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目的制备复方敏维糖浆并建立其质量控制方法。方法以维生素、马来酸氯苯那敏为主药制备糖浆剂,采用高效液相色谱法测定维生素B1和烟酰胺的含量,同时考察制剂稳定性。结果所制制剂为黄色粘稠液体,味甜;其鉴别、检查符合2010版中国药典二部糖浆剂项下的相关规定;维生素B1和烟酰胺的线性范围分别为38.808~194.040μg.mL-1(r=0.999 4),60.168~300.84μg.mL-1(r=0.999 5);回收率(n=9)分别为99.7%,99.9%;RSD分别为0.89%,0.78%。制剂于室温下放置6个月,各项指标未见明显变化。结论本制剂制备工艺简便可行,质量稳定可控。
Objective To prepare compound Minibi syrup and establish its quality control method. Methods Vitamins and chlorpheniramine maleate as the main drug preparation syrup, using high performance liquid chromatography determination of vitamin B1 and nicotinamide content, and study the stability of the preparation. The results of the preparation of the yellow viscous liquid, sweet; identification, inspection in line with the 2010 edition of the Chinese Pharmacopoeia two syrup under the relevant provisions of the linear range of vitamin B1 and nicotinamide were 38.808 ~ 194.040μg.mL-1 (r = 0.999 4), 60.168 ~ 300.84μg.mL-1 (r = 0.999 5). The recovery rates were 99.7% and 99.9%, respectively. The RSDs were 0.89% and 0.78% respectively. Formulation at room temperature for 6 months, no significant changes in various indicators. Conclusion The preparation process is simple and feasible, the quality is stable and controllable.