CN105362776B - 一种治疗甲状腺机能亢进症的中药组合物、制备方法及其应用 - Google Patents
一种治疗甲状腺机能亢进症的中药组合物、制备方法及其应用 Download PDFInfo
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Abstract
本发明公开了一种治疗甲状腺机能亢进症的中药组合物、制备方法及其应用，属于中草药技术领域，有效成分包含黄芪、白芍、党参、牡丹皮、玄参、炒白术、柴胡、桔梗、浙贝母、煅龙骨、丹参、浮小麦、牛蒡子、玉竹、红花、川芎和五味子，剂型可以为片剂、颗粒剂或胶囊剂。本发明的中药组合物疗效显著、无毒副作用，具有调气化痰，活血散结的功效，为治疗甲状腺机能亢进症的理想药品。
Description
技术领域
本发明涉及中草药技术领域，具体涉及一种治疗甲状腺机能亢进症的中药组合物、制备方法及其应用。
背景技术
甲状腺机能亢进症(简称“甲亢”)，是因为甲状腺激素分泌过多所致的一种常见内分泌病。临床以甲状腺肿大、食欲亢进、体重减轻、心动过速、情绪易于激动、怕热多汗、手抖、突眼等症状为主。以女性多见，其发病率甚高，近年似有增长趋势，其确切病因不明。现代西医学在治疗上有一定的局限性，且可产生不良反应和副作用。通过大量临床实践，比较一致的意见是，甲状腺机能亢进症病因主要是情志内伤、体质因素、饮食和水土失宜。而肝郁气滞，气血运行失常，痰湿凝聚，壅结颈前是甲亢基本病机。甲状腺机能亢进症初起多实，久病多虚。
甲亢是一种常见病，而彻底治愈并不容易，不少患者成为终身治疗的甲亢患者。在治疗第1年，患者的甲状腺功能指标最容易出现反复，即使治疗方案疗效确切，但由于安全性等原因，临床医生在治疗时仍有顾虑。这就需要探寻更安全、有效的治疗方案。
发明内容
为解决现有技术存在的缺陷，本发明旨在提供一种疗效显著、无毒副作用、治疗后不易复发的治疗甲状腺机能亢进症的中药组合物及其制备方法。
为了实现上述目的，本发明的技术方案为：
一种治疗甲状腺机能亢进症的中药组合物，其有效成分包括以下重量份的原料：
优选的，上述的一种治疗甲状腺机能亢进症的中药组合物，其有效成分包括以下重量份的原料：
优选的，所述组合物的剂型为片剂、颗粒剂或胶囊剂。
本发明还提供一种上述组合物的制备方法，采用以下步骤制成：
1)将黄芪单独粉碎，过200目筛，得到黄芪粉，备用；
2)其余17味药分别加入8倍重量的水提取三次，第一次加入8倍重量的水提取5-8小时，过滤得到第一滤液备用，所得滤渣加入8倍重量的水提取2-4小时，过滤得到第二滤液备用，所得滤渣加入8倍重量的水提取1-2小时，过滤得到第三滤液，合并第一、第二、第三滤液，50℃条件下减压浓缩合并液体积为原体积的1/4，分别得到17味药的浓缩液；
3)合并上述得到的17味药的浓缩液，于50℃条件下减压浓缩为原体积的1/10，得到膏状物；
4)向上述所得膏状物中加入步骤1)中的黄芪粉，搅拌均匀；
5)向步骤4)中所得物加入常规药用辅料，按照常规工艺制备成片剂、颗粒剂或胶囊剂。
优选的，所述提取为在50-60℃条件下加热回流提取。
本发明还提供上述的组合物在制备治疗甲状腺机能亢进症中的药物中的应用。
本发明的有益效果为：
1)本发明的中药制剂治疗甲状腺机能亢进症效果明显、疗程短、复发率低、可以免去患者长期服药的痛苦和麻烦；
2)本发明为中成药制剂，无化学成分和添加剂，对人体无毒副作用，更符合天然、健康的消费需求；
3)本发明的中药制剂具有调气化痰，活血散结的功效，较好的适应甲亢的病因“肝郁气滞，气血运行失常，痰湿凝聚，壅结颈前”，临床实验证明本发明的中药制剂疗效显著能够达到根治甲亢的目的。
本发明的附加方面和优点将在下面的描述中部分给出，部分将从下面的描述中变得明显，或通过本发明的实践了解到。
具体实施方式
以下结合具体实例，对本发明进行详细说明。
实施例1
a.称取以下重量份的原料：
b.采用以下步骤制备中药组合物：
1)将黄芪单独粉碎，过200目筛，得到黄芪粉，备用；
2)其余17味药分别加入8倍重量的水提取三次，第一次加入8倍重量的水提取8小时，过滤得到第一滤液备用，所得滤渣加入8倍重量的水提取4小时，过滤得到第二滤液备用，所得滤渣加入8倍重量的水提取2小时，过滤得到第三滤液，合并第一、第二、第三滤液，50℃条件下减压浓缩合并液体积为原体积的1/4，分别得到17味药的浓缩液；
3)合并上述得到的17味药的浓缩液，于50℃条件下减压浓缩为原体积的1/10，得到膏状物；
4)向上述所得膏状物中加入步骤1)中的黄芪粉，搅拌均匀；
5)将步骤4)中所得物置于50℃烘箱中24小时，烘干，粉碎过200目筛，得到530g细粉，与15g硬脂酸镁，210g玉米淀粉，交联聚乙烯吡咯烷酮(C-PVP)15g，羟丙基甲基纤维素(HPMC)20g混合后，压片机压制成1g左右的片剂，即得本发明的一种片剂组合物。
实施例2
a.称取以下重量份的原料：
b.采用以下步骤制备中药组合物：
1)将黄芪单独粉碎，过200目筛，得到黄芪粉，备用；
2)其余17味药分别加入8倍重量的水提取三次，第一次加入8倍重量的水提取7小时，过滤得到第一滤液备用，所得滤渣加入8倍重量的水提取3小时，过滤得到第二滤液备用，所得滤渣加入8倍重量的水提取2小时，过滤得到第三滤液，合并第一、第二、第三滤液，50℃条件下减压浓缩合并液体积为原体积的1/4，分别得到17味药的浓缩液；
3)合并上述得到的17味药的浓缩液，于50℃条件下减压浓缩为原体积的1/10，得到膏状物；
4)向上述所得膏状物中加入步骤1)中的黄芪粉，搅拌均匀；
5)将步骤4)中所得物置于50℃烘箱中24小时，烘干，粉碎过200目筛，得到861g细粉，与20g硬脂酸镁，250g玉米淀粉，交联聚乙烯吡咯烷酮(C-PVP)20g，羟丙基甲基纤维素(HPMC)20g混合后，压片机压制成1g左右的片剂，即得本发明的一种片剂组合物。
实施例3
a.称取以下重量份的原料：
b.采用以下步骤制备中药组合物：
1)将黄芪单独粉碎，过200目筛，得到黄芪粉，备用；
2)其余17味药分别加入8倍重量的水提取三次，第一次加入8倍重量的水提取6小时，过滤得到第一滤液备用，所得滤渣加入8倍重量的水提取2小时，过滤得到第二滤液备用，所得滤渣加入8倍重量的水提取2小时，过滤得到第三滤液，合并第一、第二、第三滤液，50℃条件下减压浓缩合并液体积为原体积的1/4，分别得到17味药的浓缩液；
3)合并上述得到的17味药的浓缩液，于50℃条件下减压浓缩为原体积的1/10，得到膏状物；
4)向上述所得膏状物中加入步骤1)中的黄芪粉，搅拌均匀；
5)将步骤4)中所得物置于50℃烘箱中24小时，烘干，粉碎过200目筛，得到376g细粉，与13g硬脂酸镁，150g玉米淀粉，交联聚乙烯吡咯烷酮(C-PVP)12g,羟丙基甲基纤维素(HPMC)12g混合后，压片机压制成1g左右的片剂，即得本发明的一种片剂组合物。
实施例4
1)毒性研究
选取30只健康大鼠，雌雄各半，体重为200±10g，一日内灌胃1片实施例1的片剂，相当于70Kg的成年人每日服用量的88倍，连续观察一周，大鼠无不良反应，身体状况良好，说明本品安全低毒。
2)临床疗效
临床观察200例甲亢患者，其中男34名，女166名，年龄分布为30-70岁，使用实施例1中制得的片剂，使用方法及用量为一日两次，每次2片，按照病程分组，服用3个月后对其进行效果统计，效果判定方法如下：
治愈：临床症状消失，甲状腺肿、突眼及有关体征基本恢复正常，甲状腺功能检测值T3(血清总三碘甲腺原氨酸)，T4(血清总甲状腺素)恢复正常。
显效：临床症状基本消失，甲状腺肿、突眼及有关体征明显减轻，甲状腺功能检查接近正常。
有效：临床症状明显好转，甲状腺胂、突眼及有关体征有所减轻，甲状腺功能检查有所好转。
无效：临床症状和体征无改善，T3，T4无变化。
治疗效果统计见表1：
表1本发明的片剂对甲亢的治疗效果统计表
医案举例：
张×，女，62岁，病程21年，经治疗症状好转但未痊愈，依靠长期服用药物治疗甲亢。症见两眼突出，甲状腺肿大，烦躁乏力，心悸，双手震颤，怕热，易出汗。服用实施例1的药物后一个月后症状有所好转，乏力、出汗症状减轻，服药2个月后突眼、甲状腺肿大等症状消失，眼睛基本恢复正常，服药3个月后，症状消失，T3，T4检测值正常，已经痊愈。随访5年，没有复发，面色红润，形体渐胖。
陈×，男，47岁，病程13年，经西医治疗未见好转，临床表现为，两眼突出，甲状腺肿大，形体消瘦，乏力、易出汗，服用本实施例1的药物，一个月后症状缓解，出汗情况减轻，两个月后，乏力感减轻，三个月后突眼，甲状腺肿症状消失，T3，T4检测值正常，痊愈。随访5年，未复发，精神饱满，身体渐胖。
以上临床效果检测表明：本发明的中药组合物疗效显著，痊愈率高，不易复发。
尽管已经示出和描述了本发明的实施例，本领域的普通技术人员可以理解：在不脱离本发明的原理和宗旨的情况下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由权利要求及其等同物限定。
Claims (5)
1.一种治疗甲状腺机能亢进症的中药组合物，其特征在于，其有效成分由以下重量份的原料制成：
采用以下步骤制成：
1)将黄芪单独粉碎，过200目筛，得到黄芪粉，备用；
2)其余17味药分别加入8倍重量的水提取三次，第一次加入8倍重量的水提取5-8小时，过滤得到第一滤液备用，所得滤渣加入8倍重量的水提取2-4小时，过滤得到第二滤液备用，所得滤渣加入8倍重量的水提取1-2小时，过滤得到第三滤液，合并第一、第二、第三滤液，50℃条件下减压浓缩合并液体积为原体积的1/4，分别得到17味药的浓缩液；
3)合并上述得到的17味药的浓缩液，于50℃条件下减压浓缩为原体积的1/10，得到膏状物；
4)向上述所得膏状物中加入步骤1)中的黄芪粉，搅拌均匀；
5)向步骤4)中所得物加入常规药用辅料，按照常规工艺制备成片剂、颗粒剂或胶囊剂。
2.根据权利要求1所述的一种治疗甲状腺机能亢进症的中药组合物，其特征在于，其有效成分由以下重量份的原料制成：
3.根据权利要求1或2所述的一种治疗甲状腺机能亢进症的中药组合物，其特征在于，所述组合物的剂型为片剂、颗粒剂或胶囊剂。
4.根据权利要求1所述的一种治疗甲状腺机能亢进症的中药组合物，其特征在于，所述提取为在50-60℃条件下加热回流提取。
5.权利要求1-4中任一项所述的组合物在制备治疗甲状腺机能亢进症的药物中的应用。
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