亚甲蓝注射液含量测定取样方法的研究
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摘要
目的用重量法取样代替体积取样并研究以质量/质量浓度(mg·g-1)的百分比代替质量/体积浓度(mg·m L-1)的百分比来表示亚甲蓝注射液的含量,为提高其含量测定的准确度、精密度和易操作性提供实验依据。方法用电子天平精密称取一定重量的亚甲蓝注射液,经稀释后用高效液相色谱法(HPLC法)和紫外可见分光光度法(UV-Vis法)测定亚甲蓝注射液的含量,并计算出质量/质量浓度(mg·g-1)百分比。结果重量法取样测定亚甲蓝注射液的含量,测定10次,HPLC法平均含量为99.6%,RSD=0.1%,紫外可见分光光度法平均含量为100.0%,RSD=0.1%;移液取样测定亚甲蓝注射液的含量,测定10次,HPLC法平均含量为99.6%,RSD=0.2%,UV-Vis法平均含量为99.9%,RSD=0.2%。结论重量法取样测定亚甲蓝注射液的含量与以往体积取样相比,测定结果的准确度、精密度和实验易操作性更优,且温度对测定结果的影响更小。
OBJECTIVE Using weight sampling method instead of pipette sampling method while defining percentage of mass/mass(mg· g-1) as format for representing content of methylthioninium chloride injection,instead of mass/volume(mg· m L-1). To provide experimental support for improving accuracy,precision and operational ease of assay. METHODS Took samples of methylthioninium chloride injection with using electronic balance,determinated assay of it by HPLC method and UV-Vis method after dilution. Then defined percentage of mass/mass(mg·g-1) as format for representing content of it. RESULTS Determinated assay of methylthioninium chloride injection by HPLC method and UV-Vis method,each for ten times. With using weight sampling method,the average content was 99. 6 %,RSD = 0. 1 %,(HPLC method),100. 0 %,RSD = 0. 1 %(UV-Vis method). With using former pipette sampling method,the average content was 99. 6 %,RSD = 0. 2 %(HPLC method),99. 9 %,RSD = 0. 2 %(UV-Vis method). CONCLUSION Compare weight sampling method to former pipette sampling method,the accuracy,precision and operability of assay were better,meanwhile the effect from temperature was diminished.
OBJECTIVE Using weight sampling method instead of pipette sampling method while defining percentage of mass/mass(mg· g-1) as format for representing content of methylthioninium chloride injection,instead of mass/volume(mg· m L-1). To provide experimental support for improving accuracy,precision and operational ease of assay. METHODS Took samples of methylthioninium chloride injection with using electronic balance,determinated assay of it by HPLC method and UV-Vis method after dilution. Then defined percentage of mass/mass(mg·g-1) as format for representing content of it. RESULTS Determinated assay of methylthioninium chloride injection by HPLC method and UV-Vis method,each for ten times. With using weight sampling method,the average content was 99. 6 %,RSD = 0. 1 %,(HPLC method),100. 0 %,RSD = 0. 1 %(UV-Vis method). With using former pipette sampling method,the average content was 99. 6 %,RSD = 0. 2 %(HPLC method),99. 9 %,RSD = 0. 2 %(UV-Vis method). CONCLUSION Compare weight sampling method to former pipette sampling method,the accuracy,precision and operability of assay were better,meanwhile the effect from temperature was diminished.
引文
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[2]陶鑫,陈世伟,王贵国,等.亚甲蓝注射液在肾移植术中的应用[J].临床军医杂志,2005,33(4):452-453.
[3]鲁松涛.复方亚甲蓝注射液在肛肠术后镇痛中的应用[J].临床医学,2009,29(2):67-68.
[4]邵文真,孙健,孟凡磊.复方亚甲蓝注射液在肛肠术后镇痛的疗效观察[J].中外医疗,2012,23:108-109.
[5]唐良振,李贵芹,王运红,等.复方亚甲蓝注射液在乳腺脓肿术后切口镇痛中的疗效观察[J].中国当代医药,2016,23(28):135-138.
[6]梁亚群.误差理论在化学分析中的应用[J].铜业工程,2006,2:44-46.
[7]国家药典委员会编.相对密度检查法.中国药典2015年版.四部[S].北京:化学工业出版社,2015,73-74.
[8]国家药典委员会编.亚甲蓝注射液.中国药典2015年版.二部[S].北京:化学工业出版社,2015,343-344.
[9]韩淑芹.HPLC法测定亚甲蓝注射液含量及有关物质[J].中国药师,2016,19(4):811-813.
[10]K.Bergmann,C.T.O'Konski.A spectroscopic study of methylene blue monomer,dimer,and complexes with montmorillonite[J].The journal of physical chemistry,1963,67:2169-2177.
[11]国家药典委员会编.尿素乳膏.中国药典2015年版.二部[S].北京:化学工业出版社,2015,532.