南五味子木脂素提取物清洁验证分析方法研究

Cleaning validation of the residues of Lignins in Schisandra sphenanthera on preparation equipment

目的对南五味子木脂素提取物生产所用设备进行清洁验证分析方法研究。方法采用HPLC法对南五味子木脂素提取物中主成分五味子酯甲和五味子甲素进行分析方法和取样方法研究。结果五味子酯甲的检测限(LOD)为0.12 mg·L^(-1),定量限(LOQ)为0.41μg·L^(-1),线性范围为203.5~5.09 mg·L^(-1),取样回收率为77.8%;五味子甲素的检测限(LOD)为0.24 mg·L^(-1),定量限(LOQ)为0.82 mg·L^(-1),线性范围为209.66~5.24 mg·L^(-1),取样回收率为80.9%。结论五味子酯甲和五味子甲素的分析方法和取样方法有效可行。

Abstract： Objective To study the cleaning procedure of the residues of Lignins in Schisandra sphenanthera on the preparation equipment. Methods HPLC was employed to study the sampling and testing method for schisanthin A and deoxyschizandfin in Schisandra sphenanthera on the preparation equipment. Results The calibration curve of schisanthin A was linear in the range over 203.5 - 5.09 mg ·L^-1 with LOQ of 0.12 mg ·L^-1 and LOQ of 0.41 mg ·L^-1. The calibration curve of deoxyschizandfin was linear in the range over 209.66 - 5.24 mg ·L^-1 with LOQ of 0.24 mg ·L^-1 and LOQ of 0.82 mg ·L^-1. The average recoveries for schisanthin A and deoxyschizandfin were 77.8% and 80.9%. Conclusion The sampling and testing method for schisanthin A and deoxysehizandfin was both effective and reliable.