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目的:利用六通道光纤药物溶出度过程监测仪,建立盐酸胺碘酮片剂的溶出度测定方法。方法:将6个光纤公共端部分别降入盛有900 mL0.25%十二烷基硫酸钠溶液的溶出杯,分别投入盐酸胺碘酮片,采用桨法,转速100 r·min~(-1),测定波长305 nm,参比波长为550 nm,通过计算机监视溶出过程。结果:光程6 mm,在305 nm 处胺碘酮于20.00～200.00 mg·L~(-1)范围内线性关系良好(r=0.9999),回收率试验与中国药典2000年版溶出度测定方法比较,2种测定方法无统计学意义(P>0.05)。结论:该法实现同时检测6片胺碘酮的溶出度,可直接从溶出曲线上提取相关参数;六通道光纤药物溶出过程监测系统原位、实时、连续、定量地反映了溶出迅速的特性,获得的数据信息更加完整、真实,相应软件的使用实现了体外溶出过程监测的自动化、智能化。
Objective: To establish a method for the determination of dissolution of amiodarone hydrochloride tablets by using six-channel optical fiber drug dissolution process monitor. Methods: The common ends of 6 fibers were respectively dropped into 900ml0.25% sodium dodecyl sulfate solution dissolving cup, and were respectively put into amiodarone hydrochloride tablets. The paddle method was used, the rotation speed was 100 r · min ~ (- 1). The measurement wavelength was 305 nm and the reference wavelength was 550 nm. The dissolution process was monitored by computer. Results: A linear range of 6 mm was obtained at 305 nm at a linear range of 20.00-200.00 mg · L -1 for amiodarone (r = 0.9999). The recovery test was compared with the 2000 edition of Chinese Pharmacopoeia There was no significant difference between the two methods (P> 0.05). Conclusion: This method can detect 6 dissolution rates of amiodarone at the same time and extract the relevant parameters directly from the dissolution curve. The monitoring system of six-channel optical fiber drug dissolution process reflects the rapid dissolution property in situ, in real time and quantitatively, The data obtained more complete and true, the use of the corresponding software to achieve in vitro dissolution process monitoring automation and intelligence.