摘要
目的采用高效液相色谱技术研究分析银杏达莫中游离总氨基酸含量及其与维生素C配伍的稳定性情况。方法分别制备银杏达莫注射液、银杏达莫注射液与维生素C注射液的混合液的待检样品,以17种氨基酸混合溶液和维生素C标准品为对照,进行高效液相色谱分析,绘制标准曲线,计算检出限,观察银杏达莫注射液与维生素C注射液配伍溶液外观、pH值变化及不溶性微粒数情况。结果银杏达莫注射液中17种氨基酸的回归方程相关系数最高为Leu(0.999 7),最低为Met(0.995 7);检出限最高为His(4.04μmol/L),最低为Asp(1.16μmol/L);3种银杏达莫注射液加标回收率最高的氨基酸均为Pro(107.0%、104.0%、105.2%),最低分别为Gly(75.4%)、Glu(76.1%)、Phe(75.8%),精密度最高为Ile(5.06%),最低为Gly(1.43%)。所有3种银杏达莫注射液中,17种游离氨基酸的平均总含量为61.26 mg/g。24 h内外观检测显示,3种银杏达莫注射液与维生素C配伍后的溶液均未出现沉淀、浑浊情况,无气体产生及颜色变化,pH值呈现缓慢上升的趋势,配伍的溶液中≥10μm的不溶性微粒数随时间延长而缓慢增加,而≥25μm的不溶性微粒数随时间延长基本无变化。结论采用高效液相色谱技术可以明确分析银杏达莫注射液中17种游离氨基酸的含量,银杏达莫可以与维生素C配伍使用。
Objective To analyze the content of free total amino acid in ginkgo biloba extract and dipyri- damole and its compatible stability with vitamin C by high performance liquid chromatography （HPLC）. Methods The samples of ginkgo biloba extract and dipyridamole and the mixture of ginkgo biloba extract and dipyridamole injection and vitamin C injection were prepared. Seventeen kinds of amino acid mixed solution and vitamin C standard were used as control,and the standard curve was drawn by HPLC. The detection limit was calculated, and the appearance,pH value and insoluble particles were observed in the solution of ginkgo biloba extract and dipyridamole injection mixed with vitamin C injection. Results The correlation coefficient of the regression equation of 17 amino acids in ginkgo bi- loba extract and dipyridamole injection was highest （0. 9997） in Leu and lowest （0. 995 7 ） in Met, and the highest and lowest detective limit was 4. 04 [μmol/L （His） and 1. 16 [μmol/L （Asp） respectively. The highest recovery rates of Proton were 107. 0% , 104. 0% and 105.2% （Pro） , while the lowest was Gly （75.4） , Glu （76. 1 ） and Phe （75.8） ; the highest precision was Ile （5.06%） , while the lowest was Gly （ 1.43 ）. The average content of 17 free amino acids in all three kinds of ginkgo biloba extract and dipyridamole injection was 61.26 mg/g. The solution of vitamin C mixed with three kinds of ginkgo biloba extract and dipyridamole injection had no precipitation, gas or color change within 24 h. There was an increasing tendency in pH value. The number of insoluble particles （≥10 μm） in the compatibility solution increased slowly with time, while the number of insoluble particles （≥ 25 μm） did not change. Conclusion The content of 17 free amino acids in Ginkgo biloba extract can be clearly analyzed by HPLC, and the Ginkgo biloba can be used in combination with vitamin C.
作者
李燕灵
林夏飞
LI Yah-ling;LIN Xia-fei(Department of Pharmacy;Internal Medicine-Neurology,Peking University Shenzhen Hospital,Shenzhen 518000,China)
出处
《实用药物与临床》
CAS
2018年第8期933-936,共4页
Practical Pharmacy and Clinical Remedies
基金
深圳市福田区卫生公益性科研项目(FTWS201324)
关键词
高效液相色谱
银杏达莫
氨基酸
维生素C
High performance liquid chromatography
Ginkgo biloba
Amino acids
Vitamin C
