不同厂家刻痕片及非刻痕片分剂量评价

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。

Evaluation of Divided Doses of Scored Tablets and Non-scored Tablets Produced by Different Manufacturers

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. METH-ODS： Using subdivision accuracy, difference between expected mass and real mass （d value）, loss of mass and friability as in- dex, 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 evaluat-ed with hand, scissors and tablet cutters. RESULTS： Except manufacturer D （3 methods） and manufacturer C （tablet cutter）, oth- ers 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 manufactur- er 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 physi- cal parameters.