维生素B_2片溶出度测定研究
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摘要
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 B_2 tablets using the method of Chinese Pharmacopoeia,investigate the dissolution profiles of vitamin B_2 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 B_2 tablets.Methods Basket method was adopted at 100 r/min under wavelength of 444 nm to detect the absorption value;and the dissolution was determined according to the HPLC method of Chinese Pharmacopoeia.Results Vitamin B_2 tablets dissolution was well,and vitamin B_2 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.
Objective To detect the dissolution of 249 vitamin B_2 tablets using the method of Chinese Pharmacopoeia,investigate the dissolution profiles of vitamin B_2 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 B_2 tablets.Methods Basket method was adopted at 100 r/min under wavelength of 444 nm to detect the absorption value;and the dissolution was determined according to the HPLC method of Chinese Pharmacopoeia.Results Vitamin B_2 tablets dissolution was well,and vitamin B_2 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.
引文
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[8]李建光,姚军,李新霞,等.紫外光纤化学传感原位过程检测维生素B2片溶出度[J].新疆医科大学学报,2009, 32(8):1063-1064.
[2]曾维勇,刘忠义.甲硝唑、维生素B2、珍珠粉等配伍治疗口腔溃疡临床研究[J].北方药学, 2017, 14(8):6-8.
[3]武改,付海申.阿司匹林、维生素B2联合制霉菌素治疗足癣60例观察[J].中国药师, 2014, 17(7):1181-1183.
[4]史向文,汪惟国,王茹.提高维生素B2片溶出度工艺改进之探讨[J].安徽医药, 2002, 6(3):69.
[5]中国药典[S].二部. 2010.
[6]谢沐风.溶出曲线相似性的评价方法[J].中国医药工业杂志, 2009, 40(4):308-310.
[7]谢子立. HPLC法测定维生素B2片的含量及有关物质[J].安徽医药, 2013, 17(2):204-206.
[8]李建光,姚军,李新霞,等.紫外光纤化学传感原位过程检测维生素B2片溶出度[J].新疆医科大学学报,2009, 32(8):1063-1064.