ArticleChinese medicine2019
The development of an herbal material quality control strategy considering the effects of manufacturing processes.
Article in Chinese medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed, 20 citations in OpenAlex.
- The GenusPlants (Basel, Switzerland) · 2025Review
- Market access of Chinese patent medicine products to healthcare security system in China: implications for international integration of traditional medicine into health systems.Chinese medicine · 2022Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundQuality by design (QbD) is an advanced drug quality control concept that has been gradually implemented in the optimization of manufacturing processes of Chinese medicines. However, the variation of Chinese medicinal material quality has rarely been considered in published works. Because manufacturing processes may lower the variation introduced through different batches of materials, a material quality control strategy should be developed considering the influences of manufacturing processes.
methodsIn this work, the processes of extraction, concentration, water precipitation, and chromatography for notoginseng total saponin (NTS) production were investigated while considering
resultsThe ginsenoside Rd purity and total saponin purity in the eluate were identified as process CQAs. The ethanol solution concentration used for extraction, the ethanol solution concentration used for elution, and elution time were identified as CPPs. The extractable dry matter content of
conclusionsIn this work, a quality control strategy for herbal materials was developed considering the matching of process characteristics and material quality attributes. This strategy is promising for application to other Chinese medicines.
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Registered trials
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