赵丽敏 吕欣

摘 要 目的：改进复方甘草口服溶液的制备工艺，以期得到质量稳定的产品。方法：制备添加稳定剂亚硫酸钠和助滤剂滑石粉的甘草流浸膏稀释液，调节pH在8～9，经放置、过滤后逐步加入甘油、愈创木酚甘油醚、樟脑酊等其它物料。采用棕色聚酯瓶包装。结果：该方法制得的复方甘草口服溶液，在遮光、密封的储存条件下，30个月有效期内质量稳定，无沉淀物产生。结论：改进工艺的制备方法简易、可行，制得的产品质量稳定。

关键词 复方甘草口服溶液 滑石粉 亚硫酸钠

中图分类号：TQ461 文献标志码：A 文章编号：1006-1533（2018）17-0066-02

Improvement of the process for preparation of the compound glycyrrhiza oral solution

ZHAO Limin， LYU Xin

（Shanghai Meiyou Pharmaceutical Co.， Ltd.， Shanghai 201423， China）

ABSTRACT Objective： To improve the process for preparation of the compound glycyrrhiza oral solution so as to obtain a product with stable quality. Methods： The diluted glycyrrhizae extracts were prepared by adding sodium sulfite as a stabilizer and talcum powder as a filtration aid. Glycerol， guaiacol glycerol， camphor tincture and other materials were gradually added into the filtration after the solution was adjusted to pH 8-9 and then placed for a while and finally filtrated. The product was obtained by filling into the brown polyester bottles. Results： The quality of the compound glycyrrhiza oral solution produced by this process was stable in the 30 month validity period under the condition of shading and sealed storage and no sediment was found. Conclusion： The improved process is simple and feasible and the product quality is stable.

KEy WORDS compound glycyrrhiza oral solution； talcum powder； sodium sulfite

復方甘草口服溶液，曾用名复方甘草合剂，又名棕色合剂（brown mixture），为黏膜保护性镇咳药，能减轻咽部黏膜的刺激，临床上用于治疗上呼吸道感染、支气管炎以及感冒引起的咳嗽和咯痰不爽。其处方中包含甘草流浸膏、甘油、复方樟脑酊、愈创木酚甘油醚等成分[1]。处方中的复方樟脑酊（含吗啡）为制剂核心成分之一。吗啡具有还原性，可生成伪吗啡和N-氧化吗啡。因此，制剂中吗啡含量在有效贮存期间能被空气氧化下降到不合格范围内，导致产品不合格[2]。处方中的甘草流浸膏为另一核心成分，其中的甘草甜素具有良好的解毒作用，当pH较低时，甘草酸会以沉淀析出影响产品质量[3]。有关复方甘草口服溶液制备工艺的研究较多，如，通过工艺控制，并加入亚硫酸钠作为稳定剂以提高产品质量[4]，以无水亚硫酸钠和枸橼酸钠作为抗氧剂和抗氧增效剂[5]，以维生素C为稳定剂[6]，添加稳定剂亚硫酸钠、 EDTA和增溶剂吐温-80[7]；……