综合加权评分法预测山茱萸饮片有效期

The period validity of Cornus Ficinalis by comprehensive weighted scoring method

关键词:  山茱萸  加速实验  留样观察实验  综合加权评分法  有效期

Key words:  Cornus Ficinalis  accelerated experiment  sample observation experiment  comprehensive weighted scoring method  validity period

摘要:

[目的]探究山茱萸饮片的有效期，为其临床用药的安全性和有效性提供实验依据。[方法]通过加速实验和留样观察实验，以马钱苷、莫诺苷的含量为考察指标，建立高效液相色谱（HPLC）测定方法，按药典要求测定浸出物量，采用综合加权评分法研究含量和浸出物量3个指标随时间的变化规律，预测山茱萸饮片室温下的有效期。[结果]加速实验6个月山萸肉和酒萸肉下降率分别为9.3%和1.07%，结果没有发生显著性变化，初步预测山茱萸饮片有效期可能为2 a；酒萸肉长期实验12个月的下降率为13.31%，但总含量和浸出物量仍符合中国药典标准。[结论]加速实验预测山茱萸饮片有效期的方法可行，实际有效期应以长期实验具体数据为准。

Abstract:

[Objective] Explore the validity period of Cornus of ficinalis,to provide experimental basis for its safety and effectiveness of clinical medication.[Methods] The Cornus Ficinalis by accelerated test and sample observation test,determination of loganin in Cornus,morroniside in HPLC,determination of the amount of extract in accordance with the requirement of Pharmacopoeia. Adopt comprehensive weighted scoring method and research contents and extract three index changing with the time,predict the validity of Cornus at room temperature.[Results] Accelerated test for 6 months,Cornus and Fructus Corni decrease rate was 9.3% and 1.07% respectively. the results had no significant change,preliminary prediction of Cornus Ficinalis is valid for 2 years;Fructus Corni long-term test 12 months decline rate is 13.31%,but the total content and extract amount is still in accordance with the standard of Chinese pharmacopoeia.[Conclusion] The accelerated test prediction method of Cornus Ficinalis is valid and feasible,practical and effective period should be based on the specific data for the long-term test.