吡哌酸片溶出度光纤传感实时分析研究

Study on dissolution of pipemidic acid tablets by fiber optic chemical sensor dissolution test system

目的建立吡哌酸片剂溶出度的光纤传感实时检测方法。方法采用转篮法,转速100r·min-1,以稀盐酸(24→1000)为溶出介质,用光纤化学传感药物溶出度实时分析系统在320nm处检测紫外吸收。同时用药典规定方法检测溶出浓度,以作相互对照。结果在50.5-249μg·mL-1内,吸光度与吡哌酸片的浓度成线性关系,平均回收率为100.4%。光纤传感实时检测方法所得结果与药典方法结果无显著性差异(P>0.05)。结论所建立的吡哌酸片剂溶出度的光纤传感实时检测方法可行,在位在线、连续定量地反映了药物体外溶出特性。

OBJECTIVE: To develop a fiber optic chemical sensor dissolution test system (FOCSDT) for determining the dissolution of pipemidic acid tablets. METHODS: The drug dissolution concentration was detected using the FOCSDT system, and the detection wavelength was at 320 nm. RESULTS: A good linearity was obtained over the range of 50.5-249 μg&middotmL-1. The average recovery rate was 100.4% (n = 6). The results obtained from the FOCSDT were no significantly different from the methods published in Chinese Pharmacopeia (2000) (P > 0.05). CONCLUSION: The new method established for the dissolution test of pipemidic acid tablets is feasible. As a procession analysis, FOCSDT system showed the real dissolution of drug and provided the total information.