Article(id=1236696520838402801, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1656000000000, acceptedDateStr=2022-06-24, onlineDate=1772781027277, onlineDateStr=2026-03-06, pubDate=1673712000000, pubDateStr=2023-01-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772781027277, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772781027277, creator=13701087609, updateTime=1772781027277, updator=13701087609, issue=Issue{id=1236696515473895464, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='1', pageStart='1', pageEnd='109', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772781025999, creator=13701087609, updateTime=1772782685740, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236703476982542786, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236703476982542787, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236696515473895464, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=57, endPage=64, ext={EN=ArticleExt(id=1236696521161364233, articleId=1236696520838402801, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Separation and purification of Yixintai total saponins by macroporous adsorption resin using failure mode and effects analysis combined with Box-Behnken, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Objective: To optimize the parameters in separation and purification processes of Yixintai total saponins, by using failure mode and effects analysis (FMEA) combined with Box-Behnken response surface design. Methods: The total saponins of Yixintai Compound were purified with macroporous resin (MAR), and the key process parameters of the purification process were screened by FMEA. Taking the recovery rate and mass fraction of saponins as evaluation indicators, the Box-Behnken design was used to optimize the MAR purification process of Yixintai total saponins. The optimal parameters were finally obtained in separation and purification processes of Yixintai total saponins. Results: FMEA determined four influencing factors, including the mass concentration of the sample solution, eluent volume fraction, the adsorption flow rate and the volume of the eluent as the key factors for the separation and purification of total saponins. The P values of the models established by Box-Behnken design were all below 0.05, indicating that the models had good predictive abilities. The obtained best parameters was are as follows: the mass concentration of the sample solution is 0.80 mg·mL^-1, the ethanol volume fraction is 90.0%, the adsorption flow rate is 1.7 BV·h^-1, and the eluent volume is 1.6 BV. Conclusion: The separation and purification method obtained by failure mode analysis combined with Box-Behnken optimization was stable and reliable, with high recovery rate and purity of saponins. This method is suitable for purifying Yixintai total saponins.

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目的：采用失效模式分析（failure mode and effects analysis, FMEA）结合Box-Behnken响应面优化大孔吸附树脂分离纯化益心泰总皂苷工艺参数以提升工艺效率和稳健性。方法：用D-101型大孔吸附树脂（macroporous resin, MAR）对益心泰复方的总皂苷进行纯化，通过FMEA筛选纯化工艺的关键工艺参数，采用Box-Behnken响应面法，以总皂苷质量分数和总皂苷回收率为关键工艺评价指标，对益心泰总皂苷进行纯化工艺优选，得出益心泰总皂苷最佳分离纯化工艺。结果：通过FMEA设计确定了上样液质量浓度、吸附流速、洗脱剂体积分数及洗脱剂体积4个影响因素作为总皂苷分离提纯的关键因素；Box-Behnken实验方差分析结果显示所建立模型的P值均<0.05，表明所建立的模型有较好的预测能力。最终筛选出用D-101型大孔吸附树脂分离纯化益心泰总皂苷的工艺参数为：上样液质量浓度0.80 mg·mL^-1、乙醇体积分数90.0%、吸附流速1.7 BV·h^-1、洗脱剂体积1.6 BV。结论：失效模式分析结合Box-Behnken优化大孔吸附树脂分离纯化益心泰总皂苷工艺稳定可靠，回收所得的皂苷类成分回收率和纯度均较高，为分离纯化益心泰中总皂苷提供了实验数据和思路，具有一定的参考价值和应用前景。

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陆慧玲，女，硕士研究生，主要从事中药新药研究与开发工作。E-mail: 1094144694@qq.com。

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陆慧玲，女，硕士研究生，主要从事中药新药研究与开发工作。E-mail: 1094144694@qq.com。

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