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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。
OBJECTIVE To prepare TGP-SMEDDS (total glycosides of TPG), optimize its optimal formulation and evaluate the quality of TGP-SMEDDS. Methods The pseudo-ternary phase diagram method was used to optimize the self-microemulsifying prescription. The particle size, droplet morphology, Zeta potential, surface tension, self-emulsifying time, dissolution and stability of the optimized prescription were evaluated. Results TGP-SMEDDS composed of ethyl oleate, Cremophor RH40 and Transcutol P spontaneously formed a stable microemulsion with a particle size of (47.26 ± 0.08) nm. Transmission electron microscopy showed that the morphology of TGP-SMEDDS was uniform spherical, Zeta The potential was (22.80 ± 0.42) mV. Conclusion The prepared TGP-SMEDDS has good appearance and stability, which lays the foundation for the further study of new formulations of total glycosides of Radix Paeoniae Alba.