WO2017005220A1 - 用于治疗心律失常的中药组合物及其制备方法 - Google Patents

用于治疗心律失常的中药组合物及其制备方法 Download PDF

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WO2017005220A1
WO2017005220A1 PCT/CN2016/089498 CN2016089498W WO2017005220A1 WO 2017005220 A1 WO2017005220 A1 WO 2017005220A1 CN 2016089498 W CN2016089498 W CN 2016089498W WO 2017005220 A1 WO2017005220 A1 WO 2017005220A1
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chinese medicine
medicine composition
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孙霞
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杨高林
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37—Digestive system
    • A61K35/413—Gall bladder; Bile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/57—Magnoliaceae (Magnolia family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/62—Nymphaeaceae (Water-lily family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • A61K36/725—Ziziphus, e.g. jujube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/77—Sapindaceae (Soapberry family), e.g. lychee or soapberry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968—Ophiopogon (Lilyturf)

Definitions

  • the invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating arrhythmia and a preparation method thereof.
  • Cardiac Arrhythmia refers to abnormalities in the frequency, rhythm, origin, conduction velocity, and agitation order of cardiac impulses.
  • Normal cardiac activation originates from the sinus node of the heart.
  • the signals from the sinoatrial node are transmitted to the atria and ventricles in a certain order and time, and stimulate the corresponding parts of the heart to produce excitement.
  • Arrhythmia is a common and frequently-occurring disease in the clinic. Severe arrhythmia is one of the ultimate causes of death in patients with cardiac hypertrophy, myocardial ischemia, myocardial infarction and heart failure. The arrhythmogenic mortality rate is very high, but so far, about 550,000 people have died of heart death each year in China, and the prevention of first- and second-degree cardiac death is not in place.
  • antiarrhythmic drugs are still the main method of treating arrhythmias.
  • antiarrhythmic Western medicine preparations generally have arrhythmogenic effects, as well as negative side effects, organ toxicity and other toxic side effects, especially large epidemiological tests - arrhythmia inhibition test (CAST) results
  • CAST epidemiological tests - arrhythmia inhibition test
  • the purpose of the invention is to overcome the disadvantages of the side effects of the western medicine and the ineffectiveness of the existing traditional Chinese medicine, and carefully develop the traditional Chinese medicine composition according to the principle of the Chinese medicine prescription and the preparation principle, and provide a targeted, good curative effect, short cycle and low price. It has the advantages of no toxic and side effects, and can make patients happy to accept, and can better treat a pure Chinese medicine preparation with arrhythmia.
  • the components in the formula work synergistically together, and the preparation of the drug is simple, the effect is fast, the course of treatment is short, and the arrhythmia has a good therapeutic effect.
  • the technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating arrhythmia, which can better reduce the arrhythmia index, improve the clinical signs of the patient, and prevent the arrhythmia from further worsening than the simple western medicine treatment.
  • the present invention provides a traditional Chinese medicine composition for treating arrhythmia
  • the raw material components thereof include bezoar, acanthopanax senticosus, Codonopsis pilosula, Gansong, Ejiao, Epimedium, Ephedra, Ophiopogon japonicus, and Red Quinoa, sour jujube kernel, schisandra, cassia twig, blood, longan and lotus seeds.
  • the weight fraction of each raw material component in the traditional Chinese medicine composition is 8-12 parts by weight of bezoar, 6-10 parts by weight of Acanthopanax, 4-10 parts by weight of Codonopsis pilosula, 5-10 parts by weight of Ganoderma lucidum, Ejiao 4 -9 parts by weight, epimedium 8-16 parts by weight, ephedra 8-17 parts by weight, Ophiopogon 5-11 parts by weight, red peony 4-10 parts by weight, jujube kernel 7-14 parts by weight, schisandra 10-18 weight Serving, 8-12 parts by weight of cassia twig, 12-18 parts by weight of blood, 5-10 parts by weight of longan meat, and 6-12 parts by weight of lotus seeds.
  • the parts by weight of each raw material component in the traditional Chinese medicine composition are 10-12 parts by weight of bezoar, 8-10 parts by weight of Acanthopanax, 7-10 parts by weight of Codonopsis pilosula, 8-10 parts by weight of Ganoderma lucidum, Ejiao 7-9 parts by weight, 11-16 parts by weight of Epimedium, 14-17 parts by weight of ephedra, 8-11 parts by weight of Ophiopogon japonicus, 7-10 parts by weight of Radix Paeoniae, 11-14 parts by weight of Suanzaoren, Schisandra 14-18 Parts by weight, 10-12 parts by weight of cassia twig, 15-18 parts by weight of blood, 7-10 parts by weight of longan meat, and 9-12 parts by weight of lotus seeds.
  • the parts by weight of each raw material component in the traditional Chinese medicine composition are 10 parts by weight of bezoar, 8 parts by weight of acanthopanax, 7 parts by weight of Codonopsis pilosula, 8 parts by weight of gansong, and 7 parts by weight of gelatin.
  • 11 parts by weight of Epimedium 14 parts by weight of ephedra, 8 parts by weight of Ophiopogon japonicus, 7 parts by weight of Radix Paeoniae, 11 parts by weight of Suanzaoren, 14 parts by weight of Schisandra, 10 parts by weight of cassia twig, 15 parts by weight of dried blood, Longan meat 7 Parts by weight, 9 parts by weight of lotus seeds.
  • the invention also provides a preparation method of the above traditional Chinese medicine composition, wherein the preparation steps are as follows:
  • the extract powder is mixed with powdered sugar and dextrin to prepare granules, which are passed through a 14 mesh sieve to prepare an oral granule.
  • the present invention also provides the use of the above-mentioned raw material component in the preparation of a traditional Chinese medicine composition for treating arrhythmia.
  • the invention provides a traditional Chinese medicine composition for treating arrhythmia, which can better lower the arrhythmia index, improve the clinical signs of the patient, prevent the arrhythmia from further worsening, and is non-toxic than the simple western medicine and the existing traditional Chinese medicine treatment. Side effects, high level of safety and comfort.
  • the parts by weight referred to in the present invention are a proportional relationship between the components.
  • the invention provides a traditional Chinese medicine composition for treating arrhythmia, the raw material components thereof include bezoar, acanthopanax senticosus, Codonopsis pilosula, Gansong, Ejiao, Epimedium, Ephedra, Ophiopogon japonicus, Radix Paeoniae Alba, Suanzaoren, Schisandra , cassia twig, blood, longan and lotus seeds.
  • the traditional Chinese medicine composition consists only of the above raw material components.
  • Niuhuang sweet, cool; clear heart, sputum, cold liver, interest wind, detoxification; used for fever, fainting, stroke, convulsions, seizures, seizures, larynx, sore throat, mouth sores, swollen hemorrhoids.
  • Acanthopanax senticosus Xin, slightly bitter, warm; Qi and spleen, kidney and soothe the nerves; for spleen and lung qi deficiency, physical weakness, loss of appetite, lung and kidney deficiency, chronic cough and asthma, kidney deficiency, waist and knee pain, lack of heart and spleen Insomnia and more dreams.
  • Dangshen Gan, Ping; spleen and lung, nourishing blood; for spleen and lung qi deficiency, eating less fatigue, cough and phlegm, lack of blood, pale complexion, shortness of heart, shortness of breath, thirst in Tianjin, internal heat and thirst.
  • Gansong Xin, Gan, Wen; qi and pain, open spleen and spleen; used for abdominal distension, loss of appetite, vomiting.
  • Ejiao Gan, Ping; blood and nourishing yin, moistening dryness, stopping bleeding; used for blood deficiency and chlorosis, dizziness, palpitations, muscle weakness, upset, sleeplessness, virtual wind, lung dryness, cough, vomiting blood, blood stasis Leakage, pregnancy leaks.
  • Epimedium Xin, Gan, Wen; Bushenyang, strong bones, rheumatism; for kidney yang deficiency, impotence and nocturnal emission, weak bones, rheumatism, numbness and numbness.
  • Ephedra Xin, slightly bitter, warm; sweating and dispelling cold, Xuanfei asthma, diuresis and swelling; used for cold, cold, chest tightness, cough, edema.
  • Ophiopogon japonicus sweet, slightly bitter, slightly cold; nourishing yin and fluid, moistening lungs and clearing heart; used for dry lung cough, yin deficiency, sore throat, sore throat, internal heat and thirst, upset insomnia, intestinal dry constipation .
  • Red peony bitter, slightly cold; clearing away heat and dispersing blood, dispersing silt and relieving pain; used for heat into the camp blood, warming poisonous hair spots, red eyes and swelling, liver stagnation, pain, symptoms, abdominal pain, falling and damaging, swollen sores .
  • Suanzaoren sweet, sour, flat; nourish the heart and nourish the liver, calm the nerves, soothe the sweat, Shengjin; used for virtual troubles, sleepless, horrified dreams, physical and sweaty, Tianjin wounds thirsty.
  • Schisandra acid, sweet, warm; astringent solid, Yiqi Shengjin, Bushen Ningxin; used for long-term deficiency and asthma, dream slippery essence, enuresis and frequent urination, long-term diarrhea, sweating, sweating, thirst, heat, thirst, My heart is insomnia.
  • Guizhi Xin, Gan, Wen; sweating muscles, Wentong meridians, help Yang gas, Pingchong gas; for cold and cold, cold abdominal pain, cold blood stasis, joint pain, sputum, edema , heart, porpoise.
  • Lotus seeds Gan, ⁇ , Ping; spleen and diarrhea, stop, Yishen sputum, nourish the heart and calm the nerves; for spleen deficiency Diarrhea, bring down, nocturnal emission, palpitations and insomnia.
  • each raw material component in the traditional Chinese medicine composition are 8-12 parts by weight of bezoar, 6-10 parts by weight of acanthopanax, 4-10 parts by weight of Codonopsis pilosula, 5-10 parts by weight of gansong, and Ejiao 4-9. Parts by weight, Epimedium 8-16 parts by weight, Ephedra 8-17 parts by weight, Ophiopogon 5-11 parts by weight, Radix 4-10 parts by weight, Suanzaoren 7-14 parts by weight, Schisandra 10-18 parts by weight, 8-12 parts by weight of cassia twig, 12-18 parts by weight of blood, 5-10 parts by weight of longan meat, and 6-12 parts by weight of lotus seeds.
  • the parts by weight of each raw material component in the traditional Chinese medicine composition are 10-12 parts by weight of bezoar, 8-10 parts by weight of Acanthopanax, 7-10 parts by weight of Codonopsis pilosula, 8-10 parts by weight of Ganoderma lucidum, Ejiao 7-9 parts by weight, 11-16 parts by weight of Epimedium, 14-17 parts by weight of ephedra, 8-11 parts by weight of Ophiopogon japonicus, 7-10 parts by weight of Radix Paeoniae, 11-14 parts by weight of Suanzaoren, Schisandra 14-18 Parts by weight, 10-12 parts by weight of cassia twig, 15-18 parts by weight of blood, 7-10 parts by weight of longan meat, and 9-12 parts by weight of lotus seeds.
  • the parts by weight of each raw material component in the traditional Chinese medicine composition are 10 parts by weight of bezoar, 8 parts by weight of acanthopanax, 7 parts by weight of Codonopsis pilosula, 8 parts by weight of gansong, 7 parts by weight of gelatin, and Epimedium 11 parts by weight, 14 parts by weight of ephedra, 8 parts by weight of Ophiopogon japonicus, 7 parts by weight of Radix Paeoniae, 11 parts by weight of Suanzaoren, 11 parts by weight of Schisandra, 14 parts by weight of Schisandra, 10 parts by weight of cassia twig, 15 parts by weight of dried blood, and 7 parts by weight of longan meat. Lotus seeds 9 parts by weight.
  • the traditional Chinese medicine composition for treating arrhythmia provided by the present invention can be prepared into various oral dosage forms according to a conventional dosage form preparation method.
  • the invention also provides a preparation method of the above traditional Chinese medicine composition, comprising:
  • the extract powder is mixed with powdered sugar and dextrin to prepare granules, which are passed through a 14 mesh sieve to prepare an oral granule.
  • the present invention also provides the above raw material component in preparing a traditional Chinese medicine composition for treating arrhythmia application.
  • Taboo (1) avoid eating cold food; (2) avoid eating sputum; (3) internal and external hemorrhagic disease, ulcer disease with a conviction; (4) female menstrual period, do not use during pregnancy.
  • Example 3 of the present invention Forty-eight Kunming mice weighing 18-22 g, male and female, and the traditional Chinese medicine composition of Example 3 of the present invention were administered to a mouse at a dose of 175 times the clinical daily dose for 1 week, and the test was recorded. The activity, behavior and death of the mice were sacrificed one week later for autopsy.
  • Types of arrhythmia are: sinus bradycardia (SB), sinus block (SAB), sinus rest (SA), atrioventricular block (AVB), and borderline rhythm (JR).
  • SB sinus bradycardia
  • SAB sinus block
  • SA sinus rest
  • AVB atrioventricular block
  • JR borderline rhythm
  • the disease classification includes coronary heart disease, viral myocarditis, and hyperkinesia. The diagnosis complies with ISFC and WHO standards.
  • the treatment group was administered the traditional Chinese medicine composition of Example 3, taking 5 capsules each time, 3 times a day.
  • the control group took Jianshen tablets (Shanghai Traditional Chinese Medicine Third Factory), 6 tablets each time, 3 times a day.
  • Double-blind observation taking 28 days for a course of treatment.
  • the treatment group was markedly effective in 51 cases, effective in 38 cases, and ineffective in 11 cases, the total effective rate was 89%.
  • the Jianshen group was effective in 19 cases, effective in 25 cases, and ineffective in 56 cases, with a total effective rate of 44%.
  • the total effective rate of the two groups is very significant.
  • the heart rate of the treatment group was quite satisfactory before and after treatment: SB (sinus bradycardia) + SAB (sinus block), SB (sinus bradycardia) + SA (sinus rest), I ° ⁇ III ° AVB ( Atrioventricular block) P ⁇ 0.05, SB (sinus bradycardia) P ⁇ 0.01.

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Abstract

一种用于治疗心律失常的中药组合物包括牛黄、刺五加、党参、甘松、阿胶、淫羊藿、麻黄、麦冬、赤芍、酸枣仁、五味子、桂枝、血竭、龙眼肉和莲子。该组合物可以较单纯的西药治疗更好的降低心律失常的指标，改善患者的临床征象，防止心律失常进一步恶化，并且没有毒副作用。

Description

用于治疗心律失常的中药组合物及其制备方法 技术领域
本发明涉及中医药技术领域，尤其涉及一种用于治疗心律失常的中药组合物及其制备方法。
背景技术
心律失常(Cardiac Arrhythmia)是指心脏冲动的频率、节律、起源部位、传导速度与激动次序的异常。正常的心脏激动起源于心脏的窦房结，窦房结发出的信号按一定的顺序和时间依次传递到心房和心室，激发心脏相应的部位产生激动。
心律失常是临床常见病、多发病，严重的心律失常是心肌肥厚、心肌缺血、心肌梗死及心力衰竭等患者的最终死因之一。心律失常致死率非常高，但迄今为止，在我国每年心脏性猝死者约55万人左右，心脏性猝死的一、二级预防非常不到位。
近年来，西医的非药物方式治疗心律失常取得了重大的进展，如射频导管消融根治房室结折返性心动过速、房室折返性心动过速、心房扑动和室性心动过速；埋藏式自动心脏复律除颤器(ICD)可显著改善恶性心律失常的预后。但是，心房颤动的射频导管消融的疗效不确切，恶性室性心律失常的射频导管消融成功率低，或即使接受了ICD治疗也需要长期服药。
因此，抗心律失常药物仍然是治疗心律失常的主要方法。然而，抗心律失常西药制剂普遍存在致(促)心律失常作用，以及负性变力性、脏器毒性作用等毒副反应，尤其是大型流行病学试验--心律失常抑制试验(CAST)结果表明，用I类抗心律失常药物治疗心肌梗死后病人的室性早搏和非持续性室速，非但不能改善病人的预后，反而显著增加病人的猝死和病死率。因此，选择适合的抗心律失常药物对于该疾病的防治至关重要。
中医药治疗心律失常，在缓解症状和改善生活质量等方面具有一定优势，显示了良好应用前景。心律失常属于中医“心悸”、“怔忡”的范畴。中医 学认为，心悸多由于脏腑气血阴阳虚损、内伤七情、气滞血瘀交互作用致心失所养、心脉失畅而引起。多数中医学者认为，心悸属本虚标实之证，发病乃由素体虚弱、正气亏虚(本虚)，邪毒乘虚而入(标实)，侵及心脉所致。通过分型辨证选用适宜的中成药，对于改善上述症状、控制病情有较好的疗效。
本发明的目的就是克服西药副作用大、现有中药疗效不显著等不足，按照中医组方和制备原则对中药组合物精心研制，提供一种具有针对性强、疗效好、周期短、价格低、无毒副作用等优点，又能使患者乐于接受，能较好的治疗心律失常的纯中药制剂。方中各组分相互协同起效，且药物制备简单、起效快、疗程短、对心律失常有很好的治疗作用。
发明内容
本发明所要解决的技术问题是提供一种用于治疗心律失常的中药组合物，其较单纯的西药治疗可以更好的降低心律失常的指标，改善患者的临床征象，防止心律失常进一步恶化。
为解决上述技术问题，本发明提供了一种用于治疗心律失常的中药组合物，其原料组分包括牛黄、刺五加、党参、甘松、阿胶、淫羊藿、麻黄、麦冬、赤芍、酸枣仁、五味子、桂枝、血竭、龙眼肉和莲子。
其中，所述中药组合物中各原料组分的重量份分别为牛黄8-12重量份，刺五加6-10重量份，党参4-10重量份，甘松5-10重量份，阿胶4-9重量份，淫羊藿8-16重量份，麻黄8-17重量份，麦冬5-11重量份，赤芍4-10重量份，酸枣仁7-14重量份，五味子10-18重量份，桂枝8-12重量份，血竭12-18重量份，龙眼肉5-10重量份，莲子6-12重量份。
优选地，所述中药组合物中各原料组分的重量份分别为牛黄10-12重量份，刺五加8-10重量份，党参7-10重量份，甘松8-10重量份，阿胶7-9重量份，淫羊藿11-16重量份，麻黄14-17重量份，麦冬8-11重量份，赤芍7-10重量份，酸枣仁11-14重量份，五味子14-18重量份，桂枝10-12重量份，血竭15-18重量份，龙眼肉7-10重量份，莲子9-12重量份。
进一步优选地，所述中药组合物中各原料组分的重量份分别为牛黄10重量份，刺五加8重量份，党参7重量份，甘松8重量份，阿胶7重量份， 淫羊藿11重量份，麻黄14重量份，麦冬8重量份，赤芍7重量份，酸枣仁11重量份，五味子14重量份，桂枝10重量份，血竭15重量份，龙眼肉7重量份，莲子9重量份。
本发明还提供了上述中药组合物的制备方法，其制备步骤为：
(1)将所述原料组分中的各组分按比例混合，加入相对于混合物质量5-7倍量的70％乙醇，回流提取3次，每次时间分别为1.5、1、1小时，过滤，合并滤液；
(2)65℃减压浓缩滤液，浓缩比例为1000ml药液：41g生药，然后按照50ml絮凝剂/1000ml药液的量，于45-55℃加入1％壳聚糖絮凝剂，使其沉降3小时，高速离心；
(3)取上清液，70℃-75℃浓缩至相对密度1.35-1.37，再加入虫草菌丝粉，65℃干燥4h，即得复方制剂浸膏粉；
(4)将浸膏粉与糖粉、糊精混合制颗粒，过14目筛，制成口服颗粒剂。
本发明还提供上述原料组分在制备用于治疗心律失常的中药组合物中的应用。
本发明的有益效果：
本发明提供一种用于治疗心律失常的中药组合物，其较单纯的西药和现有中药治疗可以更好的降低心律失常的指标，改善患者的临床征象，防止心律失常进一步恶化，同时无毒副作用、具有高度的安全性和舒适感。
具体实施方式
本发明提到的重量份是各组分之间的一个比例关系。
本发明提供了一种用于治疗心律失常的中药组合物，其原料组分包括牛黄、刺五加、党参、甘松、阿胶、淫羊藿、麻黄、麦冬、赤芍、酸枣仁、五味子、桂枝、血竭、龙眼肉和莲子。
进一步优选，所述中药组合物仅由上述原料组分组成。
本发明所述的中药组合物配伍合理，作用效果显著，其中：
牛黄：甘，凉；清心，豁痰，凉肝，息风，解毒；用于热病神昏，中风痰迷，惊痫抽搐，癫痫发狂，咽喉肿痛，口舌生疮，痈肿疔疮。
刺五加：辛、微苦，温；益气健脾，补肾安神；用于脾肺气虚，体虚乏力，食欲不振，肺肾两虚，久咳虚喘，肾虚腰膝酸痛，心脾不足，失眠多梦。
党参：甘，平；健脾益肺，养血生津；用于脾肺气虚，食少倦怠，咳嗽虚喘，气血不足，面色萎黄，心悸气短，津伤口渴，内热消渴。
甘松：辛、甘，温；理气止痛，开郁醒脾；用于脘腹胀满，食欲不振，呕吐。
阿胶：甘，平；补血滋阴，润燥，止血；用于血虚萎黄，眩晕心悸，肌萎无力，心烦不眠，虚风内动，肺燥咳嗽，劳嗽咳血，吐血尿血，便血崩漏，妊娠胎漏。
淫羊藿：辛、甘，温；补肾阳，强筋骨，祛风湿；用于肾阳虚衰，阳痿遗精，筋骨萎软，风湿痹痛，麻木拘挛。
麻黄：辛、微苦，温；发汗散寒，宣肺平喘，利水消肿；用于风寒感冒，胸闷咳喘，风水浮肿。
麦冬：甘、微苦，微寒；养阴生津，润肺清心；用于肺燥干咳，阴虚痨嗽，喉痹咽痛，津伤口渴，内热消渴，心烦失眠，肠燥便秘。
赤芍：苦，微寒；清热散血，散淤止痛；用于热入营血，温毒发斑，目赤肿痛，肝郁胁痛，症瘕腹痛，跌扑损伤，痈肿疮疡。
酸枣仁：甘、酸，平；养心补肝，宁心安神，敛汗，生津；用于虚烦不眠，惊悸多梦，体虚多汗，津伤口渴。
五味子：酸、甘，温；收敛固涩，益气生津，补肾宁心；用于久嗽虚喘，梦遗滑精，遗尿尿频，久泻不止，自汗盗汗，津伤口渴，内热消渴，心悸失眠。
桂枝：辛、甘，温；发汗解肌，温通经脉，助阳化气，平冲降气；用于风寒感冒，脘腹冷痛，血寒经闭，关节痹痛，痰饮，水肿，心悸，奔豚。
血竭：甘、咸，平；活血定痛，化瘀止血，生肌敛疮；用于跌打损伤，心腹瘀痛，外伤出血，疮疡不敛。
龙眼肉：甘，温；补益心脾，养血安神；用于气血不足，心悸怔忡，健忘失眠，血虚萎黄。
莲子：甘、涩，平；补脾止泻，止带，益肾涩精，养心安神；用于脾虚 泄泻，带下，遗精，心悸失眠。
所述中药组合物中各原料组分的重量份分别为牛黄8-12重量份，刺五加6-10重量份，党参4-10重量份，甘松5-10重量份，阿胶4-9重量份，淫羊藿8-16重量份，麻黄8-17重量份，麦冬5-11重量份，赤芍4-10重量份，酸枣仁7-14重量份，五味子10-18重量份，桂枝8-12重量份，血竭12-18重量份，龙眼肉5-10重量份，莲子6-12重量份。
优选地，所述中药组合物中各原料组分的重量份分别为牛黄10-12重量份，刺五加8-10重量份，党参7-10重量份，甘松8-10重量份，阿胶7-9重量份，淫羊藿11-16重量份，麻黄14-17重量份，麦冬8-11重量份，赤芍7-10重量份，酸枣仁11-14重量份，五味子14-18重量份，桂枝10-12重量份，血竭15-18重量份，龙眼肉7-10重量份，莲子9-12重量份。
进一步优选地，所述中药组合物中各原料组分的重量份分别为牛黄10重量份，刺五加8重量份，党参7重量份，甘松8重量份，阿胶7重量份，淫羊藿11重量份，麻黄14重量份，麦冬8重量份，赤芍7重量份，酸枣仁11重量份，五味子14重量份，桂枝10重量份，血竭15重量份，龙眼肉7重量份，莲子9重量份。
本发明提供的治疗心律失常的中药组合物可以根据常规剂型制备方法制备成各种口服剂型。
本发明还提供了上述中药组合物的制备方法，包括：
(1)将所述原料组分中的各组分按比例混合，加入相对于混合物质量5-7倍量的70％乙醇，回流提取3次，每次时间分别为1.5、1、1小时，过滤，合并滤液；
(2)65℃减压浓缩滤液，浓缩比例为1000ml药液：41g生药，然后按照50ml絮凝剂/1000ml药液的量，于45-55℃加入1％壳聚糖絮凝剂，使其沉降3小时，高速离心；
(3)取上清液，70℃-75℃浓缩至相对密度1.35-1.37，再加入虫草菌丝粉，65℃干燥4h，即得复方制剂浸膏粉；
(4)将浸膏粉与糖粉、糊精混合制颗粒，过14目筛，制成口服颗粒剂。
本发明还提供上述原料组分在制备用于治疗心律失常的中药组合物中的 应用。
实施例
以下采用实施例来详细说明本发明的实施方式，借此对本发明如何应用技术手段来解决技术问题，并达成技术效果的实现过程能充分理解并据以实施。
实施例1
取牛黄8重量份，刺五加6重量份，党参4重量份，甘松5重量份，阿胶4重量份，淫羊藿8重量份，麻黄8重量份，麦冬5重量份，赤芍4重量份，酸枣仁7重量份，五味子10重量份，桂枝8重量份，血竭12重量份，龙眼肉5重量份，莲子6重量份，按比例混合；加入相对于混合物质量5倍量的70％乙醇，回流提取3次，每次时间分别为1.5、1、1小时，过滤，合并滤液；65℃减压浓缩滤液，浓缩比例为1000ml药液：41g生药，然后按照50ml絮凝剂/1000ml药液的量，于45℃加入1％壳聚糖絮凝剂，使其沉降3小时，高速离心；取上清液，70℃浓缩至相对密度1.35，再加入5重量份虫草菌丝粉，65℃干燥4h，即得复方制剂浸膏粉；将浸膏粉与3重量份糖粉、2重量份糊精混合制颗粒，过14目筛，制成口服颗粒剂。
用法与用量：每日空腹服用三次。
禁忌：(1)忌食生冷食物；(2)忌食腥物；(3)内外出血症、溃疡症具一则忌服；(4)女性经期，孕期勿用。
实施例2
取牛黄12重量份，刺五加10重量份，党参10重量份，甘松10重量份，阿胶9重量份，淫羊藿16重量份，麻黄17重量份，麦冬11重量份，赤芍10重量份，酸枣仁14重量份，五味子18重量份，桂枝12重量份，血竭18重量份，龙眼肉10重量份，莲子12重量份，按比例混合；加入相对于混合物质量7倍量的70％乙醇，回流提取3次，每次时间分别为1.5、1、1小时，过滤，合并滤液；65℃减压浓缩滤液，浓缩比例为1000ml药液：41g生药，然后按照50ml絮凝剂/1000ml药液的量，于55℃加入1％壳聚糖絮凝剂，使 其沉降3小时，高速离心；取上清液，75℃浓缩至相对密度1.37，再加入7重量份虫草菌丝粉，65℃干燥4h，即得复方制剂浸膏粉；将浸膏粉与5重量份糖粉、4重量份糊精混合制颗粒，过14目筛，制成口服颗粒剂。
用法与用量、禁忌同实施例1。
实施例3
取牛黄10重量份，刺五加8重量份，党参7重量份，甘松8重量份，阿胶7重量份，淫羊藿11重量份，麻黄14重量份，麦冬8重量份，赤芍7重量份，酸枣仁11重量份，五味子14重量份，桂枝10重量份，血竭15重量份，龙眼肉7重量份，莲子9重量份，按比例混合；加入相对于混合物质量6倍量的70％乙醇，回流提取3次，每次时间分别为1.5、1、1小时，过滤，合并滤液；65℃减压浓缩滤液，浓缩比例为1000ml药液：41g生药，然后按照50ml絮凝剂/1000ml药液的量，于50℃加入1％壳聚糖絮凝剂，使其沉降3小时，高速离心；取上清液，73℃浓缩至相对密度1.36，再加入6重量份虫草菌丝粉，65℃干燥4h，即得复方制剂浸膏粉；将浸膏粉与4重量份糖粉、3重量份糊精混合制颗粒，过14目筛，制成口服颗粒剂。
用法与用量、禁忌同实施例1。
实施例4急性毒性测定
用体重18-22g昆明小鼠40只，雌雄各半，以本发明实施例3的中药组合物为对象，以临床日用量的175倍给小鼠灌胃给药，观察1周，记录受试小鼠活动、行为及死亡情况，1周后处死进行尸检。
试验证明：灌胃后无显著毒性反应，一周内也无死亡。
实施例5本发明中药组合物抗乌头碱诱发的大鼠心律失常作用的药效学研究
1.1试验方法
(1)实验动物及分组
健康清洁级SD大鼠30只，体重180±20g，雄性。(中国科学院遗传研 究所动物中心提供)，随机分为3组，每组10只。第1组为模型组，给予生理盐水；第2组为试验组，给予由实施例3方法制备的组合物；第3组为阳性对照组，给予乙胺碘呋酮。
(2)乌头碱诱发的大鼠心律失常模型的建立：以上各组灌胃体积为20ml·kg-1。试验前30min灌胃给药，然后分别给予各组大鼠腹腔注射戊巴比妥钠(30mg·kg-1)麻醉，固定于手术台，分离左颈静脉插管输入药物，尾静脉插入头皮针输入乌头碱。作II导联心电记录。用晨动泵从尾静脉以5μg·kg-1·min-1恒速推注乌头碱，直至心跳停止，其间监测心电变化。
(3)指标测定：记录室性早搏(VP)、室性心动过速(VT)、室性纤颤(VF)和心脏停跳(CA)时的乌头碱用量。
1.2统计方法：采用SPSS13.0软件进行统计分析，所有数据用均数(x±s)标准差表示，组间比较用t检验，P＜0.05认为有统计学意义。
1.3实验结果：
见表1。与模型对照组相比，组合物与阳性对照组的室性早搏(VP)、室性心动过速(VT)、室性纤颤(VF)和心脏停跳(CA)时的乌头碱用量均明显增加(P＜0.05)。
表1.本发明中药组合物对乌头碱诱发的大鼠心律失常影响(x±s，μg)
Figure PCTCN2016089498-appb-000001
注：与模型对照组比较，*P＜0.05
实施例6临床实验
1.1一般资料
设治疗组100例，对照组100例。两组在年龄、性别的分配上经统计学处理无显著性差异。心律失常类型有：窦性心动过缓(SB)、窦房传导阻滞(SAB)、窦性静止(SA)、房室传导阻滞(AVB)、交界心律(JR)。疾病分类有冠心病、病毒性心肌炎、迷走神经功能亢进。诊断符合ISFC和WHO标准。
1.2治疗方法
治疗组服用实施例3的中药组合物，每次服用5粒，每日3次。
对照组服用建参片(上海中药三厂)，每次6片，每日3次。
双盲观察，服用28天为一疗程。
1.3疗效标准
参照1979年全国中西医结合防治冠心病座谈会修订心电图疗效标准。
1.4治疗结果
治疗组显效51例，有效38例，无效11例，总有效率为89％。建参片组显效19例，有效25例，无效56例，总有效率为44％。两组总有效率相比较有非常显著意义。
治疗组治疗前后心率比较十分满意：SB(窦性心动过缓)+SAB(窦房传导阻滞)、SB(窦性心动过缓)+SA(窦性静止)、Ⅰ°～Ⅲ°AVB(房室传导阻滞)P<0.05，SB(窦性心动过缓)P<0.01。
两组患者在治疗期间都未发生明显的不良事件。未出现明显的肝肾功能损害，严重的血液系统疾病和心脑血管意外事件。说明中药组合物的治疗对患者无明显不良影响。
以上所述，仅是本发明的较佳实施例而已，并非是对本发明作其它形式的限制，任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型，仍属于本发明技术方案的保护范围。

Claims (6)

  1. 一种用于治疗心律失常的中药组合物，其特征在于：原料组分包括牛黄、刺五加、党参、甘松、阿胶、淫羊藿、麻黄、麦冬、赤芍、酸枣仁、五味子、桂枝、血竭、龙眼肉和莲子。
  2. 如权利要求1所述的中药组合物，其特征在于：各原料组分的重量份分别为牛黄8-12重量份，刺五加6-10重量份，党参4-10重量份，甘松5-10重量份，阿胶4-9重量份，淫羊藿8-16重量份，麻黄8-17重量份，麦冬5-11重量份，赤芍4-10重量份，酸枣仁7-14重量份，五味子10-18重量份，桂枝8-12重量份，血竭12-18重量份，龙眼肉5-10重量份，莲子6-12重量份。
  3. 如权利要求1或2所述的中药组合物，其特征在于：各原料组分的重量份分别为牛黄10-12重量份，刺五加8-10重量份，党参7-10重量份，甘松8-10重量份，阿胶7-9重量份，淫羊藿11-16重量份，麻黄14-17重量份，麦冬8-11重量份，赤芍7-10重量份，酸枣仁11-14重量份，五味子14-18重量份，桂枝10-12重量份，血竭15-18重量份，龙眼肉7-10重量份，莲子9-12重量份。
  4. 如权利要求1至3所述的中药组合物，其特征在于：各原料组分的重量份分别为各原料组分的重量份分别为牛黄10重量份，刺五加8重量份，党参7重量份，甘松8重量份，阿胶7重量份，淫羊藿11重量份，麻黄14重量份，麦冬8重量份，赤芍7重量份，酸枣仁11重量份，五味子14重量份，桂枝10重量份，血竭15重量份，龙眼肉7重量份，莲子9重量份。
  5. 权利要求1至4所述中药组合物的制备方法，其特征在于，制备步骤为：
    (1)将所述原料组分中的各组分按比例混合，加入相对于混合物质量5-7倍量的70％乙醇，回流提取3次，每次时间分别为1.5、1、1小时，过滤，合并滤液；
    (2)65℃减压浓缩滤液，浓缩比例为1000ml药液：41g生药，然后按照50ml絮凝剂/1000ml药液的量，于45-55℃加入1％壳聚糖絮凝剂，使其沉降3小时，高速离心；
    (3)取上清液，70℃-75℃浓缩至相对密度1.35-1.37，再加入虫草菌丝粉， 65℃干燥4h，即得复方制剂浸膏粉；
    (4)将浸膏粉与糖粉、糊精混合制颗粒，过14目筛，制成口服颗粒剂。
  6. 权利要求1-4中任一项的原料组分在制备用于治疗心律失常的中药组合物中的应用。
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