摘要
目的：建立维生素B4片溶出度检测方法。方法采用桨法，以900 mL pH6.8磷酸盐缓冲溶液为溶出介质，温度37.0℃，转速为50 r／min，选取时间为45 min，经0.45μm微孔滤膜过滤，取续滤液，采用紫外分光光度法测定维生素B4片的溶出量，检测波长为262 nm，溶出限度为标示量的80％。结果维生素B4浓度在4～16μg／mL范围内与吸光度呈良好的线性关系， r＝0.9999（n＝5），平均回收率为100.1％，RSD＝1.0％（n＝9）。结论该方法简便、灵敏、准确，对不同生产企业的处方、工艺有一定考察作用，可用于维生素B4片的溶出度测定。
Abstract
Objective To establish a test method for determining the vitamin B4 tablets dissolution.Methods Paddle method was used to 900 mL pH6.8 phosphate buffer solution as the dissolution medium, the temperature of 37℃, the speed of 50 r/min, take time for 45 min.Taking the filtrate through the 0.45μm microporous membrane filtration, vitamin B4 tablets dissolution quantity determined by ultraviolet spectrophotometry, determined the wavelength of 262 nm, dissolution limit for 80% of the labeled amount.Results Vitamin B4 concentration had a good linear relationship with the absorbance in 4~16μg/mL, r=0.9999 (n =5), the average recovery was 100.1%, RSD =1.0% (n=9).Conclusion The method is simple, sensitive and accurate, has certain effect on prescription and study of the process of different production enterprises, can be used for the dissolution determination of vitamin B4 tablets.
NETL
NSTL
维普
万方数据