舒肝健胃丸的质量标准研究

Study on Qulity Standard of Shugan Jianwei Pill

目的建立舒肝健胃丸企业内部质量控制标准。方法采用薄层鉴别法(TLC)对白芍(芍药苷)进行定性鉴别,并对所选用试验方法进行专属性及耐用性验证考察;应用超高效液相色谱法(UPLC)测定和厚朴酚与厚朴酚的总含量。结果白芍TLC鉴别中,分离度良好,阴性对照无干扰;UPLC法测定和厚朴酚与厚朴酚含量,两者平均加样回收率分别为96.3%,101.8%;RSD分别为0.96%,0.89%;和厚朴酚在2.54~101.48μg·m L^(-1)呈线性关系,回归方程(n=6)为Y=9 990.8X-5 253.3(r=1.000 0);厚朴酚在3.71~148.60μg·m L^(-1)呈线性关系,回归方程(n=6)为Y=8 149.6X+5 404.7(r=1.000 0)。结论所建立的方法简便、可靠、稳定可行,可作为企业内控标准进行质量控制,并为上升国家标准提供参考。

OBJECTIVE To establish the quality standard of Shugan jianwei pill. METHODS Used TLC to identify Paeoniae Radix Alba（ paeoniflorin）,and examed the special properties and durability of the TLC methods; used ultra performance liquid chromatography（ UPLC） method to determine the total content of honokiol and magnolol. RESULTS Radix Alba Paeoniae could be identified by TLC. A good linearity of honokiol was in the range of 2. 54- 101. 48 μg·m L^-1（ r = 1.000 0）. The average recovery of puerarin was 96.3%,and RSD was 0.96%.Magnolol was in good linearity with the range of 3. 71- 148.60 μg·m L^-1（ r = 1.000 0）.The average recovery of puerarin was 101.8%,and RSD was 0. 89%. CONCLUSION These methods are simple,sensitive,accurate and with good reproducibility. It can be used for the quality control of Shugan jianwei pills.