川芎散剂体外溶出特征研究

目的比较川芎散剂在不同介质中的溶出度,探讨川芎散剂的溶出特征。方法采用桨法,以阿魏酸为指标,利用紫外分光光度法测定川芎散剂在5种介质(水、0.1 mol/L盐酸、pH 4.5醋酸缓冲盐、pH 6.8磷酸缓冲盐、pH 7.4磷酸缓冲盐)中的溶出量,绘制溶出曲线,以相似因子法和威布尔模型评价。结果川芎散剂在5种介质中的溶出量具有差异性。在水、0.1 mol/L盐酸、pH 4.5醋酸缓冲盐和pH 6.8磷酸缓冲盐中的溶出具有相似性且符合威布尔模型,在pH 7.4磷酸缓冲盐中的溶出则发生突变,30 min即达最大溶出量。结论川芎散剂在酸性到中性再到碱性介质中溶出量逐渐增多且溶出时间缩短,在酸性和中性介质中溶出曲线相似,在碱性介质中溶出快而完全。

In Vitro Dissolution Feature of Chuangxiong Powder

Objective To compare the dissolution of Chuangxiong powder in different medium and discuss the dissolution characteristics in vitro of Changxiong powder. Methods The paddle method was adopted, the UV spectrophotometric method was developed to determine the in vitro dissolution quantity of Changxiong powder in five medium （water, 0.1 mol/L hydrochloric acid, acetate buffer of pH 4.5, phosphate buffer of pH 6.8, phosphate buffer of pH 7.4） with ferulic acid as index, and evaluated by drawing the dissolution curve and using the similar factor method and Weibull model. Results The dissolution quantity of Changxiong oral powder in five medium was different. The dissolution quantity in water, 0.1 mol/L hydrochloric acid, acetate buffer of pH 4.5 and phosphate buffer of pH 6.8 was similar and fit Weibull model, but it mutated in phosphate buffer of pH 7.4 and reached the maximum amount at 30 min. Conclusion The dissolution quantity of Changxiong powder is gradually increasing and the time is shorted in the medium from acidic to neutral then to alkaline. Dissolution curve is similar in the acidic and neutral medium. Changxiong powder dissolves out fast and completely in the alkaline medium.