Traditional Chinese medicine preparation with functions of activating collaterals and dredging collaterals as well as preparation method and application of traditional Chinese medicine preparation

Abstract

The invention provides a traditional Chinese medicine preparation with functions of activating collaterals and dredging collaterals and a preparation method and application thereof, and belongs to the field of traditional Chinese medicine preparations. The traditional Chinese medicine preparation is prepared by the following method: (1) uniformly mixing 12-16 parts by weight of aleppo avens, 3-6 parts by weight of potentilla fruticosa and 2-4 parts by weight of astragalus membranaceus, crushing, and sieving with a 50-mesh sieve to obtain powder; (2) adding the powder obtained in the step (1) into an ethanol aqueous solution with the concentration of 48-52v / v%, dipping and extracting, controlling the material-liquid ratio to be (1: 8)-(1: 12) and the extraction temperature to be 40-60 DEG C, and extracting in a countercurrent extraction manner for 1-2 hours to obtain an extracting solution; (3) filtering the extracting solution obtained in the step (2), and removing ethanol and water from the filtrate to obtain a crude extract; (4) adding petroleum ether into the crude extract obtained in the step (3) for extraction, and removing petroleum ether to obtain a refined product at the lower layer; and (5) taking the refined product in the step (4), and performing spray drying to obtain finished medicinal powder. The traditional Chinese medicine preparation treats the coronary heart disease by dredging blood vessels, improving circulation and tonifying qi and consolidating foundation.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine preparation with the function of dredging meridians and activating collaterals, its preparation method and application. Background Art

[0002] Coronary heart disease (coronary atherosclerotic heart disease) is a globally prevalent cardiovascular disease. Modern medicine mainly uses therapies such as antiplatelet, lipid regulation, and revascularization. However, long-term medication has side effects (such as bleeding risk and liver function damage) and drug resistance problems in some patients. Traditional Chinese medicine has unique advantages in improving myocardial ischemia and reducing angina attacks through multi-target regulation and overall conditioning. Currently, commonly used traditional Chinese patent medicines for promoting blood circulation to remove blood stasis in clinical practice (such as Compound Danshen Tablets and Suxiao Jiuxin Pills) mainly use Danshen and Chuanxiong as the main drugs, which have significant effects on coronary heart disease with qi and yin deficiency or phlegm and blood stasis syndrome types. However, they have limited effects on patients with the syndrome type of "blockage of collaterals with qi deficiency and blood stasis", and some medicinal materials are in short supply (such as wild Danshen). Summary of the Invention

[0003] To solve the above technical problems, based on the characteristics of ethnic medicines, the present invention uses Geum japonicum var. chinense as the monarch drug, Potentilla fruticosa as the minister drug, and Astragalus membranaceus as the assistant drug to obtain a traditional Chinese medicine preparation for dredging meridians and activating collaterals. Among them, Geum japonicum var. chinense is a traditional medicine used by the Miao ethnic group, commonly known as "Nanbuzheng", which has the effects of promoting blood circulation to remove blood stasis and invigorating the spleen and qi, and is used in Guizhou folk for heart meridian stasis syndrome; Potentilla fruticosa is commonly called "Banna" in Tibetan medicine, which can reduce lipid and inflammation, dredge collaterals and relieve pain; Astragalus membranaceus is an important drug for replenishing qi. The three can form a synergistic formula of "activating blood circulation - dredging collaterals - strengthening the root", which can be used for the prevention and treatment of coronary heart disease, especially suitable for patients with coronary heart disease of qi deficiency and blood stasis type.

[0004] The present invention adopts the following technical solutions:

[0005] The first aspect of the present invention aims to provide a traditional Chinese medicine preparation with the function of activating collaterals and dredging meridians, comprising the following raw materials in parts by weight: 12 - 16 parts of Geum japonicum var. chinense, 3 - 6 parts of Potentilla fruticosa, and 2 - 4 parts of Astragalus membranaceus.

[0006] Preferably, the traditional Chinese medicine preparation with the function of activating collaterals and dredging meridians comprises the following raw materials in parts by weight: 14 parts of Geum japonicum var. chinense, 5 parts of Potentilla fruticosa, and 3 parts of Astragalus membranaceus.

[0007] The second aspect of the present invention aims to provide a preparation method of a traditional Chinese medicine preparation with the function of activating collaterals and dredging meridians, and the preparation steps included are as follows:

[0008] (1) After mixing 12 - 16 parts of Geum japonicum var. chinense, 3 - 6 parts of Potentilla fruticosa, and 2 - 4 parts of Astragalus membranaceus by weight of the raw materials evenly, they are crushed and passed through a 50 - mesh sieve to obtain a powder;

[0009] (2) Add the powder obtained in step (1) to an ethanol aqueous solution for countercurrent extraction to obtain an extract.

[0010] Preferably, the concentration of the ethanol aqueous solution is 48 - 52 v / v%.

[0011] Preferably, the ratio of material to liquid is 1:8 - 1:12.

[0012] Preferably, the extraction temperature is 40 - 60 °C and the extraction time is 1 - 2 h.

[0013] (3) Take the extract described in step (2), filter it, and remove ethanol and water from the filtrate to obtain a crude extract.

[0014] (4) Take the crude extract described in step (3), add petroleum ether for extraction, remove the petroleum ether, and the lower layer is the refined product.

[0015] (5) Take the refined product described in step (4) and perform spray drying to obtain the finished medicinal powder.

[0016] Furthermore, the finished medicinal powder is further prepared into a preparation according to the conventional techniques in the art, including but not limited to any one of oral liquid, decoction, granule, pill, enema, capsule, suppository, freeze-dried powder.

[0017] The object of the third aspect of the present invention is to provide an application of the traditional Chinese medicine preparation with the function of activating collaterals and dredging meridians of the present invention for preventing and treating coronary heart disease, especially suitable for patients with coronary heart disease of qi deficiency and blood stasis type.

[0018] The beneficial effects of the present invention are as follows: In the present invention, Potentilla discolor Bge. dominates promoting blood circulation to remove blood stasis, Potentilla fruticosa L. reduces lipid and has anti-inflammatory effects to strengthen the effect of dredging collaterals and relieving pain, and Astragalus membranaceus (Fisch.) Bunge replenishes qi and consolidates the root. The three-dimensional treatment mode of "promoting blood circulation - anti-inflammatory - consolidating the root" not only overcomes the defect that simple blood circulation promotion is likely to damage healthy qi, but also avoids the drawback that simple qi supplementation is likely to stagnate blood stasis. In the prior art, for the treatment of coronary heart disease, long-term use of chemical drugs has side effects (such as bleeding risk, liver function damage), and currently, the commonly used traditional Chinese patent medicines for promoting blood circulation to remove blood stasis in clinical practice have limited effects on patients with the syndrome type of "collateral obstruction combined with qi deficiency and blood stasis". The present invention innovatively uses the ethnic medicine Potentilla discolor Bge. as the monarch drug, combined with Potentilla fruticosa L. and Astragalus membranaceus (Fisch.) Bunge to form a synergistic prescription of "promoting blood circulation - anti-inflammatory - consolidating the root". Research shows that this traditional Chinese medicine preparation shows good curative effects in the treatment of coronary heart disease: the high-dose traditional Chinese medicine group can achieve rapid plaque reversal (shrinking by 33% within 4 weeks), and the inflammatory factor IL-6 decreases by 37%, solving the contradiction that traditional blood circulation-promoting drugs are likely to damage healthy qi and qi-supplementing drugs are likely to stagnate blood stasis. Specific embodiments

[0019] In order to make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below in conjunction with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0020] Example 1, Preparation of Traditional Chinese Medicine Preparation

[0021] A traditional Chinese medicine preparation for activating collaterals and dredging meridians, the traditional Chinese medicine preparation is composed of raw materials in parts by weight shown in Table 1, and its specific preparation process is as follows, and the process parameters are shown in Table 2:

[0022] (1) Mix all the above-mentioned raw materials in parts by weight evenly, crush them, and sieve them to obtain powder;

[0023] (2) Add the obtained powder to an ethanol aqueous solution with a corresponding concentration for countercurrent extraction, the extraction temperature is 40-60°C, and the extraction time is 1-2 h to obtain an extract;

[0024] (3) Take the extract described in step (2), filter it, and remove ethanol and water from the filtrate to obtain a crude extract;

[0025] (4) Take the crude extract described in step (3), add petroleum ether for extraction, remove the petroleum ether, and the lower layer is the refined product;

[0026] (5) Take the refined product described in step (4), and perform spray drying to obtain the finished medicine powder for activating collaterals and dredging meridians.

[0027] Table 1 Dosage of Traditional Chinese Medicine Raw Materials

[0028]

[0029]

[0030] Table 2 Preparation Process of Traditional Chinese Medicine Composition

[0031]

[0032] After the finished medicine powder in step (5) is mixed with an appropriate amount of pharmaceutical excipients, it is made into granule sachets according to the conventional forming process or filled into capsule shells according to the conventional process to make capsules. The polysaccharide content in the above-mentioned capsules is ≥10.0%; the polyphenol content is ≥12.0%; the flavonoid content is ≥5.0%; the gallic acid content is ≥0.3%; the ellagic acid content is ≥0.5%.

[0033] Animal Model

[0034] Method: Feed mice with a high-cholesterol diet for 8-12 weeks to form a coronary atherosclerotic plaque model, and observe for 8 weeks after administration.

[0035] Grouping: blank group, model group, different doses of the traditional Chinese medicine preparation No. 5 of the present invention (the doses are respectively: 300 mg / kg, 400 mg / kg, and 500 mg / kg).

[0036] Results:

[0037] Table 3 Results of drug administration in animal experiments

[0038]

[0039]

[0040] The results showed that the high-dose traditional Chinese medicine group could achieve rapid plaque reversal (shrinking by 33% within 4 weeks), and the inflammatory factor IL-6 decreased by 37%, which could effectively treat coronary heart disease.

[0041] The pharmacological effects of each traditional Chinese medicine raw material involved in the traditional Chinese medicine composition of the embodiment of the present invention:

[0042] Geum aleppicum, a traditional Chinese medicine name. It is the dried whole herb of the Rosaceae plant Geum aleppicum Jacq. or Geum japonicum Thunb. var. chinense Bolle. Common aliases include Zhui Feng Qi, Wu Qi Chao Yang Cao, Hong Xin Cao, Shui Yang Mei, Tou Yun Yao, Lu Bian Huang, etc. It has the effects of replenishing qi and strengthening the spleen, nourishing blood and yin, moistening the lungs and resolving phlegm. It is commonly used for qi and blood deficiency, consumptive cough, and spleen deficiency with vaginal discharge. The main active ingredients are tannic acid, organic acids, and polysaccharides, etc. It can reduce blood viscosity, increase the blood flow velocity of capillaries, dilate the coronary arteries, increase coronary blood flow, and improve myocardial ischemia.

[0043] Potentilla fruticosa L., belonging to the genus Potentilla of the Rosaceae family, is a deciduous shrub, also known as Jin Lao Mei, Jin La Mei, Yao Wang Cha, etc. It is a commonly used traditional Tibetan medicine, and the Tibetan medicine name is Ban Na. Modern research has found that Potentilla fruticosa mainly contains chemical components such as flavonoids, tannins, organic acids, and phenolic acids. Pharmacological studies have proved that Potentilla fruticosa has the effects of antibacterial, anti-inflammatory, and hypoglycemic. It can inhibit platelet aggregation and improve microcirculation; protect vascular endothelium through anti-inflammatory and antioxidant effects; synergistically enhance the effect of promoting blood circulation and removing blood stasis with Geum aleppicum, and cooperate with Astragalus membranaceus to regulate qi and blood balance, forming a synergistic effect of "unblocking collaterals without damaging healthy qi" in the treatment of coronary heart disease.

[0044] Astragalus, a Chinese medicine name. It is the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the Leguminosae family. Common aliases include Yuanqi, Mianqi, Daimian, Dushen, and Shuzhi. It has the effects of replenishing qi and raising yang, strengthening the body's defense system, promoting diuresis and reducing swelling, and removing toxins and promoting tissue regeneration. It is often used for qi deficiency and fatigue, poor appetite and loose stools, sinking of the middle qi, spontaneous sweating due to superficial deficiency, qi deficiency edema, and internal heat and thirst. The main active ingredients are astragaloside IV, astragalus polysaccharides and isoflavones (calycosin isoflavones), which can enhance myocardial contractility and improve cardiac function; reduce inflammatory response by regulating immune function; promote vascular endothelial cell repair and improve microcirculation; and can synergistically enhance the effect when used with blueberry and golden pothos, playing a unique role of "replenishing qi and promoting blood circulation" in the treatment of coronary heart disease.

[0045] The safety of each Chinese medicine raw material involved in the Chinese medicine composition of the present invention:

[0046] Lanbuzheng: Lanbuzheng as the main active ingredient of drugs have been launched, such as Lanzhi Annao Capsules (approval number: National Medicine Standard Z20043647), and the drug is an over-the-counter drug, and its safety has been proven in many years of clinical application. At the same time, Lanbuzheng has in-hospital preparations launched in Yunnan Province and Hunan Province, and no adverse events have been reported.

[0047] Potentilla fruticosa: Hospitals may use it in in-house formulas for gastroenteritis and trauma hemostasis, and its good safety has been proven in many years of clinical application.

[0048] Astragalus: Marketed drugs with Astragalus as the main active ingredient include Compound Astragalus Oral Liquid (National Medicine Approval No. B20020085), Astragalus Granules (National Medicine Approval No. Z20003380), Astragalus Injection (National Medicine Approval No. Z19993151), and many other drugs. They are widely used in clinical practice and have good safety.

[0049] Although the embodiments of the present invention have been disclosed, they are not limited to the applications listed in the specification and the implementation methods, and can be fully applied to various fields suitable for the present invention. For those familiar with the art, it is easy to understand that the present invention is not limited to implementing other modifications under the general concept defined by the equivalent scope, so it does not deviate from the claims and specific details.

Claims

1. A Chinese medicine preparation having the function of activating collaterals and unblocking blood vessels, characterized in that: The traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 12-16 parts of blueberry, 3-6 parts of sweet potato and 2-4 parts of astragalus.

2. The Chinese medicine preparation having the function of activating collaterals and unblocking blood vessels as claimed in claim 1, characterized in that: The drug comprises the following raw materials in parts by weight: 14 parts of blue bud Zheng, 5 parts of golden plum, and 3 parts of astragalus.

3. The method for preparing the Chinese medicine preparation having the function of activating collaterals and unblocking blood vessels according to claim 1, characterized in that: The following steps are included: (1) The raw materials according to claim 1 or 2 are mixed uniformly, crushed, and passed through a 50-mesh sieve to obtain a powder; wherein the weight proportions of the raw materials are: 12-16 parts of blue clover, 3-6 parts of sweet potato, and 2-4 parts of astragalus; (2) adding the powder obtained in step (1) to an ethanol aqueous solution with a concentration of 48-52 v / v% for immersion extraction, with a solid-liquid ratio of 1:8-1:12, an extraction temperature of 40-60° C., extracting by countercurrent extraction, and an extraction time of 1-2 h to obtain an extract; (3) taking the extract from step (2), filtering, and removing ethanol and water from the filtrate to obtain a crude extract; (4) taking the crude extract of step (3), adding petroleum ether for extraction, removing the petroleum ether, and the lower layer is the refined product; (5) taking the refined product of step (4) and spray drying it to obtain a finished drug powder.

4. The method for preparing the Chinese medicine preparation having the function of activating collaterals and unblocking blood vessels as claimed in claim 3, characterized in that: The weight proportions of the raw materials in step (1) are: 14 parts of blue clover, 5 parts of sweet potato and 3 parts of astragalus.

5. The method for preparing the Chinese medicine preparation having the function of activating collaterals and unblocking blood vessels as claimed in claim 3, characterized in that: In step (2), the concentration of the ethanol aqueous solution is 50 v / v%, the solid-liquid ratio is 1:10, the extraction temperature is 50° C., and the extraction time is 1 h.

6. The use of the Chinese medicine preparation having the function of activating collaterals and unblocking blood vessels according to claim 1 or 2, characterized in that: The Chinese medicine preparation is used to prepare dosage forms for treating and preventing coronary heart disease, and the dosage forms include but are not limited to any one of oral liquid, decoction, granules, tablets, pills, capsules, suppositories, and lyophilized powder.

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