碘帕醇注射液处方工艺研究及质量考察

Preparation techniques and quality of iopamidol injection

目的优化碘帕醇注射液的处方工艺,为临床安全合理用药提供依据。方法工艺研究中进行原辅料相容性、活性炭吸附、p H值范围及灭菌条件等考察,考察项目为性状、p H值、溶液颜色、游离碘、无机碘化物、游离芳香胺、有关物质、氨丁三醇、依地酸钙钠、可见异物、无菌、细菌内毒素以及碘帕醇含量。结果按优化出的碘帕醇注射液处方工艺所制备的中试样品质量稳定可控,关键性能指标均在合格范围内,与被仿品关键性能指标无显著差异。结论碘帕醇注射液处方工艺合理、可行、稳定。

Objective To optimize the formula and preparation techniques of iopamidol injection and provide a basis for safe and reasonable medication in clinical practice. Methods The compatibility of the raw material and accessories, activated carbon adsorption, the range of p H and sterilization condition were checked during the research. The inspection items included characters, p H value, color of solution, free iodine, inorganic iodide, free aromatic amine, related substances, tromethamine, sodium calcium edetate, visible particles, sterile, bacterial endotoxin and content of iopamidol. Results According to the optimized formula and preparation techniques, the pilot test of iopamidol injection was prepared and the products quality was stable and controllable. The key performance indexes were all within an acceptable range. Compared with the imitations, there was no significant difference. Conclusion The formula and preparation techniques of iopamidol injection is stable, feasible and reasonable.