复方敏维糖浆的制备及质量控制

Preparation and Quality Control of Compound Chlorphenamine Maleate and Vitamin Syrup

关键词:  复方敏维糖浆  制备  质量控制

Key words:  compound chlorphenamine maleate and vitamin syrup  preparation  quality control

摘要:

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38.808~194.040 μg·mL^-1 (r=0.999 4)，60.168~300.84 μg·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。

Abstract:

OBJECTIVE To prepare compound chlorphenamine maleate and vitamin syrup, and establish the method for its quality control. METHODS The syrup was prepared with chlorphenamine maleate and vitamin as chief components. The content of vitamin B1 and nicotinamide were determined by HPLC. The stability of the preparation was investigated as well. RESULTS The preparation was yellow sticky liquid and tasted sweet. Its identification and test conformed to the related standards stated in ChP(2010). The linear ranges of vitamin B1 and nicotinamide were 38.808-194.040 μg·mL^-1 (r=0.999 4), 60.168-300.84 μg·mL^-1 (r=0.999 5); the average recovery was 99.7%, 99.9%, the RSD was 0.89%, 0.78%. After storing for 6 months under room temperature, respectively, no obvious change was noted for the preparation. CONCLUSION The preparation of compound chlorphenamine maleate and vitamin syrup is feasible in technique, stable and controllable in quality.