Uighur medicine composition for treating hyperlipidemia as well as preparation method and application of Uighur medicine composition

Abstract

The invention provides a Uighur medicine composition for treating hyperlipidemia and a preparation method and application thereof, and belongs to the technical field of Uighur medicine preparations. The Uighur medicine composition comprises the following raw materials in parts by weight: 100-300 parts of basil, 12-36 parts of anchusa, 6-18 parts of lavender, 3-9 parts of rhizoma nardostachyos, 3-9 parts of rose, 3-9 parts of fennel and 3-9 parts of pogonatherum crinitum. The Uighur medicine composition can reduce serum TC and LDL-c levels, and has the effect of reducing blood fat. Through long-time clinical application, the traditional Chinese medicine composition has a definite curative effect, can play a role in treating cardiovascular and cerebrovascular diseases, arteriosclerosis and neurasthenia while reducing blood fat, and is a compound preparation for comprehensively treating and reducing blood fat. The Uighur medicine composition can be processed into granules, and has the advantages of being stable in dosage form, convenient to carry, convenient to take and the like.

Description

Technical Field

[0001] The present invention belongs to the technical field of Uyghur medicine preparations, and in particular relates to a Uyghur medicine composition for treating hyperlipidemia, and a preparation method and application thereof. Background Art

[0002] Hyperlipidemia is a systemic metabolic disorder characterized by elevated levels of cholesterol, triglycerides, and low-density lipoprotein and low levels of high-density lipoprotein in plasma due to various reasons. It is clinically divided into five types: I, II, III, IV, and V. Any type of metabolic abnormality among the five types will lead to an increase in a specific lipoprotein. By determining which type of lipoprotein is elevated, we can determine the type of hyperlipidemia. The most common are types II and IV.

[0003] At present, the incidence of hyperlipidemia is showing a clear upward trend, and hyperlipidemia is an important factor inducing coronary atherosclerotic heart disease (CHD), arteriosclerosis, fatty liver, diabetes, obesity, etc. It is of great practical significance to find highly effective and non-toxic lipid-lowering drugs.

[0004] Western medicine has a significant effect on hyperlipidemia, especially statins, which have shown an increasing market potential. There are four main types of lipid-lowering Western medicines: (1) phenoxy aromatic acids, such as fenofibrate, gemfibrozil, bezafibrate, etc. They have strong lipid-lowering effects, rapid onset, and stronger triglyceride-lowering effects than cholesterol-lowering effects; (2) trihydroxymethylglutaryl coenzyme A reductase inhibitors, such as lovastatin, simvastatin, pravastatin, etc., which mainly lower cholesterol, have strong lipid-lowering effects, and rapid onset; (3) niacin, among which oxymetazoline is more commonly used, and has a stronger effect on lowering serum triglycerides than cholesterol-lowering effects; (4) pantethine, a derivative of coenzyme A, has the effects of lowering serum cholesterol and triglycerides and increasing high-density lipoprotein-cholesterol; in addition, there are bile acid chelating resins, clofibrate, linoleic acid, etc. While these drugs lower lipids, they can cause adverse reactions such as increased blood sugar, nausea, abdominal distension, diarrhea, and liver damage. In view of the adverse reactions of Western medicine, finding new and effective lipid-lowering Chinese medicine has become an important topic at present.

[0005] Clinically, Chinese medicine attributes hyperlipidemia to liver and kidney deficiency, spleen deficiency and phlegm dampness, qi stagnation and blood stasis, etc., so the treatment often uses drugs that nourish the liver and kidney, strengthen the spleen and eliminate dampness, promote blood circulation and remove blood stasis, clear away heat and relieve constipation, and digest food and resolve phlegm. For example: Polygonum multiflorum, Fructus Ligustri Lucidi, Lycium barbarum, Ganoderma lucidum, Cordyceps sinensis, Acanthopanax senticosus leaves, Viscum album, etc. for nourishing the liver and kidney; ginseng, Gynostemma pentaphyllum, Tangerine peel, Licorice, Hawthorn, etc. for strengthening the spleen and regulating qi; Pollen Typha, Angelica sinensis, Polygonum cuspidatum, Achyranthes bidentata, Turmeric, Panax notoginseng, Ligusticum chuanxiong, Ginkgo biloba leaves, etc. for promoting blood circulation and removing blood stasis; Portulaca oleracea, Scutellaria baicalensis, Coptis chinensis, Bupleurum, Aloe vera, Chrysanthemum, Lotus leaf, Pueraria root, etc. for clearing heat and detoxifying; Rhubarb, Cassia seed, Polygonum cuspidatum, etc. for laxative; Pinellia ternata, Laminaria japonica, Alisma orientalis, Oenothera biennis, Hippophae rhamnoides, etc. for removing dampness and removing blood stasis. It can be seen that many Chinese medicines have the effect of lowering blood lipids, but each has its own emphasis on efficacy, and the mechanisms and pathways of action are also different. Chinese medicines that have comprehensive therapeutic effects through multiple pathways are better lipid-lowering drugs.

[0006] At present, the Uyghur medicine formulas used to lower blood lipids, treat cardiovascular and cerebrovascular diseases, arteriosclerosis, and neurasthenia include: Aiti Rifeili Aifeti Muni honey paste, Yiti Rifeili honey paste, and Aifeti Meng decoction, etc. Most of the above medicines are honey pastes and decoctions, which are not suitable for long-term storage and are not convenient to carry. Therefore, in order to meet the requirements of the modernization of the traditional Chinese medicine industry, it is necessary to develop new dosage forms of Uyghur medicine suitable for industrialization. Summary of the invention

[0007] In view of this, the object of the present invention is to provide a Uyghur medicine composition for treating hyperlipidemia, and a preparation method and application thereof, which has a lipid-lowering effect, and has a stable dosage form and is easy to carry and take.

[0008] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0009] A Uyghur medicine composition for treating hyperlipidemia comprises the following raw materials by weight: 100-300 parts of basil, 12-36 parts of bugloss, 6-18 parts of lavender, 3-9 parts of nard, 3-9 parts of rose, 3-9 parts of fennel and 3-9 parts of dodder.

[0010] Preferably, the Uyghur medicine composition contains 0.08%-0.10% gallic acid and 0.17%-0.21% rosmarinic acid by weight.

[0011] The present invention also provides a method for preparing the Uyghur medicine composition, comprising the following steps: weighing raw materials according to the weight parts, mixing, decocting with water for 2-4 times, filtering and combining water extracts, concentrating under reduced pressure to obtain an extract, and drying the extract to obtain the Uyghur medicine composition.

[0012] Preferably, the raw material and water are boiled in a mass ratio of 1:8-12.

[0013] Preferably, the decocting time is 1-3 hours / time.

[0014] Preferably, the pressure of the reduced pressure concentration is 0.08 MPa, the temperature is 65-75°C, and the density is 1.22-1.25 at a temperature of 60°C.

[0015] Preferably, the drying is vacuum drying at a pressure of 0.08 MPa and a temperature of 55-65° C., until the water content of the Uyghur medicine composition is ≤ 6%.

[0016] The present invention also provides the application of the Uygur medicine composition or the preparation method of the Uygur medicine composition in preparing medicine for treating hyperlipidemia and its complications.

[0017] Preferably, the drug further comprises a pharmaceutically acceptable excipient.

[0018] Preferably, the dosage form of the drug includes clinically acceptable tablets, powders, granules or capsules.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] The present invention provides a Uyghur medicine composition for treating hyperlipidemia, which can reduce serum TC and LDL-c levels and has the effect of lowering blood lipids. After long-term clinical use, its therapeutic effect is clear, and while lowering blood lipids, it can also play a role in treating cardiovascular and cerebrovascular diseases, arteriosclerosis, and neurasthenia. It is a compound preparation for comprehensive treatment of lowering blood lipids.

[0021] The Uyghur medicine composition of the present invention can be processed into granules or other dosage forms. Compared with other Uyghur medicines currently used for lowering blood lipids, treating cardiovascular and cerebrovascular diseases, and arteriosclerosis, it has the advantages of stable dosage form, easy to carry, and convenient to take. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is the chromatogram of the mixed reference substance of gallic acid and rosmarinic acid;

[0023] Figure 2 This is a chromatogram of the Uyghur medicine composition of the present invention. DETAILED DESCRIPTION

[0024] The invention provides a Uyghur medicine composition for treating hyperlipidemia. The composition comprises the following raw materials in parts by weight: 100-300 parts of basil, 12-36 parts of ragwort, 6-18 parts of lavender, 3-9 parts of spikenard, 3-9 parts of rose, 3-9 parts of fennel and 3-9 parts of dodder; further preferably, 100-200 parts of basil, 12-24 parts of ragwort, 6-12 parts of lavender, 3-6 parts of spikenard, 3-6 parts of rose, 3-6 parts of fennel and 3-6 parts of dodder; more preferably, 100 parts of basil, 12 parts of ragwort, 6 parts of lavender, 3 parts of spikenard, 3 parts of rose, 3 parts of fennel and 3 parts of dodder.

[0025] In the present invention, the Uyghur medicine composition preferably contains 0.08%-0.10% gallic acid and 0.17%-0.21% rosmarinic acid by weight.

[0026] The present invention also provides a method for preparing the Uyghur medicine composition, comprising the following steps: weighing raw materials according to the weight portions, mixing, decocting with water for 2-4 times, preferably decocting for 3 times, filtering and combining water extracts, concentrating under reduced pressure to obtain an extract, and drying the extract to obtain the Uyghur medicine composition.

[0027] In the present invention, the raw material and water are preferably boiled in a mass ratio of 1:8-12, and more preferably the mass ratio is 1:10. The boiling time is preferably 1-3 hours / time, and more preferably 2 hours / time.

[0028] In the present invention, the pressure of the reduced pressure concentration is preferably 0.08Mpa, the temperature is 65-75°C, more preferably 70°C, and the density is 1.22-1.25 at a temperature of 60°C, more preferably 1.23-1.24 at a temperature of 60°C. The drying is preferably vacuum drying, the pressure is 0.08Mpa, the temperature is 55-65°C, more preferably 60°C, until the water content of the Uyghur medicine composition is ≤6%.

[0029] The present invention also provides the use of the Uygur medicine composition or its preparation method in the preparation of a drug for treating hyperlipidemia and its complications, wherein the complications include cardiovascular and cerebrovascular diseases, arteriosclerosis and neurasthenia. Preferably, the drug also includes a pharmaceutically acceptable excipient. Preferably, the dosage form of the drug includes a clinically acceptable tablet, powder, granule or capsule.

[0030] As an embodiment, the preparation method of the granules is as follows:

[0031] The extract of the Uyghur medicine composition is crushed and passed through a 100-mesh sieve to obtain extract powder; the extract powder is mixed with lactose at a mass ratio of 1:1.5, and an ethanol (98%) solution is added to prepare a soft material; granulation is performed through a 14-mesh sieve, dried at 60°C, and granulated through a 14-mesh sieve to prepare 1000 g of granules, thereby obtaining the granules of the Uyghur medicine composition.

[0032] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0033] Example 1

[0034] A Uyghur medicine composition for treating hyperlipidemia, wherein the raw materials are arranged by weight as follows: 100 parts of basil, 12 parts of bugloss, 6 parts of lavender, 3 parts of nard, 3 parts of rose, 3 parts of fennel and 3 parts of dodder;

[0035] The preparation method is as follows: add the required amount of seven medicinal materials, including basil, bugloss, lavender, nard, rose, fennel and dodder, and water of 8 times the weight of the seven medicinal materials, and boil them twice, each time for 1.0 hour, combine the water extracts obtained each time to obtain a water extraction mixture, and concentrate the water extraction mixture under reduced pressure to obtain a clear paste with a density of 1.22-1.25 at a temperature of 60°C, and then vacuum dry the clear paste to obtain a Uyghur medicine composition, wherein the mass percentage water content of the Uyghur medicine composition is ≤6%.

[0036] Example 2

[0037] A Uyghur medicine composition for treating hyperlipidemia, wherein the raw materials are arranged by weight as follows: 100 parts of basil, 12 parts of bugloss, 6 parts of lavender, 3 parts of nard, 3 parts of rose, 3 parts of fennel and 3 parts of dodder;

[0038] The preparation method is as follows: add the required amount of seven medicinal materials, including basil, bugloss, lavender, nard, rose, fennel and dodder, and water 10 times the weight of the seven medicinal materials, and boil for 3 times, each time for 2.0 hours; combine the water extracts obtained each time to obtain a water extraction mixture; concentrate the water extraction mixture under reduced pressure to obtain a clear paste with a density of 1.22-1.25 at a temperature of 60°C; then vacuum dry the clear paste to obtain a Uyghur medicine composition, wherein the mass percentage water content of the Uyghur medicine composition is ≤6%.

[0039] Example 3

[0040] A Uyghur medicine composition for treating hyperlipidemia, wherein the raw materials are arranged by weight as follows: 100 parts of basil, 12 parts of bugloss, 6 parts of lavender, 3 parts of nard, 3 parts of rose, 3 parts of fennel and 3 parts of dodder;

[0041] The preparation method is as follows: add the required amount of seven medicinal materials, including basil, bugloss, lavender, nard, rose, fennel and dodder, to water of 12 times the weight of the seven medicinal materials and boil for 4 times, each time for 3.0 hours, combine the water extracts obtained each time to obtain a water extraction mixture, concentrate the water extraction mixture under reduced pressure to obtain a clear paste with a density of 1.22-1.25 at a temperature of 60°C, and then vacuum dry the clear paste to obtain a Uyghur medicine composition, wherein the mass percentage water content of the Uyghur medicine composition is ≤6%.

[0042] Example 4

[0043] A Uyghur medicine composition for treating hyperlipidemia, wherein the raw materials are arranged by weight as follows: 150 parts of basil, 20 parts of bugloss, 8 parts of lavender, 5 parts of nard, 5 parts of rose, 5 parts of fennel and 5 parts of dodder; the preparation method is the same as that of Example 2.

[0044] Example 5

[0045] A Uyghur medicine composition for treating hyperlipidemia, wherein the raw materials are arranged by weight as follows: 250 parts of basil, 30 parts of bugloss, 15 parts of lavender, 7 parts of nard, 7 parts of rose, 7 parts of fennel and 7 parts of dodder; the preparation method is the same as that of Example 2.

[0046] Example 6

[0047] A Uyghur medicine composition for treating hyperlipidemia, wherein the raw materials are arranged by weight as follows: 200 parts of basil, 25 parts of ragwort, 10 parts of lavender, 6 parts of nard, 6 parts of rose, 6 parts of fennel and 6 parts of dodder; the preparation method is the same as that of Example 2.

[0048] Example 7

[0049] The Uyghur medicine composition prepared in Example 2 was taken to determine the contents of gallic acid and rosmarinic acid: a high performance liquid chromatography detection and analysis method was used.

[0050] Experimental instrument: LC-2030Plus high performance liquid chromatograph (Shimadzu Corporation, Japan).

[0051] Experimental drugs: Gallic acid reference substance (batch number: 110831-201906) and rosmarinic acid reference substance (batch number: 111871-202007) were purchased from China Food and Drug Inspection Institutes; Uyghur medicine composition of Example 2.

[0052] Experimental methods:

[0053] Chromatographic conditions: SHIMADZU column (Shim-packVP-ODS, 250 mm × 4.6 mm, 5 μm), flow rate 1.0 mL min -1 , column temperature 30°C, detection wavelength for gallic acid at 274 nm, detection wavelength for rosmarinic acid at 330 nm, acetonitrile as mobile phase A, 0.1% phosphoric acid solution as mobile phase B, gradient elution (see Table 1), injection volume 10 μL.

[0054] Table 1 HPLC content determination gradient elution

[0055]

[0056]

[0057] Preparation of reference solution: Take appropriate amount of gallic acid and rosmarinic acid reference substances, add methanol to make stock solutions containing 534 and 513 μg per 1 mL, respectively. Take the stock solutions and add methanol to dilute them into solutions containing 10.86 and 20.52 μg per 1 mL, respectively.

[0058] Preparation of the test solution: Take an appropriate amount of the Uyghur medicine composition of Example 2, grind it into powder, take about 0.5 g, accurately weigh it, put it in a ground-mouth conical flask, accurately add 100 mL of 70% methanol, weigh it, treat it with ultrasound (power 200 W, frequency 40 kHz) for 60 min, cool it, weigh it, make up the lost weight with 70% methanol, shake it well, filter it, and obtain it.

[0059] Content determination: Pipette the reference solution and the test solution separately, and calculate according to the measured peak area using the external standard method. Figure 1-2 The gallic acid content of the Uyghur medicine composition sample obtained in Example 2 was 0.9147 mg / g, and the rosmarinic acid content was 1.8686 mg / g. The Uyghur medicine compositions obtained in Examples 1-6 were further tested, and the gallic acid content in the samples was in the range of 0.08%-0.10%, and the rosmarinic acid content was in the range of 0.17%-0.21%.

[0060] Example 8

[0061] The Uygur medicine composition prepared in Example 2 was used for pharmacodynamics experiments, and the results and process are as follows:

[0062] 1. Establishment of the hyperlipidemia model in rats

[0063] High-fat emulsion was administered by gavage at 1mL / 100g for 6 weeks. Preparation of high-fat emulsion: 20g of lard was placed in a beaker, heated on an electric stove to melt, 10g of cholesterol was added to dissolve, 2g of sodium cholate and 1g of propylthiouracil were added, and 20mL of Tween 80, 20mL of propylene glycol and 30mL of distilled water were added after full stirring, and stirring was continued. After the propylthiouracil was dissolved, it was cooled to room temperature, and distilled water was added to 100mL. The normal group was gavaged with an equal volume of solvent (100mL containing 20mL of Tween 80 and 20mL of propylene glycol). According to this ratio and preparation method, 4L was prepared each time, which can be used for about 2 weeks.

[0064] 2. Animal Grouping

[0065] 72 male SD rats, weighing 220-280g, were randomly divided into 6 groups according to their body weight, namely, blank group, model group, simvastatin group, low-, medium- and high-dose groups of Uygur medicine combination, with 12 rats in each group. From the 7th week, except for the normal group which continued to be given an equal volume of solvent, the other groups continued to be gavaged with high-fat emulsion once a day in the morning, and were given low-, medium- and high-dose basil granules and simvastatin in the afternoon according to the set doses for a total of 5 weeks.

[0066] 3. Index determination

[0067] Four blood lipid items: After the last administration, blood was collected from the abdominal aorta, centrifuged at 3000rpm for 10min, and the supernatant was taken to obtain serum, which was then measured by an automatic biochemical analyzer.

[0068] Triglyceride (TG), total cholesterol (TC), low-density lipoprotein (LDL-c) and high-density lipoprotein (HDL-c) in liver homogenate: weigh 0.5 g of liver tissue, prepare 10% liver homogenate with 0.9% saline, centrifuge at 3000 rpm for 10 min, take the supernatant, and detect TG, TC, LDL-c and HDL-c with an automatic biochemical analyzer.

[0069] 4. Effect of Uyghur medicine combination on blood lipids in rats

[0070] As shown in Table 2, compared with the normal group, the TC and LDL-c levels in the model group were increased, and the differences were statistically significant (P < 0.01). Compared with the model group, the low-dose and high-dose groups of the Uyghur medicine composition significantly reduced the serum TC and LDL-c levels (P < 0.05). The low-dose group reduced the TC and LDL-c levels by 22.4% and 26.7%, respectively, while the high-dose group reduced them by 19.3% and 27.3%, respectively. Compared with the positive drug simvastatin, the inhibitory effects of the low-dose and high-dose groups of basil granules were comparable to those of simvastatin.

[0071] Table 2 Effect of the Uygur medicine composition on blood lipids in rats (x±SD)

[0072] Grouping n TG TC LDL-c HDL-c Blank group 10 0.52±0.13 1.31±0.11 0.40±0.07 0.36±0.04 Model Group 10 <![CDATA[0.28±0.07 ** ]]> <![CDATA[4.23±1.10 ** ]]> <![CDATA[1.50±0.30 ** ]]> <![CDATA[0.79±0.16 ** ]]> Simvastatin group 11 0.32±0.05 <![CDATA[3.02±0.46 ## ]]> <![CDATA[1.17±0.19 ## ]]> 0.59±0.08 Uyghur medicine composition low dose group 11 0.31±0.06 <![CDATA[3.28±0.80 # ]]> <![CDATA[1.21±0.32 # ]]> 0.60±0.11 Uyghur medicine composition medium dosage group 10 0.35±0.10 4.11±1.82 1.49±0.74 0.67±0.13 Uyghur medicine composition high dose group 10 0.31±0.06 <![CDATA[3.10±1.07 # ]]> <![CDATA[1.09±0.46 # ]]> 0.65±0.13

[0073] Note: ** P < 0.01 compared with the blank group; # P<0.05, ## P<0.01 compared with the model group.

[0074] 5. Effect of Uyghur medicine combination on TG, TC, LDL-c and HDL-c in rat liver

[0075] As shown in Table 3, compared with the normal group, the TC and LDL-c content of the liver of the model group rats increased significantly (P < 0.01). Compared with the model group, the low-dose and high-dose groups of the Uyghur medicine composition reduced the TC and LDL-c content of the liver of the rats. The low-dose group had a significant effect on reducing the TC and LDL-c content of the liver (reduced by 27.3% and 26.3%, respectively), and the difference was statistically significant (P < 0.05); while the high-dose group did not have a statistically significant effect on reducing the TC and LDL-c levels of the liver of the rats (P > 0.05), but the trend was obvious (reduced by 27.3% and 15.8%, respectively). Compared with the positive control drug, the inhibitory effect of the low-dose group of the Uyghur medicine composition was equivalent to that of simvastatin.

[0076] Table 3 Effects of the Wei Yao composition on TG, TC, LDL-c and HDL-c in rat liver

[0077]

[0078]

[0079] Note: ** P < 0.01 compared with the blank group; # P<0.05 compared with the model group.

[0080] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Uyghur medicine composition for treating hyperlipidemia, characterized in that: The following raw materials are included by weight: 100-300 parts of basil, 12-36 parts of bugloss, 6-18 parts of lavender, 3-9 parts of nard, 3-9 parts of rose, 3-9 parts of fennel, and 3-9 parts of dodder.

2. The Uyghur medicine composition according to claim 1, characterized in that: The Uyghur medicine composition contains 0.08%-0.10% of gallic acid and 0.17%-0.21% of rosmarinic acid by weight.

3. The method for preparing the Uyghur medicine composition according to claim 1 or 2, characterized in that: The following steps are involved: The raw materials are weighed according to the weight proportions, mixed, boiled with water for 2-4 times, the water extracts are filtered and combined, concentrated under reduced pressure to obtain an extract, and the extract is dried to obtain a Uyghur medicine composition.

4. The preparation method according to claim 3, characterized in that: The raw materials and water are boiled in a mass ratio of 1:8-12.

5. The preparation method according to claim 3, characterized in that: The decoction time is 1-3h / time.

6. The preparation method according to claim 3, characterized in that: The pressure of the reduced pressure concentration is 0.08 MPa, the temperature is 65-75°C, and the density is 1.22-1.25 at a temperature of 60°C.

7. The preparation method according to claim 3, characterized in that: The drying is vacuum drying at a pressure of 0.08 MPa and a temperature of 55-65° C. until the water content of the Uyghur medicine composition is ≤6%.

8. Use of the Uygur medicine composition according to claim 1 or the preparation method of the Uygur medicine composition according to any one of claims 2 to 7 in the preparation of drugs for treating hyperlipidemia and its complications.

9. The use according to claim 8, characterized in that: The drug also includes pharmaceutically acceptable excipients.

10. The use according to claim 8, characterized in that: The dosage form of the drug includes clinically acceptable tablets, powders, granules or capsules.

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