抗感利咽糖浆的制备及质量标准研究

目的：制备抗感利咽糖浆并建立其质量标准。方法：按处方和制备工艺要求制备抗感利咽糖浆。依据《中国药典》中糖浆剂的相关规定,制定可行的质量标准,对其性状、相对密度、pH等项目作规定;采用薄层色谱（TLC）法对处方中的大青叶、连翘进行鉴别检查;采用高效液相色谱（HPLC）法对处方中黄芩、虎杖的主要成分黄芩苷、虎杖苷进行定性定量分析。结果：TLC中特征斑点清晰;黄芩苷、虎杖苷与其他成分分离良好;黄芩苷在16.0-240.0μg/mL浓度范围内与峰面积有良好线性关系,平均回收率98.71%,RSD为0.67%;虎杖苷在32.0-480.0μg/mL浓度范围内与峰面积有良好线性关系,平均回收率97.02%,RSD为1.03%。抗感利咽糖浆质量稳定,其性状、相对密度、pH值等指标均符合标准要求。结论：抗感利咽糖浆制备工艺简单可行,所建立的质量标准可用于该制剂的质量控制。

Study on Preparation and Quality Standard of Kangganliyan Syrup

Objective： To prepare Kangganliyan syrup and establish its quality standard. Methods： The constituents such as Isatidis Folium,Forsythiae Fructus in Kangganliyan syrup were identified by TLC. The content of Baicalin,Polydatin in Kangganliyan syrup were identified and determined by HPLC. Results： The characterisic spots in TLC were noted. The peaks of the two ingredients are segregated effectively. The linear range of Baicalin was 16. 0 - 240. 0 μg /mL and the average recovery was 98. 71%（n = 5）,RSD =0. 67%. The linear range of Polydatin was 32. 0 - 480. 0 μg /mL and the average recovery was 97. 02%（ n = 5）,RSD = 1. 03%.Conclusions： This method is simple and reliable,and can be used quality control of Kangganliyan syrup.