| OBJECTIVE To prepare Amlodipine Besylate flexible nano-liposomes (AM-FNL), analyse the quality and character and optimize the best formula.METHODS AM-FNL was prepared by film-ultrasonic technique and purified by exclusion chromatography with Sephadex G-50. The recovery and concentration of AM-FNL was determined by ultraviolet spectrophotometry (UV) and high performance liquid chromatography (HPLC). The envelope efficiency and drug loading of AM-FNL were taken as criteria. The formula of AM-FNL was optimized by orthogonal design.RESULTS The particle size of AM-FNL was well-distributed. The linear detection range of AM-FNL concentration was 1-50μg/ml. The average recovery is (100.12±0.54)% and (99.88±0.57)%, and the concentration is (101.4±1.75)% and (100.6±0.86)% determined by UV and HPLC respectively. The optimum formula of AM-FNL was AM: phosphatidylcholine 1 : 20, phosphatidylcholine: cholesterol 1:3, sodium cholate: phosphatidylcholine 1:1, hydrating medium pH=7.4. The encapsulation efficiency of the optimum formula was (88.89±0.45)%, the drug loading was (1.91±0.01)% and the mean particle size was 79.23±3.07nm. CONCLUSIONS The flexible nano-liposomes are feasible in preparation techniques and the analysis methods in vitro are stable and reliable. The optimum formula of AM-FNL is reasonable in prescription, high in encapsulation efficiency and reliable in performance. It may be used in transdermal drug delivery system.
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