目的 通过添加亚硫酸钠、EDTA作稳定剂,吐温80作增溶剂,解决复方甘草口服溶液中吗啡含量不稳定问题,得到澄清、质量合格的制剂.方法 在复方甘草口服溶液原制备工艺中添加了稳定剂亚硫酸钠4 g、EDTA 0.6 g和增溶剂吐温803 g,调节pH值至8.0,用100 ml棕色聚酯瓶灌装,即得复方甘草口服溶液成品药液.结果 制剂澄清,质量合格,吗啡含量稳定.结论 该方法可行,工艺简单,制剂稳定,适合大规模生产.
Objective To obtain a clear and qualified compound glycyrrhiza oral solution by using NaSO3 and EDTA as stabi-lizers and Tween80 as solubilizer so as to solve the problem of morphine content instability. Methods NaSO34g and EDTA 0.6 g as stabilizers,and Tween803 g as solubilizer were added in the traditional method. The pH of the solution was adjusted to 8.0. Then the solution was obtained and filled in the brown polyester bottle. Results The preparation was clear,qualified and the content of mor-phine was steady. Conclusion The improved method is feasible,simple,stabilized and suitable for manufacturing.