摘要
目的研究抗生丸质量控制方法,以提高其质量标准。方法在原标准的基础上增加了抗生丸中红花、木瓜、甘草和白芍4味药材的显微鉴别和木瓜的薄层鉴别;改进了甘草的薄层鉴别;建立了高效液相色谱(HPLC)法对芍药苷进行含量测定。采用Agilent ZORBAX SB-C18(250 mm×4.6 mm,5μm)色谱柱,流动相为乙腈-水(12:88),检测波长230 nm,流速为1.0 ml/min,柱温为35℃。结果显微鉴别、薄层鉴别专属性强;HPLC法测定结果显示芍药苷在9.71~97.07μg/ml浓度范围内有良好的线性关系,平均回收率为102.18%,RSD为0.86%。结论该方法操作简便、结果准确、重现性好,可作为抗生丸质量标准控制的方法。
Objective To study quality control method of Kangsheng Pills in order to improve quality standard. Methods Microscopic identifications of Safflower, Fruetus Chaenolnelis Spceiosae, Glyeyrrhiza Uralensis Fiseh and Ra- dix Paeoniae Alba and thin layer chromatography （TLC） identification of Fruetus Chaenolnelis Speeiosae were added on the basis of original standard, and TLC conditions of Glyeyrrhiza Uralensis Fiseh were improved, and high-performance liquid chromatography （HPLC） was established to detect Paeoniflorin content. The chromatographic column was Agilent Zorbsx SB-C18 （250 mm×4.6 mm, 5 μm） ; mobile phase was eolnposed of aeetonitrile and water （12：88） at a flow rate of 1.0 ml/min. The detection wavelength was 230 nln, and eolulnn temperature was 35℃. Results Microscopic i- dentification and TLC identification had highly specific. HPLC result showed that Paeoniflorin had good linear correlation in the concentration range of 9.71-97.07μ g/lnl, and the average recovery rate was 102.18% , and relative standard de- viation （RSD） was 0.86%. Conclusion The method is easy to operate with accurate results and good reproducibility, and therefore it can be used as a method for quality control of Kangsheng Pills.
作者
李云霞
周娜
王波云
成西霞
戴卫红
LI Yun-xia;ZHOU Na;WANG Bo-yun;CHENG Xi-xia;DAI Wei-hong(Department of Pharmacy,Bethune Interna-tional Peace Hospital of PLA,Shijiazhuang,050082,Chin)
出处
《解放军医药杂志》
CAS
2018年第8期91-95,共5页
Medical & Pharmaceutical Journal of Chinese People’s Liberation Army
基金
军队医疗机构制剂标准提高科研专项面上课题(14ZJZ03-4)
关键词
抗生丸
中药显微鉴定
色谱法
高压液相
芍药苷
Kangsheng Pills
TCD microscopic identifie
Chromatography, high pressure liquid
Paeoniflorin
