Traditional Chinese medicine composition for lowering lipid as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for lowering lipid as well as a preparation method and application. The lipid-lowering traditional Chinese medicine composition provided by the invention comprises a lipid-lowering core component and an auxiliary component, wherein the lipid-lowering core component consists of mallotus oblongifolius and lignum dalbergiae odoriferae; the auxiliary components comprise hawthorn and salvia miltiorrhiza. The lipid-lowering traditional Chinese medicine composition provided by the invention is simple in components, can remarkably improve various indexes of blood lipid of hyperlipidemia model animals, can reduce the body weight of the model animals, and can also reduce the expression quantity of inflammatory factors TNF-alpha of the hyperlipidemia model animals.

Description

[0001] Priority application This application claims priority to the Chinese invention patent application [2024119186453] "A Chinese medicine composition for lipid lowering, preparation method and application" filed on December 24, 2024, which is incorporated by reference in its entirety. Technical Field

[0002] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for reducing lipids, a preparation method and an application thereof. Background Art

[0003] Hyperlipidemia has become a common clinical disease and one of the "three major killers" threatening human life and health. It is closely related to the occurrence of various cardiovascular diseases. Therefore, research on effective lipid-lowering programs is of great significance for the prevention and treatment of cardiovascular diseases.

[0004] Although chemical drugs have obvious clinical therapeutic effects, they have a single target and are prone to adverse reactions (such as blood sugar disorders, rhabdomyolysis, abnormal liver function, etc.). Compared with chemical drugs, traditional Chinese medicine has the advantages of high safety, multiple pathways, and low price in lipid-lowering treatment. In addition, traditional Chinese medicine can not only lower blood lipids, but also has multiple effects such as anti-oxidation, lowering blood sugar, and enhancing immunity, which can achieve both symptomatic and root treatment. Therefore, traditional Chinese medicine lipid-lowering drugs can provide patients with safer and more effective treatment options. However, traditional Chinese medicine faces the problem of unclear treatment mechanism and unclear treatment effect. Therefore, improving the efficacy and safety of traditional Chinese medicine treatment is the key to the development of new traditional Chinese medicine.

[0005] The patent with publication number CN110742990A and invention name "A Chinese medicine composition, preparation and application for treating non-alcoholic simple fatty liver" discloses an active composition, including 24-36 parts of partridge tea, 8-12 parts of oriental rhizome, 8-12 parts of turmeric, 8-12 parts of astragalus, 8-12 parts of hawthorn, 8-12 parts of lotus leaf, 8-12 parts of salvia miltiorrhiza and 2-4 parts of notoginseng powder. The active composition has the effects of removing dampness and promoting bile secretion, eliminating greasiness, and lowering blood lipids. It has been experimentally verified that it has an effect on non-alcoholic simple fatty liver and can eliminate multiple abnormal liver function indicators in patients with non-alcoholic simple fatty liver. However, a variety of heat-clearing and purgative ingredients (such as oriental rhizome and lotus leaf) are added to the active composition, but these ingredients are relatively irritating to the gastrointestinal tract. In addition, notoginseng powder is not suitable for all people.

[0006] In summary, it is necessary to propose new methods and strategies to improve existing technologies. Summary of the invention

[0007] The object of the present invention is to provide a Chinese medicine composition for reducing lipids, a preparation method and an application thereof, so as to partially solve or alleviate the above-mentioned deficiencies in the prior art. The present invention specifically adopts the following technical solutions.

[0008] On one hand, the present invention provides a traditional Chinese medicine composition for reducing blood lipids, comprising a core component for reducing blood lipids and auxiliary components, wherein the core component for reducing blood lipids consists of quail tea and dalbergia odorifera; the auxiliary components include hawthorn and salvia miltiorrhiza; the weight ratio of quail tea and dalbergia odorifera in the core component for reducing blood lipids is 6-10:1; the weight ratio of hawthorn and salvia miltiorrhiza in the auxiliary components is 1:5-1; and the total weight of the core component for reducing blood lipids is less than the total weight of the auxiliary components.

[0009] Furthermore, the weight ratio of partridge tea to dalbergia odorifera in the lipid-lowering core ingredient includes 6:1, 7:1, 8:1, 9:1 or 10:1.

[0010] Furthermore, the weight ratio of hawthorn and salvia miltiorrhiza in the auxiliary ingredients includes 1:1, 2:1, 3:1, 4:1 or 5:1.

[0011] In some preferred embodiments, the weight ratio of hawthorn to salvia miltiorrhiza in the auxiliary ingredients is 1:1.

[0012] Furthermore, the weight ratio of the lipid-lowering core ingredient to the auxiliary ingredient is 13:40 to 35:40.

[0013] Furthermore, the Chinese medicine composition specifically comprises the following materials in parts by weight: 10-40 parts of partridge tea, 3-10 parts of dalbergia odorifera, 20-40 parts of hawthorn, and 20-40 parts of salvia miltiorrhiza.

[0014] Furthermore, the Chinese medicine composition specifically includes the following materials in parts by weight: 10-30 parts of partridge tea, 3-7 parts of dalbergia odorifera, 20-30 parts of hawthorn, and 20-30 parts of salvia miltiorrhiza.

[0015] In some preferred embodiments, the Chinese medicine composition for lowering blood lipids comprises 20 parts of hawthorn, 20 parts of salvia miltiorrhiza, 30 parts of partridge tea, and 5 parts of dalbergia odorifera.

[0016] In other preferred embodiments, the Chinese medicine composition comprises: 10-30g of partridge tea, 3-7g of dalbergia odorifera, 20-30g of hawthorn, and 20-30g of salvia miltiorrhiza.

[0017] More preferably, the Chinese medicine composition comprises: 10g of partridge tea, 3g of dalbergia odorifera, 20g of hawthorn, and 20g of salvia miltiorrhiza.

[0018] Furthermore, the Dalbergia odorifera includes Dalbergia odorifera medicinal materials and Dalbergia odorifera oil extracted and prepared from the Dalbergia odorifera medicinal materials in the above proportion by weight.

[0019] Furthermore, the Dalbergia odorifera medicinal material includes Dalbergia odorifera powder and / or Dalbergia odorifera sheets.

[0020] Furthermore, the Chinese medicine composition is extracted by water extraction and / or alcohol extraction.

[0021] Another aspect of the present invention is to provide a preparation method.

[0022] The preparation method of the above-mentioned Chinese medicine composition comprises the following steps: S01: Prepare the first material, including the following materials in parts by weight: 10-40 parts of partridge tea, 20-40 parts of hawthorn and 20-40 parts of salvia miltiorrhiza; prepare 3-10 parts of dalbergia odorifera as the second material; S02: Add 10-20 times the volume of pure water by weight of the first material to fully soak, decoct and extract at 90-100°C for 60-100 min, and filter to obtain the first extract; add 5-10 times the volume of pure water by weight of the material again, continue to decoct and extract at 90-100°C for 60-100 min; then add the second material, decoct for 10-30 min, and filter to obtain the second extract; combine the two extracts, concentrate, and dry to obtain a dry paste.

[0023] In some preferred embodiments, the decoction temperature is 95-100° C.; and the decoction time after adding the second material is 10-20 min.

[0024] Furthermore, the preparation method further comprises the following steps: S02: After the first material and the second material are evenly mixed, high-concentration ethanol with a volume of 6-10 times the weight of the materials is added, and ultrasonic treatment is performed to fully mix and soak, and then reflux extraction is performed at 60-75°C for 60-100 minutes, and the first extract is obtained by filtering; 6-10 times the volume of high-concentration ethanol is added again, and reflux extraction is performed at 60-75°C for 60-100 minutes, and the second extract is obtained by filtering; the two extracts are combined, concentrated, and dried to obtain a dry paste.

[0025] In some preferred embodiments, the ultrasonic treatment time is 30-60 min; the reflux extraction temperature is 65-75° C.; the ethanol used is high-concentration ethanol, such as 75% ethanol; and the volume of high-concentration ethanol added for the first time is 8-10 times the weight of the material.

[0026] A Chinese medicine preparation comprising any of the above Chinese medicine compositions and / or other pharmaceutically acceptable excipients and / or adjuvants.

[0027] The term "pharmaceutically acceptable" as used herein refers to compounds, raw materials, compositions and / or dosage forms that are suitable for contact with patient tissues without excessive toxicity, irritation, allergic reaction, other complications or with a reasonable benefit / risk ratio within the scope of reasonable medical judgment. "Pharmaceutically acceptable excipients and / or adjuvants" refer to pharmaceutically acceptable carriers, diluents or excipients, which are added at appropriate steps in the drug preparation process.

[0028] Furthermore, the dosage form of the traditional Chinese medicine preparation includes granules, powders, tablets, capsules and / or pills.

[0029] For example, for oral administration in the form of tablets, the active Chinese medicine composition can be mixed with a pharmaceutically acceptable oral non-toxic inert carrier (such as glycerol, mannitol, sorbitol, etc.), and can also be mixed with a lubricant (such as talc, colloidal silicon dioxide, magnesium stearate, etc.), a preservative, a dispersant or a disintegrant to prepare a predetermined dosage form.

[0030] In the Chinese medicine composition for reducing lipids provided by the present invention, partridge tea has the effects of reducing lipids and digesting food; the partridge tea is warm in nature, fragrant and pungent, warms and relieves stagnation, and has the effects of promoting blood circulation and dispersing blood stasis, stopping bleeding and relieving pain; and partridge tea is compatible to form the core lipid-lowering component of the present invention. In addition, hawthorn and salvia miltiorrhiza are also supplemented. Hawthorn tastes sour and sweet, has a flat qi, enters the Taiyin spleen and the Jueyin liver meridians of the foot, eliminates accumulation and breaks knots, promotes blood circulation and relieves blood stasis. It can eliminate and grind, and all old meat, food retention, blood syndrome and gas blocks are eliminated. Salvia miltiorrhiza tastes bitter and slightly cold, enters the Shaoyin and Jueyin meridians of the hand as the minister medicine, and the "Compendium of Materia Medica" states that it can grind and break stagnation, break old blood, generate new blood, dredge blood vessels, and is a good product for promoting blood circulation.

[0031] Beneficial technical effects: (1) The present invention provides a new lipid-lowering Chinese medicine composition. The lipid-lowering Chinese medicine composition has a streamlined composition of only 4 ingredients, but has been verified to have a significant lipid-lowering effect in cell experiments and animals. It has been verified that the lipid-lowering Chinese medicine composition provided by the present invention can significantly improve various blood lipid indicators of hyperlipidemia model animals, reduce the body weight of model animals, and reduce the expression of inflammatory factor TNF-α in hyperlipidemia model animals, and its efficacy is better than that of the chemical drug rosuvastatin. The above results prove that the lipid-lowering Chinese medicine composition provided by the present invention has a good lipid-lowering (including reducing blood lipids and body weight) effect. In addition, since the lipid-lowering composition provided by the present invention has streamlined ingredients, the overall safety of the drug is high, and it is easier to achieve standardized monitoring of quality control in industrial production.

[0032] (2) Specifically, the lipid-lowering Chinese medicine composition provided by the present invention comprises partridge tea and dalbergia odorifera as the core lipid-lowering ingredients, and is supplemented with hawthorn and salvia miltiorrhiza. The present invention conducts rigorous exploration of the material ratio, and the final compound obtained can take into account both good efficacy and high safety.

[0033] (3) The present invention uses HepG2 cells to establish a lipid accumulation model to screen the optimal ratio and extraction method of the lipid-lowering composition. The optimal lipid-lowering Chinese medicine composition can reduce the lipid accumulation of HepG2 cells and reduce the intracellular triglyceride (TG) content.

[0034] (4) The present invention established an acute hyperlipidemia animal model by intraperitoneally injecting 75% egg yolk milk into mice, and detected the total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), and high-density lipoprotein (HDL-C) in the serum of mice. The TC, TG, and LDL-C levels in the high-dose group of the lipid-lowering Chinese medicine composition were significantly reduced, and the HDL-C level was significantly increased. In terms of reducing TC and TG, the lipid-lowering Chinese medicine composition experimental group was superior to the chemical drug rosuvastatin group (positive control group). The experimental results show that the lipid-lowering Chinese medicine composition of the present invention can significantly reduce the TC, TG, and LDL-C levels in the serum of hyperlipidemia mice, increase the HDL-C content, and has good lipid-lowering activity in vivo.

[0035] (5) The present invention establishes a rat hyperlipidemia model induced by a high-fat diet to explore the effect of the lipid-lowering Chinese medicine composition on improving the body weight of hyperlipidemia rats. The lipid-lowering Chinese medicine composition of the present invention can significantly reduce the TC, TG, and LDL-C levels in the serum of hyperlipidemia rats, increase the HDL-C content, and has good lipid-lowering activity in vivo. In addition, the weight growth rate of rats given the lipid-lowering Chinese medicine composition decreased, and the effect was better than that of the positive control group, which also proved that the lipid-lowering Chinese medicine composition of the present invention has the effect of reducing body weight. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. In all the drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, each element or part is not necessarily drawn according to the actual scale. Obviously, the drawings described below are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without paying creative labor.

[0037] Figure 1 The weight growth rate of rats in the chronic hyperlipidemia model in one embodiment of the present invention; Figure 2 The liver condition of rats in a chronic hyperlipidemia model in one of the embodiments of the present invention; Figure 3 This is the determination of the levels of inflammatory factors in the serum of rats with chronic hyperlipidemia model in one of the embodiments of the present invention. DETAILED DESCRIPTION

[0038] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0039] Herein "and / or" includes any and all combinations of one or more of the associated listed items.

[0040] Herein, "plurality" means two or more than two, ie, it includes two, three, four, five, etc.

[0041] As used in this specification, the term "about" typically means + / - 5% of the stated value, more typically + / - 4% of the stated value, more typically + / - 3% of the stated value, more typically + / - 2% of the stated value, even more typically + / - 1% of the stated value, and even more typically + / - 0.5% of the stated value.

[0042] In this specification, some embodiments may be disclosed in a format of being in a range. It should be understood that this description of "being in a range" is only for convenience and brevity, and should not be interpreted as a rigid limitation on the disclosed range. Therefore, the description of the range should be considered to have specifically disclosed all possible sub-ranges and independent numerical values ​​within this range. For example, the description of the range 1-6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within this range, such as 1, 2, 3, 4, 5 and 6. Regardless of the breadth of the range, the above rules apply.

[0043] Example 1 This embodiment provides an example of a Chinese medicine composition for reducing lipids, comprising the following raw materials in parts by weight: 20 parts of hawthorn, 20 parts of salvia miltiorrhiza, 30 parts of quail tea, and 5 parts of aloeswood powder; wherein quail tea and aloeswood constitute the core components for reducing lipids; hawthorn and salvia miltiorrhiza serve as auxiliary components. The preparation method includes pretreatment, extraction, and posttreatment, as follows.

[0044] A. Pretreatment: crush the raw materials hawthorn, salvia miltiorrhiza and partridge tea in the formula ratio through a 40-60 mesh sieve to obtain material a for later use; crush the raw material dalbergia odorifera in the formula ratio through a 40-60 mesh sieve to obtain material b for later use.

[0045] B. Extraction: Add 10 times the volume of pure water by weight of material a to material a, soak for 30 minutes, then boil and extract at 95-100℃ for 60 minutes, filter to obtain the first extract, add 8 times the volume of pure water by weight of material again, continue to boil and extract at 95-100℃ for 80 minutes, then add material b, boil for 10 minutes, filter to obtain the second extract. Filter and combine the two extracts, concentrate, and dry to obtain a dry paste.

[0046] C. Post-processing: Grind the dry paste to obtain fine powder, add appropriate amount of auxiliary materials and mix evenly to obtain a traditional Chinese medicine preparation that helps lower blood lipids.

[0047] The lipid-lowering Chinese medicine composition provided in this example (referred to as Composition 1) was used for cell experiments to detect the effect of Composition 1 on Oil Red O staining of HepG2 cells and the determination of intracellular TG content. The degree of damage of Composition 1 to HepG2 cells was detected by MTT experiment to evaluate the in vitro lipid-lowering activity of Composition 1.

[0048] The results showed that compared with the blank group, a large number of red lipid droplets appeared in the model group (without any drug treatment), and the TG content in the model group was significantly increased (P<0.001). Compared with the model group, the number and size of red lipid droplets in the experimental group were significantly reduced (P<0.001), with good dose dependence. Furthermore, the higher the concentration of composition 1, the fewer the number of red lipid droplets. The above results show that composition 1 prepared in this example can effectively reduce the TG content in HepG2 cells induced by oleic acid, reduce the lipid accumulation of HepG2 cells, and has good in vitro lipid-lowering activity.

[0049] Table 1 CCK8 toxicity test of lipid-lowering composition in Example 1 Table 2 Efficacy of lipid-lowering composition of Example 1 in cell experiment The results were further verified by establishing animal hyperlipidemia models, including acute hyperlipidemia models in mice and chronic hyperlipidemia models in rats.

[0050] Mouse acute hyperlipidemia model: An acute hyperlipidemia animal model was established by intraperitoneal injection of 75% egg yolk milk into mice. The total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-C), and high-density lipoprotein (HDL-C) in the serum of the mouse model were detected to further verify that the lipid-lowering composition of Example 1 had a significant lipid-lowering effect.

[0051] Experimental methods: Take a few fresh eggs, make a small hole in the bottom to drain the egg white, gently place the egg yolk in an empty beaker, insert a needle into the egg yolk film to absorb the egg yolk liquid, put it in a 100mL volumetric flask, measure 75mL of egg yolk liquid and dilute it to 100mL with physiological saline. Stir the egg yolk milk solution with a magnetic stirrer for 10 minutes to make the egg yolk milk solution uniform in order to reduce the error. It is temporarily prepared when used.

[0052] Weigh 5.00g of CMC-Na accurately, place it in a beaker, add 800mL of purified water, stir evenly, place it in a 1000mL volumetric flask, and add purified water to the mark to prepare a 0.5% CMC-Na solution.

[0053] Accurately weigh 6.5 mg of rosuvastatin (1.30 mg / kg) and place it in a 100 mL volumetric flask, suspend it in 0.5% CMC-Na solution and make it up to 100 mL. Prepare a 0.065 mg / mL drug solution sample.

[0054] Weigh 1.23 g of the compound (2.47 g / kg) accurately and place them in 10 mL volumetric flasks, suspend them in 0.5% CMC-Na solution and make up to 10 mL. Prepare a 123 mg / mL compound drug solution sample.

[0055] The mice were randomly divided into 6 groups, 6 mice in each group, which were set as blank control group, 75% egg yolk milk high-fat model group, and combination 1 administration group (low dose 1.24g / kg, medium dose 2.47g / kg, high dose 4.94g / kg), and rosuvastatin was used as the positive drug control group. The blank control group and the 75% egg yolk milk high-fat model group were gavaged with 0.5% CMC-Na at 0.2ml / 10g per day, and the other drug groups were gavaged with 0.2ml / 10g of the corresponding drug per day. The drug was administered continuously for 5 days. 2h after the last administration, each group was intraperitoneally injected with 0.5ml / mouse of 75% egg yolk milk saline solution to cause experimental hyperlipidemia. Fasting after 8h, gavage after 12h, and blood was collected after 1h. The serum was centrifuged and separated by eyeball blood collection method to determine the contents of TC, TG, LDL-C and HDL-C respectively). Experiments have shown that the high-dose group of Composition 1 has the effect of significantly reducing TC, TG, and LDL-C.

[0056] Table 3 Evaluation table of the pharmacodynamic effects of the lipid-lowering composition of Example 1 based on mouse experiments Note: Compared with the blank group a p<0.05, b p<0.01; compared with the model group c p<0.05, d p<0.01.

[0057] Compared with the blank group, the TC, TG and LDL-C levels in the serum of the mice in the model group were significantly increased, and the HDL-C content was significantly decreased. Compared with the model group, the TC, TG and LDL-C levels in the serum of the mice in the positive group were significantly decreased, and the HDL-C content was significantly increased. The TC, TG and LDL-C levels in the serum of the mice in the high-dose group of composition 1 were significantly decreased, and the HDL-C content was significantly increased.

[0058] The above results show that the experimental group is superior to the positive control group in reducing TC and TG. Specifically, composition 1 can significantly reduce the TC, TG, and LDL-C levels in the serum of hyperlipidemia mice and increase the HDL-C content, and has good lipid-lowering activity in vivo.

[0059] Rat chronic hyperlipidemia model: A high-fat diet-induced hyperlipidemia rat model was established, and the total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL-C), and high-density lipoprotein (HDL-C) in the rat serum were detected. The composition 1 provided by the present invention had an improving effect on the blood lipid indexes of the high-fat group rats.

[0060] Table 4 Evaluation table of the pharmacodynamic effects of the lipid-lowering composition of Example 1 based on rat experiments Note: The high / medium / low doses of Composition 1 in Table 4 are 3.9 g / kg, 1.95 g / kg and 0.975 g / kg, respectively.

[0061] Compared with the blank group, the TC, TG and LDL-C levels in the serum of the model group rats were significantly increased, and the HDL-C content was significantly decreased. Compared with the model group, the TC, TG and LDL-C levels in the serum of the positive group mice were significantly decreased, and the HDL-C content was significantly increased. The TC, TG and LDL-C levels in the serum of the mice in the high-dose group of composition 1 were significantly decreased, and the HDL-C content was significantly increased. And it is superior to the positive control group in reducing TC, TG and LDL-C. Specifically, composition 1 can significantly reduce the TC, TG and LDL-C levels in the serum of hyperlipidemia rats, increase the HDL-C content, and has good lipid-lowering activity in vivo.

[0062] Furthermore, 60 SPF SD rats that passed the quarantine were randomly divided into 6 groups according to their body weight, namely, high-dose group, medium-dose group, low-dose group, positive control group (given rosuvastatin), model group and normal control group; 10 rats in each group. The model group and the normal control group were given the same volume of solvent (0.5% carboxymethyl cellulose solution). The hyperlipidemia model animals were fed with a high-fat feed, and the normal control group animals were fed with a breeding feed for 4 weeks before administration. During the administration period, the normal control group animals were fed with a breeding feed, and the animals in the other groups were fed with a high-fat feed. The rats were weighed before the experiment, after modeling and after administration, and the results are as follows: Figure 1 , where the dosing group represented the high dose of Composition 1 at 3.9 g / kg. Figure 1 It can be seen that under the condition of continuous feeding with high-fat diet, the weight growth rate of rats in the drug administration group decreased, and the effect was better than that of the positive control group, which proved that the Chinese medicine composition for lipid-lowering in Example 1 also has the effect of reducing body weight.

[0063] Furthermore, on the day after the last administration, the animals were anesthetized with chloral hydrate, blood was collected from the abdominal aorta, body weight was measured, and liver tissue was obtained. Figure 2 .

[0064] Figure 2 It can be seen that the color and appearance of the liver of rats in the high (MLGmH), medium (MLGmM), low dose (MLGmL) group of composition 1 and the model control group are significantly different from those in the normal control group. The model group has fatty liver caused by high fat, and the cross section of the normal liver is uniform in color and has no obvious fat particles. However, obvious yellow fat particles can be seen on the cross section of the fatty liver.

[0065] Therefore, composition 1 improves the pathological changes of liver tissue in hyperlipidemia rats; it can effectively reduce liver cell cavitation, reduce fat accumulation in the liver, and effectively restore the normal morphology of liver cells.

[0066] The content of inflammatory factor TNF-α in rat serum was further determined. The experimental results are shown in Figure 3 The results showed that compared with the control group, the TNF-α content in the serum of the model group rats was significantly increased, and the TNF-α inflammatory factor content in the positive control group and the medium and high dose groups of Composition 1 was significantly reduced after administration, and the efficacy of Composition 1 was significantly better than that of the positive control group, among which the high dose group of Composition 1 had the best effect.

[0067] Example 2 This embodiment provides another example of a Chinese medicine composition for reducing lipids, comprising the following raw materials in parts by weight: 20 parts of hawthorn, 20 parts of salvia miltiorrhiza, 30 parts of quail tea, and dalbergia odorifera oil (a volatile oil of dalbergia odorifera extracted from 5 parts of dalbergia odorifera medicinal materials); wherein quail tea and dalbergia odorifera oil constitute the core components for reducing lipids; hawthorn and salvia miltiorrhiza serve as auxiliary components. The preparation method includes pretreatment, extraction and posttreatment, as follows.

[0068] A. Pretreatment: crush the raw materials hawthorn, salvia miltiorrhiza and partridge tea in the formula ratio and pass them through a 40-60 mesh sieve to obtain material a for later use, and use the dalbergia odorifera oil in the formula ratio as material b for later use.

[0069] B. Extraction: Add 10 times the volume of pure water by weight of material a to material a, soak for 30 minutes, then boil and extract at 95-100℃ for 60 minutes, filter to obtain the first extract; add 8 times the volume of pure water by weight of material again, continue to boil and extract at 95-100℃ for 80 minutes, then add material b, boil for 10 minutes, filter to obtain the second extract. Filter and combine the two extracts, concentrate, and dry to obtain a dry paste.

[0070] C. Post-processing: crush the dry paste to obtain fine powder, add appropriate amount of auxiliary materials and mix evenly to obtain the target Chinese medicine composition that helps lower blood lipids.

[0071] This example provides a Chinese medicine composition for lipid-lowering (referred to as Composition 2). Cell experiments were performed to detect the effect of Composition 2 on Oil Red O staining of HepG2 cells and the determination of intracellular TG content. The degree of damage of Composition 2 to HepG2 cells was detected by MTT experiment to evaluate the in vitro lipid-lowering activity of Composition 2.

[0072] Compared with the blank group, a large number of red lipid droplets appeared in the model group, and the TG content in the model group was significantly increased (P<0.001). Compared with the model group, the number and size of red lipid droplets in composition 2 were significantly reduced (P<0.001), with good dose dependence. The higher the concentration of composition 2, the fewer the number of red lipid droplets. The above results show that composition 2 can reduce the TG content in HepG2 cells induced by oleic acid, reduce the lipid accumulation of HepG2 cells, and has good in vitro lipid-lowering activity.

[0073] Table 5 CCK8 toxicity test of lipid-lowering composition in Example 2 Table 6 Efficacy of lipid-lowering composition of Example 2 The same measurement method as in Example 1 further confirmed that Composition 2 had a significant lipid-lowering effect in animal experiments.

[0074] Experimental methods: Take a number of fresh eggs and make a small hole in the bottom to drain the egg white. Place the egg yolk gently in an empty beaker and insert a syringe into the egg yolk film to draw out the egg yolk liquid. Place it in a 100mL volumetric flask and measure 75mL of egg yolk liquid. Dilute it to 100mL with physiological saline. Stir the egg yolk milk solution with a magnetic stirrer for 10 minutes to make the egg yolk milk solution uniform in order to reduce errors. Prepare it temporarily when using. Weigh 5.00g CMC-Na accurately, place it in a beaker, add 800mL purified water, stir evenly, place it in a 1000mL volumetric flask, add purified water to the mark, and prepare a 0.5% CMC-Na solution.

[0075] Accurately weigh 6.5 mg of rosuvastatin (1.30 mg / kg) into a 100 mL volumetric flask, suspend it in 0.5% CMC-Na solution and make up to 100 mL to prepare a 0.065 mg / mL drug solution sample.

[0076] Weigh 1.17 g of the compound (2.34 g / kg) accurately and place them in 10 mL volumetric flasks, suspend them in 0.5% CMC-Na solution and make up to 10 mL. Prepare a 117 mg / mL compound drug solution sample.

[0077] Mice were randomly divided into 6 groups, 6 mice in each group, set as blank control group, 75% egg yolk milk high-fat model group, drug group (low 1.17 g / kg, medium 2.34 g / kg, high dose 4.68 g / kg), rosuvastatin as positive drug control group. The blank control group and 75% egg yolk milk high-fat model group were gavaged with 0.5% CMC-Na at 0.2 ml / 10 g daily, and the other drug groups were gavaged with 0.2 ml / 10 g volume of the corresponding drug daily. The drug was administered for 5 consecutive days. 2 hours after the last administration, each group was intraperitoneally injected with 75% egg yolk milk saline solution 0.5 ml / mouse to cause experimental hyperlipidemia. Fasting after 8 hours, gavage after 12 hours, and blood was collected after 1 hour. The serum was centrifuged and separated by eyeball blood collection method to determine the contents of TC, TG, LDL-C and HDL-C respectively).

[0078] Table 7 Evaluation table of the pharmacodynamic effects of the lipid-lowering composition of Example 2 based on animal experiments Note: Compared with the blank group a p<0.05, b p<0.01; compared with the model group c p<0.05, d p<0.01.

[0079] Example 3 This embodiment provides another example of a Chinese medicine composition for reducing lipids, comprising the following medicinal pieces by weight: 20 parts of hawthorn, 20 parts of salvia miltiorrhiza, 30 parts of quail tea, and 5 parts of dalbergia odorifera. Among them, quail tea and dalbergia odorifera constitute the core components of lipid-lowering; hawthorn and salvia miltiorrhiza serve as auxiliary components. The preparation method includes pre-treatment, extraction and post-treatment.

[0080] Mix all the materials evenly, add 75% ethanol in an amount of 8 times the weight of the materials, perform ultrasonic treatment for 30 minutes, extract under reflux at 65-75°C for 60 minutes, filter to obtain the first filtrate, add 75% ethanol in an amount of 6 times the weight of the materials, extract under reflux at 65-75°C for 60 minutes, filter to obtain the second filtrate. Combine the two extracts, concentrate, and dry to obtain a dry paste.

[0081] This example provides a Chinese medicine composition for lipid reduction (referred to as composition 3). The cell experiment detected the effect of composition 3 on HepG2 cell Oil Red O staining and the intracellular TG content. The MTT experiment detected the degree of damage of composition 3 to HepG2 cells, and the in vitro lipid-lowering activity of composition 3 was evaluated. Compared with the blank group, a large number of red lipid droplets appeared in the model group, and the TG content in the model group was significantly increased (P<0.001). Compared with the model group, the number and size of red lipid droplets in composition 3 were significantly reduced (P<0.001), with good dose dependence. The higher the concentration of composition 3, the fewer the number of red lipid droplets. The above results show that composition 3 can reduce the TG content in HepG2 cells induced by oleic acid, reduce the lipid accumulation of HepG2 cells, and has good in vitro lipid-lowering activity.

[0082] Table 8 CCK8 toxicity test of lipid-lowering composition in Example 3 Table 9 Efficacy of the lipid-lowering composition of Example 3 in cell experiment Example 4 This embodiment provides another example of a Chinese medicine composition for reducing lipids, comprising the following raw materials in parts by weight: 20 parts of hawthorn, 20 parts of salvia miltiorrhiza, 30 parts of partridge tea, and dalbergia odorifera oil (dalbergia odorifera volatile oil extracted from 5 parts of dalbergia odorifera medicinal materials). The preparation method includes pre-treatment, extraction and post-treatment.

[0083] Mix all the materials evenly, add 75% ethanol in an amount of 8 times the weight of the materials, perform ultrasonic treatment for 30 minutes, reflux extract at 65-75°C for 60 minutes, filter to obtain the first filtrate, add 6 times the volume of 75% ethanol again, reflux extract at 65-75°C for 60 minutes, filter to obtain the second filtrate; combine the two extracts, concentrate, and dry to obtain a dry paste.

[0084] This example provides a Chinese medicine composition for lipid reduction (referred to as composition 4). The cell experiment detected the effect of composition 4 on HepG2 cell Oil Red O staining and the intracellular TG content. The MTT experiment detected the degree of damage of composition 4 to HepG2 cells, and the in vitro lipid-lowering activity of composition 4 was evaluated. Compared with the blank group, a large number of red lipid droplets appeared in the model group, and the TG content in the model group was significantly increased (P<0.001). Compared with the model group, the number and size of red lipid droplets in composition 4 were significantly reduced (P<0.001), with good dose dependence. The higher the concentration of composition 4, the fewer the number of red lipid droplets. The above results show that composition 4 can reduce the TG content in HepG2 cells induced by oleic acid, reduce the lipid accumulation of HepG2 cells, and has good in vitro lipid-lowering activity.

[0085] Table 10 CCK8 toxicity test of lipid-lowering composition of Example 4 Table 11 Efficacy of the lipid-lowering composition of Example 4 in cell experiment Example 5 This example further provides component screening and verification of the above-mentioned Chinese medicine composition for lowering blood lipids.

[0086] First, this example provides a composition without dalbergia odorifera as a comparison.

[0087] Comparative composition 1: 30 parts of partridge tea, 10 parts of oriental rhizome, 10 parts of turmeric, 10 parts of astragalus, 10 parts of hawthorn, 10 parts of lotus leaf, 10 parts of salvia miltiorrhiza, and 3 parts of Panax notoginseng powder.

[0088] Table 12 Comparison of cell survival rate in CCK-8 toxicity assay Note: Usually, a cell survival rate of less than 50% indicates high toxicity. Usually, the drug concentration with a cell survival rate greater than 70% is selected as the effective drug concentration.

[0089] Table 13 Efficacy test based on triglyceride reduction rate Note: The higher the triglyceride reduction rate (TG), the better the drug efficacy.

[0090] The above experimental results show that at the same drug dose, the lipid-lowering composition shown in Composition 1 has a more obvious efficiency in lowering triglycerides than the control composition; in addition, at the same drug dose, the lipid-lowering composition shown in Composition 1 has a higher cell survival rate than the control composition, proving that Composition 1 is less toxic and safer to use.

[0091] In addition, this embodiment also provides effect verification of other composition ratios.

[0092] Table 14 Comparison of cell survival rate in CCK-8 toxicity assay Table 15 Efficacy test based on triglyceride reduction rate The above experimental results show that when the total amount of the lipid-lowering core component is greater than the total amount of the auxiliary component (comparative composition 3), the toxicity of the composition is the lowest but the efficacy is the weakest; when the total amount of the auxiliary component is increased and the total amount of the lipid-lowering core component is further reduced (comparative composition 4), the toxicity of the composition is enhanced, but the highest dose of 1200µg / mL can still make the cell survival rate higher than 50%, so the weight ratio of the lipid-lowering core component and the auxiliary component in the composition should not be less than 13:40.

[0093] Furthermore, the efficacy of Composition 1 and Comparative Composition 2 was verified in a mouse acute hyperlipidemia model. The establishment of the mouse acute hyperlipidemia model was the same as the method in Example 1.

[0094] An acute hyperlipidemia animal model was constructed by intraperitoneal injection of 75% egg yolk milk into mice. The total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL-C), and high-density lipoprotein (HDL-C) in the serum of mice were detected. The composition 1 provided by the present invention improved the blood lipid indexes of the hyperlipidemia group mice, and could reduce the TC, TG, and LDL-C content in the serum of mice, and increase the HDL-C content. The efficacy was significantly improved after adding Dalbergia odorifera.

[0095] Table 16 Comparison of blood lipid detection in mice Note: The high / medium / low doses of composition 1 are 4.94 g / kg, 2.47 g / kg and 1.24 g / kg respectively. The dose of comparative composition 2 is 4.94 g / kg.

[0096] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation modes, which are merely illustrative rather than restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are within the protection of the present invention.

Claims

1. A Chinese medicine composition for reducing lipids, characterized in that: The invention comprises a lipid-lowering core component and auxiliary components, wherein the lipid-lowering core component is composed of quail tea and dalbergia odorifera; the auxiliary components include hawthorn and salvia miltiorrhiza; the weight ratio of quail tea and dalbergia odorifera in the lipid-lowering core component is 6-10:1; the weight ratio of hawthorn and salvia miltiorrhiza in the auxiliary components is 1:5-1; and the total weight of the lipid-lowering core component is less than the total weight of the auxiliary components.

2. The Chinese medicine composition according to claim 1, characterized in that The weight ratio of the lipid-lowering core ingredient to the auxiliary ingredient is 13:40 to 35:

40.

3. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition comprises the following materials in parts by weight: 10-40 parts of partridge tea, 3-10 parts of dalbergia odorifera, 20-40 parts of hawthorn, and 20-40 parts of salvia miltiorrhiza.

4. The Chinese medicine composition according to claim 3, characterized in that: The traditional Chinese medicine composition comprises the following materials in parts by weight: 10-30 parts of partridge tea, 3-7 parts of dalbergia odorifera, 20-30 parts of hawthorn, and 20-30 parts of salvia miltiorrhiza.

5. The Chinese medicine composition according to claim 3 or 4, characterized in that: The dalbergia odorifera comprises dalbergia odorifera medicinal materials and dalbergia odorifera oil extracted and prepared from the dalbergia odorifera medicinal materials in the aforementioned weight proportions.

6. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is extracted by water extraction and / or alcohol extraction.

7. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The following steps are involved: S01: Prepare the first material, including the following materials in parts by weight: 10-40 parts of partridge tea, 20-40 parts of hawthorn and 20-40 parts of salvia miltiorrhiza; prepare 3-10 parts of dalbergia odorifera as the second material; S02: Add 10-20 times the volume of pure water by weight of the first material to fully soak, decoct and extract at 90-100°C for 60-100 min, and filter to obtain the first extract; add 5-10 times the volume of pure water by weight of the material again, continue to decoct and extract at 90-100°C for 60-100 min; then add the second material, decoct for 10-30 min, and filter to obtain the second extract; combine the two extracts, concentrate, and dry to obtain a dry paste.

8. The preparation method according to claim 7, characterized in that: The following steps may also be included: S02: After the first material and the second material are evenly mixed, high-concentration ethanol with a volume of 6-10 times the weight of the materials is added, and ultrasonic treatment is performed to fully mix and soak, and then reflux extraction is performed at 60-75°C for 60-100 minutes, and the first extract is obtained by filtering; 6-10 times the volume of high-concentration ethanol is added again, and reflux extraction is performed at 60-75°C for 60-100 minutes, and the second extract is obtained by filtering; the two extracts are combined, concentrated, and dried to obtain a dry paste.

9. A Chinese medicine preparation, characterized in that: The invention comprises the Chinese medicine composition according to any one of claims 1 to 4 and / or other pharmaceutically acceptable excipients and / or adjuvants.

10. The Chinese medicine preparation according to claim 9, characterized in that: The dosage forms of the traditional Chinese medicine preparation include granules, powders, tablets, capsules and / or pills.

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