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| 229批国产注射用头孢噻肟钠的质量评价 | |
| 引用本文： | 姚蕾,王立新,王红梅,高志峰,胡昌勤. 229批国产注射用头孢噻肟钠的质量评价[J]. 药品评价, 2012, 9(11): 22-27 |
| 作者姓名： | 姚蕾 王立新 王红梅 高志峰 胡昌勤 |
| 作者单位： | 1. 中国食品药品检定研究院,食品药品技术监督所,北京,100050 2. 中国食品药品检定研究院,化学药品检定所,北京,100050 3. 厦门市药品检验所抗生素室,福建,厦门,361012 |
| 摘 要： | 目的:对国产注射用头孢噻肟钠的质量现状进行评价。方法:按中国药典及有关标准进行检验,利用统计学方法分析检验结果。结果:44个企业生产的229批注射用头孢噻肟钠中,12批不合格,占5.24%,涉及8个厂家。溶液的澄清度是主要的不合格项。结论:目前国产注射用头孢噻肟钠存在的主要质量问题是溶液的澄清度和成盐问题。 |
| 关 键 词： | 注射用头孢噻肟钠 质量评价 |
Quality Assessment for 229 Batches of Domestic Cefotaxime Sodium Injection Samples |
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| YAO Lei , WANG Li-xin , WANG Hong-mei , GAO Zhi-feng , HU Chang-qin. Quality Assessment for 229 Batches of Domestic Cefotaxime Sodium Injection Samples[J]. Drug Evaluation, 2012, 9(11): 22-27 | |
| Authors: | YAO Lei WANG Li-xin WANG Hong-mei GAO Zhi-feng HU Chang-qin |
| Affiliation: | 1.National Institute for Food and Drug Control,Institute for Food and Drug Technical Supervision,Beijing,100050,China;2.National Institute for Food and Drug Control,Institute for Drug Control,Beijing,100050,China;3.Xiamen Institute for Drug Control,Division of Antibiotics,Xiamen,361012,China |
| Abstract: | Objective: To evaluate the quality of cefotaxime sodium for injections at present.Methods: All the samples were examined according to the Chp.and other approved criteria.The data were analyzed by statistic methods.Results: 12 batches of samples produced by 8 pharmaceutical factories were found unqualified among 229 batches of samples produced by 44 pharmaceutical factories,with the disqualification rate of 5.24%.The clarity of cefotaxime solution was the major item of disqualification in all these preparations.Conclusions: The solution’s clarity and the salification of cefotaxime were the main problems for qualities of these domestic preparations. |
| Keywords: | cefotaxime sodium for injection Quality evaluation |
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