中药饮片《药品生产质量管理规范》中标准适应性评估

Adaptability Evaluation of Standard on Chinese Herbal Pieces Quality Management

目的根据2010年修订的《药品生产质量管理规范》(GMP)附录中药饮片质量管理要求,探讨中药材检验结果用于中药饮片质量评价的评估方法是否可行。方法通过对2015年版《中国药典(一部)》收载中药材和中药饮片标准的比较,分析中药材与中药饮片标准的适应性,评估中药材与中药饮片检验结果的相关性。结果与结论 2015年版《中国药典》的部分中药材标准与中药饮片标准相适应,中药材检验结果可以引用至中药饮片检验报告。

Objective To discuss the adaptability evaluation method of quality of Chinese herbal pieces and chinese herbal medicine on the basis of GMP （revised 2010） appendix chapter of Chinese herbal pieces quality management requirements. Methods Based on the comparison of Chinese herbal medicine and Chinese herbal pieces standard in China Pharmacopeia（2015 edition, volume I ）, the adaptability of their quality standard was compared, and the correlation of test results between them was evaluated. Results and Conclusion Part of the standards of the Chinese herbal medicine is adaptable to the Chinese herbal pieces in China Pharmacopeia （2015 edition）. The test results of Chinese herbal medicine can be reference to the inspection report of the Chinese herbal pieces.