质量源于设计(quality by design,QbD)是一种始于预先定义的目标,采用科学和风险管理的方法来增加对产品和过程的理解并用于过程质量控制的系统方法。QbD主要用于制药工艺开发过程,但其核心思想与分析方法开发过程具有相通之处,因而分...质量源于设计(quality by design,QbD)是一种始于预先定义的目标,采用科学和风险管理的方法来增加对产品和过程的理解并用于过程质量控制的系统方法。QbD主要用于制药工艺开发过程,但其核心思想与分析方法开发过程具有相通之处,因而分析方法质量源于设计(analytical quality by design,AQbD)应运而生。应用AQbD时,需首先定义分析方法目标(analytical target profile,ATP),并根据目标对关键方法属性(critical method attributes,CMAs)和关键方法参数(critical method parameters,CMPs)进行全面评估,结合实验设计(design of experiment,DOE)和统计分析建立分析方法设计空间(design space,DS),并基于设计空间制定方法控制策略(control strategy),通过系统化、结构化、层层递进的方式建立分析方法,以提高分析结果的准确性和可靠性。目前,AQbD已应用于HPLC、UPLC、CE、ELISA、UPLC-MS、LC-MS/MS和GC-MS/MS等分析方法的开发过程。本文综述了AQbD基本组成部分、实施路径、在分析方法开发中的应用和未来发展趋势,以期对药物分析和药品质量控制工作提供借鉴。展开更多
分析质量源于设计(analytical quality by design,AQbD)的理念指引着制药企业运用科学知识和质量风险管理进行系统的分析方法开发和维护。生物制品的质量控制部分是其药学研究和评价的关键内容,是保证药物安全有效、持续稳定的重要手段...分析质量源于设计(analytical quality by design,AQbD)的理念指引着制药企业运用科学知识和质量风险管理进行系统的分析方法开发和维护。生物制品的质量控制部分是其药学研究和评价的关键内容,是保证药物安全有效、持续稳定的重要手段。质量控制采用的分析方法关系着质量控制体系是否可靠。分析方法的生命周期管理包括分析方法的开发、验证、转移、变更、持续改进等多个阶段。本文将根据生物制品的质量控制特点和药学审评经验,介绍分析方法生命周期管理的概念、应用以及审评考虑。展开更多
The objective of this study was to offer a review of previous works on Tinospora cordifolia(TC) metabolomics with a highlight on the use of metabolomics in comparative evaluations between varieties and selection of op...The objective of this study was to offer a review of previous works on Tinospora cordifolia(TC) metabolomics with a highlight on the use of metabolomics in comparative evaluations between varieties and selection of optimum cultivation, collection, and extraction procedures, providing insights into pharmaceutical and food product quality monitoring. Scholarly databases were searched to gather relevant information on TC's therapeutic usefulness, phytoconstituent studies, metabolomics, and applications. Pub Chem was used to learn the structures of several of the metabolites. The various medicinal properties of TC were extensively researched. The most essential portions of the plant in Ayurvedic medicines are the stems. Bioactive phytochemicals such as steroidal lactones, alkaloids, diterpenoids, and phenolic compounds are present in the roots and leaves. Metabolomic analysis revealed that, in addition to the season and geographical region of the sample collected, the metabolite profiles of TC also depend on the parts of the plant taken as a sample and also the plant's stage of growth. The amounts of secondary metabolites differed between morpho/chemotypes within the TC species. Despite the fact that research on TC began several decades ago, the diversity of phytoconstituents was not appreciated because of a lack of reliable techniques for phytochemical fingerprinting. The uncovering of several novel metabolites was aided by advances in chromatography combined with mass spectrometry. To produce a full metabolomic profile, researchers used mutually complementary techniques. Following that, data analysis and searches against spectrum databases allowed for signal annotation and interpretation of metabolites in large quantities without separating them separately. The current review includes a critical assessment of metabolomic data and an overview of the technique's various applications. It is vital to establish the metrics of quality control of herbal medicines in order to accomplish formulation purity assessments. Such展开更多
文摘分析质量源于设计(analytical quality by design,AQbD)的理念指引着制药企业运用科学知识和质量风险管理进行系统的分析方法开发和维护。生物制品的质量控制部分是其药学研究和评价的关键内容,是保证药物安全有效、持续稳定的重要手段。质量控制采用的分析方法关系着质量控制体系是否可靠。分析方法的生命周期管理包括分析方法的开发、验证、转移、变更、持续改进等多个阶段。本文将根据生物制品的质量控制特点和药学审评经验,介绍分析方法生命周期管理的概念、应用以及审评考虑。
文摘The objective of this study was to offer a review of previous works on Tinospora cordifolia(TC) metabolomics with a highlight on the use of metabolomics in comparative evaluations between varieties and selection of optimum cultivation, collection, and extraction procedures, providing insights into pharmaceutical and food product quality monitoring. Scholarly databases were searched to gather relevant information on TC's therapeutic usefulness, phytoconstituent studies, metabolomics, and applications. Pub Chem was used to learn the structures of several of the metabolites. The various medicinal properties of TC were extensively researched. The most essential portions of the plant in Ayurvedic medicines are the stems. Bioactive phytochemicals such as steroidal lactones, alkaloids, diterpenoids, and phenolic compounds are present in the roots and leaves. Metabolomic analysis revealed that, in addition to the season and geographical region of the sample collected, the metabolite profiles of TC also depend on the parts of the plant taken as a sample and also the plant's stage of growth. The amounts of secondary metabolites differed between morpho/chemotypes within the TC species. Despite the fact that research on TC began several decades ago, the diversity of phytoconstituents was not appreciated because of a lack of reliable techniques for phytochemical fingerprinting. The uncovering of several novel metabolites was aided by advances in chromatography combined with mass spectrometry. To produce a full metabolomic profile, researchers used mutually complementary techniques. Following that, data analysis and searches against spectrum databases allowed for signal annotation and interpretation of metabolites in large quantities without separating them separately. The current review includes a critical assessment of metabolomic data and an overview of the technique's various applications. It is vital to establish the metrics of quality control of herbal medicines in order to accomplish formulation purity assessments. Such
