金茵清热口服液的制备及质量标准研究

Study on Preparation and Quality Standard of Jinyinqingre Oral Liquid

目的:制备金茵清热口服液并建立其质量标准。方法:采用薄层色谱(TLC)法对金茵清热口服液中大黄、黄芪进行定性鉴别,采用高效液相色谱(HPLC)法对制剂中金银花、茵陈、栀子、丹参的主要成分绿原酸、栀子苷、丹酚酸B进行定性、定量测定。结果:TLC中特征斑点清晰。HPLC法中绿原酸、栀子苷、丹酚酸B分离度好,绿原酸在6.32～306.60μg/mL的浓度范围内有良好的线性关系,平均回收率为98.72%,RSD为1.30%;栀子苷在12.04～602.00μg/mL浓度范围内有良好线性关系,平均回收率为99.43%,RSD为0.80%;丹酚酸B在2.668～133.400μg/mL浓度范围内有良好线性关系,平均回收率为95.08%,RSD为1.98%。金茵清热口服液质量稳定,性状、相对密度、pH值等检验指标符合标准要求。结论:本文建立的制备工艺简单可行,建立的质量标准可用于金茵清热口服液的质量控制。

Objective： To prepare Jinyinqingre oral liquid and establish its quality standard. Methods： The constituents such as rhubarb and astragalus in Jinyinqingre oral liquid were identified by TLC. The contents of chlorogenic acid, geniposide and salvianolic acid B in Jinyinqingre oral liquid were identified and determined by HPLC. Results： The eharacterisic spots in TLC were noted. The peaks of the three ingredients were segregated effectively. The linear range of chlorogenie acid was 6.32 - 306.60μg/mL and the average recovery was 98.72% , RSD= 1.30%. The linear range of geniposide was 12.04 - 602.00 μg/mL and the average recovery was 99.43% , RSD=0. 80%. The linear range of salvianolic acid B was 2. 668- 133. 400 μg/mL and the average recovery was 95.08% , RSD= 1.98%. Conclusions： This method is simple and reliable, and it can be used fbr the quality control of Jinyingqingre oral liquid.