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目的完善全天麻胶囊的质量控制方法,建立多指标成分评价全天麻胶囊质量的方法。方法采用HPLC方法;Phe-nomenex Hydro-RP 80A(4.6 mm×150 mm,4μm)色谱柱;流动相为乙腈-0.1%磷酸,梯度洗脱:流速1 mL.min-1;柱温:40℃;检测波长:270 nm。结果天麻素、对羟基苯甲醇、对羟基苯甲醛和巴利森苷进样量分别在0.40～6.4μg(r=0.999 7),0.064～1.0μg(r=0.999 8),0.020～0.32μg(r=0.999 7),0.60～9.5μg(r=0.999 9)与峰面积呈良好线性关系,平均回收率(n=9)分别为100.8%(RSD 2.3%)、100.5%(RSD 3.4%)、101.9%(RSD 2.1%)、100.4%(RSD 2.5%);25批次样品中被测成分总量具有较好的一致性(RSD 3.4%)。结论该方法可用于评价全天麻胶囊的质量。
Objective To improve the quality control method of Tianma Capsule and to establish a method for evaluating the quality of Quantiapis capsule by using multiple index components. Methods The HPLC method was carried out on a Phe-nomenex Hydro-RP 80A (4.6 mm × 150 mm, 4 μm) column. The mobile phase consisted of acetonitrile-0.1% phosphoric acid with a gradient of 1 mL.min-1. Detection wavelength: 270 nm. Results The injection volume of gastrodin, p - hydroxybenzyl alcohol, p - hydroxybenzaldehyde and barison glycoside were 0.40 ~ 6.4μg (r = 0.999 7), 0.064-1.0μg (r = 0.999 8), 0.020-0.32μg r = 0.999 7). The average recoveries (n = 9) were 100.8% (RSD 2.3%) and 100.5% (RSD 3.4%) respectively for the range of 0.60-9.5μg (r = 0.999 9) 101.9% (RSD 2.1%) and 100.4% (RSD 2.5%). The 25 batches of samples had good consistency (3.4% RSD) of the total tested components. Conclusion This method can be used to evaluate the quality of all Tianma capsule.