丁酸氯维地平脂微球注射液的制备及质量评价

发布时间：2018-09-01 18:13

【摘要】：目的制备丁酸氯维地平脂微球注射液,并对所制备的脂微球注射液进行质量评价,确保制剂安全、稳定。方法采用高压均质法制备丁酸氯维地平脂微球注射液,通过单因素考察得到最佳处方和制备工艺,并对制剂进行了理化性质的表征及稳定性考察。结果确定最优处方为丁酸氯维地平0.5 g·L-1、油相大豆油200 g·L-1、乳化剂蛋黄卵磷脂12 g·L-1、稳定剂油酸0.3 g·L-1、等渗调节剂甘油22.5 g·L-1、p H调节剂Na OH以及注射用水适量。油水两相在70℃混合,高速分散机20 000 r·min-1,剪切10次,每次1 min,转移至微射流中103 425 k Pa均质12次,115℃灭菌30 min,即得。结论所设计的工艺可用于制备脂微球注射液。
[Abstract]:Objective to prepare chlorvedipine butyrate lipid microsphere injection and evaluate the quality of the prepared lipid microsphere injection to ensure the safety and stability of the preparation. Methods Clouvedipine butyrate microsphere injection was prepared by high pressure homogenization method. The best formulation and preparation process were obtained by single factor investigation. The physicochemical properties and stability of the preparation were also investigated. The results showed that the optimal formulation was chlorvedipine butyrate 0.5 g L -1, oil soybean oil 200 g L -1, emulsifier egg yolk lecithin 12 g L -1, stabilizer oleic acid 0.3 g L -1, isoosmotic regulator glycerol 22.5 g L -1 and injection water appropriate amount. The oil-water two-phase was mixed at 70 鈩，

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