蒙药小白蒿与炒白蒿的质量标准研究

Study on Quality Standard of Xiaobaihao and Chaobaihao

目的：制订蒙药小白蒿饮片的质量标准草案。方法：用薄层鉴别法对小白蒿、炒白蒿含有的主要止血有效成分绿原酸建立鉴别方法;照《中华人民共和国药典》（2010年版一部）与检查项相关规定,对该二品种进行逐项检查;用HPLC测定小白蒿、炒白蒿中绿原酸建立了定量分析方法。结果：质量标准鉴别中绿原酸薄层斑点清晰可辨;各检查项数据均符合《中华人民共和国药典》要求。含量测定的色谱条件中色谱柱：Grace Smart RP18（250 mm×4.6 mm,5μm）;波长：327 mm;流动相：乙腈-0.4%磷酸溶液（12∶88）;流速：1.0 m L/min;柱温25℃;色谱柱理论塔板数按绿原酸色谱峰面积计算不得超过3 000;与相邻峰的分离度（R〉1.5）,空白无干扰;线性范围为2~12 g（R2=0.9998）;平均回收率为105.775%（RSD=2.8%）。结论：质控方法可靠,灵敏度高,专属,稳定,准确,重现性好。

Objective： To draft the quality specification of Xiaobaihao slices. Methods： Chlorogenic acid,the main hemostatic component in Xiaobaihao and Chaoxiaobaihao was identified by TLC identification method. According to the inspection correlation stipulation provisioned in the Chinese Pharmacopoeia（ 2010 edition）,the Xiaobaihao and Chaoxiaobaihao were inspected item by item and quantitative analysis method was established with the highly effective liquid phase for chlorogenic acid. Results： In the quality specification,the chlorogenic acid spot in TLC was clear and easily distinguished and all test items conformed to the Chinese Pharmacopoeia（ 2010 edition）. Chromatographic column in content determination was set as Grace Smart RP18（ 250 mm ×4. 6 mm 5 μm）; Wave length was 327 nm; Flowing was at the second grade; nitrile was 0. 4% phosphoric acid solution（ 12 ∶88）; flow speed was 1. 0m L / min; and the column warm was set at 25 ℃. The theoretical plate number was less than 1000 according to the chlorogenic acid computation. Compared with the neighboring peak degree of dissociation（ R 1. 5）,there was no obvious disturbance. The linear scope was 2 ~ 12 μg（ R2= 0. 9998）,and the average returns-ratio was 105. 775%（ RSD = 2. 8%）. Conclusion： The indictment method is reliable,stable and accurate with high sensitivity,specificity and replicability.