国家药品抽检品种左羟丙哌嗪胶囊二氧化钛含量测定及评价

Analysis and Evaluation of Titanium Dioxide in Empty Capsules of Evodropropizine Capsule in National Drug Sampling Inspection

目的对2022年国家药品抽检品种左羟丙哌嗪胶囊样品空心胶囊中的二氧化钛含量进行检测、分析和评估,以期为国家药品监管提供参考,确保公众用药安全。方法采用微波消解法进行样品前处理,以电感耦合等离子体质法(ICP-MS)对3个厂家55批左羟丙哌嗪胶囊样品空心胶囊中二氧化钛的含量进行测定。结果二氧化钛在0~500 ng·mL^(-1)范围内线性关系良好,相关系数为0.9999,最低检出浓度为0.004%,精密度试验显示RSD为1.8%,平均回收率为101.1%~106.3%。55批样品空心胶囊中二氧化钛含量均在0.76%~2.40%范围内。空心胶囊二氧化钛含量均符合《药剂学》中提到空心胶囊可添加2%~3%二氧化钛作为遮光剂的规定,但质量尚存在差异。结论左羟丙哌嗪胶囊品种空心胶囊中二氧化钛的含量均符合规定,国家监管有效,监管部门应继续加强监管,生产厂家应优化空心胶囊生产工艺,使空心胶囊二氧化钛含量得到控制,为其今后在药品领域更为合理的应用提供科学参考和理论依据。

OBJECTIVE To determine the content oftitanium dioxide in empty capsules of levodropropizine capsule in national drug sampling inspection in 2022,and to evaluate it,to provide reference for the national drug supervision and ensure the drug safety for the public.METHODS Microwave digestion method was adopted in the pre-treatment of the samples,then ICP-MS was applied in the analysis of oftitanium dioxide content about 55 batches of samples from 3 manufactures.RESULTS The good linear relation was determined in the range of 0-500 ng·mL^(-1) by ICP-MS with a regression coefficient of 0.9999.The detection limit was 0.004%.The precision test result showed the RSD was 1.8%and the average recovery rate was 101.1%-106.3%.All the results of the content of chromium in empty capsules meet the requirement,but the quality was still ifferent.The contents of oftitanium dioxide in empty capsules of 55 batches of samples was in the range of 0.76%-2.40%.CONCLUSION The test results of the content of oftitanium dioxide in capsule meet the requirement of《pharmaceutics》mentioned that the empty capsules can add 2%-3%titanium dioxide as a sunscreen.It shows that the national supervision was effective but should continue to be strengthened.Manufacturers should optimize the whole production process of empty capsules to control the content of oftitanium dioxide in empty capsules.It provides scientific reference and theoretical basis for its more reasonable application in drug field in the future.