对9厂家103批猴头菌片的质量评价  

Eval uation and Analysis of the Quality of Houtoujun Tablets among Nine Manufactors

作　　者：王蓓蓓[1] 

机构地区：[1]江苏省淮安市食品药品检验所,淮安223300

出　　处：《药学与临床研究》2016年第1期29-32,共4页Pharmaceutical and Clinical Research

摘　　要：目的:考察现行质量标准的科学性,评价猴头菌片的质量现状及存在的问题。方法:按照2012年江苏省评价性抽验计划总体要求,采用现行标准对抽验样品进行法定检验;建立或完善了用于探索性研究的多个方法:采用原子吸收法测定猴头菌片中铅(Pb)、镉(Cd)、砷(As)、汞(Hg)、铜(Cu)的含量;采用HPLC法测定猴头菌片中腺苷含量;采集猴头菌片的近红外光谱,利用OPUS软件进行处理,建立猴头菌片的近红外光谱一致性检验模型。结果:法定检验:103批次猴头菌片质量均符合标准规定。探索性研究:103批次猴头菌片中均不同程度检出重金属及有害元素,不同厂家含量测定结果差异显著,近红外光谱一致性检验模型可用于药品监督抽样的快速筛查。结论:目前绝大部分猴头菌片的产品质量符合现行标准要求;新建方法能有效弥补现行标准的缺陷,更真实地反映药品质量,有助于发现产品中的质量问题,促进产品质量的提高。Objective: To evaluate the suitability of statutory standard and the quality condition of Houtoujun tablets. Methods: According to the general requirements of assessment programs in Jiangsu2010, samples of Houtoujun tablets were examined using statutory testing methods; meanwhile, some methods for exploratory research were established or improved: lead(Pb), cadmium(Cd), arsenic(As), mercury(Hg) and copper(Cu) were determined by atomic absorption spectrometry; adenosine was determined by HPLC; Near-infrared spectra(NIR) were collected and assessed by the 0PUS analysis software for conformity. Results: Statutory inspection: 103 batches of Houtoujun tablets samples accorded with the demand.Exploratory research: 103 batches of Houtoujun tablets had different contents of heavy metals and harmful elements, the results showed significant difference among different manufacturers. The model of near infrared spectral consistency test can be used for rapid screening in drug monitoring and sampling. Conclusion: At present, the product quality of most Houtoujun tablets can meet the current standards; while the new method can effectively make up for the defects of current standard, which can reflect the quality of drugs more truly, help to find problems and promote the improvement of product quality.

关 键 词：猴头菌片 评价性抽验 质量评价 质量标准 

分 类 号：R927.11[医药卫生—药学]