CN105833169A - 一种颅脑损伤后遗症的药物制剂 - Google Patents

一种颅脑损伤后遗症的药物制剂 Download PDF

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CN105833169A
CN105833169A CN201610193361.1A CN201610193361A CN105833169A CN 105833169 A CN105833169 A CN 105833169A CN 201610193361 A CN201610193361 A CN 201610193361A CN 105833169 A CN105833169 A CN 105833169A
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倪瑞云
张建国
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Abstract

本发明涉及一种用于颅脑损伤后遗症的药物制剂，其乳香、升麻、延胡索、莪术、当归、蒲公英、桃仁、川芎、柏子仁、赤芍、远志、丹参、枸杞子、薏苡仁、石菖蒲、女贞子、茯神、牡丹皮、没药、钩藤、丝瓜络、菟丝子、苏木、酸枣仁、决明子、麦冬、大蓟制备而成。诸药合用，相得益彰，应用前景广阔。

Description

一种颅脑损伤后遗症的药物制剂
技术领域
本发明属于中药药物技术领域，具体的，涉及一种以中草药为原料临床护理颅脑损伤后遗症的药物制剂。
背景技术
颅脑损伤是一种常见外伤，可单独存在，也可与其他损伤复合存在。其分类根据颅脑解剖部位分为头皮损伤、颅骨损伤与脑损伤，三者可合并存在。头皮损伤包括头皮血肿、头皮裂伤、头皮撕脱伤。颅骨骨折包括颅盖骨线状骨折、颅底骨折、凹陷性骨折。脑损伤包括脑震荡、弥漫性轴索损伤、脑挫裂伤、脑干损伤。按损伤发生的时间和类型又可分为原发性颅脑损伤和继发性颅脑损伤。按颅腔内容物是否与外界交通分为闭合性颅脑损伤和开放性颅脑损伤。根据伤情程度又可分为轻、中、重、特重四型。颅脑损伤是常见的致残性疾病。在我国颅脑损伤主要的发病原因是交通事故。近年来我国经济的快速发展，汽车保有量成倍增加，TBI已经成为一个沉重的公共卫生问题。 在过去的20年里，由于急救、影像、重症监护和康复等学科的进展，颅脑损伤患者的护理水平已明显提高。但是，仍没有确切的临床治疗手段能逆转颅脑损伤病理进程、改善遗留的神经系统功能障碍。
颅脑损伤后综合征又称为脑外伤后综合征是指病人颅脑损伤后3 个月以上，仍然有头痛、头晕、记忆力减退、烦躁易怒、情绪不稳、肢体麻木、耳鸣、失眠、多梦、心悸等植物神经功能失调样症状，其显著特点是实验室检查和影像学资料无阳性结果，但患者关于身体各部位不适的主诉与自觉症状的严重程度常超出临床检查结果。脑外伤后综合征严重影响人类健康，是上世纪九十年代WHO 重点招标领域之一。随着社会经济高速发展，高空作业、交通事故、自然灾害等导致的脑外伤患者增多，脑外伤后综合征越来越受到我国政府和卫生工作者的重视。
现有技术中，颅脑损伤后综合症的治疗包括降低颅内压、清除自由基、高压氧、营养脑神经等措施，目前虽然治疗该病的药物较多，但却普遍存在疗效不太理想的问题，并且现有的治疗药物大多数为西药，这些西药虽然有一定的疗效，但其存在毒副作用也比较明显。
脑外伤后综合征的发病原因尚无定论，国内外研究者通过对脑外伤后综合征患者行颅脑MRI 和SPECT 等检查，发现其发病机制可能与下列情况有一定关系: 外伤破坏了脑组织的细微结构; 脑外伤后脑血管长期处于痉挛状态导致脑组织缺血缺氧; 亦或是脑组织损伤后瘢痕的牵拉。脑外伤后综合征主要包括头痛、头晕、神经过敏、恶心、情绪不稳、易怒、易疲劳、睡眠障碍、注意力集中障碍、记忆力障碍等症状，其中以头痛最为常见。但头痛的性状、部位各不相同，发作无规律，与情绪不佳、疲劳、失眠相关，患者因此而焦躁不安。头晕是其较常见的症状之一，患者往往感到头昏、思维不清晰，或有一种混乱迷糊的感觉。神经过敏和易激惹也是较常见的症状，一般由外界环境因素引起。另外，诸如记忆力减退、注意力难以集中、易疲劳、失眠等症状可能是心理因素作用的结果。其它还可见到一些自主神经功能失调的表现，如心悸、耳鸣、血压波动、多汗、月经失调、性功能障碍等。
中医学对该病也有广泛的认知：本病属中医学眩晕+不寐+郁证范畴，系由突然的头部外伤使精神产生高度的惊恐，从而肾精暗耗，肝失条达，郁而化火，上扰清空，或外伤击头招致髓海膜络血脉损伤，而致气滞血瘀或因内伤心脾，生化不旺，血行不周，致血虚不能上奉于脑。主要病机是瘀恋脑络，未得清澈，伤后瘀阻，气血难以上注以致脑失所养，髓海空虚。血为气之母，气为血之帅，血瘀则气滞，气滞血瘀谓之不通，不通则痛，故皆有头痛，且头痛常系脑外伤综合征的主症，外伤后的血瘀往往兼有血虚，尤其是外伤后病症拖延较久者。病久则虚，心失所养，难主神明或气血亏虚，故感头晕、精神不振、乏力、耳鸣、多汗、失眠心悸、情绪不稳、记忆力减退。
现有技术中药处方缺乏辩证，治疗周期长，对症性不强，疗效不明显，甚至还会给患者带来副作用，增加患者痛苦，从天然药物中寻找有效、安全的药物，已经成为临床治疗脑外伤综合征重要方向。
发明内容
本发明的目的在于提供一种用于颅脑损伤后遗症的药物制剂。辨证论治一直是中医药治疗疾病的核心理论，如何针对主要病机用药同时兼顾次要病机，兼顾共性与个性的治疗，从而最大程度体现中医治疗疾病的内涵与外延，是中成药配伍的一个现实难题。申请人针对颅脑损伤后遗症的主要病机特点，结合大量秘方根据多年的医行实践，通过对传统中药的研究，并结合辩证论证，多方收集众家之长，寻求最佳治疗方案，有效保护脑组织，阻断继发的病理损害，对提高颅脑损伤的治愈率，减少并发症均有较好作用。
为实现本发明目的，本发明采用的技术方案如下：
一种用于颅脑损伤后遗症的药物制剂，其由下述原料制备而得：
乳香、升麻、延胡索、莪术、当归、蒲公英、桃仁、川芎、柏子仁、赤芍、远志、丹参、枸杞子、薏苡仁、石菖蒲、女贞子、茯神、牡丹皮、没药、钩藤、丝瓜络、菟丝子、苏木、酸枣仁、决明子、麦冬、大蓟。
优选地，所述药物由下述重量配比的原料制备而得：
乳香35份、升麻35份、延胡索35份、莪术35份、当归33份、
蒲公英33份、桃仁33份、川芎30份、柏子仁30份、赤芍30份、
远志30份、丹参28份、枸杞子28份、薏苡仁25份、石菖蒲25份、
女贞子25份、茯神25份、牡丹皮25份、没药22份、钩藤22份、
丝瓜络20份、菟丝子20份、苏木20份、酸枣仁18份、决明子18份、
麦冬15份、大蓟15份。
本发明的药物其制备方法为：
1)称取各原料药，备用；
2）取乳香、莪术、蒲公英、桃仁、柏子仁、远志、枸杞子、薏苡仁、牡丹皮、酸枣仁、决明子混合均匀，加4倍重量的水武火煮沸，然后文火煎煮1小时，过滤收集滤液和滤渣；往滤渣中添加3倍重量水，武火煮沸，然后文火煎煮1小时，过滤收集滤液；合并两次滤液，冷却后，浓缩成密度为1.2g/ml的浸膏；80℃烘干后，粉碎成粉末，即为复合物I；
3）取剩余成分加入相对于混合物3倍重量75%（体积分数）的乙醇，回流提取2次，每次1小时，提取液合并，浓缩至密度为1.2g/ml的清膏，80℃烘干，粉碎制备复合物II；
4) 将复合物I和复合物II混合搅拌均匀，灭菌消毒制得胶囊剂产品。
本发明的优点是纯中药制剂，具有益气活血，化瘀通络，除痰开窍，滋补肝肾，填精补髓开窍通脑之功效。可提高机体的细胞和体液免疫功能，抗疲劳，抗应激，促进机体恢复。主治头痛、头昏、失眠、容易疲倦、注意力涣散、记忆力减退、耳鸣多汗等症，用于各种原因引起的颅脑损伤后遗症。
本发明药物的组分均采用天然的中药原料，其配制简便，药源广泛，成本低廉，其遵循中医的处方用药原则，诸药合用，相得益彰，本发明制剂服用量小，药物有效成分易于释放，吸收快，生物利用度高，使药效能够充分发挥，经临床应用验证，其疗效显著可靠，药性平和，未出现毒副作用，应用前景广阔。
具体实施方式
实施例1
一种用于颅脑损伤后遗症的药物制剂，其由下述重量配比的原料制备而得：
乳香35份、升麻35份、延胡索35份、莪术35份、当归33份、
蒲公英33份、桃仁33份、川芎30份、柏子仁30份、赤芍30份、
远志30份、丹参28份、枸杞子28份、薏苡仁25份、石菖蒲25份、
女贞子25份、茯神25份、牡丹皮25份、没药22份、钩藤22份、
丝瓜络20份、菟丝子20份、苏木20份、酸枣仁18份、决明子18份、
麦冬15份、大蓟15份。
本发明的药物其制备方法为：
1)称取各原料药，备用；
2）取乳香、莪术、蒲公英、桃仁、柏子仁、远志、枸杞子、薏苡仁、牡丹皮、酸枣仁、决明子混合均匀，加4倍重量的水武火煮沸，然后文火煎煮1小时，过滤收集滤液和滤渣；往滤渣中添加3倍重量水，武火煮沸，然后文火煎煮1小时，过滤收集滤液；合并两次滤液，冷却后，浓缩成密度为1.2g/ml的浸膏；80℃烘干后，粉碎成粉末，即为复合物I；
3）取剩余成分加入相对于混合物3倍重量75%（体积分数）的乙醇，回流提取2次，每次1小时，提取液合并，浓缩至密度为1.2g/ml的清膏，80℃烘干，粉碎制备复合物II；
4) 将复合物I和复合物II混合搅拌均匀，灭菌消毒制得胶囊剂产品。
本发明药物用于治疗脑外伤综合征，每次口服0.5g，一日两次，两周一个疗程。
实施例2
临床资料
选择入院治疗的门诊脑外伤后综合征患者82例
纳入标准： （1）有明显的脑外伤病史，其急性创伤已恢复；
（2）伴有头痛"失眠"多梦"耳鸣"心悸"多汗"注意力不集中"恶心及食欲下降等自觉症状，但无确切的神经系统阳性体征，头颅CT、MRI检查亦无异常发现；
（3）距脑外伤发生时间3 个月。
排除高血压病、心血管疾病及颅内占位性病变。其中男性43例，女性39 例，年龄20－53岁，随机分为治疗组与对照组分别41例、41例，两组患者年龄、临床表现、病程及病情严重程度等资料差异无统计学意义(p>0.05)，具有可比性。
治疗方法：
对照组给予口服盐酸氟桂利嗪5mg，每日一次，阿司匹林肠溶片300mg，每日一次，谷维素30mg，每日2次，眩晕加敏司朗6mg，每日1次。
实验组给予实施例1制备的药物，每次口服0.5g，一日两次，两周一个疗程。
疗效评估临床疗效按据《现代神经外科学》的疗效判定标准。用药前后自身对照。
治愈：主要自觉症状消失，能正常工作、学习和生活；
好转：主要自觉症状基本消失，遇刺激略感不适；
有效：临床症状较治疗前减轻，但常有复发，尚不能恢复正常生活和工作；
无效：主要自觉症状无改善或加重以及出现新的症状，在治疗前及治疗后进行血常规、尿常规、肝功、肾功、血糖、心电图、脑电图、体重、血压测定对照。
表1 治疗效果
组别 例数 治愈 好转 有效 无效 总有效率
实验组 41 26 7 5 3 92.7%
对照组 41 16 7 4 14 65.9％
实验组较对照组差异显著。
实施例3
典型病例
陈某，不慎从高处摔下，造成颅脑摔伤，住院治疗时伴有呕吐、心烦、不思饮食、头鸣头痛等现象。治疗半年后，患者常有头部胀痛、割裂痛或跳痛，失眠、疲劳、情绪欠佳、工作不顺利或外界的喧嚣而加剧。病人还常有情绪不稳定、容易疲倦、失眠、注意力不集中、记忆力减退，舌淡，苔白，脉沉弱无力，双尺脉尤甚，表情痛苦，但神志清醒。CT检查无明显异常。诊断：脑海震损，证属血瘀血虚，寒热虚实夹杂，西医诊断为脑外伤后综合征。治法：给予实施例1制备的药物制剂，服药一周后头痛头晕大为好转，续服。两个疗程后，诸症消失。随访半年，无头痛、头晕现象，精神睡眠、记忆力均好转。
以上列举的仅是本发明的最佳具体实施例。显然，本发明不限于以上实施例，还可以有许多变形。本领域的普通技术人员能从本发明公开的内容直接导出或联想到的所有变形，均应认为是本发明的保护范围。

Claims (3)

1.一种用于颅脑损伤后遗症的药物制剂，其由下述原料制备而得：
乳香、升麻、延胡索、莪术、当归、蒲公英、桃仁、川芎、柏子仁、赤芍、远志、丹参、枸杞子、薏苡仁、石菖蒲、女贞子、茯神、牡丹皮、没药、钩藤、丝瓜络、菟丝子、苏木、酸枣仁、决明子、麦冬、大蓟。
2.根据权利要求1所述的药物制剂，其特征在于由下述重量配比的原料制备而得：
乳香35份、升麻35份、延胡索35份、莪术35份、当归33份、
蒲公英33份、桃仁33份、川芎30份、柏子仁30份、赤芍30份、
远志30份、丹参28份、枸杞子28份、薏苡仁25份、石菖蒲25份、
女贞子25份、茯神25份、牡丹皮25份、没药22份、钩藤22份、
丝瓜络20份、菟丝子20份、苏木20份、酸枣仁18份、决明子18份、
麦冬15份、大蓟15份。
3.根据权利要求1-2所述的药物制剂，其特征在于，所述药物的制备方法如下：
1）称取各原料，备用；
2）取乳香、莪术、蒲公英、桃仁、柏子仁、远志、枸杞子、薏苡仁、牡丹皮、酸枣仁、决明子，混合均匀，加4倍重量的水武火煮沸，然后文火煎煮1小时，过滤收集滤液和滤渣；往滤渣中添加3倍重量水，武火煮沸，然后文火煎煮1小时，过滤收集滤液；合并两次滤液，冷却后，浓缩成密度为1.2g/ml的浸膏；80℃烘干后，粉碎成粉末，即为复合物I；
3）取剩余原料，混合，加入相对于混合物3倍重量75%（体积分数）的乙醇，回流提取2次，每次1小时，提取液合并，浓缩至密度为1.2g/ml的清膏，80℃烘干，粉碎制备复合物II；
4)将复合物I和复合物II混合搅拌均匀，灭菌消毒即得。
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CN1961928A (zh) * 2005-11-10 2007-05-16 杨文龙 一种治疗血瘀证的活血化瘀药物及其制备方法
CN102258738A (zh) * 2011-07-12 2011-11-30 陶长年 一种治疗颅脑损伤的中药组方
CN102764401A (zh) * 2011-07-12 2012-11-07 陶长年 一种治疗颅脑损伤的中药组方
CN104524462A (zh) * 2014-12-26 2015-04-22 陈蔚峰 一种治疗颅脑损伤或颅内肿瘤手术后眩晕症的中药配方

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CN1961928A (zh) * 2005-11-10 2007-05-16 杨文龙 一种治疗血瘀证的活血化瘀药物及其制备方法
CN102258738A (zh) * 2011-07-12 2011-11-30 陶长年 一种治疗颅脑损伤的中药组方
CN102764401A (zh) * 2011-07-12 2012-11-07 陶长年 一种治疗颅脑损伤的中药组方
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