摘要
为建立复方氨酚苯海拉明片溶出曲线UPLC检测方法,并对市售产品及参照药品体外溶出过程进行考察,分析影响溶出行为的处方、工艺、环境因素,为复方氨酚苯海拉明片的质量和疗效一致性评价工作提供参考。该文采用Waters ACQUITY UPLC BEH C18(2.1 mm×50 mm,1.7μm)色谱柱,以水(磷酸调p H至2.5)与乙腈为流动相梯度洗脱,流量0.5 m L/min,检测波长216 nm(对乙酰氨基酚和盐酸苯海拉明)和205 nm(咖啡因和盐酸麻黄碱);溶出曲线试验采用桨法,选用4种溶出介质各900 m L/500 m L,转速50 r/min。结果表明各生产企业样品批内溶出曲线相似度均较差,同一介质中不同企业样品间溶出行为差异大。该方法简便、准确,可用于复方氨酚苯海拉明片的溶出曲线测定。
In order to establish the dissolution detection method for compound paracetamol and diphenhydramine tablets by UPLC and the process of the dissolution were investigated.Prescription process,environmental factors influencing the dissolution behavior were studied and analyzed,providing reference for the evaluation of quality and efficacy consistency of compound paracetamol and diphenhydramine tablets.In this paper,Waters ACQUITY UPLC BEH C18(2.1 mm×50 mm,1.7μm)was adopted with the mobile phase consisting of water(ajusted pH 2.5 with phosphoric acid)-acetonitrile for gradient elution,the flow rate was 0.5 mL/min,and their detection wavelengths were 216 nm and 205 nm;The dissolution was tested with paddle method at 50 r/min with 900 mL(or 500 mL)in 4 dissolution mediums.The results show that the similarity of the dissolution curves of samples in all manufacturers was poor,and the dissolution behavior among different manufacturers in the same medium was quite different.This method is simple,accurate and can be used for the determination of dissolution curves of compound paracetamol and diphenhydramine tablets.
作者
陈星宇
刘美玲
朱恒怡
袁军
徐小平
钱广生
CHEN Xingyu;LIU Meiling;ZHU Hengyi;YUAN Jun;XU Xiaoping;QIAN Guangsheng(West China School of Pharmacy,Sichuan University,Chengdu 610041,China;Sichuan Institute for Food and Drug Control,Chengdu 611731,China)
出处
《中国测试》
CAS
北大核心
2018年第8期41-46,共6页
China Measurement & Test
