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[Optimization of ethanol precipitation process of Nauclea officinalis extract based on concept of quality by design(QbD)].
Pei, Xiao-Ting; Liu, Ke; Peng, Lei; Yin, Deng-Ke; Zeng, Ji-Kai; Chen, Wei-Dong.
Afiliação
  • Pei XT; College of Pharmacy, Anhui University of Chinese Medicine Hefei 230012, China Yangtze Delta Drug Advanced Research Institute Nantong 226133, China He Rong Jia Pharmaceutical Technology (Nantong) Co., Ltd. Nantong 226133, China.
  • Liu K; College of Pharmacy, Anhui University of Chinese Medicine Hefei 230012, China Yangtze Delta Drug Advanced Research Institute Nantong 226133, China He Rong Jia Pharmaceutical Technology (Nantong) Co., Ltd. Nantong 226133, China.
  • Peng L; He Rong Jia Pharmaceutical Technology (Nantong) Co.,Ltd. Nantong 226133, China.
  • Yin DK; College of Pharmacy, Anhui University of Chinese Medicine Hefei 230012, China.
  • Zeng JK; Hainan Senqi Pharmaceutical Co., Ltd. Haikou 570100, China.
  • Chen WD; College of Pharmacy, Anhui University of Chinese Medicine Hefei 230012, China MOE-Anhui Joint Collaborative Innovation Center for Quality Improvement of Anhui Genuine Chinese Medicinal Materials Hefei 230012, China Institute of Traditional Chinese Medicine Resources Protection and Development Hefei
Zhongguo Zhong Yao Za Zhi ; 48(24): 6653-6662, 2023 Dec.
Article em Zh | MEDLINE | ID: mdl-38212025
ABSTRACT
The ethanol precipitation process of Nauclea officinalis extract was optimized based on the concept of quality by design(QbD). Single factor tests were carried out to determine the levels of test factors. The ethanol volume fraction, pre-ethanol precipitation drug concentration, and ethanol precipitation time were taken as critical process parameters(CPPs). With the comprehensive scores of strictosamide transfer rate and solid removal rate as the critical quality attributes(CQAs), Box-Behnken design was employed to establish the mathematical models and space design between CPPs and CQAs, and the obtained optimal operating space was validated. The optimal operating space included ethanol volume fraction of 65%-70%, pre-ethanol precipitation drug concentration of 22-27 mg·mL~(-1), and ethanol precipitation time of 12 h. Based on the concept of QbD, this study adopted the design space to optimize the ethanol precipitation process of N. officinalis extract, which provided a reliable theoretical basis for the quality control in the production process of N. officinalis preparations. Moroever, this study provided a reference value for guiding the research and industrial production of traditional Chinese medicines.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos de Ervas Chinesas Tipo de estudo: Diagnostic_studies / Prognostic_studies Idioma: Zh Revista: Zhongguo Zhong Yao Za Zhi Assunto da revista: FARMACOLOGIA / TERAPIAS COMPLEMENTARES Ano de publicação: 2023 Tipo de documento: Article País de afiliação: China

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos de Ervas Chinesas Tipo de estudo: Diagnostic_studies / Prognostic_studies Idioma: Zh Revista: Zhongguo Zhong Yao Za Zhi Assunto da revista: FARMACOLOGIA / TERAPIAS COMPLEMENTARES Ano de publicação: 2023 Tipo de documento: Article País de afiliação: China