Study on the Preparation Process and Quality Control of Naringin Liposome Gel / 中国药房

ABSTRACT

OBJECTIVE:To optimize the preparation process of Naringin liposome gel,and to establish the quality control method of the gel. METHODS:The preparation method of Naringin liposome was investigated by single factor test with encapsula-tion percentage as index. The phosphatide concentration,the proportion of phosphatide to cholesterol and the proportion of phospha-tide to drug in the liposomes were optimized by orthogonal design. Using formability,spread performance and stability as compre-hensive evaluation indicator,the dosage of carbopol and triethanolamine and drug-loading amount in the gels were optimized by or-thogonal design. The quality control method of the gel was established preliminarily. RESULTS:Naringin liposomes were prepared by the method of ethanol injection;the optimal formulation of the liposomes was as follows as phosphatide 30 mg/ml,the propor-tion of phosphatide to cholesterol 3∶1,the proportion of phosphatide to drug 10∶1;that of the gels was as follows as carbopol 0.30 g,triethanolamine 1.0 g,drug-loading amount 1.0 g/20 g. Average encapsulation efficiency of validation test was 40.19% for Lipo-some(RSD=0.10%,n=3);comprehensive score was 9.8,average content of naringin was 0.58%(accounting for 96.67% of la-bel amount)for gels. The quality control method of the preparation was established,i.g. identification,content determination. CON-CLUSIONS:The optimal preparation formulation is feasible,and the preparation is controllable in quality.