口服片剂分劈重量差异性的研究

Weight variation of dispensed split tablets

目的探讨口服片剂分劈后的重量差异性。方法收集常分劈服用的12种处方药片,采用手工分劈和刀刻分劈,用《美国药典》(第24版)中适用于整片药片的剂量单位一致性测试,分析分劈药片的重量一致性。结果手工分劈的片剂中有6种未通过一致性测试,刀刻分劈的有5种未通过一致性测试。带有刻痕的片剂较无刻痕的分劈效果好。结论药片分劈导致了高比率的质量变异,仅适用于一些低毒和剂量-反应关系相对平坦的药物。

OBJECTIVE To determine the level of weight informity of pharmacy-dispensed split tablets. METHODS 12 kinds of oral prescriptions were collected （20 tablets each kind, and 10 ones splitted by knife and 10 ones splitted by hand） ,and fragment weights（FWs） were determined. We tested and analyzed the weight variation of the spilt tablets on the basis of the dosage consistency mentioned in USP which was applied to the whole tablet. RESULTS 6 kinds of prescriptions sphtted by hand and 5 kinds of prescriptions splitted by knife didnt pass the consistent test after splitting. It was relatively easy to break off the tablet with nick in half. The dosage lost inevitably during the process of splitting the tablet. CONCLUSION Tablet splitting result in a high incidence of weight variation, therefore it can only be applied to those drugs with low toxicities and relatively flat dose-effect curve.