关节康胶囊质量标准研究

目的:建立关节康胶囊的质量标准。方法:采用薄层色谱法(TLC)对制剂中的肿节风、独一味、鹿衔草、白芍、川芎进行定性鉴别;采用高效液相色谱法(HPLC)测定制剂中异嗪皮啶、山栀苷甲酯、8-O-乙酰山栀苷甲酯总和、芍药苷的含量。结果:TLC鉴别特征清晰,阴性对照无干扰;HPLC结果显示异嗪皮啶、山栀苷甲酯、8-O-乙酰山栀苷甲酯、芍药苷分别在0.00175~0.01750 mg(r=0.9996)、0.00425~0.04250 mg(r=0.9995)、0.00240~0.02400 mg(r=0.9993)、0.00750~0.09000 mg(r=0.9992)范围内线性关系良好,平均回收率分别为99.50%、98.37%、99.24%、99.75%,RSD分别为1.99%(n=6)、1.41%(n=6)、1.99%(n=6)、1.72%(n=6)。结论:关节康胶囊的定性、定量方法准确、简便,可用于关节康胶囊的质量控制。

Study on Quality Standard of Guanjiekang Capsules

Objective:To establish the quality standard of Guanjiekang Capsules. Methods:Zhongjiefeng(Sarcandra glabra),Duyiwei(Lamiophlomis rotata),Luxiancao(Pyrola herba),Baishao(Radix paeoniae alba),Chuanxiong(Rhizoma chuanxiong) were identified by thin layer chromatography(TLC). Isofraxidin,Shanzhiside,8-O-acetyl Shanzhiside,paeoniflorin were determined by high performance liquid chromatography(HPLC).Results:The TLC spots were clear,negative control without interference. HPLC results showed sofraxidin,Shanhiside,8-O-acetyl Shanzhiside,paeoniflorin concentration in 0.00175~0.01750 mg(r= 0.9996),0.00425~0.04250 mg(r= 0.9995),0.00240~0.02400 mg(r= 0.9993),0.00750~0.09000 mg(r= 0.9992) had a good linear relationship,the average recovery were:99.50%,98.37%,99.24%,99.75%,RSD were 1.99%(n= 6),1.41%(n= 6),1.99%(n= 6),1.72%(n= 6) respectively. Conclusion:The qualitative and quantitative methods were accurate and simple and it can be used for the quality control of Guanjiekang capsules.