抗妇炎胶囊中苦参碱和氧化苦参碱的含量测定

Determination of the Content of Matrine and Oxymatrine in Kangfuyan Capsules

目的 建立同时测定抗妇炎胶囊中苦参碱和氧化苦参碱含量的方法。方法 采用高效液相色谱法（HPLC）测定苦参碱和氧化苦参碱的含量，采用Thermo色谱柱（规格4．6mm×250mm，5μm）；乙腈-磷酸盐缓冲液（取磷酸二氢钾1．36g。加1ml三乙胺，加水至1000ml用磷酸调节pH5．5）为流动相，梯度洗脱；流速：1ml／min；检测波长为220nm。结果 苦参碱在0．170～0．0106mg／ml之间与峰面积积分值呈良好的线性关系（r=0．9999），平均加样回收率99．9％。RSD=2．9l％；氧化苦参碱在0．0055～0．088mg／ml之间与峰面积积分值呈良好的线性关系（r=0．9998），平均加样回收率98．1％。RSD为2．5l％。结论 该方法简便、快速准确，可提高该制剂定量控制指标。

Objective To establish a method for simultaneous determination of the content of Matrine and Oxymatrine in Kangfuyan Capsules. Methods HPLC method was carried out through Thermo C18 column, using acetontrile- phosphate buffer solution （contained 1.36 g potassium dihydrogen phosphate and lml triethylarmine, add water to 1000 ml adjusted to pH 5.5 with phosphate acid） as mobile phase, elute in gradient mode. The flow rate was 1.0 ml rain with detective wavelength of 220 nm. Results The calibration curve of Matrine was linear within the range of 0. 170 -0. 010 6 mg/ml（ r =0.999 9）. The average recoveries of Matrine was 99.9% , RSD was 2.91% , the calibration curve of Oxymatrine was linear within tile range of 0. 005 5 - 0. 088 mg/ ml （ r = 0. 999 8 ）. The average recoveries of Oxymatrine was 98.1%, RSD was 2.51%. Conclusion The method is simple, fast and accurate, it increases the quality control index of Kangfuyan Capsules.