功效成分控制理气舒心片质量.doc

功效成分控制理气舒心片质量
[摘要] 目的总黄***为理气舒心片的功效成分,建立总黄***的测定方法,控制理气舒心片质量。方法采用紫外-可见分光光度法测定总黄***含量,通过回流法提取,NaNO3-Al(NO3)3法显色测定样品吸光度,以芦丁为标准溶液计算求得总黄***含量。~,r=,%,%。结论三批理气舒心片样品总黄***~,该方法简便快捷,结果准确,重现性好,适用于理气舒心片中总黄***的测定。
[关键词] 理气舒心片;功效成分;芦丁;紫外-可见分光光度法
[中图分类号] [文献标识码] A [文章编号] 2095-0616(2017)07-35-04
Effect position control Qi Shuxin tablets quality
SHI Lei FAN Chunling CHEN Shangkun
Songyuan Institute for food and drug control,Songyuan 138000,China
[Abstract] Objective The total flavone is ponents of Qi Shuxin establish the determination of total flavonoids
,and to control Qi Shuxin tablets quality. Methods UV Vis Spectrophotometry was used to determine total flavonoids by refluxing method,NaNO3-Al(NO3)3 was used to color determine sample was as the standard solution to calculate the total flavonoids content. Results Rutin had good linear relationship within the range from to ,r= average recovery was %,RSD was %. Conclusion Total flavonoids content of the three batch of Qi Shuxin tablets samples is Between - method is simple,rapid,accurate and is suitable for determination of total flavonoids of Qi in Shuxin tablets.
[Key words] Qi Shuxin tablets;ponent;Rutin;UV Vis Spectrophotometry
功效成分是指?c中成药的功效直接相关的活性成分或活性成分群,是中成药疗效的基础。目前大部分的中成药标准是以指标成分控制药品中某味药材质量,比如用甘草酸的含量评价含甘草的中药复方制剂的质量,这种方法不能完全体现中成药的药用价值和自然属性。理气舒心片的处方由当归、沉香、茯苓等18味组成,具有解肝郁,行气滞,祛胸痹的功效,主要用于气滞血瘀症冠心病,心绞痛,心律不齐,气短腹胀,胸闷心悸。因处方中大多药味具有共性成分,无法以单一指标成分控制处方中药材质量。文献报道总黄***具有增加心肌营养血流量,降低心肌耗氧量,提高动物耐缺氧能力,降低血清胆固醇,抑制血小板聚集等作用,符合理气舒心片的功能主治,可以认为总黄***为理气舒心片的功效成分
[1-5]。理气舒心片原收载于《卫生部药品标准》中药成方制剂第四册,标准中仅有一项蒲黄的显微鉴别,无法准确控制药品质量[6]。总黄***的含量测定方法主要有分光光度法、薄层色谱扫描法、高效液相色谱法、超临界流体色谱法和毛细管电泳法等,高效液相色谱法和毛细管电泳法灵敏度高,准确性好,但在测定时需要较多的黄***化合物对照品,相对成本较高。薄层色谱扫描法和超临界流体色谱法灵敏度低,重现性差,也需要较多的黄***化合物对照品。紫外-可见分光光度法为最常用的总黄***测定方法之一,具有仪器廉价、操作简单、检测成本低、不需要总黄***中各黄***化合物对照品等优点。为确保用药安全有效,本次试验以芦丁为对