3厂家华法林钠片分剂量的评价

目的:评价3厂家华法林钠片分剂量的合理性。方法:对A(进口,未包衣)、B(国产,糖衣片)、C(国产,薄膜衣片)厂家的华法林钠片进行分剂量,分别由1名学生用切药器、剪刀、小刀将整片进行二、四等分;由另外2名学生用剪刀和2名药师用磨粉分包将整片进行三、五等分(n=30)。参照《欧洲药典》第6版,对二、四等分片进行分剂量准确性评价,对二、三、四、五等分片进行等分片脆碎度评价,并考察3厂家片剂的崩解时限。结果:3厂家二、三、四、五等分分剂量准确性均不符合《欧洲药典》规定。3种方法二、四等分分剂量合格率无明显差异,2名学生(除五等分外)间比较、2名药师间比较分剂量合格率均无明显差异。仅A厂家片剂的等分片脆碎度符合规定,B、C厂家片剂3种方法分剂量的等分片脆碎度均不符合规定。A、B、C厂家片剂的崩解时限分别为3、29、23min。结论:3厂家的华法林钠片均不适合用切药器、剪刀、小刀或磨粉分包分剂量。

Evaluation of Subdivision of Warfarin Sodium Tablets from 3 Enterprises

OBJECTIVE：To evaluate rationality of splitting warfarin sodium tablets from 3 enterprises.METHODS：Tablet cutter,scissor and knife were used to divide whole tablet from enterprise A（imported uncoated tablets）,B（domestic sugar-coated tablets） and C（domestic film-coated tablets） into half and quarter parts by a student.For one third and one fifth parts,the method scissor by 2 students and pulverizing by 2 pharmacists were applied（n=30）,meanwhile European Pharmacopeia 6.0（EP 6.0） and other standards were adopted to evaluate the accuracy of subdivision of half and quarter parts and friability of all the subdivision.The disintegration time of tablets from 3 enterprises was investigated.RESULTS：The accuracy of subdivision of Warfarin sodium tablets from 3 enterprises could not met the requirement specified in EP 6.0.There was no significant difference in the pass rate of subdivision of half and quarter parts among 3 methods,there was no significant difference in the pass rate of subdivision between 2 students（except fifth parts） or 2 pharmacists.As to friability test for equal parts,enterprise A met the standard while enterprises B and C not.The disintegration time were 3,29 and 23 min for 3 enterprises.CONCLUSION：It is not rational to subdivide Warfarin sodium tablets by above methods.