药品包装防伪技术进展及在感官鉴别中的应用

Progress of Anti-counterfeiting Technology and Its Application in Sensory Identification of Drugs

目的药品包装引入防伪技术已成为制药行业的发展趋势。本文介绍近年防伪技术及其在药品感官鉴别中的应用,为该项工作的标准化提供新思路。方法收集多个品牌药品厂家近6年来的药品包装,归纳分析其防伪技术的发展和演变,结合相关的防伪技术国家标准,对药品包装所应用的防伪技术或手段进行统计和辨识。结果药品包装防伪技术主要有3方面发展趋势:从单一防伪技术向综合防伪技术发展;从低防伪力度向高防伪力度发展;从低识别性能向高识别性能发展。但防伪技术作为药品感官鉴别方法尚未实现规范化和标准化。结论各种防伪技术特征在药品监督检查工作中越来越重要,药品监管迫切需要尽快实现药品感官鉴别方法的规范化和标准化。

Objective To introduce the anti-counterfeiting technology in recent years and its application in sensory identification of drugs, and provide new ideas for the standardization of pharmaceutical sensory identification, based on the fact that anti-counterfeiting technology induced to drug packaging has become a tendency in the pharmaceutical industry. Methods Packages of brand drugs produced by different pharmaceutical manufacturers in the recent six years were collected. The development and evolution of anti-counterfeiting technology used in the package were summarized and analyzed. The statistical analysis and identification of anti-counterfeiting techniques or means applied in drug packages were performed according to relevant national standards for anti-counterfeiting technology. Results There are three major developing trends of anti-counterfeiting technology： from single technique to multiple techniques, from a low capability to a high one, from a low identification performance to a high one. However, the anti-counterfeiting technology has not been standardized and normalized as a sensory identification method for drugs. Conclusion The packaging anti-counterfeiting technology is playing a more and more important role in drug testing. Based on the urgent needs of drug regulation, we should achieve standardization of drugs sensory identification methods as soon as possible.