《中国医院制剂规范》中炉甘石洗剂质量标准执行缺陷文献分析  

Literature analysis of implementation defects of calamine lotion quality standards in “Standard of hospital preparations in China”

作　　者：马佩杰[1] 马聪[2] 马俊强[3] 张妍[4] 熊琳[1] 董武[1] 

机构地区：[1]宝鸡市中心医院,陕西宝鸡721008 [2]南昌大学第一临床医学院,江西南昌330031 [3]宝鸡职业技术学院,陕西宝鸡721006 [4]宝鸡市妇幼保健院,陕西宝鸡721000

出　　处：《中国医院药学杂志》2016年第14期1212-1216,共5页Chinese Journal of Hospital Pharmacy

摘　　要：目的:全面了解炉甘石洗剂质量标准执行过程中存在的问题缺陷,为质量标准的建立和完善以及《规范》的修订和再版提供参考。方法:采用回顾性方法,对1995-2014年在国内公开发表的有关依据《规范》对炉甘石洗剂进行质量控制并提出问题缺陷的15篇文献按文献产生时间、文献执行标准、文献提出的问题和缺陷进行归纳、统计、分析。结果:1995-2014年《规范》一直未修订和再版;炉甘石洗剂至今尚无统一、完善的质量控制方法;依据《规范》对质量标准执行中有氧化锌含量过高、过低偏差较大;含量限度宽泛无上限;检测方法麻烦、误差大;缺少对苯酚的含量监控;《规范》与药典对炉甘石原料中氧化锌标准不统一的问题,炉甘石洗剂质量标准缺陷较多。结论:增加苯酚质量控制,完善炉甘石洗剂质量标准,《规范》亟需修订再版。OBJECTIVE To learn problems of calamine lotion quality standards during execution,provide a reference for establishment and improvement of quality standards,revision and republication of the Standard of hospital preparations in China.METHODS Retrospective method was adopted to research15 literatures on defects of calamine lotion quality control from1995 to 2014,which were summarized and analyzed by problems and defects proposed,publish times and executive standards.RESULTS Standard of hospital preparations in China had not been revised or republished from1995 to 2014,and no unified and comprehensive quality control method was available for calamine lotion till now.Defects of quality standard of calamine lotion included high deviation of zinc oxide content,no limit for content,troublesome detection method with large errors,no monitoring for phenol content,inconsistent quality standard for zinc oxide in raw materials.CONCLUSION ＂ Standard of hospital preparations in China＂ should be revised to enhance quality control over phenol and improve the quality standard of calamine lotion.

关 键 词：氧化锌 质量标准 炉甘石洗剂 含量限度 《中国医院制剂规范》 

分 类 号：R943[医药卫生—药剂学]