CN1059103C - 一种治疗心脑血管疾病的药物 - Google Patents
一种治疗心脑血管疾病的药物 Download PDFInfo
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- CN1059103C CN1059103C CN96117334A CN96117334A CN1059103C CN 1059103 C CN1059103 C CN 1059103C CN 96117334 A CN96117334 A CN 96117334A CN 96117334 A CN96117334 A CN 96117334A CN 1059103 C CN1059103 C CN 1059103C
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Abstract
本发明公开了一种治疗心脑血管疾病的药物。其由下述重量比的原料制成：水蛭15-40%、细辛5-10%、川芎7-50%、红花10-20%、人参8-28%、天麻10-30%。本发明具有显著降低纤维蛋白原和血脂、降低血小板凝集和血浆比粘度的作用。它既保留了中药各自的优点，又有协同互为补充的作用，减少了药物各自的副作用，增加了治疗效果。经临床应用，安全、有效，是预防和治疗脑血管疾患的一种理想药物。
Description
本发明属于中药类，主要涉及的是一种治疗心脑血管疾病的药物。
心脑血管疾患，是当今危害人类身体健康的大敌，同时也是造成人类死亡的重要疾病之一。研究报告表明：血液粘滞性增高，是缺血性脑血管的发生和发展的重要环节，而血小板聚集功能与缺血性脑血管病关系密切，血小板的聚集功能在血液流动止血及血栓形成中有重要的作用，血小板最大聚率是衡量血小板聚集性的敏感指标；血浆粘度很大程度上决定于血浆中大分子成份(纤维蛋白原、胆固醇、B-脂蛋白、三酸甘油脂、白蛋白等)的含量。临床上所应用的血液流变学的检测，可以给人们揭示血液的粘稠度、血小板的聚集率等，进而可以预报中风的前兆，从而采取有效的预防措施。目前，临床对心脑血管疾患所采取的治疗方法及服用的药品种类虽然很多，但普遍疗效却不甚理想。
本发明的目的即由此产生，提出一种治疗心脑血管疾病的药物。该药物可显著降低纤维蛋白原和血脂、降低血小板凝集和血浆比粘度，通过服用该药可起到益气活血、化瘀降浊、祛风活络、预防脑血栓形成的作用。
为实现上述目的，本发明在中医理论思想：“君、臣、佐、使及标本兼治”的指导下，经过临床反复实践，在大量筛选、论证的基础上，提出的解决方案如下：其由下述重量比的原料制成：
水蛭15-40％、细辛5-10％、川芎7-50％
红花10-20％、人参8-28％、天麻10-30％
本发明药物的原料组成中，以水蛭、红花为君药，主要功用：破血通瘀，临床实践证明该药有降低血液粘稠度，增加血流量，改善微循环可以防止脑血栓形成。人参为臣药，功在补气增强活血化瘀药物之作用，“气为血帅”、“血为气母”、“气行则血行，气止则血凝”，人参补气就在于推动血液加快流通作用。天麻、细辛为佐药，具有祛风降浊、通窍止痛的作用，可直接治疗由于血粘度过高而出现的肢体麻木、眩晕、疼痛、震摇等症。川芎为使药，可引诸药直达病所，同时川芎又是一味活血祛风的药物，是血中之气药，具有活血行气、散风止痛的作用，近代有关药理研究证实，川芎含有大量的川芎嗪，为扩张血管，增加血流量，降低血粘度的重要药物。
另一方面从中医的标本兼治角度上讲，认为活血化瘀、降脂降浊、增加血液流通、改善微循环为本病的治疗之本。以水蛭、红花、川芎主之，以行气、祛风、通络、止痛、改善症状为本病之标。常见的症状如肢体麻木、眩晕、乏力、胸闷、气短、肌肉疼痛等。以天麻、细辛、人参、川芎等主之。在临床上二者之间互为联系、相互影响，所以在治疗上相互作用，相辅相成。如祛风与活血、行气与化瘀、活血与止痛等常常联系在一起，又可达到较单纯用药为好的结果。
本发明药物的化学成分与理化性质如下：
1、水蛭为水蛭科动物蚂蟥Whitmania Pigra Whitman水蛭Hirudo nipponia whiawan或柳叶蚂蟥Whitmania acr-anulata Whiaman的干燥体。水蛭的唾腺中含有水蛭素〔hirudin〕，是一种由碳、氢、氮硫等上元素组成的酸物质，易溶于水。此外，其分泌物中含有一种组织胺样物质及肝素〔hep-arim〕等。
2、红花为菊科植物红花Carthamus tinctoricusl的干燥花。红花含有红花醌甙、新红花甙和红花甙等甙类。红花含红化黄色素。从色素中分离出红色素和黄色素，此二种成分较不稳定，其中红色素受热易发生变化，在热溶液中稳定性差。另外，红花还含有6-羟基山萘黄素、山萘黄素3-萄葡糖甙、槲皮素3-萄葡糖甙、槲皮素7-萄葡糖甙、山萘黄素3-芸香糖甙和芸香甙。
3、天麻为兰科植物天麻Gastrodia elate blame的干燥根茎。天麻含维生纱A类物质，香夹兰醇、香夹兰醛，从天麻中还可分离出天麻素(gastrodin)，此为天麻中主要成分。此外还含有天麻甙元一对羟基苯甲醇、β-谷甾醇等。天麻素等主要成份易溶于水，故采用水煮法加工的成品，含量较低，尤以搓去皮后水煮者，天麻素降低最多，甚至有的样品降至0，而煎煮液中却含有大量天麻素。
4、川芎为伞形科植物川芎〔igusticum chmamxiong hort〕的干燥根茎，含挥发油、生物碱、酚性物质、中性物质(内酯类)、有机酸等。生物碱部分有川芎嗪(tetrame thylpyazine)异亮氨酰缬氨酸内酰胺和黑麦碱(Perlolyrine)，属于β-咔啉衍生物。酚性部分由阿魏酸、大黄酚、瑟丹酸和4-羟基-3一丁基苯酞；挥发油化学成份主要是藁本内脂(含58％)，3-丁叉苯酞(5.29％)及香松烯(6.08％)等。
5、细辛为马兜铃科植物北细辛Asarum heterotropoi-des Frvar mandshuricum(Maxim)Kitag，汉城细辛AsarumSieboldii Miq var seoulense Nakai或华细辛Asarum Sibol-dii Miq的干燥全草。北细辛含挥发油约3％，主要成份甲基丁香油酚(methyleugend)，其它成份有α-蒎烯、莰烯、月桂烯，1.8-桉叶素(1，8-Cineole)，对一聚伞花烯(P-C-Ymene)r-松油烯(r-terqinene)，异松油烯(terpinolene)、龙脱离、黄樟醚、甲基丁香酚、细辛醚等。华细辛含挥发油2.75％，主要成份含甲基丁香油酚(约占50％)。其它成份有α-蒎烯、莰烯、β-蒎烯、月桂烯，1，8-按叶素、龙脑、黄樟醚甲基丁香酚、细辛醚等。汉城细辛挥发油中含有α-蒎烯、莰烯、乙酸龙脑脂、黄樟醚、甲基丁香酚、细辛醚等。此外，细辛中金属离子总含量为20360PPm，锌、铜比值为9.5，含有钾、钠、镁、钙、铁、锰、铜、锌等元素。
6、人参：为五加科植物人参Panaxginseng C、A、Mey的干燥根。根含总甙约4％，须根中含量较主根高，是14种以上皂甙的混合物，分别称为人参皂甙Ro、Ra1、Ra1、Rb1、Rb2、Rc、Rd、Re、Rf、Rg1、Rg2、Rh1等，均为三萜皂甙。其中以玛烷系皂甙为主要活性成份，其中Ra1、Ra1、Rb1、Rb2、Rb3、Rc、Rd等，酸水斛后产生人参二醇，Re、Rf、Rg1、Rg2、Rh等水斛后产生人参三醇。R0为齐墩果烷系皂甙，其皂甙元为齐墩果酸。含挥发油均0.12％，油中成份有β-揽香烯(β-Ele-meae)、人参炔醇(Pamawynol)及多环氧物人参醇(Pamawy-dol)等。此外，尚含多种低分子肽、氨基酸、单糖、双糖、三聚糖、有机酸、B族维生素、维生素C、β-谷甾醇及其葡萄糖甙。人参皂甙大多数是白色无定形粉末或无色针昌，味微甘苦，具有引湿性。一般对酸不稳定(人参皂甙R0除外)，弱酸下即可水斛，但在水斛后得不到真正的原形皂甙元，易溶于水、甲醇、乙醇，可溶于正丁醇、醋酸，醋酸乙酯、不溶于乙醚、苯。人参皂甙Rg1、分子式C42H72O14，分子量800，uv入neor208，为无色半结晶物(正丁醇-甲基乙基酮)，mp194-196.5℃[d]115+320(吡啶)。溶于甲醇、吡啶及热丙酮，稍溶于醋酸乙酯及氯仿。大鼠腹腔注射10mg/Kg，4小时后骨髓细胞的DNA的生物合成明显增加，对蛋白质或脂肪的生物合成作用与对DAN的生物合成的作用有大致相同的倾向。
本发明的初步稳定性试验结果如下：
药品初步稳定性试验报告
| 放置时间(实验日期)结果项目 | 0月(95年3月1日) | 1月(95年4月7日) | 2月(95年5月10日) | 3月(95年6月10日) | |
| 性 状 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | |
| 外 观 | 符合规定 | 符合规定 | 符合规定 | 符合规定 | |
| 鉴别 | 1、红花 | 呈正反应 | 呈正反应 | 呈正反应 | 呈正反应 |
| 2、川芎 | 呈正反应 | 呈正反应 | 呈正反应 | 呈正反应 | |
| 3、细辛 | 呈正反应 | 呈正反应 | 呈正反应 | 呈正反应 | |
| 鉴别 | 水份(％) | 5.7 | 5.7 | 5.8 | 5.9 |
| 崩解时限 | 11′ | 12′ | 13′ | 13′ | |
| 装量差异 | 符合规定 | 符合规定 | 符合规定 | 符合规定 | |
| 含量测定(mg/g) | 0.129 | 0.128 | 0.131 | 0.127 | |
药品初步稳定性试验报告
| 放置时间(实验日期)结果项目 | 0月(95年3月7日) | 1月(95年4月7日) | 2月(95年5月10日) | 3月(95年6月10日) | |
| 性 状 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | |
| 外 观 | 符合规定 | 符合规定 | 符合规定 | 符合规定 | |
| 鉴别 | 1、红花 | 呈正反应 | 呈正反应 | 呈正反应 | 呈正反应 |
| 2、川芎 | 呈正反应 | 呈正反应 | 呈正反应 | 呈正反应 | |
| 3、细辛 | 呈正反应 | 呈正反应 | 呈正反应 | 呈正反应 | |
| 鉴别 | 水份(％) | 5.7 | 5.8 | 5.8 | 5.9 |
| 崩解时限 | 11′ | 12′ | 12′ | 12′ | |
| 装量差异 | 符合规定 | 符合规定 | 符合规定 | 符合规定 | |
| 含量测定(mg/g) | 0.134 | 0.137 | 0.131 | 0.128 | |
药品初步稳定性试验报告
| 放置时间(实验日期)结果项目 | 0月(95年3月7日) | 1月(95年4月7日) | 2月(95年5月10日) | 3月(95年6月10日) | |
| 性 状 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味或微苦 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | 本品为硬胶囊，内容物为棕黄色粉末气香微腥味咸微苦 | |
| 外 观 | 符合规定 | 符合规定 | 符合规定 | 符合规定 | |
| 鉴别 | 1、红花 | 呈正反应 | 呈正反应 | 呈正反应 | 呈正反应 |
| 2、川芎 | 呈正反应 | 呈正反应 | 呈正反应 | 呈正反应 | |
| 3、细辛 | 呈正反应 | 呈正反应 | 呈正反应 | 呈正反应 | |
| 鉴别 | 水份(％) | 5.9 | 5.9 | 5.8 | 5.9 |
| 崩解时限 | 14′ | 14′ | 13′ | 14′ | |
| 装量差异 | 符合规定 | 符合规定 | 符合规定 | 符合规定 | |
| 含量测定(mg/g) | 0.123 | 0.127 | 0.125 | 0.124 | |
本发明毒性试验如下：
长期毒性试验：
受试动物健康Wistar大鼠60只，雌雄各半，体重91±14g。将大鼠随机分为A、B、C三组，每组20只，雌雄各半，剂量分组为：
A组(对照组)：5％羧甲基纤维素溶液(2.25ml/100g体重)。
B组：高效脑心宁3.0g/Kg体重(13.33％、2.25ml/100g体重)。
C组：高效脑心宁1.5g/Kg体重(6.665％、2.25ml/100g体重)。
上述各组灌药量随体重变化而定。每天灌胃一次，连续六天，休息一天，共三个月。灌胃量每周根据体重变化调整一次，三个月后，各组随机取10只大鼠处死，采集颈静脉血，测定血常规指标，生化指标、脏体比值和病理组织学检查。实验结果表明：该药对大鼠生长发育及心、脑、肾、肾上腺、脾、生殖器管等没有不良影响，也未观察到对血液系统的影响，肾功能正常。但长期服用可引起大鼠肝脏增大，肝功能异常，但未见病理改变，剂量过大长期使用可致大鼠肺内出血。
急性毒性实验：
受试动物昆明种小鼠20只，体重20-22g，雌雄各半。用5％羟甲基纤维素作为赋形剂，配制浓度为10％的高效脑心宁悬液(超过此浓度无法灌入小鼠胃内)，每10g体重小鼠胃量为0.4ml，即给药最大剂量为4g/Kg体重，在1日内分早、中、晚三次灌入。实验结构表明：灌胃后小鼠出现倦缩、活动减少，1天后活动自如，饮食正常，连续观察七天，未见死亡。仅于灌胃第二天，观察到两只小鼠鼻腔内出现少量血性分泌物，三天后恢复正常。
本发明临床疗效观察如下：
本组病例均经神经内科就诊经血液流变学检查为高粘滞血症的脑血管病病人，308例中，男182例，女126例，年龄26-78岁，平均59岁，脑血栓124例，脑出血68例，TIA42例，脑动脉硬化症74例(诊断标准依照1978年第二届全国神经精神科，学术会议关于脑血管病的诊断要点)，病程最短者6小时，最长者9年，有192例作了头颅CT检查，其中102例病灶区为低密度阴影62例有脑萎缩。
治疗方法：
根据血液流变检查结果，服用高效防栓片，每日三次，每次1-3片，一个月一为疗程。一个疗程后复查血液流变，在观察期间停用一切影响血液变的药物。
疗效观察：
疗效观察包括脑功能改变及血液流变学改变两部分。表1：
高效防栓片对脑功能影响观察(308例)
| 头痛头晕 | 眩晕眼花 | 运动障碍 | 构音障碍 | 感觉障碍 | 共济失调 | 视力障碍 | 球麻痹 | ||
| 治疗前 | 273 | 32 | 117 | 28 | 65 | 19 | 17 | 26 | |
| 治疗后例 | 治愈 | 187 | 18 | 51 | 12 | 32 | 7 | 5 | 11 |
| 好转 | 65 | 12 | 57 | 14 | 28 | 10 | 11 | 13 | |
| 无效 | 21 | 2 | 9 | 2 | 5 | 2 | 1 | 2 | |
有效率达92.42％表2：
高效防栓片治疗前后血液流变学指标测定
平均值±标准差
全血比 血浆化 红细胞 血沉 血小板 纤维蛋治疗阶段 粘度(比) 粘度(比) 压积％ nm/n 聚集率％ 血原mg/％治疗前 5.98±0.72 1.86±0.07 49.10±1.10 23.62±1.96 72.10±2.50 442.36±1.42治疗后 5.17±0.62 1.52±0.06 46.65±0.9 20.20±2.0 52.06±2.24 349.16±7.2P值＜0.05＜0.01＞0.05＞0.05＜0.01＜0.01表3：
高效防栓片治疗前后血脂改变
平均值±标准差
胆固醇 B～脂蛋白 三酸甘油脂治疗阶段 (mg％) (mg％) (mg％)治疗前 247.2±3.12 396.22±7.39 149.06±4.12治疗后 182.3±2.12 301.17±8.22 107.91±3.27
P值 ＜0.01 ＜0.01 ＜0.01
临床应用结果表明：高效脑心宁可以降低血小板聚集率及血浆化粘度，降低纤维蛋白原和血脂，使血液粘滞性下降，脑血循环改善，进而脑功能改善，临床表现为头痛、头晕的现象消失，肢体运动功能也逐渐恢复和好转。在服用高效脑心宁前血小板聚体率增高(72.10±2.50％)，治疗后明显下降(52.06±2.24％)，经统计学处理，有显著性差异(P＜0.01)，由于血小板聚集性下降，抑制了血栓形成的早期环节，因而有预防血栓形成的作用。服用高效脑心宁前后纤维蛋白原平均值由442.36±1.42mg％降至349.16±7.2mg％，经统计数处理，有显著性差异(P＜0.01)，胆固醇、B-脂蛋白及三酸甘油脂经治疗后均有明显下降，血浆粘度比由1.80±0.07下降至1.52±0.06。
本发明采用传统工艺方法生产制作，可生产为胶囊或片剂。它既保留了中药各自的优点，又有协同互为补充的作用。减少了药物各自的付作用，增加了治疗效果，经临床应用，安全、有效，是预防和治疗脑血管疾患的一种理想药物。
本发明给出的详细实施例如下：
实施例1
组 份 用 量
水 蛭 40％
细 辛 10％
川 芎 50％
实施例2：
Claims (1)
1、一种治疗心脑血管疾病的药物，其特征在于：它是由下述重量比的原料制成的药剂：
水蛭15-40％、细辛5-10％、川芎7-50％
红花10-20％、人参8-28％、天麻10-30％。
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1122243A (zh) * | 1995-08-16 | 1996-05-15 | 岳泰出 | 消栓通脉散 |
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| CN1185331A (zh) | 1998-06-24 |
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