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目的:考察联苯双酯干混悬剂的体外溶出行为及其稳定性。方法:采用HPLC法测定联苯双酯干混悬剂的体外溶出度,考察不同转速(50,75,100 r·min~(-1))、不同溶出介质(pH 6.8磷酸盐缓冲液、0.05 mol·L~(-1)盐酸溶液、水和pH 4.5醋酸盐缓冲液)对溶出结果的影响。进行联苯双酯干混悬剂的影响因素试验(高温、高湿和强光照射)、加速稳定性试验[温度为(37±5)℃,相对湿度为76%±5%]和长期稳定性试验[温度为(25±3)℃,相对湿度为60%±5%]。结果:联苯双酯干混悬剂在pH 6.8磷酸盐缓冲液(50 r·min~(-1))中溶出行为较快且平缓;影响因素试验结果表明联苯双酯干混悬剂不易储存在高温、高湿的条件下;在加速试验和长期稳定性试验中放置6个月后样品的各项考察指标未发生明显变化。结论:所制备的联苯双酯干混悬剂体外溶出符合要求,稳定性良好。
OBJECTIVE: To investigate the in vitro dissolution behavior and stability of bifendate suspension. Methods: The dissolution rate of bifendate suspension in vitro was determined by HPLC. The effects of different rotational speed (50,75,100 r · min -1), different dissolution media (pH 6.8 phosphate buffer, 0.05 mol · L -1 hydrochloric acid solution, water and pH 4.5 acetate buffer) on dissolution results. Experiments were carried out to determine the influencing factors of bifendate suspension (high temperature, high humidity and bright light), accelerated stability test (temperature 37 ± 5 ℃, relative humidity 76% ± 5%) and long-term stability Sexual Testing [Temperature (25 ± 3) ° C, Relative Humidity 60% ± 5%]. Results: The dissolution of bifendate suspension in pH 6.8 phosphate buffer solution (50 r · min -1) was faster and more gentle. The influencing factors of the test results showed that the BDS dry suspension was not easy Stored at high temperature and high humidity conditions; accelerated test and long-term stability test placed 6 months after the sample of the inspection indicators did not change significantly. Conclusion: The prepared bifendate dry suspension in vitro dissolution meets the requirements and the stability is good.