清咽喉雾化液的制备及质量标准研究

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％，RSD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。

Preparation and Quality Standard Study of Clear Throat Atomization Liquid

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.