司坦唑醇自微乳制备及其质量评价

摘要

Objective To prepare the microemulsion delivery system of Stanozolol and to establish its quality evaluation . Methods The microemulsion delivery system was prepared with OP 40 emulsifier, Tween-80 and isopropyl alcohol ,and its size distribution, Zeta potential and stability were examined. The contents of Stanozolol were determined by HPLC . Results The microemulsion of Stanozolol was stable well. The average particle size and Zeta potential were 33. 32 nm and 4. 35mV, respectively. The linear range of Stanozolol was 0.639~3.195 μg(R2 = 1). The average recovery of Trenbolone Acetate was 99. 91% (RSD =0.05% ). Conclusions The preparation technique of the microemulsion is simple and feasible ,and its quality is stable and controllable.%目的 制备司坦唑醇自微乳给药体系并建立其质量评价方法.方法 以乳化剂OP-10、异丙醇和吐温-80制备司坦唑醇自微乳给药系统,考察其粒径分布、电动电势和稳定性.采用HPLC法测定司坦唑醇的含量.结论 所得自微乳稳定性良好,平均粒径为33.32 nm,电动电势为4.35 mV.司坦唑醇HPLC分析的线性范围为0.639～3.195 μg(R2=1);平均回收率为99.91%(RSD＝0.05%).结论该制剂制备工艺简便可行,质量稳定可控.