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Integrating chemical similarity and bioequivalence: A pilot study on quality consistency evaluation of dispensing granule and traditional decoction of Scutellariae Radix by a totality-of-the-evidence approach.
Liang, Dan; Yin, Ying-Hao; Miao, Lan-Yun; Zheng, Xian; Gao, Wen; Chen, Xiang-Dong; Wei, Mei; Chen, Sheng-Jun; Li, Song; Xin, Gui-Zhong; Li, Ping; Li, Hui-Jun.
Afiliação
  • Liang D; State Key Laboratory of Natural Medicines, China Pharmaceutical University, No. 24 Tongjia Lane, Nanjing, 210009, China.
  • Yin YH; State Key Laboratory of Natural Medicines, China Pharmaceutical University, No. 24 Tongjia Lane, Nanjing, 210009, China.
  • Miao LY; State Key Laboratory of Natural Medicines, China Pharmaceutical University, No. 24 Tongjia Lane, Nanjing, 210009, China.
  • Zheng X; State Key Laboratory of Natural Medicines, China Pharmaceutical University, No. 24 Tongjia Lane, Nanjing, 210009, China.
  • Gao W; State Key Laboratory of Natural Medicines, China Pharmaceutical University, No. 24 Tongjia Lane, Nanjing, 210009, China.
  • Chen XD; Guangdong Efong Pharmaceutical Co., Ltd., Foshan, 528244, China.
  • Wei M; Guangdong Efong Pharmaceutical Co., Ltd., Foshan, 528244, China.
  • Chen SJ; Jiangyin Tianjiang Pharmaceutical Co., Ltd., Jiangyin, 214400, China.
  • Li S; Jiangyin Tianjiang Pharmaceutical Co., Ltd., Jiangyin, 214400, China.
  • Xin GZ; State Key Laboratory of Natural Medicines, China Pharmaceutical University, No. 24 Tongjia Lane, Nanjing, 210009, China. Electronic address: xinguizhong1984@126.com.
  • Li P; State Key Laboratory of Natural Medicines, China Pharmaceutical University, No. 24 Tongjia Lane, Nanjing, 210009, China.
  • Li HJ; State Key Laboratory of Natural Medicines, China Pharmaceutical University, No. 24 Tongjia Lane, Nanjing, 210009, China. Electronic address: cpuli@163.com.
J Pharm Biomed Anal ; 169: 1-10, 2019 May 30.
Article em En | MEDLINE | ID: mdl-30826486
There is an increasing focus on the quality consistency evaluation of dispensing granule in traditional Chinese medicines (TCMs). According to the guideline from Chinese Pharmacopoeia Commission, the substantial equivalence of dispensing granule and traditional decoction should be determined, and the chromatographic fingerprint has been recommended as a comprehensive qualitative approach to assess the quality consistency between dispensing granule and traditional decoction. However, a high-degree chemical similarity does not equal a bioequivalence. Attempting to realize the quality evaluation by integrating chemical consistency and bioequivalence, we herein proposed a totality-of-the-evidence approach based on clustering analysis and equivalence evaluation taking the dispensing granule and traditional decoction of Scutellariae Radix (SR) as a typical case. Chemical fingerprints were developed by high performance liquid chromatography coupled with photodiode array detector and quadrupole time-of-flight mass spectrometry (HPLC-PDA/QTOF-MS). Subsequently, a feature selection strategy, integrated linear and nonlinear correlation analysis, was carried out to assess the correlation between chemical profiles and biological activities. Finally, quality consistency between the dispensing granule and the traditional decoction was determined by bioactive marker-guided hierarchical clustering analysis (HCA), k-means clustering method and bioequivalence evaluation. The available evidence suggested that not all the dispensing granule of SR were sufficiently similar to the traditional decoction. This study provides an applicable methodology for quality consistency evaluation of dispensing granule and traditional decoction in TCMs.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos de Ervas Chinesas / Scutellaria baicalensis Tipo de estudo: Diagnostic_studies / Qualitative_research Idioma: En Revista: J Pharm Biomed Anal Ano de publicação: 2019 Tipo de documento: Article País de afiliação: China País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos de Ervas Chinesas / Scutellaria baicalensis Tipo de estudo: Diagnostic_studies / Qualitative_research Idioma: En Revista: J Pharm Biomed Anal Ano de publicação: 2019 Tipo de documento: Article País de afiliação: China País de publicação: Reino Unido