清咽喉雾化液的制备及质量标准研究

Preparation and Quality Standard Study of Clear Throat Atomization Liquid

目的:制备清咽喉雾化液,并建立其质量控制方法。方法:以黄芩、黄连、黄柏、金银花、鱼腥草等制备清咽雾化液;采用薄层色谱法对金银花、黄芩进行鉴别;用高效液相色谱法测定绿原酸的含量;对制剂进行稳定性试验。结果:所得制剂为黄棕色至棕褐色的液体。各项检查均符合《中国药典(2010版一部)》相关规定。绿原酸含量在1.90～13.97μg(r=0.9991)范围内与峰面积呈良好线性关系,平均回收率为98.1%,R SD为3.70%。结论:该制剂制备工艺简单可行,所建立的质量控制方法可靠,制剂质量稳定。

Objective： To prepare Clear Throat Atomization Liquid, and establish its quality control method. Methods： With radix scutellariae, rhizoma coptidis, cortex phellodendri, honeysuckle, hearb cordate etc. to prepare Clear Throat Atomi- zation Liquid; using thin layer chromatography （TLC） of honeysuckle, radix scutellariae were identified; using high perform- ance liquid chromatography （HPLC） method for determining the content of chlorogenic acid; stability test was carried out on the preparation. Results： The preparation was a yellow brown to brown liquid. All the inspection were conform to the Chinese phar- macopoeia （2010 edition） ＂relevant provision＂. The content of chloregenic acid was linear in the rage of 1.90 - 13. 971xg （r= 0. 9991 ）, the average recovery was 98. 1%, R SD was 3.70%. Conclusion： The formulation preparation technology is simple and feasible; the established quality control method is reliable; the preparation quality is stable.