注射用丁二磺酸腺苷蛋氨酸的制备及稳定性研究

目的制备注射用丁二磺酸腺苷蛋氨酸及其注射用溶剂并考察其稳定性。方法以含量、有关物质、酸碱度为指标,筛选处方及制备工艺;考察了3批样品的稳定性。结果最佳处方为丁二磺酸腺苷蛋氨酸500.0 g、甘露醇200.0 g、磷酸36.1 mL、磷酸氢二钠59.1 g,以该处方制备的3批样品在市售包装条件下经加速、室温留样试验考察,质量稳定。结论处方设计合理,工艺可行。

Studies on the preparation technology and stability of ademetionine 1,4-butanedisulfonate for injection

Objective To prepare ademetionine 1,4-butanedisulfonate for injection,its solution for injection and to study its stability.Methods The formular and preparation technology of ademetionine 1,4-butanedisulfonate for injection were optimized with the index of contents,substances and pH value;stabilities of three batches of samples were investigated.Results The best formula was found as follows:500.0 g of ademetionine 1,4-butanedisulfonate,200.0 g of mannitol,36.1 mL of phosphoric acid and 59.1 g of secondary sodium phosphate.Three batches of sample preparations manufactured under this formula were found to be stable in quality in the accelerated test and room temperature storage test under the condition of commercial packing.Conclusions The formula design is reasonable and the preparation technology is feasible.