市售乳膏剂水分活度分布规律及应用  

Distribution and Application of Water Activity of Commercial Cream Preparations

作　　者：闵红 李林樾 呼延婷婷 安凤秋[3] MIN Hong;LI Linyue;HUYAN Tingting;AN Fengqiu(Shaanxi Institute for Food and Drug Control,Xi′an,Shaanxi,China 710065;NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiolgy,Xi′an,Shaanxi,China 710065;School of Environmental and Chemical Engineering,Xi′an Polytechnic University,Xi′an,Shaanxi,China 710048)

机构地区：[1]陕西省食品药品检验研究院,陕西西安710065 [2]国家药品监督管理局药品微生物检测技术重点实验室,陕西西安710065 [3]西安工程大学环境与化学工程学院,陕西西安710048

出　　处：《中国药业》2022年第15期84-87,共4页China Pharmaceuticals

基　　金：2017年国家药品标准提高项目[食药监办药化管〔2017〕139号]。

摘　　要：目的探讨市售乳膏剂的水分活度分布规律及应用。方法采用水分活度仪,于25℃条件下,检测32家生产企业的31个品种、共108批次乳膏剂的水分活度。结果乳膏剂的平均水分活度为0.5719~0.9987[95%CI(0.9491,0.9683)],水分活度为0.5719~0.8047,0.8048~0.8435,0.8436~0.8823,0.8824~0.9211,0.9212~0.9599,0.9600~0.9987的乳膏剂数量分别占0.93%,3.70%,2.78%,3.70%,14.81%,74.07%。结论乳膏剂适合多数革兰阴性菌、革兰阳性菌、部分芽孢杆菌属、霉菌、酵母菌的生长,主要潜在污染菌为革兰阴性菌。对于水分活度较低的乳膏剂,可通过风险评估来减少微生物限度检查的频次,实施跳批次检查。Objective To investigate the distribution and application of water activity of commercial cream preparations.Methods The water activity of 108 batches of cream preparations belonging to 31 varieties from 32 manufacturers was determined by the water activity meter at 25℃.Results The average water activity of the cream preparations was 0.5719-0.9987[95%CI(0.9491,0.9683)].The number of cream preparations with water activity of 0.5719-0.8047,0.8048-0.8435,0.8436-0.8823,0.8824-0.9211,0.9212-0.9599 and 0.9600-0.9987 accounted for 0.93%,3.70%,2.78%,3.70%,14.81%and 74.07%,respectively.Conclusion The cream preparations are suitable for the growth of most Gram-negative bacteria,Gram-positive bacteria,some bacillus,mold and yeast.The main potential contaminating bacteria are Gram-negative bacteria.For cream preparations with low water activity,we can reduce the frequency of microbial limit test through risk assessment and implement batch-skipping test.

关 键 词：乳膏剂 水分活度 分布规律 药品微生物安全评价 质量控制 

分 类 号：R917[医药卫生—药物分析学] R986[医药卫生—药学]