摘要
按照2015年版《中国药典》四部通则1101中的规定,对注射用盐酸丙帕他莫进行无菌检查方法适用性研究,建立该样品的无菌检查方法。通过采用薄膜过滤法,每支样品用5 mL(20 mg/mL)的专用溶媒枸橼酸钠注射液溶解,再以0.1%无菌蛋白胨水溶液为冲洗液,分别冲洗200、300、400 mL/筒进行试验,观察各试验组的菌生长情况。结果表明,阴性对照和样品组均无菌生长,在3 d内所有阳性对照组和冲洗量400 mL/筒时的试验组,菌生长良好。因此注射用盐酸丙帕他莫无菌检查,可采用薄膜过滤法,每支样品用5 mL(20 mg/mL)的专用溶媒枸橼酸钠注射液溶解,过滤相当于3.0 g供试品后,再以0.1%无菌蛋白胨水溶液冲洗400 mL/筒,以金黄色葡萄球菌作为阳性对照菌。
Based on the provisions of the general rule 1101 of the fourth part of the Chinese Pharmacopoeia(2015 Edition),the applicability of the sterility test method of propacetamol hydrochloride for injection was investigated,and the sterility test method of the sample was established.By means of membrane filtration,each sample was dissolved by 5 mL of special solvent sodium citrate injection with a concentration of 20 mg/mL,and then 0.1%sterile peptone aqueous solution was used as rinse solution,each cylinder was rinsed 200,300,400 mL,respectively,and the growth of bacteria in each test group was observed.The results showed that both the negative control group and the sample group grew asepsis,and the positive control group and the test group at 400 mL per tube grew well within 3 days.Therefore,film filtration method can be adopted for propacetamol hydrochloride sterility test.Each sample is dissolved with 5 mL(20 mg/mL)of the special solvent sodium citrate injection,which is equivalent to 3.0 g of the sample,and then 400 mL of each tube is washed with 0.1%aseptic peptone solution,with staphylococcus aureus as the positive control bacteria.
作者
陈扣宝
吕小燕
CHEN Kou-bao;LV Xiao-yan(Hefei Food and Drug Inspection Center,Hefei 230088,China)
出处
《化学试剂》
CAS
北大核心
2020年第7期840-844,共5页
Chemical Reagents
关键词
盐酸丙帕他莫
无菌检查
方法适用性
薄膜过滤法
注射剂
propacetamol hydrochloride
sterility test
applicability of the method
membrane filtration
injection
