舒肛软膏质量控制方法研究  

Study on the quality control method of Shugang Ointment(舒肛软膏)

作　　者：祁梅[1] 顾志荣[1] 张锐 马转霞 许爱霞[1] 葛斌[1] QI Mei;GU Zhirong;ZHANG Rui;MA Zhuanxia;XU Aixia;GE Bin(Department of Pharmacy,Gansu Provincial People’s Hospital,Lanzhou,Gansu,730000,China;College of Pharmacy,Gansu University of Chinese Medicine,Lanzhou,Gansu,730101,China)

机构地区：[1]甘肃省人民医院药剂科,甘肃兰州730000 [2]甘肃中医药大学药学院,甘肃兰州730101

出　　处：《甘肃中医药大学学报》2023年第3期34-43,共10页Journal of Gansu University of Chinese Medicine

基　　金：甘肃省中医药管理局科研项目(GZK-2019-41);甘肃省人民医院研发攻关项目(18GSSY2-3)。

摘　　要：目的建立舒肛软膏的质量控制方法。方法采用薄层色谱(TLC)法对舒肛软膏中主要药材薄荷、防风、荆芥、苦参进行定性鉴别;采用高效液相色谱(HPLC)法同时测定多指标成分(升麻素苷、阿魏酸、芦丁、5-O-甲基维斯阿米醇苷、槲皮苷)含量并建立HPLC指纹图谱。结果薄荷、防风、荆芥、苦参的TLC斑点清晰,阴性对照无干扰。升麻素苷、阿魏酸、芦丁、5-O-甲基维斯阿米醇苷、槲皮苷的回归方程分别为Y=1.02×10^(7)X-4.24×102(r=0.9996),Y=1.60×10^(7)X+3.56×10^(4)(r=0.9999),Y=1.49×10^(7)X-9.38×10^(3)(r=0.9998),Y=2.30×10^(7)X+2.60×10^(4)(r=0.9996),Y=4.30×10^(7)X+1.50×10^(5)(r=0.9997),线性范围分别为0.0044~0.1332,0.0024~0.0720,0.0058~0.1728,0.0065~0.1935,0.0048~0.1440 mg/mL,平均加样回收率分别为100.09%,100.53%,100.13%,99.95%,99.83%,RSD分别为1.32%,1.59%,1.24%,0.77%,1.74%;10批样品指纹图谱与对照图谱之间的相似度均大于0.98,表明舒肛软膏质量均一性好,指纹图谱共确定了21个共有峰,并指认出了其中7个色谱峰。结论该方法简单易行,专属性、准确性、稳定性和重复性均符合方法学要求,可用于舒肛软膏的质量控制。Objective To establish the quality control method of Shugang Ointment(舒肛软膏).Methods Thin-layer chromatography(TLC)was used to qualitatively identify Mentha haplocalyx,Saposhnikovia divaricata,Schizonepeta tenuifolia,and Sophora flavescens.High performance liquid chromatography(HPLC)was used to simultaneously determine the content of multi-index components(cimicifugin glycoside,ferulic acid,rutin,5-O-methylvisualitol glycoside,quercetin)and establish HPLC fingerprint.Results The TLC spots of Mentha haplocalyx,Saposhnikovia divaricata,Schizonepeta tenuifolia,and Sophora flavescens were clear,and the negative control had no interference.The regression equations of cimicifugin glycoside,ferulic acid,rutin,5-O-methylvisualitol glycoside,quercetin were Y=1.02×10^(7)X-4.24×102(r=0.9996),Y=1.60×10^(7)X+3.56×10^(4)(r=0.9999),Y=1.49×10^(7)X-9.38×10^(3)(r=0.9998),Y=2.30×10^(7)X+2.60×10^(4)(r=0.9996),and Y=4.30×10^(7)X+1.50×10^(5)(r=0.9997),respectively.The linear ranges were 0.0044~0.1332,0.0024~0.0720,0.0058~0.1728,0.0065~0.1935,and 0.0048~0.1440 mg,respectively.The average recovery ratios were 100.09%,100.53%,100.13%,99.95%,and 99.83%,and the RSD were 1.32%,1.59%,1.24%,0.77%,and 1.74%,respectively.The similarity between the fingerprint spectra of 10 batches of samples and the control spectra is greater than 0.98,indicating good quality uniformity of Shugang Ointment.A total of 21 common peaks were identified in the fingerprint spectra,and 7 of them were identified as chromatographic peaks.Conclusion The method was simple and easy tooperate,and its specificity,accuracy,stability and repeatability met the methodological requirements.It can be used for the quality control for Shugang Ointment.

关 键 词：舒肛软膏 薄层色谱 高效液相色谱 多指标成分 指纹图谱 质量控制 

分 类 号：R284.2[医药卫生—中药学]