炎琥宁肠溶微丸中炎琥宁含量测定的方法学研究

The Methodology Study on Andrographolide Content Determination in Yanhuning Enteric Coating Pellets

目的:建立炎琥宁肠溶微丸中炎琥宁含量测定方法,为炎琥宁口服制剂的研究提供依据。方法:配制炎琥宁和炎琥宁肠溶微丸辅料的蒸馏水溶液,分别于200～400 nm波长范围内扫描确定最佳波长并进行精密度和回收率实验。结果:炎琥宁在251 nm处有最大吸收峰,所建立方法在20～50μg/mL浓度范围内线性关系良好,日内、日间精密度及提取回收率RSD均小于3%。结论:紫外分光光度法测定炎琥宁肠溶微丸中炎琥宁的含量方法简便、灵敏、专属性强。

Objective：To establish a method for determination of andrographolide in Yanhuning enteric-coated pellets and to provide evidence for the new oral preparations.Methods：The distilled water solution of Andrographolide and adjuvant of Yanhuning enteric-coated pellets were prepared,and scanned respectively in 200~400 nm wavelength range to determine the optimal wavelength.The precision and recovery experiments were done.Results： Andrographolide in 251 nm place had maximum absorption peaks.A good linearity was obtained in the concentration range of 20~50 μg/mL.The RSD of intra-day,inter-day precision and extraction recovery were all less than 3%.Conclusion：The method for UV spectrophotometry for the determination of andrographolide content of the Yanhuning enteric-coated pellets is simple,sensitive and has strong specificity.