氨酚待因片中杂质的交叉检查  

Cross Check Impurities in Paracetamol and Codeine Phosphate Tablets

作　　者：江培[1] 

机构地区：[1]哈尔滨商业大学药学院,哈尔滨150076

出　　处：《黑龙江医药》2017年第1期12-17,共6页Heilongjiang Medicine journal

摘　　要：目的:本文主要通过对氨酚待因片(Ⅵ)进行制剂通则检查、总灰分含量测定、酸不溶性灰分含量测定、水分含量测定、以及重金属限量测定等一系列研究来进行该药中所含杂质的交叉检查,进而对该药的杂质性研究甚至全方位研究进行补充。方法:此外,本实验还进行了磷酸可待因含量的测定。结果:结果显示,该药制剂通则符合药典规定;总灰分含量为0.6650%;酸不溶性灰分含量为0.3192%;水分含量为0.6088%;重金属限量在百万分之十以内,均符合规格,所含杂质较少,是合格的上市药。结论:磷酸可待因在50.4~117.6μg/ml浓度范围内呈良好线性关系,r=0.9993,测得其含量为标示量的99.82%Objective：This paper mainly aims at the impurity cross-check of Paracetamol and codeine phosphate tablets（Ⅰ）through a series of studies on general preparation check, determination of total ash content, determination of acid insoluble ash content, determination of moisture content, as well as the determination of heavy metals limited, in order to improve the significance of impurities research of this drug even the comprehensive research of it. Method：In addition, the experiment was also conducted to determine codeine phosphate content. Results：The results showed that the general preparation check is in accordance with the provision of the pharmacopoeia; the total ash content is 0.6650%; the acid insoluble ash content is 0.3192%; the moisture content is 0.6088%; the heavy metals limited is under 10 ppm. In conclusion, all the results are in line with the specifications. Conclusion：The Paracetamol and codeine phosphate tablets（Ⅰ） contains little impurity and is qualified listed drug; the calibration curve was linear in the range of50.4~117.6μg /ml（r= 0. 9993）, with mean content of 99.82% compared to labeled amount

关 键 词：氨酚待因片(Ⅵ) 杂质检查 制剂通则 总灰分 酸不溶性灰分 水分 重金属 含量测定 

分 类 号：R927[医药卫生—药学]