谷维素片的质量分析与评价  

Quality Analysis and Evaluation of Oryzanol Tablets

作　　者：张近近 吴晓睿 丰明悦 王慧 Zhang Jinjin;Wu Xiaorui;Feng Mingyue;Wang Hui(Zaozhuang Institute for Food and Drug Control,Zaozhuang 277100,China)

机构地区：[1]枣庄市食品药品检验检测中心,山东枣庄277100

出　　处：《山东化工》2024年第8期150-154,158,共6页Shandong Chemical Industry

摘　　要：目的:对谷维素片进行质量分析与评价。方法:通过法定标准检验结合探索性研究的方式,对山东省内药品质量风险监测抽样的43批次谷维素片进行分析检验,分析不同企业产品的质量差异。结果:通过法定标准检验,43批次谷维素片均符合规定,但仍然存在同一企业产品批间差异大,含量接近限度等问题;探索性研究中,HPLC法测定含量,部分样品含量测定结果低于法定标准限度要求。结论:目前谷维素片总体质量较好,但仍存在一定问题,建议企业加强内部质控管理,优化工艺参数,提高制剂工艺稳定性。Objective:To analyze and evaluate the quality of oryzanol tablets.Methods:43 batches of oryzanol tablets sampled by risk monitoring in Shandong Province were analyzed and tested by legal standard combined with exploratory research,and the quality differences of products from different enterprises were analyzed.Results:The 43 batches of oryzanol tablets were all met to the requirement,but there were still some problems,such as significant differences among batches of products from the same manufacturer,and the content was close to the limit.In the exploratory study,the results of determination of the content of some samples by HPLC were lower than the legal standard limit.Conclusion:The overall quality of oryzanol tablets is good,but there are still some problems.It is suggested that enterprises should strengthen internal quality control management,optimize process parameters and improve the stability of preparation process.

关 键 词：谷维素片 风险监测 质量评价 

分 类 号：TQ461[化学工程—制药化工]