摘要
目的建立糠酸莫米松鼻喷雾剂微生物计数方法,研究该制剂的抑菌效力。方法按《中国药典》2015年版四部“微生物计数法”及“抑菌效力检查法”,以大肠埃希菌、铜绿假单胞菌、金黄色葡萄球菌、黑曲霉和白色念珠菌为试验菌,对糠酸莫米松鼻喷雾剂进行微生物计数回收率实验和抑菌效力检查。结果采用平皿倾注法(稀释液为含0.1%卵磷脂+0.3%吐温-80的无菌氯化钠-蛋白胨缓冲液),5种实验菌的回收率均>70%;细菌组在供试品接种2d后,计数值减少均>2lg;在接种7d后,计数值减少均>3lg,且在28d时均无增加;真菌组在供试品接种14d后,计数值减少均>2lg,且在以后至28d均无增加。结论糠酸莫米松鼻喷雾剂可采用平皿法进行微生物计数,其抑菌剂的抑菌能力可达到《中国药典》2015年版四部“鼻用制剂抑菌效力判断标准A”的要求。
Objective Establish a microbial counting method for mometasone furoate nasal spray to evaluate the antibacterial efficacy of the preparation. Method According to the “microbial counting method” and “bacteriostasis potency test method” in the four parts of the Chinese Pharmacopoeia (2015 edition), the recovery rate of microbial counting and bacteriostasis potency of mometasone furoate nasal spray were tested with Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Aspergillus Niger and Candida albicans as test bacteria. Result The recovery rates of five experimental bacteria were more than 70% by plate pouring method (dilution solution was 0.1% lecithin + 0.3% Tween-80 sterile sodium chloride-peptone buffer solution). After inoculation for 2 days, the counts of bacteria group decreased by more than 2 lg;after inoculation for 7 days, the counts of bacteria group decreased by more than 3 lg, and did not increase at 28 days. After 14 days of inoculation, the counting value of the fungal group decreased decreased by more than 2 lg, and did not increase from later to 28 days. Conclusion The microbial contents in mometasone furoate nasal spray can be counted by plate method. Its bacteriostasis ability can meet the requirements of “Standard A for judging the bacteriostasis efficacy of nasal preparations” published in the Chinese Pharmacopoeia 2015 edition.
作者
易秋艳
王灿
崔学文
罗慧萍
黄瑛
Yi Qiuyan;Wang Can;Cui Xuewen;Luo Huiping;Huang Ying(Food and Drug Inspection and Testing Institute of Sichuan Province,Chengdu, Sichuan, 611731, China)
出处
《西南国防医药》
CAS
2019年第8期843-845,共3页
Medical Journal of National Defending Forces in Southwest China
关键词
糠酸莫米松鼻喷雾剂
微生物计数
抑菌效力
平皿倾注法
mometasone furoate nasal spray
microbial count
antibacterial efficacy
plate pouring method
