论文部分内容阅读
目的:建立香连丸中内酯类成分的溶出度测定方法,揭示其体外溶出行为及关键影响因素。方法:采用小杯法,利用HPLC测定香连丸中木香烃内酯、去氢木香内酯在不同p H,搅拌桨转速和聚山梨酯-80质量分数条件下的溶出量,计算累积溶出率,绘制溶出曲线。采用软件Origin Pro 8.0对溶出曲线进行模型拟合,计算溶出参数。结果:在各种p H介质及转速条件下,香连丸中木香烃内酯、去氢木香内酯的6 h累积溶出率均<50%;当介质中聚山梨酯-80质量分数>0.3%时,2种成分的4 h累积溶出率均>90%,说明已溶出完全,且随着聚山梨酯-80质量分数的升高,2种成分的T50(溶出50%所用时间)和Td(溶出63.2%所需时间)均明显缩短,溶出速率加快。结论:香连丸中内酯类成分的体外溶出不完全,介质中表面活性剂质量分数对其溶出有较为显著的影响。
OBJECTIVE: To establish a method for the determination of the dissolution of lactones in Xianglian pills and to reveal its dissolution behavior in vitro and the key influencing factors. Methods: The small cup method was used to determine the elution amount of carnitol lactone and dehydrocostusolol in Xianglian pills under different p H, propeller rotational speed and polysorbate-80 mass fraction, and the cumulative Dissolution rate, draw the dissolution curve. Dissolution curves were modeled using Origin Pro 8.0 software to calculate dissolution parameters. Results: The dissolution rates of allolignan and dehydrocostuslane in Xianglian pills were all less than 50% under various conditions of p H medium and rotational speed. When the mass fraction of polysorbate-80 > 0.3%, the cumulative elution rates of the two components were> 90% at 4 h, indicating that the dissolution rate had been completely eluted. With the increase of polysorbate-80 mass fraction, the T50 of the two components (50% dissolution time) And Td (63.2% of the time required for dissolution) were significantly shortened, dissolution rate accelerated. CONCLUSION: The lactone components in Xianglian pills are not completely eluted in vitro, and the mass fraction of surfactants in the medium has a significant effect on its dissolution.