安肠胶囊质量标准提升研究  

Improvement of the Quality Standard of Anchang Capsules

作　　者：覃翔[1] 林忆龙 陈壮[1] 李婉铭 韦娈静 廖强 QIN Xiang;LIN Yilong;CHEN Zhuang;LI Wanming;WEI Luanjing;LIAO Qiang(Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine,Nanning,Guangxi,China 530011;Guilin Medical College,Guilin,Guangxi,China 541100;Nanning Institute for Food and Drug Control,Nanning,Guangxi,China 530004)

机构地区：[1]广西中医药大学附属瑞康医院,广西南宁530011 [2]桂林医学院,广西桂林541100 [3]广西壮族自治区南宁市食品药品检验所,广西南宁530004

出　　处：《中国药业》2021年第24期69-73,共5页China Pharmaceuticals

基　　金：2020年中央补助广西中药壮瑶药院内制剂孵化推广项目[桂中医药发[2020]8号]。

摘　　要：目的提升安肠胶囊的质量标准。方法采用薄层色谱(TLC)法对制剂中黄芪、白头翁、补骨脂、白术进行定性鉴别,并检查乌头碱限量;采用高效液相色谱(HPLC)法测定制剂中毛蕊异黄酮葡萄糖苷的含量,色谱柱为Shim-pack GIST C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸水溶液(梯度洗脱),流速为1.0 mL/min,检测波长为260 nm,柱温为30℃,进样量为10μL。结果黄芪、白头翁、补骨脂、白术的TLC特征斑点清晰,与杂质斑点分离较好,且阴性对照无干扰,未检出乌头碱。毛蕊异黄酮葡萄糖苷进样量在74.96~262.23 ng(R^(2)=1.0000,n=6)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于2.0%(n=6);平均加样回收率为97.86%,RSD为1.47%(n=6)。结论所建立的方法操作简便快捷,结果准确可靠,专属性强,重复性和稳定性均较好,能更全面地控制安肠胶囊的质量。Objective To improve the quality standard of Anchang Capsules.Methods Thin-layer chromatography(TLC)method was used for the qualitative identification of Astragali Radix,Pulsatillae Radix,Psoraleae Fructus and Atractylodis Macrocephalae Rhizoma in Anchang Capsules,and to check the limit of aconitine.High-performance liquid chromatography(HPLC)method was used for the content determination of calycosin-7-glucoside in Anchang Capsules,the chromatographic column was Shim-pack GIST C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution(gradient elution),the flow rate was 1.0 m L/min,the detection wavelength was 260 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The TLC characteristic spots of Astragali Radix,Pulsatillae Radix,Psoraleae Fructus and Atractylodis Macrocephalae Rhizoma were clear and well separated from the impurity spots,the negative sample had no interference,and aconitine was not detected by TLC.Calycosin-7-glucoside showed a good linear relationship in the range of 74.96-262.23 ng(R^(2)=1.0000,n=6).The RSDs of precision,stability and repeatability tests were less than 2.0%(n=6).The average recovery of calycosin-7-glucoside was 97.86%with an RSD of 1.47%(n=6).Conclusion The established method is simple,rapid,accurate and reliable,has strong specificity,good repeatability and stability,which can more comprehensively control the quality of Anchang Capsules.

关 键 词：安肠胶囊 薄层色谱法 高效液相色谱法 毛蕊异黄酮葡萄糖苷 质量标准 

分 类 号：R917[医药卫生—药物分析学] R975[医药卫生—药学]