复方氨酚那敏颗粒中胆红素鉴别和含量测定探究.doc

复方氨酚那敏颗粒中胆红素鉴别和含量测定探究 　　[摘要] 目的 建立复方氨酚那敏颗粒中胆红素的测定方法。 方法 采用薄层色谱法鉴别复方氨酚那敏颗粒中的胆红素；采用紫外-可见分光光度法测定复方氨酚那敏颗粒中胆红素的含量。 结果 薄层鉴别斑点清晰，阴性对照无干扰；胆红素的浓度在0.8064～8.064 μg/ml范围内与吸光度线性关系良好（r=0.9997），平均回收率为100.0%，RSD为1.5%（n=9）。 结论 该方法简便、准确、稳定且无干扰，可作为该制剂中胆红素的质量控制标准。 [关键词] 复方氨酚那敏颗粒；薄层色谱；胆红素；紫外-可见分光光度法 [中图分类号] R286.0 [文献标识码] A [文章编号] 1674-4721（2013）11（a）-0054-03 Study on the identification and content determination of bilirubin from compound paracetamol and chlorphenamine maleate granules MA Yue-min1 ZENG Chang-qing2 HUANG Chun-hui2 SONG Xiao-xiao1 1.Shenzhen Institute for Drug Control，Shenzhen 518057，China；2.School of Pharmacy Guangdong Pharmaceutical University，Guangzhou 510000，China [Abstract] Objective To establish a method for the determination and identification of bilirubin in aminophenol from compound paracetamol and chlorphenamine maleate granules. Methods A TLC method was developed to identify bilirubin in compound paracetamol and chlorphenamine maleate granules.The content of bilirubin was determined by UV spectrophotometry. Results The bilirubin spot of TLC were clear，negative control was no interference.The linear calibration curve for bilirubin was obtained in the concentration range of 0.8064-8.064 μg/ml（r=0.9997）.The average recoveries （n=9） were 100.0%，RSD=1.5%. Conclusion The method is simple，sensitivity，and stable，and could be used as the quality control method of bilirubin for compound paracetamol and chlorphenamine maleate granules. [Key words] Compound paracetamol and chlorphenamine maleate granules；Thin layer chromatography；Bilirubin；UV-Spectrophotomety 复方氨酚那敏颗粒为抗感冒药，用于感冒引起的鼻塞、头痛、咽喉痛、发热等症状。现行标准为《国家药品标准》化学药品地方标准上升国家标准第三册，标准编号：WS-10001-（HD-0256）-2002，国外药典未见有收载。复方氨酚那敏颗粒的主要成分为每袋含对乙酰氨基酚250 mg、咖啡因15 mg、人工牛黄10 mg、马来酸氯苯那敏1 mg[1]。胆红素是牛黄的主要功效成分，也是评价人工牛黄品质优劣的依据之一，为更好的控制其质量，本研究采用薄层色谱法及紫外-可见分光光度法对胆红素进行鉴别及含量测定[2]，现报道如下。 1 材料与方法 1.1 实验材料 岛津UV2450紫外-可见分光光度计；硅胶GF254薄层板（青岛海洋化工厂分厂，0.2～0.25 mm）（10 cm×10 cm），硅胶G薄层板（青岛海洋化工厂分厂，0.2～0.25 mm）（10 cm×10 cm）