笔式注射器剂量准确度测试方法研究

      Study on Testing Methods of Pen-injector's Dosing Accuracy

      • 摘要: 目的 提出一种准确度的测试方法,减少配合使用检验药液试剂量,降低抽检和自检测试成本。方法 依据ISO 11608-1:2014中标准大气环境下的剂量准确度测试的要求,采用所提测试方法与国外相关研究中的测试方法,对同一批可重复使用的笔式注射器样品做剂量准确度测试,并对两种方法所测数据进行处理。结果 经过实验测试与分析,两种方法所测数据均未超过ISO标准中所规定的剂量准确度限值要求。两种方法在测试60 U和30 U剂量时并无显著性差异,在测试1 U剂量时,具有显著性差异。结论 两种方法均可以完成剂量准确度测试,但所提方法减少了2/3的检验药液使用量,有效地减少浪费,降低测试成本。

         

        Abstract: Objective An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests. Methods According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed. Results After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested. Conclusion Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.

         

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