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目的评价性抽验对注射用硫普罗宁进行质量分析,为质量标准的提高和临床用药提供参考,同时希望通过评价结果的反馈,使生产厂家对自身产品的质量有客观的了解,能够更好地进行完善。方法采用不同生产厂家各自的现行标准对酸度、干燥失重、有关物质、溶液的澄清度与颜色和含量进行比较。结果 122批样品的酸度、干燥失重、溶液的澄清度与颜色和含量结果均符合各自的标准规定,但不同生产厂家的结果测定值离散性较大,有4批样品中的有关物质不符合规定,合格率为96.7%。结论注射用硫普罗宁急需制定统一的质量标准,从而更好的控制产品质量,且不同生产厂家的产品质量存在一定的差异,建议相关部门应注重完善生产工艺。
Objective To evaluate the quality of the injection of tiopronin for the purpose of improving the quality standards and clinical drug reference, and hope that the feedback through the evaluation results, so that manufacturers have an objective understanding of the quality of their products can be better Perfect. Methods The acidity, loss on drying, and the clarity and color and content of the relevant substances and solutions were compared using the respective current standards of different manufacturers. Results The acidity, weight loss, clarity and color of the solution and the results of the content of the 122 batches of samples all met their own standards. However, the discrete values of the results of different manufacturers were quite large. The relevant substances in 4 batches of samples did not meet the requirements , With a pass rate of 96.7%. Conclusions Sipopramine for injection is in urgent need of setting uniform quality standards so as to better control the quality of products. There are certain differences in product quality among different manufacturers, and it is suggested that relevant departments should pay attention to perfecting the production process.