CAJ | 학술논문

目的优选紫杉醇自微乳的处方工艺,并研究其稳定性。方法以性状、粒径、含量、有关物质、细菌内毒素等为测定指标,考查不同pH和不同活性炭用量对工艺的影响,筛选出优化处方,并对其进行稳定性研究。结果制备的紫杉醇自微乳为淡黄色澄明液体,平均粒径19.6 nm,呈Gauss分布。紫杉醇自微乳释药体系( PTX-SMEDDS)经高速离心后稳定,影响因素实验结果表明,PTX-SMEDDS对高温和光不稳定。6个月的加速实验表明,各项指标均无明显变化。确定紫杉醇自微乳应密封、低温避光保存。结论紫杉醇自微乳制备工艺简便,制剂稳定,载药量高,适宜开发为注射自微乳释药体系。
목적우선자삼순자미유적처방공예,병연구기은정성。방법이성상、립경、함량、유관물질、세균내독소등위측정지표,고사불동pH화불동활성탄용량대공예적영향,사선출우화처방,병대기진행은정성연구。결과제비적자삼순자미유위담황색징명액체,평균립경19.6 nm,정Gauss분포。자삼순자미유석약체계( PTX-SMEDDS)경고속리심후은정,영향인소실험결과표명,PTX-SMEDDS대고온화광불은정。6개월적가속실험표명,각항지표균무명현변화。학정자삼순자미유응밀봉、저온피광보존。결론자삼순자미유제비공예간편,제제은정,재약량고,괄의개발위주사자미유석약체계。
Objective To study the preparation and stability of paclitaxel self-microemulsifying drug delivery system ( PTX-SMEDDS) . Methods The formulation of the PTX-SMEDDS was optimized by monitoring the appearance, particle size, concentration, relative substance, and bacterial endotoxin. Influence of different pH and different dosage of activated carbon on PTX-SMEDDS was investigated. Subsequently it was subjected to stability studies. Results The PTX-SMEDDS was a translucent diluted-yellow solution with a mean diameter of 19. 6 nm. High speed centrifugal test indicated PTX-SMEDDS was stable. The result of the influential factor tests showed PTX-SMEDDS was unstable to high temperature and light. In the accelerated tests for 6 months, the quality of PTX-SMEDDS was stable. The samples should be sealed and stored at low temperature and shady place. Conclusion Easily prepared and stable formulation of PTX-SMEDDS is achieved, and further investigation is warranted to develop self-microemulsifying drug delivery system for injection.