云芝胞内糖肽口服制剂质量评价

Quality Evaluation of Coriolus Versicolor Intracellular Glycopeptides Oral Preparations

目的:了解云芝胞内糖肽口服制剂的质量现状并发现存在的质量问题,完善质量标准,为药品监管提供技术支持。方法:从全国范围内抽取54批次云芝胞内糖肽口服制剂样品,依据现行质量标准检验,从药品安全性、有效性等方面进行探索性研究,建立多项检测方法全面分析其质量情况。结果及结论:云芝胞内糖肽口服制剂在原料工艺和制剂工艺中均发现与批准工艺不符的问题,其质量标准有待完善和提高。

Objective:To analyze the overall quality status and related quality problems of Coriolus versicolor intracellular glycopeptides oral preparations in order to improve the quality standard and provide technical support for drug supervision.Methods:According to the current quality standard,54 batches of Coriolus versicolor intracellular glycopeptides oral preparations from the whole country were tested.Moreover,based on the problems found in the tests,exploratory research was carried out in aspects of authenticity,safety and effectiveness of these drugs,and a number of detection methods were established to fully analyze their quality.Results&Conclusion:It is found that the raw material process and preparation process are inconsistent with the approved processes,and the quality standards need to be improved.