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目的:建立压可平Ⅱ胶囊中两种主成分阿替洛尔和硝苯地平的溶出度测定方法。方法:采用小杯法,转速为50 r·min-1,参照日本《医疗用药品品质情报集》中的溶出度试验条件并根据样品实际情况作出相应调整,采用HPLC法分别考察压可平Ⅱ胶囊在p H 1.2的人工胃液(含0.5%十二烷基硫酸钠溶液)、p H 4.0醋酸盐缓冲液(含0.5%十二烷基硫酸钠溶液)、p H 6.8磷酸盐缓冲液(含0.25%十二烷基硫酸钠溶液)及水(含0.25%十二烷基硫酸钠溶液)中的体外溶出行为。结果:阿替洛尔、硝苯地平与压可平Ⅱ胶囊中其他成分分离度良好,阿替洛尔、硝苯地平在10~30μg·ml-1浓度范围呈良好线性关系(r=0.999 6和r=0.999 8),两者在四种不同溶出介质中的平均回收率分别为99.64%(RSD=0.73%),99.55%(RSD=0.65%),99.53%(RSD=0.47%),99.54%(RSD=0.51%)和99.52%(RSD=0.61%),99.52%(RSD=0.72%),99.51%(RSD=0.63%),99.61%(RSD=0.59%)(n=9);压可平Ⅱ胶囊中两种主成分阿替洛尔和硝苯地平在四种不同的溶出介质中溶出度的均一性良好。结论:该方法简便、准确,重复性好,可用于该胶囊的溶出度测定。
OBJECTIVE: To establish a method for the determination of the dissolution of two main components, atenolol and nifedipine, in pressure-ping-ping capsule. Methods: The small cup method was used, the rotation speed was 50 r · min-1. According to the dissolution test conditions in the Japanese medical quality intelligence kit and according to the actual situation of the samples, Capsules were prepared in artificial gastric juice (containing 0.5% sodium dodecyl sulfate solution), pH 4.0 acetate buffer (containing 0.5% sodium lauryl sulfate solution), pH 6.8 phosphate buffer Containing 0.25% sodium lauryl sulfate solution) and water (containing 0.25% sodium lauryl sulfate solution) in vitro dissolution behavior. Results: The separation of atenolol, nifedipine and the other components in the tablet was good. Atenolol and nifedipine showed good linearity in the range of 10 ~ 30μg · ml-1 (r = 0.999 6 And r = 0.999 8). The average recoveries of the two compounds in four different dissolution media were 99.64% (RSD = 0.73%), 99.55% (RSD = 0.65%), 99.53% (RSD = 0.47%), 99.54% (RSD = 0.51%) and 99.52% (RSD = 0.61%), 99.52% (RSD = 0.72%), 99.51% (RSD = 0.63%) and 99.61% (RSD = 0.59% The two main components of Ke Ping II capsules atenolol and nifedipine in four different dissolution medium dissolution of the good uniformity. Conclusion: The method is simple, accurate, reproducible and can be used for the determination of dissolution of the capsule.