分劈药片的剂量准确性考察

Accuracy Study of Tablet-Splitting

目的评价药片分劈的准确性,为儿童口服片剂分剂量时的安全用药提供参考。方法用手工、剪刀、刀片、切药器4种分劈方法分别对8种不同大小的药片进行对半分劈,并对其中7种药片进行1/4片分劈;参考欧洲药典半片分剂量评价标准测评本次药片分劈情况。结果针对8种药品的对半分劈中,有6种药品通过了切药器分劈半片测试;7种需分劈1/4片的片剂用4种分劈方法均未通过测试。结论不是所有的片剂(尤其是非刻痕片)都适合分劈。半片分劈时,切药器可能会提高药片的分劈准确度。4种分劈方法用于药片分劈1/4片时重量差异都较大,分劈准确性低,存在一定的用药安全隐患,应引起重视。当分劈无法避免时,直径大于6 mm的药片推荐使用切药器。

OBJECTIVE To evaluate the accuracy of splitting tablets and provide references for safe medication of children orally taking divided tablets. METHODS Eight kinds of tablets with different sizes were split into half-tablet by hand, scissors, blade, and tablet-splitter, among which seven kinds of tablets were divided into quarter. The splitting results were tested according to the half-dose evaluation standards of the European Pharmacopoeia. RESULTS Among the eight kinds of drugs split into half-tablets, six divided by tablet-splitter passed the test ; meanwhile, all of the seven kinds of tablets divided into quarter by the four methods failed the test. CONCLUSION Not all tablets, especially unscored tablets, are fit for splitting. Tablet-splitter may improve the accuracy of tablet- splitting when dividing into half-tablet. The weight variabilities of the four approaches to split tablets are obvious, and the splitting ac- curacy is low, which may cause a drug safety risk we should pay attention to. Furthermore, tablet-splitter is recommended to divide tablets with diameters greater than 6 mm when splitting cannot be avoided.