目的 制备去甲斑蝥素固体自微乳并对其稳定性进行考察。方法 以包封率和收率为考察指标,采用球晶制备技术,正交设计优化制备工艺,实现球晶技术一步固化去甲斑蝥素自微乳,并对去甲斑蝥素固体自微乳粒径大小、电位、自乳化速率、稳定性等进行考察。结果 去甲斑蝥素自微乳最佳处方的平均包封率和收率分别为77.39%和84.5%,粒径为22.76nm,Zeta电位为-2.77mV。自乳化速率在不同介质中相差不大,50s内均可完成自乳化。稳定性实验显示,去甲斑蝥素自微乳的粒径大小、电位和包封率在60℃及强光照试验下无变化。结论 自制的去甲斑蝥素固体自微乳稳定可靠。
Objective To investigate the preparation and stability of norcantharidin solid self-microemulsion. Methods With encapsulation efficiency and yield as evaluation indices, the spherical crystallization technique was used for preparation, and an orthogonal design was used for the optimization of preparation process to realize the solidification of norcantharidin self-microemulsion in a single step. Norcantharidin solid self-microemulsion was evaluated in the aspects of particle size, potential, self-emulsifying rate, and stability. Results The best prescription of norcantharidin self-microemulsion had a mean encapsulation efficiency of 77.39%, a mean yield of 84.5%, a particle size of 22.76 nm, and a Zeta potential of -2.77 mV. There was no significant difference in self-emulsifying rate between different media, and self-emulsification was completed within 50 seconds. The stability test showed that there were no changes in particle size, potential, or encapsulation efficiency of norcantharidin self-microemulsion at a temperature of 60℃ and after exposure to strong light. Conclusion The self-made norcantharidin solid self-microemulsion is stable and reliable.