摘要
目的:通过高效液相法测定不同灭菌参数下甲硝唑注射液中甲硝唑含量,筛选出最优灭菌参数。方法:采用Agilent Extend-C18色谱柱(4.6 mm×250 mm,5μm);水∶甲醇(80∶20)为流动相;流速为1.0 ml/min;柱温30℃;检测波长为320 nm,测定在121℃、15 min和115℃、30 min的灭菌参数条件下甲硝唑注射液含量,判断所选灭菌参数的合理性。结果:两种参数测定灭菌前药液甲硝唑平均含量为101.57%,过度杀灭法灭菌之后药液含量为101.47%,测定采用残存概率法灭菌后药液含量为101.60%。不同灭菌参数下甲硝唑活性成分含量与灭菌前对比线性关系良好。结论:高效液相测定法快速、准确,重现性良好,按照欧盟风险级别决策树筛选出甲硝唑注射液的最优灭菌工艺为终端过度杀灭法。
Objective： By high performance liquid chromatography determination of metronidazole content of different sterilization parameters metronidazole injection, selection of the optimal sterilization parameters. Methods： The Agilent Extend-C18 analytical column（250mm×4.6 mm, 5 μm） was adopted with the mobile phase of water： Alcohol（80：20） at a flow rate of 1.5 m L/min; The column temperature was at 30 ℃; The detection wavelength was at 320 nm, 121 ℃ 15 min, the content of effective components metronidazole injection in 115 ℃ 30 min sterilization parameters. Results： The average content of metronidazole determination before sterilization liquid is divided into 101.57%, with excessive killing sterilization after liquid content is 101.47%, determined by the probability of survival after sterilization liquid content of 101.60%. The content of active component of different sterilization parameters of metronidazole and before sterilization contrast difference. Conclusion： The method is fast rapid, convenient, in accordance with the level of risk decision trees screened Metronidazole injection sterilization using terminal over kill sterilization accurate and can be used for the metronidazole in metronidazole injection.
出处
《中国医学装备》
2015年第2期37-39,共3页
China Medical Equipment
关键词
高效液相色谱
甲硝唑
含量测定
High performance liquid chromatography
Metronidazole
Content determination
作者简介
通讯作者李凤霞，女，（1978-），硕士，主管药师。黑龙江中医药大学附属第一医院药剂科，从事临床用药安全及药剂学研究。lifengxia1022@163．com
