孟鲁司特钠咀嚼片细菌计数检查方法的比较与优化

目的:优化孟鲁司特钠咀嚼片细菌计数检查方法。方法:用两种稀释剂分别制备供试液,按2010年版《中国药典》进行回收率试验,比较不同计数方法回收率的高低,以选择该药品最佳的细菌计数方法。结果:添加0.5%大豆卵磷脂和4%聚山梨酯80的稀释剂可去除孟鲁司特钠咀嚼片的抗菌活性,细菌计数检查方法为常规法回收率可达70%以上;未添加中和剂组细菌计数检查方法为常规法回收率低于70%,需用1∶1 000稀释级常规法才能使回收率达到70%以上。结论:采用稀释剂中添加0.5%大豆卵磷脂和4%聚山梨酯80法可优化孟鲁司特钠咀嚼片的细菌计数检查方法。

Comparison and Optimization of Bacterial Counting Method for Montelukast Sodium Chewable Tablets

Objective: To optimize bacterial counting method for Montelukast Sodium Chewable Tablets. Methods: Based on Chinese Pharmacopoeia (2010 edition), two types of diluents were used to prepare sample solutions that were applied for bacterial recovery assay. In this study, the optimal bacterial counting method for the Montelukast Sodium Chewable Tablet was figured out by comparing the bacterial recovery rates using the two diluents. Results: The antibiotic activity of Montelukast Sodium Chewable Tablets was largely compromised by addition of 0.5% lecithin and 4% polysorbate80 to the sample solution. The bacterial recovery rate was shown higher than 70% with the routine plate counting method. On the other hand, the recovery rate for the sample without neutralization agents was less than 70%, it could be reached only if the sample solution was diluted to 1/1000 as performed routinely. Conclusion: The bacterial counting method for Montelukast Sodium Chewable Tablets was set up optimally by adding 0.5% lecithin and 4% polysorbate80 to the diluent.