孟鲁司特钠咀嚼片细菌计数检查方法的比较与优化

摘要

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 as -say.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 1/1 000 as performed routinely.Conclusion:The bacte-rial counting method for Montelukast Sodium Chewable Tablets was set up optimally by adding 0.5%lecithin and 4%polysorbate80 to the diluent.%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∶1000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。