Application of qi-blood foundation strengthening oral liquid in preparation of medicine for improving hyperlipidemia

Abstract

The invention provides application of qi and blood strengthening oral liquid in preparation of a medicine for improving hyperlipidemia, and belongs to the technical field of medicine preparations. According to the invention, the mass ratio relationship among the components and the preparation method thereof are researched, and especially in the preparation process, the traditional Chinese medicine components are extracted by means of high-pressure steam heating, vacuum concentration and the like under different pressures in batches and stages, so that the obtained oral liquid for consolidating qi and blood is high in content of effective components, and has a good effect on consolidating qi and blood. The oral liquid for consolidating qi and blood can significantly improve hyperlipidemia, and has potential clinical application value.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical preparation technology, specifically to the application of Qi Xue Gu Ben oral liquid in the preparation of drugs for improving hyperlipidemia. Background Technology

[0002] Hyperlipidemia refers to excessively high levels of lipids in the blood, which can directly cause serious health problems such as atherosclerosis and coronary heart disease. The clinical manifestations of hyperlipidemia are mainly xanthoma caused by lipid deposition in the dermis and arteriosclerosis caused by lipid deposition in the vascular endothelium. Although hyperlipidemia can cause xanthoma, its incidence is not very high; and the occurrence and development of atherosclerosis is a slow and gradual process. Therefore, in most cases, most patients do not have obvious symptoms or abnormal signs. Many people only discover elevated plasma lipoprotein levels during blood biochemistry tests for other reasons.

[0003] Hyperlipidemia can be divided into primary and secondary types. Primary hyperlipidemia is related to congenital and genetic factors, caused by single-gene or multi-gene defects that lead to abnormalities in receptors, enzymes, or apolipoproteins involved in lipoprotein transport and metabolism, or by environmental factors (diet, nutrition, drugs) and through unknown mechanisms. Secondary hyperlipidemia often occurs in metabolic disorders (diabetes, hypertension, myxedema, hypothyroidism, obesity, liver and kidney diseases, hyperadrenocorticism), or is related to other factors such as age, sex, season, alcohol consumption, smoking, diet, physical activity, mental stress, and emotional activity.

[0004] Hyperlipidemia is a common and frequently occurring disease among middle-aged and elderly people. With improved living standards and changes in lifestyle, its incidence has increased significantly, and the age of onset has also decreased. Atherosclerosis caused by hyperlipidemia is a major cause of coronary heart disease, hypertension, and cerebrovascular diseases. Therefore, the treatment of hyperlipidemia is crucial and has attracted widespread attention worldwide. The ultimate goal of treating hyperlipidemia is to inhibit the further development of arteriosclerosis, thereby preventing death from cardiovascular and cerebrovascular diseases.

[0005] For example, Chinese patent CN118806855A discloses a traditional Chinese medicine composition for preventing and treating coronary heart disease, hypertension, hyperlipidemia, hyperglycemia, or hyperuricemia and gout caused by arteriosclerosis. The preparation method includes first extracting Salvia miltiorrhiza, hawthorn, and jujube seed with a solvent, filtering to obtain an extract and residue 1; then extracting Lycium barbarum, Astragalus membranaceus, Polygonatum sibiricum, chrysanthemum, and Lycium chinense root bark with alcohol to obtain an alcohol extract and residue 2. Residue 1, residue 2, processed Polygonum multiflorum, Epimedium brevicornu, Ligustrum lucidum, Angelica sinensis, and Cuscuta chinensis are mixed and enzymatically hydrolyzed to obtain an enzymatic hydrolysate; finally, the extract, alcohol extract, and enzymatic hydrolysate are mixed and dried to obtain the final product. This invention employs a special preparation process, resulting in significantly enhanced efficacy and a statistically significant difference compared to the positive control group.

[0006] For example, Chinese patent CN118593536B discloses a traditional Chinese medicine composition for preventing and treating arteriosclerosis and coronary heart disease. This composition includes the following components: apigenin, vitamin B1, emodin, β-epimedium, jujube seed saponin, hyperoside, methyl tanshinone, tanshinone, betulinic acid, betaine, and wolfberry polysaccharide. This composition, with its clearly defined components, achieves reduced dosage and formula, and exhibits significant therapeutic effects.

[0007] However, existing traditional Chinese medicine compositions are not very effective in lowering total cholesterol, triglycerides, and low-density lipoprotein levels, or in increasing high-density lipoprotein levels. Therefore, there is a need to develop a Qi Xue Gu Ben oral liquid that can improve hyperlipidemia and its application. Summary of the Invention

[0008] Based on the shortcomings of existing technologies, this invention uses Qi Xue Gu Ben oral liquid as a foundation. By studying the mass ratio between components and its preparation method, especially by using different solvents to extract traditional Chinese medicine components during the preparation process, the Qi Xue Gu Ben oral liquid of this invention is obtained. This Qi Xue Gu Ben oral liquid can improve cardiovascular and cerebrovascular diseases such as hyperlipidemia by reducing the content of total cholesterol, triglycerides, and low-density lipoprotein, and increasing the content of high-density lipoprotein, and has potential clinical application value.

[0009] This invention is implemented as follows: On the one hand, this invention provides the application of Qi Xue Gu Ben Oral Liquid in the preparation of drugs to improve hyperlipidemia.

[0010] The drug mentioned is one that can lower total cholesterol, triglycerides, and low-density lipoprotein levels.

[0011] The drug mentioned is one that can increase the level of high-density lipoprotein.

[0012] The drug described is capable of lowering total cholesterol, triglycerides, and low-density lipoprotein levels, while increasing high-density lipoprotein levels.

[0013] Preferably, the Qi and Blood Strengthening Oral Liquid is prepared by the following method: (1) Weigh lotus seeds and pine nuts, crush them, and then soak them to obtain soaking liquid for later use; (2) Weigh the rose hips and extract them to obtain extract A, which is then set aside. (3) Weigh out Acanthopanax senticosus, Schisandra chinensis, Epimedium, Morinda officinalis, Cuscuta chinensis, Ligustrum lucidum, Anemarrhena asphodeloides, Phellodendron chinense, Lycium barbarum, Rehmannia glutinosa, Polygonum multiflorum, Polygonatum sibiricum, Rubus idaeus, Dioscorea opposita, Ziziphus jujuba var. spinosa, pine needles and Platycladus orientalis seeds for extraction to obtain extract B, which is used for later use; (4) Take the soaking solution, extract A and extract B and concentrate them to obtain the extract; mix the extract with honey and purified water to obtain the Qi and Blood Strengthening Oral Liquid.

[0014] The particle size of the pulverized material in step (1) above is 250μm-850μm; the ratio of water added to the mass of the medicinal material during soaking is 4-6:1; preferably 4:1; the soaking time is 3-5 hours; preferably 4 hours.

[0015] In step (1) above, stir for 2-5 minutes every 30 minutes during the soaking process.

[0016] In step (2) above, the ratio of water added to the mass of medicinal materials is 5-8:1, preferably 6:1; the extraction is by decoction, and the number of decoctions is 2-3, preferably 2; the first decoction time is 1.5-2.5 hours, preferably 2 hours, and the second decoction time is 0.5-1.5 hours, preferably 1 hour.

[0017] The extraction process in step (3) above involves a water-to-medicinal-material ratio of 5-8:1, preferably 6:1. The extraction is performed by decoction, which is performed 2-3 times, preferably 2 times. The first decoction takes 3-6 hours, preferably 5 hours, and the second decoction takes 2-4 hours, preferably 3 hours.

[0018] The extraction described in step (3) above needs to be carried out under high-pressure steam heating conditions.

[0019] The steam pressure is 0.05-0.2 MPa from the initial heating to before boiling, 0.01-0.05 MPa within 1 hour after boiling, and 0.1-0.15 MPa from 1 hour after boiling to the end.

[0020] The temperature in step (3) above is 95-100℃.

[0021] The concentration pressure in step (4) above is 0.01-0.15 MPa, the vacuum degree is less than 0.08 MPa, the temperature is 55-75℃, and the concentration is stopped when the relative density is 1.16-1.21 (60-70℃).

[0022] The Qi and Blood Strengthening Oral Liquid, by weight, comprises the following components: 70-90 parts of Rosa rugosa fruit, 70-90 parts of Acanthopanax senticosus, 20-30 parts of Schisandra chinensis, 20-30 parts of Epimedium brevicornu, 5-10 parts of Morinda officinalis, 5-10 parts of Cuscuta chinensis, 5-10 parts of Ligustrum lucidum, 15-30 parts of Anemarrhena asphodeloides, 15-30 parts of Phellodendron chinense, 5-10 parts of Lycium barbarum, 30-50 parts of Nelumbo nucifera, 5-10 parts of Rehmannia glutinosa, 15-30 parts of Polygonum multiflorum, 10-20 parts of Polygonatum sibiricum, 20-30 parts of Rubus idaeus, 5-15 parts of Dioscorea opposita, 30-50 parts of Pine nuts, 10-15 parts of Ziziphus jujuba var. spinosa, 5-15 parts of pine needles, and 5-15 parts of Platycladus orientalis.

[0023] Preferably, the Qi and Blood Strengthening Oral Liquid comprises, by weight, the following components: 75-85 parts of Rosa rugosa fruit, 75-85 parts of Acanthopanax senticosus, 22-28 parts of Schisandra chinensis, 22-28 parts of Epimedium brevicornu, 6-8 parts of Morinda officinalis, 6-8 parts of Cuscuta chinensis, 6-8 parts of Ligustrum lucidum, 20-25 parts of Anemarrhena asphodeloides, 20-25 parts of Phellodendron chinense, 6-8 parts of Lycium barbarum, 35-45 parts of Nelumbo nucifera, 6-8 parts of Rehmannia glutinosa, 20-25 parts of Polygonum multiflorum, 12-18 parts of Polygonatum sibiricum, 22-28 parts of Rubus idaeus, 8-12 parts of Dioscorea opposita, 35-45 parts of Pine nuts, 12-14 parts of Ziziphus jujuba var. spinosa, 8-12 parts of pine needles, and 8-12 parts of Platycladus orientalis.

[0024] Preferably, the Qi and Blood Strengthening Oral Liquid comprises, by weight, the following components: 80 parts of Rosa rugosa fruit, 80 parts of Acanthopanax senticosus, 25 parts of Schisandra chinensis, 25 parts of Epimedium, 8 parts of Morinda officinalis, 8 parts of Cuscuta chinensis, 8 parts of Ligustrum lucidum, 20 parts of Anemarrhena asphodeloides, 20 parts of Phellodendron chinense, 8 parts of Lycium barbarum, 40 parts of Nelumbo nucifera, 8 parts of Rehmannia glutinosa, 25 parts of Polygonum multiflorum, 15 parts of Polygonatum sibiricum, 25 parts of Rubus idaeus, 10 parts of Dioscorea opposita, 40 parts of Pine nut, 12 parts of Ziziphus jujuba var. spinosa, 10 parts of pine needles, and 10 parts of Platycladus orientalis seed.

[0025] Compared with the prior art, the present invention has the following beneficial effects: 1. This invention studies the mass ratio between components and their preparation method, especially the preparation method. During the preparation process, the traditional Chinese medicine components are extracted using batch extraction, pressurized extraction, and pressurized concentration to obtain the Qi Xue Gu Ben oral liquid described in this invention. This Qi Xue Gu Ben oral liquid can reduce total cholesterol, triglycerides, and low-density lipoprotein levels, while increasing high-density lipoprotein levels. Furthermore, the improvement effect increases with increasing dosage, indicating that the Qi Xue Gu Ben oral liquid prepared by this invention has a good therapeutic effect on improving cardiovascular and cerebrovascular diseases such as hyperlipidemia and has potential clinical application value.

[0026] Especially when extracting seventeen kinds of medicinal materials such as Acanthopanax senticosus and Schisandra chinensis, high-pressure steam heating is used for extraction. The steam pressure is controlled from the initial heating to boiling at 0.05-0.2 MPa, and within 1 hour after boiling at 0.01-0.05 MPa; and from 1 hour after boiling to the end at 0.1-0.15 MPa. This helps to quickly dissolve the active ingredients, increases the content of active ingredients in the extract, and is more conducive to the efficacy of the medicine. Controlling the pressure to 0.01-0.15 MPa, the vacuum degree to less than 0.08 MPa, and the temperature to 55-75℃ during the drug concentration process can better reduce the loss of the active ingredients in the drug and retain the active ingredients in the drug to a greater extent, thereby ensuring the stability of the drug.

[0027] 2. In this invention, Acanthopanax senticosus, Rosa rugosa, Schisandra chinensis, and Ziziphus jujuba var. spinosa are the principal herbs, accompanied by Anemarrhena asphodeloides, Phellodendron chinense, Rehmannia glutinosa, and Polygonum multiflorum as assistant herbs, and Epimedium brevicornu, Morinda officinalis, Cuscuta chinensis, and Rubus idaeus as adjuvant herbs, supplemented by Platycladus orientalis seed and pine needles as adjuvant herbs. The overall formula focuses on regulating and tonifying qi and blood, strengthening the spleen and kidneys, and calming the mind and spirit. The principal, assistant, adjuvant, and adjuvant herbs complement each other, and the medicinal properties are coordinated. It can not only improve insomnia and palpitations, but also strengthen the spleen and replenish qi, nourish yin and reduce fire, and tonify the kidneys and replenish essence. The overall formula reflects the characteristics of traditional Chinese medicine's syndrome differentiation and treatment. In the preparation process, the various extract components are comprehensively utilized and rationally combined, which can be efficiently absorbed to exert their effects. At the same time, through specific extracts and extraction methods, the resulting oral liquid for strengthening qi and blood has a high content of effective components and has a significant effect on improving hyperlipidemia. Detailed Implementation

[0028] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0029] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the invention, 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 in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0030] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention are obtained through conventional commercial means.

[0031] In the following examples, “part” and “g” have the same meaning, that is, 1 part = 1g.

[0032] Example 1: A Qi and Blood Strengthening Oral Liquid and its Preparation Method The ingredients are as follows by weight: 80 parts of Rosa rugosa fruit, 80 parts of Acanthopanax senticosus, 25 parts of Schisandra chinensis, 25 parts of Epimedium, 8 parts of Morinda officinalis, 8 parts of Cuscuta chinensis, 8 parts of Ligustrum lucidum, 20 parts of Anemarrhena asphodeloides, 20 parts of Phellodendron chinense, 8 parts of Lycium barbarum, 40 parts of Nelumbo nucifera, 8 parts of Rehmannia glutinosa, 25 parts of Polygonum multiflorum, 15 parts of Polygonatum sibiricum, 25 parts of Rubus idaeus, 10 parts of Dioscorea opposita, 40 parts of Pine nuts, 12 parts of Ziziphus jujuba var. spinosa, 10 parts of pine needles, and 10 parts of Platycladus orientalis seed.

[0033] The preparation method is as follows: (1) Weigh lotus seeds and pine nuts and crush them to 500μm. Then add 4 times the amount of water and soak for 4 hours. Stir for 5 minutes every 30 minutes during the soaking process to obtain the soaking solution for later use. (2) Weigh out the rose hips and add 6 times the amount of water for two decoctions. The first extraction time is 2 hours and the second extraction time is 1 hour. Combine the decoctions to obtain extract A for later use. (3) Weigh out Acanthopanax senticosus, Schisandra chinensis, Epimedium, Morinda officinalis, Cuscuta chinensis, Ligustrum lucidum, Anemarrhena asphodeloides, Phellodendron chinense, Lycium barbarum, Rehmannia glutinosa, Polygonum multiflorum, Polygonatum sibiricum, Rubus idaeus, Dioscorea opposita, Ziziphus jujuba var. spinosa, pine needles and Platycladus orientalis seeds, add 6 times the amount of water and decoct for extraction twice. The first extraction time is 5 hours and the second decoction time is 3 hours. The extraction must be carried out under high pressure steam heating. During the extraction process, the steam pressure should be controlled as follows: from the initial heating to before boiling, the steam pressure is 0.1 MPa; within 1 hour after boiling, the steam pressure is 0.03 MPa; from 1 hour after boiling to the end, the steam pressure is 0.12 MPa and the temperature is 95℃. Combine the decoction liquids to obtain extract B, which is ready for use. (4) Take the soaking solution, extract A and extract B and concentrate them. The concentration steam pressure is 0.03-0.06 MPa, the vacuum degree is -0.06 to -0.08 MPa, the temperature is 55-60℃, and the concentration is carried out until the relative density is 1.16-1.21 (60-70℃) to obtain the extract. Mix the extract with honey at a mass ratio of 1:1, and then add purified water to mix to obtain the Qi and Blood Strengthening Oral Liquid.

[0034] Example 2: A Qi and Blood Strengthening Oral Liquid and its Preparation Method The ingredients are as follows by weight: 70 parts of Rosa rugosa fruit, 90 parts of Acanthopanax senticosus, 20 parts of Schisandra chinensis, 30 parts of Epimedium, 10 parts of Morinda officinalis, 5 parts of Cuscuta chinensis, 5 parts of Ligustrum lucidum, 30 parts of Anemarrhena asphodeloides, 30 parts of Phellodendron chinense, 10 parts of Lycium barbarum, 30 parts of Nelumbo nucifera, 10 parts of Rehmannia glutinosa, 15 parts of Polygonum multiflorum, 10 parts of Polygonatum sibiricum, 30 parts of Rubus idaeus, 5 parts of Dioscorea opposita, 50 parts of Pine nuts, 10 parts of Ziziphus jujuba var. spinosa, 5 parts of pine needles, and 15 parts of Platycladus orientalis seed.

[0035] The preparation method is as follows: (1) Weigh lotus seeds and pine nuts and crush them to 500μm. Then add 6 times the amount of water and soak for 3 hours. Stir for 5 minutes every 30 minutes during the soaking process to obtain the soaking solution for later use. (2) Weigh out the rose hips and add 5 times the amount of water for two decoctions. The first extraction time is 2.5 hours and the second extraction time is 1.5 hours. Combine the decoctions to obtain extract A for later use. (3) Weigh out Acanthopanax senticosus, Schisandra chinensis, Epimedium, Morinda officinalis, Cuscuta chinensis, Ligustrum lucidum, Anemarrhena asphodeloides, Phellodendron chinense, Lycium barbarum, Rehmannia glutinosa, Polygonum multiflorum, Polygonatum sibiricum, Rubus idaeus, Dioscorea opposita, Ziziphus jujuba var. spinosa, pine needles and Platycladus orientalis seeds, add 6 times the amount of water and decoct twice for extraction. The first extraction time is 3 hours and the second extraction time is 4 hours. The extraction should be carried out under high pressure steam heating. During the extraction process, the steam pressure should be controlled as follows: from the initial heating to before boiling, the steam pressure should be 0.05 MPa; within 1 hour after boiling, the steam pressure should be 0.05 MPa; from 1 hour after boiling to the end, the steam pressure should be 0.1 MPa and the temperature should be 98℃. Combine the decoctions to obtain extract B, which is ready for use. (4) Take the soaking solution, extract A and extract B and concentrate them. The concentration steam pressure is 0.03-0.06 MPa, the vacuum degree is -0.06 to -0.08 MPa, the temperature is 55-60℃, and the concentration is carried out until the relative density is 1.16-1.21 (60-70℃) to obtain the extract. Mix the extract with honey at a mass ratio of 1:1, and then add purified water to mix to obtain the Qi and Blood Strengthening Oral Liquid.

[0036] Example 3: A Qi and Blood Strengthening Oral Liquid and its Preparation Method The ingredients are as follows by weight: 85 parts of Rosa rugosa fruit, 75 parts of Acanthopanax senticosus, 28 parts of Schisandra chinensis, 22 parts of Epimedium, 6 parts of Morinda officinalis, 6 parts of Cuscuta chinensis, 6 parts of Ligustrum lucidum, 20 parts of Anemarrhena asphodeloides, 20 parts of Phellodendron chinense, 8 parts of Lycium barbarum, 45 parts of Nelumbo nucifera, 6 parts of Rehmannia glutinosa, 20 parts of Polygonum multiflorum, 18 parts of Polygonatum sibiricum, 22 parts of Rubus idaeus, 12 parts of Dioscorea opposita, 45 parts of Pine nuts, 12 parts of Ziziphus jujuba var. spinosa, 12 parts of pine needles, and 8 parts of Platycladus orientalis seeds.

[0037] The preparation method is as follows: (1) Weigh lotus seeds and pine nuts and crush them to 500μm. Then add 5 times the amount of water and soak for 3 hours. Stir for 5 minutes every 30 minutes during the soaking process to obtain the soaking solution for later use. (2) Weigh out the rose hips and add 8 times the amount of water for two decoctions. The first extraction time is 1.5 hours and the second extraction time is 0.5 hours. Combine the decoctions to obtain extract A for later use. (3) Weigh out Acanthopanax senticosus, Schisandra chinensis, Epimedium, Morinda officinalis, Cuscuta chinensis, Ligustrum lucidum, Anemarrhena asphodeloides, Phellodendron chinense, Lycium barbarum, Rehmannia glutinosa, Polygonum multiflorum, Polygonatum sibiricum, Rubus idaeus, Dioscorea opposita, Ziziphus jujuba var. spinosa, pine needles and Platycladus orientalis seeds, add 6 times the amount of water and decoct twice for extraction. The first extraction time is 6 hours and the second extraction time is 2 hours. The extraction should be carried out under high pressure steam heating. During the extraction process, the steam pressure should be controlled as follows: from the initial heating to before boiling, the steam pressure should be 0.2 MPa; within 1 hour after boiling, the steam pressure should be 0.01 MPa; from 1 hour after boiling to the end, the steam pressure should be 0.1 MPa and the temperature should be 95℃. Combine the decoctions to obtain extract B, which is ready for use. (4) Take the soaking solution, extract A and extract B and concentrate them. The concentration steam pressure is 0.03-0.06 MPa, the vacuum degree is -0.06 to -0.08 MPa, the temperature is 55-60℃, and the concentration is carried out until the relative density is 1.16-1.21 (60-70℃) to obtain the extract. Mix the extract with honey at a mass ratio of 1:1, and then add purified water to mix to obtain the Qi and Blood Strengthening Oral Liquid.

[0038] Comparative Example 1 The difference from Example 1 lies in the preparation method, as detailed below: Weigh the medicinal materials used in the formula of Example 1, crush the lotus seeds and pine nuts to 500μm, soak them in 4 times the amount of water for 4 hours, stir, filter, and set aside the filtrate; boil the rose hips twice with 6 times the amount of water, the first time for 2 hours and the second time for 1 hour, filter, combine the filtrates, and set aside; boil the remaining medicinal materials twice with 6 times the amount of water, the first time for 3 hours and the second time for 2 hours, filter, combine the filtrates, combine with the above medicinal liquid, heat and concentrate to a thick paste with a relative density of not less than 1.10 (20℃), add honey and mix with the thick paste in a 1:1 ratio, then add purified water and mix, stir well, dispense and sterilize to obtain the final product.

[0039] Comparative Example 2 The difference from Example 1 is that: in step (3), the steam pressure is controlled to be 0.25 MPa from the initial heating to before boiling, and 0.08 MPa within 1 hour after boiling; the steam pressure is 0.18 MPa from 1 hour after boiling to the end, and the temperature is 95°C. The rest is the same as in Example 1.

[0040] Comparative Example 3 The difference from Example 1 is that the specific operation of step (3) is different, specifically: (3) Weigh out Acanthopanax senticosus, Schisandra chinensis, Epimedium, Morinda officinalis, Cuscuta chinensis, Ligustrum lucidum, Anemarrhena asphodeloides, Phellodendron chinense, Lycium barbarum, Rehmannia glutinosa, Polygonum multiflorum, Polygonatum sibiricum, Rubus idaeus, Dioscorea opposita, Ziziphus jujuba var. spinosa, pine needles and Platycladus orientalis seeds, add 6 times the amount of water and decoct once for 8 hours. The extraction should be carried out under high pressure steam heating. During the extraction process, the steam pressure should be controlled as follows: from the initial heating to before boiling, the steam pressure should be 0.2 MPa; within 1 hour after boiling, the steam pressure should be 0.01 MPa; from 1 hour after boiling to the end, the steam pressure should be 0.1 MPa and the temperature should be 95℃. Combine the decoctions to obtain extract B, which is ready for use.

[0041] Everything else is the same as in Example 1.

[0042] Comparative Example 4 The difference from Example 1 is that the concentration pressure in step (4) is 0.2 MPa, the vacuum degree is -0.08 MPa, the temperature is 60°C, and the rest is the same as in Example 1.

[0043] Effect test: I. Detection of active ingredient content: (1) Berberine hydrochloride Determined by high performance liquid chromatography (General Chapter 0512, Chinese Pharmacopoeia 2025).

[0044] Chromatographic conditions and system suitability test: Octadecylsilane-bonded silica gel was used as the stationary phase, and acetonitrile-0.1% phosphoric acid solution (containing 0.1 mL of triethylamine per 100 mL) (30:70) was used as the mobile phase; the detection wavelength was 345 nm. The theoretical plate number, calculated based on the berberine hydrochloride peak, should not be less than 2000.

[0045] Preparation of reference solution: Take an appropriate amount of berberine hydrochloride reference standard, accurately weigh it, and add methanol to prepare a solution containing 6 μg per 1 mL.

[0046] Preparation of the test solution: Accurately measure 5 mL of this product and place it in a 25 mL volumetric flask. Add an appropriate amount of hydrochloric acid-methanol (1:99) mixed solution, shake, and then dilute to the mark with hydrochloric acid-methanol (1:99) mixed solution. Shake well, filter, and take the filtrate to obtain the test solution.

[0047] Assay: Accurately pipette 20 μL each of the reference solution and the test solution into the liquid chromatograph. Measure to obtain the final result.

[0048] (2) Epimedoside Determined by high performance liquid chromatography (General Chapter 0512, Chinese Pharmacopoeia 2015).

[0049] Chromatographic conditions and system suitability test: Octadecylsilane-bonded silica gel was used as the stationary phase, and acetonitrile-water (25:75) was used as the mobile phase; the detection wavelength was 270 nm. The theoretical plate number, calculated based on the icariin peak, should not be less than 1500.

[0050] Preparation of reference solution: Take an appropriate amount of icariin reference standard, accurately weigh it, and add methanol to prepare a solution containing 15 μg per 1 mL.

[0051] Preparation of the test solution: Accurately measure 10 mL of this product and place it in a 25 mL volumetric flask. Add an appropriate amount of methanol, shake, then dilute with methanol to the mark, shake well, filter, and take the filtrate to obtain the test solution.

[0052] Determination method: Accurately pipette 20 μL of the reference solution and the test solution into the liquid chromatograph and determine the result.

[0053] The test substances for the above-mentioned test articles are extract B and Qi Xue Gu Ben oral liquid obtained in Examples 1-3 and Comparative Examples 1-4, respectively.

[0054] The extraction rate is calculated as follows: W% = [(C × V) / m] × 100% in: W represents the extraction rate; C represents the concentration of berberine hydrochloride or icariin; V represents the volume of extract B or Qi and Blood Strengthening Oral Solution; m represents the mass of Phellodendron bark or Epimedium.

[0055] The test results are shown in Table 1 below.

[0056] Table 1

[0057] According to the test results in Table 1 above, the extraction efficiency of the effective components berberine hydrochloride or icariin in the Qi Xue Gu Ben oral liquid provided in Examples 1-3 of this invention is relatively high, that is, the content of effective components is relatively high, and the extraction rate can still be maintained after concentration. This indicates that the Qi Xue Gu Ben oral liquid in Examples 1-3 has a high and stable content of effective components.

[0058] In Comparative Example 1, the extraction efficiency of berberine hydrochloride or icariin obtained by conventional extraction methods was significantly reduced, and the stability was also significantly reduced.

[0059] In Comparative Example 2, changing the pressure before and after boiling during extraction significantly reduced the content of berberine hydrochloride or icariin in the product, thus decreasing the content of active ingredients.

[0060] In Comparative Example 3, the extraction time and the pressure before and after boiling were changed during extraction, and the contents of berberine hydrochloride or icariin in the product were significantly reduced. The content of the active ingredient in the product obtained by extending the extraction time was even lower. It may be that the active ingredient is lost during long-term extraction.

[0061] In Comparative Example 4, changing the pressure parameter of concentration will, to a certain extent, affect the loss of the active ingredient, reduce the content of the active ingredient, and the change rate of the active ingredient is significantly higher than that in Examples 1-3.

[0062] II. Pharmacodynamic detection Pharmacodynamic experiment of the composition of the present invention on atherosclerosis Test animals: SPF-grade healthy male KM mice (Spebefu (Beijing) Biotechnology Co., Ltd., license number: SCXK (Beijing) 2024-0001), body weight 20-22 g. They were housed in the animal house of Beijing University of Chinese Medicine, the temperature of the breeding room was 20°C-22°C, and the relative humidity was 60%-70%. Ethical review number: BUCM-2024062401-2201.

[0063] High-fat diet: 15% animal oil, 18% sucrose, and 3% egg yolk were added to the basal diet.

[0064] Establishment of an animal model of atherosclerosis: Randomly select 5 rats as the normal group, and the rest are used as the experimental group for modeling. Except for the rats in the normal group fed with ordinary pellet feed, the rats in the other groups are fed with high-fat diet. The rats are allowed to eat and drink freely for 4 weeks. After fasting overnight for 12 h, the normal group is intraperitoneally injected with the same dose of normal saline. Except for the normal group, the other rats are intraperitoneally injected with 1% STZ (streptozotocin) solution at 45 mg / kg body weight and continue to be fed with high-fat diet for modeling. The experiment lasts for 12 weeks. When HE staining shows that the model rats have formed atherosclerosis, the modeling is successful.

[0065] Grouping and administration: The model rats were randomly divided into 6 groups: normal group, model group, positive group, low-dose group of Example 1, medium-dose group of Example 1, and high-dose group of Example 1, with 5 rats in each group. On the morning of the day after successful modeling, gavage administration was started once a day. The positive group was administered atorvastatin calcium suspension at 2 mg / kg; The low, medium, and high doses of the Qi and Blood Strengthening Oral Liquid prepared in Example 1; the daily human dosage of the Qi and Blood Strengthening Oral Liquid is 30 mL, and 95.25 g of dry extract powder is equivalent to the standard prescription amount (1000 mL). Calculated according to 3.15 times, 6.3 times, and 12.6 times of the daily human dosage and a body weight of 60 kg, the daily dosages of the low, medium, and high-dose groups of the Qi and Blood Strengthening Oral Liquid are 150 mg / kg, 300 mg / kg, and 600 mg / kg, respectively.

[0066] The normal group was given the same dose of physiological saline. After 12 weeks of continuous gavage administration, the rats were fasted but allowed to drink water for 12 hours. They were then sacrificed and anesthetized by intraperitoneal injection of 3% sodium pentobarbital at 2 mL / kg. Blood was collected from the femoral artery, and serum was separated. Biochemical indicators were measured by ELISA to assess the levels of total cholesterol, triglycerides, low-density lipoprotein, and high-density lipoprotein. The results are shown in Table 2 below.

[0067] Table 2

[0068] Note: Compared with the normal group, * P < 0.01; compared with the model group, # P < 0.05 ## P < 0.01.

[0069] The test results in the table above show that the Qi Xue Gu Ben oral liquid prepared by this invention can reduce total cholesterol, triglycerides, and low-density lipoprotein levels, and increase high-density lipoprotein levels. Moreover, the improvement effect increases with the increase of dosage, indicating that the Qi Xue Gu Ben oral liquid prepared by this invention has a good therapeutic effect on improving cardiovascular and cerebrovascular diseases such as hyperlipidemia.

[0070] The above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art can still make modifications or equivalent substitutions to the specific implementation schemes of the present invention, and these modifications or equivalent substitutions do not depart from the spirit and scope of the present invention, and are all within the protection scope of the claims of the present invention.

Claims

1. Application of Qi Xue Gu Ben Oral Liquid in the preparation of drugs to improve hyperlipidemia.

2. The application according to claim 1, characterized in that: The drug mentioned is one that can lower total cholesterol, triglycerides, and low-density lipoprotein levels.

3. The application according to claim 1, characterized in that: The drug mentioned is one that can increase the level of high-density lipoprotein.

4. The application according to claim 1, characterized in that: The drug described is capable of lowering total cholesterol, triglycerides, and low-density lipoprotein levels, while increasing high-density lipoprotein levels.

5. The application according to any one of claims 1-4, characterized in that: The Qi and Blood Strengthening Oral Liquid is prepared by the following method: (1) Weigh lotus seeds and pine nuts, crush them, and then soak them to obtain soaking liquid for later use; (2) Weigh the rose hips and extract them to obtain extract A, which is then set aside. (3) Weigh out Acanthopanax senticosus, Schisandra chinensis, Epimedium, Morinda officinalis, Cuscuta chinensis, Ligustrum lucidum, Anemarrhena asphodeloides, Phellodendron chinense, Lycium barbarum, Rehmannia glutinosa, Polygonum multiflorum, Polygonatum sibiricum, Rubus idaeus, Dioscorea opposita, Ziziphus jujuba var. spinosa, pine needles and Platycladus orientalis seeds for extraction to obtain extract B, which is used for later use; (4) Take the soaking solution, extract A and extract B and concentrate them to obtain the extract; mix the extract with honey and purified water to obtain the Qi and Blood Strengthening Oral Liquid. The extraction described in step (3) needs to be carried out under high-pressure steam heating conditions; the steam pressure from the initial heating to boiling is 0.05-0.2MPa, the steam pressure is 0.01-0.05MPa within 1 hour after boiling, and the steam pressure is 0.1-0.15MPa from 1 hour after boiling to the end, and the temperature is 95-100℃.

6. The application according to claim 5, characterized in that: The particle size of the pulverized material in step (1) is 250μm-850μm; the ratio of water added to the mass of the medicinal material during soaking is 4-6:1; the soaking time is 3-5 hours; and the material is stirred for 2-5 minutes every 30 minutes during the soaking process.

7. The application according to claim 5, characterized in that: In step (2), the ratio of water added to the mass of medicinal materials is 5-8:

1. The extraction is carried out by decoction, which is carried out twice. The first decoction takes 1.5-2.5 hours, and the second decoction takes 0.5-1.5 hours.

8. The application according to claim 5, characterized in that: The extraction process in step (3) involves a water-to-medicinal-material ratio of 5-8:

1. The extraction is performed by decoction, which is repeated twice. The first decoction takes 3-6 hours, and the second decoction takes 2-4 hours.

9. The application according to claim 5, characterized in that: The Qi and Blood Strengthening Oral Liquid, by weight, comprises the following components: 70-90 parts of Rosa rugosa fruit, 70-90 parts of Acanthopanax senticosus, 20-30 parts of Schisandra chinensis, 20-30 parts of Epimedium brevicornu, 5-10 parts of Morinda officinalis, 5-10 parts of Cuscuta chinensis, 5-10 parts of Ligustrum lucidum, 15-30 parts of Anemarrhena asphodeloides, 15-30 parts of Phellodendron chinense, 5-10 parts of Lycium barbarum, 30-50 parts of Nelumbo nucifera, 5-10 parts of Rehmannia glutinosa, 15-30 parts of Polygonum multiflorum, 10-20 parts of Polygonatum sibiricum, 20-30 parts of Rubus idaeus, 5-15 parts of Dioscorea opposita, 30-50 parts of Pine nuts, 10-15 parts of Ziziphus jujuba var. spinosa, 5-15 parts of pine needles, and 5-15 parts of Platycladus orientalis.

10. The application according to claim 9, characterized in that: The Qi and Blood Strengthening Oral Liquid, by weight, comprises the following components: 80 parts of Rosa rugosa fruit, 80 parts of Acanthopanax senticosus, 25 parts of Schisandra chinensis, 25 parts of Epimedium, 8 parts of Morinda officinalis, 8 parts of Cuscuta chinensis, 8 parts of Ligustrum lucidum, 20 parts of Anemarrhena asphodeloides, 20 parts of Phellodendron chinense, 8 parts of Lycium barbarum, 40 parts of Nelumbo nucifera, 8 parts of Rehmannia glutinosa, 25 parts of Polygonum multiflorum, 15 parts of Polygonatum sibiricum, 25 parts of Rubus idaeus, 10 parts of Dioscorea opposita, 40 parts of Pine nut, 12 parts of Ziziphus jujuba var. spinosa, 10 parts of pine needles, and 10 parts of Platycladus orientalis seed.

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