病区药房配发的分劈药片的重量变异性

Weight variability of pharmacy-dispensed split tablets

目的 探讨病区药房分劈并发出的药物半片重量的变异性。方法 收集我院由病区药房发出的10种处方药片,每种10片,共计200个分劈半片。测定分劈片的重量(FW)。采用《美国药典》第24版(USP24)剂量单位一致性测定方法,将每种处方药的FW均值与其理论重量(TW)均值进行比较,分析分劈药片的重量变异性。结果 在200个分劈药片中,有21个(10. 5% )重量偏离其FW均值的15%,涵盖了10种药片中的6种(60% ); 20个(10% )重量偏离其TW均值的15%,涵盖了10种药片中的5种(50% )。10种分劈药片中有7种(70% )SD大于FW均值的6%。而TW的SD没有一个超出USP的6%限值。在总的10种处方药的分劈片中,只有3种(30% )符合USP标准,即FW不超过其FW均值的15%且SD不大于6%。结论 药片分劈导致了难以接受的高比例重量变异。不宜将药片分劈作为一种普遍性做法。

Aim To determine the level of weight uniformity of fragments from tablets split into halves and dispensed by pharmacy. Methods Ten dispensed prescriptions containing 200 split tablet halves were collected, and fragment weights（FWs） were determined, We tested and analyze the weight variation of the split tablet on the basis of the dosage consistency mentioned in the USP which is applied to the whole tablet by comparing the mean FW with the mean TW of each dispensed prescription. Results 21 （ 10.5% ） of 200 fragments, contained in 6（60% ） of the 10 dispensed prescriptions,had weights that deviated by more than 15% from the mean FW. 20 （ 10% ） , contained in 5（50% ） of 10 dispensed prescriptions,had weights that deviated by more than 15% from mean TW. A total of 7 （70%） of the 10 dispensed had standard deviations（SDs） that were more than 6% of the mean FW. None of the TWs displayed an SD greater than the USP limit of 6%. Only 3（30% ） of the 10 dispensed prescriptions met USP standards,with FWs not exceeding 15% of mean FW and SDs of no greater than 6%. Conclusion Tablet splitting resulted in an unacceptably high incidence of weight variation. We recommend against the general practice of splitting tablets.