CN1824070A - 芫蒿护肝胶囊及其制备与有效成分含量测定方法 - Google Patents
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Abstract
本发明提供一种具有解毒护肝功效的芫蒿护肝胶囊，含中药黄芫花主药成分与辅料，为胶囊剂型，包括软胶囊、滴丸、肠溶胶囊以及长效缓(控)释胶囊等。其中辅助成分是制备胶囊剂的常用添加剂。该剂型克服了芫稿护肝片剂、散剂或颗粒剂存在的缺点，具有避光、防潮等作用，并能掩盖药物的不良味感，防止与减缓药物的分解，且较片剂等吸收快，临床应用方便。
Description
技术领域：
本发明涉及中药技术领域。涉及一种具有解毒护肝功效的以黄芫花为主药的口服制剂，特别是涉及一种芫蒿护肝胶囊制剂。
背景技术：
芫蒿护肝片是以中药黄芫花为主药，经加工提取制成的一种口服制剂，其标准来源为国家标准，国家药品监督管理局药品标准WS-11802(ZD-1082)-2002。具有解毒护肝功效。临床常用于治疗肝脏损害所致的全身乏力，食欲不振，腹胀，肝区疼痛及失眠等症；也用于急慢性病毒性肝炎和中毒性肝炎具有上述症状患者。临床应用时间较长，因疗效确切，不良反应少，临床评价较高。
但由于片剂本身的技术缺陷，加之黄芫花提取物总黄酮类有效成分大部分为多羟基醌式或酚式分子结构，氧化性强，易受外界潮气、空气与光线等多种因素影响，产生各种杂质，从而影响其稳定性与疗效。
发明内容
本发明的目的在于能提供一种克服上述缺点，能避光、防潮、防止或减缓药物及其有效成分解，且能掩盖药物不良臭味和吸收较片剂更好的芫蒿护肝胶囊制剂。包括普通硬胶囊、软胶囊、滴丸、肠溶胶囊和长效缓(控)释胶囊等。
本发明芫蒿护肝胶囊，为胶囊剂型，包括主药黄芫花及其提取有效成分与辅助成分。主药黄芫花经水煎煮、提取、浓缩等步骤得到其有效成分总黄酮。辅助成分是胶囊剂型常用添加剂，包括润滑剂、稀释剂，助悬剂，抗氧剂及表面活性剂等。主药黄芫花提取物(浸膏)与添加剂的配合比列为主药∶润滑剂＝1∶1～20，主药∶稀释剂＝1∶0～10，主药∶助悬剂＝1∶0～10，主药∶抗氧剂＝1∶0～1，主药∶表面活性剂＝1∶0～1.5。其中，润滑剂是聚乙二醇、乳糖、聚硅酮、二氧化硅、硬脂酸及其盐、聚乙烯吡咯烷酮、羟丙基纤维素、滑石粉、微晶纤维素、羟乙基纤维素、甲基纤维素及要用淀粉等：稀释剂是明胶。聚乙二醇、植物油、矿物油及油酸乙酯等；助悬剂是10～30％油蜡混合物(组份按重量份计是氢化大豆油1份、黄蜡1份、短链植物油4份，或用1～16％聚乙二醇4000或聚乙二醇6000)；抗氧剂是亚硫酸氢钠、硫代硫酸钠等；表面活性剂是硬脂酸钠盐、月桂酸钠盐等。其胶囊的制备按一般通法，包括选择透明、半透明或不透明三种肠溶材料中的一种。可做成肠溶性胶囊、软胶囊、滴丸、长效缓释胶囊等。
具体实施方式
实施例1
取黄芫花2000g，粉碎，加水煎煮二次，每次1.5～2.5小时，合并煎液，滤过，滤液浓缩至相对密度为1.25～1.55(45～60℃)的稠膏，加辅料淀粉170g，制粒、干燥，加微晶纤维素35g，混合均匀，过两次120目筛，填入硬胶囊制成1000粒胶囊。每粒胶囊内容物，以60％乙醇作溶剂，浸出物不得少于25.0％，每粒胶囊所含黄芫花总黄酮以芦丁计，不少于0.1mg(≥0.1mg/粒)。
实施例2
取上述黄芫花稠膏250g，，聚乙二醇4000计量200g.。先将主药稠膏与20％量的聚乙二醇4000混合，用胶体磨粉碎，然后加入余量聚乙二醇混合均匀，得药液，另配明胶溶液用自动旋转扎囊机制得芫蒿护肝胶囊1000粒。每粒含内容物，以60％乙醇作溶剂，浸出物不得少于25％。
实施例3
取上述黄芫花水提浓缩浸膏600g、乳糖50g、聚乙烯吡咯烷酮15g、羟丙基甲基纤维素80g、滑石粉50g。先将主药浸膏与羟丙基纤维素混合均匀，并加入乳糖，再用聚乙烯吡咯烷酮制成微丸，灌装胶囊1000粒，制成芫蒿护肝长效缓释胶囊。每粒内容物以60％乙醇作溶剂，浸出物不得少于75％。
Claims (4)
1、一种具有解毒护肝功效的芫蒿护肝胶囊，含中药黄芫花主药成分和辅料，其特征在于为胶囊剂型，包括软胶囊、滴丸、肠溶胶囊以及长效缓(控)释胶囊等。
2、如权利要求1所述芫蒿护肝胶囊制剂，其特征在于每粒胶囊相当于药材量为2.1g～10.5g；每粒胶囊用40～80％乙醇作溶剂，浸出物不得少于20.0％(即≥20％)。
3、如权利要求1所述芫蒿护肝胶囊，其特征在于主药黄芫花是经提取、加工制得，且提取物与辅料的比例可为1∶0～10或20。
4、如权利要求1所述芫蒿护肝胶囊，其特征在于应用紫外可见分光光度法，建立测定其制剂中所含主药有效成分总黄酮的方法。且每粒胶囊中所含黄芫花总黄酮不低于0.1mg(即≥0.1mg)。
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101612257B (zh) * | 2009-07-07 | 2012-05-23 | 四川国康药业有限公司 | 黄芫花提取物的制备方法及治疗肝病的药物 |
| CN104237151A (zh) * | 2014-10-14 | 2014-12-24 | 宁波枫康生物科技有限公司 | 一种铁皮石斛药材的质量检测方法 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101612257B (zh) * | 2009-07-07 | 2012-05-23 | 四川国康药业有限公司 | 黄芫花提取物的制备方法及治疗肝病的药物 |
| CN104237151A (zh) * | 2014-10-14 | 2014-12-24 | 宁波枫康生物科技有限公司 | 一种铁皮石斛药材的质量检测方法 |
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