苯磺贝他斯汀片的研制与体外评价

发布时间：2018-04-12 11:26

本文选题：苯磺贝他斯汀片 + 溶出度　；参考：《中国医药工业杂志》2017年10期

【摘要】：建立了高效液相色谱法测定苯磺贝他斯汀片的溶出度,并进行自制品与原研品在不同pH值溶出介质中的溶出曲线一致性评价。采用Agilent C_8色谱柱,以0.05 mol/L磷酸二氢钾溶液(用磷酸调至pH 3.0)∶乙腈(70∶30,含1.0 mg/ml戊烷磺酸钠),检测波长260 nm。以盐酸(pH 1.2)、乙酸盐缓冲液(pH 4.5)和磷酸盐缓冲液(pH 6.8)各900 ml为溶出介质,在转速50 r/min下,考察自制品与原研品的溶出度,并通过计算溶出曲线相似因子(f2)评价两者溶出行为的相似性。苯磺贝他斯汀检测的线性范围为3.6~18.0μg/ml;精密度、重复性和稳定性试验的RSD2.0%;3种溶出介质中的回收率分别为99.7%、100.2%和100.3%,RSD2.0%。自制品与原研品在盐酸(pH 1.2)中30 min时的溶出度均大于95%,在3种溶出介质中的f2值均大于65。表明自制品与原研品的体外溶出行为相似,质量一致性良好。
[Abstract]:A high performance liquid chromatography (HPLC) method was established for the determination of dissolution of benzobestatin tablets, and the consistency of dissolution curves between self-made and original products in different pH solution was evaluated.A Agilent C8 column was used with 0.05 mol/L potassium dihydrogen phosphate solution (adjusted to pH 3.0 with phosphoric acid: acetonitrile 70: 30, containing 1.0 mg/ml sodium pentane sulfonate). The detection wavelength was 260 nm.In this paper, the dissolution rate of the self-made and the original product was investigated at a rotational speed of 50 r/min, with pH 1.2 渭 m, pH 4.5 (pH 4.5) and pH 6.8 ml, respectively, in the buffer solution of sodium hydrochloride and phosphate buffer respectively, and the dissolution rate of the prepared product and the original product were investigated at a rotational speed of 50 r/min.The similarity of dissolution behavior was evaluated by calculating the similarity factor of dissolution curve.The linear range of benzenesurastatin was 3.6 ~ 18.0 渭 g / ml, and the recoveries of RSD 2.0 and RSD 2.0 were 99.7% and 100.3%, respectively.The dissolution of both the self-made and the original product in pH 1.2) was greater than 95 at 30 min, and the F _ 2 value in the three kinds of dissolution media was higher than 65.The results showed that the dissolution behavior of the self-made product was similar to that of the original product in vitro, and the quality was consistent.
【作者单位】：上海交通大学附属国际和平妇幼保健院药剂科;
【分类号】：O657.72;TQ460.72

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