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本文研究含亲水性药物脂质体,在冻干/再水化过程中改善质量的途径。冻干包括三个步骤,先是产品冻结,以后开始升华(初级干燥),最后次级干燥。为了在再水化后保持最高的药物量,在三个步骤中均需要最佳的操作参数。作者以亲水而不与双分子层相互作用的羧基荧光素(CF)为模型药物,以氢化大豆磷脂和双十六烷基磷酸酯等材料,用经典薄膜法制备负电荷多层脂质体。并研究冻结速度、温度、时间(样品保持于选定温度的时间)以及不同类型和浓度对冻结保护剂的影响。
This article studies ways to improve the quality of hydrophilic drug-containing liposomes during lyophilization / rehydration. Freeze-drying consists of three steps, first freezing the product, then sublimation (primary drying) and finally secondary drying. In order to maintain the highest amount of drug after rehydration, the best operating parameters are required in all three steps. The authors used carboxyfluorescein (CF), which is hydrophilic and not interacting with bilayers, as a model drug to hydrogenate soy lecithin and dicetylphosphate and other materials to prepare negatively charged multilamellar liposomes . And study the rate of freezing, temperature, time (the time the sample is kept at the selected temperature), and the effect of different types and concentrations on the cryoprotectant.