复方氨酚烷胺片(胶囊)中主成分含量均匀度测定  

Determination of Content Uniformity of Main Components in Compound Paracetamol and Amantadine Hydrochloride Tablets(Capsules)

作　　者：梁静 李超 黄俊 罗立骏 徐登 冯琴 程辉跃 LIANG Jing;LI Chao;HUANG Jun;LUO Lijun;XU Deng;FENG Qin;CHENG Huiyue(Chongqing Institute for Food and Drug Control·NMPA Key Laboratory for Quality Monitoring of Narcotic Drugs and Psychotropic Substances,Chongqing,China 401121)

机构地区：[1]重庆市食品药品检验检测研究院·国家药品监督管理局麻醉精神药品质量监测重点实验室,重庆401121

出　　处：《中国药业》2023年第23期7-12,共6页China Pharmaceuticals

基　　金：重庆市技术创新与应用发展专项资助项目[cstc2020jscx-msxmX0237]。

摘　　要：目的建立测定复方氨酚烷胺片(胶囊)中咖啡因和马来酸氯苯那敏含量均匀度的高效液相色谱(HPLC)法,并探讨其对重量/装量差异的影响。方法色谱柱为YMC-C_(18)柱(250 mm×4.6 mm,5μm),流动相为0.1 mol/L磷酸盐缓冲液(pH 3.0)-甲醇(60∶40,V/V),流速为1.0 mL/min,检测波长为275 nm(对乙酰氨基酚)和225 nm(咖啡因、马来酸氯苯那敏),柱温为35℃,进样量为5μL(对乙酰氨基酚)和20μL(咖啡因、马来酸氯苯那敏)。考察S值较大3家生产企业产品的重量/装量差异和主成分含量均匀度的关系。结果44家复方氨酚烷胺片生产企业的106批样品中,主成分含量均匀度的合格率为91.84%(90/98);52家复方氨酚烷胶囊生产企业的135批样品中,胶囊剂主成分含量均匀度的合格率为94.87%(111/117)。片剂生产企业C、胶囊生产企业E的产品每片(粒)中3种主成分含量与片重(粒重)曲线高度一致,但重量/装量差异的RSD分别为3.31%和2.25%;胶囊企业K的产品装量差异的RSD为1.35%,但仅对乙酰氨基酚的含量同装量差异呈正相关。结论建立的主成分含量均匀度测定方法专属性强,可为复方氨酚烷胺片(胶囊)的质量控制提供参考。建议生产企业根据主成分的投料量,按从大到小的顺序进行逐级混合,以提高产品的混合均匀度;同时,应在质量标准中增加咖啡因和马来酸氯苯那敏2种主成分的含量及含量均匀度的控制项目。Objective To establish a high-performance liquid chromatography(HPLC)method for determining the content uniformity of caffeine and chlorpheniramine maleate in Compound Paracetamol and Amantadine Tablets(Capsules),and to investigate its effect on the weight difference.Methods The chromatographic column was YMC-C_(18)column(250 mm×4.6 mm,5μm),the mobile phase was 0.1 mol/L phosphate buffer(pH 3.0)-methanol(60∶40,V/V),the flow rate was 1.0 mL/min,the detection wavelengths were 275 nm(acetaminophen)and 225 nm(caffeine,chlorphenamine maleate),the column temperature was 35℃,and injection volumes were 5μL(acetaminophen)and 20μL(caffeine,chlorpheniramine maleate).The relationship between the weight difference and the content uniformity of main components of products from three manufacturers with higher S-value was investigated.Results Among the 106 batches of samples from 44 manufacturers of Compound Paracetamol and Amantadine Tablets,the qualification rate for the content uniformity of the main components was 91.84%(90/98).Among the 135 batches of samples from 52 manufacturers of Compound Paracetamol and Aminophene Capsules,the qualification rate for the content uniformity of the main components was 94.87%(111/117).The contents of three main components in each tablet of tablet manufacturer C and each granule of capsule manufacturer E were highly consistent with the curve of tablet weight(granule weight),but RSDs of weight difference were 3.31%and 2.25%,respectively.The RSDs of the weight difference for capsule manufacturer K was 1.35%,but only the content of acetaminophen was positively correlated with the weight difference.Conclusion The established method for determining the content uniformity of main components has strong specificity and can provide a reference for the quality control of Compound Paracetamol and Amantadine Tablets(Capsules).It is recommended that the manufacturers mix the main ingredients in a step-by-step order from large to small according to their inventory,in order to improve the mixing u

关 键 词：复方氨酚烷胺片(胶囊) 对乙酰氨基酚 咖啡因 马来酸氯苯那敏 含量均匀度 生产工艺 逐级混合 

分 类 号：R917[医药卫生—药物分析学] R971.1[医药卫生—药学]