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目的:建立坎地沙坦酯自微乳制剂,并评价其质量。方法:通过溶解度试验、三元相图的研究筛选了坎地沙坦酯自微乳处方,在此基础上制备坎地沙坦酯自微乳制剂;建立HPLC法测定坎地沙坦酯自微乳中药物的含量;对自微乳的外观性状、形态、粒径及粒径分布、含量和稳定性进行研究,并对制剂进行了溶出度的考察。结果:坎地沙坦酯自微乳为无色澄明液体且稳定性良好,遇水形成O/W型微乳,稀释100倍后电镜下观察成圆球形,平均粒径为37.6 nm。经计算后坎地沙坦酯自微乳化液载药量为10.5 mg.mL-1。体外释放试验表明自微乳制剂受溶出介质的影响小。结论:坎地沙坦酯自微乳制备工艺简单,性质稳定,质量易控。
Objective: To establish candesartan cilexetil self-microemulsions and evaluate its quality. METHODS: The formulation of candesartan cilexetil self-microemulsion was screened through the study of solubility test and ternary phase diagram. The candesartan cilexetil self-microemulsion was prepared based on this study. The content of drug in milk; the appearance, shape, particle size and particle size distribution, content and stability of the self-microemulsion were studied, and the dissolution of the preparation was investigated. Results: Candesartan cilexetil self-microemulsion was a colorless and clear liquid with good stability. O / W microemulsion was formed in water. After diluted 100 times, the particles were observed to be spherical by electron microscopy with an average particle size of 37.6 nm. After calculation, the drug load of candesartan cilexetil self-microemulsion was 10.5 mg.mL-1. In vitro release tests showed that self-microemulsion formulations were less affected by the dissolution medium. Conclusion: The preparation of candesartan cilexetil self-microemulsion is simple, stable in nature and easy to control.