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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 Qingyan laryngeal fluid and to establish its quality control method. Methods: The Qingyan nebulized liquid was prepared with Scutellaria baicalensis, Rhizoma Coptidis, Phellodendron amurense, Honeysuckle, Houttuynia cordata, etc. The honeysuckle and Scutellaria baicalensis Georgi were identified by TLC, the content of chlorogenic acid was determined by high performance liquid chromatography, Stability test. Results: The resulting formulation is a yellow-brown to tan liquid. The inspection are in line with the “Chinese Pharmacopoeia (2010 version of a”) "relevant provisions. The chlorogenic acid content showed a good linear relationship with the peak area in the range of 1.90 ~ 13.97μg (r = 0.9991) with the average recovery of 98.1% and R SD of 3.70%. Conclusion: The preparation process of the preparation is simple and feasible, the established quality control method is reliable and the preparation quality is stable.