ArticleChinese herbal medicines2020
Critical pharmaceutical process identification considering chemical composition, biological activity, and batch-to-batch consistency: A case study of notoginseng total saponins.
Article in Chinese herbal medicines, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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4 citing papers in PubMed.
- Multi-pathway targeting by natural products in chronic respiratory diseases: Opportunities, challenges, and future perspectives.Chinese herbal medicines · 2026Article
- HDACs targeting from traditional Chinese medicine: mechanisms and therapeutic potential in rheumatoid arthritis.Frontiers in pharmacology · 2026Review
- Phytogenic feed additives as natural antibiotic alternatives in animal health and production: A review of the literature of the last decade.Animal nutrition (Zhongguo xu mu shou yi xue hui) · 2024Review
- Progress of cGAS-STING signaling pathway-based modulation of immune response by traditional Chinese medicine in clinical diseases.Frontiers in immunology · 2024Review
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6 authors.
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Abstract
Objective: Critical pharmaceutical process identification (CPPI) is an important step in the implementation of quality by design concept to traditional Chinese medicines (TCMs). Risk assessment methods are usually used in CPPI. However, risk evaluation is usually subjective. The purpose of this work is to present a more objective CPPI method. Methods: A CPPI method considering chemical composition, biological activity, and batch-to-batch consistency was presented in this work. The manufacturing process of notoginseng total saponins (NTS) was investigated as an example. The changes of chemical composition, biological activity, and chemical composition consistency after main processes were measured and compared. A significant change of them indicated a critical process. Results: After extraction process and chromatography process, saponin purity and chemical composition similarity remarkably increased, and saponin content variations decreased. Thrombin inhibitory activity was remarkably decreased after chromatography process. Because of the large influences on NTS quality, extraction process and chromatography process were identified to be critical processes of NTS. Conclusion: Based on a comprehensive and objective examination of the role of each process, critical pharmaceutical processes can be identified. A similar method can also be applied to other TCM processes.
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