论文部分内容阅读
目的:研究对微晶纤维素3种含水量测定方法及其结果,建立不确定度评定的数学模型,并对不确定度进行评估。方法:参照《中国药典:2015版》附录中《干燥失重法》、《费休氏水分测定法》和《快速水分测定法》要求,测定微晶纤维素含水量。结果:微晶纤维素的含水量,采用干燥失重法测定结果为4.310%,扩展不确定度为0.060%(k=2);采用费休氏容量法测定结果为4.55%,扩展不确定度为0.26%(k=2);采用快速水分测定法测定结果为4.05%,扩展不确定度为0.70%(k=2)。结论:干燥失重法不确定度较小,费休氏容量法受人员操作和环境温湿度影响较大,而快速水分测定法因为仪器精度而不确定度较大;这为今后开展该类项目检测,对其结果准确性的控制提供了技术参数。
OBJECTIVE: To study the determination methods and the results of three kinds of water content of microcrystalline cellulose, establish the mathematical model to evaluate the uncertainty, and evaluate the uncertainty. Methods: The microcrystalline cellulose water content was determined according to the requirements of “Loss on drying method”, “Feishou moisture measurement method” and “Rapid moisture determination method” in appendix of “Chinese Pharmacopoeia: 2015 edition”. Results: The water content of microcrystalline cellulose was 4.310% by dry weight loss method, with an extended uncertainty of 0.060% (k = 2). The measured value was 4.55% by Fehler’s volumetric method with an extended uncertainty of 0.26% (k = 2). The result of fast water determination was 4.05% and the extended uncertainty was 0.70% (k = 2). CONCLUSION: The method of dry weight loss is less uncertain, the FH method is greatly affected by personnel operation and environmental temperature and humidity, while the rapid moisture measurement method is more uncertain due to the precision of the instrument. , The accuracy of the control of the results provided technical parameters.