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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。
Objective: To evaluate the rationality of 3 doses of warfarin sodium tablets. Methods: The warfarin sodium tablets of A (imported, uncoated), B (domestic, sugar-coated tablets) and C (domestic, film-coated tablets) were divided by 1 student using a drug- , The knife will be the whole piece of two or four equally divided by the other two students with scissors and two pharmacists with the powder sub-package the whole piece three or five equally divided (n = 30). With reference to the sixth edition of the “European Pharmacopoeia”, the second and fourth sub-tablets were evaluated on the accuracy of sub-doses, and the second, third, fourth and fifth sub-tablets were evaluated for their fragmentation. Disintegration time limit. Results: The dosage of two, three, four, five cents did not meet the “European Pharmacopoeia” requirements. There was no significant difference in the passing rate of the three methods between two and four equal doses. There was no significant difference in passing rate among the two pharmacists among the two students (excluding the five equal points). Only A manufacturers tablets equal pieces fragility meet the regulations, B, C manufacturers tablets three kinds of methods divided doses of fragmentation fragmentation are not in line with the provisions. A, B, C manufacturers tablet disintegration time were 3,29,23 min. CONCLUSIONS: All 3 manufacturers of warfarin sodium tablets are unsuitable for sub-divided doses using a cutter, scissors, knife or powder.