注射用灯盏花素(灯盏花素注射液)中7种抑菌剂考察  

7 antimicrobial agents in breviscapine for injection(breviscapine injection)

作　　者：丁琳 樊宝娟 吴芳 杜玮 罗定强 DING Lin;FAN Bao-juan;WU Fang;DU Wei;LUO Ding-qiang(Shaanxi Institute for Food and Drug Control,Xi’an 710065)

机构地区：[1]陕西省食品药品监督检验研究院,西安710065

出　　处：《中南药学》2020年第9期1551-1553,共3页Central South Pharmacy

基　　金：国家级抽验任务。

摘　　要：目的建立同时测定注射用灯盏花素(灯盏花素注射液)中7种抑菌剂(L-半胱氨酸、L-甲硫氨基酸、柠檬酸、没食子酸、苯甲醇、间甲酚、三氯叔丁醇)的高效液相色谱法。方法采用Thermo syncronis aQ-C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈(A)-水(磷酸调pH值至2.0)(B)梯度洗脱,检测波长为210 nm;流速为1.0 mL·min^-1;柱温35℃。结果L-半胱氨酸、L-甲硫氨基酸、柠檬酸、没食子酸、苯甲醇、间甲酚、三氯叔丁醇分离度良好,线性范围分别为10.4~156、21.0~315、32.1~482、0.198~2.98、0.701~10.5、0.715~10.7、21.0~315μg·mL-1(r=1.000)。91批样品中均未检出7种抑菌剂。结论该方法准确、灵敏、简便,可用于注射用灯盏花素(灯盏花素注射液)中7种抑菌剂的检查。Objective To establish a high performance liquid chromatography(HPLC)method for the determination of L-cysteine,L-methionine,citric acid,gallic acid,benzyl alcohol,m-cresol and chlorobutanol in breviscapine for injection(breviscapine injection).Methods A Thermo syncronis aQ-C18 column(250 mm×4.6 mm,5μm)was used for the separation with mobile phase of acetonitrile-water(using phosphoric acid to adjust pH to 2.0)in gradient mode.The detection wavelength was 210 nm,the flow rate was 1.0 mL·min^-1 and the column temperature was 35℃.Results L-cysteine,L-methionine,citric acid,gallic acid,benzyl alcohol,m-cresol and chlorobutanol were well separated,which showed good linearity at 10.4-156,21.0-315,32.1-482,0.198-2.98,0.701-10.5,0.715-10.7,and 21.0-315μg·mL-1(r=1.000),respectively.The 7 antimicrobial agents were not detected in 91 batches of samples.Conclusion This accurate,sensitive and convenient method is suitable for the determination of 7 antimicrobial agents in breviscapine for injection(breviscapine injection).

关 键 词：注射用灯盏花素(灯盏花素注射液) L-半胱氨酸 L-甲硫氨基酸 柠檬酸 没食子酸 苯甲醇 间甲酚 三氯叔丁醇 

分 类 号：R927[医药卫生—药学]