دورية أكاديمية
Using UPLC-LTQ-Orbitrap-MS and HPLC-CAD to Identify Impurities in Cycloastragenol, Which Is a Pre-Clinical Candidate for COPD.
| العنوان: | Using UPLC-LTQ-Orbitrap-MS and HPLC-CAD to Identify Impurities in Cycloastragenol, Which Is a Pre-Clinical Candidate for COPD. |
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| المؤلفون: | Zhu F; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China., Zhang X; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China.; College of Pharmacy, Shandong University of Traditional Chinese Medicine, Jinan 250355, China., Du BY; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China., Zhu XX; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China., Zhao GF; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China., Sun Y; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China.; College of Pharmacy, Shandong University of Traditional Chinese Medicine, Jinan 250355, China., Yao QQ; Jining Medical University, Jining 272067, China., Liang HB; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China.; College of Pharmacy, Shandong University of Traditional Chinese Medicine, Jinan 250355, China., Yao JC; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China., Liu Z; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China., Zhang GM; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China.; College of Pharmacy, Shandong University of Traditional Chinese Medicine, Jinan 250355, China., Qin GF; State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine, Lunan Pharmaceutical Group Co., Ltd., Linyi 273400, China. |
| المصدر: | Molecules (Basel, Switzerland) [Molecules] 2023 Aug 31; Vol. 28 (17). Date of Electronic Publication: 2023 Aug 31. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: MDPI Country of Publication: Switzerland NLM ID: 100964009 Publication Model: Electronic Cited Medium: Internet ISSN: 1420-3049 (Electronic) Linking ISSN: 14203049 NLM ISO Abbreviation: Molecules Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Basel, Switzerland : MDPI, c1995- |
| مواضيع طبية MeSH: | Sapogenins* , Pulmonary Disease, Chronic Obstructive*/drug therapy , Astragalus Plant*, Chromatography, High Pressure Liquid |
| مستخلص: | Chronic obstructive pulmonary disease (COPD) is a highly prevalent disease that has become the third leading cause of death worldwide. Cycloastragenol (CAG), which is the genuine sapogenin of the main active triterpene saponins in Astragali radix , is a bioavailable pre-clinical candidate for chronic obstructive pulmonary disease (COPD), and it was investigated in our previous study. In order to progress medical research, it was first efficiently produced on a 2.5-kg scale via Smith degradation from astragaloside IV (AS-IV). Simultaneously, since the impurity profiling of a drug is critical for performing CMC documentation in pre-clinical development, a study on impurities was carried out. As these structures do not contain chromophores and possess weak UV absorption characteristics, HPLC-CAD and UPLC-LTQ-Orbitrap-MS were employed to carry out the quality control of the impurities. Then, column chromatography (CC), preparative thin-layer chromatography (PTLC), and crystallization led to the identification of 15 impurities from CAG API. Among these impurities, compounds 1, 4 , 9 , 10 , 14 , and 15 were elucidated via spectroscopic analysis, and 2 - 3, 5 - 8 , and 11 - 13 were putatively identified. Interestingly, the new compounds 9 and 14 were rare 10, 19-secocycloartane triterpenoids that displayed certain anti-inflammatory activities against LPS-induced lymphocyte cells and CSE-induced MLE-12 cells. Additionally, a plausible structural transformation pathway of the degradation compounds from CAG or AS IV was proposed. The information obtained will provide a material basis to carry out the quality control and clinical safety assurance of API and related prescriptions. Reasonable guidance will also be provided regarding the compounds with weak UV absorption characteristics. |
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| معلومات مُعتمدة: | tscy20200329 Taishan Industry Leading Talents Project of Shandong Province; tscy20200332 Taishan Industry Leading Talents Project of Shandong Province |
| فهرسة مساهمة: | Keywords: 10,19-secocycloartane triterpenoids; HPLC-CAD; Smith degradation; UPLC-LTQ-Orbitrap-MS; astragaloside IV; cycloastragenol; impurities |
| المشرفين على المادة: | X37D9F2L0V (cycloastragenol) 0 (Sapogenins) |
| تواريخ الأحداث: | Date Created: 20230909 Date Completed: 20230911 Latest Revision: 20230911 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC10489802 |
| DOI: | 10.3390/molecules28176382 |
| PMID: | 37687212 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1420-3049 |
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| DOI: | 10.3390/molecules28176382 |