健身安胎丸质量标准研究Quality Standard for Jianshen Antai Pills
谢强,陈繁华,王志梅
XIE Qiang,CHEN Fan-hua,WANG Zhi-mei(Meizhou Institute for Drug Control
摘要(Abstract):
目的提高健身安胎丸的质量控制标准。方法采用薄层色谱法(TLC)对制剂中香附、当归和川芎进行定性鉴别;采用高效液相色谱法(HPLC)测定芍药苷的含量。选择C18柱,以乙腈-水(15∶85)为流动相,流速为1.0ml/min,检测波长为230nm。结果在TLC图谱中可检出香附、当归和川芎的特征斑点。芍药苷在6.032~150.80μg/ml的浓度范围内线性关系良好,Y=14.15854X-6.09559(r=0.99991),平均回收率为100.8%,相对标准偏差值(RSD)为1.8%(n=6)。结论该方法简便、准确、专属性强,可用于该制剂的质量控制。
Objective To improve the standard for quality control of Jianshen Antai Pills. Methods Rhizoma Chuanxiong,Rhizoma Cyperi,and Radix Angelica sinensis in this medicine were identified by TLC. The content of Paeoniflorin was determined by HPLC. The C18 column was adopted,and the acetonitril-water (15∶85) solution was used as the mobile phase,the flow rate was 1.0 ml/min. The detective wavelength was set at 320 nm. Results Rhizoma Chuanxiong,Rhizoma Cyperi,and Radix Angelica sinensis could be identified by TLC. Paeoniflorin showed a good linear relationship at the range of 6.032~150.80 μg/ml (r=0.999 91). The average recovery was 100.8%,with RSD of 1.8% (n=6). Conclusion The method is simple,reliable,accurate,and can be applied to the quality control of the preparation.
关键词(KeyWords):
健身安胎丸;TLC;芍药苷;HPLC
Jianshen Antai pills; TLC; Paeoniflorin; HPLC
基金项目(Foundation):
作者(Author):
谢强,陈繁华,王志梅
XIE Qiang,CHEN Fan-hua,WANG Zhi-mei(Meizhou Institute for Drug Control