyperlipemia has the advantages that the effect of treating hyperlipemia with intermingled phlegm and blood stasis is obvious, the hyperlipemia can be effectively improved, the medication is safe, no obvious adverse reaction exists, and the traditional Chinese medicine composition is an innovation of hyperlipemia treatment medicines.

Description

1. Technical Field

[0001] The invention relates to the field of medicine, in particular to a traditional Chinese medicine composition for treating hyperlipidemia. 2. Background Technology

[0002] Hyperlipidemia is a common clinical disease and an important cause of the development of early atherosclerosis in cardiovascular and cerebrovascular events. Hyperlipidemia is closely related to the onset of coronary heart disease and cerebrovascular disease. The current drug treatment for hyperlipidemia is not ideal, the total effective rate needs to be improved, and there are many side effects. Finding effective drugs with fewer side effects to treat hyperlipidemia is the focus and difficulty of current research.

[0003] Hyperlipidemia belongs to the category of "phlegm syndrome", "deficiency", "chest obstruction" and "vertigo" in traditional Chinese medicine. Common clinical symptoms include chest tightness, irritability, abdominal distension, poor appetite, fatigue, dizziness, etc., which are mostly caused by the accumulation of fat in the body, the aggravation of dampness and phlegm, the damage of viscera function, the dysfunction of viscera, and the obstruction of qi and blood circulation, thus forming hyperlipidemia. Traditional Chinese medicine has unique advantages such as multiple pathways, multiple targets and few side effects, which can significantly improve the symptoms and progression of hyperlipidemia. Under the guidance of traditional Chinese medicine theory, the application research of innovative Chinese medicine combination in the treatment of hyperlipidemia with phlegm and blood stasis syndrome has important medical, life science and sociological significance. III. Summary of the invention

[0004] In view of the above situation, in order to solve the defects of the prior art, the purpose of the present invention is to provide a Chinese medicine composition for treating hyperlipidemia, which can effectively solve the problem of medication for hyperlipidemia.

[0005] The technical solution solved by the present invention is that the traditional Chinese medicine composition is prepared from the following raw materials by weight: 15-25g of lotus leaf, 13-23g of oriental rhizome, 6-12g of safflower, 6-12g of peach kernel, 4-8g of tuckahoe, 4-8g of atractylodes macrocephala, 4-8g of patchouli, 4-8g of perilla, 8-16g of pinellia tuber, 8-16g of gynostemma pentaphyllum, 8-16g of cassia seed, 6-12g of ligusticum chuanxiong and 4-8g of scutellaria baicalensis, the raw materials are mixed together, soaked in water and decocted twice, 8 times the total weight of the raw materials are added for the first time, decocted for 1h to obtain the first decoction, 6 times the total weight of the raw materials are added for the second time, decocted for 0.5h to obtain the second decoction, the two decoctions are combined, filtered, and concentrated to 1 / 4-1 / 6 of the amount of water added to obtain the composition.

[0006] The invention has abundant raw materials, a simple preparation method, is easy to produce, and is convenient to take. It has the effects of clearing away heat and dampness, removing turbidity and lowering lipids. It has obvious effects in treating hyperlipidemia and phlegm and blood stasis syndrome, can effectively improve hyperlipidemia, is safe to use, and has no obvious adverse reactions. It is an innovation in drugs for treating hyperlipidemia. 4. Specific implementation methods

[0007] The specific implementation modes of the present invention are further described in detail below in conjunction with the embodiments.

[0008] Example 1

[0009] In a specific implementation of the present invention, the raw materials can be prepared from the following raw materials by weight: 15g of lotus leaf, 13g of oriental rhizome, 6g of safflower, 6g of peach kernel, 4g of poria, 4g of atractylodes macrocephala, 4g of patchouli, 4g of eupatorium, 8g of pinellia, 8g of gynostemma pentaphyllum, 8g of cassia seed, 6g of ligusticum chuanxiong and 4g of scutellaria baicalensis. The raw materials are mixed together, soaked in water and decocted twice, 8 times the total weight of the raw materials are added for the first time, decocted for 1h to obtain the first decoction, 6 times the total weight of the raw materials are added for the second time, decocted for 0.5h to obtain the second decoction, the two decoctions are combined, filtered, and concentrated to 1 / 4 of the amount of water added to obtain the product.

[0010] Example 2

[0011] In a specific implementation of the present invention, the present invention can also be prepared from the following raw materials by weight: 20g of lotus leaf, 18g of oriental rhizome, 9g of safflower, 9g of peach kernel, 6g of poria, 6g of atractylodes macrocephala, 6g of patchouli, 6g of ephedra sinica, 12g of pinellia tuber, 12g of gynostemma pentaphyllum, 12g of cassia seed, 9g of ligusticum chuanxiong and 6g of scutellaria baicalensis. The above raw materials are mixed together, soaked in water and decocted twice. For the first time, 8 times the total weight of the raw materials are added for decoction, and 1 hour is decoctioned to obtain the first decoction. For the second time, 6 times the total weight of the raw materials are added for decoction, and 0.5 hour is decoctioned to obtain the second decoction. The two decoctions are combined, filtered, and concentrated to 1 / 5 of the amount of water added.

[0012] Example 3

[0013] In a specific implementation of the present invention, the present invention can also be prepared from the following raw materials by weight: 25g of lotus leaf, 23g of oriental rhizome, 12g of safflower, 12g of peach kernel, 8g of Poria, 8g of Atractylodes macrocephala, 8g of Patchouli, 8g of Perilla frutescens, 16g of Pinellia ternata, 16g of Gynostemma pentaphyllum, 16g of Cassia seed, 12g of Ligusticum chuanxiong and 8g of Scutellaria baicalensis. The above raw materials are mixed together, soaked in water and decocted twice. For the first time, 8 times the total weight of the raw materials are added, decocted for 1 hour to obtain the first decoction. For the second time, 6 times the total weight of the raw materials are added, decocted for 0.5 hour to obtain the second decoction. The two decoctions are combined, filtered, and concentrated to 1 / 6 of the amount of water added.

[0014] In the prescription of the present invention, lotus leaf and orientalis rhizome can clear away heat and dampness, remove turbidity and reduce fat as the main medicine, safflower and peach kernel can promote blood circulation and remove blood stasis as the minister, Poria cocos and Atractylodes macrocephala can invigorate the spleen and replenish qi, dry dampness and promote diuresis, Patchouli and Perilla frutescens can aromatically remove dampness, Pinellia tuber can dry dampness and resolve phlegm, Gynostemma pentaphyllum can enter the lungs and remove phlegm, Cassia seed can moisten the intestines and relieve constipation, so that the phlegm heat of the lungs can be discharged from the intestines and viscera, and the dampness and turbidity can be removed, Scutellaria baicalensis can clear away heat but not allow the heat evil to burn the body fluids to form phlegm, Chuanxiong can disperse qi and promote qi circulation and lead the medicine into the Jueyin meridian, all the medicines are used together to clear away heat and dampness, remove phlegm and remove turbidity, and play the effect of reducing fat. The Chinese medicine composition has the effects of clearing heat and dampness, removing turbidity and reducing fat, is effectively used for the syndrome of phlegm and blood stasis in hyperlipidemia, and has achieved satisfactory results through clinical trials. The relevant test data are as follows:

[0015] 1. Clinical efficacy observation data

[0016] 1. Purpose of the experiment: To explore the effectiveness and safety of Chinese medicine combination in treating hyperlipidemia (phlegm and blood stasis syndrome).

[0017] 2. Experimental design: randomized, double-blind, controlled trial.

[0018] 3. Subject population

[0019] (1) Inclusion criteria:

[0020] ①18 years old ≤ ≤ 80 years old.

[0021] ② Meet the diagnostic criteria for hyperlipidemia in Western medicine. According to the Diagnostic Criteria for Hyperlipidemia in the Chinese Adult Dyslipidemia Prevention and Treatment Guidelines, under normal dietary conditions, blood lipid tests after fasting for 12 to 14 hours meet one of the following four items: ① TC ≥ 5.2 mmol / L (200 mg / dL); ② TG ≥ 1.70 mmol / L (150 mg / dL); ③ LDL-C ≥ 3.4 mmol / L (130 mg / dL); ④ HDL-C ≤ 1.0 mmol / L (40 mg / dL).

[0022] ③ Meet the diagnostic criteria of hyperlipidemia (phlegm and blood stasis syndrome) in traditional Chinese medicine, refer to the "Guidelines for Clinical Research of New Chinese Medicines", main symptoms: chest tightness; secondary symptoms: irritability, abdominal distension, poor appetite, fatigue, dizziness, dark tongue or ecchymosis, white greasy or turbid greasy tongue coating, and slippery pulse. ; With the main symptoms, ≥ two secondary symptoms can be diagnosed.

[0023] ④Voluntarily sign the informed consent form.

[0024] (2) Exclusion criteria

[0025] ① Patients with severe primary diseases of cerebrovascular, liver, kidney and blood system and severe heart failure;

[0026] ②Patients with mental illness;

[0027] ③ Pregnant, lactating women and those planning to become pregnant;

[0028] ④ Those with allergic constitution and allergic to the medications they take;

[0029] ⑤ Those who have recently participated in other research and those who have taken Chinese herbal medicine or Chinese patent medicine;

[0030] ⑥ Patients who are judged by the researchers to be unsuitable for participation in this study.

[0031] 4. Sample size

[0032] A total of 120 cases were included, 60 in the treatment group and 60 in the control group.

[0033] 5. Treatment options

[0034] ① Randomly divided into a control group and an experimental group, and received lipid-lowering treatment for hyperlipidemia.

[0035] ②Control group: Oral administration of atorvastatin (Pfizer Pharmaceuticals Co., Ltd., specification: 10 mg), 1 tablet each time, once a day.

[0036] The treatment course is 4 weeks, with 1 course of treatment in total.

[0037] ③ Experimental group: On the basis of the control group, the Chinese medicine composition of Example 2 of the present invention was given twice a day, warm, for a course of 4 weeks.

[0038] A total of 1 course of treatment.

[0039] 5.1 Observation indicators:

[0040] ①Main efficacy indicators: changes in total cholesterol (TC), triacylglycerol (TG), and low-density lipoprotein cholesterol (LDL-C) levels before and after treatment;

[0041] ②Secondary efficacy index: TCM syndrome score before and after treatment, referring to the "Guidelines for Clinical Research of New Chinese Medicines" (Trial) and "Standards for Diagnosis and Efficacy of TCM Internal Medicine Diseases", the main symptoms are divided into four levels: none, mild, moderate, and severe, scored 0, 2, 4, and 6 points respectively, and the secondary symptoms are divided into four levels: none, mild, moderate, and severe, scored 0, 1, 2, and 3 points respectively. Markedly effective: the main clinical symptoms and secondary symptoms basically or completely disappeared, and the syndrome score decreased by more than 70%; effective: the clinical symptoms were significantly improved, and the syndrome score decreased by 30% to 70%; ineffective: the clinical symptoms did not improve significantly, and the syndrome score decreased by less than 30%; aggravated: the clinical symptoms worsened, and the score after treatment exceeded the score before treatment.

[0042] ③Safety indicators: observe vital signs, routine blood tests, routine urine tests; routine stool tests (when there is bowel movement), fecal occult blood (when there is bleeding tendency and there is bowel movement), liver and kidney function indicators. TCM syndrome scoring was performed at the 0th and 4th weeks of treatment; routine blood tests, routine urine tests, routine stool tests, liver function, and kidney function were tested at the 0th, 1st, and 4th weeks.

[0043] 6. Clinical efficacy criteria

[0044] Markedly effective: After treatment, clinical symptoms basically disappear, serum cholesterol, triglycerides, and low-density lipoprotein return to normal or decrease by ≥40%;

[0045] Effective: After treatment, clinical symptoms improved, and serum cholesterol, triglycerides, and low-density lipoprotein decreased by ≥20%;

[0046] Ineffective: After treatment, clinical symptoms slightly improved or not improved, serum cholesterol, triglycerides, and low-density lipoprotein decreased by <20%.

[0047] 7. Statistical analysis

[0048] SPSS22.0 statistical software was used for analysis. The measurement data were expressed as (x±s). The independent sample t test was used for comparison between groups with normal distribution, and the independent sample rank sum test was used for comparison with non-normal distribution. The paired sample t test was used for comparison within the group with normal distribution, and the paired sample rank sum test was used for comparison with non-normal distribution. The chi-square test was used for count data, and the rank sum test was used for rank data. P<0.05 was considered statistically significant.

[0049] 8. Test results

[0050] Comparison of TC, TG and LDL-C between the two groups before and after treatment: After treatment, TC, TG and LDL-C decreased in both groups (P<0.05), and the experimental group was better than the control group (P<0.05). The results are shown in Tables 1, 2 and 3.

[0051] Table 1 TC (x±s) of the two groups before and after treatment

[0052]

[0053] Note: Compared with the group before treatment, * P<0.05; compared with the control group after treatment, # P<0.05.

[0054] Table 2 TG (x±s) of the two groups before and after treatment

[0055]

[0056] Note: Compared with the group before treatment, *P<0.05; compared with the control group after treatment, # P<0.05.

[0057] Table 3 LDL-C (x±s) before and after treatment in the two groups

[0058]

[0059] Note: Compared with the group before treatment, * P<0.05; compared with the control group after treatment, # P<0.01.

[0060] (2) Comparison of total TCM syndrome scores between the two groups before and after treatment

[0061] After treatment, the total score of TCM syndrome decreased in both groups (P<0.05), and the decrease in the total score of TCM syndrome in the experimental group was lower than that in the control group (P<0.05). The results are shown in Table 4.

[0062] Table 4 Comparison of total scores of TCM syndromes between the two groups before and after treatment (x±s)

[0063]

[0064] Note: Compared with the group before treatment, * P<0.05; compared with the control group after treatment, # P<0.05.

[0065] (3) Comparison of clinical efficacy between the two groups

[0066] The total effective rate of the experimental group was higher than that of the control group (P<0.05). The results are shown in Table 5.

[0067] Table 5 Comparison of clinical efficacy of TC between the two groups (%)

[0068]

[0069] Note: Compared with the control group, # P<0.05.

[0070] Table 6 Comparison of clinical efficacy of TG between the two groups (%)

[0071]

[0072] Note: Compared with the control group, ## P<0.01.

[0073] Table 7 Comparison of clinical efficacy of LDL-C between the two groups (%)

[0074]

[0075] Note: Compared with the control group, #P<0.05.

[0076] (4) Safety of the two groups before and after treatment

[0077] No adverse events occurred in both groups during the treatment, and no obvious abnormal changes were found in blood routine, urine routine, stool routine, liver function, and kidney function before and after treatment.

[0078] 9. Conclusion

[0079] The preparation method of the invention is simple, easy to produce, convenient to take, has obvious curative effect in treating hyperlipidemia with phlegm and blood stasis syndrome, can reduce TC, TG, and LDL-C levels, and reduce the total score of TCM symptoms of hyperlipidemia with phlegm and blood stasis syndrome, has good safety, and has no obvious adverse reactions. It is an innovation in the treatment of hyperlipidemia drugs and has practical clinical significance and promotion and application value.

[0080] It should be pointed out that the above is only a preferred embodiment of the present invention and does not limit the present invention in any form. Any technician familiar with the profession can make changes or modify the technical contents disclosed above into equivalent embodiments with equivalent changes without departing from the scope of the technical solution of the present invention, which all fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating hyperlipidemia, characterized in that: The Chinese medicine composition is prepared from the following raw materials by weight: 15-25g of lotus leaf, 13-23g of oriental rhizome, 6-12g of safflower, 6-12g of peach kernel, 4-8g of tuckahoe, 4-8g of atractylodes macrocephala, 4-8g of patchouli, 4-8g of perilla, 8-16g of pinellia tuber, 8-16g of gynostemma pentaphyllum, 8-16g of cassia seed, 6-12g of ligusticum chuanxiong and 4-8g of scutellaria baicalensis. The raw materials are mixed together, soaked in water and then decocted twice, water 8 times the total weight of the raw materials is added for the first time, decocted for 1h to obtain the first decoction, water 6 times the total weight of the raw materials is added for the second time, decocted for 0.5h to obtain the second decoction, the two decoctions are combined, filtered, and concentrated to 1 / 4-1 / 6 of the amount of water added to obtain the composition.

2. The Chinese medicine composition for treating hyperlipidemia according to claim 1, characterized in that: The invention is prepared from the following raw materials by weight: 15g lotus leaf, 13g oriental rhizome, 6g safflower, 6g peach kernel, 4g poria, 4g atractylodes, 4g patchouli, 4g ephedrine, 8g pinellia, 8g gynostemma pentaphyllum, 8g cassia seed, 6g ligusticum chuanxiong and 4g scutellaria baicalensis. The raw materials are mixed together, soaked in water and decocted twice. For the first time, 8 times the total weight of the raw materials are added and decocted for 1 hour to obtain the first decoction. For the second time, 6 times the total weight of the raw materials are added and decocted for 0.5 hour to obtain the second decoction. The two decoctions are combined, filtered and concentrated to 1 / 4 of the amount of water added to obtain the product.

3. The Chinese medicine composition for treating hyperlipidemia according to claim 1, characterized in that: The invention is prepared from the following raw materials by weight: 20g lotus leaf, 18g oriental rhizome, 9g safflower, 9g peach kernel, 6g poria, 6g atractylodes, 6g patchouli, 6g ephedrine, 12g pinellia, 12g gynostemma pentaphyllum, 12g cassia seed, 9g ligusticum chuanxiong and 6g scutellaria baicalensis. The raw materials are mixed together, soaked in water and decocted twice. For the first time, 8 times the total weight of the raw materials are added and decocted for 1 hour to obtain the first decoction. For the second time, 6 times the total weight of the raw materials are added and decocted for 0.5 hour to obtain the second decoction. The two decoctions are combined, filtered and concentrated to 1 / 5 of the amount of water added.

4. The Chinese medicine composition for treating hyperlipidemia according to claim 1, characterized in that: The invention is prepared from the following raw materials by weight: 25g lotus leaf, 23g oriental rhizome, 12g safflower, 12g peach kernel, 8g poria, 8g atractylodes, 8g patchouli, 8g perilla, 16g pinellia, 16g gynostemma pentaphyllum, 16g cassia seed, 12g ligusticum chuanxiong and 8g scutellaria baicalensis. The raw materials are mixed together, soaked in water and decocted twice. For the first time, 8 times the total weight of the raw materials are added and decocted for 1 hour to obtain the first decoction. For the second time, 6 times the total weight of the raw materials are added and decocted for 0.5 hour to obtain the second decoction. The two decoctions are combined, filtered and concentrated to 1 / 6 of the amount of water added.

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