CN104524245A - 用于治疗儿童多动症的中药组合物及其制剂 - Google Patents
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Abstract
本发明公开了一种用于治疗儿童多动症的中药组合物，按重量份计由以下组分组成：人参15-30份、天麻8-15份、黄芪12-18份、五味子10-20份、枸杞16-22份、酸枣仁4-8份、茯苓9-14份、龟甲5-10份、石菖蒲20-30份、山茱萸11-20份、山药7-11份、桑椹5-10份、炙甘草18-30份；该中药组合物可以按照中药制剂学的常规方法制成各种适合临床治疗需要的中药制剂，例如胶囊剂，能够有效治疗儿童多动症，疗效确切，总有效率高，毒副作用低，且组方药材来源广泛、价格低廉。
Description
技术领域
本发明属于医药技术领域，涉及一种中药组合物及其制剂。
背景技术
儿童多动症，又称注意缺陷多动障碍（ADHD），其表现主要为与年龄和发育水平不相称的注意力不集中、注意时间短暂、活动过度和冲动，常伴有学习困难、品行障碍和适应不良，是儿童期常见的一类心理疾病。国内外调查发现其患病率为3-7%，男女比为4-9：1。儿童多动症危害甚广，不仅患儿人际交往和自尊心，影响其学校生活和家庭生活，还影响患儿健康和安全，甚至会影响患儿终身。
儿童多动症的病因和发病机制目前尚不明确，大多数认为是多种因素相互作用所致，比如家族遗传、神经递质失衡、母亲妊娠期间吸烟饮酒、患儿早产、产后出现缺血缺氧性脑病以及甲状腺功能障碍等等。中医学上将儿童多动症归于 “失聪”、“健忘”、“疳症”、“虚烦”、“不寐”、“妄动”、“妄为”等范畴。中医学认为，小儿先天禀赋不足、后天失调或因他病所伤，造成体质偏盛偏衰，动静变化有所失制，其脏腑病变多表现为心、肝、脾、肾四脏的功能失常，而以肾阴不足为本，虚阳浮亢，心肝火盛为其标。
发明内容
本发明的目的在于提供一种用于治疗儿童多动症的中药组合物及其制剂，疗效确切，总有效率高，毒副作用低，组方药材来源广泛，价格低廉。
具体技术方案如下：
1. 用于治疗儿童多动症的中药组合物，按重量份计由以下组分组成：人参15-30份、天麻8-15份、黄芪12-18份、五味子10-20份、枸杞16-22份、酸枣仁4-8份、茯苓9-14份、龟甲5-10份、石菖蒲20-30份、山茱萸11-20份、山药7-11份、桑椹5-10份、炙甘草18-30份。
优选的，所述中药组合物按重量份计由以下组分组成：人参15份、天麻8份、黄芪12份、五味子10份、枸杞16份、酸枣仁4份、茯苓9份、龟甲5份、石菖蒲20份、山茱萸11份、山药7份、桑椹5份、炙甘草18份。
优选的，所述中药组合物按重量份计由以下组分组成：人参30份、天麻15份、黄芪18份、五味子20份、枸杞22份、酸枣仁8份、茯苓14份、龟甲10份、石菖蒲30份、山茱萸20份、山药11份、桑椹10份、炙甘草30份。
更优选的，所述中药组合物按重量份计由以下组分组成：人参22份、天麻12份、黄芪15份、五味子15份、枸杞20份、酸枣仁6份、茯苓12份、龟甲7份、石菖蒲25份、山茱萸16份、山药9份、桑椹8份、炙甘草23份。
上述中药组合物中，人参、天麻为君药，人参滋阴补气，宁神益智，清热生津，可强壮中枢神经，安定身心并恢复疲劳，增强记忆能力；天麻润而不燥，主入肝经，长于平肝息风，可治头目晕眩、神经衰弱、小儿惊风等症；黄芪、五味子、枸杞、酸枣仁、茯苓、龟甲、石菖蒲均为臣药，具有益气固表，促进反应力和精神集中力、宁心安神的作用；山茱萸、山药、桑椹、炙甘草均为佐药，能补益肝肾、补脾益气，缓解疲劳，增强抗应激能力。
2. 以上述用于治疗儿童多动症的中药组合物制成的中药制剂。
优选的，所述制剂为胶囊剂。
更优选的，所述胶囊剂的制备方法是将中药组合物中的各组分分别在40-60℃烘干，粉碎过60目筛，再按重量比例将各组分混合均匀，装入空胶囊，即得。
本发明的有益效果在于：本发明提供的中药组合物及其制剂能够有效治疗儿童多动症，疗效确切，显效率为76.9-88.5%，总有效率为92.3-100%，毒副作用低，且组方药材来源广泛，价格低廉，具有良好的开发应用前景。
具体实施方式
为了使本发明的目的、技术方案和优点更加清楚，下面对本发明的优选实施例进行详细的描述。
实施例1、中药组合物（组方1）及其胶囊剂的制备
1、中药组合物（组方1）的组成（按重量份计）：人参15份、天麻8份、黄芪12份、五味子10份、枸杞16份、酸枣仁4份、茯苓9份、龟甲5份、石菖蒲20份、山茱萸11份、山药7份、桑椹5份、炙甘草18份。
2、胶囊剂的制备：先将组方1中各组成药物分别在40-60℃烘干，粉碎过60目筛，再按组方1所述比例将各组成药物混合均匀，装入空胶囊，每粒胶囊装2g，即得。
实施例2、中药组合物（组方2）及其胶囊剂的制备
1、中药组合物（组方2）的组成（按重量份计）：人参30份、天麻15份、黄芪18份、五味子20份、枸杞22份、酸枣仁8份、茯苓14份、龟甲10份、石菖蒲30份、山茱萸20份、山药11份、桑椹10份、炙甘草30份。
2、胶囊剂的制备：先将组方2中各组成药物分别在40-60℃烘干，粉碎过60目筛，再按组方2所述比例将各组成药物混合均匀，装入空胶囊，每粒胶囊装2g，即得。
实施例3、中药组合物（组方3）及其胶囊剂的制备
1、中药组合物（组方3）的组成（按重量份计）：人参22份、天麻12份、黄芪15份、五味子15份、枸杞20份、酸枣仁6份、茯苓12份、龟甲7份、石菖蒲25份、山茱萸16份、山药9份、桑椹8份、炙甘草23份。
2、胶囊剂的制备：先将组方3中各组成药物分别在40-60℃烘干，粉碎过60目筛，再按组方3所述比例将各组成药物混合均匀，装入空胶囊，每粒胶囊装2g，即得。
临床药效试验
78例患儿均符合《中国精神疾病分类方案与诊断标准》（第2版修订版）的儿童多动症诊断标准，翻手实验、指鼻实验、点指实验均为阳性，排除顽皮正常儿童、精神发育迟滞、品行障碍或神经系统疾病等；其中男58例，女20例，年龄5-14岁，平均年龄9岁，病程1-16个月，平均病程8个月。
将78例患儿分为三组，每组26例，三组在性别、年龄、病程等方面比较无显著性差异（P>0.05）。
第一组：口服实施例1制备的胶囊剂，每天三次，每次1粒，温开水送服，饭后服用，一个月为一个疗程，连续服用三个疗程观察疗效。
第二组：口服实施例2制备的胶囊剂，每天三次，每次1粒，温开水送服，饭后服用，一个月为一个疗程，连续服用三个疗程观察疗效。
第三组：口服实施例3制备的胶囊剂，每天三次，每次1粒，温开水送服，饭后服用，一个月为一个疗程，连续服用三个疗程观察疗效。
参照《最新国内外疾病诊疗标准》中制订临床疗效标准：
① 显效：主要症状消失或显著改善，翻手试验、指鼻试验、点指试验均为阴性；
② 有效：主要症状改善，翻手试验、指鼻试验、点指试验均好转；
③ 无效：用药后无变化，翻手试验、指鼻试验、点指试验无改善。
三组治疗效果见下表：
治疗效果一览表
治疗过程中，对三组患儿均进行血、尿等肝肾功能指标监测，结果未见异常。
其中典型病例如下：
患儿吴某，女，7岁，体型微胖，来时脚不住走动，常出现双手指微动，说话多，臀部爱扭动，不愿意坐卧，翻手试验、指鼻试验、点指试验等辅助诊断指标均为阳性。口服实施例1制得的胶囊剂，每天三次，每次1粒。服药1月后，多动症状有明显好转，可安静坐下，连续服药3月后，多动症状完全消失，翻手试验、指鼻试验、点指试验均为阴性。
患儿陈某，男，10岁，多动出现约7个月，翻手试验，指鼻试验，点指试验等辅助诊断指标均为阳性，医院诊断为多动症。口服实施例2制得的胶囊剂，每天三次，每次1粒。服药2月后，多动症状消失，翻手试验、指鼻试验、点指试验均为阴性。
患儿周某，男，8岁，课堂上小动作多，手腿动不停，不停找同学讲话，练习写作时心不在焉，翻手试验，指鼻试验，点指试验等辅助诊断指标均为阳性，医院诊断为多动症。口服实施例3制得的胶囊剂，每天三次，每次1粒。连续服药3月后，上课时不再调皮，注意力集中，学习成绩好转，翻手试验、指鼻试验、点指试验均为阴性。
患儿李某，女，5岁，手脚喜多动，上课注意力不集中，不听从老师教导，不遵守纪律，经常与其他小朋友发生矛盾和争吵，不能友好相处，学习成绩差，语言表达不够明确；翻手试验，指鼻试验，点指试验等辅助诊断指标均为阳性，医院诊断为多动症。口服实施例3制得的胶囊剂，每天三次，每次1粒。服药1月后，注意力较以前集中，可安静坐下。继续服药2月后，上课时不再调皮，小动作减少，能与其他小朋友友好相处，学习成绩明显好转，翻手试验、指鼻试验、点指试验均为阴性。
患儿张某，女，7岁，不能静坐，上课注意力不集中，学习成绩差，智力基本正常；翻手试验，指鼻试验，点指试验等辅助诊断指标均为阳性，医院诊断为多动症。口服实施例3制得的胶囊剂，每天三次，每次1粒。服药50天后，上课时能安静听课，注意力较以前集中，继续服用2月后，多动症状消失，学习成绩明显进步，翻手试验、指鼻试验、点指试验均为阴性。
Claims (7)
1.用于治疗儿童多动症的中药组合物，其特征在于，按重量份计由以下组分组成：人参15-30份、天麻8-15份、黄芪12-18份、五味子10-20份、枸杞16-22份、酸枣仁4-8份、茯苓9-14份、龟甲5-10份、石菖蒲20-30份、山茱萸11-20份、山药7-11份、桑椹5-10份、炙甘草18-30份。
2.根据权利要求1所述的用于治疗儿童多动症的中药组合物，其特征在于，按重量份计由以下组分组成：人参15份、天麻8份、黄芪12份、五味子10份、枸杞16份、酸枣仁4份、茯苓9份、龟甲5份、石菖蒲20份、山茱萸11份、山药7份、桑椹5份、炙甘草18份。
3.根据权利要求1所述的用于治疗儿童多动症的中药组合物，其特征在于，按重量份计由以下组分组成：人参22份、天麻12份、黄芪15份、五味子15份、枸杞20份、酸枣仁6份、茯苓12份、龟甲7份、石菖蒲25份、山茱萸16份、山药9份、桑椹8份、炙甘草23份。
4.根据权利要求1所述的用于治疗儿童多动症的中药组合物，其特征在于，按重量份计由以下组分组成：人参30份、天麻15份、黄芪18份、五味子20份、枸杞22份、酸枣仁8份、茯苓14份、龟甲10份、石菖蒲30份、山茱萸20份、山药11份、桑椹10份、炙甘草30份。
5.以权利要求1至4任一项所述的用于治疗儿童多动症的中药组合物制成的中药制剂。
6.根据权利要求5所述的中药制剂，其特征在于，所述制剂为胶囊剂。
7.根据权利要求6所述的中药制剂，其特征在于，所述胶囊剂的制备方法是将中药组合物中的各组分分别在40-60℃烘干，粉碎过60目筛，再按重量比例将各组分混合均匀，装入空胶囊，即得。
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