Traditional Chinese medicine composition for reducing total cholesterol

Abstract

The invention provides a traditional Chinese medicine composition for treating hyperlipidemia and application of the composition for treating hyperlipidemia. The traditional Chinese medicine composition is composed of uncaria, chrysanthemum, tribulus terrestris, mangnolia officinalis, elecampane, rhizoma atractylodis, radix trichosanthis, pogostemon cablin, radix puerariae, exocarpium citri grandis, radix angelicae, semen coicis, fructus oryzae germinatus, mint, poria cocos and Guangdong medicated leaven.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for lowering total cholesterol. Background Technology

[0002] Hyperlipidemia, often referred to as high blood lipids or dyslipidemia, typically refers to elevated levels of triglycerides (TG) and / or total cholesterol (TC) in blood plasma. It also includes elevated low-density lipoprotein cholesterol (LDL-C) and decreased high-density lipoprotein cholesterol (HDL-C).

[0003] Based on the different types of lipoproteins that cause elevated levels, hyperlipidemia is clinically classified into the following four types: hypercholesterolemia, hypertriglyceridemia, mixed hyperlipidemia, and low high-density lipoprotein cholesterol (HDL-C). The clinical classification is shown in the table below:

[0004] Total cholesterol Triglycerides High-density lipoprotein cholesterol hypercholesterolemia Increase normal normal Hypertriglyceridemia normal Increase normal Mixed hyperlipidemia Increase Increase normal Low high-density lipoprotein cholesterol normal normal reduce

[0005] High cholesterol levels in the blood, especially high levels of low-density lipoprotein (LDL), can increase the risk of cardiovascular disease. Furthermore, cholesterol buildup on arterial walls can lead to conditions such as atherosclerosis. Currently, most cholesterol-lowering drugs used clinically are chemical drugs, which can cause varying degrees of side effects. For example, statins can cause gastrointestinal reactions, liver damage, rhabdomyolysis, and abnormal blood sugar levels.

[0006] Traditional Chinese medicine (TCM) believes that hyperlipidemia is mainly related to the formation of turbidity, meridian blockage, and venous obstruction. Treatment methods include tonifying qi and strengthening the spleen, removing blood stasis and lowering lipids. Commonly used drugs include Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Astragalus membranaceus, Paeonia lactiflora, Angelica sinensis, Salvia miltiorrhiza, Crataegus pinnatifida, Prunus persica, Carthamus tinctorius, etc. Currently, the main TCM preparations that can be used to treat hyperlipidemia include Xuezhikang capsules (red yeast rice), Zhibituo capsules (crab, Atractylodes macrocephala, red yeast rice), Tongmai Jiangzhi tablets (pencil grass, Ligusticum chuanxiong, lotus leaf, Panax notoginseng, Zanthoxylum bungeanum), Dantian Jiangzhi pills (Salvia miltiorrhiza, Panax notoginseng, Polygonum multiflorum, ginseng, Polygonatum sibiricum, Alisma plantago-aquatica, Angelica sinensis, Ligusticum chuanxiong, cinnamon, Epimedium brevicornu, Acanthopanax senticosus), Zhibitai capsules (Atractylodes macrocephala, Crataegus pinnatifida, Alisma plantago-aquatica, red yeast rice), etc. As can be seen, most of these TCM preparations also contain red yeast rice, which contains a variety of natural statins. Therefore, the side effects of statin drugs, such as liver and kidney damage, still exist.

[0007] Therefore, finding safer, more effective, and cheaper drugs to lower blood lipids remains a key focus of research for many medical and scientific researchers. Summary of the Invention

[0008] This invention provides a traditional Chinese medicine composition capable of treating hyperlipidemia and its application in the preparation of drugs for treating hyperlipidemia.

[0009] The traditional Chinese medicine composition is as follows:

[0010] Uncaria rhynchophylla 20-50 parts by weight, Chrysanthemum 40-100 parts by weight

[0011] Tribulus terrestris 20-50 parts by weight, Magnolia officinalis 80-200 parts by weight

[0012] Costus root 80-200 parts by weight, Atractylodes lancea 80-200 parts by weight

[0013] Trichosanthes root 60-150 parts by weight; Patchouli 80-200 parts by weight

[0014] 80-200 parts by weight of kudzu root and 40-100 parts by weight of tangerine peel

[0015] Angelica dahurica 80-200 parts by weight; Coix seed 100-250 parts by weight

[0016] Rice sprouts 60-150 parts by weight, mint 40-100 parts by weight

[0017] Poria cocos 160-400 parts by weight, Guangdong Shenqu 80-200 parts by weight.

[0018] Furthermore, the traditional Chinese medicine composition of the present invention is as follows:

[0019] Uncaria rhynchophylla 30-40 parts by weight, Chrysanthemum 60-80 parts by weight

[0020] Tribulus terrestris 30-40 parts by weight, Magnolia officinalis 120-160 parts by weight

[0021] 120-160 parts by weight of costus root and 120-160 parts by weight of atractylodes rhizome.

[0022] Trichosanthes root 90-120 parts by weight; Patchouli 120-160 parts by weight

[0023] 120-160 parts by weight of kudzu root and 60-80 parts by weight of tangerine peel

[0024] Angelica dahurica 120-160 parts by weight, Coix seed 171 parts by weight

[0025] Rice sprouts 90-120 parts by weight, mint 60-80 parts by weight

[0026] Poria cocos 240-320 parts by weight, Guangdong Shenqu 120-160 parts by weight.

[0027] Preferably, the traditional Chinese medicine composition of the present invention is:

[0028] Uncaria rhynchophylla 34 parts by weight, Chrysanthemum 68 parts by weight

[0029] Tribulus terrestris 34 parts by weight, Magnolia officinalis 136 parts by weight

[0030] 136 parts by weight of Costus root and 136 parts by weight of Atractylodes lancea.

[0031] 102 parts by weight of Trichosanthes kirilowii pollen and 136 parts by weight of Patchouli.

[0032] 136 parts by weight of kudzu root and 68 parts by weight of tangerine peel

[0033] Angelica dahurica 136 parts by weight, Coix lacryma-jobi 171 parts by weight

[0034] Rice sprouts 102 parts by weight, mint 68 parts by weight

[0035] Poria cocos 273 parts by weight, Guangdong Shenqu 136 parts by weight.

[0036] The traditional Chinese medicine composition is prepared by extraction according to the following method:

[0037] Costus root, Atractylodes lancea, Mentha haplocalyx, Pogostemon cablin, and Citrus reticulata peel are steam distilled for 1-3 hours, and the volatile oil is collected and stored separately. The dregs and the aqueous solution after oil extraction are decocted with water 1-3 times, each time for 1-3 hours. The decoction is filtered, the filtrates are combined, concentrated, cooled, and ethanol is added to make the alcohol content reach 30-60%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and concentrated into a clear paste for later use.

[0038] Uncaria rhynchophylla, Tribulus terrestris, Chrysanthemum morifolium, Magnolia officinalis, and Guangdong Shenqu (a type of fermented medicinal herb) are decocted with water 1-3 times, each time for 1-3 hours. The decoctions are combined, filtered, concentrated, cooled, and ethanol is added to make the alcohol content reach 30-60%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and the mixture is concentrated into a clear extract for later use.

[0039] Coix seed and rice sprout are decocted with water 1 to 3 times, each time for 0.5 to 2 hours. The decoctions are combined, filtered, concentrated, cooled, and ethanol is added to make the alcohol content reach 30 to 60%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and concentrated into a clear extract for later use.

[0040] Poria cocos, Trichosanthes kirilowii, Angelica dahurica, and Pueraria lobata are decocted with water 1 to 3 times, each time for 0.5 to 3 hours. The decoctions are combined, filtered, concentrated, cooled, and ethanol is added to make the alcohol content reach 40 to 80%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and the mixture is concentrated into a clear extract for later use.

[0041] Mix the above-mentioned extracts, add volatile oil and appropriate excipients, and prepare the corresponding formulation.

[0042] Preferably, the traditional Chinese medicine composition is prepared by extraction according to the following method:

[0043] Costus root, Atractylodes lancea, Mentha haplocalyx, Pogostemon cablin, and Citrus reticulata peel are steam distilled for 2 hours, and the volatile oil is collected and stored separately. The residue and the aqueous solution after oil extraction are decocted twice with water, 1.5 hours each time. The decoction is filtered, the filtrates are combined, and concentrated to a relative density of 1.08-1.12 (60℃). After cooling, ethanol is added to make the alcohol content reach 45%. The mixture is allowed to stand overnight, filtered, the ethanol is recovered, and the mixture is concentrated into a clear extract for later use.

[0044] Uncaria rhynchophylla, Tribulus terrestris, Chrysanthemum morifolium, Magnolia officinalis, and Guangdong Shenqu were decocted twice with water, the first time for 2 hours and the second time for 1.5 hours. The decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.02-1.05 (60℃). After cooling, ethanol was added to make the alcohol content reach 40%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0045] Coix seed and rice sprouts were decocted twice with water, one hour each time. The decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.02-1.05 (60℃). After cooling, ethanol was added to make the alcohol content reach 45%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0046] Poria cocos, Trichosanthes kirilowii, Angelica dahurica, and Pueraria lobata were decocted twice with water, the first time for 2 hours and the second time for 1 hour. The decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.02-1.05 (60℃). After cooling, ethanol was added to make the alcohol content reach 60%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0047] Take the above-mentioned clear paste, mix it with volatile oil and various conventional excipients required for preparing different dosage forms, and make any kind of pharmaceutical preparation, such as disintegrants, lubricants, binders, etc., and prepare any commonly used dosage form using conventional Chinese medicine preparation methods, such as tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, powders, capsules, soft capsules, pills, granules, oral liquids, granules, drop pills, micro-pills, intramuscular injections, drip injections, ointments, ointments, hard plasters, etc.; the best preparations are tablets, drop pills, oral liquids, granules, capsules, and soft capsules.

[0048] Furthermore, the hyperlipidemia described in this invention is hypercholesterolemia.

[0049] Furthermore, the hyperlipidemia described in this invention is a mixed type of hyperlipidemia.

[0050] The use of the traditional Chinese medicine composition described in this invention for treating hyperlipidemia has also been verified through the following experiments:

[0051] 1. Test substance

[0052] 1.1 Name: Pharmaceutical composition extract of the present invention (test substance / reference standard number AN-20240119-02)

[0053] 1.2 Batch number and expiration date: The batch number is 2309603, and the expiration date is December 2024.

[0054] 1.3 Physical and chemical properties and biological characteristics: The property is a dark brown viscous semi-solid; it is prepared according to the method of Example 1 of the present invention. The content is 5.70 g of crude drug per gram of extract.

[0055] 2. Experimental materials

[0056] 2.1 Experimental animals

[0057] 2.1.1 Basic situation

[0058] (1) Animal strain: SD rats.

[0059] (2) Number of animals:

[0060] 24 females; 24 males.

[0061] (3) Purchased age: PND18.

[0062] (4) Age at first administration: PND21.

[0063] (5) Gender during the trial: Half male and half female.

[0064] ((6) Weight range:

[0065] Females: 46.3 - 51.4 g; Males: 40.8 - 51.0 g.

[0066] (7) Source: Guangdong Provincial Center for Medical Experimental Animals.

[0067] (8) Grade: SPF grade

[0068] (9) Experimental animal production license number: SCXK(Guangdong)2022 - 0002 (valid until March 28, 2027), Guangdong Provincial Department of Science and Technology. Experimental animal quality certificate number: 44007200130531.

[0069] 3. Test methods

[0070] 3.1 Dose and group design

[0071] Table 1 List of group and dose design

[0072]

[0073]

[0074] ①A, B, C, and D represent the negative control group and the low, medium, and high dose groups, respectively; ②All groups were administered the drug by gavage once a day; ③The weight of PND21 rats was calculated as 50g.

[0075] 3.2 Test Procedure

[0076] Grouped administration: Forty-eight qualified animals were selected and randomly divided into a negative control group (Group A) and low-, medium-, and high-dose groups of the test substance (Groups B-D) according to weight and sex, with 12 animals in each group, half male and half female. The low-, medium-, and high-dose groups were administered the extract of the traditional Chinese medicine composition of this invention by gavage at doses of 3.2 g / kg, 6.4 g / kg, and 12.8 g / kg, respectively, while Group A was administered ultrapure water. The administration volume for all groups was 10 mL / kg, once a day, 7 days a week. Animals 1, 2, 4, 7, 8, and 10 in each group were administered the drug for 30 consecutive days, and animals 3, 5, 6, 9, 11, and 12 in each group were administered the drug for 90 consecutive days.

[0077] 3.3 Laboratory tests

[0078] 3.3.1 Hematology

[0079] Rats were fasted for 12-18 hours and anesthetized by subcutaneous injection of Sutacetin 50 at 0.4 mL / kg. Blood was collected from the abdominal aorta. Approximately 1 mL of blood was collected and anticoagulated with EDTA-K2. Blood samples were analyzed using either an XT-2000iv fully automated blood analyzer (Sysmex, Japan) or an XN-10[B3] fully automated blood analyzer (Sysmex, Japan). Detailed detection indicators are shown in Table 2. Blood samples were tested within 1 hour of anticoagulation preparation, and the ambient temperature was controlled between 15 and 30°C during testing.

[0080] Table 2 Hematological Examination Table

[0081]

[0082]

[0083] 3.3.2 Coagulation function

[0084] Rats were fasted for 12-18 hours and anesthetized subcutaneously with 0.4 mL / kg of acetaminophen (Salvastatin 50). Blood was collected from the abdominal aorta. Approximately 2 mL of blood was collected and anticoagulated with sodium citrate (1:9 volume ratio to blood). The blood collection tube was centrifuged at 2000g relative centrifugation at 20°C for 15 minutes. Plasma samples were collected and analyzed using a CS-1300 fully automated coagulation analyzer (Sysmex, Japan). The ambient temperature during testing should be controlled between 15 and 30°C. Detailed testing parameters are shown in Table 3. Plasma samples were tested within 8 hours of preparation, with the ambient temperature controlled between 15 and 30°C.

[0085] Table 3. Coagulation Function Test Table

[0086] Note: The rats in the negative control group, low, medium and high dose groups were numbered 1 to 30, with males numbered 1 to 15 and females numbered 16 to 30.

[0087] 3.3.3 Biochemical tests

[0088] Rats were fasted for 12-18 hours and anesthetized subcutaneously with 0.4 mL / kg of sulfadiazine (Vitamin B50). Blood was collected from the abdominal aorta. Approximately 2.5 mL of blood was collected and allowed to stand at room temperature for 30 minutes to 4 hours. The blood collection tube was then centrifuged at 20°C for 15 minutes using a relative centrifugal force of 2000 g to collect the serum. + K + Cl - Electrolyte analysis was performed using a URIT-910CPlus electrolyte analyzer. Except for the globulin-to-globulin ratio, all other indicators were measured using a 7100 biochemical analyzer (Hitachi, Japan). Details of the measured indicators are shown in Table 4. Serum samples were tested within 24 hours of preparation, with the ambient temperature controlled between 18 and 30°C during testing.

[0089] Table 4 Biochemical Test Table

[0090] Note: 1) "*" indicates that the result value is calculated. Albumin / Globulin (A / G) = Globulin (GLB) / Albumin (ALB).

[0091] 3.4. Animal anesthesia and euthanasia methods

[0092] Animals scheduled for necropsy were anesthetized subcutaneously with 0.4 mL / kg of Sertazoline 50. After the rats reached the surgical anesthesia stage, they were euthanized by blood collection from the abdominal aorta. Animals to be culled were euthanized by carbon dioxide inhalation.

[0093] 3.5 Statistical Analysis Methods

[0094] All data were entered into Excel 2003 for statistical analysis. Mean ± standard deviation were calculated for hematological, coagulation function, and blood biochemistry data across different sexes and groups. Before comparing experimental groups, an analysis of variance (F-test) was performed. When the variances were homogeneous, the Student-T test (unpaired T-test) was used for statistical analysis; when the variances were unequal, a corrected Student-T test was used. Qualitative data from animal urine tests were compared between groups based on their incidence and severity.

[0095] 4. Test Results

[0096] 4.1 Observation results under normal conditions

[0097] No obvious abnormalities were observed in the general condition of male and female animals in the negative control group and the low, medium and high dose groups.

[0098] 4.2 Hematology and Coagulation Function

[0099] Hematological and coagulation function results are shown in Tables 5 to 7.

[0100] Table 5. Effects of the traditional Chinese medicine composition of the present invention on hematological effects in SD rats after 90 consecutive days of administration to PND21 juvenile rats.

[0101]

[0102] Note: (1) Groups A, B, C, and D represent the negative control group, low-dose group, medium-dose group, and high-dose group, respectively; (2) Compared with the negative control group, "*" indicates P<0.05; "**" indicates P<0.01.

[0103]

[0104]

[0105] Compared with the negative control group,

[0106] In the low-dose group, female animals showed decreased RDW-SD (P<0.05) and increased Fbg (P<0.05) during the mid-dose administration period. In the late-dose group, female animals showed decreased PDW (P<0.05).

[0107] In the mid-dose group, male animals showed decreased RDW-CV and RET (P<0.05), and prolonged EO% and APTT (P<0.05 or P<0.01). At the end of the dosing period, male animals showed shortened TT (P<0.05), and female animals showed decreased PDW, MPV, and P-LCR (P<0.01).

[0108] In the mid-term of high-dose administration, male animals showed decreased WBC, RDW-CV, NEUT, LYMPH, EO, and RET (P<0.05 or P<0.01), and prolonged PT (P<0.05). At the end of administration, male animals showed decreased WBC and HFR (P<0.05), while female animals showed increased MCV (P<0.05) and decreased PDW, MPV, and P-LCR (P<0.01).

[0109] No significant differences were observed in other indicators among other animals (P>0.05). The above indicators lacked a clear dose-dependent relationship and had no toxicological significance.

[0110] 4.3 Blood Biochemistry

[0111] The blood biochemistry results are shown in Tables 8 and 9.

[0112]

[0113]

[0114] Compared with the negative control group,

[0115] At the end of the low-dose administration period, female animals showed decreased levels of ALT, TP, GLB, Ca, and TCHO (P<0.05 or P<0.01).

[0116] In the mid-term of administration, male animals in the medium-dose group showed decreased levels of GLU, P, and TG (P<0.05). In the late-term of administration, male animals showed decreased levels of ALT and TCHO (P<0.05 or P<0.01).

[0117] During the mid-term of high-dose administration, male animals showed decreased TCHO levels (P<0.05); female animals showed decreased TP, ALB, and CK-MB levels (P<0.05 or P<0.01). At the end of the administration period, male animals showed decreased ALT, AST, and LDH levels (P<0.05); female animals showed decreased ALT, AST, TP, GLB, Ca, and TCHO levels (P<0.05 or P<0.01), while ALB and GGT levels increased (P<0.05).

[0118] Among the above indicators, the decrease in TCHO in female animals showed a certain dose-dependent relationship, which is considered to be related to the test substance. Other indicators lacked obvious dose-dependent relationships and had no toxicological significance.

[0119] 5. Experimental Conclusions

[0120] Under the conditions of this experiment, the traditional Chinese medicine composition of the present invention was administered orally to SD rats and PND21 young SD rats at doses of 3.2 g / kg, 6.4 g / kg, and 12.8 g / kg for 90 days, once a day.

[0121] ① No significant changes related to the test substance were observed in general observations, hematological and coagulation function of the animals in each group.

[0122] ② The lipid marker TCHO decreased in a dose-dependent manner at low, medium, and high doses. Based on the above experimental results, it can be concluded that the traditional Chinese medicine composition of this invention has the effect of reducing TCHO in a dose-dependent manner. Detailed Implementation

[0123] The present invention will be further illustrated by specific embodiments below. These embodiments are for illustrative purposes only and are not intended to limit the invention. Simple modifications made to the present invention based on its essence are all within the scope of protection claimed by the present invention.

[0124] Example 1

[0125] Prescription composition:

[0126] Uncaria rhynchophylla 34 parts by weight, Chrysanthemum 68 parts by weight

[0127] Tribulus terrestris 34 parts by weight, Magnolia officinalis 136 parts by weight

[0128] 136 parts by weight of Costus root and 136 parts by weight of Atractylodes lancea.

[0129] 102 parts by weight of Trichosanthes kirilowii pollen and 136 parts by weight of Patchouli.

[0130] 136 parts by weight of kudzu root and 68 parts by weight of tangerine peel

[0131] Angelica dahurica 136 parts by weight, Coix lacryma-jobi 171 parts by weight

[0132] Rice sprouts 102 parts by weight, mint 68 parts by weight

[0133] Poria cocos 273 parts by weight, Guangdong Shenqu 136 parts by weight.

[0134] Preparation method:

[0135] Costus root, Atractylodes lancea, Mentha haplocalyx, Pogostemon cablin, and Citrus reticulata peel are steam distilled for 2 hours, and the volatile oil is collected and stored separately. The residue and the aqueous solution after oil extraction are decocted twice with water, 1.5 hours each time. The decoction is filtered, the filtrates are combined, and concentrated to a relative density of 1.08-1.12 (60℃). After cooling, ethanol is added to make the alcohol content reach 45%. The mixture is allowed to stand overnight, filtered, the ethanol is recovered, and the mixture is concentrated into a clear extract for later use.

[0136] Uncaria rhynchophylla, Tribulus terrestris, Chrysanthemum morifolium, Magnolia officinalis, and Guangdong Shenqu were decocted twice with water, the first time for 2 hours and the second time for 1.5 hours. The decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.02-1.05 (60℃). After cooling, ethanol was added to make the alcohol content reach 40%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0137] Coix seed and rice sprouts were decocted twice with water, one hour each time. The decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.02-1.05 (60℃). After cooling, ethanol was added to make the alcohol content reach 45%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0138] Poria cocos, Trichosanthes kirilowii root, Angelica dahurica root, and Pueraria lobata root were decocted twice with water, the first time for 2 hours and the second time for 1 hour. The decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.02-1.05 (60℃). After cooling, ethanol was added to make the alcohol content reach 60%. The mixture was left to stand overnight, filtered, and the ethanol was recovered. The filtrate was then concentrated into a clear extract for later use. The above clear extract was mixed with an appropriate amount of water, stirred evenly, and 90g of sucrose was added. The mixture was heated, stirred, and boiled for 0.5 hours. After filtering, an appropriate amount of water was added to the filtrate and cooled to below 60℃. The prepared volatile oil (volatile oil: polysorbate 80 (1:6)) was added, and water was added to 1000ml. The mixture was mixed evenly, sealed, and sealed at 121℃.

[0139] The oral liquid is obtained by autoclaving for 20 minutes.

[0140] Example 2

[0141] Prescription composition:

[0142] Uncaria rhynchophylla 20 parts by weight, Chrysanthemum 80 parts by weight

[0143] Tribulus terrestris 50 parts by weight, Magnolia officinalis 80 parts by weight

[0144] 100 parts by weight of costus root and 120 parts by weight of atractylodes lancea.

[0145] 60 parts by weight of Trichosanthes kirilowii pollen and 80 parts by weight of Patchouli

[0146] 200 parts by weight of kudzu root and 100 parts by weight of dried tangerine peel

[0147] Angelica dahurica 100 parts by weight, Coix seed 200 parts by weight

[0148] Rice sprouts 130 parts by weight, mint 80 parts by weight

[0149] 300 parts by weight of Poria cocos and 200 parts by weight of Guangdong Shenqu (a type of fermented wheat).

[0150] Preparation method:

[0151] Costus root, Atractylodes lancea, Mentha haplocalyx, Pogostemon cablin, and Citrus reticulata peel are steam distilled for 1 hour, and the volatile oil is collected and stored separately. The dregs and the aqueous solution after oil extraction are decocted with water 3 times, 1 hour each time. The decoction is filtered, the filtrates are combined, concentrated, cooled, and ethanol is added to make the alcohol content reach 60%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and concentrated into a clear paste for later use.

[0152] Uncaria rhynchophylla, Tribulus terrestris, chrysanthemum, Magnolia officinalis, and Guangdong Shenqu were decocted three times with water, one hour each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 50%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0153] Coix seed and rice sprouts were decocted three times with water, each time for 0.5 hours. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 30%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0154] Poria cocos, Trichosanthes kirilowii, Angelica dahurica, and Pueraria lobata were decocted three times with water for 0.5 hours each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 40%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0155] Mix the above-mentioned extract, dry it, and pulverize it to obtain a fine powder of dry extract. Add the prepared volatile oil (volatile oil: polysorbate 80 (1:6)), dextrin inclusion complex, and sodium carboxymethyl starch. Mix well and granulate with 30% ethanol. The amount of granules used is 40% of the total amount of dry extract powder, dextrin inclusion complex, and excipients. Dry the granules, add silica gel, mix well, and fill them into pharmaceutical capsules to obtain capsules.

[0156] Example 3

[0157] Prescription composition:

[0158] Uncaria rhynchophylla 50 parts by weight, Chrysanthemum 100 parts by weight

[0159] Tribulus terrestris 20 parts by weight, Magnolia officinalis 80 parts by weight

[0160] 200 parts by weight of costus root and 200 parts by weight of atractylodes rhizome.

[0161] 100 parts by weight of Trichosanthes kirilowii pollen and 150 parts by weight of Patchouli

[0162] 180 parts by weight of kudzu root and 100 parts by weight of dried tangerine peel

[0163] Angelica dahurica 80 parts by weight, Coix seed 200 parts by weight

[0164] Rice sprouts 150 parts by weight, mint 40 parts by weight

[0165] 400 parts by weight of Poria cocos and 100 parts by weight of Guangdong Shenqu (a type of fermented wheat).

[0166] Preparation method:

[0167] Costus root, Atractylodes lancea, Mentha haplocalyx, Pogostemon cablin, and Citrus reticulata peel are steam distilled for 1 hour, and the volatile oil is stored separately. The dregs and the aqueous solution after oil extraction are decocted once with water for 3 hours. The decoction is filtered, the filtrates are combined, concentrated, cooled, and ethanol is added to make the alcohol content reach 60%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and concentrated into a clear paste for later use.

[0168] Uncaria rhynchophylla, Tribulus terrestris, chrysanthemum, Magnolia officinalis, and Guangdong Shenqu were decocted once with water for 3 hours. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 30%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0169] Coix seed and rice sprouts were decocted once with water for 2 hours. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 50%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use. Poria cocos, trichosanthes root, angelica dahurica, and kudzu root were decocted once with water for 3 hours. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 70%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0170] Mix the above-mentioned extract, dry it, and pulverize it to obtain a fine powder of dry extract; add 10 times the amount of cyclodextrin to the volatile oil to obtain a cyclodextrin inclusion complex; add polyethylene glycol, mix well, and compress into soft capsules according to the soft capsule preparation method.

[0171] Example 4

[0172] Prescription composition:

[0173] Uncaria rhynchophylla 40 parts by weight, Chrysanthemum 60 parts by weight

[0174] Tribulus terrestris 30 parts by weight, Magnolia officinalis 120 parts by weight

[0175] 120 parts by weight of costus root and 120 parts by weight of atractylodes rhizome.

[0176] 90 parts by weight of Trichosanthes kirilowii pollen and 150 parts by weight of Patchouli

[0177] 140 parts by weight of kudzu root and 60 parts by weight of dried tangerine peel

[0178] Angelica dahurica 150 parts by weight, Coix lacryma-jobi 190 parts by weight

[0179] Rice sprouts 90 parts by weight, mint 80 parts by weight

[0180] Poria cocos 220 parts by weight, Guangdong Shenqu 110 parts by weight.

[0181] Preparation method:

[0182] Costus root, Atractylodes lancea, Mentha haplocalyx, Pogostemon cablin, and Citrus reticulata peel are steam distilled for 2 hours, and the volatile oil is collected and stored separately. The dregs and the aqueous solution after oil extraction are decocted twice with water, each time for 2 hours. The decoction is filtered, the filtrates are combined, concentrated, cooled, and ethanol is added to make the alcohol content reach 40%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and concentrated into a clear paste for later use.

[0183] Uncaria rhynchophylla, Tribulus terrestris, chrysanthemum, Magnolia officinalis, and Guangdong Shenqu were decocted twice with water for 2 hours each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 50%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear paste for later use.

[0184] Coix seed and rice sprout were decocted twice with water, one hour each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 450%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use. Poria cocos, trichosanthes root, angelica dahurica, and kudzu root were decocted twice with water, two hours each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 60%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0185] Mix the above-mentioned extracts, dry them, and pulverize them to obtain a fine powder of dry extract; encapsulate the volatile oil with dextrin to obtain dextrin-encapsulated material; add xylitol, xanthan gum, sodium bicarbonate, starch, and citric acid for later use; mix the above raw materials evenly, compress them into tablets, and make effervescent tablets to obtain the final product.

[0186] Example 5

[0187] Prescription composition:

[0188] Uncaria rhynchophylla 40 parts by weight, Chrysanthemum 70 parts by weight

[0189] Tribulus terrestris 40 parts by weight, Magnolia officinalis 120 parts by weight

[0190] 120 parts by weight of costus root and 120 parts by weight of atractylodes rhizome.

[0191] 130 parts by weight of Trichosanthes kirilowii pollen and 90 parts by weight of Patchouli

[0192] 150 parts by weight of kudzu root and 80 parts by weight of dried tangerine peel

[0193] Angelica dahurica 110 parts by weight, Coix lacryma-jobi 180 parts by weight

[0194] Rice sprouts 120 parts by weight, mint 80 parts by weight

[0195] 200 parts by weight of Poria cocos and 150 parts by weight of Guangdong Shenqu (a type of fermented wheat).

[0196] Preparation method:

[0197] Costus root, Atractylodes lancea, Mentha haplocalyx, Pogostemon cablin, and Citrus reticulata peel are steam distilled for 2 hours, and the volatile oil is collected and stored separately. The dregs and the aqueous solution after oil extraction are decocted twice with water, 1 hour each time. The decoction is filtered, the filtrates are combined, concentrated, cooled, and ethanol is added to make the alcohol content reach 40%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and concentrated into a clear paste for later use.

[0198] Uncaria rhynchophylla, Tribulus terrestris, Chrysanthemum morifolium, Magnolia officinalis, and Guangdong Shenqu were decocted twice with water, 1.5 hours each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 60%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the extract was concentrated into a clear paste for later use.

[0199] Coix seed and rice sprouts were decocted twice with water, one hour each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 50%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0200] Poria cocos, Trichosanthes kirilowii, Angelica dahurica, and Pueraria lobata were decocted twice with water for one hour each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 60%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0201] Mix the above-mentioned extract, dry it, and pulverize it to obtain a fine powder of dry extract; encapsulate the volatile oil with dextrin to obtain a dextrin-encapsulated product; mix the fine powder of dry extract and the dextrin-encapsulated product evenly, add polyvinylpyrrolidone, mix well, granulate, dry, and granulate; add magnesium stearate, mix well, and compress into tablets to obtain tablets.

[0202] Example 6

[0203] Prescription composition:

[0204] Uncaria rhynchophylla 30 parts by weight, Chrysanthemum 70 parts by weight

[0205] Tribulus terrestris 30 parts by weight, Magnolia officinalis 140 parts by weight

[0206] 140 parts by weight of costus root and 140 parts by weight of atractylodes rhizome.

[0207] 100 parts by weight of Trichosanthes kirilowii pollen and 140 parts by weight of Patchouli

[0208] 140 parts by weight of kudzu root and 70 parts by weight of dried tangerine peel

[0209] Angelica dahurica 140 parts by weight, Coix seed 170 parts by weight

[0210] 100 parts rice sprouts, 70 parts mint

[0211] Poria cocos 270 parts by weight, Guangdong Shenqu 140 parts by weight.

[0212] Preparation method:

[0213] Costus root, Atractylodes lancea, Mentha haplocalyx, Pogostemon cablin, and Citrus reticulata peel are steam distilled for 2 hours, and the volatile oil is collected and stored separately. The dregs and the aqueous solution after oil extraction are decocted twice with water, 1 hour each time. The decoction is filtered, the filtrates are combined, concentrated, cooled, and ethanol is added to make the alcohol content reach 40%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and concentrated into a clear paste for later use.

[0214] Uncaria rhynchophylla, Tribulus terrestris, Chrysanthemum morifolium, Magnolia officinalis, and Guangdong Shenqu were decocted twice with water, 1.5 hours each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 60%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the extract was concentrated into a clear paste for later use.

[0215] Coix seed and rice sprouts were decocted twice with water, one hour each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 50%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0216] Poria cocos, Trichosanthes kirilowii, Angelica dahurica, and Pueraria lobata were decocted twice with water for one hour each time. The decoctions were combined, filtered, concentrated, cooled, and ethanol was added to make the alcohol content reach 60%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use.

[0217] Mix the above-mentioned extract, dry it, and pulverize it to obtain a fine powder of dry extract; encapsulate the volatile oil with dextrin to obtain a dextrin-encapsulated compound; take the dry extract powder and the dextrin inclusion compound, mix them evenly, add 6 times the amount of the dry extract powder and the dextrin inclusion compound in a mixture of polyethylene glycol 6000: polyethylene glycol 1500 = 3:2, heat to melt, and drop it into a condensed liquid of liquid methyl silicone oil: liquid paraffin = 1:3 at a dropping rate of 25-75 drops / min to obtain drop pellets.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a drug for treating hyperlipidemia, wherein, The traditional Chinese medicine composition is: Uncaria rhynchophylla 20-50 parts by weight, Chrysanthemum 40-100 parts by weight Tribulus terrestris 20-50 parts by weight, Magnolia officinalis 80-200 parts by weight Costus root 80-200 parts by weight, Atractylodes lancea 80-200 parts by weight Trichosanthes root 60-150 parts by weight; Patchouli 80-200 parts by weight 80-200 parts by weight of kudzu root and 40-100 parts by weight of tangerine peel Angelica dahurica 80-200 parts by weight; Coix seed 100-250 parts by weight Rice sprouts 60-150 parts by weight, mint 40-100 parts by weight Poria cocos 160-400 parts by weight, Guangdong Shenqu 80-200 parts by weight.

2. The application as described in claim 1, characterized in that, The traditional Chinese medicine composition is: Uncaria rhynchophylla 30-40 parts by weight, Chrysanthemum 60-80 parts by weight Tribulus terrestris 30-40 parts by weight, Magnolia officinalis 120-160 parts by weight 120-160 parts by weight of costus root and 120-160 parts by weight of atractylodes rhizome. Trichosanthes root 90-120 parts by weight; Patchouli 120-160 parts by weight 120-160 parts by weight of kudzu root and 60-80 parts by weight of tangerine peel Angelica dahurica 120-160 parts by weight, Coix seed 171 parts by weight Rice sprouts 90-120 parts by weight, mint 60-80 parts by weight Poria cocos 240-320 parts by weight, Guangdong Shenqu 120-160 parts by weight.

3. The application as described in claim 1, characterized in that, The traditional Chinese medicine composition is: Uncaria rhynchophylla 34 parts by weight, Chrysanthemum 68 parts by weight Tribulus terrestris 34 parts by weight, Magnolia officinalis 136 parts by weight 136 parts by weight of Costus root and 136 parts by weight of Atractylodes lancea. 102 parts by weight of Trichosanthes kirilowii pollen and 136 parts by weight of Patchouli. 136 parts by weight of kudzu root and 68 parts by weight of tangerine peel Angelica dahurica 136 parts by weight, Coix lacryma-jobi 171 parts by weight Rice sprouts 102 parts by weight, mint 68 parts by weight Poria cocos 273 parts by weight, Guangdong Shenqu 136 parts by weight.

4. The application according to any one of claims 1 to 3, characterized in that, The traditional Chinese medicine composition was prepared by extraction according to the following method: Costus root, Atractylodes lancea, Mentha haplocalyx, Pogostemon cablin, and Citrus reticulata peel are steam distilled for 1-3 hours, and the volatile oil is collected and stored separately. The dregs and the aqueous solution after oil extraction are decocted with water 1-3 times, each time for 1-3 hours. The decoction is filtered, the filtrates are combined, concentrated, cooled, and ethanol is added to make the alcohol content reach 30-60%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and concentrated into a clear paste for later use. Uncaria rhynchophylla, Tribulus terrestris, Chrysanthemum morifolium, Magnolia officinalis, and Guangdong Shenqu (a type of fermented medicinal herb) are decocted with water 1-3 times, each time for 1-3 hours. The decoctions are combined, filtered, concentrated, cooled, and ethanol is added to make the alcohol content reach 30-60%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and the mixture is concentrated into a clear extract for later use. Coix seed and rice sprout are decocted with water 1 to 3 times, each time for 0.5 to 2 hours. The decoctions are combined, filtered, concentrated, cooled, and ethanol is added to make the alcohol content reach 30 to 60%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and concentrated into a clear extract for later use. Poria cocos, Trichosanthes kirilowii, Angelica dahurica, and Pueraria lobata are decocted with water 1 to 3 times, each time for 0.5 to 3 hours. The decoctions are combined, filtered, concentrated, cooled, and ethanol is added to make the alcohol content reach 40 to 80%. The mixture is left to stand overnight, filtered, the ethanol is recovered, and the mixture is concentrated into a clear extract for later use. Mix the above-mentioned extracts, add volatile oil and appropriate excipients, and prepare the corresponding formulation.

5. The application according to claim 4, characterized in that, The traditional Chinese medicine composition was prepared by extraction according to the following method: Costus root, Atractylodes lancea, Mentha haplocalyx, Pogostemon cablin, and Citrus reticulata peel are steam distilled for 2 hours, and the volatile oil is collected and stored separately. The residue and the aqueous solution after oil extraction are decocted twice with water, 1.5 hours each time. The decoction is filtered, the filtrates are combined, and concentrated to a relative density of 1.08-1.12 (60℃). After cooling, ethanol is added to make the alcohol content reach 45%. The mixture is allowed to stand overnight, filtered, the ethanol is recovered, and the mixture is concentrated into a clear extract for later use. Uncaria rhynchophylla, Tribulus terrestris, Chrysanthemum morifolium, Magnolia officinalis, and Guangdong Shenqu were decocted twice with water, the first time for 2 hours and the second time for 1.5 hours. The decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.02-1.05 (60℃). After cooling, ethanol was added to make the alcohol content reach 40%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use. Coix seed and rice sprouts were decocted twice with water, one hour each time. The decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.02-1.05 (60℃). After cooling, ethanol was added to make the alcohol content reach 45%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use. Poria cocos, Trichosanthes kirilowii, Angelica dahurica, and Pueraria lobata were decocted twice with water, the first time for 2 hours and the second time for 1 hour. The decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.02-1.05 (60℃). After cooling, ethanol was added to make the alcohol content reach 60%. The mixture was left to stand overnight, filtered, the ethanol was recovered, and the mixture was concentrated into a clear extract for later use. Mix the above-mentioned extracts, add volatile oil and appropriate excipients, and prepare the corresponding formulation.

6. The application according to claim 1, characterized in that, The hyperlipidemia mentioned above refers to hypercholesterolemia.

7. The application according to claim 1, characterized in that, The hyperlipidemia mentioned is a mixed type of hyperlipidemia.

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