常通舒颗粒的质量标准提升研究

Improvement in Quality Standard for ChangTongShu Granules

目的在现行标准基础上,提升常通舒颗粒质量标准,以更有效地控制产品质量。方法增加了何首乌、当归、火麻仁薄层色谱鉴别方法;增加了赤芍中芍药苷HPLC含量测定方法,所用色谱柱为Agilent TC-C_(18)(2)(250mm×4.6mm,5μm),流动相为乙腈-0.1%磷酸溶液(12∶88,V/V),流量为1.0mL·min^(-1),检测波长230nm。结果当归、何首乌、赤芍、火麻仁的TLC法鉴别专属性强,且阴性均无干扰;含量测定结果显示,芍药苷浓度在(17.50~105.00)μg·mL^(-1)内与峰面积呈良好的线性关系(r=0.9993),RSD=1.18%(n=6),平均加样回收率为100.72%。结论本方法操作简便、准确、专属性强、重复性好,能更好地控制常通舒颗粒的质量。

OBJECTIVE Based on the current standard,the quality standard of ChangTongShu granule is improved to control the product quality more effectively.METHODS The TLC identification methods of polygonum multiflorum,radix angelicae sinensis and hemp kernel were added.The HPLC method for the determination of paeoniflorin in red peony root was added.The chromatographic column was Agilent TC-C 18(2)(250mm×4.6mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(12:88,V/V),the flow rate was 1.0mL·min-1,and the detection wavelength was 230nm.RESULTS TLC identification of radix angelicae sinensis,radix polygoni multiflori,radix paeoniae paeoniae and radix cannabis was highly specific,and the results showed that the concentration of paeoniflorin in the(17.50-105.00)μg·mL-1 showed a good linear relationship with the peak area(r=0.9993),with an average recovery of 100.72%and RSD=1.18%(n=6).CONCLUSION This method is simple,accurate,specific and reproducible,and can better control the quality of ChangTongShu granules.