CN102319355B - 一种治疗多动症的中药组方及其丸剂的制备方法 - Google Patents
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Abstract
本发明涉及一种治疗多动症的中药组方及其丸剂的制备方法。其组方是由以下重量配比的药材组成：石菖蒲6份，远志6份，茯苓12份，人参8份，当归10份，茯神12份，麦冬9份，甘草2份。丸剂的制备方法为：称取处方药材，混合，烘干，粉碎成80-120目细粉，加入与药粉重量比为1：1的炼蜜，混合均匀，制条，以3克/丸成丸，蜂蜡封存，即得。本发明组方对多动症的治疗疗效显著，用药安全性高；制备方法简单环保，辅料安全、口味好，符合儿童用药市场需求。
Description
技术领域
本发明涉及一种治疗多动症的中药组方及其丸剂的制备方法。
背景技术
多动症又称注意力缺陷多动症(ADHD)，或脑功能轻微失调综合征, 是一种常见的儿童行为异常疾病。 这类患儿的智力正常或基本正常， 但学习、行为及情绪方面有缺陷，主要表现为注意力不集中，注意短暂，活动过多，情绪易冲动，学习成绩普遍较差，在家庭及学校均难与人相处。多动症的患病率国外报道在5%~10%，国内调查在10%以上。
现代医学多采用抗兴奋剂疗法，只能控制症状却不能治疗根本，且该类药物应用于儿童多具有较大的毒副作用。
中医学认为，静属阴，动属阳。小儿生长发育迅速，必须要依赖阴精的充分补充。多动症是由于患儿受先天或者后天因素的影响，造成阴虚阳亢，阴精不足，筋脉失养，肝阳上亢，五脏不调，则生躁动，表现为注意力不集中、抽动不止、健忘等症状。
本发明治疗病毒性肺炎的中药组方所涉及中药材的研究现状如下：
石菖蒲：【来源】为天南星科植物石菖蒲Acorus tatarinowii Schott的干燥根茎。【性味归经】辛、苦，温。归心、胃经。【功能主治】开窍豁痰，醒神益智，化湿开胃。用于神昏癫痫，健忘失眠，耳鸣耳聋，脘痞不饥，噤口下痢。【用法用量】3～l0g。
远志：【来源】本品为远志科植物远志Polygala tenui oli＆Willd．或卵叶远志Polygala sibirica L的干燥根。【性味归经】苦、辛，温。归心、肾、肺经。【功能主治】安神益智，交通心肾，祛痰，消肿。用于心肾不交引起的失眠多梦、健忘惊悸、神志恍惚，咳痰不爽，疮疡肿毒，乳房肿痛。【用法用量】3～l0g。
茯苓：【来源】本品为多孔菌科真菌茯苓Poria cocos(Schw.)Wolf的干燥菌核。【性味归经】甘、淡，平。归心、肺、脾、肾经。【功能主治】利水渗湿，健脾，宁心。用于水肿尿少，痰饮眩悸，脾虚食少，便溏泄泻，心神不安，惊悸失眠。【用法用量】10～15g。
人参：【来源】本品为五加科植物人参Panax ginseng C．A. Mey．的干燥根和根茎。【性味归经】甘、微苦，微温。归脾、肺、心、肾经。【功能主治】大补元气，复脉固脱，补脾益肺，生津养血，安神益智。用于体虚欲脱，肢冷脉微，脾虚食少，肺虚喘咳，津伤口渴，内热消渴，气血亏虚，久病虚赢，惊悸失眠，阳痿官冷。【用法用量】3～9g。
当归：【来源】为伞形科植物当归Angelica sin:ensis (Oliv.)Diels的干燥根。【性味归经】甘、辛，温。归肝、心、脾经。【功能主治】血活血，调经止痛，润肠通便。用于血虚萎黄，眩晕心悸，月经不调，经闭痛经，虚寒腹痛，风湿痹痛，跌扑损伤，痈疽疮疡，肠燥便秘。酒当归活血通经。用于经闭痛经，风湿痹痛，跌扑损伤。【用法用量】6～12g。
茯神：【来源】为多孔菌科卧孔属植物茯苓（Poria cocos Schw.）Wolf 的菌核，药用部分为干燥菌核体。【性味归经】性平，味甘、淡。归心、脾经。【功能主治】宁心、安神、利水。用于心虚惊悸，健忘，失眠，惊痫，小便不利。【用法用量】10～15g。
麦冬：【来源】为百合科植物麦冬Ophiopogon japonicus(L.f)Ker-Gawl.的干燥块根。【性味归经】甘、微苦，微寒。归心、肺、胃经。【功能主治】养阴生津，润肺清心。用于肺燥干咳，阴虚痨嗽，喉痹咽痛，津伤口渴，内热消渴，心烦失眠，肠燥便秘。【用法用量】6～12g。
甘草：【来源】为豆科植物甘草 Glycyrrhiza uralensis Fisch.、胀果甘草 Glycyrrhiza inflata Bat. 或光果甘草 Glycyrrhiza glabra L. 的干燥根及根茎。【性味归经】甘，平。归心、肺、脾、胃经 。【功能主治】补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。用于脾胃虚弱，倦怠乏力，心悸气短，咳嗽痰多，脘腹、四肢挛急疼痛，痈肿疮毒，缓解药物毒性、烈性。【用法用量】1.5～9g。
发明内容
本发明旨在提供一种治疗多动症的中药组方及其成药的制备方法，通过选择合适的药物及其配比并制定其丸剂的制备方法，达到安全有效治疗多动症并使其适于在儿童市场推广应用的目的。
为了达到上述目的，本发明采用以下技术方案：
一种治疗多动症的中药组方产品，其特征在于，它是由以下重量配比的药材组成：石菖蒲6份，远志6份，茯苓12份，人参8份，当归10份，茯神12份，麦冬9份，甘草2份。
将本发明中药组方制备成丸剂的工艺：称取处方药材，混合，烘干，粉碎成80-120目细粉，加入与药粉重量比为1：1的炼蜜，混合均匀，制条，以3克/丸成丸，蜂蜡封存，即得。
用法用量：正常成人一日1次，一次1丸。
本方明的有益效果：
中医学理论认为，多动症乃阴虚阳亢、五脏失调所致。方中当归、茯神引神固位；菖蒲、远志安神益智；麦冬养阴生津、清心去烦；人参补脾益肺、生津养血；茯苓健脾宁心；甘草调和诸药。诸药合用，共奏滋阴养血，宁心安神之效。从而从根本上治疗多动症。
临床试验证实，本发明组方治疗多动症治愈率达46.7%，显效率达到41.7%，总有效率达到97.2%，无明显毒副作用；本发明丸剂的制备方法简便易行，以蜂蜜为辅料安全无毒、口味优良。作为儿童用药非常适合市场需求和临床应用。
下面结合临床试验数据来说明本发明的有益效果：
自2003年10月至2011年9月，发明人在烟台中医医院应用本发明最佳组方制备成的丸剂（以下称多动丸）治疗儿童多动症患者180例，并与同期应用匹莫林治疗120例进行对照观察。
（Ｉ）、临床资料
所有病例均为烟台中医医院门诊患者，符合多动症诊断标准。共300例，按就诊序号（约3：2）随机分成两组，治疗组180例，其中男156例，女24例；年龄为4—13岁（平均9岁）；病程1—4年（平均3年）；对照组120例，男112例，女8例；年龄4—12岁（平均9岁）；病程1—4年（平均3年）。两组年龄、性别、病程及病情经统计学处理，无显著性差异，具有可比性（P>0.05）。
（Ⅱ）、治疗方法
1、治疗方案
治疗组口服多动丸，每次1粒，每日1次，30天为一个疗程；
对照组服用匹莫林每日晨１次服20mg，30天为一疗程。
2、观察指标：
a．需要其静坐的场合下难以静坐，常常动个不停。
b．容易兴奋和冲动。
c．常干扰其他儿童的活动。
d．做事常有始无终。
e．注意难以保持集中，常易转移。
f．要求必须立即得到满足，否则就产生情绪反应。
g．经常多话，好插话或喧闹。
h．难以遵守集体活动的秩序和纪律。
i．动作笨拙，精巧动作较差。学习成绩差，但不是由智力障碍引起。
观测上述各项治疗前后之变化。服药期间临床症状及体征每周记录1次，不良反应随时记录。
3、统计学处理：组间百分率比较采用ｘ2检验，组间均数比较用方差分析t检验。
（Ⅲ）、疗效标准
临床治愈：症状及临床体征消失，两年之内未复发，其他客观检查指标基本正常；显效：症状及临床体征显著减轻，其他客观检查指标明显改善；有效：临床体征有减轻，但程度不显著者，其他客观检查指标有改善；无效：临床体征无改善或加重，其他客观检查指标未见改善或加重。
（Ⅳ）、治疗结果
1、两组总疗效比较见表1。
表1 两组总疗效比较例
| n | 治愈 | 显效 | 有效 | 无效 | 不良反应例 | 总有效率（％） | |
| 治疗组 | 180 | 84 | 75 | 16 | 5 | 0 | 97.2 |
| 对照组 | 120 | 45 | 36 | 27 | 12 | 7 | 81.7 |
两组疗效比较P<0.05。
可见，本发明最佳重量配比处方制得的药物对于治疗多动症效果良好，且几乎没有不良反应发生，服用安全性高。
根据上述临床实验数据，结合本发明治疗多动症的中医学机理分析和本领域公知常识，本领域技术人员容易推知，运用本发明中的药材，在常规用量范围内，即石菖蒲3-10份、远志3-10份、茯苓10-15份、人参3-9份、当归6-12份、茯神10-15份、麦冬6-12份、甘草1.5-9份，可以取得与本发明最佳重量配比处方制得的药物类似的技术效果。
具体实施方式
为了更好地理解和实施本发明，下面结合具体实施例进一步说明本发明。
具体实施例1
称取石菖蒲6份，远志6份，茯苓12份，人参8份，当归10份，茯神12份，麦冬9份，甘草2份；混合，烘干，粉碎成80-120目细粉，加入与药粉重量比为1：1的炼蜜，混合均匀，制条，以3克/丸成丸，蜂蜡封存，即得丸剂。
口服，每日1次，一次1丸。
具体实施例2
称取石菖蒲3份，远志3份，茯苓10份，人参3份，当归6份，茯神10份，麦冬6份，甘草1.5份；混合，烘干，粉碎成80-120目细粉，加入与药粉重量比为1：1的炼蜜，混合均匀，制条，以3克/丸成丸，蜂蜡封存，即得丸剂。
口服，每日1次，一次1丸。
具体实施例3
称取石菖蒲10份，远志10份，茯苓15份，人参9份，当归12份，茯神15份，麦冬12份，甘草9份；混合，烘干，粉碎成80-120目细粉，加入与药粉重量比为1：1的炼蜜，混合均匀，制条，以3克/丸成丸，蜂蜡封存，即得丸剂。
口服，每日1次，一次1丸。
Claims (2)
1.一种治疗多动症的中药组方产品，其特征在于，它是由以下重量配比的药材组成：石菖蒲6份，远志6份，茯苓12份，人参8份，当归10份，茯神12份，麦冬9份，甘草2份。
2.按照权利要求1所述的治疗多动症的中药组方产品，其特征在于，其丸剂的制备方法为：称取处方药材，混合，烘干，粉碎成80-120目细粉，加入与药粉重量比为1：1的炼蜜，混合均匀，制条，以3克/丸成丸，蜂蜡封存，即得。
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| CN1442195A (zh) * | 2003-04-09 | 2003-09-17 | 钟元能 | 一种治疗儿童多动症的药物及其制备方法 |
| CN1803180A (zh) * | 2005-01-13 | 2006-07-19 | 北京凯瑞创新医药科技有限公司 | 一种药物组合物及其制备方法和质量控制方法 |
| CN1857558A (zh) * | 2006-03-14 | 2006-11-08 | 辽宁好护士药业（集团）有限责任公司 | 一种治疗儿童多动症的中药及制备方法 |
| CN101129649A (zh) * | 2007-08-31 | 2008-02-27 | 浙江大学 | 一种治疗多动症的中药复方制剂及其制备方法和用途 |
| CN101130007A (zh) * | 2007-09-14 | 2008-02-27 | 尹克华 | 治疗神经衰弱性失眠的中药 |
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| CN1803180A (zh) * | 2005-01-13 | 2006-07-19 | 北京凯瑞创新医药科技有限公司 | 一种药物组合物及其制备方法和质量控制方法 |
| CN1857558A (zh) * | 2006-03-14 | 2006-11-08 | 辽宁好护士药业（集团）有限责任公司 | 一种治疗儿童多动症的中药及制备方法 |
| CN101129649A (zh) * | 2007-08-31 | 2008-02-27 | 浙江大学 | 一种治疗多动症的中药复方制剂及其制备方法和用途 |
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