注射用复方甘草甜素三组分的含量测定
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李红菊, 张向荣,李三鸣,杨婷媛
(沈阳药科大学 药学院, 辽宁 沈阳 110016)
摘要: 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。
关键词: 药剂学; 含量测定; 反相高效液相色谱法; 注射用复方甘草甜素
中图分类号：R283 文献标识码：A
contents
Determination of three kinds of component in compound glycyrrhizin injection
LI Hong-jü, ZHANG Xiang-rong, LI San-ming, YANG Ting-yuan
(School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China)
Abstract: Objective To develop the determination method of glycyrrhizin, two kinds of amino acid in compound glycyrrhizin injection. Methods RP-HPLC, bromometry and formol titration were respectively used to determine the contents of glycyrrhizin, cysteine hydrochloride and two amino acids. Results A good linear ranging of glycyrrhizin , cysteine hydrochloride and glycin was 0.03-0.61 kg·L-1, 0.1-1.2 kg·L-1, 2-20 kg·L-1. Within the linear range they showed good linear relation (r = 0.999 3, r=0.999 5，r=0.999 9) , and A =3.614×106ρ–1.611×104，V=19.015ρ+0.146 6，V=1.330 2ρ+0.139 3 were found respectively. The average recoveries were 99.8%(RSD =0.32%)，100.8 %(RSD= 1.17%)，100.5 %(RSD = 1.02 %)respectively. Conclusion The method was simple , rapid and well reproducible. It can be used as a reliable method for the quality control of compound glycyrrhizin injection .
Key words pharmacy; contents mensuration; RP-HPLC; compound glycyrrhizin injection
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