摘要
目的：建立郁李仁配方颗粒的质量标准。方法：采用薄层色谱（TLC）法对郁李仁配方颗粒中的苦杏仁苷进行定性分析,采用高效液相色谱（HPLC）法测定制剂中苦杏仁苷的含量。色谱柱为GP-Phenyl,流动相为乙腈-水（10∶90,V/V）,流速为0.8 ml/min,检测波长为210 nm,柱温为30℃,进样量为5μl。结果：苦杏仁苷的TLC图斑点清晰、分离较好,阴性对照无干扰。苦杏仁苷质量浓度在50.92~611.04μg/ml范围内与其峰面积积分值呈良好线性关系（r=0.999 8）;精密度试验的RSD〈2%,稳定性、重复性试验的RSD〈3%;平均加样回收率为101.07%,RSD为0.64%（n=6）。结论：该方法操作简单、灵敏、专属性强、重复性好,可作为郁李仁配方颗粒的质量控制方法。
OBJECTIVE： To establish the quality standard of Pruni Semen formula granules. METHODS：Pruni Semen formula granules were identified by TLC. The content of amygdalin was determined by HPLC. The determination was performed on GP-Phenyl column with mobile phase consisted of acetonitrile-water （ 10 ： 90, V/V） at the flow rate of 0.8 ml/min. The detection wavelength was set at 210 nm, and column temperature was 30 %.The sample size was 5 μl. RESULTS： TLC spots of amygdalin were clear and well-separated without interference from negative control. The linear range of amygdalin was 50.92-611.04 μg/ml （r=0.999 8） with an average recovery of 101.07% （RSD=0.64% ,n=6）. RSD of precision test was lower than 2%, and RSDs of stability and reproducibility tests were lower than 3%. CONCLUSIONS： The method is simple, sensitive, specific and reproducible, and can be used for the quality control for Semen pruni formula granules.
出处
《中国药房》
CAS
北大核心
2015年第3期386-388,共3页
China Pharmacy
基金
上海市中医药标准化研究项目(No.ZYSNXD-CCBZH)
