荆肤止痒颗粒质量标准提高研究

Study of improving quality standard on Jingfuzhiyang Granules

目的：对荆肤止痒颗粒质量标准进行再提高研究。方法采用高效薄层色谱法（HPTLC）鉴别处方中君药荆芥；采用高效液相色谱法（HPLC）测定臣药野菊花中蒙花苷的含量,色谱条件院Agilent Zobrax SB-C18（250 mm×4.6 mm,5μm）色谱柱,以乙腈-2%冰醋酸水溶液（21：79）为流动相,柱温20益,流速1.0 mL/min,检测波长334 nm。结果荆芥的供试品色谱与对照药材色谱在相应的位置上有相同的粉红色斑点,阴性样品溶液无干扰斑点,方法专属性强、重复性好；蒙花苷HPLC含量测定方法分离度好、准确度高,蒙花苷在15.26～762.96 ng范围内呈良好的线性关系,回归方程Y =12.7672X ＋17.25418,r=0.99998,定量限度为1.83 ng,平均加样回收率为101.28%,RSD为0.28%（n=9）。结论通过对君药荆芥和臣药野菊花的质量控制方法的建立和验证,提高了荆肤止痒颗粒的质量标准,能更好地监控该产品的质量。

Objective To improve quality standards of Jingfuzhiyang Granules. Methods High performance thin layer chromatography （HPTLC） was used to identify Schizonepetae Herba that was monarch drug in Jingfuzhiyang Granules, and high performance liquid chromatography （HPLC） was used to determine the content of buddleoside in Chrysanthemi Indici Flos that was ministerial drug. Chromatographic conditions：Agilent Zobrax SB-C18 （250 mm×4.6 mm, 5μm）, mo-bile phase：acetonitrile-2%acetic acid water （21：79）, column temperature：20℃, flow speech：1.0 mL/min, detective wave-length：334 nm. Results The test product and the reference drug chromatographic had the pink color of the spots in the corresponding position, but the negative sample excepted. So the HPTLC had good specificity and repeatability. The resolution of HPLC was qualified, which had high accuracy. Buddleoside had a good linearity in the range of 15.26-762.96 ng, and the regression equation was Y =12.7672X ＋17.254 18 （r=0.999 98）. The average recovery was 101.28%and RSD was 0.28%（n=9）. Conclusion Through the establishment and validation of quality control method of Schizonepetae Herba and Chrysanthemi Indici Flos respectively, the quality standard on Jingfuzhiyang Granules has been improved to monitor the quality of the products better.