维生素D3固体分散体片制备与稳定性研究

Preparation of Solid Dispersion of Vitamin D3 and Its Stability Study

关键词:  维生素D3  固体分散体  制备  稳定性

Key words:  vitamin D3  solid dispersion  preparation  stability

摘要:

采用固体分散技术制备维生素D3 固体分散体片，选用L4（23）正交表设计试验，筛选出维生素D3固体分散体片的最佳制备工艺；维生素D3和载体PEG-6000按照1∶20的比例，经60 ℃水浴，在避光的情况下进行固体分散包被。对维生素D3固体分散体进行光稳定性试验和加速试验，以维生素D3含量为检测指标，通过HLPC测定含量进行质量控制。结果表明，维生素D3固体分散体片降解微小，维生素D3含量可保持在较高水平，较普通片性质稳定。维生素D3固体分散体可有效保护药物的成分，提高生物利用率，减少毒副反应。

Abstract:

The optimum preparing process method was selected and optimized by the L4（23）orthogonal test. The best preparation process of vitamin D3 solid dispersion was as follows: the ratio of vitamin D3 to vector PEG-6000 was 1∶20, which was coated in a constant temperature bath at 60 ℃ and under dark condition. The quality control of vitamin D3 solid dispersion was determined by the illumination test and accelerate test, and the content of vitamin D3 was determined by HPLC. After the illumination test and accelerate test, the vitamin D3 solid dispersion was scarcely degraded, and the content of vitamin D3 could remain at a high level. Compared with the nature pieces of vitamin D3, the solid dispersion of vitamin D3 was stable. The solid dispersion of vitamin D3 had good stability, but still should be kept in dry, normal temperature and dark place. Obviously, the solid dispersion of vitamin D3 can protect drug ingredients and improve bioavailability, and reduce adverse reaction.