非诺贝特固体脂质纳米颗粒的高剪切均质化表征

Muhimmatul Khoiriyah, Jason Merari Perangirangin, Ilham Kuncahyo
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摘要

非诺贝特是一种可用于治疗高脂血症的药物,其溶解度差,渗透性高,属于生物制药分类系统II类。这导致需要改进使用固体脂质纳米颗粒(SLN)方法制成的药物输送系统(DDS)。利用析因22 Design Expert 12确定配方,采用高剪切均质法制备SLN非诺贝特。以0.31-1.25%的GMS和1.25-2%的Tween-40配制成配方,将所有原料混合至乳液形成,继续进行SLN关键参数测试。从试验结果来看,非诺贝特SLN的关键参数为8个配方的粒径490;561;601;697;916;1040;1818和2410纳米。多分散性指数分别为0.02;0.04;0.08;0.30;0.35;0.48;0.51和0.65。8个公式的zeta电位值依次为2.8;3.5;4.2;4.8;5.5;5.8;8.1和8.8 mV。计算非诺贝特类药物的SLN效率连续值为77.23;78.53;79.51;80.47;81.17;87.38;87.39和87.82%。SLN方法可以改善纳入生物制药分类系统II类的药物,试验结果分布在粒径范围内,吸附药物在70%以上。
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Fenofibrate Characterization of Solid Lipid Nanoparticles Using the High Shear Homogenization Method
Fenofibrate is a drug that can be used to treat hyperlipidemia where the drug is included in the category of Biopharmaceutical classification system II with poor solubility and high permeability. This causes the need to improve the drug delivery system (DDS) made using the solid lipid nanoparticle (SLN) method. SLN fenofibrate can be made using the high shear homogenization method by determining the formula using Factorial 22 Design Expert 12. The formula is made with a concentration of 0.31-1.25% GMS and 1.25-2% Tween-40, then SLN fenofibrate is made by mixing all ingredients until an emulsion is formed and continued with the SLN critical parameter test. From the test results, the critical parameters of SLN fenofibrate for the particle size of 8 formulas 490; 561; 601; 697; 916; 1040; 1818, and 2410 nm. The results obtained for the polydispersity index, respectively, were 0.02; 0.04; 0.08; 0.30; 0.35; 0.48; 0.51, and 0.65. The zeta potential value of the 8 formulas obtained successive values of 2.8; 3.5; 4.2; 4.8; 5.5; 5.8; 8.1, and 8.8 mV. Calculation of the efficiency of the SLN fenofibrate drug obtained successive values of 77.23; 78.53; 79.51; 80.47; 81.17; 87.38; 87.39, and 87.82%. The SLN method can improve drugs that are included in the Biopharmaceutical classification system class II category with the distribution of test results in the particle size range, and the adsorbed drug is more than 70%.
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