摘要
目的:应用累积中药指纹图谱对决明子脐贴累积释放度进行评价并验证。方法:基于《中药指纹图谱及其数字化》理论,提出累积中药指纹图谱的概念、原理及计算公式,以决明子脐贴透皮累积释放度的计算为例,与《中华人民共和国药典》2020年版四部通则0931项下溶出度和释放度的数据处理结果进行比较。结果:决明子脐贴各成分在第24小时的累积释放度存在差异,有14种成分超过80.0%,1种成分低于10.0%。累积中药指纹图谱与《中华人民共和国药典》2020年版规定方法不同取样时间点累积释放度计算结果比较,误差均值绝对值均小于2.3%。结论:累积中药指纹图谱可用于中药制剂累积释放度的评价,结果准确、操作简便,为中药制剂的质量控制和检查提供了新的方向。
Objective:To evaluate and validate the cumulative release rate of transdermal patches containing Cassia seed extract using cumulative traditional Chinese medicine fingerprint(TCM fingerprint).Methods:Based on the theory in Fingerprint of Traditional Chinese Medicine and Its Digitization,the concept,principle,and calculation formula of cumulative TCM fingerprint were established.Taking the transdermal cumulative release rate of transdermal patches containing Cassia seed extract as an example,the results were compared with the data processing outcomes of dissolution rate and release tests rate specified under item 0931 in General Chapter of Chinese Pharmacopoeia(ChP)2020 Edition.Results:The cumulative release rate of components in transdermal patches containing Cassia seed extract varied at 24 hours:14 components exceeded 80.0%,while 1 component was below 10.0%.When comparing cumulative TCM fingerprint with the cumulative release rate results at different sampling time points specified in ChP 2020,the absolute values of the mean error were all below 2.3%.Conclusion:The cumulative TCM fingerprint can be applied to evaluate the cumulative release rate of TCM preparations,with accurate results and simple operation,offering a new approach for quality control and inspection of TCM preparations.
作者
鄢海燕
黄莉
邹纯才
Yan Haiyan;Huang Li;Zou Chuncai(Pharmacy School of Wannan Medical College,Wuhu,Anhui 241002,China)
出处
《大理大学学报》
2025年第8期20-29,共10页
Journal of Dali University
基金
安徽高校省级自然科学研究重大项目(KJ2016SD60)
皖南医学院药剂学一流本科课程(2019ylkc017)
安徽省省级质量工程项目药剂学专项(2019kfkc084)。
关键词
累积中药指纹图谱
决明子脐贴
释放度
验证
cumulative TCM fingerprint
transdermal patches containing Cassia seed extract
release rate
validation
