葛根素自微乳的制备及其质量控制Self-Microemulsifying System of Puerarin and Its Quality Evaluation
冯灿;李影雄;李子鸿;王汝上;
FENG Can;LI Ying-xiong;LI Zi-hong;WANG Ru-shang;Foshan Hospital of TCM;Guangzhou Consun Drug Research Ltd.;
摘要(Abstract)：
目的制备葛根素自微乳给药系统并建立其质量评价方法。方法以乳化剂OP-10、Cremophor RH40、Transcutol P制备葛根素自微乳给药系统,考察其外观、Zeta电位、粒径分布及稳定性;采用高效液相色谱法建立葛根素自微乳的质量评价方法。结果所得自微乳稳定性良好,平均粒径为32.31 nm,电动电势为-19.98 mV(n=3)。葛根素的HPLC分析线性范围为0.2133.195μg;平均回收率为100.25%(n=9),RSD=0.49%。结论本制剂制备工艺简便,质量稳定可控,符合良好的身微乳制剂的要求。
Objective To prepare the puerarin( PUE) self-microemulsifying drug delivery system( Pue-SMEDDS),and to establish its quality evaluation. Methods The Pue-SMEDDS was prepared with OP-10 emulsifier,Cremophor RH40 and Transcutol P,and its appearance,Zeta potential,size distribution and stability were examined. The contents of puerarin were determined by HPLC. Results The Pue-SMEDDS was stable well,the average particle size and Zeta potential were 32. 31 nm and- 19. 98 mV( n = 3),respectively. The linear range of Stanozolol was 0. 213 3.195μg;平均回收率为100.25%(n=9),RSD=0.49%。结论本制剂制备工艺简便,质量稳定可控,符合良好的身微乳制剂的要求。
Objective To prepare the puerarin( PUE) self-microemulsifying drug delivery system( Pue-SMEDDS),and to establish its quality evaluation. Methods The Pue-SMEDDS was prepared with OP-10 emulsifier,Cremophor RH40 and Transcutol P,and its appearance,Zeta potential,size distribution and stability were examined. The contents of puerarin were determined by HPLC. Results The Pue-SMEDDS was stable well,the average particle size and Zeta potential were 32. 31 nm and- 19. 98 mV( n = 3),respectively. The linear range of Stanozolol was 0. 213 3. 195 μg. The average recovery of Trenbolone Acetate was 100. 25%( n = 9),RSD = 0. 49%. Conclusion The preparation technique of the microemulsion is simple and feasible,and its quality is stable and controllable,which meets the needs of good SMEDDS formulation.
关键词(KeyWords)：
葛根素;自微乳给药系统;质量评价
puerarin(PUE);self-microemulsifying drug delivery system;quality evaluation
基金项目(Foundation):
作者(Authors):
冯灿;李影雄;李子鸿;王汝上;
FENG Can;LI Ying-xiong;LI Zi-hong;WANG Ru-shang;Foshan Hospital of TCM;Guangzhou Consun Drug Research Ltd.;
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