抗菌素粉针剂无菌检查的最佳冲洗量及冲洗方法的实验研究

Studies on The Optimum Washing Conditions and Methods in The Test For Sterility of Powder Injection of Antibiotics

目的:对中国药典2000年版(二部)的抗菌素粉针剂,进行薄膜过滤无菌检查法最佳冲洗量和冲洗方法的实验研究。方法:观察各种规格粉针剂在不同冲洗条件下,阳性菌生长情况。选择适合抗菌素粉针剂无菌检查的冲洗量和冲洗方法。结论:抗菌素粉针剂每支用50～100ml溶剂量溶解,以1000ml的总冲洗量分5次振摇冲洗,为最佳冲洗方法,且具有实际指导意义。

This paper studied the washing conditions and method of powder injections of antibiotics are checked by membrane-filter procedure in the Chinese Pharmacopoeia (Edition2000,VolⅡ). Method:Observed the growth of positive contrast bacterium on the various washingcondition and selected a optimum washing condition for checking membrane-filter pow-derinjection of antibiotics. Conclusion:The optimum washing method for powder antibiotics is divided the powder of each of six with 50-100ml solvent respectively,then washed vibrantly five times with l000ml0. 9%NaCl. It is important meaning for actual operation.