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Archive > Volume 12 Issue 1 > 2020,12(1):29-35. DOI:https://doi.org/10.1016/j.chmed.2019.11.002 Prev Next

Original articles

Critical pharmaceutical process identification considering chemical composition, biological activity, and batch-to-batch consistency: A case study of notoginseng total saponins

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    摘要:


    Abstract:
    Objective: Critical pharmaceutical process identification (CPPI) is an important step in the implementa- tion 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 con- sistency 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 com- position 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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    Project Supported:
    The authors would like to acknowledge the supports of the National Project for Standardization of Chinese Materia Medica (ZYBZH-C-YN-58) and Standardization Program of Ministry of Sci- ence and Technology of Yunnan Province, China (2017ZF001).

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