右旋糖酐在注射用醋酸卡泊芬净无菌检查中的应用

目的：通过无菌方法学验证试验，建立注射用醋酸卡泊芬净的无菌检查法。方法：样品分别用0.9%无菌氯化钠溶液溶解，采用薄膜过滤法处理，每膜分别用0.9%无菌氯化钠溶液和右旋糖酐40葡萄糖注射液冲洗若干次，并在培养基中加入右旋糖酐1g，以白色念珠菌为阳性对照菌。结果：各验证菌株均能够正常生长，方法可行。结论：通过添加外源的右旋糖酐，使真菌通过利用外源的肽聚糖用于自身细胞壁的合成，从而消除了醋酸卡泊芬净的抑菌作用，建立了抗真菌药物注射用醋酸卡泊芬净的无菌检查法。

Application of Dextran in Sterility Test of Caspofungin Acetate for Injection

Objective: To establish a sterility test method for Caspofungin Acetate for Injection according to validation test. Methods: Samples were dissolved by 0.9% sodium chloride solution, and the test was carried out by the technique of membrane filtration. Each membrane was rinsed several times by 0.9% sodium chloride solution and dextran 40 glucose injection, respectively. Dextran 1g was added to the culture medium. Positive control bacteria was Candida albicans. Results: All the test strains grew well and the method was feasible. Conclusion: The effect of exogenous dextran, which makes fungi through the synthesis of its cell wall peptidoglycan exogenous utilization, thereby eliminating the antibacterial effect of caspofungin acetate. Method of sterility test for Caspofungin Acetate for Injection was established.