氨咖黄敏胶囊的质量分析

Quality analysis for paracetamol,caffein,atificial cow-bezoar and chlorphenamine maleate capsules

目的:评价氨咖黄敏胶囊的总体质量和现行质量标准的可行性。方法:通过对氨咖黄敏胶囊的现行法定标准检验和探索性研究检验综合评价其质量状况。结果:本次评价性抽样共检验氨咖黄敏胶囊103批,按现行法定标准检验,合格率为100.0%;通过探索性研究检验,合格率仅为32.0%。结论:通过评价发现,氨咖黄敏胶囊按现行标准检验总体质量良好。但现行标准项目设置简单,不能全面有效控制药品质量,有必要进一步提高质量标准。

Objective： To evaluate the quality of paracetamol,caffein,atificial cow-bezoar and chlorphenamine maleate Capsules（PCACC Capsules） and feasibility of current standards.Methods： Through the test with current standards and the exploratory research to evaluate its quality.Results： 103 batches of PCACC Capsules were tested through this evaluating inspection.The qualified rate of current standards test was 100%;and its passing rate of exploratory research inspection was only 32.0%.Conclusion： The study found that the overall quality of PCACC Capsules tested by current inspection standards was good.But the current inspection standards were simple.They can not control the drug quality and needs to be further improved.