两厂家生产的注射用兰索拉唑配伍稳定性的比较

Comparison of the compatibility stability of Lansoprazole for injection from two manufacturers

目的比较两个不同厂家生产的注射用兰索拉唑与0.9%氯化钠注射液的配伍稳定性。方法模拟临床用药,在室温条件下测定样品放置不同时间后兰索拉唑的含量、p H、不溶性微粒、颜色及澄清度;用SPSS 15.0软件进行统计分析。结果在观察时间内,两个厂家生产的样品溶液中,兰索拉唑的浓度均呈现先减少后增加的趋势,溶液的p H均随时间的延长呈下降趋势;10、25μm不溶性微粒数在4 h内均基本符合《中国药典》的要求,颜色均未发生变化,保持澄清。结论注射用兰索拉唑与0.9%氯化钠注射液配伍后应放置在阴凉处并尽快使用;两个厂家生产的注射用兰索拉唑与0.9%氯化钠注射液配伍后,在兰索拉唑的含量、p H、不溶性微粒、溶液颜色、溶液澄清度等方面的制剂水平相同。

OBJECTIVE To compare the compatibility stability of Lansoprazole for injection between two manufacturers with 0.9% sodium chloride injection. METHODS Having simulated the clinical use of drugs,the different batches of the Lansoprazole for injec- tion from two manufacturers were determined under the conditions of room temperature for 0,1,2,3 and 4 h. The results of content, pH insoluble particles, color and clarity were analyzed with SPSS 15.0 statistical software. RESULTS During the observation time, the concentration of Lansoprazole showed a trend of increase after the first reduce. The pH value of the solution was on the decline along with the change of time. The number of 10 μm and 25 μm insoluble particles kept consistent with the requirements of ChP. At the same time,there was no change in the color and the clarity. CONCLUSION After compatibility with 100 mL of 0.9% sodium chloride injection, the infusion should be placed in the shade and used as soon as possible. Under ambient conditions, the products from the two manufacturers have the same level in the content, pH, insoluble particles, color and clarity.