PMID- 37633162 OWN - NLM STAT- MEDLINE DCOM- 20230911 LR - 20230911 IS - 1873-264X (Electronic) IS - 0731-7085 (Linking) VI - 235 DP - 2023 Oct 25 TI - Comparative pharmacokinetic analysis of six major bioactive constituents using UPLC-MS/MS in samples isolated from normal and diabetic nephropathy rats after oral administration of Gushen Jiedu capsule. PG - 115638 LID - S0731-7085(23)00407-7 [pii] LID - 10.1016/j.jpba.2023.115638 [doi] AB - Berberine, palmatine, physcion, rhein, calycosin-7-O-glucoside, and ferulic acid are six major active consituents that are present in Gushen Jiedu capsule (GSJD) extracts. The aim of this study was to determine the pharmacokinetics of the six active consituents in vivo by a rapid, sensitive, and precise UPLC-MS/MS method, which were compared between normal and diabetic nephropathy (DN) rats. Good separation of the target analytes and internal standards (ketoprofen and puerarin) was obtained on a Waters BEH C(18) UPLC column with a mobile phase of 0.1 % formic acid acetonitrile-0.1 % formic acid water. All the calibration curves showed good linearity with a regression coefficient (r(2)) of >/= 0.9908. The lower limits of quantification (LLOQ) for berberine, palmatine, physcion, rhein, calycosin-7-O-glucoside, and ferulic acid were 20, 2.5, 20, 20, 2.5, and 2.5 ng/mL, respectively. The relative standard deviations (RSDs) of intra-day and inter-day precision were all within 12.66 %, and the relative errors of intra-day and inter-day accuracy ranged from - 15.00 to 14.93 %. Good extraction recovery and matrix effects were obtained. The stability study confirmed the stability of the six analytes (RSD < 15 %). Finally, the data showed that the pharmacokinetic parameters (especially CLz/F, AUC and T(max)) of the six target analytes in DN rats were significantly different from those in normal rats. PK studies under pathological conditions could provide new thoughts to elucidate the underlying mechanism of GSJD and promote the clinical development of GSJD to treat DN. CI - Copyright (c) 2023 Elsevier B.V. All rights reserved. FAU - Zhang, Lei AU - Zhang L AD - Department of Pharmacy, Beijing Shijitan Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing, China. FAU - Yang, Chunjing AU - Yang C AD - Department of Pharmacy, Beijing Shijitan Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing, China. FAU - Zhao, Yidan AU - Zhao Y AD - Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China. FAU - Yang, Zhirui AU - Yang Z AD - Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing, China; Beijing Institute of Clinical Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China. FAU - Meng, Xintong AU - Meng X AD - Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use, Beijing, China. FAU - Yan, Dan AU - Yan D AD - Beijing Institute of Clinical Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China; Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China. Electronic address: danyan@ccmu.edu.cn. LA - eng PT - Journal Article DEP - 20230811 PL - England TA - J Pharm Biomed Anal JT - Journal of pharmaceutical and biomedical analysis JID - 8309336 RN - AVM951ZWST (ferulic acid) RN - 0YIW783RG1 (formic acid) RN - H6PT94IV61 (physcione) RN - YM64C2P6UX (rhein) RN - 0I8Y3P32UF (Berberine) RN - 0 (Glucosides) SB - IM MH - Animals MH - Rats MH - *Berberine MH - Chromatography, High Pressure Liquid MH - Chromatography, Liquid MH - *Diabetic Nephropathies/drug therapy MH - Tandem Mass Spectrometry MH - Administration, Oral MH - Glucosides MH - *Diabetes Mellitus OTO - NOTNLM OT - Diabetic nephropathy OT - Gushen Jiedu capsule OT - Pharmacokinetics OT - UPLC-MS/MS COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2023/08/27 05:43 MHDA- 2023/09/11 06:42 CRDT- 2023/08/26 18:08 PHST- 2023/04/21 00:00 [received] PHST- 2023/07/07 00:00 [revised] PHST- 2023/08/07 00:00 [accepted] PHST- 2023/09/11 06:42 [medline] PHST- 2023/08/27 05:43 [pubmed] PHST- 2023/08/26 18:08 [entrez] AID - S0731-7085(23)00407-7 [pii] AID - 10.1016/j.jpba.2023.115638 [doi] PST - ppublish SO - J Pharm Biomed Anal. 2023 Oct 25;235:115638. doi: 10.1016/j.jpba.2023.115638. Epub 2023 Aug 11.