肝炎治疗药苦参碱葡萄糖注射液的研制

Preparation of Matrine and Glucose Injection for Hepatitis Therapeutic Drug

为研制供临床直接使用的大容量苦参碱葡萄糖注射液，采用苦参碱浓配，葡萄糖先浓配除热原、后稀配混合苦参碱溶液、精滤、灌封、灭菌等制得苦参碱葡萄糖注射液，并建立质量标准。结果表明：试制3批样品均符合质量标准要求，稳定性考察未见明显变化。研制的苦参碱葡萄糖注射液处方及工艺合理可行、质量标准可控、稳定性良好。

To study the preparation of matrine and glucose injection for clinic use, the injection is prepared by diluting matfine and glucose with injeetion water in high concentration first, after the pyragen is diseovered, diluting the mixture to the labeled concentration, then filtering the mixture with 0.22μm membranee filter, filling into bottle, and finally sterilizing with steam at 115℃/30 min. Three batch of samples are prepared to meet the quality standard built by ourselves, and to have no observable changes in stability test. The preseription and process of making matfine and glucose injection is practicable. The quality standard of the injection is controllable with good stability.