| 张文燕,郭福庆.天津市医院制剂抽检微生物限度检查结果及质量分析[J].中国药事,2019,33(1):100-107 |
| 天津市医院制剂抽检微生物限度检查结果及质量分析 |
| Results of Microbial Limit Tests and Quality Analysis of Hospital Preparation Sampling Inspection of Tianjin |
| 投稿时间：2018-05-31 |
| DOI：10.16153/j.1002-7777.2019.01.018 |
| 中文关键词: 医院制剂 微生物限度检查 质量分析 |
| 英文关键词: hospital preparation microbial limit test quality analysis |
| 基金项目: |
|
| 摘要点击次数: 1563 |
| 全文下载次数: 805 |
| 中文摘要: |
| 目的：依据《中国药典》2015年版，对抽检的41批医院制剂进行微生物限度检查和质量分析。方法：检验方法为制剂生产医院提供，并根据药典要求，对每批样品进行控制菌检查时均加入阳性对照。结果：抽检的41批医院制剂样品微生物限度检查，37批次检验结果均符合规定，1批次检验结果不符合规定，3批样品由于医院提供的微生物限度检查的方法依据为2010版《中国药典》，不符合现行药典要求，故而未做检验。结论：医院制剂微生物限度检查方面存在诸多问题，应引起各方重视。 |
| 英文摘要: |
| Objective:To carry out the microbial limit tests and quality analysis of 41 batches of hospital preparations according to the Chinese Pharmacopeia 2015 edition. Methods:The examining methods were provided by the hospitals which manufactured the preparations. According to the requirements of the Chinese Pharmacopeia 2015 edition, positive controls were added in each patch of the samples for specific microorganisms test. Results:Among all the 41 batches of hospital preparations in microbial limit test, 37 batches met the test requirements, 1 batch did not meet the requirements and 3 batches were not tested, because the 3 batches of samples did not meet the requirement of The Chinese Pharmacopeia 2015 edition but were based on The Chinese Pharmacopeia 2010 edition. Conclusion:There existed many problems in the microbial limit test of hospital preparations, which should be paid more attention to by all parties. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |