Evaluation of Dosage form Characteristics of Fuzi Lizhongwan Based on Dissolution Behavior / 中国实验方剂学杂志

ABSTRACT

Objective:Based on the previous studies, to investigate the dissolution behavior of Fuzi Lizhongwan by simultaneously determining the dissolution of benzoylmesaconine, benzoylaconine and benzoylhypaconine in Aconiti Lateralis Radix Praeparata. Method:The simultaneous determination of benzoylmesaconine, benzoylaconine and benzoylhypaconine in Fuzi Lizhongwan was established by HPLC-QQQ-MS. The dissolution amounts of three compositions in 15 batches of Fuzi Lizhongwan from 5 manufacturers at different time points, the cumulative dissolution was calculated and the dissolution curve was drawn. The f2 similarity factor method was adopted to evaluate similarity of dissolution curves of index components in different batches of samples from the same manufacturer, and to evaluate similarity of dissolution curves of samples from different manufacturers based on the same index component. The dissolution model of Fuzi Lizhongwan was concluded by fitting with the dissolution data. Result:When hydrochloric acid solution with pH of 1.2 was used as the dissolution medium, the three alkaloids had the best dissolution effect. The dissolution behavior of three monoester alkaloids in Fuzi Lizhongwan was basically synchronous and the dissolution lasted for 24 h. Three batches of samples from the same manufacturer (manufacturer 1, 3, 4 and 5) appeared to be similar on dissolution behavior, indicating that the dissolution behavior of the majority of samples from different manufacturers was similar. The dissolution behavior of batch 1 sample was different from batch 2 and 3 samples in manufacturer 2, suggesting that the quality of different batches of samples in manufacturer 2 might be different. The fitting results of dissolution data of index components in samples from different manufacturers were consistent, and the Weibull model was the best. Conclusion:Index components in fifteen batches of samples from 5 manufacturers are continuously dissolved within 24 h, indicating that the samples have the characteristics of slow dissolution. The dissolution curves of samples from the same manufacturer are similar to each other, indicating that the quality of different batches of products from most manufacturers is stable. The dissolution behavior of benzoylmesaconine, benzoylaconine and benzoylhypaconine in samples form different manufacturers has some differences, which may be caused by the source of medicinal materials and preparation technology parameters.