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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 sub-dosage of three different methods for the different manufacturers of captopril tablets and acetaminophen tablets (Ⅱ) scored tablets and non-scored tablets to promote rational drug use. Methods: The accuracy of dose, the expected weight and the actual weight difference (d), the percentage of weight loss, equal fragmentation as an indicator, using hand breaking, scissors, (No scoring) compound captopril tablets and C plant (no scoring), D plant (scored) compound paracetamol tablets (Ⅱ) sub-dose evaluation. Results: Except D factory (3 methods), C factory (cut drug device), other manufacturers or methods did not meet the dose accuracy of the “European Pharmacopoeia” 6th edition. Compared with the hand breaking method, the d value of C factory scissors method was significantly decreased (P <0.05). Compared with the scissors method, the d value of D factory cutting medication method was significantly decreased (P <0.01). Among the three methods, the percentages of weight loss were statistically significant (P <0.01). Among them, the scissors method> cutting drug device (except for the B plant)> hand breaking method. Fragmentation of equal pieces results show that, A plant cut drug device failed, B plant 3 methods are unqualified, and the rest of the manufacturers or methods are qualified. Conclusion: Scored tablets are more suitable for sub-dose than non-scored tablets. The specific dosage method should be selected according to the physical parameters of tablets.