布洛芬混悬液分剂量的准确性考察

Accuracy Analysis on the Divided Dosage of Ibuprofen Suspension

目的:考察5个厂家儿童常用退热药布洛芬混悬液分剂量的准确性。方法:用药品附带的分剂量工具,按照说明书规定的"一次用量"量取布洛芬混悬液。采用《国际药典》2018年版中规定的方法,对用药时分剂量的准确性检验。结果:药品分剂量准确性合格率仅为54%,并随着"一次用量"体积的减小而降低;药品附带的量杯的"一次用量"处容量检定合格率仅为40%,并随着标称容量的减小而降低;用滴管调整量杯取的药量后,分剂量准确性提高至84%。结论:应改善多剂量包装口服液体药品分剂量的方式和工具;在药品标准中增加对分剂量准确性检验的项目和方法,以确保用药剂量的准确。

Objective: To study the accuracy of the dividing dosage method for ibuprofen suspension produced by 5 brands. Methods: Ibuprofen suspension was divided using the measuring devices included in the products and operated as "single dosage" according to the drug instructions. Accuracy of divided doses was evaluated according to the International Pharmacopoeia,ninth edition. Results: The accuracy rate of doses divided by the measuring device was only 54%,which declined as the volume of dosage decreased. The accuracy rate of the volume labeled on the measuring cup was only 40%,and decreased as the volume getting smaller. The accuracy rate of divided doses increased to 84% after adjusting the dividing method with a dropper. Conclusion: The measuring device provided by multi-dose liquid products for oral use should be modified. Testing method and requirement for ensuring the accuracy of divided doses should be added in the drug standard to ensure accurate using doses.