维生素B2片溶出度测定研究

Studies on determination of dissolution of Vitamin B2 Tablets

目的用《中国药典》方法测定249批次维生素B2片的溶出度,同时,考察其中6个厂家样品在4种不同pH值溶出介质中的溶出曲线,并对溶出度紫外法与HPLC测定法进行比较,为全面评价药品质量提供依据。方法采用转篮法,4种不同溶出介质各600 mL,转速为100 r/min,检测波长444 nm;HPLC测定溶出度参考《中国药典》2015年版维生素B2原料的含量测定方法。结果维生素B2片总体溶出状况较好,不同厂家样品、同厂家不同批号样品均有相似的溶出行为;液相法与紫外法测定差异较大。结论溶出度测定紫外法专属性不高,建议采用液相法测定;部分厂家产品质量不稳定,应改善生产工艺。

Objective To detect the dissolution of 249 vitamin B2 tablets using the method of Chinese Pharmacopoeia,investigate the dissolution profiles of vitamin B2 tablets from 6 pharmaceutical factories in four dissolution mediums,compare the dissolution between UV spectrophotometry and HPLC,and provide the basis for a comprehensive evaluation of the quality of vitamin B2 tablets.Methods Basket method was adopted at 100 r/min under wavelength of 444nm to detect the absorption value;and the dissolution was determined according to the HPLC method of Chinese Pharmacopoeia.Results Vitamin B2 tablets dissolution was well,and vitamin B2 tablets had similar dissolution behavior with different manufacturers and different products by the same manufacturer.Conclusion The UV spectrophotometry in dissolution examination was not strong on specificity,and give an introduction of HPLC method to determinate.It is advised that some pharmaceutical manufacturers should improve the product quality by changing the formulation and process.