清热抗甲片的定性定量方法研究

Qualitative and quantitative study of Qingre Kangjia tablets

目的建立清热抗甲片的定性定量方法。方法应用TLC鉴别方内炒白芍、黄连、栀子;采用HPLC同时测定清热抗甲片中芍药苷和丹酚酸B的含量,并测定盐酸小檗碱、丹皮酚和栀子苷的含量。结果 TLC图谱中呈现出这3种物质的特征性斑点,且斑点显色清晰,分离度好;芍药苷、丹酚酸B、盐酸小檗碱、丹皮酚、栀子苷分别在6.1~54.9、6.8~61.2、9.98~89.82、1.62~14.56、3.81~34.3μg·mL^(-1)与峰面积线性关系良好,r分别为0.9995、0.9999、0.99998、0.9999、0.9998,平均加样回收率分别为101.2%,RSD=3.0%(n=6)、98.7%,RSD=0.30%(n=6)、97.2%,RSD=1.8%(n=6)、100.5%,RSD=0.30%(n=6)、100.3%,RSD=1.8%(n=6)。结论文中检测方法简单易行,重复性好,可以用于清热抗甲片的质量控制。

Objective To establish the quality control standard for Qingre Kangjia tablets. Methods We identified the quality of prescription of stir-baked Paeoniae Radix Alba, Coptidis Rhizoma and Garden jasminoides Ellis by TLC, and tested the content of paeoniflorin and salvianolic acid B by HPLC simultaneously, as well as the content of berberine hydrochloride, paeonol and jasminoidin. Results The characteristic spots can be detected on the TLC atlas. The spots developed were clear and well separated. Paeoniflorin, salvianolic acid B, berberine hydrochloride, paeonol and jasminoidin gained a good linearity within 6.1-54.9 μg·mL^（-1）（r =0.9995）, 6.8-61.2 μg·mL^（-1）（r = 0.9999）, 9.98-89.82 μg·mL^（-1）（r = 0.99998）, 1.62-14.56 μg·mL^（-1）（r= 0.9999）, and 3.81-34.3 μg·mL^（-1）（r = 0.9998）; while the average recovery for the above mentioned was 101.2%, RSD = 3.0%（n = 6）; 98.7%, RSD = 0.30%（n = 6）; 97.2%, RSD = 1.8%（n = 6）; 100.5%, RSD= 0.3%（n = 6）; and 100.3%, RSD = 1.8%（n = 6）, respectively. Conclusion The method is feasible and reproducible, and can be used to control the quality of the prescription.