马钱子对照提取物的研究及其在马钱子药材及复方制剂质量控制中的应用

目的：研制马钱子对照提取物，建立采用该对照提取物对马钱子药材和复方制剂进行质量控制的方法。方法：采用Symmetry Shield^TM RP C₁₈（4.6 mm×250 mm，5 μm）色谱柱，以乙腈-0.01 mol·L^-1庚烷磺酸钠与0.02 mol·L^-1磷酸二氢钾等量混合溶液（21∶79）为流动相，流速1 mL·min^-1，检测波长260 nm，柱温30℃。对对照提取物的均匀性、稳定性进行考察，并进行赋值；对马钱子药材和骨刺片进行含量测定。结果：马钱子对照提取物的均匀性（F-test）和稳定性良好，士的宁和马钱子碱的平均含量（n=6）分别为49.9%（RSD=1.0%）和45.4%（RSD=0.59%）。采用对照提取物测定马钱子药材及复方制剂共8批次，测定结果与采用士的宁和马钱子碱单体对照品测得的结果基本一致。结论：本文初步验证了马钱子对照提取物可替代单体对照品用于马钱子药材及复方制剂的质量控制。

Objective:To develop the reference extract of Strychni Semen and establish the quality control method to evaluate the crude drug and preparation of Strychi Semen with the prepared reference extract.Methods:The HPLC analysis was performed on a Symmetry Shield^TM RP C₁₈ column(4.6 mm×250 mm,5 μm)with a mixture of acetonitrile and a mixture solution of equal quantities of 0.01 mol·L^-1 sodium heptane sulfonate solution and 0.02 mol·L^-1 potassium dihydrogen phosphate solution(21:79)as the mobile phase at a flow rate of 1 mL·min^-1.The wavelength was set at 260 nm and the column temperature was 30℃.Homogeneity,stability and value of the reference extract were investigated and crude drug and preparation of Strychi Semen were analyzed.Results:The reference extracts of Strychni Semen showed good homogeneity and stability.The average contents of strychnine and brucine were 49.9% and 45.4% and the RSDs were 1.0% and 0.59%,respectively.The quantitative results of 8 batches of crude drug and preparations obtained with the reference extract and the separate reference substances were basically the same.Conclusion:The presented method is feasible for quality control of reference extract of Strychni Semen,which is suitable to replace separate reference substances in assay of strychnine and brucine.

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