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目的考察注射型植入剂体外释放方法的可行性。方法建立模型药物诺氟沙星的反相高效液相色谱测定方法,以直接注射法、单向圆筒法、透析袋法及自制圆筒法考察注射型植入剂的体外释药特性,并与大鼠皮下注射的释放结果作比较。结果注射型植入剂体内释药速率明显快于体外,体内持续释药阶段(1～20d)接近零级释药(r=0.9935),而体外持续释药阶段以15d为界分为缓慢释药、快速释药两个阶段。4种体外释放方法中,自制圆筒法的突释阶段较为接近体内释药。结论注射型植入剂的4种体外释放方法均有一定的缺陷,不能完全模拟药物在体内的释放情况,注射型植入剂的体外释放方法有待于进一步探索。
Objective To investigate the feasibility of in vitro release methods of injectable implants. Methods The model drug norfloxacin was established by reversed-phase high performance liquid chromatography (RP-HPLC). The in vitro release characteristics of injectable implants were investigated by direct injection, unidirectional cylinder method, dialysis bag method and self-made cylinder method. Compared with the results of subcutaneous injection in rats. Results The in vivo release rate of injectable implants was significantly faster than that of in vitro. The in vivo sustained release phase (1 ~ 20d) was close to zero release (r = 0.9935), while the sustained release phase in vitro was divided into slow release Medicine, rapid release of two stages. Among the four in vitro release methods, the burst phase of the self-made cylinder method is closer to the in vivo release. Conclusion All four in vitro release methods of injectable implants have certain defects, which can not fully simulate the drug release in vivo. The in vitro release of injectable implants remains to be further explored.