十滴水现行标准质量分析

Quality analysis of Shidi Shui tested with current standard

目的:评价十滴水的产品质量和现行质量标准的可行性。方法:按十滴水现行检验标准中国药典2005年版一部检验。结果:按现行国家标准检验十滴水共165批次,合格135批,不合格为30批。不合格项目有乙醇量4批;樟脑含量5批;桉油含量26批。结论:导致乙醇量、桉油含量不符合规定的主要因素是生产企业未严格按照生产工艺生产和包装材质选择不合理。现行质量标准需要修订。

Objective：To evaluate quality of Shidi Shui and feasibility of current standard.Methods：Shidi Shui were tested with current standard in ChP 2005 Vol Ⅰ.Results：165 batches of Shidi Shui were tested.There were 30 batches which were out-of-specification and 135 batches which were up to specification.Items of out-of-specification batches were Ethanol content（4 batches）,Assay of Camphor（5 batches）and assay of Cineole（26 batches）.Conclusion：The critical factors inducing out-of-specification were that manufacturing steps were not in accordance with GMP’s requirement and packaging materials were out of place.Current standard should be revised.