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静脉注射用的脂肪乳剂直接按美国药典第20版收载的二种无菌试验方法(直接接种法和薄膜过滤法)检查均不适宜。因直接接种法使培养基产生混浊而影响观察细菌生长;而薄膜过滤法由于脂肪乳剂的球粒将薄膜滤孔堵塞而无法进行。本文报道以二甲亚砜为溶剂,使脂肪乳剂溶解后用薄膜过滤法作无菌试验。关于二甲亚砜的抗菌作用曾有报道;但对其抑制细菌和抑制真菌的性能有争论。为确定其抑菌和抑真菌效能和选择适宜浓度用于无菌试验;以枯草杆菌(ATCC6633)、金黄色葡萄球菌(ATCC6538)、白含珠菌(ATCC 10231)、绿脓杆菌(ATCC 9027)、产气荚膜杆
Intravenous lipid emulsions are not directly suitable for the two sterility tests (direct inoculation and membrane filtration) contained in the U.S. Pharmacopeia, 20th edition. Due to the direct inoculation method, the culture medium was turbid to influence the growth of the bacteria. However, the membrane filtration method was unable to perform the filtration because the pellets of the fat emulsion clogged the membrane filter pores. This paper reports the use of dimethyl sulfoxide as a solvent to dissolve fat emulsion membrane filtration method for sterility test. Antimicrobial effects on dimethylsulfoxide have been reported; however, there is debate about its ability to inhibit bacteria and inhibit fungi. To determine their antibacterial and fungicidal efficacy and select the appropriate concentration for the sterile test; Bacillus subtilis (ATCC6633), Staphylococcus aureus (ATCC6538), Candida albicans (ATCC 10231), Pseudomonas aeruginosa (ATCC9027) Gas capsule rod