复方粉防己颗粒质量标准的研究

Study on Quality Standards for Compond Stephaniatetrandran Garnules

目的建立复方粉防己颗粒的质量标准.方法对粉防己、茵陈、葛根3味中药,采用薄层色谱法定性鉴别,用薄层扫描法对粉防己中粉防己碱进行定量分析,建立其质量标准.结果在薄层色谱中检出粉防己碱;加样回收率为100.62%,RSD=1.98%,(n=5),线性范围为0.6～3.6μg,标准曲线Y＝168 014X+10 263,r=0.999 4,重复性RSD=2.68%(n=5)同板精密度RSD=2.98% (n=5).结论其定性定量方法简便、准确、专属性强,重现性好,可作为该制剂的质量控制方法.

Aim To revise the quality control standard for Compond Stephaniatetrandran Granules. Methods The technique of TLC was used to identify the Hanfangji, Yinchen, Gegen. TLCS was used to analyse tetrandrine quantiatively in Hanfangji. Results The tetrandrine can be identified by TLC. The average recovery was 100.62 %, RSD = 1.98 %, （ n = 5） ,The calibration curves were linear between 0.6 - 3.6 μg（ r = 0.999 4） ,with good repetition, RSD =2.68%, （ n = 5） and precision RSD = 2.98 % （ n = 5）. Conclusion The method was simple, accurate, reliable, and suitable for quality control of the production.