HPLC法测定桃仁配方颗粒中苦杏仁苷及其不确定度评价
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摘要
目的:建立桃仁配方颗粒中苦杏仁苷的含量测定方法,对其测定结果进行不确定度评价。方法:采用高效液相色谱法测定桃仁配方颗粒中苦杏仁苷的含量,并对实验过程中各个因素对结果不确定度的贡献进行具体分析,得到在95%置信区间下测量结果的扩展不确定度及其合成不确定度。结果:桃仁配方颗粒中苦杏仁苷含量测定结果的合成不确定度为0. 83%,在95%置信区间下测量结果的扩展不确定度为2. 36mg/g,最终得其报告不确定度为(142. 17±2. 36) mg/g。结论:本文利用方法学验证和不确定度的相关理论进行全面评价,证明其含量测定结果的准确性和可靠性,为其他配方颗粒的质量评价提供参考。
Objective: To establish a method for the determination of amygdalin in formula granules of peach kernel,the measurement results are evaluated with uncertainty. Method: HPLC was used to determine the content of amygdalin in peach kernel formula granules.And the uncertainty introduced by various factors was evaluated clearly in the process of measurement. Finally,the uncertainty of synthesis was calculated and the uncertainty of the measurement results was given in the 95% confidence interval. Results: The synthetic uncertainty of amygdalin content in peach kernel formula granules was 0. 83%. In the 95% confidence interval,the extended uncertainty of the measurement results was 2. 36 mg/g. The report uncertainty of the measurement results was( 142. 17 ± 2. 36) mg/g. Conclusion: In this paper,methodology verification and uncertainty related theories are used for comprehensive evaluation,and it proves the accuracy and reliability of content determination of amygdalin in the formula granules results. Meanwhile,it provides references for quality evaluation of other formula particles.
Objective: To establish a method for the determination of amygdalin in formula granules of peach kernel,the measurement results are evaluated with uncertainty. Method: HPLC was used to determine the content of amygdalin in peach kernel formula granules.And the uncertainty introduced by various factors was evaluated clearly in the process of measurement. Finally,the uncertainty of synthesis was calculated and the uncertainty of the measurement results was given in the 95% confidence interval. Results: The synthetic uncertainty of amygdalin content in peach kernel formula granules was 0. 83%. In the 95% confidence interval,the extended uncertainty of the measurement results was 2. 36 mg/g. The report uncertainty of the measurement results was( 142. 17 ± 2. 36) mg/g. Conclusion: In this paper,methodology verification and uncertainty related theories are used for comprehensive evaluation,and it proves the accuracy and reliability of content determination of amygdalin in the formula granules results. Meanwhile,it provides references for quality evaluation of other formula particles.
引文
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[12]何玲玲,韦国兵,胡奇军.高效液相色谱法测定银黄口服液中黄芩苷含量及不确定度分析[J].中国现代医学杂志,2015,25(34):15-18.
[13]汤庆发,谢颖,陈飞龙,等.苦杏仁中苦杏仁苷的存在形式及其影响因素[J].中国实验方剂学杂志,2013,19(8):107-109.
[14]刘易,龚莹,郭磊,等.中成药中氰苷及其差向异构体的成分分析[J].药物分析杂志,2016(6):1 011-1 019.
[2]饶毅,魏惠珍,张洁,等.不确定度评定在中药领域中的应用[J].江西中医药大学学报,2008,20(5):52-54.
[3]张竹.高效液相色谱法测定阿奇霉素片含量的不确定度分析[J].中国药物经济学,2016,11(12):22-25.
[4]刘立民,侯雄军,汤韶明,等. HPLC法测定桉芩止咳糖浆中黄芩苷及其不确定度评定[J].现代中西医结合杂志,2016,25(19):2152-2 154.
[5]宋增炫,陈媛,蓝红梅. HPLC法测定氯霉素滴眼液含量的不确定度分析[J].中国医药科学,2017,7(5):31-33.
[6]魏惠珍,谢菲,饶毅,等. HPLC法测定元胡止痛胶囊中延胡索乙素及其不确定度评定[J].中草药,2012,43(2):299-302.
[7]秦立,王莹,张利,等. HPLC测定氯氮平片含量的测量不确定度评定[J].中国现代应用药学,2015,32(2):189-194.
[8]饶毅,张洁,李新南,等. HPLC法测定大豆异黄酮的不确定度评定[J].中草药,2008,39(11):1 667-1 670.
[9]刘立.量化分析测量不确定度指南[M].北京:中国计量出版社,2003.
[10]陆明,范国荣,汪杨,等.测量不确定度在药品领域的应用[J].医药导报,2013,32(8):1 053-1 057.
[11]Islam MD,Turcu M S,Cannavan A. Comparison of methods for the estimation of measurement uncertainty for an analytical method for sulphonamides[J]. Food Additives&Contaminants,2008,25(12):1 439-1 450.
[12]何玲玲,韦国兵,胡奇军.高效液相色谱法测定银黄口服液中黄芩苷含量及不确定度分析[J].中国现代医学杂志,2015,25(34):15-18.
[13]汤庆发,谢颖,陈飞龙,等.苦杏仁中苦杏仁苷的存在形式及其影响因素[J].中国实验方剂学杂志,2013,19(8):107-109.
[14]刘易,龚莹,郭磊,等.中成药中氰苷及其差向异构体的成分分析[J].药物分析杂志,2016(6):1 011-1 019.