藏药石榴健胃丸(片、散)质量标准提升研究

Quality standard improvement of Tibetan Shiliu Jianwei pills (tablets or powder)

目的提高石榴健胃丸(片、散)的质量标准。方法建立石榴健胃丸(片、散)中豆蔻、肉桂、荜茇的TLC法,建立同时测定桉油精、桂皮醛、胡椒碱3种成分含量的GC法并确立其限度。结果石榴健胃丸(片、散)TLC图中,各组分与相应对照品、对照药材相同位置上,均显相同颜色的斑点,且阴性样品无干扰;桉油精、桂皮醛、胡椒碱分别在23.63~236.28、91.12~638.26、154.98~929.86μg·mL^(-1)内与峰面积线性关系良好(r均>0.9983),平均加样回收率分别为99.42%、100.03%、99.79%,RSD分别为1.4%、0.82%、0.30%(n=6)。石榴健胃丸(片、散)样品中桉油精、桂皮醛、胡椒碱的含量分别为0.03~0.24、0.03~1.15、0.80~2.53 mg·g^(-1)。结论该方法可以用于石榴健胃丸(片、散)中桉油精、桂皮醛、胡椒碱含量的同时测定,可作为石榴健胃丸(片、散)的质量控制方法。

Objective To improve the quality standard of Shiliu Jianwei pills(tablets or powder).Methods TLC method was established to identify Cardamom, Cinnamon and Cubeb longum in Shiliu Jianwei pills(tablets or powder). GC method for the simultaneous determination of eucalyptol,cinnamaldehyde, piperine and their respective limits was established. Results The TLC of Shiliu Jianwei pills(tablets or powder) showed spots of the same color at the same position with the reference substance and reference medicinal materials, and the negative control had no interference. The linearity of eucalyptol, cinnamaldehyde and piperine was 23.63 ~ 236.28, 91.12 ~ 638.26 and 154.98 ~ 929.86μg·mL^(-1), respectively(r > 0.9983). The average recovery was 99.42%, 100.03%, and 99.79%, and RSD was 1.4%, 0.82%, and 0.30%(n = 6). The content of eucalyptol, cinnamaldehyde and piperine in Shiliu Jianwei pills(tablets and powder) ranged 0.03 ~ 0.24, 0.03 ~ 1.15 and 0.80 ~ 2.53 mg·g^(-1),respectively. Conclusion The method can be used to simultaneous determine the content of eucalyptol,cinnamaldehyde and piperine. It can also be used for the quality control of Shiliu Jianwei pills(tablets or powder).