摘要
目的建立脂脱劲颗粒的质量标准。方法采用薄层色谱(TLC)法定性鉴别制剂中的制何首乌、女贞子、茯苓、木瓜;采用高效液相色谱(HPLC)法测定制剂中芍药苷的含量,色谱柱为Agilent Hedera Lichrospher柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸水溶液(18∶82,V/V),流速为1.0 mL/min,检测波长为230 nm,柱温为35℃,进样量为10μL。结果制何首乌、女贞子、茯苓、木瓜的TLC图斑点清晰,分离度好,且阴性对照无干扰。芍药苷质量浓度在21~168μg/mL范围内与峰面积线性关系良好(r=0.9995,n=5);精密度、稳定性、重复性试验结果的RSD均小于3.0%,平均加样回收率为100.64%,RSD为1.64%(n=9)。结论该方法操作简便,结果准确可靠,可用于脂脱劲颗粒的质量控制。
Objective To establish a quality standard of Zhituojing Granules.Methods Polygoni Multiflori Radix Praeparata,Ligustri Lucidi Fructus,Poria and Chaenomelis Fructus in the preparation were qualitatively identified by the thin-layer chromatography(TLC)method.The content of paeoniflorin in the preparation was determined by the high-performance liquid chromatography(HPLC)method;the chromatographic column was the Agilent Hedera Lichrospher column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution(18∶82,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 230 nm,the column temperature was 35℃,and the injection volume was 10μL.Results The TLC chromatograms of Polygoni Multiflori Radix Praeparata,Ligustri Lucidi Fructus,Poria and Chaenomelis Fructus showed clear spots,good resolution,and there was no interference from the negative reference.The linear range of paeoniflorin was 21-168μg/mL(r=0.9995,n=5).The RSDs of precision,stability and repeatability tests were all lower than 3.0%.The average recovery rate of paeoniflorin was 100.64%with an RSD of 1.64%(n=9).Conclusion This method is easy,accurate and reliable,which can be used for the quality control of Zhituojing Granules.
作者
唐安福
苏倩雯
崔恩忠
汤淏
潘海娟
TANG Anfu;SU Qianwen;CUI Enzhong;TANG Hao;PAN Haijuan(General Hospital of Eastern Theater Command,PLA,Nanjing,Jiangsu,China 210002)
出处
《中国药业》
CAS
2024年第16期96-99,共4页
China Pharmaceuticals
基金
中国人民解放军军队医疗机构制剂标准提高科研专项课题[14ZJZ16-3]。
