脂降宁片制备工艺和质量标准的研究.doc

脂降宁片制备工艺和质量标准研究 徐广棚 盐城恒盛化工有限公司 22455 摘 要 目的：研究脂降宁片制备工艺及质量标准。方法：葛根粉碎成粗粉，加乙醇加热回流提取，取其滤液。其余何首乌等五味加水煎煮，滤液与上述葛根提取液合并，浓缩至稠膏状，减压干燥，与氯贝酸铝分别粉碎过筛，混匀，制成颗粒，干燥，加入维生素Ｃ，混匀，压片，包糖衣。通过鉴别、检查、含量测定来进行质量标准研究。结果:按此工艺制得的片剂，质量符合标准要求。葛根素含量在0.0618-0.5562ug范围内呈良好的线性关系。平均加样回收率为99.3%，RSD为0.52%(n=5)。结论：脂降宁片的处方合理，制备工艺可行，质量控制方法专属性强，简便，准确，可作为脂降宁的质量控制标准。 关键词：脂降宁片，制备工艺，质量标准，葛根素 Abstract Objective: introduce zhijiangning slice production process and study its quality standards. Methods: puerarin shattered into thick powder, ethanol refluxing extraction heating, take the filtrate. The tastes of multiflower knotweed etc, water decocting, filtrate and the puerarin extract merger, concentrated till cream, decompression and dry , as well as aluminum chloride acid, blending, crushing sifted , respectively, made into granular, dry, add vitamin C, blending, pressure, sugar-coated accordingly. Through the inspection, identification and content determination to conduct quality standards. Result : This product is a tablet, meet the standards. Puerarin content in the range of 0.0618-0.5562ug good linear relationship. The average recovery was 99.3%, RSD was 0.52% (n = 5) Conclusion: Zhijiangning prescription tablet reasonable, practical preparation, quality control methods are sensitive, simple, accurate, and can be used as lipid lowering Nings quality control standards. Key word: Zhijiangning , Preparation, Quality standards, Puerarin 脂降宁是中药成方制剂，具有行气散瘀，活血通经，益精血，降血脂。主要用于治疗胸痹心痛，眩晕耳鸣，肢体麻木，高脂血症或合并高血压，冠心病，动脉硬化等的高脂血症。临床应用效果很好，能够有效的降低血压，血脂。目前市场上脂降宁有颗粒剂，胶囊剂等剂型，片剂的生产和使用较少。脂降宁片剂比普通的剂型具有更多的优点：起效快，生物利用度高，避免胃肠反应和肝首过效应。本文，将从制备和剂型上加以研究，通过特殊的提取工艺，选用相应的辅料，制成有良好疗效的片剂。通过查找相关文献和实验，对脂降宁片剂的质量控制标准进行研究。 1仪器与试剂 1.1仪器： GFFJ-8微粉碎机组（江阴瑰宝实业总公司）；WK60型颗粒机(江苏泰兴制药机械二厂)；ZP-7A型旋转式压片机(上海天驹制药有限公司)；DHG9140A型电热恒温干燥箱(上海圣欣科学仪器有限公司)；硅胶G，青岛海洋化工有限公司；微晶纤维素（MCC，淮南山河药用辅料有限公司）；低取代羟丙基纤维素(LHPC，营口长城制药厂)；羧甲基淀粉钠(CMSNa，湖州展望化学药业有限公司)；微粉硅胶(上海嘉辰化工有限公司)；聚乙烯吡咯烷酮（PVP，湖州展望化学药业有限公司）。提取方法的选择根据处方中有效成分的