摘要
目的：探讨苦参总碱控释微丸的质量控制方法。方法：采用HPLC法测定苦参总碱控释微丸中苦参碱和氧化苦参碱的含量。结果：苦参碱线性范围为0．1—1．002mg／mL，加样回收率为103．3％；氧化苦参碱线性范围为0．1—0．996mg／mL，加样回收率为98．47％；精密度符合要求；所测3批控释微丸中苦参碱和氧化苦参碱含量平均为（38．66±1．20）mg／g、（68．12±1．62）mg／g。结论：HPLC法稳定可靠，可用于该制剂的质量控制。
Objective： To discuss the quantity control of Total Matrine Controlled Release Micropellets （ TM - CRMP）. Methods ： High performance liquid chromatogram was used to determinate MAT and OMAT content in the TM - CRMP. Results ： Through methodology research, we receive the good separation and peak figures of MAT and OMAT. As for MAT,linear range is 0.1-0.996mg/mL. Recycle rate is 103.3%. As for OMAT,linear range is 0.1-1.002mg/mL. Recycle ratio is 98.47%. Precision meets the specification. The mean content of MAT and OMAT in TM- CRMP are（ 38.66±1.20）mg and （68.12 ± 1.62）mg per lgram. Conclusions：The method is faster and more convenient,can be used to control quantity of TM- CRMP.
出处
《中医药学刊》
2006年第9期1754-1755,共2页
Study Journal of Traditional Chinese Medicine
关键词
HPLC
苦参总碱
控释微丸
HPLC
total matrine
controlled release micropellets
