复方敏维糖浆的制备及质量控制.PDF

复方敏维糖浆的制备及质量控制 于桂兰，杨建春，张琦，王春艳，唐靖禹(唐山市妇幼保健院，河北 唐山 063000) 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。 关键词：复方敏维糖浆；制备；质量控制 中图分类号：R943.3;R944.12 文献标志码：B 文章编号：1007-7693(2010)09-0851-04 Preparation and Quality Control of Compound Chlorphenamine Maleate and Vitamin Syrup YU Guilan, YANG Jianchun, ZHANG Qi, WANG Chunyan, TANG Jingyu( Women and Children’s Hospital of Tangshan, Tangshan 063000, China) 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. KEY WORDS: compound chlorphenamine maleate and vitamin syrup; prepara