论文部分内容阅读
肌苷片是临床常用的生化药物,收载于卫生部药品标准。广西药检所陶宙镕等对本药品进行质量考察时发现,按部颁标准检测紫外吸收时,绝大多数厂家的产品符合规定,仅有标示“广东河源市康泰制药厂”的8批产品的γ_(max)和γ_(min)有2~3mm的偏差,初步分析可能与片剂辅料的影响有关。我们在药品抽验中也发现类似问题,为了进一步弄清紫外吸收波长出现偏差的原因,我们对有关样品进行了PC和HPLC检测分析,发现4批紫外吸收波长有偏差的样品,可检出明显杂质成分,虽然按部颁标准检验含量符合规定,但用HPLC法测定结果含肌苷仅为50%左右,说明这些产品是用劣质原
Inosine tablets are commonly used in clinical biochemical drugs, contained in the Ministry of Health drug standards. Guangxi Drug Prosecutors Tao Zhou and other quality inspection of the drug found that, according to the ministerial standards UV detection, the vast majority of manufacturers of products meet the requirements, only labeled “Guangdong Heyuan Kangtai Pharmaceutical Factory,” the 8 batches of products γ_ (max) and γ min (min) 2 ~ 3mm deviation, preliminary analysis may be related to the impact of tablet accessories. We also found similar problems in the drug testing. In order to further understand the reasons for the deviation of UV absorption wavelength, we conducted PC and HPLC analysis of the samples and found that 4 batches of samples with deviated UV absorption wavelength could detect obvious impurities Ingredients, although according to the ministerial standard test content in line with the provisions, but by HPLC assay results containing only about 50% inosine, indicating that these products are poor quality