摘要
目的建立补髓生血散(Ⅰ)的质量标准方法。方法采用薄层色谱法,对处方中的白芍、赤芍、牡丹皮、连翘、阿胶、鹿角胶、当归进行定性鉴别;采用高效液相色谱法,对处方中的芍药苷进行定量分析。结果薄层色谱鉴别结果表明,供试品色谱中,在对照品和对照药材图谱相应位置上均显相同颜色斑点,且阴性对照无干扰。高效液相色谱法定量结果表明,芍药苷在0.09~4.69μg范围内呈良好的线性关系(r=1.000),测得平均回收率为95.66%(RSD为0.22%,n=6)。结论本研究建立的方法可作为该制剂生产过程中质量控制及检验的标准,更好地把控药品疗效与临床用药安全。
Objective To establish a quality standard for Busui Shengxue powder(Ⅰ).Methods Radix paeoniae alba,radix paeoniae rubra,moutan park,fructus forsythia,colla corii gelatin,deer-horn glue and angelica sinensis in Busui Shengxue powder(Ⅰ)were qualitatively identified by TLC while paeoniflorin was quantitatively analyzed by HPLC.Results TLC identification showed that the same color characteristic spots of the control chromatogram appeared in corresponding positions of the sample chromatogram without interference from negative samples.HPLC quantitative results showed that paeoniflorin showed a good linear relationship in the range of 0.09μg to 4.69μg(r=1.000),and the average recovery was 95.66%(RSD=0.22%,n=6).Conclusion The method used in this study can be used as a standard for quality control and inspection in the process of preparation production so as to improve drug efficacy and clinical drug safety.
作者
胡丹
张贵英
苏传洋
王习文
常乐
祝雨薇
郭烨
曹红
HU Dan;ZHANG Gui-ying;SU Chuan-yang;WANG Xi-wen;CHANG Le;ZHU Yu-wei;GUO Ye;CAO Hong(Administration for Drug and Instrument Supervision and Inspection of PLAJLSF,Beijing 100166,China;Inner Mongolia Medical University,Hohhot 100059,Chin)
出处
《解放军药学学报》
CAS
2022年第3期214-218,共5页
Pharmaceutical Journal of Chinese People's Liberation Army
基金
风湿用药质量评价体系的研究,No.13ZJZ16。
