基于AQbD理念的大补阴丸(浓缩丸)定量指纹图谱方法开发

任佳龙; 颉佳乐; 朱琳; 赵敏彤; 朱加明; 吴杭莎; 龚行楚

doi:10.13748/j.cnki.issn1007-7693.20252734

基于AQbD理念的大补阴丸(浓缩丸)定量指纹图谱方法开发

Development of Quantitative Fingerprint Method for Dabuyin Pills(Concentrated Pills) Based on the AQbD Concept

摘要

摘要:
目的基于分析质量源于设计理念，采用高效液相色谱-紫外检测技术建立大补阴丸(浓缩丸)中5-羟甲基糠醛、3-O-阿魏酰奎尼酸、新芒果苷和盐酸小檗碱4种成分的定量指纹图谱分析方法。
方法先确定潜在的关键方法参数(critical method parameters，CMPs)，然后通过确定性筛选设计辨识关键方法属性(critical method attributes，CMAs)，再采用逐步回归法建立CMPs与CMAs之间的定量关系模型。采用蒙特卡罗法建立了方法可操作设计区域(method operable design region，MODR)，并成功验证。用Plackett-Burman设计评价分析方法的耐用性。
结果根据该4种成分所建立的分析方法可操作区域较为可靠，方法耐用性较好。不同批次大补阴丸(浓缩丸)之间、各批次与对照指纹图谱的相似度均>0.95，表明各批次大补阴丸(浓缩丸)的一致性良好。
结论该方法耐用性良好并通过方法学验证，可用于大补阴丸(浓缩丸)中4种成分含量的测定。

Abstract:
OBJECTIVE To establish a quantitative fingerprint analysis method for the simultaneous determination of 4 components, namely 5-hydroxymethylfurfural, 3-O-feruloylquinic acid, neomangiferin and berberine hydrochloride, in Dabuyin Pills(concentrated pills) based on the concept of analytical quality by design, using high performance liquid chromatography-ultraviolet detection.
METHODS Firstly, potential critical method parameters(CMPs) were identified. Then, critical method attributes(CMAs) were distinguished through definitive screening design. Subsequently, quantitative relationship models between CMPs and CMAs were established using stepwise regression. The method operable design region(MODR) was established by the Monte Carlo method and successfully verified. The robustness of the analytical method was evaluated using the Plackett-Burman design.
RESULTS The established operable design region based on the analytical method for these 4 components was reliable, and the method exhibits favorable robustness. The similarity values between different batches of Dabuyin Pills(concentrated pills) and between each batch and the reference fingerprint were all greater than 0.95, indicating that the consistency among different batches of Dabuyin Pills(concentrated pills) was good.
CONCLUSION This method has good durability and has been verified by methodology, and can be used for the determination of the contents of 4 components in Dabuyin Pills(concentrated pills).

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