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目的:研究完善卫生散的质量标准。方法:薄层色谱法鉴别制剂中的红参、人工牛黄、五倍子;HPLC法测定制剂中没食子酸的含量,色谱柱为Waters C_(18)(250 mm×4.6 mm,5μm),流动相为甲醇-0.2%磷酸(8∶92),流速为1.0 ml·min~(-1),检测波长为273 nm,柱温为30℃,进样量为10μl。结果:鉴别阴性对照均无干扰;含量测定方法中没食子酸的线性范围为0.062 0~1.858 5μg(r=0.999 9),回收率为101.8%(RSD=0.46%,n=6)。结论:所建方法简单、可靠,可作为卫生散的质量控制标准。
Objective: To study and improve the quality standards of San San. Methods: Red ginseng, artificial bezoar and Chinese nutgall were identified by thin-layer chromatography. The content of gallic acid in the preparation was determined by HPLC. The mobile phase was Waters C 18 (250 mm × 4.6 mm, 5 μm) with methanol -0.2% phosphoric acid (8:92), the flow rate was 1.0 ml · min -1, the detection wavelength was 273 nm, the column temperature was 30 ℃ and the injection volume was 10μl. Results: No negative control was identified. The linear range of the content of gallic acid was 0.062 0 ~ 1.858 5μg (r = 0.999 9). The recovery rate was 101.8% (RSD = 0.46%, n = 6). Conclusion: The proposed method is simple and reliable, which can be used as the quality control standard of Sanhua San.