甄少立（广州市第一人民医院 510180 ）
摘要：目的：探讨甲硝唑注射液的最佳制备条件。方法：采用均匀设计法，对可能影甲硝唑注射液的三个因素（注射用水温度，静置时间，活性炭用量）在三个水平上进行考察，并对试验结果进行重复数据的偏最小二乘法回归分析与残差分析。结果：甲硝唑注射液的最佳条件是：注射用水温度：80 ℃，静置时间：15(min.),活性碳用量：0.025（%） 。采用途最佳制备条件验证试验所制得两批产品所测得其含量为：99.31%，99.35%,较前6个试验号的结果都高。并且注射液中不溶性微粒检察及格。结论：优化条件是可信的。均匀设计法以及偏最小二乘法在均匀设计的结果数据处理均是较好方法。
关键词：
Investigation on Metronidazole Injection Preparation Condition with Uniform Desigh Method
Zhen Shao Li (First Manicipal People’s Hospital of GuangZhou 510180)
ABSTRACT OBJECTIVE: To study the best preparation condition of Metronidazole Injection. METHOD: The three faction(temperature of water for injection, static time, quantity of active carbon) that may affect the quality of Metronidazole injection were experimentally 0bserver in three levels by using Uniform Design. The repetition trials of result was analyzed with partial least square and residual analysis. RESULTS: The best preparation condition of metronidazole injection is: the temperature of water for injection is 80℃;the static time is 15 minutes ;the quantity of active carbon is 0.025%.Verification experiment of adopting the best preparation condition make two batches of product measure its contanit is 99.31%,99.35%. It is higher than 6 experiments results of number. And pass the test for Particulate Matter in Injection. CONCLUSION :Optimum seeking condition is believable, Uniform Design method and partial least square in result data of Uniform Design processing are better methods all.资料来自:中国药师-专业站 |