双氯芬酸钠脂质体凝胶剂的研制
Study on diclofenac sodium liposome hydrogel
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摘要: 目的 研制双氯芬酸钠脂质体凝胶,并进行评价。方法 运用薄膜蒸发法制备了双氯芬酸钠脂质体,然后用卡波姆 (Carbopol)为基质制得凝胶。并建立了一阶导数紫外分光光度法进行测定。结果 测得样品低、中、高 3个浓度的平均回收率分别为 (101.1±0.86)%,(99.90±1.04)%和 (100.5±0.91)%。脂质体经凝胶柱分离后测得平均包封率为 43.6%,经库尔特计数器测得平均粒径为 1.37μm。凝胶分别于冰箱 (4℃)和室温下密封保存 0.5、1、3、6mo,6mo后的包封率下降分别为 4.4%、6.8%。结论 经初步评价,将双氯芬酸钠制成脂质体凝胶剂是可行的。Abstract: OBJECTIVE To prepare a liposome hydrogel of diclofenac sodium(DCS) and evaluate it. METHODS The DCS liposomes were prepared by the conventional thin film hydration method at first, to which the carbopol was added as a support base for preparation of the hydrogel of DCS. An one-order derivative UV spectrophotometry was established to evaluate the DCS in hydrogel.RESULTS The average recoveries of three samples were (101.1±0.86)%,(99.90±1.04)%和(100.5±0.91)%, respectively and the average encapsulation efficiency of liposomes is 43.6% after separated by gel minicolumn. The particle sizes of liposomes were determined by a coulter counter and d50 was 1.37μm. In stability of test, the hydrogel was stored for 0.5, 1, 3 or 6 months at 4℃ or at room temperature, and the encapsulated efficiency of liposomes was decreased by 4.4% or 6.8% respectively after six months.CONCLUTION:It is feasible to prepare a liposome hydrogel of DCS after an initial evaluation.
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Key words:
- Diclofenac sodium /
- liposomes /
- hydrogel /
- preparation /
- quality control
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