舒肝健胃丸质量标准研究

Quality control for Shugan Jianwei Wan

目的研究舒肝健胃丸的质量控制方法。方法采用薄层色谱(TlC)法对舒肝健胃丸处方中的香附、白芍、柴胡、延胡索进行定性鉴别;采用高效液相色谱(hplC)法对厚朴中的厚朴酚与和厚朴酚进行含量测定,色谱柱为hyperSil odS2 C18柱(150 mm×4.6 mm,5μm),流动相为乙腈-水-冰醋酸(60∶38∶2),检测波长294 nm,柱温35℃,流速1 ml/min,进样量10μl。结果 TlC鉴别专属性强,斑点清晰,且阴性对照无干扰;含量测定中,厚朴酚与和厚朴酚的回归方程分别为Y=12 335X-4 745.1(r=0.999 1),Y=1598.1X-3 569.4(r=0.999 3)。结果表明,厚朴酚与和厚朴酚分别在3.13~62.60μg/ml,1.995~39.900μg/ml范围内呈良好的线性关系;厚朴酚与和厚朴酚平均回收率分别为99.60%,98.54%。结论所建立的方法操作简便,专属性强,稳定、准确,重现性好,可用于该制剂的质量控制。

Objective To study the quality control method for Shugan Jianwei Wan. Methods Cyperus rotundus,radix paeoniae alba,radix bupleuri,rhizoma corydalis were identified qualitatively by TLC; the contents of magnolol and honokiol were determined by HPLC. The HPLC separation was performed on the column of Hypersil ODS2 C18( 200 mm × 4. 6 mm,2. 5 μm) with the mobile phase of acetonitrile-water-glacial acetic acid( 60∶ 38∶2),the detecting wavelength was 294 nm,the column temperature was 35 ℃,the flow rate was 1 m L / min,the sample size was 1 0 μL. Results Qualitative identification by TLC was specific,the spots were clear and the negative control showed no interference. The regression equations of magnolol and honokiol were Y = 12 335X-4 745. 1( r = 0. 999 1) and Y = 1 598. 1X-3 569. 4( r = 0. 999 3) respectively. Their calibration curves were in good linearity in the range of 3. 13 to 62. 60 μg / m L,1. 995 to 39. 900 μg / m L with average recoveries of 99. 60%,98. 54% respectively. Conclusion The method is easy and simple,specific,accurate and reliable also with good reproducibility.It can be used to identify and evaluate the quality of Shugan Jianwei Wan.