分析药品微生物限度检验误差影响因素

Analysis of error factors for drug microbial limit test

目的总结分析药品微生物限度检验中影响误差的因素。方法选取2011年3月-2013年3月期间,本室所检验的药品1340批,统计微生物限度检验过程中出现的误差以及误差率,并统计主要误差影响因素及其分布。结果本室药品微生物限度检验误差为29.1%(390例),其中,单因素占26.7%,多因素占73.3%。主要影响因素有供试液的制备过程、药物自身性质、操作环境、培养基、检验设备以及菌落计数等因素。结论在药品的微生物限度检查过程中,应严格无菌室的消毒管理,并加强检验过程中所使用的检验器具进行全面消毒灭菌处理,加强对培养基质量以及供试液制备过程的控制,并熟练掌握被测药品的性质及其对于检验结果准确性的影响,并合理调整检验方法,全面消除误差影响因素,从而减少并防止在微生物限度检验中出现误差。

Objective To analyze the factors leading to pharmaceutical microbial limit testing errors. Methods A total of 1340 batches of drugs were collected to analyze microbial limit testing errors and error rate, as well as the main influencing fac- tors and the distribution of these factors. Results The drug microbial limit testing error ratio was 29.1% （390 cases）, single factor accounted for 26.7% and multiple factor accounted for 73.3%. The main influencing factors included the preparation process of the test solution, the drug nature, the operating environment, media, testing equipment and colony counts and other factors. Conclusion In the process of drug microbial limit test, strict disinfection administration on sterile room and apparatus used in the inspection process, the medium quality control and the test solution preparation, as well as the proficiency in drug nature and influence on accuracy of the test results should be all considered to improve the inspection method, thus reducing and preventing the possible errors in microbial limit test.