目的: 研究药品检测实验室LIMS系统溶出度ELN通用模板的建立方法。方法: 通过对各国药典个论和溶出度通则的整理,排查并比较溶出度检查的检测方法和判定依据。根据溶出度检查的实验特点,将ELN通用模板设计为由溶出信息、试剂信息、检测方法、对照品信息和测定结果等多个工作簿(worksheet)组成的Microsoft® Excel®文件,在每个工作簿中编制实验相关信息的单元格,采用IF、MOD、POWER、ROUNDDOWN、ROUND和COUNTIF等函数编辑计算公式并锁定。除文字型原始数据须通过手动输入或以下拉菜单方式选定之外,仪器的检测原始数据分别通过串口或由ECM上传至ELN指定单元格,再由锁定的计算公式自动计算得到经修约至整数位的溶出度结果,并自动按相应的药典判定标准进行结果的判定。结果: 本文建立的ELN通用模板适用于溶出度检查的电子原始记录,模板涵盖HPLC和UV检测方法,可自动根据ChP及EP、USP、JP溶出度通则的不同判定流程进行分阶段的结果判定,具有较强的实用性。使用经验证的通用模板可满足数据完整性的要求,大大降低人为的计算、修约和判定的差错,提高工作效率。结论: 溶出度ELN通用模板满足政府药品检测实验室检测品种多、检验任务重复性小的工作特点,具有灵活性和便捷性,可供其他药品检测实验室借鉴。
Objective: To establish the universal electronic laboratory notebook (ELN) templates in laboratory information management system (LIMS) for dissolution tests in pharmaceutical testing laboratories. Methods: The testing methods and decision criteria of dissolution tests as per the monographs and general notice of dissolution test in ChP, EP, USP, and JP were investigated and compared. Based on the characteristics of the dissolution tests, the universal ELN templates were designed to be Microsoft® Excel® workbooks composed of a number of worksheets. The universal ELN template for dissolution test of HPLC method contains the following worksheets, i.e., worksheets of dissolution method, reagents, HPLC method, system suitability test, reference substances and dissolution results, while that of UV method includes the worksheets of dissolution method, reagents, UV method, blank solution, reference standards, and dissolution results. Necessary worksheet cells with adequate information are filled as per the quality standard, and equations using Excel functions such as IF, MOD, POWER, ROUNDDOWN, ROUND and COUNTIF, etc., are edited. The worksheet cells are then locked. The text type raw data should be introduced into the ELN cell by manual inputting or selecting from the drop down list, while the raw data acquired by analytical instruments could be transferred to the designated ELN cell via serial communication or ECM. The dissolution results are automatically calculated and rounded to integer by locked equations using these raw data, and whether the results comply with the requirements according to corresponding pharmacopoeia or not will be judged automatically in ELN. Results: The established universal ELN templates are of high practicability. The templates are applicable for the electronic recording for dissolution tests covering the testing methods of HPLC and UV, and the testing conclusion can be automatically drawn according to the stage-by-stage determination flowchart of dissolution test in ChP, EP, USP or JP. The utilization of validated universal ELN templates meets the requirements of data integrity, decreases the occurrence of the errors caused by manual calculation, data rounding and the result judging, and promotes testing efficiency. Conclusion: The universal ELN templates for dissolution tests, being flexible and convenient, can meet the demand of government pharmaceutical testing laboratories which have a wide variety and low repeatability of testing samples. The establishment of the ELN templates in this article can offer reference for other pharmaceutical testing laboratories.
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