目的 通过研究3个批次无菌异丙醇在3种不同洁净度的环境中开瓶后，瓶内外观、无菌状态及异丙醇含量是否受到环境影响，初步确定无菌异丙醇开瓶后有效期。方法  从3个批次无菌异丙醇中每个批次随机选取162瓶，每个批次分别放置在A级、D级无菌室，无级别库房各54瓶。喷瓶的喷嘴始终处于打开状态，每个工作日进行3次喷雾操作。在第0、1、7、14、21、30天，检测异丙醇溶液的外观性状；采用薄膜过滤法测定异丙醇溶液中微生物的污染情况；采用气相色谱法测定异丙醇含量，并用独立样本t检验方法进行统计学分析。结果  实验期间所有异丙醇溶液外观无变色、无沉淀、无悬浮物，气味无变化，未出现微生物污染；异丙醇含量为体积分数（69.98~70.17）%，达到标示含量。通过统计学分析，异丙醇含量差异无统计学意义（t值0.07~2.18，p值均＞0.05）。结论  异丙醇在A级、D级无菌室和无级别库房开瓶后使用时间建议不超过30 d。

Objective  To determine the validity period by confirming whether the appearance, sterility, and isopropanol content of 3 batches of sterile isopropanol solution were affected by the environment after opened in 3 environments with different cleanliness level. Method  162 bottles were randomly selected from each of 3 batches of sterile isopropanol solution, and placed in 3 environments with A, D and no cleanliness,54bottles each,respectively. During the experiment, the nozzles of bottles were kept open, and spray operation was carried out 3 times per working day. On days 0, 1, 7, 14, 21, and 30 , appearance of isopropanol solutions was observed by direct observation, the microbial contamination in isopropanol solutions was measured by membrane filtration method,and the content of isopropanol was measured by gas chromatography and analyzed by independent sample t test method. Result  All isopropanol solutions had no change in color and odor, and no precipitation, suspended matter, or microbial pollution.The contents of isopropanol were between （69.98~70.17）% and reached the labeled content,and there was no statistically significant change in the content of isopropanol （t values:0.07~2.18，p values all＞0.05）. Conclusion  The sterile isopropanol solution is suggested to be used  in A,D and no cleanliness environments within 30 days after opened.