对掰分药片重量差异及微生物污染的考察

目的:提高用药安全性和有效性。方法:对5种掰分药片的重量差异及微生物限度按《中国药典》要求进行考察。结果:5种掰分药片的重量差异不符合《中国药典》规定,并有不同程度的微生物污染。结论:建议制药企业增加适合小儿、妇女、老人及特殊病人使用的剂量规格药品。如必须掰分药品,药剂人员应采用无菌法在超净化工作台上将药品掰开分装在环氧乙烷灭菌塑料小袋中,并于当天用于病人。

Investigation on Weight Variations and Microbial Contaminations of 5 Tablets Broken off with Hands

OBJECTIVE:To improve medication safety and efficacy.METHODS:5different tablets broken off with hands were investigated with respect to weight variations and microbial limits by reference to Chinese Pharmacopeia.RESULTS:The5kinds of tablets broken off with hands were not in conformity with Chinese Pharmacopeia with respect to weight variation and which involved different degrees of microbial contaminations.CONCLUSION:It is recommended that pharmaceutical enterˉprises should add more dosage forms of standard drugs that suitable for the use of children,women,the aged and particular patients.If the separately packaged drugs must be broken off with hands,aseptic method should be applied in which the drugs were broken off by the pharmacists on the sterile air bench before being separately packed with sterilized plastic pouches(which were sterilized with anprolene),and which should be administered to the patients for taking during the same day.