CN104547762A - 一种治疗脑损伤后综合征的药物组合物及其制备方法 - Google Patents
一种治疗脑损伤后综合征的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明的目的在于公开一种治疗脑损伤后综合征的药物组合物及其制备方法,本发明的目的还在于公开该组合物的制备方法。本发明药物组合物的原料药组成比例为:制成该药的原料药的组成及重量份为:天麻100—220份,白芍100—200份,龟甲20—100份,鳖甲20—100份,麦芽50—100份,茯苓50—100份,山药30—100份,地骨皮30—100份,银柴胡30—100份,莲子心30—100份,麦冬30—100份、天冬20—120份、桑椹20—90份,丹参10—90份,青木香10—80份,枳壳30—90份,酸枣仁30—100份,柏子仁30—100份,法半夏30—160份,石决明30—160份,牡蛎30—160份,甘草50—160份。本发明药物可以加入常规辅料,按照常规工艺,制成临床可接受的片剂、胶囊剂。<!-- 2 --><!-- 3 -->
Description
技术领域
本发明涉及一种药物组合物及其制备方法,具体的说,涉及一种治疗脑损伤后综合征的药物组合物及其制备方法。
背景技术
脑损伤后综合征是指脑损伤3个月后,病人仍然有头痛、头昏、癔症样发作等自主神经功能失调或精神症状,但神经系统检查无确切的阳性体征,甚至CT、MRI检查也无异常发现。既往曾称为脑震荡后综合征或脑损伤后神经官能症。
脑外伤后综合征的临床特点为主观症状较重而客观体征缺如或轻微,主要是头昏、头痛和神经系统功能障碍等表现。头晕头痛最为多见,约占78%,以弥漫性头部胀痛及搏动性头痛为主,持久而严重,发作时间不定,以下午为多,部位常在额颞部或枕后部,有时累及整个头部,或头顶压迫感,或呈环形紧箍感,因而终日昏沉、焦躁不安。位于枕后的头痛经常伴有颈部肌肉紧张及疼痛,多与颅颈部损伤有关。头痛的发作可因失眠、疲劳、情绪欠佳、工作不顺利或外界的喧嚣而加剧。
头晕亦较为常见,约占50%。病人往往陈诉为头晕目眩,其实多非真正的眩晕,而是主观感到头部昏浊、思维不够清晰,或是一种混乱迷糊的感觉。有时自认为身体不能保持平衡,常因转动头部或改变体位而加重,但神经检查并无明确的前庭功能障碍或共济失调,给予适当的对症治疗和安慰鼓励之后,症状即可减轻或消失,但不久又复出现。
癔症样反应:病人情绪多波动,易激惹、发怒,有时可有肌痉挛性发作、视力下降、听力下降、闭目不语和不由自主的哭笑,甚至发生癔症性瘫痪,重者呈木僵或缄默状态。经神经系统查体,多无确切的阳性体征。
轻度或中度闭合性颅脑损伤,伤后一般情况恢复较好,但头昏、头痛及某些程度不一的自主神经功能失调或精神性症状却经久不愈,给患者的学习、工作和生活带来严重的影响。
目前西药治疗效果不理想,祖国医学博大精深,通过组方配伍,在治疗脑损伤后综合征治疗的研究还刚开始,尚无疗效确定的药物。
发明内容
本发明的目的在于公开一种治疗脑损伤后综合征的药物组合物,本发明的目的还在于公开该组合物的制备方法。
本发明所涉及的一种治疗脑损伤后综合征的药物组合物,它主要是由原料药天麻、白芍、龟甲、鳖甲、麦芽、茯苓、山药、地骨皮、银柴胡、莲子心、麦冬、天冬、桑椹、丹参、青木香、枳壳、酸枣仁、柏子仁、法半夏、石决明、牡蛎、甘草。
君药天麻平肝熄风,臣药白芍补肝阴,龟甲、鳖甲补肾阴,麦芽、茯苓和山药补脾益胃,地骨皮、银柴胡、莲子心清虚热,麦冬、天冬滋阴,桑椹滋阴补血生津,共为佐药,丹参活血通络,青木香、枳壳舒肝理气,酸枣仁,柏子仁养心安神,法半夏祛脉络之痰,石决明,牡蛎平抑肝阳,共为使药,甘草调和诸药全方合用,诸药合用共奏平肝潜阳、滋补肝肾之功效。
本发明用于临床常见的肝阳上亢型的脑损伤后综合征患者,症见头昏,乏力,目赤,少寐多梦,眩晕呕吐耳鸣,腹胀纳呆,小便清长,舌红赤少苔,脉虚微。
本发明的中药组合物及其药物组分的用量也是经过发明人进行大量摸索总结得出的。
所述的一种治疗脑损伤后综合征的药物组合物的组成及重量份为:天麻100—220份,白芍100—200份,龟甲20—100份,鳖甲20—100份,麦芽50—100份,茯苓50—100份,山药30—100份,地骨皮30—100份,银柴胡30—100份,莲子心30—100份,麦冬30—100份、天冬20—120份、桑椹20—90份,丹参10—90份,青木香10—80份,枳壳30—90份,酸枣仁30—100份,柏子仁30—100份,法半夏30—160份,石决明30—160份,牡蛎30—160份,甘草50—160份。
所述的一种治疗脑损伤后综合征的药物组合物的进一步的组成及重量份为:天麻120—200份,白芍120—180份,龟甲40—80份,鳖甲40—80份,麦芽60—90份,茯苓60—90份,山药50—90份,地骨皮50—90份,银柴胡50—90份,莲子心40—90份,麦冬40—90份、天冬40—100份、桑椹30—80份,丹参20—80份,青木香20—70份,枳壳40—80份,酸枣仁40—90份,柏子仁40—90份,法半夏40—100份,石决明40—100份,牡蛎40—100份,甘草60—120份。
所述的一种治疗脑损伤后综合征的药物组合物的优选的组成及重量份为:天麻200份,白芍180份,龟甲80份,鳖甲80份,麦芽80份,茯苓80份,山药80份,地骨皮80份,银柴胡70份,莲子心70份,麦冬70份、天冬70份、桑椹60份,丹参30份,青木香40份,枳壳50份,酸枣仁50份,柏子仁50份,法半夏50份,石决明50份,牡蛎50份,甘草100份。
所述的一种治疗脑损伤后综合征的药物组合物的优选的组成及重量份为:天麻150份,白芍150份,龟甲50份,鳖甲50份,麦芽60份,茯苓60份,山药60份,地骨皮60份,银柴胡60份,莲子心60份,麦冬50份、天冬60份、桑椹40份,丹参40份,青木香30份,枳壳50份,酸枣仁50份,柏子仁50份,法半夏60份,石决明60份,牡蛎60份,甘草120份。
所述的一种治疗脑损伤后综合征的药物组合物的优选的组成及重量份为:天麻120份,白芍120份,龟甲40份,鳖甲40份,麦芽70份,茯苓70份,山药70份,地骨皮70份,银柴胡70份,莲子心60份,麦冬60份、天冬60份、桑椹60份,丹参60份,青木香50份,枳壳40份,酸枣仁40份,柏子仁40份,法半夏40份,石决明40份,牡蛎40份,甘草80份。
总之,本发明组成君、臣、佐、使俱全,配伍严谨,相辅相成,共奏诸药合用共奏平肝潜阳、滋补肝肾之功效。
本发明药物可以加入常规辅料,按照常规工艺,制成临床可接受的片剂、胶囊剂等。
本发明药物的制备的片剂或胶囊剂的方法包括如下步骤:
龟甲,鳖甲,茯苓、山药以上四味粉碎成细粉,过筛,其余十八味水煎,浓缩,50%醇沉,过滤后,滤液浓缩,二者混匀,制颗粒,干燥,装胶囊或压片。
本发明药物的制备方法优选包括如下步骤:龟甲,鳖甲,茯苓、山药以上四味粉碎成细粉,过筛。其余十八味水煎2次,每次30分钟,浓缩,50%醇沉,过滤后,滤液浓缩,喷雾干燥,混匀,制颗粒,干燥,制成胶囊或片剂。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。
实施例1
1、处方:
天麻200g,白芍180g,龟甲80g,鳖甲80g,麦芽80g,茯苓80g,山药80g,地骨皮80g,银柴胡70g,莲子心70g,麦冬70g、天冬70g、桑椹60g,丹参30g,青木香40g,枳壳50g,酸枣仁50g,柏子仁50g,法半夏50g,石决明50g,牡蛎50g,甘草100g。
2.制法:
龟甲,鳖甲,茯苓、山药以上四味粉碎成细粉,过筛。其余十八味水煎2次,每次30分钟,浓缩,50%醇沉,过滤后,滤液浓缩,喷雾干燥,混匀,制颗粒,干燥,制成1000片剂。
实施例2
1、处方:
天麻150g,白芍150g,龟甲50g,鳖甲50g,麦芽60g,茯苓60g,山药60g,地骨皮60g,银柴胡60g,莲子心60g,麦冬50g、天冬60g、桑椹40g,丹参40g,青木香30g,枳壳50g,酸枣仁50g,柏子仁50g,法半夏60g,石决明60g,牡蛎60g,甘草120g。
2.制法:
龟甲,鳖甲,茯苓、山药以上四味粉碎成细粉,过筛。其余十八味水煎2次,每次30分钟,浓缩,50%醇沉,过滤后,滤液浓缩,喷雾干燥,混匀,制颗粒,干燥,制成1000胶囊。
实施例3
1、处方:
天麻120g,白芍120g,龟甲40g,鳖甲40g,麦芽70g,茯苓70g,山药70g,地骨皮70g,银柴胡70g,莲子心60g,麦冬60g、天冬60g、桑椹60g,丹参60g,青木香50g,枳壳40g,酸枣仁40g,柏子仁40g,法半夏40g,石决明40g,牡蛎40g,甘草80g。
2、工艺:
龟甲,鳖甲,茯苓、山药以上四味粉碎成细粉,过筛。其余十八味水煎2次,每次30分钟,浓缩,50%醇沉,过滤后,滤液浓缩,喷雾干燥,混匀,制颗粒,干燥,制成1000片剂。
实施例4临床实验:脑清片对治疗脑损伤后综合征的临床观察
【试验药品】
受试药物:脑清片:0.35g/粒,由实施例1制得,用前用蒸馏水配成所需的浓度的混悬液。
【入选病例】
临床资料
1.1一般资料随机选择脑外伤后综合症患者共40例,按照随机分组原则分为治疗组20例和对照组20例。
1.2诊断标准根据王忠诚院士1998年主编的《神经外科学》第1版制定的标准:(1)有明确的头部外伤史;(2)以轻度或中度闭合性脑损伤为主;(3)伤后恢复较好,但头昏、头痛、失眠多梦、记忆力减退、焦虑、烦躁易怒、思想不能集中、恶心呕吐、耳鸣及某些程度不一的植物神经功能失调症状(如心悸、多汗、性功能下降或月经紊乱)经久不愈。症状持续至伤后3个月以上者;(4)自觉症状明显,临床上没有确切的神经系统阳性体征。通过CT、MRI等检查亦无异常发现。
2、治疗与观察方法:
对照组患者给予常规治疗及高压氧治疗,每日1次。12次为1个疗程,疗程间休息2天,两个疗程后统计疗效。治疗组则在对照组基础上加用脑清片,每日3次,每次2粒。
3、疗效评定:
疗效标准(1)痊愈:自觉症状消失,恢复正常,生活自理,恢复学习、工作或劳动。(2)显效:自觉症状明显好转,基本恢复生活自理能力,基本恢复学习、
工作或劳动。(3)有效:症状减轻,生活尚不能完全自理,尚不能正常参加学习、工作或劳动。(4)无效:症状、体征与治疗前无改变。
4、统计学分析:
采用SPSS13.0进行数据分析,计数资料采用χ2检验。
5、结果见表1:
表1对治疗脑损伤后综合征的疗效对比表
从表1可见,,治疗组与对照组疗效比较见表1,治疗组与对照组相比较,两组比较有显著性差异(P<0.05)。
Claims (7)
1.一种治疗脑损伤后综合征的药物组合物,其特征在于:制成该药的原料药的组成及重量份为:天麻100—220份,白芍100—200份,龟甲20—100份,鳖甲20—100份,麦芽50—100份,茯苓50—100份,山药30—100份,地骨皮30—100份,银柴胡30—100份,莲子心30—100份,麦冬30—100份、天冬20—120份、桑椹20—90份,丹参10—90份,青木香10—80份,枳壳30—90份,酸枣仁30—100份,柏子仁30—100份,法半夏30—160份,石决明30—160份,牡蛎30—160份,甘草50—160份。
2.根据权利要求1所述的一种治疗脑损伤后综合征的药物组合物,其特征在于:制成该药的原料药的组成及重量份为:天麻120—200份,白芍120—180份,龟甲40—80份,鳖甲40—80份,麦芽60—90份,茯苓60—90份,山药50—90份,地骨皮50—90份,银柴胡50—90份,莲子心40—90份,麦冬40—90份、天冬40—100份、桑椹30—80份,丹参20—80份,青木香20—70份,枳壳40—80份,酸枣仁40—90份,柏子仁40—90份,法半夏40—100份,石决明40—100份,牡蛎40—100份,甘草60—120份。
3.根据权利要求2所述的一种治疗脑损伤后综合征的药物组合物,其特征在于:制成该药的原料药的组成及重量份为:天麻200份,白芍180份,龟甲80份,鳖甲80份,麦芽80份,茯苓80份,山药80份,地骨皮80份,银柴胡70份,莲子心70份,麦冬70份、天冬70份、桑椹60份,丹参30份,青木香40份,枳壳50份,酸枣仁50份,柏子仁50份,法半夏50份,石决明50份,牡蛎50份,甘草100份。
4.根据权利要求2所述的一种治疗脑损伤后综合征的药物组合物,其特征在于:制成该药的原料药的组成及重量份为:天麻150份,白芍150份,龟甲50份,鳖甲50份,麦芽60份,茯苓60份,山药60份,地骨皮60份,银柴胡60份,莲子心60份,麦冬50份、天冬60份、桑椹40份,丹参40份,青木香30份,枳壳50份,酸枣仁50份,柏子仁50份,法半夏60份,石决明60份,牡蛎60份,甘草120份。
5.根据权利要求2所述的一种治疗脑损伤后综合征的药物组合物,其特征在于:制成该药的原料药的组成及重量份为:天麻120份,白芍120份,龟甲40份,鳖甲40份,麦芽70份,茯苓70份,山药70份,地骨皮70份,银柴胡70份,莲子心60份,麦冬60份、天冬60份、桑椹60份,丹参60份,青木香50份,枳壳40份,酸枣仁40份,柏子仁40份,法半夏40份,石决明40份,牡蛎40份,甘草80份。
6.如权利要求1—5任一所述的药物组合物的制备方法,其特征在于:龟甲,鳖甲,茯苓、山药以上四味粉碎成细粉,过筛,其余十八味水煎,浓缩,50%醇沉,过滤后,滤液浓缩,二者混匀,制颗粒,干燥,装胶囊或压片。
7.如权利要求6所述的药物组合物的制备方法,其特征在于:龟甲,鳖甲,茯苓、山药以上四味粉碎成细粉,过筛。其余十八味水煎2次,每次30分钟,浓缩,50%醇沉,过滤后,滤液浓缩,喷雾干燥,混匀,制颗粒,干燥,制成胶囊或片剂。
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