注射用甘露聚糖肽两种含量测定方法的比较  

Comparision two kinds of content determination method of mannatide for injection

作　　者：金伟华[1] 陈华[1] 张明[1] 蒲志强[1] 

机构地区：[1]成都军区总医院药剂科,四川成都610083

出　　处：《药学实践杂志》2016年第1期62-65,共4页Journal of Pharmaceutical Practice

摘　　要：目的 比较注射用甘露聚糖肽的两种含量测定方法。方法 分别采用分光光度法和高效液相色谱法测定D-甘露糖的含量。结果 分光光度法测定中,供试品溶于苯酚溶液和硫酸中,于490nm波长处检测,D-甘露糖衍生物浓度线性范围是10.2~51μg/ml（r=0.999 1）,平均含量为92.14%,RSD平均值为1.17%。HPLC法测定中,用色谱柱：Gemini C18（250mm×4.6mm,5μm）;流动相：乙腈-0.02mol/L乙酸铵溶液（20∶80）,流速：1ml/min;检测波长：250nm;柱温：30℃;进样量：10μl。检测结果,平均含量为83.47%,RSD平均值为0.65%,两种方法均能有效测定D-甘露糖的含量。结论 分光光度法测定的平均含量较高,但检测中使用的苯酚有特殊臭味、有毒、具腐蚀性,对操作者会造成一定的危险性;HPLC法专属性强,色谱图更直观,对操作者的危害性和刺激性较小。同时建立一种测定D-甘露糖的新方法。Objective To compare two methods in the determination of mannatide for injection. Methods The contents were determined by spectrophotometry and HPLC method. Results In the samples determined by Spectrophotometric Determi- nation,soluble in phenol solution and sulfuric acid, was detected at wavelength 490 nm, D- mannose derivatives linear concen tration range is 10.2-51 μg/ml （r=0. 999 1）, the average content was 92.14%, the average RSD value was 1. 17%. In the HPLC determination, with color spectrum column： Gemini C18 （250 mm × 4. 6 ram, 5 μm ）, mobile phase acetonitrile -0.02 mol/L ammonium acetate solution （20 ： 80）, flow rate： 1 ml/min, the detection wavelength was at 250 nm, column temperature： 30 ℃, sample size： 10 μ1 detection. The average content ws 83. 47%, the average RSD value was 0.65%, the content of two kinds of methods could effectively determine the D- mannose. Conclusion The average content for spectrophotometry was higher, but the phenol was used in detection of special odor, poisonous, corrosive, would cause a cer- tain risk. HPLC was exclusive,chromatogram was more intuitive, on the operator harmfulness and less irritating. A new meth od for the determination of D- mannose was established at the same time.

关 键 词：注射用甘露聚糖肽 高效液相色谱法 分光光度法 D-甘露糖 

分 类 号：R927[医药卫生—药学] R979.5