复方盐酸利多卡因栓的质量控制

Study on the quality standard for compound suppositories of lidocaine hydrochloride

目的：建立复方利多卡因栓的质量控制标准。方法：采用络合滴定法测定氧化锌的含量，用高效液相色谱法测定盐酸利多卡因的含量。结果：络合滴定法操作简使，终点突跃明显；回收率为100．0％（RSD=0．36％）。高效液相色谱法专属性强，在10．1～4040．0mg·L^-1范围内呈良好的线性关系（r=1．0000）；回收率为100．0％（RSD=0．64％）。结论：本试验制订的质量标准可以很好地控制复方盐酸利多卡因栓的质量。

OBJECTIVE To set up the quality standard for compound suppositories of lidocaine hydrochloride. METHODS Complexation titration was used to determine the content of Zinc oxide, while lidocaine hydrochloride was determined by HPLC. RESULTS Complexation titration was simple and the end point was obvious, the recovery was 100. 0% （RSD = 0. 36%）. HPLC was specific, the linear range was 10. 1 - 4 040. 0 mg·L^-1 with a good correlation coefficient（r= 1. 000 0）, the recovery was 100. 0% （RSD= 0. 64%）. CONCLUSION The quality standard established can be used to control the quality of compound suppositories of lidocaine hydrochloride.