柴芩软胶囊质量标准研究

目的 制定新药柴芩软胶囊质量控制方法.方法 采用TLC法对方中的柴胡、葛根、山豆根和升麻进行定性鉴别;用HPLC测定黄芩中黄芩苷的含量.色谱条件:Diamonsil C18(250 mm×4.6 mm;5 μm)色谱柱;流动相:甲醇-水-磷酸(47:53:0.2);流速:1.0 mL/min;检测波长:280 nm;柱温:20℃.结果 柴胡、山豆根、葛根、升麻的供试品与对照药材及对照品色谱在相应的位置上均有相同颜色的斑点,阴性样品溶液无干扰,专属性强;黄芩苷在0.28～1.40 μg范围内具有良好的线性关系(r=0.9999),平均回收率为99.74％,RSD为0.85％.结论 该法能有效地控制产品质量.

Study of quality standard for Chaiqin Soft Capsule

Objective To establish the quality standards of the new medicine Chaiqin Soft Capsule. Methods Radix bupleuri, radix puerariae, sophora tonkinensis and rhizoma cimicifugae were identified by TLC; and the content of baiealin in scutellaria baiealensis was determined by HPLC. The HPLC system was with Diamonsil C18 （250 mm×4.6 mm; 5 μm） column, the mobile phase was methanol-water-phosphoric acid （47：53：0.2）, flowing rate was 1.0 mL/min, UV detecting wavelength was at 280 nm and the column temperature were at 20℃. Results The test product, the ref- erence drug and the reference standard chromatographic had the same color of the spots in the corresponding position but the negative sample excepted. The study on the quality control showed that the characteristic of identification by TLC was distinct and highly specific, Baicalin showed a good linear relationship at a range of 0.28-1.40 μg （r = 0.9999）, the average recovery was 99.74%, RSD was 0.85%. Conclusion The method can effectively control the quali- ty of products.