苦参碱固体自微乳制剂的制备及其评价
Preparation and evaluation of matrine solid self-microemulsifying granule
傅春升 1李洪松 2张学顺1
作者信息
- 1. 山东中医药大学附属医院,山东济南250011
- 2. 山东中医药大学药学院,山东济南250355
- 折叠
摘要
目的 制备苦参碱固体自微乳颗粒,并对其进行质量评价.方法 通过固体吸附材料的优选,制备了苦参碱固体自微乳颗粒,建立了HPLC法测定颗粒中苦参碱及其体外溶出度的方法；对溶解后微乳的类型、pH值、Zeta电位、粒径进行研究.结果 选择微粉硅胶与甘露醇质量比2∶1为固体吸附材料,每克苦参碱微乳液需加微粉硅胶0.42 g,微晶纤维素0.21 g,50℃恒温干燥后成淡黄色的苦参碱自微乳颗粒,遇水快速形成澄明的液体,平均粒径79 nm,pH值为7.95,Zeta电位-1.34 mV,载药量23.51 mg/g,45 min内累积溶出94.2％以上.结论 苦参碱固体自微乳的制备工艺简单,制剂稳定,可为水难溶性药物的开发提供一个新方法、新思路.
Abstract
Objective To develop the matrine solid self-microemulsifying drug delivery syetem (S-SMEDDS) and to evaluate its quality. Methods The matrine solid self-microemulsifying granule was prepared through the optimization of solid adsorption material, the HPLC method and dissolution test were used to determine the drug content in matrine S-SMEDDS, and the particle form, pH value, Zeta potential, and particle size were studied after it was dissolved. Results The ratio of micro powder silica gel and mannitol (2 :1) was selected as the solid adsorption material, and 1 g of matrine micro-emulsion needed to add 0.42 g of micronized silica gel and 0.21 g of microcrystalline cellulose. The color of the matrine microemulsion particle was pale yellow after 50℃ constant temperature drying. Transparent liquid was formed quickly after it was dissolved. The average particle size was 79 run, the pH value was 7.95, the Zeta potential was -1.34 mV, the drug loading was 23.51 mg/g, and the cumulative dissolution was over 94.2% within 45 min. Conclusion The preparation technology of matrine S-SMEDDS is simple and stable, and provides a means for the research and development of dissolvable drugs.
关键词
苦参碱/固体自微乳化给药系统/固体吸附材料/溶出度Key words
matrine/solid self-microemulsifying drug delivery system/dissolution rate引用本文复制引用
出版年
2013
NETL
NSTL
维普
万方数据