生脉粉针剂中五味子醇甲和总木脂素的含量测定

目的建立生脉粉针剂中五味子醇甲的HPLC含量测定方法和总木脂素的紫外分光光度含量测定方法。方法采用HiQSilC18柱(250.0mm×4.6mm,5μm),乙腈水(体积比为50∶50)为流动相,流速1.0mL·min-1,测定波长254nm,柱温25℃,对生脉粉针剂中的五味子醇甲进行含量测定。采用紫外分光光度法在254nm波长下对总木脂素进行含量测定。结果五味子醇甲进样量在0.150～0.562μg内线性关系良好(r=0.9999),平均回收率97.7%,RSD为1.15%(n=9)。总木脂素质量浓度在3.12～31.2mg·L-1内线性关系良好(r=0.9996),平均回收率为101.2%,RSD为0.94%(n=9)。结论HPLC法和UV法分别测定五味子醇甲和总木脂素,可用于制剂的含量测定。

Quantitative determination of schisandrin and lignanoid in Shengmai freeze drying preparation for injection

Objective To develop a quantitative method for determining the contents of schisandrin and lignanoid in Shengmai freeze drying preparation (traditional Chinese medicines) for injection by reversed-phase high performance liquid chromatography and UV method,respectively.Methods ODS column((250.0 mm×)(4.6 mm),(5 μm)) was used in HPLC with mobile phase: acetonitrile -water (V∶V=50∶50);flow rate:1.0 mL·min~(-1);detection wavelength:(254 nm) for schisandrin;and detection wavelength (254 nm) for lignanoid by UV method.Results The linear range of schisandrin is 0.150 ～ (0.562 μg) (r=(0.999 9)).The average recovery is 97.7%,RSD=1.15% (n=9).And the linear range of lignanoid is 3.12～31.2 mg·L~(-1) (r=(0.999 6)).The average recovery is 101.2%,RSD=0.94% (n=9).Conclusions The HPLC and UV method are reliable,accurate and suitable for the determination of schisandrin and lignanoid in Shengmai freeze drying preparation for injection,respctively.