抗感胶囊的质量标准研究

Quality Standards for Kanggan Capsules

目的:建立抗感胶囊的质量标准。方法:采用薄层色谱法(TLC)对制剂中拳参、连翘、升麻进行定性鉴别。使用高效液相色谱法(HPLC)同时测定绿原酸、连翘酯苷A、木犀草苷这三种主要成分的含量。结果:薄层鉴别专属性强,斑点清晰,阴性无干扰。高效液相色谱检测的浓度范围:绿原酸在0.020 48~2.048 mg/mL,连翘酯苷A在0.024 09~2.409 mg/mL,木犀草苷在0.007 82~0.782 mg/mL范围内分别具有良好的线性关系。精密度,重复性,稳定性试验RSD均小于5%。加样回收率分别为99.19%、99.97%、101.08%,RSD分别为0.55%、0.72%、1.70%。结论:该方法重复性好,稳定可靠,可用于抗感胶囊的质量控制。

Objective:To establish the quality standards for Kanggan Capsules.Methods:Thin-layer chromatography(TLC)was used to qualitatively identify Polygonum bistorta,Forsythia Suspensa and Cimicifuga foetida.The contents of chlorogenic acid,cynaroside,and forsythoside A were determined using high performance liquid chromatography(HPLC).Results:TLC identification was highly specific,with clear spots and no interference.The concentration ranges of HPLC:chlorogenic acid was in 0.020 48~2.048 mg/mL,forsythoside A in 0.024 09~2.409 mg/mL,and cynaroside in 0.007 82~0.782 mg/mL,respectively,with good linear relationship.The precision,repeatability and stability of RSD were less than 5%.The recoveries were 99.19%,99.97%and 101.08%,and RSD values were 0.55%,0.72%and 1.70%,respectively.Conclusion:This method has good repeatability,stability and reliability and it can used for quality control of Kanggan Capsules.