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目的:本实验旨在开发一种胶原酶缓释微球制剂,用以治疗手掌腱膜挛缩症,以减小现有水针剂的不足。方法:利用水相-水相乳化法和低温冷冻相分离法两种方法制备载药颗粒,分别将其包裹于PLGA微球内,制备成胶原酶微球,并用扫描电镜考察其表面形态,对其粒径进行统计学分析,测定体外释放行为并比较。结果:两种方法制备的微球表面光滑圆整,都可以达到缓释的效果,一个星期内释药完全。水相-水相乳化法制备的微球比低温冷冻相分离制备的微球粒径大,且具有统计学差异(P<0.05)。水相-水相乳化法制备的微球粒径较均一,其体外释放更加平缓,突释较小。结论:本研究制得的胶原酶微球能实现理想的体外缓释效果,解决了现有技术中胶原酶粉针剂型快速释放并分散的问题。
Objective: This experiment aims to develop a collagenase microspheres preparation for the treatment of palmar aponeurosis contracture in order to reduce the shortcomings of existing water injection. Methods: The drug-loaded particles were prepared by aqueous phase-water phase emulsification and cryogenic phase separation, and then encapsulated in PLGA microspheres to prepare collagenase microspheres. The surface morphology of the microspheres was observed by scanning electron microscopy. The particle size of the statistical analysis, determination of in vitro release behavior and comparison. Results: The microspheres prepared by the two methods had a smooth and round surface and achieved the sustained release effect. The drug release was complete within one week. Microspheres prepared by aqueous phase-emulsification method had larger particle sizes than those prepared by cryogenic phase separation, with statistical significance (P <0.05). The particle size of microspheres prepared by water phase and aqueous phase emulsification is more uniform, the in vitro release is more gentle and the release is smaller. Conclusion: The collagenase microspheres prepared in this study can achieve the desired sustained release effect in vitro and solve the problem of rapid release and dispersion of collagenase powder injection in the prior art.