Traditional Chinese medicine composition for treating chronic heart failure and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic heart failure. The traditional Chinese medicine composition is prepared from 9 parts of radix aconiti lateralis preparata, 10 parts of fructus psoraleae, 15 parts of polyporus umbellatus, 15 parts of poria cocos, 15 parts of rhizoma atractylodis macrocephalae, 12 parts of ligusticum wallichii, 20 parts of astragalus membranaceus, 15 parts of salvia miltiorrhiza, 10 parts of cassia twig, 12 parts of semen lepidii and 8 parts of rhodiola rosea. The traditional Chinese medicine composition has the effects of resisting oxidation, improving myocardial injury, resisting myocardial hypertrophy, regulating calcium and regulating heart functions and signal channels, and is good in clinical curative effect and safety.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating chronic heart failure (CHF) based on the principles of warming yang and promoting water excretion and activating blood circulation to dissipate blood stasis. BACKGROUND

[0002] Chronic heart failure is the end stage of cardiovascular disease, and the western medicine treatment mainly includes diuresis, cardiotonic and vasodilation. However, long-term application has problems such as electrolyte disorder and drug resistance. Traditional Chinese medicine has advantages in improving symptoms and quality of life through multi-target regulation. In the prior art, although traditional Chinese medicine such as compound Danshen dripping pills and Qili Qiangxin capsules has certain curative effect, the prescription mainly focuses on a single pathogenesis (such as blood stasis or qi deficiency), and lacks specificity for the combined pathogenesis of heart-kidney yang deficiency and water retention.

[0003] The present application is based on the theory of "heart-kidney disease", and optimizes the prescription compatibility by taking warming and tonifying heart and kidney, activating blood and promoting water excretion as the core, and verifies its multiple mechanisms such as antioxidant, anti-myocardial hypertrophy and signal pathway regulation through experiments, and has significant clinical effect and high safety. SUMMARY

[0004] The present application provides a traditional Chinese medicine composition for treating chronic heart failure, which is composed of prepared aconite 9-12 parts, buzhui 10-15 parts, poria cocos 15-20 parts, poria cocos 15 parts, white atractylodes 15 parts, chuanxiong 12 parts.

[0005] In one possible solution, the composition further comprises radix angelicae sinensis 20 parts, salvia miltiorrhiza 15 parts, cassia twig 10 parts, trichosanthes kirilowii 12 parts, rhodiola 8 parts, dried tangerine or orange peel 6 parts, and licorice 6 parts.

[0006] In one possible solution, the composition is in the form of granules, capsules or oral liquid.

[0007] In one possible solution, the composition is used for preparing a medicine for treating chronic heart failure.

[0008] Meanwhile, the present application also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:

[0009] S1, reflux extracting prepared aconite and buzhui with 70% ethanol for 2 times, and concentrating the combined extract to be alcohol-free;

[0010] S2, decocting the remaining medicinal materials with water for 3 times, and concentrating the combined filtrate into extract;

[0011] S3, combining the alcohol extract and water extract, and adding excipients to prepare finished products.

[0012] In a possible solution, the processing method of the prepared product in S1 is: baking the He Shun Pian to a surface slightly yellow at 120 DEG C.

[0013] The Chinese medicine composition for treating chronic heart failure and the preparation method thereof have the beneficial effects that:

[0014] (1) Anti-oxidation and improvement of myocardial injury

[0015] Experiments show that the composition of the present application can significantly improve the activities of SOD and GSH-Px (P<0.01) in myocardial tissue, reduce the level of MDA (P<0.05), and reduce the ISO-induced myocardial cell apoptosis by activating the Nrf2 signaling pathway;

[0016] (2) Anti-myocardial hypertrophy and calcium regulation

[0017] The prepared Aconitum and Salvia miltiorrhiza in the composition can block the L-type calcium channel, inhibit the calcium influx (reduce the intracellular Ca 2+ concentration by 35%), and improve the myocardial cell skeleton reorganization (Western blot shows that the expression of alpha-actinin is up-regulated) by inhibiting the generation of mitochondrial ROS;

[0018] (3) Regulation of heart function and signaling pathway

[0019] In the CHF rat model, the composition can increase the LVEF by 18.7% (P<0.01) and reduce the BNP level by 42.3% (P<0.05), and the effects are related to the activation of the PI3K / Akt pathway and the inhibition of the Caspase-9 apoptosis pathway;

[0020] (4) Clinical efficacy and safety

[0021] 70 cases of heart-kidney yang deficiency type CHF patients were randomly controlled, and the results show that:

[0022] The total effective rate of the Chinese medicine group (western medicine + the composition of the present application) is 87.5%, which is significantly higher than that of the control group (65.7%, P<0.05);

[0023] The 6-minute walking distance is increased by 58.2 meters (the control group is 32.1 meters, P<0.01);

[0024] The TCM syndrome score reduction rate is 61.3% (the control group is 38.9%, P<0.05);

[0025] No abnormal liver and kidney function or electrolyte disorder is found. DETAILED DESCRIPTION

[0026] In order to make the purposes, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are some embodiments but not all of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0027] The technical solutions of the present application will be described in detail below with specific embodiments. The following specific embodiments can be combined with each other, and some embodiments can not be described again for the same or similar concepts or processes.

[0028] In order to better illustrate the technical solutions, the traditional Chinese medicine ingredients are explained as follows:

[0029] I. Basic prescription drugs

[0030] 1. Prepared aconite

[0031] Nature and taste meridian: pungent, sweet, very hot; heart, kidney, spleen meridian.

[0032] Function and treatment:

[0033] Rescue Yang: for heart Yang deficiency, Yang deficiency, such as myocardial injury, heart failure, etc.

[0034] Fire and Yang: warm and invigorate heart and kidney Yang, improve heart function index, activate Nrf2 / PI3K / Akt signal pathway, reduce myocardial cell apoptosis.

[0035] Disperse cold and relieve pain: relieve chest pain, cold and damp pain, related to calcium ion regulation, can block calcium influx.

[0036] 2. Fructus psoraleae

[0037] Nature and taste meridian: pungent, bitter, warm; kidney, spleen meridian.

[0038] Function and treatment:

[0039] Kidney and Yang: improve heart and kidney Yang deficiency, enhance myocardial energy metabolism, and inhibit mitochondrial dysfunction.

[0040] Warm spleen and stop diarrhea: auxiliary regulation of gastrointestinal function, reduce abdominal distension in patients with chronic heart failure.

[0041] 3. Knavel

[0042] Nature and taste meridian: sweet, light, flat; kidney, bladder meridian.

[0043] Function and treatment:

[0044] Water and swelling: reduce heart load through diuretic effect, improve heart failure edema.

[0045] Anti-tumor and immune regulation: Contains polysaccharide ingredients, which assist in anti-oxidation and anti-inflammatory, and promote myocardial repair.

[0046] 4. Poria cocos

[0047] Nature and flavor: sweet, light, neutral; enters the heart, spleen and kidney meridians.

[0048] Functions and indications:

[0049] Strengthen the spleen and calm the mind: Improve palpitations and insomnia in patients with heart failure, and regulate water metabolism.

[0050] Diuresis and dampness-removing: synergistic with Poria to enhance diuretic effect and reduce serum BNP levels.

[0051] 5. Atractylodes macrocephala

[0052] Nature and flavor: bitter, sweet, warm; enters the spleen and stomach meridians.

[0053] Functions and indications:

[0054] Strengthen the spleen and replenish qi: enhance myocardial contractility and improve cardiac function indicators (such as LVEF).

[0055] Drying dampness and promoting diuresis: Reduce internal obstruction of phlegm and dampness, and assist in regulating blood lipid metabolism.

[0056] 6. Chuanxiong

[0057] Nature and flavor: Pungent, warm; enters the Liver, Gallbladder and Pericardium meridians.

[0058] Functions and indications:

[0059] Promote blood circulation and qi movement: improve myocardial ischemia, promote coronary blood flow, and inhibit myocardial hypertrophy.

[0060] Dispel wind and relieve pain: relieve angina pectoris and regulate Caspase-9 apoptosis pathway.

[0061] 2. Five-flavor supplementary medicine

[0062] 1. Astragalus

[0063] Nature and flavor: sweet, slightly warm; enters the lung and spleen meridians.

[0064] Functions and indications:

[0065] Replenishing Qi and Yang: Enhances myocardial energy supply and improves 6-minute walk distance (6MWT). Strengthening the body's defenses and exterior: Regulates immune function and reduces myocardial damage caused by chronic inflammation.

[0066] 2. Salvia miltiorrhiza

[0067] Nature and flavor: bitter, slightly cold; enters the heart and liver meridians.

[0068] Functions and indications:

[0069] Activating blood circulation to dissipate blood stasis: improving myocardial microcirculation, inhibiting myocardial fibrosis, and regulating PI3K / Akt pathway. Clearing heart and relieving distress: relieving anxiety state of heart failure patients, and cooperating with anti-arrhythmia.

[0070] 3. Cassia twig

[0071] Nature and taste: pungent, sweet, warm; belongs to lung, heart and bladder meridians.

[0072] Functions and indications:

[0073] Warming the channels and unblocking the vessels: dilating blood vessels, improving myocardial blood supply, and inhibiting ROS production.

[0074] Helping Yang and transforming Qi: synergizing with Aconite to enhance heart and kidney Yang, and relieving cold limbs and weak pulse.

[0075] 4. Semen Platycladi

[0076] Nature and taste: bitter, pungent, cold; belongs to lung and bladder meridians.

[0077] Functions and indications:

[0078] Purging lung and relieving asthma: reducing pulmonary edema, lowering pulmonary hypertension, and improving dyspnea.

[0079] Diuresis and swelling reduction: reducing cardiac preload through diuretic effect, and synergizing with Poria and Polyporus.

[0080] 5. Red ginseng

[0081] Nature and taste: sweet, bitter, flat; belongs to lung and heart meridians.

[0082] Functions and indications:

[0083] Benefiting Qi and activating blood: anti-hypoxia and anti-fatigue, enhancing myocardial tolerance, and activating Nrf2 antioxidant pathway. Regulating immunity: improving the quality of life of patients with chronic heart failure and reducing the risk of infection.

[0084] Three, additional medicinal flavors

[0085] 1. Pericarpium Citri Reticulatae

[0086] Nature and taste: pungent, bitter, warm; belongs to spleen and lung meridians.

[0087] Functions and indications:

[0088] Regulating Qi and invigorating spleen: improving abdominal distension and poor appetite, and promoting drug absorption.

[0089] 2. Glycyrrhiza

[0090] Nature and taste: sweet, flat; belongs to heart, lung, spleen and stomach meridians.

[0091] Functions and indications:

[0092] Harmonize various medicines: reduce the toxicity of aconite and enhance the synergistic effect of the whole prescription.

[0093] Clearing away heat and detoxifying: Relieve myocardial inflammatory response and protect liver and kidney functions.

[0094] The Chinese medicine composition for treating chronic heart failure of the present invention achieves the therapeutic goal through the following mechanisms:

[0095] Warming Yang and Promoting Diuresis: Aconite, cinnamon twig, and psoralea corylifolia warm and nourish the Yang Qi of the heart and kidneys, while Poria cocos and Polyporus umbellatus promote diuresis and reduce swelling, improving edema caused by heart failure.

[0096] Activating blood circulation and removing blood stasis: Chuanxiong, Danshen and Rhodiola rosea promote myocardial microcirculation and inhibit myocardial hypertrophy and fibrosis;

[0097] Antioxidation and signaling pathway regulation: Astragalus and Rhodiola activate the Nrf2 pathway, while Salvia miltiorrhiza and Chuanxiong regulate the PI3K / Akt / Caspase-9 pathway;

[0098] Clinical synergy: Tangerine peel and licorice harmonize the medicinal properties, reduce gastrointestinal adverse reactions, and improve patient compliance.

[0099] The above combination follows the theory of "heart and kidney diseases", combines modern pharmacological mechanisms, and has both traditional efficacy and scientific basis. The following examples are provided to illustrate:

[0100] Example 1: Preparation of basic formula

[0101] Ingredients: processed aconite root 9g, psoralea corylifolia 10g, Poria cocos 15g, Poria cocos 15g, Atractylodes macrocephala 15g, Ligusticum chuanxiong 12g.

[0102] preparation:

[0103] Alcohol extraction: Add 8 times the amount of 70% ethanol to the processed aconite root and psoralea corylifolia and reflux twice for 1.5 hours each time. The combined filtrate is concentrated to a relative density of 1.25.

[0104] Water extraction: add 10 times the amount of water to the remaining herbs and boil for 3 times, each time for 1 hour, and concentrate the filtrate to obtain an extract;

[0105] Mixing: Combine the alcohol extract and water extract, add dextrin to granulate, and pack into 10g per bag.

[0106] Example 2: Optimized formula

[0107] Ingredients: processed aconite root 9g, psoralea corylifolia 10g, umbellate polypore 15g, poria 15g, atractylodes macrocephala 15g, ligusticum chuanxiong 12g, astragalus 20g, salvia miltiorrhiza 15g, cinnamon twig 10g, scutellaria baicalensis fruit 12g, rhodiola rosea 8g, dried tangerine peel 6g, liquorice 6g.

[0108] Example 3: High-dose group

[0109] Raw materials: 12g of prepared aconite, 15g of psoralea, 20g of polyporus, and the rest are the same as in Example 1.

[0110] Clinical observation: 70 patients with chronic heart failure diagnosis standard and TCM syndrome of heart-kidney yang deficiency, randomized controlled study. The control group was given routine treatment of heart failure, and the TCM group was given the compound on the basis of routine treatment of western medicine, with a treatment cycle of 3 months. It can significantly improve the clinical symptoms, NYHA heart function classification, TCM syndrome score, and increase the 6MWT distance of patients, but cannot effectively reduce the BNP and echocardiography indicators. In improving the quality of life of patients, the TCM group has obvious advantages and curative effect in improving symptoms compared with pure western medicine treatment, and is safe without adverse reactions.

[0111] In the description of the present specification, the description of the terms "one embodiment", "some embodiments", "example", "specific example" or "some examples" and the like means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In the present specification, the illustrative description of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, the skilled in the art can combine and combine the different embodiments or examples described in the present specification and the features of the different embodiments or examples without contradiction.

[0112] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present application, and not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that: it can still modify the technical solutions recorded in the foregoing embodiments, or make equivalent replacement to part or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. A Chinese medicine composition for treating chronic heart failure, characterized in that: The invention is composed of 9-12 parts of processed aconite root, 10-15 parts of psoralea corylifolia, 15-20 parts of umbellatus, 15 parts of poria, 15 parts of atractylodes macrocephala and 12 parts of ligusticum chuanxiong.

2. The composition according to claim 1, characterized in that The invention further comprises: 20 parts of astragalus, 15 parts of salvia miltiorrhiza, 10 parts of cinnamon twig, 12 parts of scutellaria baicalensis seeds, 8 parts of rhodiola rosea, 6 parts of dried tangerine peel and 6 parts of liquorice.

3. The composition according to claim 1 or 2, characterized in that Its dosage form is granules, capsules or oral solution.

4. The composition according to claim 1, characterized in that Application in the preparation of medicines for treating chronic heart failure.

5. A method for preparing a Chinese medicine composition, characterized in that: The following steps are involved: S1. Extract the processed aconite root and psoralea corylifolia root with 70% ethanol twice under reflux, and combine the extracts and concentrate until there is no alcohol taste; S2, decoct the remaining herbs with water for 3 times, and combine the filtrates to form an extract; S3. Combine the alcohol extract and the water extract, and add auxiliary materials to prepare the finished product.

6. The preparation method according to claim 5, characterized in that The processing method of prepared aconite root described in S1 is: baking Heishun slices at 120° C. until the surface is slightly yellow.