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2004年,在全省整顿医疗机构制剂工作中,我所对辖区内10家医疗机构的109个品种,327批自制制剂进行了质量标准复核和样品检验。发现医疗机构制剂质量及质量标准存在较多问题。制剂不合格率为12%,不合格项目涉及到: 鉴别、装量、微生物限度、粒度、含量测定等。包装或标签不符合要求的为7％,主要问题是:容器未密封、标签内容错误等;质量标准需要规范或修订的高达90％,主要问题有:编排顺序不规范、书写错误、检验项目不合理、检验方法无法重现等。本文对复核和检验的结果进行了总结和分析。
In 2004, in the whole province to reorganize the preparation of medical institutions, I carried out the quality standard review and sample test on 109 varieties and 327 batches of homemade preparations of 10 medical institutions in the area. Found that the quality of medical institutions and quality standards there are more problems. Formulation failure rate of 12%, substandard projects related to: identification, loading volume, microbial limits, particle size, determination of content. Packaging or labeling does not meet the requirements of 7%, the main problems are: unsealed containers, labels and other content errors; quality standards need to be normative or revised up to 90%, the main problems are: layout irregularities, writing errors, test items Reasonable, test methods can not reproduce. This paper summarizes and analyzes the results of review and verification.