CN105687591A - 一种神经外科术前干预药物组合物 - Google Patents

一种神经外科术前干预药物组合物 Download PDF

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CN105687591A
CN105687591A CN201610128879.7A CN201610128879A CN105687591A CN 105687591 A CN105687591 A CN 105687591A CN 201610128879 A CN201610128879 A CN 201610128879A CN 105687591 A CN105687591 A CN 105687591A
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王芳
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Abstract

一种神经外科术前干预药物组合物，由下述原料制成：乌蛇，罗布麻，地骨皮，荸荠，夏枯草，当归，川芎，白花蛇，黄芩，紫花地丁，黄滑松茸，连翘，向日葵花，枸杞，凤眼莲，白术，丹参，玄参，亮叶桦皮，节节草。上述原料重量配比如下：乌蛇∶罗布麻∶地骨皮∶荸荠∶夏枯草∶当归∶川芎∶白花蛇∶黄芩∶紫花地丁∶黄滑松茸∶连翘∶向日葵花∶枸杞∶凤眼莲∶白术∶丹参∶玄参∶亮叶桦皮∶节节草为∶10∶15∶5∶13∶15∶10∶8∶11∶14∶9∶6∶5∶15∶10∶7∶8∶6∶2∶2∶9。本发明药物组合物成本低廉，其疗效确切、毒副作用小，适于广泛推广应用。

Description

一种神经外科术前干预药物组合物
技术领域
本发明属于中药技术领域，尤其涉及一种神经外科术前干预药物组合物。
背景技术
神经外科，也常称作脑外科，是外科的一个支系，以外科的方法来治疗神经系统的疾病。神经外科被公认为医学上地位最高的领域，其原因是要完成这样的手术对医生所需要的极其复杂的知识基础以及要获得进行这样的手术的允许所需要经过的严格的选择。神经外科手术，尤其是涉及开颅手术的患者，由于麻醉、创伤、高颅压、气管导管刺激、外界因素的影响，其术后并发症较其他外科手术要高得多。如特发性全麻后寒战(postanesthesiashivering，PS)的发生率，既往文献报道，普通外科手术为5％～38％，而开颅手术则为13％～65％。所谓特发性全麻后寒战，也称“硫喷妥钠样强直”，属于麻醉并发症。生理状态下的寒战是机体对低体温的代偿反应，通过骨骼肌快速节律性收缩而产热。而颅脑外科手术后的发生机制则与术后大脑体温调节中枢功能紊乱有关，且同时伴有麻醉状态下的交感神经功能阻滞，热量再分布调节失常。
目前，对于PS的治疗为针对性的对症治疗，多采用吗啡受体兴奋剂哌替啶，或者中枢呼吸兴奋药物多沙普仑。但寒战出现的同时即会伴发机体代谢率显著升高导致的心肺负荷增加；甚至心肌缺血；同时还会损害血小板功能，凝血级联反应抑制，失血量显著增加，输血量增多。因此如何在术前进行有效干预，降低PS的发生率，且不会引发其他的术后并发症，是神经外科开颅手术的研究新课题。
发明内容
针对上述现有技术中存在的问题，本发明旨在提供一种神经外科术前干预药物组合物。
本发明采取如下技术方案：
一种神经外科术前干预药物组合物，由下述原料制成：乌蛇，罗布麻，地骨皮，荸荠，夏枯草，当归，川芎，白花蛇，黄芩，紫花地丁，黄滑松茸，连翘，向日葵花，枸杞，凤眼莲，白术，丹参，玄参，亮叶桦皮，节节草。
上述原料重量配比如下：乌蛇∶罗布麻∶地骨皮∶荸荠∶夏枯草∶当归∶川芎∶白花蛇∶黄芩∶紫花地丁∶黄滑松茸∶连翘∶向日葵花∶枸杞∶凤眼莲∶白术∶丹参∶玄参∶亮叶桦皮∶节节草为：10∶15∶5∶13∶15∶10∶8∶11∶14∶9∶6∶5∶15∶10∶7∶8∶6∶2∶2∶9。
该组合物的制备过程如下：
A：取所述中药组合物中重量组分的各药材，第一次煎煮加药材总重量的12-15倍的水煎煮提取，煎煮两个小时：第二次加入十倍量的水，煎煮一个半小时，滤出药液待用；第三次加入八倍量的水，煎煮一小时，滤出药液待用；合并三次煎液，过滤，收集滤液，浓缩至50-60℃时相对密度为1.5的清膏；
B：将步骤A制得的清膏放置至室温后，加乙醇使含乙醇量至重量百分比55-70％，静置三十小时，取上清液；上清液回收乙醇，减压浓缩至60℃时相对密度为1.3-1.5的清膏，随后在3200r/min的转速下离心；在65℃-80℃喷雾干燥，得干浸膏；
C：将步骤B制得的干浸膏粉碎，加入适量蔗糖、糊精混合，以乙醇为润湿剂，制粒，干燥，整粒，可制得颗粒剂。
本发明的有益效果为：该药物组合物成本低廉，其疗效确切、毒副作用小，适于广泛推广应用。
具体实施方式
为了便于理解，下面通过实施例，对本发明技术方案作进一步具体描述：
一种神经外科术前干预药物组合物，由下述原料制成：乌蛇，罗布麻，地骨皮，荸荠，夏枯草，当归，川芎，白花蛇，黄芩，紫花地丁，黄滑松茸，连翘，向日葵花，枸杞，凤眼莲，白术，丹参，玄参，亮叶桦皮，节节草。
上述原料重量份数配比如下：乌蛇10克，罗布麻15克，地骨皮5克，荸荠13克，夏枯草15克，当归10克，川芎8克，白花蛇11克，黄芩14克，紫花地丁9克，黄滑松茸6克，连翘5克，向日葵花15克，枸杞10克，凤眼莲7克，白术8克，丹参6克，玄参2克，亮叶桦皮2克，节节草9克。
该组合物的制备过程如下：
A：取所述中药组合物中重量组分的各药材，第一次煎煮加药材总重量的12-15倍的水煎煮提取，煎煮两个小时：第二次加入十倍量的水，煎煮一个半小时，滤出药液待用；第三次加入八倍量的水，煎煮一小时，滤出药液待用；合并三次煎液，过滤，收集滤液，浓缩至50-60℃时相对密度为1.5的清膏；
B：将步骤A制得的清膏放置至室温后，加乙醇使含乙醇量至重量百分比55-70％，静置三十小时，取上清液；上清液回收乙醇，减压浓缩至60℃时相对密度为1.3-1.5的清膏，随后在3200r/min的转速下离心；在65℃-80℃喷雾干燥，得干浸膏；
C：将步骤B制得的干浸膏粉碎，加入适量蔗糖、糊精混合，以乙醇为润湿剂，制粒，干燥，整粒，可制得颗粒剂。
急性毒性试验：取小鼠80只，体重22-25克，对小鼠灌胃胶囊溶液，对给药的半数致死量(LD50)进行了试验测定，但未测到LD50，因此进行了最大耐受量试验。结果：以最大给药量120g/kg灌胃，相当于成人临床拟日用剂量的280倍，七日内小鼠无一死亡，处死小鼠解剖观察各脏器未发现毒性反应，给药组与对照组小鼠无任何差异。
六个月长期毒性试验：取大鼠80只，体重180～220g，将实验药物设定为高、中、低三个剂量，分别为40g/kg、20g/kg、10g/kg，按人用(75kg为标准)剂量1.1g/kg/天计算，为人用有效剂量的40倍、20倍和10倍；另设一对照组，连续灌胃给药90天、180天和部分动物停药10天后，观察对大鼠各项生理、生化指标的影响。实验结果表明：不同剂量给大鼠连续口服180天，对大鼠的进食量和体重增长无影响。对肝肾功能未发现明显毒性作用。对血常规、血生化、尿液生化及骨髓片等均未见明显影响，各组间与对照组比较无明显差异。
临床论证：
为了验证本发明药物组合物的效果，2014年9月-2015年10月，门诊处随机抽取130例神经外科全麻下颅脑手术患者，且术前3日内未使用昂丹司琼、曲马朵、可乐定等治疗寒战的药物。手术原因包括：幕上肿瘤33例，后颅窝肿瘤20例，脑室肿瘤10例，脑血管病10例，垂体瘤15例，颅咽管瘤3例，癫痫手术5例，其他手术如脑积水、颅骨修补等34例。年龄在23～72岁之间，平均年龄40.2±5.8岁，其中男性患者65例，女性患者65例。随机分为治疗组和对照组，其中治疗组男性患者32例，女性患者32例，平均年龄39.6±5.3岁，对照组男性患者33例，女性患者33例，平均年龄40.2±6.9岁，两组性别、年龄、病程等比较，差异均无显著性意义(P＞0.05)，具有可比性。
治疗方法：对照组常规术前术后给药，通过皮肤进行保温。治疗组在对照组的基础上，从术前三天开始，分别以本发明制备的颗粒剂，口服一次10mg，一日三次，合计三天。
结果分析：术后六小时内PS发生率分别为：对照组43％(28/65)，治疗组6.1％(4/65)。治疗组寒战发生率明显低于对照组。两组患者其他麻醉后恢复室(PACU)并发症比较：见下表，
对照组、治疗组在心血管相关并发症、消化系并发症、精神系并发症、呼吸系并发症、苏醒延迟方面差异无统计学意义。
上述实施例只是对本发明技术方案的举例说明或解释，而不应理解为对本发明技术方案的限制，显然，本领域的技术人员可对本发明进行各种修改和变型而不脱离本发明的精神和范围。倘若这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也包含这些修改和变型在内。

Claims (1)

1.一种神经外科术前干预药物组合物，由下述原料制成：乌蛇，罗布麻，地骨皮，荸荠，夏枯草，当归，川芎，白花蛇，黄芩，紫花地丁，黄滑松茸，连翘，向日葵花，枸杞，凤眼莲，白术，丹参，玄参，亮叶桦皮，节节草；
上述原料重量配比如下：乌蛇∶罗布麻∶地骨皮∶荸荠∶夏枯草∶当归∶川芎∶白花蛇∶黄芩∶紫花地丁∶黄滑松茸∶连翘∶向日葵花∶枸杞∶凤眼莲∶白术∶丹参∶玄参∶亮叶桦皮∶节节草为∶10∶15∶5∶13∶15∶10∶8∶11∶14∶9∶6∶5∶15∶10∶7∶8∶6∶2∶2∶9。
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