基于水分活度的三种口服溶液洋葱伯克霍尔德菌群检验研究  

Study on the Detection of Burkholderia Cepacia Complex in Three Oral Solutions Based on Water Activity

作　　者：陈新颜 喻喜华 CHEN Xinyan;YU Xihua(Sinopharm Xingsha Pharmaceuticals(Xiamen)Co.,Ltd,Xiamen Key Laboratory of Maternal and Infant Health and Nutrition Products,Xiamen Fujian 361026,China)

机构地区：[1]国药控股星鲨制药(厦门)有限公司,厦门市母婴健康营养产品重点实验室,福建厦门361026

出　　处：《药品评价》2023年第11期1337-1342,共6页Drug Evaluation

摘　　要：目的建立盐酸左西替利嗪口服滴剂、乳果糖口服溶液、葡萄糖酸钙锌口服溶液洋葱伯克霍尔德菌群的检查方法,测定三种口服溶液的水分活度及分析洋葱伯克霍尔德菌群代表菌生长情况,为不同水分活度口服溶液中洋葱伯克霍尔德菌群控制提供参考。方法取三种口服溶液1∶10供试液,采用直接接种法进行洋葱伯克霍尔德菌群检查方法适用性试验,接入洋葱伯克霍尔德菌群代表菌作为阳性对照。通过水分活度测量仪测定三种口服溶液和洋葱伯克霍尔德菌群代表菌对照菌悬液水分活度,在三种口服溶液中分别接种洋葱伯克霍尔德菌群代表菌,于特定时间点进行活菌计数,并绘制生长曲线。结果阳性对照组检出洋葱伯克霍尔德菌群,供试品组和阴性对照组未检出洋葱伯克霍尔德菌群。洋葱伯克霍尔德菌群代表菌对照菌悬液水分活度大于0.99,盐酸左西替利嗪口服滴剂水分活度为0.708~0.742,乳果糖口服溶液水分活度为0.841~0.847;葡萄糖酸钙锌口服溶液水分活度为0.967~0.978。葡萄糖酸钙锌口服溶液水分活度接近洋葱伯克霍尔德菌最低水分活度0.95要求。接种三种代表菌的口服溶液在0.5 h后活菌计数l g值均出现下降,至1.5 h后平板菌落数计数均为0。结论建立盐酸左西替利嗪口服滴剂、乳果糖口服溶液、葡萄糖酸钙锌口服溶液三种口服溶液洋葱伯克霍尔德菌群的检查方法。洋葱伯克霍尔德菌群代表菌在这三种不同水分活度的口服溶液中均不易生长。Objective This study aimed to provide reference for the control of burkholderia cepacia complex in oral solutions of different water activities by establishing an examination method of levocetirizine hydrochloride oral drops,calcium zinc gluconate oral solution,lactulose oral solution,determining the water activity of the three oral solutions and analyzing the burkholderia cepacia complex.Methods Three oral solutions of 1∶10 were tested for burkholderia cepacia complex by direct inoculation and water activity meter was used to determine water activity of the three oral solutions and the burkholderia cepacia complex control suspension.Firstly,burkholderia cepacia complex was inoculated in each of the three oral solutions,and then the number of live bacteria was counted at specific time points,and the growth curve of the number was drawn accordingly.Results Burkholderia cepacia complex was detected in the positive control group and not in the test article group nor in the negative control group.The water activity of burkholderia cepacia complex representative control bacteria suspension was greater than 0.99,the water activity of levocetirizine hydrochloride oral drops was 0.708-0.742,the water activity of lactulose oral solution was 0.841-0.847,and the water activity of calcium zinc gluconate oral solution was 0.967-0.978,which approached the requirement of the minimum water activity of burkholderia cepacia complex 0.95.The number of the three representative oral solutions decreased after 0.5 h,and the number of plate colonies was 0 after 1.5 h.Conclusion The study established an examination method for burkholderia cepacia complex in levocetirizine hydrochloride oral drops,lactulose oral solution and calcium zinc gluconate oral solution.Burkholderia cepacia complex is not easy to grow in these three oral solutions with different water activity.

关 键 词：洋葱伯克霍尔德菌 细菌载量 口服溶液 水分活度 活菌计数 生长影响 

分 类 号：R446.5[医药卫生—诊断学]