Determination of Dissolution in Xihuang Pills and Comparison of Different Pelleting Methods
Objective To establish methods for determining the dissolution rate of Xihuang pills,compare the similarity of dissolution curves between the pan-made method and plastic-made method,and evaluate the consistency of samples produced by the pan-made method and plastic-made method.Methods By screening four kinds of dissolution media,three kinds of rotational speed and two kinds of determination methods,pH 1.2 hydrochloric acid was finally determined as the dissolution medium,the dissolution speed was 100 r·min-1,the dissolution method was the small cup method,and the volume ratio of the dissolution sample to the dissolution medium was 3 g/200 mL.At the same time,the dissolution degree of bilirubin in Xihuang pill from the pan made method and plastic-made method was determined,and the similarity of dissolution curve was evaluated by difference factor(f1)and similarity factor(f2)in model-independent method.Results The dissolution rate reached the highest at 90 min.According to the determined dissolution test parameters,the precision,repeatability and stability of bilirubin all met the requirements.The dissolution degree of bilirubin in the two production processes was similar.Conclusion The quality of the products produced by the pan-made method process and plastic-made method process is no obvious influence,and the quality of the products is consistent.
万方数据
维普
