匹咖卡因注射液质量控制研究

Studies on quality standard of pijakayin injection

目的制订匹咖卡因注射液的质量控制标准。方法采用中和法测定盐酸普鲁卡因的含量;用四苯硼钠剩余滴定法测定盐酸普鲁卡因和氨基比林的总量,经计算可得氨基比林的含量;用一阶导数光谱法测定安钠咖的含量。结果各成分的平均回收率为100.1%~103.4%之间,RSD值在0.34%~0.59%(n=5)之间。结论对于复方制剂来说,本法简便可行,重现性好,可用于该制剂的质量控制。

OBJECTIVE To work out the quality control standard of pijakayin injection.METHODS The procaine hydrochloride in the preparation was determined by neutralizationtitration,The total contents of procaine hydrochloride and aminopyrine in the preparation was determined by sodium tetraphenylborion residual titration,so as to get the content of aminopyrine by calculation.The anaka in the preparation was determined by first derivative spectrometry. RESULTS The average recovery was 100.1%~103.4%,and RSD was 0.34%~0....