目的制备赤芍总苷自微乳化给药系统(TGP-SMEDDS),优选其最佳处方,并对其进行初步的质量评价。方法采用伪三元相图法优化自微乳化处方,并对最佳处方进行粒径、乳滴形态、Zeta电位、表面张力、自乳化时间、溶出度及稳定性评价。结果由油酸乙酯、Cremophor RH40和Transcutol P组成的TGP-SMEDDS遇水可自发形成粒径为(47.26±0.08)nm的稳定微乳液,透射电镜下观察TGP-SMEDDS形态为均匀的球形,Zeta电位为(22.80±0.42)mV。结论制备的TGP-SMEDDS外观及稳定性良好,为赤芍总苷新剂型的进一步研究奠定了基础。

ObjectiveTo prepare the self-microemulsifying drug delivery system containing total glycosides in Paeoniae Radix Rubra (TGP-SMEDDS), optimize the formula, and preliminarily evaluate the quality. Methods The formula of self- microemulsifying was optimized with pseudo-ternary phase diagram. The droplet size and shape, Zeta potential, surface tension, self-microemulsifying time, dissolution, and stability were also evaluated. Results The TGP-SMEDDS composed of ethyl oleate, Cremophor RH40, and Transcutol P could spontaneously form a stable microemulsion with diameter about (47.26 ± 0.08) nm in water. TGP-SMEDDS presented uniform spherical drops under transmission electron microscope, and the Zeta potential was (?22.80 ± 0.42) mV. Conclusion The TGP-SMEDDS has good appearance and stability, which provides a strong foundation for the further research on new dosage forms of TGP.

辽宁省自然科学基金项目(20092015);沈阳市科学技术计划项目(F10-205-1-28);辽宁大学“211工程”三期建设项目