注射用紫杉醇亚微乳的制备及其性质考察

目的制备静脉注射用紫杉醇亚微乳并考察其理化性质。方法采用高压匀质法制备紫杉醇亚微乳,考察处方和工艺主要因素对乳剂相关性质的影响,评价其质量,并对血管刺激性进行考察。结果优化条件下制备的紫杉醇亚微乳粒度分布均匀,平均粒径为（168±22）nm,多分散系数为（0.89±0.05）,Zeta电位为-（33.9±0.5）mV,稳定性较好,血管刺激性小。结论紫杉醇亚微乳处方和工艺合理可靠,安全性好,便于生产和临床使用。

Preparation and Characteristics of Paclitaxel Submicroemulsion for Injection

Objective To prepare paclitaxel submicroemulsion for injection and investigate its physical- chemical properties. Methods A high pressure homogenizer was used to prepare paelitaxel submicroemulsion. The effect of different formulation and preparation factors on properties of paclitaxel submicroemulsion was evaluated. The possibility of vascular irritation was observed. Results Paclitaxel submicroemulsion for injection prepared using the optimal formula and technology had no vascular irritation and exhibited good particle size distribution and stabil- ity. The particle size, polydispersity index and zeta potential were （168 ±22） nm, （0.89 ±0.06）and - （33.9 ± 0.5 ） mV, respectively. Conclusion Paclitaxel submicroemulsion for injection is well-designed in formula, reliable in technology, and easy to manufacture and use.