Traditional Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia and preparation method thereof

Abstract

The present invention belongs to the technical field of Chinese medicine preparation, and specifically relates to a Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia and a preparation method thereof. The Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia of the present invention is composed of the following raw materials in parts by weight: 8-20 parts of stinking knotweed, 8-20 parts of polyphemus, 1-5 parts of astragalus, 1-5 parts of mistletoe, 3-6 parts of siler, 1-5 parts of glossy privet, 1-5 parts of oriental rhizome, 1-2 parts of eucommia bark, 1-2 parts of ligusticum, 1-2 parts of ligusticum, 1-2 parts of chuanxiong, and 1-2 parts of earthworm. The Chinese medicine composition of the present invention has good antihypertensive and lipid-lowering effects, can effectively treat hypertension, has little side effects, and is particularly suitable for hypertension combined with hyperlipidemia.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine preparation, and specifically relates to a Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia and a preparation method thereof. Background Art

[0002] Hypertension is a common chronic disease in clinical practice. It is difficult to cure and has a long course of illness. The elderly are the main patients. It is a dangerous cause of cardiovascular and cerebrovascular diseases and can easily cause functional failure of related organs in patients. Most patients have hyperlipidemia. Hypertension and hyperlipidemia affect each other, further accelerating the progression of the disease.

[0003] Commonly used antihypertensive drugs include calcium antagonists, angiotensin converting enzyme inhibitors, angiotensin antagonists, diuretics and beta-receptor blockers, which can quickly lower blood pressure, and the range of blood pressure reduction is large. They are prone to hypotension, hypokalemia, kidney, heart, liver, brain damage, and rapid rebound of blood pressure after drug withdrawal. Compared with Western medicine, although Chinese medicine does not lower blood pressure by a large margin, it has unique advantages in correcting the circadian rhythm of blood pressure and stabilizing blood pressure reduction, which can reduce the occurrence of adverse events. Clinically, the treatment of hypertension combined with hyperlipidemia is mostly combined medication. Patients have to take both hypertension drugs and hyperlipidemia drugs. Drug interactions lead to more complications and side effects in patients, such as the increase in rhabdomyolysis caused by the combination of amlodipine besylate tablets and simvastatin tablets, and the cost is high.

[0004] In view of the shortcomings of the existing technology, it is urgent to develop an effective and safe Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia. Summary of the invention

[0005] The purpose of the present invention is to provide a Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia, which can effectively treat hypertension or hypertension combined with hyperlipidemia and has little side effects; the present invention also provides a preparation method thereof.

[0006] The traditional Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia of the present invention is composed of the following raw materials in parts by weight: 8-20 parts of scutellaria baicalensis, 8-20 parts of polyphylla, 1-5 parts of astragalus, 1-5 parts of viburnum, 3-6 parts of siler, 1-5 parts of glossy privet, 1-5 parts of oriental water plantain, 1-2 parts of eucommia bark, 1-2 parts of ligustrum lucidum, 1-2 parts of ligustrum lucidum, and 1-2 parts of earthworm.

[0007] The medicinal materials of the Chinese medicine composition are as follows:

[0008] The herb of Boenninghausenia albiflora (Hook.) Reichb. ex Meissn. is the dried whole herb of the Rutaceae plant. The herb of Selliguea mairei (Brause) Christenh. is the dried rhizome of the Polypodiaceae plant. Astragalus is the dried root of the Leguminosae plant Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or the Leguminosae plant Astragalus membranaceus (Fisch.) Bge.. The herb of Taxillus chinensis (DC.) Danser is the dried stems and branches with leaves of the Herb of Taxillus chinensis (DC.) Danser. The herb of Saposhnikovia divaricata (Turcz.) Schischk. is the dried root of the Umbelliferae plant Saposhnikovia divaricata (Turcz.) Schischk. Fructus Ligustri Lucidi is the dried mature fruit of Ligustrum lucidumAit., a plant of Oleaceae. Rhizoma Alismatis is the dried tuber of Alisma orientale (Sam.) Juzep., a plant of Alismataceae. Eucommia ulmoides Oliv. is the dried bark of Eucommia ulmoides Oliv., a plant of Eucommia ulmoides. Ligusticum chuanxiong Hort. is the dried rhizome of Ligusticum chuanxiong Hort., a plant of Apiaceae. Pheretima aspergillum (E.Perrier), Pheretima vulgaris Chen, Pheretima guillelmi (Michaelsen), or Pheretima pectinifera Michaelsen, animals of Pheretima family.

[0009] Ye Tianshi, a doctor in the Qing Dynasty, said: "Long-term and frequent illnesses will inevitably damage the collaterals. The collaterals are where blood gathers, and long-term illness will lead to blood stasis." As hypertension progresses, long-term illness will inevitably enter the collaterals and blood vessels will be blocked. Therefore, the treatment principles and methods for this indication are: activate blood circulation and dissipate blood stasis, dispel wind and activate collaterals, and nourish the kidney, replenish qi and activate blood circulation.

[0010] The taste of stinking knotweed is bitter and warm in nature. It has the effects of promoting blood circulation and dispersing blood stasis, relieving the symptoms of malaria, and detoxifying. Wa medicine, Lisu medicine, and Dai medicine are used to treat various inflammations. Modern pharmacological studies have shown that stinking knotweed has anti-inflammatory, analgesic, and insecticidal effects. The taste of polyphemus is bitter and slightly astringent, and it is slightly cold in nature. It enters the spleen and stomach meridians. It has the effects of dispelling wind and activating collaterals, eliminating accumulation and relieving constipation, reducing fire, relieving pain, and diuresis. It is clinically used to treat stomachache caused by food accumulation, abdominal distension and constipation, rheumatic tendon and bone pain, etc. There are few studies on its chemical composition and pharmacological effects. The two are used together to promote blood circulation and dissipate blood stasis, dispel wind and activate collaterals, and are the main medicines.

[0011] Astragalus, sweet and slightly warm, belongs to the lung and spleen meridians, can not only replenish kidney qi, but also replenish essence. Modern pharmacological studies have shown that Astragalus has many pharmacological effects such as anti-inflammatory, anti-oxidation, immunomodulation, promoting intestinal peristalsis, improving lung ventilation function, anti-cancer, hypoglycemic, and promoting the expression of hematopoietic factors; Mulberry parasite is bitter and sweet in nature, belongs to the liver and kidney meridians, and has the effects of removing rheumatism, nourishing the liver and kidney, strengthening tendons and bones, and calming the fetus. Modern pharmacological studies have shown that Mulberry parasite has anti-inflammatory, analgesic, hypoglycemic, antihypertensive, anti-tumor and neuroprotective effects; the two are matched with the main medicine, which can not only enhance the power of promoting blood circulation and dispersing blood stasis, dispelling wind and activating collaterals, but also play the role of tonifying the kidney. Combined with Saposhnikovia divaricata, pungent, sweet and warm, it belongs to the bladder, lung and spleen meridians, and has the function of dispelling wind, overcoming dampness and relieving pain. It can not only enhance the power of dispersing wind and collaterals, penetrating toxic evil, but also prevent dampness and dryness from damaging body fluids. Modern pharmacological studies have shown that Saposhnikovia divaricata has antipyretic, sedative, analgesic, anti-inflammatory, antibacterial, anti-tumor, immunity enhancement, anticoagulant, anti-allergic effects; Ligustrum lucidum, bitter and flat, enters the liver and kidney meridians, and has the functions of benefiting liver and kidney yin and improving eyesight; it is also combined with Alisma orientalis, which is sweet and cold and enters the kidney, to promote diuresis, penetrate dampness, relieve heat, replenish kidney deficiency, and relieve kidney turbidity. It can not only reduce and relieve the dampness and turbidity caused by kidney qi deficiency and poor gasification, but also restrain the heat-damaging and dispersing drugs from damaging the vital energy. It has the functions of tonifying and relieving, dispersing and lowering, and the opposites complement each other and are used for mutual restraint. Modern pharmacological studies have shown that Ligustrum lucidum has anti-tumor, antioxidant, anti-inflammatory and analgesic, liver protection, anti-osteoporosis, immunomodulatory, hypoglycemic and lipid-lowering, antibacterial and antiviral effects; Alisma orientalis has diuretic, anti-calculus, anti-nephritis effects, effects on the cardiovascular system, effects on the immune system, as well as anti-inflammatory effects, lipid-lowering, liver protection, hypoglycemic and anti-tumor effects. Astragalus, mistletoe, siler, glossy privet fruit and oriental water plantain are all ministerial drugs.

[0012] Eucommia ulmoides is sweet and warm. It enters the liver and kidney meridians. It nourishes the liver and kidneys and strengthens the tendons and bones. Modern pharmacological studies have shown that Eucommia ulmoides has anti-inflammatory, antioxidant, antihypertensive, hypoglycemic, lipid-lowering, anti-fatigue, anti-aging, and liver protection effects. Chuanxiong is pungent and warm, and can promote qi and relieve depression, dispel wind, activate blood circulation, and relieve pain. Modern pharmacological studies have shown that Chuanxiong has analgesic, anti-inflammatory, antioxidant, anti-tumor, anti-coagulant, anti-depressant, anti-aging, anti-atherosclerosis, cell protection, and heart function improvement effects. Pheretima is salty and cold. It enters the liver, spleen, and bladder meridians. It is specialized in promoting blood circulation, removing blood stasis, and promoting menstruation, and diuresis. Modern pharmacological studies have shown that Pheretima has anticoagulant, antithrombotic, anti-tumor, antihypertensive, and antiasthmatic effects. Eucommia ulmoides, Chuanxiong, and Pheretima are adjuvants.

[0013] The whole prescription is compatible with all the medicines to promote blood circulation and disperse blood stasis, dispel wind and activate collaterals, and tonify the kidney, invigorate qi and promote blood circulation. The three methods are adopted simultaneously, tonifying while promoting circulation, combining tonification and dispersion, descending while ascending, and taking into account both the symptoms and the root cause.

[0014] The method for preparing the Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia of the present invention comprises the following steps:

[0015] (1) extracting the herb of scutellaria baicalensis, the fruit of Ligustrum lucidum, Eucommia ulmoides, Ligusticum chuanxiong and Saposhnikovia divaricata by reflux extraction with an alcohol-containing solvent, concentrating the extract under reduced pressure and then drying it in a vacuum at low temperature;

[0016] (2) boiling and extracting Astragalus, Morus altissima and Rhizoma Alismatis, concentrating the extract under reduced pressure and then drying it under low temperature vacuum;

[0017] (3) extracting the polypody arthropod fern and earthworm by percolation, concentrating the percolation solution under reduced pressure and freeze-drying it;

[0018] (4) The extracts obtained in steps (1), (2) and (3) are mixed and prepared into a desired dosage form, that is, a Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia is prepared.

[0019] in:

[0020] The alcohol reflux extraction in step (1) is performed by reflux extraction with 50wt% or 70wt% ethanol for 2 times, each time for 1 hour, wherein 50wt% or 70wt% ethanol in an amount of 8 times the total weight of Herba Scutellariae, Fructus Ligustri Lucidi, Eucommia ulmoides, Rhizoma Chuanxiong and Saposhnikovia divaricata is added for the first time, and 50wt% or 70wt% ethanol in an amount of 6 times the total weight of Herba Scutellariae, Fructus Ligustri Lucidi, Eucommia ulmoides, Rhizoma Chuanxiong and Saposhnikovia divaricata is added for the second time.

[0021] The decoction extraction in step (2) is performed by adding water for decoction extraction twice, each time for 1 hour, wherein 8 times the total weight of astragalus, mistletoe and orientalis is added in the first time, and 6 times the total weight of astragalus, mistletoe and orientalis is added in the second time.

[0022] In step (3), the percolation extraction is performed using 15 wt% or 40 wt% ethanol, and the percolation liquid equivalent to 10 times the total weight of the polypody arthropoda and the earthworm is collected.

[0023] The dosage form is one of oral liquid, tablet, capsule or granule.

[0024] Compared with the prior art, the present invention has the following beneficial effects:

[0025] (1) The Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia described in the present invention can significantly lower blood pressure, and the antihypertensive effect is relatively stable, has no obvious effect on heart rate, and has little side effects. It is particularly suitable for hypertension combined with hyperlipidemia.

[0026] (2) The Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia of the present invention has the effect of lowering triglycerides.

[0027] (3) The Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia described in the present invention can reduce the angiotensin converting enzyme ACE in rats, thereby reducing the formation of angiotensin II; it can increase the serum NO level, thereby dilating blood vessels; it has an inhibitory effect on the inflammatory factors IL-6, IL-1β, and TNF-α, thereby inhibiting the occurrence of vascular inflammatory lesions, and has obvious advantages over the positive control drug; the results of non-clinical safety evaluation show that the Chinese medicine composition described in the present invention has no toxic side effects and is safe to use.

[0028] (4) The method for preparing the Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia described in the present invention adopts low-temperature vacuum drying or freeze-drying in the preparation process, which can effectively retain the heat-sensitive medicinal ingredients. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 The SBP (systolic blood pressure) of rats in each group at different administration cycles of the Chinese medicine composition granules described in Example 1 of the present invention;

[0030] Figure 2 The DBP (diastolic blood pressure) of rats in each group at different administration cycles of the Chinese medicine composition granules described in Example 1 of the present invention;

[0031] Figure 3 This is the MBP (mean blood pressure) of rats in each group at different administration cycles of the Chinese medicine composition granules described in Example 1 of the present invention. DETAILED DESCRIPTION

[0032] The present invention is further described below with reference to the embodiments.

[0033] Example 1

[0034] The Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia described in Example 1 is composed of the following raw materials, by weight: 8 parts of Herba Lysimachiae, 8 parts of Pteris multiflora, 1 part of Astragalus, 1 part of Viscum album, 3 parts of Saposhnikovia divaricata, 1 part of Ligustrum lucidum, 1 part of Orientalis almirabilis, 1 part of Eucommia ulmoides, 1 part of Ligusticum chuanxiong, and 1 part of Pheretima.

[0035] The preparation method of the Chinese medicine composition granules for treating hypertension or hypertension combined with hyperlipidemia described in Example 1 is carried out according to the following steps:

[0036] According to the weight components, weigh 8 parts by weight of Herba Lysimachiae, 8 parts by weight of Pteris multiparis, 1 part by weight of Astragalus, 1 part by weight of Viscum album, 3 parts by weight of Saposhnikovia divaricata, 1 part by weight of Fructus Ligustri Lucidi, 1 part by weight of Alisma Orientalis, 1 part by weight of Eucommia ulmoides, 1 part by weight of Rhizoma Chuanxiong, and 1 part by weight of Pheretima.

[0037] Reflux extract the herb of stinking knotweed, Ligustrum lucidum, Eucommia ulmoides, Ligusticum chuanxiong and Saposhnikovia divaricata with 70% ethanol twice, each time for 1 hour. The first time, 8 times the total weight of the herb of stinking knotweed, Ligustrum lucidum, Eucommia ulmoides, Ligusticum chuanxiong and Saposhnikovia divaricata were added. The second time, 6 times the total weight of the herb of stinking knotweed, Ligustrum lucidum, Eucommia ulmoides, Ligusticum chuanxiong and Saposhnikovia divaricata were added. The extract was filtered, the filtrate was concentrated under reduced pressure, and then dried in a low-temperature vacuum (the drying material temperature was 80°C and the drying time was 2h), crushed and set aside.

[0038] Take Astragalus, Viscum album and Alisma orientalis, add water and boil and extract twice, each time for 1 hour. The first time, add 8 times the total weight of water of Astragalus, Viscum album and Alisma orientalis, and the second time, add 6 times the total weight of water of Astragalus, Viscum album and Alisma orientalis. Filter, reduce pressure and concentrate the filtrate, then dry it in low-temperature vacuum (the drying material temperature is 80°C and the drying time is 2h), crush it and set aside.

[0039] The polyplumbago and earthworm were extracted by percolation with 40% ethanol, and the percolation liquid equivalent to 10 times the total weight of the polyplumbago and earthworm was collected. The percolation liquid was concentrated under reduced pressure and then freeze-dried (the freeze-drying procedure was specifically as follows: open the shelf refrigeration solenoid valve, set the temperature to -45°C, and maintain it for 3 hours; open the condensation cylinder refrigeration solenoid valve to reduce the temperature to -45°C, start the induced draft fan, and the vacuum degree of the drying box was 0.15MPa; the refrigerant temperature was set to -10°C and maintained for 30 hours; the refrigerant temperature was set to 10°C and maintained for 5 hours; the refrigerant temperature was set to 40°C and maintained for 2 hours, and the vacuum degree reached 0.1MPa), crushed and set aside.

[0040] The three powders are mixed evenly, 5% dextrin is added, mixed evenly, and dry granulated to obtain a traditional Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia.

[0041] Example 2

[0042] The Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia described in Example 2 is composed of the following raw materials, in parts by weight: 20 parts of Herba Lysimachiae, 20 parts of Pteris multiflora, 5 parts of Astragalus, 5 parts of Viscum album, 6 parts of Saposhnikovia divaricata, 5 parts of Ligustrum lucidum, 5 parts of Alisma orientalis, 2 parts of Eucommia ulmoides, 2 parts of Ligusticum chuanxiong, and 2 parts of Pheretima.

[0043] The preparation method of the Chinese medicine composition granules for treating hypertension or hypertension combined with hyperlipidemia described in Example 2 is carried out according to the following steps:

[0044] According to the weight components, weigh 20 parts by weight of Herba Lysimachiae, 20 parts by weight of Pteris multiparis, 5 parts by weight of Astragalus, 5 parts by weight of Viscum album, 6 parts by weight of Saposhnikovia divaricata, 5 parts by weight of Ligustrum lucidum, 5 parts by weight of Alisma orientalis, 2 parts by weight of Eucommia ulmoides, 2 parts by weight of Ligusticum chuanxiong, and 2 parts by weight of Pheretima.

[0045] Reflux extraction of Herba Clerodendrum Fibrosum, Fructus Ligustri Lucidi, Eucommia ulmoides, Rhizoma Chuanxiong and Saposhnikovia divaricata was performed twice with 50% ethanol, each time for 1 hour. The first time, 8 times the total weight of Herba Clerodendrum Fibrosum, Fructus Ligustri Lucidi, Eucommia ulmoides, Rhizoma Chuanxiong and Saposhnikovia divaricata were added. The second time, 6 times the total weight of Herba Clerodendrum Fibrosum, Fructus Ligustri Lucidi, Eucommia ulmoides, Rhizoma Chuanxiong and Saposhnikovia divaricata were added. The extraction was filtered, and the filtrate was concentrated under reduced pressure and then dried under low-temperature vacuum (the drying material temperature was 80°C and the drying time was 2h), crushed and set aside.

[0046] Take Astragalus, Viscum album and Alisma orientalis, add water and boil and extract twice, each time for 1 hour. The first time, add 8 times the total weight of water of Astragalus, Viscum album and Alisma orientalis, and the second time, add 6 times the total weight of water of Astragalus, Viscum album and Alisma orientalis. Filter, reduce pressure and concentrate the filtrate, then dry it in low-temperature vacuum (the drying material temperature is 80°C and the drying time is 2h), crush it and set aside.

[0047] The polyplum arthropoda and earthworm were extracted by percolation with 15% ethanol, and the percolation liquid equivalent to 10 times the total weight of the polyplum arthropoda and earthworm was collected. The percolation liquid was concentrated under reduced pressure and then freeze-dried (the freeze-drying procedure was specifically as follows: open the shelf refrigeration solenoid valve, set the temperature to -45°C, and maintain it for 3 hours; open the condensation cylinder refrigeration solenoid valve to reduce the temperature to -45°C, start the induced draft fan, and the vacuum degree of the drying box was 0.15MPa; the refrigerant temperature was set to -10°C and maintained for 30 hours; the refrigerant temperature was set to 10°C and maintained for 5 hours; the refrigerant temperature was set to 40°C and maintained for 2 hours, and the vacuum degree reached 0.1MPa), crushed and set aside.

[0048] The three powders are mixed evenly, 15% starch and 0.5% magnesium stearate are added, mixed evenly, granulated, tableted, and film-coated to obtain a traditional Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia.

[0049] Example 3

[0050] The traditional Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia described in Example 3 is composed of the following raw materials, in parts by weight: 14 parts of scutellaria baicalensis, 14 parts of polypody arthropoda, 3 parts of astragalus, 3 parts of viburnum, 4 parts of siler, 3 parts of glossy privet, 3 parts of oriental water chestnut, 1 part of eucommia, 1 part of ligusticum chuanxiong, and 1 part of earthworm.

[0051] The preparation method of the Chinese medicine composition granules for treating hypertension or hypertension combined with hyperlipidemia described in Example 3 is carried out according to the following steps:

[0052] According to the weight components, weigh 14 parts by weight of Herba Lysimachiae, 14 parts by weight of Pteris multiparis, 3 parts by weight of Astragalus, 3 parts by weight of Viscum album, 4 parts by weight of Saposhnikovia divaricata, 3 parts by weight of Ligustrum lucidum, 3 parts by weight of Alisma orientalis, 1 part by weight of Eucommia ulmoides, 1 part by weight of Ligusticum chuanxiong, and 1 part by weight of Pheretima.

[0053] Reflux extract the herb of stinking knotweed, Ligustrum lucidum, Eucommia ulmoides, Ligusticum chuanxiong and Saposhnikovia divaricata with 70% ethanol twice, each time for 1 hour. The first time, 8 times the total weight of the herb of stinking knotweed, Ligustrum lucidum, Eucommia ulmoides, Ligusticum chuanxiong and Saposhnikovia divaricata were added. The second time, 6 times the total weight of the herb of stinking knotweed, Ligustrum lucidum, Eucommia ulmoides, Ligusticum chuanxiong and Saposhnikovia divaricata were added. The extract was filtered, the filtrate was concentrated under reduced pressure, and then dried in a low-temperature vacuum (the drying material temperature was 80°C and the drying time was 2h), crushed and set aside.

[0054] Take Astragalus, Viscum album and Alisma orientalis, add water and boil and extract twice, each time for 1 hour. The first time, add 8 times the total weight of water of Astragalus, Viscum album and Alisma orientalis, and the second time, add 6 times the total weight of water of Astragalus, Viscum album and Alisma orientalis. Filter, reduce pressure and concentrate the filtrate, then dry it in low-temperature vacuum (the drying material temperature is 80°C and the drying time is 2h), crush it and set aside.

[0055] The polyplumbago and earthworm were extracted by percolation with 40% ethanol, and the percolation liquid equivalent to 10 times the total weight of the polyplumbago and earthworm was collected. The percolation liquid was concentrated under reduced pressure and then freeze-dried (the freeze-drying procedure was specifically as follows: open the shelf refrigeration solenoid valve, set the temperature to -45°C, and maintain it for 3 hours; open the condensation cylinder refrigeration solenoid valve to reduce the temperature to -45°C, start the induced draft fan, and the vacuum degree of the drying box was 0.15MPa; the refrigerant temperature was set to -10°C and maintained for 30 hours; the refrigerant temperature was set to 10°C and maintained for 5 hours; the refrigerant temperature was set to 40°C and maintained for 2 hours, and the vacuum degree reached 0.1MPa), crushed and set aside.

[0056] The three powders are mixed evenly, 10% dextrin is added, mixed evenly, and filled into capsules to obtain a traditional Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia.

[0057] Example 4: A pharmacodynamics test was performed on the Chinese medicine composition prepared in Example 1 of the present invention.

[0058] 1. Experimental Materials

[0059] 1.1 Experimental animals

[0060] Young spontaneously hypertensive rats (SHR), SPF grade, male, 60, purchased at 12-14 weeks of age, weighing 258-293 g at the time of first administration, provided by Beijing Weitonglihua Experimental Animal Technology Co., Ltd., experimental animal certificate number: 1100112011038325, animal production license number: SCXK (Beijing) 2016-0006.

[0061] WKY young rats, SPF grade, male, 10, purchased at 12-14wk old, weighing 275-312g at the time of first administration, provided by Beijing Weitonglihua Experimental Animal Technology Co., Ltd., experimental animal certificate number: 1100112011038324, animal production license number: SCXK (Beijing) 2016-0006.

[0062] 1.2 Test and reference substances

[0063] 1.2.1 Test sample: the Chinese medicine composition granules described in Example 1 of the present invention, batch number: 20020523, properties: brown to brown granules, specification: 6.5 g / bag, provided by Ruiyang Pharmaceutical Co., Ltd.

[0064] 1.2.2 Reference substance: Amlodipine besylate tablets: Batch number: DD2766, production date: 2019.12.11, expiration date: 2024.11, specification: 5 mg, produced by Pfizer Pharmaceuticals Co., Ltd.

[0065] Valsartan capsules: Batch number: X2679, production date: 2019.11, expiration date: 2022.10, specification: 80 mg, provided by Beijing Novatis Pharmaceuticals Co., Ltd.

[0066] 1.2.3 Preparation of drug delivery preparations

[0067] Preparation method of the test sample: Pour the corresponding mass of the Chinese medicine composition granules described in Example 1 of the present invention into a mortar and grind them into powder, transfer the powder to a 200mL glass bottle, add pure water, stir and soak for half an hour, stir with a magnetic stirrer for 30 minutes to mix, and finally add pure water to the final volume. The high, medium and low concentrations of the Chinese medicine composition granules solution described in Example 1 of the present invention are 0.72, 0.36, and 0.18 g / mL, respectively. Storage conditions and stability after preparation: Store at room temperature and stable within 72 hours.

[0068] Preparation method of amlodipine besylate: Take 1 tablet of amlodipine besylate (5 mg), grind it thoroughly in a mortar, slowly add 5 mL of 0.5% CMC (sodium carboxymethyl cellulose) solution to fully suspend, add it while grinding, transfer the suspended liquid to, wash the mortar with 0.5% CMC solution 3 times, 5 mL each time, the final volume is 28 mL, and the drug concentration is about 0.18 mg / mL. Storage conditions and stability after preparation: prepare it before use.

[0069] Preparation method of valsartan: Take 1 valsartan capsule (80 mg) and place it in a mortar and grind it thoroughly. Slowly add 5 mL of 0.5% CMC solution to suspend it thoroughly while grinding. Transfer the suspended liquid to a 100 mL glass bottle and wash the mortar with 0.5% CMC solution 3 times, 10 mL each time, to a final volume of 56 mL. The drug concentration is about 1.43 mg / mL.

[0070] Storage conditions and stability after preparation: Prepare before use.

[0071] 1.2.4 Other main reagents

[0072] Sodium carboxymethyl cellulose (CMC-Na), batch number: F20110211, specification: 500g / bottle, Sinopharm Chemical Reagent Co., Ltd.

[0073] 10% chloral hydrate solution, batch number: 0714A20, specification: 500mL / bottle, Leagene Technology Co., Ltd.

[0074] Rat interleukin 6 (IL-6) ELISA kit, batch number: 202010, 202101, Mybiosource, USA.

[0075] Rat interleukin 1β (IL-1β) ELISA kit, batch number: 202010, 202101, Mybiosource, USA.

[0076] Rat tumor necrosis factor (TNF-α) ELISA kit, batch number: 202010, Mybiosource, USA.

[0077] Rat angiotensin converting enzyme (ACE) ELISA kit, batch number: 202010, Mybiosource, USA.

[0078] Rat norepinephrine (NE) ELISA kit, batch number: Dec2020, Shanghai ELISA Biotechnology Co., Ltd.

[0079] Nitric oxide (NO) test kit, batch number: 20210113, Nanjing Jiancheng Bioengineering Institute.

[0080] 1.3 Main instruments and equipment required for the test

[0081] BP-2010A non-invasive blood pressure measurement and analysis system, Beijing Softron Biotechnology Co., Ltd.

[0082] LE203E / 02 electronic balance, Mettler-Toledo Instruments (Shanghai) Co., Ltd.

[0083] ACS-JJ-Tiger electronic price computing scale, Mettler-Toledo (Changzhou) Measurement Technology Co., Ltd.

[0084] Hitachi 7180 fully automatic biochemical analyzer, Hitachi High-Technologies Corporation, Japan.

[0085] UV2201 UV-visible spectrophotometer, Shimadzu Corporation, Japan.

[0086] Spectra Max I3 multi-function microplate reader, MD Company, USA.

[0087] 1.4 Main software / data systems used in the experiment

[0088] BP-2010A non-invasive blood pressure measurement and analysis system, WPS Office software (WPS text, WPS spreadsheet), SPSS17.0 statistical analysis software, SoftMax Pro data analysis software.

[0089] 2 Experimental methods and observation indicators

[0090] 2.1 Dosage design

[0091] The high, medium and low doses of the Chinese medicine composition granules described in Example 1 of the present invention are 7.2, 3.6 and 1.8 g / kg respectively, and the drug is administered twice a day, with each dose being 3.6, 1.8 and 0.9 g / kg.

[0092] The starting dose of amlodipine besylate for the treatment of hypertension is 5 mg once a day, and the maximum dose is 10 mg once a day. Based on 10 mg / time, according to the body surface area conversion method for equivalent doses of 70 kg adults and 200 g rats, this dose is equivalent to a rat dose of 10×0.018 / 0.2=0.9 mg / kg. The designed dose for this experiment is 0.9 mg / kg / d, once a day.

[0093] The clinical dosage of valsartan is 80 mg, once a day. Calculated as 80 mg / time, according to the body surface area conversion method of equivalent dose for adults of 70 kg and rats of 200 g, this dose is equivalent to a rat dose of 80×0.018 / 0.2=7.2 mg / kg. The designed dose for this experiment is 7.2 mg / kg / d, once a day.

[0094] The dosage design of this experiment is shown in Table 1.

[0095] Table 1 Dosage design table

[0096]

[0097] 2.2 Model preparation

[0098] Spontaneously hypertensive rats (SHR rats).

[0099] 2.3 Animal grouping and drug administration

[0100] The valsartan and amlodipine besylate groups were given the corresponding drug solution once a day by gavage, and the administration volume was 5 mL / kg. The Chinese medicine composition granule group described in Example 1 of the present invention was given the corresponding drug solution twice a day by gavage, and the administration volume was 5 mL / kg / time. The model group and the WKY group were given 5 mL / kg / time of pure water, twice a day. The administration was continued for 8 wk.

[0101] 2.4 Index Check

[0102] General condition observation: The general condition of the rats was observed every day, including appearance, activity, diet and excretion.

[0103] Body weight and blood pressure: The body weight and blood pressure of rats were measured once a week.

[0104] Determination of relevant indicators: On the second day after the last administration, the animals were anesthetized with 10% chloral hydrate at 0.4 ml / 100 g by intraperitoneal injection, blood was collected from the abdominal aorta, and serum was collected by centrifugation to detect the levels of cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), NO (nitric oxide), IL-6 (interleukin 6), IL-1β (interleukin 1β), TNF-α (tumor necrosis factor), ACE (angiotensin converting enzyme) and norepinephrine (NE).

[0105] 2.5 Statistical analysis

[0106] SPSS 17.0 statistical software was used to perform one-way ANOVA, T test or nonparametric test on the data, and the data were expressed as (x±SD). If the variance of the measurement data was equal, the one-way ANOVA LSD test was used for inter-group comparison. If the variance of the measurement data was unequal, the one-way ANOVA Dunnet's T3 test was used. P<0.05 was considered statistically significant.

[0107] 2.6 Results

[0108] 2.6.1 General physical signs observation

[0109] The rats were in a normal state throughout the experiment, with no obvious abnormalities in their activities, mental state, diet, excretion, etc. No animal deaths occurred.

[0110] 2.6.2 Weight and weight gain

[0111] Due to species differences, there were significant differences in body weight between young SHR and WKY rats during the entire experimental period (0-8wk) (P<0.05), and the body weight of SHR rats was significantly lower than that of WKY rats.

[0112] Weight gain: After 1wk of administration, the weight gain of rats in the amlodipine besylate group was slower than that in the model group (P<0.05). After 5wk of administration, the weight gain of rats in the high-dose test sample group was slower, which was statistically significant (P<0.05). No other statistical differences were found (P>0.05).

[0113] Body weight: After 1wk of administration, the body weight of rats in the amlodipine besylate group was lighter than that in the model group (P<0.05). After 3wk of administration, the body weight of rats in the medium-dose group of the test product was higher than that in the model group (P<0.05). After 4-5wk of administration, the body weight of rats in the high-dose group of the test product decreased compared with that in the model group, which was statistically significant (P<0.05). After 6-8wk of administration, there was no statistical difference in the body weight of rats in each administration group and the model group (P>0.05).

[0114] 2.6.3 Blood pressure

[0115] Due to species differences, during the entire experimental period (0-8wk), there were significant differences in SBP, DBP, MBP and HR between young SHR rats and WKY rats (P<0.05), and the blood pressure of SHR rats was significantly higher than that of WKY rats.

[0116] Compared with the model group, valsartan and amlodipine besylate (1-8wk) could significantly reduce SBP, DBP and MBP of young SHR rats, and the results were statistically significant (P<0.05). Both had no significant effect on HR.

[0117] After continuous administration for 1-8wk, at multiple time points, the test product had a certain antihypertensive effect on SBP, DBP and MBP; compared with the model group, the difference was obvious, and the antihypertensive effect was weaker than that of valsartan and amlodipine besylate, as described below:

[0118] After 1wk of administration, compared with the model group, the high, medium and low doses of the test product could significantly reduce the SBP, DBP and MBP of young SHR rats, with statistical differences (P<0.05); compared with valsartan, the SBP, DBP and MBP of the high, medium and low dose groups of the test product had significant differences (P<0.05); compared with amlodipine, the DBP of the medium dose group of the test product had significant differences (P<0.05). There were no significant differences among the other groups (P>0.05).

[0119] After 2 weeks of administration, compared with the model group, the high dose of the test product could significantly reduce the SBP of young SHR rats (P<0.05), the medium dose could significantly reduce the SBP and MBP (P<0.05), and the low dose could significantly reduce the SBP, DBP and MBP (P<0.05); compared with valsartan, the SBP, DBP and MBP of the high dose group of the test product were significantly different (P<0.05), and the SBP and DBP of the medium dose group were significantly different (P<0.05); compared with amlodipine besylate, the DBP, MBP of the high dose of the test product and the DBP of the medium dose were significantly different (P<0.05). There were no significant differences in the other groups (P>0.05).

[0120] After 3 weeks of administration, compared with the model group, the high and medium doses of the test product significantly reduced the SBP and MBP of young SHR rats (P<0.05), and the low dose significantly reduced the SBP, DBP and MBP (P<0.05); compared with valsartan, the SBP, DBP and MBP indexes of the high and medium dose groups of the test product were significantly different (P<0.05); compared with amlodipine besylate, the SBP, DBP, MBP of the high dose of the test product and the DBP and MBP of the medium dose were significantly different (P<0.05). There were no significant differences in the other groups (P>0.05).

[0121] After 4 weeks of administration, compared with the model group, the high dose of the test product can significantly reduce SBP (P<0.05), and the medium and low doses can significantly reduce SBP, DBP and MBP (P<0.05); compared with valsartan, the SBP, DBP and MBP indexes of the high dose group of the test product were significantly different (P<0.05), the SBP, MBP of the medium dose group and the SBP and DBP indexes of the low dose group were significantly different (P<0.05); compared with amlodipine, the SBP, DBP and MBP of the high dose group of the test product were significantly different (P<0.05). There were no significant differences in the other groups (P>0.05).

[0122] After 5 weeks of administration, compared with the model group, the medium and low doses of the test product could significantly reduce SBP (P<0.05); compared with valsartan, except for the low dose of MBP, the high, medium and low doses of the test product had significant differences in SBP, DBP and MBP (P<0.05). Compared with amlodipine, the high dose group of the test product had significant differences in SBP and MBP (P<0.05), and there were no significant differences in the other groups (P>0.05).

[0123] After 6wk and 7wk of administration, compared with the model group, except for the high dose of DBP, the high, medium and low doses of the test sample significantly reduced the SBP, DBP and MBP of SHR (P<0.05); after 6wk of administration, compared with the valsartan and amlodipine besylate groups, the SBP, DBP and MBP indexes of the high, medium and low dose groups of the test sample were significantly different (P<0.05). After 7wk of administration, compared with the valsartan and amlodipine groups, the SBP of the high and medium doses of the test sample was significantly different (P<0.05). There was no significant difference in the other groups (P>0.05).

[0124] After 8 weeks of administration, compared with the model group, except for the medium-dose DBP and MBP, the test product can significantly reduce the SBP, DBP and MBP of SHR (P<0.05); compared with valsartan, the SBP of the high-dose group of the test product and the SBP, DBP and MBP of the medium and low doses of the test product are significantly different (P<0.05); compared with amlodipine besylate, the SBP, DBP and MBP of the medium-dose group of the test product are significantly different (P<0.05). There were no significant differences in the other groups (P>0.05). The results are summarized in Table 2. Figures 1 to 3 .

[0125]

[0126]

[0127] 2.6.4 Blood lipids

[0128] Compared with the WKY group, the TG level in the model group increased, and the TC and LDL-C levels decreased (P<0.05); the TC and LDL-C levels in each drug-treated group decreased (P<0.05). Compared with the model group, the TC level in the valsartan group decreased; the TG levels in the high, medium and low dose groups of the test product decreased (P<0.05). Compared with the valsartan group, the serum HDL-C level in the high dose group of the test product was higher than that in the valsartan group; the serum TG levels in the medium and low dose groups were lower than that in the valsartan group (P<0.05).

[0129] See Table 3 for the statistical results.

[0130] Table 3 Rat blood lipid results

[0131]

[0132] * , compared with the model group, P < 0.05;

[0133] Δ , compared with the WKY group, P < 0.05;

[0134] @ , compared with the valsartan group, P<0.05.

[0135] 2.6.5 Inflammatory factors and ACE, NE

[0136] The experimental results showed that compared with the WKY group, the serum IL-6, IL-1β, TNF-α, and ACE levels of SHR in the model group were significantly increased, and the results were statistically significant (P<0.05); the serum NE level was decreased (P<0.05); and there was no significant difference in NO level (P>0.05).

[0137] Compared with the model group, the serum NO level in the amlodipine besylate group was significantly increased, and the ACE content was decreased (P<0.05); the serum ACE level in the valsartan group was decreased (P<0.05); the serum NO level in the high-dose group of the test sample was increased, and the ACE content was decreased (P<0.05); the serum NO level in the medium-dose group was increased, and the IL-1β and ACE levels were decreased (P<0.05); the serum IL-6, IL-1β, TNF-α, and ACE levels in the low-dose group were all decreased (P<0.05). Compared with the model group, there was no significant difference in the NE level among the drug-administered groups (P>0.05).

[0138] Compared with the valsartan group, the serum NO level in the high-dose group was higher than that in the valsartan group (P<0.05); the serum IL-6, TNF-α and ACE levels in the medium-dose group were lower than those in the valsartan group (P<0.05); the serum IL-6, IL-1β, TNF-α and ACE levels in the low-dose group were lower than those in the valsartan group (P<0.05).

[0139] Compared with the amlodipine besylate group, the serum ACE level in the medium-dose group was lower than that in the amlodipine besylate group (P<0.05); the serum IL-6, TNF-α and ACE levels in the low-dose group were lower than those in the amlodipine besylate group (P<0.05).

[0140] See Table 4-5 for statistical results.

[0141] Table 4 IL-6, IL-1β and NO levels in rat serum

[0142]

[0143] * , compared with the model group, P < 0.05;

[0144] Δ , compared with the WKY group, P < 0.05;

[0145] @ , compared with the valsartan group, P < 0.05;

[0146] & , compared with the amlodipine besylate group, P<0.05.

[0147] Table 5 TNF-α, ACE, NE levels in rat serum

[0148]

[0149] * , compared with the model group, P < 0.05;

[0150] Δ , compared with the WKY group, P < 0.05;

[0151] @ , compared with the valsartan group, P < 0.05;

[0152] & , compared with the amlodipine besylate group, P<0.05.

[0153] 2.6.6 Conclusion

[0154] 2.6.6.1 The Chinese medicine composition granules described in Example 1 of the present invention have a blood pressure lowering effect, and the blood pressure lowering effect is relatively stable and has no significant effect on heart rate.

[0155] 2.6.6.2 The Chinese medicine composition granules described in Example 1 of the present invention have the effect of lowering triglycerides, and their effect on improving blood lipids is better than valsartan.

[0156] 2.6.6.3 The antihypertensive effects of the Chinese medicine composition granules described in Example 1 of the present invention are: first, it reduces the angiotensin converting enzyme ACE in rats, thereby reducing the formation of angiotensin II; second, it increases the serum NO level, thereby relaxing blood vessels; third, it inhibits the inflammation factors IL-6, IL-1β, and TNF-α, thereby inhibiting the occurrence of vascular inflammatory lesions, which has obvious advantages compared with the positive control drug. This study did not find that the Chinese medicine composition granules described in Example 1 of the present invention had a significant relationship with norepinephrine.

[0157] Example 5: Safety analysis and evaluation of the Chinese medicine composition described in Example 1 of the present invention

[0158] 1. Safety Pharmacology The effects of the Chinese medicine composition granules described in Example 1 of the present invention on the central nervous system, respiratory system and cardiovascular system were mainly studied.

[0159] (1) Effect of single intragastric administration of the Chinese medicine composition granules described in Example 1 of the present invention on the central nervous system of SD rats

[0160] SD rats were given a single oral administration of the Chinese medicine composition granules of Example 1 of the present invention in three dose groups (4.0, 7.5, 15.0 g / kg / d), and the modified Irwin's test was performed before administration, 1, 2, 4 and 24 hours after administration to test the observation indexes, and the body temperature of the animals was measured before administration, 2 and 24 hours after administration. The test results showed that compared with the solvent control group in the same period, no obvious abnormalities were found in the observation indexes of the animals in each dose group of the Chinese medicine composition granules of the present invention at each time point before and after administration.

[0161] That is, a single oral gavage administration of the Chinese medicine composition granules described in Example 1 of the present invention at a dose of 4.0, 7.5, and 15.0 g / kg / d to SD rats had no significant effect on the central nervous system.

[0162] (2) Effect of single intragastric administration of the Chinese medicine composition granules described in Example 1 of the present invention on the respiratory system of SD rats

[0163] The 3 dose groups (4.0, 7.5, 15.0 g / kg / d) of the Chinese medicine composition granules described in Example 1 of the present invention were administered by single oral gavage to awake unrestrained SD rats, and the respiratory system indices were recorded and analyzed before administration, 1 hour, 2 hours, 4 hours and 24 hours after administration using a whole body plethysmography system. The test results showed that compared with the vehicle control group in the same period, no abnormal changes related to the test product were observed in the respiratory indices (respiratory rate, tidal volume, minute ventilation) of male and female animals in each dose group of the test product after administration.

[0164] That is, a single oral gavage of the Chinese medicine composition granules described in Example 1 of the present invention (4-15 g / kg / d) to SD rats had no significant effect on the respiratory system.

[0165] (3) Safety pharmacology test of the Chinese medicine composition granules described in Example 1 of the present invention by gavage on Beagle dogs

[0166] In this study, conscious Beagle dogs pre-embedded with telemetry implants were gavaged with the Chinese medicine composition granules described in Example 1 of the present invention (2.0, 3.75 and 7.5 g / kg / d). The detection indicators included blood pressure (systolic pressure, diastolic pressure, mean arterial pressure) and electrocardiogram (heart rate, RR interval, PR interval, QRS complex duration, QT interval, corrected QT interval) indicators, and the obtained cardiovascular system telemetry data were collected and analyzed. The time points for experimental data collection were: before administration, 0.5, 1, 2, 4, 10 and 24 hours after administration. During the experiment, all animals did not show abnormal clinical signs related to the test product. Compared with the solvent control group in the same period, no abnormal changes in the electrocardiogram and blood pressure indicators of animals in each dosage group were found to be related to the Chinese medicine composition granules described in Example 1 of the present invention.

[0167] That is, when Beagle dogs were given a single oral administration of the Chinese medicine composition granules described in Example 1 of the present invention (2.0, 3.75, 7.5 g / kg), no abnormal changes were observed in blood pressure and electrocardiogram indexes.

[0168] 2. Summary of toxicology studies

[0169] (1) Single-dose toxicity test

[0170] In the "Single-dose toxicity test of the Chinese medicine composition granules described in Example 1 of the present invention on ICR mice by oral gavage", the Chinese medicine composition granules described in Example 1 of the present invention were administered to ICR mice by oral gavage at a dose of 30 g / kg. Watery stools were observed in a few animals, and no effects were observed on body weight and food intake indicators, and no toxic target organs were observed; the dose of 30 g / kg was its maximum tolerated dose.

[0171] (2) Repeated dose toxicity test

[0172] In the "Toxicity test of repeated administration of the Chinese medicine composition granules described in Example 1 of the present invention to SD rats by oral gavage for 26 consecutive weeks", SD rats were given the Chinese medicine composition granules described in Example 1 of the present invention by oral gavage for 26 consecutive weeks, with a recovery period of 4 weeks. The research results showed that: at a dose of 4.0g / kg / d, there was no significant effect on all indicators; at a dose of 7.5g / kg / d, an increase in the wet weight of the liver organ and a mild hypertrophy of the central hepatocytes of the liver lobule without damaging effects were observed, and no other significant effects were observed; at a dose of 15.0g / kg / d, a decrease in the food intake of male animals and an increase in the wet weight of the liver organs of both male and female animals and a mild hypertrophy of the central hepatocytes of the liver lobule without damaging effects were observed, and no other significant effects were observed; the effects on food intake and liver can be restored after drug withdrawal.

[0173] The results of safety pharmacology and toxicology studies show that the Chinese medicine composition granules described in Example 1 of the present invention have almost no toxic side effects at a higher dosage, which provides a safety basis for the clinical development and application of the drug.

Claims

1. A Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia, characterized in that: The invention is prepared from the following raw materials by weight: 8-20 parts of stinking grass, 8-20 parts of polypody arthropoda, 1-5 parts of astragalus, 1-5 parts of mistletoe, 3-6 parts of siler, 1-5 parts of glossy privet, 1-5 parts of oriental water plantain, 1-2 parts of eucommia bark, 1-2 parts of ligustrum lucidum, 1-2 parts of ligustrum lucidum, and 1-2 parts of earthworm.

2. The Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia according to claim 1, characterized in that: The herb is the dried whole herb of the herb of the Rutaceae plant. The multi-winged arthropod fern is the dried rhizome of the multi-winged arthropod fern of the Polypodiaceae family.

3. The Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia according to claim 1, characterized in that: Astragalus is the dried root of Astragalus mongolica or Astragalus membranaceus. Mulberry parasite is the dried leafy stems and branches of the plant Morus alba of the Morus alba family; Saposhnikovia divaricata is the dried root of Saposhnikovia divaricata plant of Umbelliferae family; Ligustrum lucidum is the dried mature fruit of Ligustrum lucidum of the Oleaceae family. Alisma is the dried tuber of Alisma orientalis, a plant of the Alismataceae family.

4. The Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia according to claim 1, characterized in that: Eucommia ulmoides is the dried bark of Eucommia ulmoides, a plant of the Eucommia family; Chuanxiong is the dried rhizome of the plant Chuanxiong of the Umbelliferae family; Earthworm is the dried body of Earthworm, Pheretima quinata, Pheretima common, Pheretima William or Pheretima blind, all of which belong to the family Lumbricidae.

5. A method for preparing the Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia according to claim 1, characterized in that: The following steps are involved: (1) extracting Herba Clematidis, Fructus Ligustri Lucidi, Eucommia ulmoides, Rhizoma Chuanxiong and Saposhnikovia divaricata by reflux extraction with an alcohol-containing solvent, concentrating the extract under reduced pressure and then drying it under vacuum at low temperature; (2) boiling and extracting Astragalus, Morus altissima and Rhizoma Alismatis, concentrating the extract under reduced pressure and then drying it under low temperature vacuum; (3) extracting the polypody arthropod fern and earthworm by percolation, concentrating the percolation liquid under reduced pressure and freeze-drying it; (4) mixing the extracts obtained in steps (1), (2) and (3) to prepare a desired dosage form, that is, preparing a Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia; in: The alcohol reflux extraction in step (1) is performed by reflux extraction with 50 wt% or 70 wt% ethanol twice, each time for 1 hour, and 50 wt% or 70 wt% ethanol is added in an amount of 8 times the total weight of Herba Scutellariae, Fructus Ligustri Lucidi, Eucommia ulmoides, Rhizoma Chuanxiong and Saposhnikovia divaricata in the first extraction, and 50 wt% or 70 wt% ethanol is added in an amount of 6 times the total weight of Herba Scutellariae, Fructus Ligustri Lucidi, Eucommia ulmoides, Rhizoma Chuanxiong and Saposhnikovia divaricata in the second extraction.

6. The method for preparing the Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia according to claim 5, characterized in that: The decoction extraction in step (2) is performed by adding water for decoction extraction twice, each time for 1 hour, the first time adding water 8 times the total weight of Astragalus, Loranthus and Alisma orientalis, and the second time adding water 6 times the total weight of Astragalus, Loranthus and Alisma orientalis.

7. The method for preparing the Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia according to claim 5, characterized in that: In step (3), the percolation extraction is performed by percolation extraction using 15 wt% or 40 wt% ethanol, and a percolation liquid equivalent to 10 times the total weight of the polypody arthropoda and the earthworm is collected.

8. The method for preparing the Chinese medicine composition for treating hypertension or hypertension combined with hyperlipidemia according to claim 5, characterized in that: The dosage form is one of oral liquid, tablet, capsule or granule.

Images