茵栀黄注射液质量标准研究

Quality standard of Yinzhihuang Injections

目的:完善茵栀黄注射液(菌陈提取物、栀子提取物、黄芩苷提取物、金银花提取物)的质量标准。方法:茵栀黄注射液由四味提取物投料制成,对指标成分分别用薄层色谱法和高效液相色谱法进行鉴别和含量测定研究。结果:建立了黄芩苷、栀子苷、绿原酸三项薄层鉴别以及绿原酸、栀子苷、黄芩苷和对羟基苯乙酮四项含量测定。绿原酸、栀子苷、黄芩苷和对羟基苯乙酮的加样回收率分别为99.8%、99.2%、100.1%和99.9%,RSD分别为0.81%(n=6),1.20%(n=6),1.90%(n=6)和0.55%(n=6);薄层图谱斑点清晰,空白无干扰。结论:建立了专属性强的TLC鉴别和HPLC含量测定项目,方法简便、准确、重现性好,可较全面地控制茵栀黄注射液的质量。

AIM：To establish the quality specification of Yinzhihuang Injection （extract of Herba Artemisiae scopariae,extract of Fructus Gardeniae,extract of Radix Scutellariae,extract of Flos Lonicerae Japonicae）; METHODS：Extractum Artemisiae Scopariae、 Extractum Fructus gardeniae、 Extractum Flos lonicerae and Extractum Radix scutellariae were identified by TLC and were determined by HPLC. RESULTS：The average recoveries of chlorogenil、gardenoside、baicalin and p-hydroxyacetophenone were 99.8%,99.2%,100.1% and 99.9%,respectively.nil,gardenoside,baicatin and p-hydroxyacetophenone were 99.8% ,99.2%, 100. 1% and 99.9%, respectively. RSD were 0.81%, 1.20%, 1. 90% and 0.55%, respectively. The TLC sports developed were fairly clear, and the blank test showed no interference. CONCLUSION： The method developed is simple and accurate with good reproducibility, and the method can be used for quality control of Yinzhihuang Injection.