摘要
目的制备苦参碱自微乳制剂,并对其进行质量评价。方法通过溶解度试验、伪三元相图的研究,筛选出苦参碱自微乳最佳处方;在此基础上制备苦参碱自微乳制剂,建立HPLC法测定自微乳中苦参碱的方法;对自微乳的外观、形态、粒径及其分布、Zeta电位、载药量和稳定性进行考察。结果苦参碱自微乳最佳处方为苦参碱-油酸-油酸乙酯-EL-40-异丙醇(0.5∶0.15∶0.15∶0.35∶0.35);制备的苦参碱自微乳为澄明液体,流动性、稳定性好,遇水形成O/W型微乳,平均粒径(68.00±0.07)nm(n=3),平均载药量为42.689 mg/mL(n=3)。结论自微乳制剂制备工艺简单、性质稳定,为苦参碱自微乳制剂的进一步研究奠定基础。
Objective To develop the matrine self-microemulsifying drug delivery system （SMEDDS） and evaluate its quality. Methods The solubility test and pseudotemary phase diagram were utilized to select proper matrine microemulsions prescription. On this basis, matrine-SMEDDS was formulated and HPLC method was used to determine the drug content in matrine-SMEDDS; The appearance, morphology, particle size, particle size distribution, Zeta potential, drug loading, and stability of matrine in the liposome were studied. Results The best prescription of matrine-SMEDDS was matrine-oleic-ethyloleate-EL-40-isopropanol （0.5 ： 0.15 ： 0.15 ： 0.35 ： 0.35）. The selected matrine-SMEDDS was transparent liquid with good liquidity and stability and could form O/W type microemulsion with water, with an average particle size of （68.00 ± 0.07） nm （n = 3）. The average drug loading was 42.689 mg/mL （n = 3）. Conclusion The preparation technology is simple and stable, and provides a strong foundation for research of matrine-SMEDDS.
出处
《中草药》
CAS
CSCD
北大核心
2013年第4期414-419,共6页
Chinese Traditional and Herbal Drugs
关键词
苦参碱
自微乳制剂
伪三元相图
HPLC
O
W型微乳
matrine
self-microemulsifying
pseudoternary phase diagram
HPLC
O/W type microemulsion
