不同厂家刻痕片及非刻痕片分剂量评价

摘要

目的:评价对不同厂家复方卡托普利片和复方对乙酰氨基酚片(Ⅱ)的刻痕片及非刻痕片采用3种方法的分剂量情况,促进合理用药.方法:以分剂量准确性、期望重量与实际重量差值(d)、重量损失百分比、等分片脆碎度为指标,采用手掰、剪刀、切药器3种方法对A厂(有刻痕)、B厂(无刻痕)的复方卡托普利片及C厂(无刻痕)、D厂(有刻痕)的复方对乙酰氨基酚片(Ⅱ)进行分剂量评价.结果:除D厂(3种方法)、C厂(切药器法)外,其余厂家或方法分剂量准确性均不符合《欧洲药典》第6版的规定.与手掰法比较,C厂剪刀法d值明显降低(P＜0.05)；与剪刀法比较,D厂切药器法d值明显降低(P＜0.01).3种方法间比较分剂量后重量损失百分比均具有统计学意义(P均＜0.01),其中剪刀法＞切药器法(除B厂外)＞手掰法.等分片脆碎度结果表明,A厂切药器法不合格,B厂3种方法均不合格,其余厂家或方法均合格.结论:刻痕片较非刻痕片更适合分剂量,具体分剂量方法需根据药片物理参数情况进行选择.%OBJECTIVE: To evaluate the subdivision of scored tablets and non-scored tablet of Compound captopril tablets and Compound paracetamol tablets ( II ) from different manufacturers with 3 methods, to promote the rational use of medicines. METHODS: Using subdivision accuracy, difference between expected mass and real mass (d value), loss of mass and friability as index, the subdivision of Compound captopril tablets from manufacturer A (scored tablet) and manufacturer B (non-scored tablet) and Compound paracetamol tablets (II) from manufacturer C (non-scored tablet) and manufacturer D (scored tablet) were evaluated with hand, scissors and tablet cutters. RESULTS: Except manufacturer D (3 methods) and manufacturer C (tablet cutter), others could not comply with the specification of Ph. Eur. (6th edition). Compared with manual splitting, d value of manufacturer C decreased significantly when splitted by scissors (P<0.05); compared with scissors splitting, d value of manufacturer D decreased significantly when splitted by tablet cutters (P<0.01). There was statistical significance in the difference of loss of mass among 3 methods (P<0.01), among which loss of mass of scissors method was the highest, followed by tablet cutters (except manufacturer B) and manual splitting. The friability of equal divided tablet showed that tablet cutters method of manufacturer A and 3 methods of manufacturer B were all not up to standard, while other manufacturers or methods passed the test CONCLUSION: Scored tablet is quite fit to be subdivided, compared with non-scored tablet. The selection of subdivision method should be in line with the physical parameters.