关键词: font-size:medium, ">氨咖黄敏胶囊；胶囊壳；铬；安全评价

Abstract: Objective： To determine the content of chromium in capsule shells of paracetamol，caffeine，artificial cow-bezoar and chlorphenamine maleate capsules in national drug sampling inspection in 2020, 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 graphite furnace atomic absorption spectrometry was applied in the analysis of chromium content about 290 batches of samples from 79 manufactures. Results: The contents of chromium in capsules shells of 290 batches of samples were all less than 2 ppm，and only one batch was more than 1 ppm. The precision test result showed the RSD was 1.5% and the average recovery rate was 96.5%-105.3%. All the results of the content of chromium in capsule shells meet the requirement, but the quality was still different. Conclusion: The test results of the content of chromium in capsule shells of paracetamol，caffeine，artificial cow-bezoar and chlorphenamine maleate capsules meet the requirement of Chinese pharmacopoeia. It shows that the national supervision was effective but should continue to be strengthened. Manufacturers should optimize the whole production process of capsule shells to control the content of chromium in capsule shells lowest and to ensure the safety of capsules.

Key words: Paracetamol, caffeine, artificial cow-bezoar and chlorphenamine maleate capsules； Capsule shell； Chromium； Safety evaluation