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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。
Objective: To prepare anti-sympathetic pharyngeal syrup and establish its quality standard. Methods: Prepared anti-sympathetic pharyngeal syrup according to prescription and preparation process requirements. Based on the relevant provisions of the Chinese Pharmacopoeia in the syrup, to develop a viable quality standards, its properties, relative density, pH and other items for the provisions of the thin layer chromatography (TLC) prescription of Folium, Forsythia Identification test; using high performance liquid chromatography (HPLC) method of prescription Scutellaria, Polygonum cuspidatum main components of baicalin, polydatin Qualitative and quantitative analysis. Results: The spots were clear in TLC, and baicalin and polydatin were well separated from other components. The concentration of baicalin in the range of 16.0 ~ 240.0μg / mL had a good linear relationship with the peak area, with an average recovery of 98.71% and a RSD of 0.67%. Polydatin had a good linear relationship with the peak area in the range of 32.0 ~ 480.0μg / mL with the average recovery of 97.02% and RSD of 1.03%. Anti-sense of pharyngeal syrup quality and stability, its properties, relative density, pH and other indicators are in line with standard requirements. Conclusion: The preparation of anti-sympathetic pharynx syrup is simple and feasible. The established quality standards can be used for the quality control of the preparation.