左旋四氢巴马汀分散片的鉴别及含量测定  

Identification and determination of L-tetrahydropalmatine dispersible tablets

作　　者：黄兴振[1] 龙翊婷[1] 蒋伟哲[1] 巫玲玲[1] 谭珍媛[1] 

机构地区：[1]广西医科大学,广西南宁530021

出　　处：《华西药学杂志》2014年第3期334-336,共3页West China Journal of Pharmaceutical Sciences

基　　金：广西自然科学基金项目(2013GXNSFBA019129);海洋药物研发中心-校企共建科技创新平台(桂教科研[2013]8号-4);西南特色民族药物开发工程研究中心-校地校企共建科技创新平台((桂教科研[2013]8号-5)

摘　　要：目的测定左旋四氢巴马汀分散片的含量。方法通过化学法和HPLC法定性鉴别左旋四氢巴马汀，并参照《中国药典》要求进行检查，采用HPLC测定左旋四氢巴马汀分散片的含量。结果定性鉴别了左旋四氢巴马汀。HPLC法测定了3批样品中左旋四氢巴马汀，平均含量分别为98．26％、99．27％、99．88％。左旋四氢巴马汀0．2032～2．0320μg与峰面积的线性关系良好（r=0．9999），平均回收率为99．30％，RSD=1．77％。结论所用方法操作简便、精密度高、结果准确可靠，可用于左旋四氢巴马汀分散片的质量控制。OBJECTIVE To establish the quality standards of L - tetrahydropalmatine dispersible tablets. METHODS L - tetrahydropalmatine in L - tetrahydropalmatine dispersible tablets were identified by TLC and HPLC, using HPLC method for the content determination of L - tetrahydropalmatine dispersible tablets. RESULTS L - tetrahydropalmatine could be identified qualitatively, the appearance, dissolution rate, dispersible uniformity and content uniformity of dispersible tablets were in line with quality standards. The Linear relationship of L - tetrahydropalmatine was good in the range of 0. 2032 - 2. 0320 μg（ r = 0. 9999 ）. The average recovery was 99.30% with a RSD of 1.77%. The average content of 3 batches were 98.26% ,99.27% and 99.88% ,respectively. CONCLUSION The method is simple, accurate and specific. It can be used for the quality control of products.

关 键 词：左旋四氢巴马汀 分散片 鉴别 高效液相色谱法 质量标准 

分 类 号：R917[医药卫生—药物分析学]