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目的建立测定注射用复方甘草甜素中甘草酸及两种氨基酸含量的方法。方法采用RP-HPLC法测定注射用复方甘草甜素中甘草酸的含量;溴量法测定盐酸半胱氨酸的含量;甲醛滴定法测定氨基酸的总量。结果甘草酸质量浓度在0.03~0.61 kg·L-1内,盐酸半胱氨酸质量浓度在0.1~1.2 kg·L-1内,甘氨酸质量浓度在2~20 kg·L-1内线性相关良好(r=0.999 3、r=0.999 5、r=0.999 9),回归方程分别为A=3.614×106ρ–1.611×104、V=19.015ρ+0.146 6、V=1.330 2ρ+0.139 3;平均回收率分别为99.8%(RSD=0.32%)、100.8%(RSD=1.17%)、100.5%(RSD=1.02%)。结论所采用的方法可作为该制剂质量检验的定量方法。
Objective To establish a method for determination of glycyrrhizic acid and two amino acids in compound glycyrrhizin for injection. Methods The content of glycyrrhizic acid in compound glycyrrhizin for injection was determined by RP-HPLC method. The content of cysteine hydrochloride was determined by bromine method. The total amount of amino acids was determined by formaldehyde titration method. Results The concentration of glycyrrhizic acid was 0.03-0.61 kg · L-1, the concentration of cysteine hydrochloride was within 0.1-1.2 kg · L-1, and the concentration of glycine was within 2 ~ 20 kg · L-1 (r = 0.999 3, r = 0.999 5, r = 0.999 9). The regression equations were A = 3.614 × 106ρ-1.611 × 104, V = 19.015ρ + 0.146 6, V = 1.330 2ρ + 0.139 3, respectively. The average recoveries They were 99.8% (RSD = 0.32%), 100.8% (RSD = 1.17%) and 100.5% (RSD = 1.02%) respectively. Conclusion The method used can be used as a quantitative method for the quality control of this preparation.