3种小儿用药片的分剂量评价

Evaluation of three pediatric dose tablets

目的考察3种小儿用药片分剂量对剂量准确性和质量的影响,为临床合理应用分剂量药品提供参考。方法对3种小儿用药片采用刀片分割法（A法）和磨粉分包法（B法）进行分剂量处理,每组各处理30份,精密称定质量,计算平均片质量和合格率,根据统计学结果分析比较A、B法分剂量的准确性;用A、B法分剂量成2等份,将整片与各半片分剂量于室温条件下放置10 d,定期采样,进行含量测定,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 3种小儿用药片用A、B法分剂量后,剂量的合格率范围分别为30.00%-93.33%、6.67%-30.00%,2种方法之间的差异具有统计学意义（P〈0.05）;含量测定结果均符合有关规定,但半片与整片的溶出曲线不相似,f2值范围分别是31.6-47.3、15.7-27.2。结论小儿用成人药片分剂量使用,剂量准确性差,溶出行为变化大,特别是磨成粉末状态,临床用药应引起足够重视;确需使用分剂量药品时,应尽量避免磨粉分包使用。

Objective To evaluate the effect of three pediatric dose tablets on the accuracy and the quality and provide the reference for clinical reasonable application dose drug.Methods By using blade segmentation method（A） and pulverizing method（B）,three kinds of pediatric tablets were divided doses of treatment for treatment 30 and weighed accurately.The average weight and conformity percentage were calculated.According to statistical analysis of dose results,the accuracy of the method A and B was evaluated.By using A and B divided dose into halves,the whole dose and halves were placed at room temperature for 10 days.After regular sampling,the contents were determined,and f2 similarity factor method and the whole piece of dissolving curve similarity comparison was used to evaluated the accuracy of these methods.Results After the three kinds of pediatric tablets were divided by A,B method,the conformity percentage ranges were 30.00%-93.33% and 6.67%-30.00%,and there was significant difference existed between the two methods（P〈0.05）.The content was in conformity with the relevant provisions,but the half and whole solution curves were not similar,and the f2 was 31.6-47.3 and 15.7-27.2.Conclusions The accuracy of three tablets A,B divided doses was not ideal,and the dissolution behavior varied greatly,especially the ground into powder,so clinical medication should be more attention.When the clinical need uses the divided dose drug,it should try to avoid the subcontract with milling sub.