注射用透明质酸钠复合溶液中氨基酸含量的测定  

Determination of Amino Acid Content in Injectable Compound Solution of Hyaluronic Acid

作　　者：孟晓依 李春月 王欣 王程霖 孟强 高川 MENG Xiao-yi;LI Chun-yue;WANG Xin;WANG Cheng-lin;MENG Qiang;GAO Chuan(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Shandong Jinan 250101)

机构地区：[1]山东省医疗器械和药品包装检验研究院,山东济南250101

出　　处：《中国医疗器械信息》2025年第3期37-40,共4页China Medical Device Information

摘　　要：文章建立了氨基酸分析仪法测定注射用透明质酸钠复合溶液中氨基酸含量的分析方法。根据注射用透明质酸钠复合溶液样品中各氨基酸的添加量用0.02mol/L盐酸溶液进行稀释定容,保证样品中氨基酸浓度在线性范围内。采用阳离子交换色谱柱分离后,以茚三酮显色液做柱后衍生,反应温度为135℃,检测波长为440nm(脯氨酸)、570nm(盐酸赖氨酸、亮氨酸、甘氨酸)进行测定,以外标法定量。甘氨酸在10.35~103.50μg/mL、亮氨酸在2.72~27.22μg/mL、盐酸赖氨酸在2.64~26.42μg/mL、脯氨酸在7.62~76.20μg/mL均线性良好,线性相关系数均为1.0。甘氨酸、亮氨酸、盐酸赖氨酸、脯氨酸检出限分别为4.14ng/mL、15.24ng/mL、6.34ng/mL、45.72ng/mL。甘氨酸、亮氨酸、盐酸赖氨酸、脯氨酸的平均加标回收率分别为99.19%、99.99%、99.40%、99.27%,相对标准偏差分别为0.34%、0.26%、0.25%、0.47%。该方法具有灵敏度好、准确性高、专属性强等特点,可用于注射用透明质酸钠复合溶液中氨基酸含量的测定。An analytical method for the determination of amino acid content in sodium hyaluronate composite solution for injection was established by amino acid analyzer method.According to the addition of each amino acid in the sample of sodium hyaluronate composite solution for injection,0.02mol/L hydrochloric acid solution was used to dilute and determine the volume to ensure that the concentration of amino acids in the sample was within the linear range.After separation by cation-exchange chromatographic column,ninhydrin chromogenic solution was used as column and derivatized at a reaction temperature of 135℃,and the detection wavelength was 440nm(proline)and 570nm(lysine hydrochloride,leucine,glycine)for determination,and quantified by external standard method.Glycine was 10.35~103.50μg/mL,leucine was 2.72~27.22μg/mL,lysine hydrochloride was 2.64~26.42μg/mL,and proline was 7.62~76.20μg/mL all had good linearity,and the linear correlation coefficient was 1.0.The limits of detection of glycine,leucine,lysine hydrochloride and proline were 4.14ng/mL,15.24ng/mL,6.34ng/mL and 45.72ng/mL,respectively.The average recoveries of glycine,leucine,lysine hydrochloride and proline were 99.19%,99.99%,99.40%and 99.27%,respectively,and the relative standard deviations were 0.34%,0.26%,0.25%and 0.47%,respectively.This method has the characteristics of good sensitivity,high accuracy and strong specificity,and can be used for the determination of amino acid content in sodium hyaluronate composite solution for injection.

关 键 词：注射用透明质酸钠复合溶液 盐酸赖氨酸 亮氨酸 甘氨酸 脯氨酸 氨基酸分析仪 定量 

分 类 号：TB324[一般工业技术—材料科学与工程]