Jiangzhuo Quyu Granules for treating hyperlipidemia, its preparation method and application

Abstract

The present invention discloses Jiangzhuo Quyu Granules for treating hyperlipidemia, which is a preparation made from raw medicinal materials in the following weight ratios: 20 - 30 parts of ginseng, 15 - 25 parts of atractylodes macrocephala, 20 - 30 parts of poria cocos, 18 - 22 parts of cuscuta chinensis, 12 - 18 parts of eucommia ulmoides, 10 - 20 parts of dipsacus asperoides, 20 - 30 parts of wolfberry fruit, 15 - 25 parts of safflower, 20 - 30 parts of motherwort, 10 - 20 parts of notoginseng, 10 - 20 parts of cistanche deserticola, 20 - 30 parts of cinnamon, 15 - 25 parts of epimedium, 12 - 18 parts of pinellia ternata, 20 - 30 parts of platycodon grandiflorum, 10 - 20 parts of fritillaria cirrhosa, 20 - 30 parts of sterculia lychnophora, 20 - 30 parts of peucedanum praeruptorum, 15 - 25 parts of mulberry bark, 20 - 30 parts of immature bitter orange, 15 - 25 parts of magnolia officinalis, and also discloses its preparation method and use in the preparation of drugs for treating hyperlipidemia, and the hyperlipidemia is of the phlegm-turbidity obstruction syndrome type.

Description

Technical Field

[0001] The present invention relates to a Jiangzhuo Quyu granule for treating hyperlipidemia, its preparation method and application, belonging to the field of medicine. Background Art

[0002] Blood lipids refer to the lipids contained in plasma or serum, including cholesterol (CH), triglyceride (TG), phospholipid (PL), free fatty acid (FFA), etc. Cholesterol is further divided into cholesterol ester and free cholesterol, and the sum of the two is total cholesterol (TC). Blood lipids combine with apolipoproteins to form lipoproteins that dissolve in plasma for transport and metabolism. According to differences in their composition, density, and properties, blood lipoproteins can be divided into chylomicrons, very low density lipoproteins, low density lipoproteins, intermediate density lipoproteins, and high density lipoproteins using electrophoresis and ultracentrifugation methods. Disorders occur in blood lipid metabolism; abnormalities occur in fat metabolism or transport; the concentration of one or several lipids in plasma, including the levels of plasma TC and TG, is too high or the level of plasma HDL is too low; when the contents of TC, TG, and various lipoproteins in human plasma are higher than the normal values of the same age, it is called hyperlipidemia. Hyperlipidemia can be divided into two categories: primary and secondary. Primary is related to congenital and genetic factors. It is caused by single-gene defects or polygenic defects, resulting in abnormalities in receptors, enzymes, or apolipoproteins involved in lipoprotein transport and metabolism, or due to environmental factors (diet, nutrition, drugs) and through unknown mechanisms. Secondary is mostly secondary to metabolic disorders (diabetes, hypertension, myxedema, hypothyroidism, obesity, liver and kidney diseases, adrenal cortical hyperfunction), or is related to other factors (age, gender, season, alcohol consumption, smoking, diet, physical activity, mental stress, emotional activity).

[0003] Hyperlipidemia falls within the categories of "phlegm syndrome", "consumptive impairment", "chest impediment", "dizziness" in traditional Chinese medicine. Traditional Chinese medicine theory holds that high blood lipid is a pathological product and also a pathogenic factor, belonging to the pathological category of "phlegm" in traditional Chinese medicine. However, the meaning of phlegm is very broad, and hyperlipidemia is only a part of phlegm syndrome. It cannot be considered that all phlegm syndromes are accompanied by hyperlipidemia. The difference between the two lies in that phlegm can reach everywhere in the body, while hyperlipidemia only exists in the blood vessels. Phlegm can be divided into broad sense, narrow sense, tangible and intangible. Hyperlipidemia can be determined through detection and is the phlegm in the narrow sense and tangible form. Moreover, blood lipid is transformed from yin essence and has the properties of viscosity and deposition. If blood lipid is too high, it will be more sticky and deposited, which is different from normal fat. Therefore, its pathogenesis can be summarized as "the clear transforms from the turbid, and fat is generated from phlegm". The causes of hyperlipidemia include congenital spleen deficiency with phlegm accumulation; or excessive stomach fire, improper diet, overindulgence in fatty and sweet foods, resulting in endogenous phlegm turbidity; or being old and weak, with the decline of visceral qi, yin deficiency with phlegm stagnation, eventually leading to the accumulation of phlegm and blood stasis, transforming into lipid turbidity and retaining in the body to cause disease. The pathological changes are congenital spleen deficiency, excessive internal retention of phlegm-dampness, and poor transportation and transformation, resulting in the accumulation of lipid turbidity. Or in the case of a yang-excessive constitution, excessive stomach fire, overindulgence in fatty and sweet foods, leading to the accumulation of phlegm-heat and transforming into lipid turbidity. Or long-term accumulation of phlegm, entering the collaterals to form blood stasis, and causing the retention of phlegm and blood stasis. Or being old and weak, with the decline of visceral qi, liver-kidney yin deficiency, yin failing to transform into blood, instead becoming phlegm turbidity, the accumulation of phlegm and blood stasis can also transform into lipid turbidity and retain in the body to cause disease.

[0004] Hyperlipidemia mainly belongs to the categories of "phlegm-dampness" and "blood stasis" in traditional Chinese medicine and can be treated from the three viscera of the liver, kidney, and spleen. The liver has liver qi and liver yin. If the liver yin is consumed, the liver yang is relatively hyperactive, generating internal wind and disturbing the clear orifices. When the spleen fails to generate sufficient essence and the source of the five zang-organs declines, the essence of the five zang-organs is insufficient and the kidney loses its storage function, resulting in insufficient kidney water, the liver losing nourishment, and the liver yang rising, which can lead to symptoms such as headache and dizziness. The liver is a firm organ and relies on kidney water for nourishment. When the liver and kidney are yang-deficient, there will be dizziness, dry eyes, soreness and weakness of the waist and knees, restlessness and chest tightness, etc. Treating with the methods of nourishing the liver, softening the liver, tonifying the kidney, and nourishing yin can often achieve the purpose of reducing blood lipid.

[0005] Traditional Chinese medicine has obvious advantages in the treatment of hyperlipidemia, mainly manifested in: ① treatment diversity, in addition to drug treatment, there are also non-drug treatment methods such as acupuncture, acupoint catgut embedding, and traditional Chinese medicine characteristic diet and exercise therapy; ② starting from the whole, treating both the symptoms and the root cause, the treatment methods are individualized and can be adjusted in a timely manner according to different stages of the disease course; ③ the curative effect is definite, the safety is high, the adverse reactions are few, and it can effectively improve the clinical symptoms of patients. Therefore, actively promoting the treatment plan of traditional Chinese medicine or the combination of traditional Chinese and Western medicine is of great medical significance for improving the blood lipid indexes of hyperlipidemia patients, reducing complications, and protecting target organs. However, at present, some traditional Chinese medicine prescriptions claim to be able to treat hyperlipidemia, but there is no research on the syndrome types. Summary of the Invention

[0006] The purpose of the present invention is to provide a Jiangzhuo Quyu granule for treating hyperlipidemia, its preparation method and application.

[0007] The present invention provides a Jiangzhuo Quyu granule for treating hyperlipidemia, which is a preparation prepared from raw medicinal materials in the following weight ratios: 20 - 30 parts of ginseng, 15 - 25 parts of atractylodes macrocephala, 20 - 30 parts of poria cocos, 18 - 22 parts of cuscuta chinensis, 12 - 18 parts of eucommia ulmoides, 10 - 20 parts of dipsacus asperoides, 20 - 30 parts of wolfberry fruit, 15 - 25 parts of safflower, 20 - 30 parts of motherwort, 10 - 20 parts of notoginseng, 10 - 20 parts of cistanche deserticola, 20 - 30 parts of cinnamon, 15 - 25 parts of epimedium, 12 - 18 parts of pinellia ternata, 20 - 30 parts of platycodon grandiflorum, 10 - 20 parts of fritillaria cirrhosa, 20 - 30 parts of sterculia lychnophora, 20 - 30 parts of peucedanum praeruptorum, 15 - 25 parts of mulberry bark, 20 - 30 parts of immature bitter orange, 15 - 25 parts of magnolia officinalis.

[0008] The Jiangzhuo Quyu granule for treating hyperlipidemia is a preparation prepared from raw medicinal materials in the following weight ratios: 25 parts of ginseng, 20 parts of atractylodes macrocephala, 25 parts of poria cocos, 20 parts of cuscuta chinensis, 15 parts of eucommia ulmoides, 15 parts of dipsacus asperoides, 25 parts of wolfberry fruit, 20 parts of safflower, 25 parts of motherwort, 15 parts of notoginseng, 15 parts of cistanche deserticola, 25 parts of cinnamon, 20 parts of epimedium, 15 parts of pinellia ternata, 25 parts of platycodon grandiflorum, 15 parts of fritillaria cirrhosa, 25 parts of sterculia lychnophora, 5 parts of peucedanum praeruptorum, 20 parts of mulberry bark, 25 parts of immature bitter orange, 20 parts of magnolia officinalis.

[0009] The Jiangzhuo Quyu granule for treating hyperlipidemia is a granule prepared by adding pharmaceutically acceptable excipients or auxiliary components to the extracts of raw medicinal materials in each weight ratio.

[0010] The preparation method of the Jiangzhuo Quyu granule for treating hyperlipidemia is as follows:

[0011] a. Weigh safflower, motherwort, and cinnamon in each weight ratio, extract volatile oil, and include it with cyclodextrin for standby;

[0012] b. Add the medicinal residues in step a to other raw medicinal materials, extract with water, collect the extract, and concentrate;

[0013] c. Add ethanol to the concentrated solution, let it stand, filter, collect the ethanol precipitation solution, and concentrate it into a dry extract;

[0014] d. Mix the dry extract evenly with the volatile oil cyclodextrin clathrate, add excipients, and prepare it into a granule.

[0015] For the preparation method of the Jiangzhuo Quyu granule for treating hyperlipidemia, the time for extracting volatile oil in step a is 4 hours; the conditions for water extraction in step b are: add 10 times the dry weight of all medicinal materials of water, reflux and extract 2 times, each extraction time is 1 - 2 h, and concentrate the obtained extract to a relative density of 1.20 g / ml at 25°C; in step c, add 95% v / v ethanol aqueous solution to the concentrated solution until the ethanol concentration is 85% v / v.

[0016] The invention relates to a use of the Jiangzhuo Quyu granules for treating hyperlipidemia in preparing a drug for treating hyperlipidemia.

[0017] The Jiangzhuo Quyu granules for treating hyperlipidemia are used in the preparation of a drug for treating hyperlipidemia, wherein hyperlipidemia is a syndrome of phlegm and turbidity obstruction.

[0018] All medicinal materials meet the pharmacopoeia standards.

[0019] The causes of this disease can be divided into internal and external factors. The internal causes are mainly caused by dysfunction of the liver, spleen and kidney. External factors such as improper diet, excessive indulgence in rich and sweet foods, excessive leisure and lack of work, and emotional imbalance directly or indirectly affect the internal organs, leading to imbalance in the circulation of qi, blood and body fluids, fat metabolism disorder, the formation of phlegm coagulation, dampness, blood stasis, etc., which hinder water and moisture metabolism and are important pathogenic factors of hyperlipidemia. The Heart Disease Branch of the Chinese Association of Traditional Chinese Medicine divides hyperlipidemia into phlegm and turbidity obstruction type, liver and kidney yin deficiency type, qi stagnation and blood stasis type, spleen and kidney yang deficiency type and other syndrome types. Most people believe that the cause and pathogenesis of this disease is that the spleen fails to function properly, the liver fails to release, and the kidney qi is deficient, resulting in phlegm or blood stasis blocking the meridians and causing the disease. Therefore, the phlegm and turbidity obstruction type is sometimes also seen in other syndrome types. The clinical manifestations of phlegm-turbidity obstruction syndrome primarily include obesity, a heavy head, chest tightness, vomiting and vomiting with phlegm, and numbness and heaviness in the limbs. Secondary symptoms include palpitations, insomnia, a bland mouth, and poor appetite. Tongue and pulse: a fat tongue with a greasy coating and a wiry, slippery pulse. "Sweet and fat rich people are the disease of rich food. Blockage and stagnation, with no communication between the upper and lower parts, are the disease of worry." "The Spiritual Pivot: The 36th Chapter on the Differentiation of the Five Pathological Strokes and Body Fluids" states, "The body fluids of the five grains, when combined to form a paste, seep into the bone cavities, nourish the brain and marrow, and flow down to the groin." Hyperlipidemia is a syndrome of underlying deficiency and superficial excess. Pathological changes involve the spleen, kidney, and liver, with deficiency of vital energy as the underlying cause and phlegm and blood stasis as the superficial symptoms. Improper diet, excessive fatigue, and emotional disturbances directly or indirectly affect the internal organs, leading to dysfunction and disrupted fat metabolism, resulting in the formation of phlegm-dampness and blood stasis, which are key pathogenic factors of hyperlipidemia. The pathogenesis of this disease is originally spleen dysfunction and kidney qi deficiency, with phlegm turbidity and blood stasis as the main symptoms. If you blindly eliminate phlegm, activate blood circulation and remove blood stasis, it will be counterproductive and aggravate the symptoms of spleen deficiency and kidney deficiency. Spleen dysfunction leads to endogenous phlegm turbidity. Irregular diet damages the spleen and stomach, spleen dysfunction, water retention and condensation into phlegm. "Shibuzhai Medical Book" says: "Husband's disease is spleen disease. The spleen is Taiyin, the most yin among yin." Spleen dysfunction is the most critical pathological basis of phlegm turbidity stagnation syndrome. Therefore, the present invention first uses the method of spleen function and kidney qi tonification.

[0020] When the liver fails to regulate and release blood, vascular tension develops, impairing blood flow. This poor blood flow can lead to blood stasis, the pathological basis of hyperlipidemia. Kidney deficiency and essence deficiency lead to a complex system of phlegm and blood stasis. The kidney is the foundation of innate constitution, while the spleen is the foundation of acquired constitution. The spleen's proper function of transportation and transformation depends on the warmth of kidney yang. Therefore, insufficient kidney essence and kidney yang deficiency inevitably lead to spleen dysfunction. Treatment principles that promote blood circulation, resolve blood stasis, and tonify kidney yang are recommended.

[0021] The mutual binding of phlegm and stasis is an important pathological product of hyperlipidemia. Phlegm turbidity and stasis are both pathological products and pathological factors. They can cause diseases alone or interact with each other. Some studies believe that wherever there is phlegm turbidity, there is stasis. Stasis is caused by phlegm, and phlegm gives rise to stasis. There is a causal relationship between phlegm and stasis, which runs through the entire course of hyperlipidemia. Using phlegm-resolving herbs on the basis of promoting blood circulation to remove stasis can achieve twice the result with half the effort.

[0022] Once phlegm turbidity condenses, qi movement will be more blocked, so it can form masses and nodules. The initial formation is related to the deficiency of yang qi in the body or emotional depression, the spleen's failure to transport essence properly, resulting in the condensation of phlegm turbidity. Once phlegm turbidity condenses, it will further obstruct the flow of qi and blood, and the emotion will become more depressed. Affecting each other in this way and causing a chain reaction, the mass will become larger and firmer. It is said in "Danxi's Methods of Treatment" that those who are good at treating phlegm do not directly treat phlegm but regulate qi. When qi is smooth, all the body fluids will follow qi and become smooth.

[0023] This invention uses ginseng, atractylodes macrocephala, and poria cocos to strengthen the spleen, and dodder seed, eucommia ulmoides, dipsacus asperoides, and wolfberry fruit to tonify kidney qi, which together serve as the sovereign herbs; safflower, motherwort, and notoginseng to promote blood circulation to remove stasis, serving as the ministerial herbs; cistanche deserticola, cinnamon, and epimedium to warm the kidney yang, serving as the assistant herbs; pinellia ternata, platycodon grandiflorum, fritillaria cirrhosa, and sterculia lychnophora to resolve phlegm, and peucedanum praeruptorum, morus alba root bark, aurantii fructus immaturus, and magnolia officinalis to regulate qi, serving as the envoy herbs. The whole formula contains ginseng, atractylodes macrocephala, poria cocos, dodder seed, eucommia ulmoides, dipsacus asperoides, wolfberry fruit, safflower, motherwort, notoginseng, cistanche deserticola, cinnamon, epimedium, pinellia ternata, platycodon grandiflorum, fritillaria cirrhosa, sterculia lychnophora, peucedanum praeruptorum, morus alba root bark, aurantii fructus immaturus, and magnolia officinalis, which can strengthen the spleen, tonify kidney qi, promote blood circulation to remove stasis, warm the kidney yang, resolve phlegm, and regulate qi, and has a significant curative effect on hyperlipidemia of the phlegm turbidity obstruction syndrome type.

[0024] Pharmacodynamic studies have shown that in the hyperlipidemia model group of rats, TC, TG, and LDL in blood lipids were significantly increased, and HDL-C was significantly decreased, indicating that the hyperlipidemia model was successfully established. In the Example 1 group, TC, TG, and LDL decreased, and HDL increased, and there were statistical differences (P < 0.01), indicating that this invention can treat hyperlipidemia. After the establishment of the hyperlipidemia model in rats, SOD decreased and MDA increased. Compared with the hyperlipidemia model group, SOD increased and MDA decreased in the Example 1 group, indicating that this invention may play a role in treating hyperlipidemia through antioxidant effects.

[0025] Clinical studies have shown that when comparing the levels of blood lipid metabolism in the two groups of patients, the levels of TG, TC, and LDL-C in the Example 1 group were significantly decreased, while the level of HDL-C was significantly increased (P < 0.05), and the effect was better than that of the control group (P < 0.05); when comparing the clinical curative effects of the two groups, the clinical effective rate of the Example 1 group after treatment was 94%, which was significantly higher than the effective rate of 78% in the control group; when comparing the TCM syndrome scores before and after treatment in the two groups, the main symptoms, secondary symptoms, and total scores of the TCM syndromes in both groups were lower than those before treatment, and the Example 1 group was lower than the control group after treatment, with a statistically significant difference (P < 0.05), indicating that the present invention has a good therapeutic effect on hyperlipidemia of the phlegm-turbidity obstruction syndrome type. Detailed implementation manners

[0026] The present invention will be further described below in conjunction with the detailed implementation manners. It should be understood that these examples are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the content recorded in the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms also fall within the scope defined by the appended claims of the present application.

[0027] Example 1: Take 25 g of ginseng, 20 g of atractylodes macrocephala, 25 g of poria cocos, 20 g of dodder seeds, 15 g of eucommia ulmoides, 15 g of dipsacus asperoides, 25 g of wolfberry fruits, 20 g of safflower, 25 g of motherwort, 15 g of notoginseng, 15 g of cistanche deserticola, 25 g of cinnamon, 20 g of epimedium, 15 g of pinellia ternata, 25 g of platycodon grandiflorum, 15 g of fritillaria cirrhosa, 25 g of sterculia lychnophora, 5 g of peucedanum praeruptorum, 20 g of mulberry bark, 25 g of immature bitter orange, and 20 g of magnolia officinalis. The preparation method is as follows:

[0028] a. Weigh safflower, motherwort, and cinnamon in the respective weight ratios, extract the volatile oil for 4 hours, and perform cyclodextrin inclusion, and set aside for later use;

[0029] b. Add the other raw material herbs to the medicinal residues from step a, add water in an amount 10 times the dry weight of all the herbs, reflux and extract twice, with each extraction time being 2 h, and concentrate the obtained extract to a relative density of 1.20 g / ml at 25 °C;

[0030] c. Add 95% v / v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v / v, let it stand, filter, collect the alcohol-precipitated solution, and concentrate it into a dry extract;

[0031] d. Mix the dry extract evenly with the volatile oil cyclodextrin inclusion complex, add starch, and prepare into granules.

[0032] Example 2: Take 20 g of ginseng, 25 g of atractylodes macrocephala, 20 g of poria cocos, 22 g of dodder seeds, 12 g of eucommia ulmoides, 20 g of dipsacus asperoides, 20 g of wolfberry fruits, 25 g of safflower, 20 g of motherwort, 20 g of notoginseng, 10 g of cistanche deserticola, 30 g of cinnamon, 15 g of epimedium, 18 g of pinellia ternata, 20 g of platycodon grandiflorum, 20 g of fritillaria cirrhosa, 20 g of sterculia lychnophora, 30 g of peucedanum praeruptorum, 15 g of mulberry bark, 30 g of immature bitter orange, 15 g of magnolia officinalis. The preparation method is as follows:

[0033] a. Weigh safflower, motherwort, and cinnamon in the respective weight ratios, extract the volatile oil for 4 hours, and perform cyclodextrin inclusion for later use;

[0034] b. Add the other raw material herbs to the medicinal residues from step a, add water in an amount 10 times the dry weight of all the herbs, reflux and extract twice, with each extraction time being 1 h. Concentrate the obtained extract to a relative density of 1.20 g / ml at 25°C;

[0035] c. Add 95% v / v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v / v, let it stand, filter, collect the alcohol precipitation solution, and concentrate it into a dry extract;

[0036] d. Mix the dry extract evenly with the volatile oil cyclodextrin inclusion complex, add dextrin, and prepare it into granules.

[0037] Example 3: Take 30 g of ginseng, 15 g of atractylodes macrocephala, 30 g of poria cocos, 18 g of dodder seeds, 18 g of eucommia ulmoides, 10 g of dipsacus asperoides, 30 g of wolfberry fruits, 15 g of safflower, 30 g of motherwort, 10 g of notoginseng, 20 g of cistanche deserticola, 20 g of cinnamon, 25 g of epimedium, 12 g of pinellia ternata, 30 g of platycodon grandiflorum, 10 g of fritillaria cirrhosa, 30 g of sterculia lychnophora, 20 g of peucedanum praeruptorum, 25 g of mulberry bark, 20 g of immature bitter orange, 25 g of magnolia officinalis. The preparation method is as follows:

[0038] a. Weigh safflower, motherwort, and cinnamon in the respective weight ratios, extract the volatile oil for 4 hours, and perform cyclodextrin inclusion for later use;

[0039] b. Add the other raw material herbs to the medicinal residues from step a, add water in an amount 10 times the dry weight of all the herbs, reflux and extract twice, with each extraction time being 2 h. Concentrate the obtained extract to a relative density of 1.20 g / ml at 25°C;

[0040] c. Add 95% v / v ethanol aqueous solution to the concentrated solution until the ethanol concentration reaches 85% v / v, let it stand, filter, collect the alcohol precipitation solution, and concentrate it into a dry extract;

[0041] d. Mix the dry extract evenly with the volatile oil cyclodextrin inclusion complex, add starch, and prepare it into granules.

[0042] Example 4: Pharmacodynamic study of the present invention on hyperlipidemic rats

[0043] Experimental animals and drug administration methods: Wistar rats weighing 180 - 220 g, both male and female, with 10 animals in each group. The blank control group had a normal diet; in Example 1 group of the present invention: gavaged at a dose of 5 g crude drug amount / 100 g body weight, once a day; hyperlipidemia model group: fed with a high-fat diet, 20 g / animal / day. The animals in each of the above groups were continuously fed for 4 weeks. After the last drug administration, they were fasted for 12 h, allowed unlimited water intake. After weighing, 5 mL of blood was collected by decapitation. After centrifuging at 3000 r / min for 15 - 20 min using a centrifuge, the obtained serum samples were divided into two parts. One part was used to detect blood lipids (TC, TG, HDL, LDL), and the other part was used to detect SOD and MDA.

[0044] Experimental results: The effects of the present invention on blood lipids in hyperlipidemic rats are shown in Table 1; the effects of the present invention on SOD and MDA in hyperlipidemic rats are shown in Table 2.

[0045] Table 1 Effects of the present invention on blood lipids in hyperlipidemic rats (x±s, n = 10)

[0046] Group TC (mmol / L) TG (mmol / L) HDL-C (mmol / L) LDL-C (mmol / L) Blank control group 1.89±0.47 0.42±0.13 1.64±0.39 1.06±0.27 Model group <![CDATA[5.69±1.28 ** > <![CDATA[0.76±0.25 ** > <![CDATA[1.03±0.26 ** > <![CDATA[4.98±0.57 ** > Example 1 group <![CDATA[3.25±1.13 ## > <![CDATA[0.52±0.19 # > <![CDATA[2.19±0.43 ## > <![CDATA[3.18±0.53 # >

[0047] Compared with the blank control group: ** P < 0.01; compared with the model control group: # P < 0.05, ## P < 0.01.

[0048] Table 2 Effects of the present invention on SOD and MDA in hyperlipidemic rats (x±s, n = 10)

[0049] Group SOD (U / mL) MDA (mmol / L) Blank control group 356.23±36.89 7.892±1.473 Model group <![CDATA[286.34±42.73 ** > <![CDATA[9.341±1.857 ** > Example 1 group <![CDATA[375.93±37.96 ## > <![CDATA[6.932±1.533 # >

[0050] Compared with the blank control group: ** P < 0.01; compared with the model control group: # P < 0.05, ## P < 0.01.

[0051] Conclusion: From Table 1, it can be seen that in the hyperlipidemia model group of rats, TC, TG, and LDL in blood lipids were significantly increased, and HDL-C was significantly decreased, indicating that the hyperlipidemia model was successfully established. In Example 1 group, TC, TG, and LDL were decreased, and HDL was increased, and there were statistical differences (P < 0.01), indicating that the present invention can treat hyperlipidemia. It can be seen from Table 2 that after modeling in the hyperlipidemia model group of rats, SOD was decreased and MDA was increased. Compared with the hyperlipidemia model group, in Example 1 group, SOD was increased and MDA was decreased, indicating that the present invention treats hyperlipidemia possibly by exerting antioxidant effects.

[0052] Example 5: Clinical study of the present invention on hyperlipidemia

[0053] General information: 100 patients with hyperlipidemia and syndrome of phlegm-dampness blocking and obstructing diagnosed by Nanjing Hospital of Traditional Chinese Medicine from January 2022 to January 2023 were selected. They were divided into a treatment group and a control group according to the random number table method. There were 50 cases in the treatment group, including 26 males and 24 females; the average age was 65.72 years old, and the course of disease was 5.65 ± 1.23 years. There were 50 cases in the control group, including 24 males and 26 females; the average age was 63.32 years old, and the course of disease was 6.76 ± 1.82 years.

[0054] Diagnostic criteria: Drawn up with reference to the "Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese Adults (Revised Edition 2016)", patients have not used any Western or traditional Chinese medicines for lipid-lowering at present, and any one of the following 3 items can be used for diagnosis; for the normal population, LDL-C ≥ 3.4 mmol / L, for patients with hypertension and diabetes, LDL-C ≥ 2.6 mmol / L, for patients with coronary heart disease, LDL-C ≥

[0055] 1.8 mmol / L. The traditional Chinese medicine diagnostic criteria were drawn up with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines: Trial" in 2002. Main symptoms: obesity, heavy head as if wrapped, chest tightness, vomiting and nausea of phlegm, numbness and heaviness of limbs; secondary symptoms: palpitation, insomnia, tastelessness in the mouth, poor appetite; tongue and pulse: fat tongue with slippery and greasy coating, string-taut and slippery pulse; at the same time, meeting ≥ 2 main symptoms and ≥ 2 secondary symptoms means the syndrome is diagnosed as phlegm-dampness blocking and obstructing syndrome.

[0056] Administration method: Control group: Oral Xuezhikang Capsules (Beijing Beida Weixin Biotechnology Co., Ltd., approval number of national drug standard Z20080068), 2 capsules each time, each capsule containing 0.3 grams, twice a day, taken after breakfast and dinner; the group of Example 1 of the present invention: Take the granules prepared in Example 1 of the present invention, and the daily dosage is: ginseng 25 g, atractylodes macrocephala 20 g, poria cocos 25 g, dodder 20 g, eucommia ulmoides 15 g, dipsacus asperoides 15 g, wolfberry fruit 25 g, safflower 20 g, motherwort 25 g, notoginseng 15 g, cistanche deserticola 15 g, cinnamon 25 g, epimedium 20 g, pinellia ternata 15 g, platycodon grandiflorum 25 g, fritillaria cirrhosa 15 g, sterculia lychnophora 25 g, peucedanum praeruptorum 5 g, mulberry bark 20 g, immature bitter orange 25 g, magnolia officinalis 20 g, taken three times a day. The treatment time for both groups was 8 weeks.

[0057] Blood lipid indexes: The patients' TC, TG, LDL-C, and HDL-C were measured before treatment and 8 weeks after treatment respectively.

[0058] Traditional Chinese medicine syndrome score: Record the traditional Chinese medicine syndrome scores before and after treatment, including main symptoms (obesity, heavy head as if wrapped, chest tightness, vomiting and nausea of phlegm, numbness and heaviness of limbs), secondary symptoms (palpitation, insomnia, tastelessness in the mouth, poor appetite) and tongue and pulse and other items. Among them, the main symptoms are graded as none, mild, moderate, and severe, and are scored 0, 2, 4, and 6 points respectively; the secondary symptoms are graded as none, mild, moderate, and severe, and are scored 0, 1, 2, and 3 points respectively.

[0059] Efficacy evaluation criteria: Marked effect: After treatment, clinical symptoms basically or completely disappear, fasting serum TC decreases by >20%; HDL-C increases by >0.26 mmol / L, TG decreases by >40%, LDL-C decreases by >20%; Effective: After treatment, clinical symptoms are significantly improved, TC decreases by 10%-20%, HDL-C increases by 0.10-0.26 mmol / L, TG decreases by 20%-40%, LDL-C decreases by 10%-20%; Ineffective: The above criteria are not met.

[0060] Results: The comparison of blood lipid indexes between the two groups before and after treatment is shown in Table 1, the comparison of clinical efficacy between the two groups is shown in Table 2, and the comparison of TCM syndrome scores between the two groups before and after treatment is shown in Table 3.

[0061] Table 1 Comparison of blood lipid indexes between the two groups before and after treatment

[0062]

[0063] Table 2 Comparison of clinical efficacy between the two groups

[0064] Group Marked effect Effective Ineffective Total effective rate (%) Control group 15 24 11 78 Example 1 group 32 15 3 94

[0065] Table 3 Comparison of TCM syndrome scores between the two groups before and after treatment

[0066]

[0067] Compared with the same group before treatment: * P < 0.05; Compared with the control group after treatment: # P < 0.05

[0068] Results: Comparing the blood lipid metabolism levels of the two groups of patients, the levels of TG, TC and LDL-C in the Example 1 group were significantly decreased, while the level of HDL-C was significantly increased (P < 0.05), and the effect was better than that of the control group (P < 0.05); Comparing the clinical efficacy of the two groups, the clinical effective rate of the Example 1 group after treatment was 94%, which was significantly higher than the effective rate of 78% in the control group; Comparing the TCM syndrome scores of the two groups before and after treatment, the main symptoms, secondary symptoms and total scores of the TCM syndromes of the two groups were all lower than those before treatment, and the Example 1 group was lower than the control group after treatment, and the difference was statistically significant (P < 0.05), indicating that the present invention has a good therapeutic effect on hyperlipidemia of phlegm-turbidity obstructing syndrome type.

[0069] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Jiangzhuo Quyu granule for treating hyperlipidemia, characterized in that: It is The preparation is prepared from the following raw medicinal materials in the following weight ratio: 20-30 parts of ginseng, 15-25 parts of atractylodes, 20-30 parts of poria, 18-22 parts of dodder seeds, 12-18 parts of eucommia bark, 10-20 parts of dipsaccharum officinale, 20-30 parts of wolfberry, 15-25 parts of safflower, 20-30 parts of motherwort, 10-20 parts of notoginseng, 10-20 parts of cistanche, 20-30 parts of cinnamon, 15-25 parts of epimedium, 12-18 parts of pinellia, 20-30 parts of platycodon, 10-20 parts of fritillaria cirrhosa, 20-30 parts of sterculia lychnophora, 5-30 parts of peucedanum, 15-25 parts of mulberry bark, 20-30 parts of immature bitter orange, and 15-25 parts of magnolia officinalis.

2. The Jiangzhuo Quyu Granules for treating hyperlipidemia according to claim 1, wherein: The preparation is prepared from the following raw medicinal materials in the following weight proportions: 25 parts of ginseng, 20 parts of atractylodes macrocephala, 25 parts of poria, 20 parts of dodder seeds, 15 parts of eucommia bark, 15 parts of dipsaccharin, 25 parts of wolfberry, 20 parts of safflower, 25 parts of motherwort, 15 parts of notoginseng, 15 parts of cistanche, 25 parts of cinnamon bark, 20 parts of epimedium, 15 parts of pinellia, 25 parts of platycodon, 15 parts of fritillaria cirrhosa, 25 parts of sterculia lychnophora, 5 parts of peucedanum peucedanum, 20 parts of mulberry bark, 25 parts of immature bitter orange, and 20 parts of magnolia officinalis.

3. The Jiangzhuo Quyu Granules for treating hyperlipidemia according to claim 1, wherein: The granules are prepared by adding pharmaceutically acceptable auxiliary materials or auxiliary components into the extracts of raw medicinal materials in various weight proportions.

4. The Jiangzhuo Quyu Granules for treating hyperlipidemia according to claim 1, wherein: The preparation method comprises the following steps: a. Weigh safflower, motherwort, and cinnamon in different weight ratios, extract volatile oil, and enclose them in cyclodextrin for later use; b. Add the Chinese medicinal residue from step a to other raw medicinal materials, extract with water, collect the extract, and concentrate; c. Add ethanol to the concentrate, let it stand, filter, collect the alcohol precipitate, and concentrate it into a dry extract; d. Evenly mix the dry extract and the volatile oil cyclodextrin inclusion compound, add auxiliary materials, and prepare granules.

5. The Jiangzhuo Quyu Granules for treating hyperlipidemia according to claim 4, wherein: Preparation method a) Extracting volatile oil for 4 hours; b) Water extraction conditions: Adding 10 times the dry weight of all medicinal materials with water, reflux extraction twice, each extraction time 1-2 hours, and concentrating the resulting extract to a relative density of 1.20 g / ml at 25° C.; c) Adding 95% v / v ethanol aqueous solution to the concentrated solution to an ethanol concentration of 85% v / v.

6. Use of the Jiangzhuo Quyu granules for treating hyperlipidemia as claimed in claim 1 in the preparation of a drug for treating hyperlipidemia.

7. Use of Jiangzhuo Quyu Granules for treating hyperlipidemia as claimed in claim 6 in the preparation of a medicament for treating hyperlipidemia, characterized in that: Hyperlipidemia is a syndrome of phlegm and turbidity obstruction.

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