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目的:评价三种片剂药品小儿分剂量用药对其有效成分含量及溶出度的影响,为临床合理应用分剂量药品提供参考。方法:对三种小儿用药片分别采用刀片分割(A法)和磨粉分包(B法)分剂量成2等份,室温条件下放置7 d,定期采样,各分剂量分别进行含量和有关物质测定,并采用f2相似因子法与整片进行溶出曲线相似性比较。结果:三种小儿用药片用A法、B法分剂量后,其含量和有关物质检查均符合有关规定,但半片与整片的溶出曲线不相似,f2值范围分别是32~48、16~27。结论:小儿用药以成人药片分剂量使用,其溶出行为变化较大,特别是磨成粉末状态(B法),临床用药应引起足够重视。
Objective: To evaluate the effect of three kinds of tablets in children on their active ingredients and dissolution rate, and provide a reference for clinical application of divided doses. Methods: The three kinds of pediatric tablets were divided into two equal parts by blade division (A method) and milling subcontracting (B method), and placed for 7 days at room temperature. Samples were taken regularly and the contents and contents Material determination, and f2 similarity factor method with the whole piece of dissolution curve similarity comparison. Results: The contents of three kinds of pediatric tablets with A method and B method were all accordant with the relevant regulations. However, the dissolution curves of the half tablets and the whole tablets were not similar. The range of f2 values were 32 ~ 48, 16 ~ 27. Conclusion: Pediatric medication with adult pills in divided doses, the dissolution behavior of the larger changes, especially into the powder state (B method), clinical medication should cause enough attention.