人丹质量标准的研究

 目的建立人丹的质量控制标准。方法对制剂中砂仁、茴香、甘草、胡椒采用显微鉴别法,并采用薄层色谱法对制剂中肉桂、丁香、木香进行定性鉴别;同时采用气相色谱法测定制剂中薄荷脑、冰片的含量,以高效液相色谱法测定儿茶中儿茶素和表儿茶素的含量。结果薄荷脑、冰片的平均回收率分别为98.4%,RSD为1.76%(n=6)和97.7%,RSD为0.77%(n=6);儿茶素、表儿茶素的平均回收率分别为99.0%,RSD为0.86%(n=6)和98.2%,RSD为1.26%(n=6)。显微特征明显,薄层图谱斑点清晰,空白无干扰。结论方法简便、准确、重现性好,可作为该制剂的质量控制标准。

Study on the quality specification of Rendan pill

OBJECTIVE To establish the quality specification of Rendan pill. MOTHODS Fructus Amomi, Fructus Anisi Stellati, Radix Glycyrrhizae and Fructus Kperis were identified by microscopic identification, and Cortex Cinnamomi, Flos Caryophylli and Radk Aucklandiae were identified by TLC. Borneolum syntheticum and mentholum were determined by GC, catechu was determined by HPLC. RESULTS The average recovery rate of paeoniflorin were 98.4% ,99.0% and 98.2% ,RSD were 0.77% ,0.86% and 1.26% . The microscopic characretis-tics were obvious.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 the Rendan pill.