小儿止喘泡腾片的研制和质量控制

Preparation and quality control for treatment of children bronchial asthma with effervescent tablets

目的：研究小儿止喘泡腾片的制备及质量控制标准。方法：设计处方和制备工艺，应用反相高效液相色谱法一次性完成多组份药物含量测定。结果：氧茶碱、盐酸溴己新及马采酸氟笨那敏线性范围分剐为62．5～625μg／ml(r=0．9992)、12．5～25μg／ml（r=0．9996)、1．25～12．5μg／ml(r=0．9998)。回收率和RSD值分别为99．12％、0．98％；98．85％、1．04％；98．03％、1．02％、结论：该制剂性质稳定，配方合理。含量测定方法简便快捷，具有临床应用价值。

Objective: To study the preparation and quality control for treatment of children bronchial asthma with effervescent tablets. Methods: With a prescri ption presigned and techniques for producing effervescent tablets established, t he content of the multi components has been determined by reversed phase high p erfomance liquid chromatography. Results: The aminophyline and bromhexine hydroc hloride and chlorphenamine maleate linear within ranges of 62.5~625 ìg/ml (r=0. 9992), 12.5~125 ìg/ml (r=0.9992), 1.25~12.5 ìg/ml (r=0.9992). The recovery inc idences and RSDs were 99.12%, 0.98%; 98.85%, 1.04%: 98.03%, 1.02% respectively. Conclusion: The method of preparation is reasonable, stable, the content determi nation was simple which suggests the clinical significance of this thempeutis sc heme.