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目的:对西红花苷对照提取物准确赋值,并评估特性量值的不确定度。方法:按中国药典2010年版一部西红花项下HPLC分析方法,以西红花苷Ⅰ和西红花苷Ⅱ为指标考察对照提取物的均匀性,5家实验室协作定值,并评估不确定度。结果:对照提取物的均匀性良好,西红花苷Ⅰ和西红花苷Ⅱ的标示含量和扩展不确定度分别为(68.9±1.9)%和(23.0±0.9)%。结论:通过协作定值及不确定度评估可实现西红花苷对照提取物的可靠赋值。
OBJECTIVE: To accurately assign the crocin control extracts and assess the uncertainty of the characteristic values. Methods: According to the Chinese Pharmacopoeia 2010 edition of a saffron under HPLC analysis method to crocin Ⅰ and crocin Ⅱ as an indicator of the uniformity of the control extract, five laboratories set the value of cooperation and evaluation is not Determine the degree. Results: The homogeneity of the control extract was good. The labeled content and extended uncertainty of crocin Ⅰ and crohin Ⅱ were (68.9 ± 1.9)% and (23.0 ± 0.9)%, respectively. CONCLUSIONS: The reliable assignment of crocin control extracts can be achieved through collaborative setting and uncertainty assessment.