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目的制备磷酸苯丙哌林缓释胶囊,并考察与磷酸苯丙哌林缓释片的生物等效性。方法采用熔融法固体分散技术和滴丸工艺,制备磷酸苯丙哌林缓释胶囊;用RP-HPLC法测定Beagle犬单次和多次口服磷酸苯丙哌林缓释胶囊和参比制剂的血药浓度,并进行生物等效性评价。结果磷酸苯丙哌林两种制剂的体外释放基本一致,在Beagle犬体内均具缓释特征。结论磷酸苯丙哌林缓释胶囊具有缓释特征,与缓释片等效。
Objective To prepare sustained release capsules of benproperine phosphate and evaluate the bioequivalence with benproperine phosphate sustained release tablets. Methods Melting solid dispersions and dropping pills were used to prepare benproperine phosphate sustained-release capsules. The single and multiple oral doses of benproperine phosphate sustained release capsules and reference preparations were determined by RP-HPLC Drug concentration, and bioequivalence assessment. Results Both in vitro and in vivo release of benproperine phosphate were consistent and sustained release in Beagle dogs. Conclusion The sustained release tablets of benproperine phosphate have the characteristics of sustained release and are equivalent to sustained release tablets.