Objective: To investigate the effects of Compound α-Ketoacid Tablets on renal function, renal fibrosis indexes and oxidative stress in patients with diabetic nephropathy. Methods: A total of 180 patients with diabeti...Objective: To investigate the effects of Compound α-Ketoacid Tablets on renal function, renal fibrosis indexes and oxidative stress in patients with diabetic nephropathy. Methods: A total of 180 patients with diabetic nephropathy admitted to Nephrology Department of our hospital were randomly divided into control group and observation group, 90 cases in each group. The patients in the control group were given conventional treatment, such as antihypertensive drugs, diet and blood glucose control, and the patients in the observation group were given Compound α-Ketoacid Tablets on the basis of the control group. Renal function, renal fibrosis index and oxidative stress levels were compared between the two groups before and after treatment. Results: After treatment, the levels of serum ALB, BUN, Cr, Hcy, VEGF and MDA in two groups were significantly decreased than those before the treatment, and the levels of ALB, Hcy, VEGF and MDA in the observation group were significantly lower than those in the control group, the difference was statistically significant. After treatment, the levels of serum GFR, HGF, T-AOC and SOD in two groups were significantly increased than that before the treatment, and the levels of HGF, T-AOC and SOD in the serum of the observation group were significantly higher than that in the control group, the difference was significant. Conclusion:The Compound α-Ketoacid Tablets has good effect in the treatment of diabetic nephropathy. It can effectively improve the state of renal fibrosis and reduce the oxidative stress reaction of the patients, so as to achieve the protection of the kidney.展开更多
After gene mutation, the pcDNA3.1/APP595/596 plasmid was transfected into HEK293 cells to establish a cell model of Alzheimer's disease. The cell model was treated with donepezil or compound Danshen tablets after cul...After gene mutation, the pcDNA3.1/APP595/596 plasmid was transfected into HEK293 cells to establish a cell model of Alzheimer's disease. The cell model was treated with donepezil or compound Danshen tablets after culture for 72 hours. Reverse transcription-PCR showed that the mRNA expression of amyloid protein precursor decreased in all groups following culture for 24 hours, and that there was no significant difference in the amount of decrease between donepezil and compound Danshen tablets. Our results suggest that compound Danshen tablets can reduce expression of the mRNA for amyloid protein precursor in a transgenic cell model of Alzheimer's disease, with similar effects to donepezil.展开更多
[ Objective ] This study was conducted to improve quality standard of Compound Danshen tablets. [ Method] Tanshinones in Compound Danshen tab- lets were determined by HPLC method. [ Result] A good linear relationship ...[ Objective ] This study was conducted to improve quality standard of Compound Danshen tablets. [ Method] Tanshinones in Compound Danshen tab- lets were determined by HPLC method. [ Result] A good linear relationship was found in the range of 0.10 -0.50 μg, and the average recovery rate was 100.59% (RSD = 1.38% ). [ Conclusion] The method is simple, rapid and reproducible, and could be used as a method for quality control of Compound Danshen Tablets.展开更多
The content of berberine hydrochloride(BH)in compound berberine tablets(CBTs)is subject to strict requirements.Its content is usually measured based on chemical analysis.In this paper,the fluorescence spectral imaging...The content of berberine hydrochloride(BH)in compound berberine tablets(CBTs)is subject to strict requirements.Its content is usually measured based on chemical analysis.In this paper,the fluorescence spectral imaging method was used to study the relative content of BH from a physics perspective.By comparing the relative fluorescence intensity of self-made CBTs with di®erent mass percentages of BH,a linear positive relationship was observed between the BH content and the relative fluorescence intensity,and accordingly the quality of CBTs of different brands was evaluated.The results indicate that the fluorescence spectral imaging method can be a simple,fast and nondestructive semi-quantitative analysis method to determine the content of BH in CBTs,and this method has great potential in the quality control of CBTs.展开更多
Compound glycyrrhizin tablets(CGT)is a glycyrrhizin-containing preparation for the treatment of chronic hepatic diseases,it contained Glycyrrhizin,Monoammonium Glycyrrhizinate,Aminoacetic Acid and Methionine.CGT has b...Compound glycyrrhizin tablets(CGT)is a glycyrrhizin-containing preparation for the treatment of chronic hepatic diseases,it contained Glycyrrhizin,Monoammonium Glycyrrhizinate,Aminoacetic Acid and Methionine.CGT has been shown to have anti-inflammatory,anti-oxidative,and anti-viral effects.Although pseudo-hyperaldosteronism was reported as its important side effects,the frequency was unknown.A 59-year-old male patient with tuberculous pleurisy received CGT to prevent impairment in liver function which was caused by antituberculosis drugs.After more than one month,it appeared edema in the lower extremity,blood pressure increased,serum potassium lowed,serum sodium raised at the normal high limit.Finally,it was improved by suspending the CGT and diuretic treatment.展开更多
Objective:To study the effect of Compound Biejiaruangan Tablets combined with entecavir therapy on liver fibrosis process and immune response state in patients with chronic hepatitis b.Methods: Patients with chronic v...Objective:To study the effect of Compound Biejiaruangan Tablets combined with entecavir therapy on liver fibrosis process and immune response state in patients with chronic hepatitis b.Methods: Patients with chronic viral hepatitis b who were treated in the Affiliated Hospital of Inner Mongolia Medical University between May 2015 and March 2017 were selected as the research subjects and divided into the combined group who accepted Compound Biejiaruangan Tablets combined with entecavir therapy and the control group who accepted entecavir monotherapy. The contents of collagen metabolism indexes and inflammatory response molecules in serum as well as the contents of immune cells in peripheral blood were determined before treatment and 24 weeks after treatment.Results: 24 weeks after treatment, PC-III, C-IV, MMP1, MMP2, TIMP1, IL-1β, IL-18, MIF, RANTES, MIP-1 and MIP-1β contents in serum as well as Th2, Treg and Th17 contents in peripheral blood of both groups of patients were significantly lower than those before treatment whereas Th1 contents in peripheral blood were significantly higher than those before treatment, and PC-III, C-IV, MMP1, MMP2, TIMP1, IL-1β, IL-18, MIF, RANTES, MIP-1 and MIP-1β contents in serum as well as Th2, Treg and Th17 contents in peripheral blood of combined group of patients were significantly lower than those of control group whereas Th1 content in peripheral blood was significantly higher than that of control group.Conclusion: Compound Biejiaruangan Tablets combined with entecavir therapy can delay the liver fibrosis process and improve the immune response state in patients with chronic hepatitis b.展开更多
Objective:To investigate the effects of tripterygium glycosides combined with compoundα-ketoacid tablets on inflammatory response, oxidative stress and urinary TGF-β1 and IV-C levels in patients with chronic renal f...Objective:To investigate the effects of tripterygium glycosides combined with compoundα-ketoacid tablets on inflammatory response, oxidative stress and urinary TGF-β1 and IV-C levels in patients with chronic renal failure.Methods: 102 patients with chronic renal failure admitted to Shuguang hospital from January 2017 to June 2018 were randomly divided into observation group (51 cases) and control group (51 cases). In the control group, the tripterygium glycosides tablets were orally administered, and the observation group was orally administered with tripterygium glycosides tablets and compoundα-keto acid tablets. The inflammatory response, oxidative stress index and urinary TGF-β1, IV-C levels were compared between the two groups.Results: There was no significant difference in CRP and TNF-α levels between the two groups before treatment (P>0.05). After treatment, the levels of CRP and TNF-α in the observation group were (9.32±1.10) mg/L and (3.14±0.36) ng/L, respectively, and the levels of CRP and TNF-α in the control group were (15.34±1.31) mg/ L, (5.01±0.53) ng / L. The CRP and TNF-α levels in the two groups were lower than those before treatment, and the CRP and TNF-α in the observation group were significantly lower than those in the control group (P<0.05). Before treatment, there was no significant difference in MDA, SOD and GSH-PX levels between the two groups (P>0.05). After treatment, the MDA level of the observation group was (3.01±0.32) μmol/L, and the MDA level of the control group was (5.17±0.61) μmol/L. The MDA of the two groups was lower than that before treatment, and the MDA of the observation group was significantly lower than that of the control group (P<0.05). After treatment, the levels of SOD and GSH-PX in the observation group were (101.45±13.16) U/L and (94.83±7.17) U/L, respectively. The levels of SOD and GSH-PX in the control group were (88.87±12.05) U/L, (87.38 ± 6.32) U/L. The SOD and GSH-PX of the two groups were higher than those before treatment, and the SOD and GSH-PX of the observation group were significantly higher than the control group (P<0.05). Before treatment, there was no significant difference in TGF-β1 and IV-C levels between the two groups (P>0.05). After treatment, the levels of TGF-β1 and IV-C in the observation group were (1.05±0.24) ng/L and (5.05±1.13) μg/L, respectively, and the levels of TGF-β1 and IV-C in the control group were (1.36±, respectively). 0.26) ng/L, (7.07±1.24) μg/L. The levels of TGF-β1 and IV-C in the two groups were lower than those before treatment, and the TGF-β1 and IV-C in the observation group were significantly lower than those in the control group (P<0.05).Conclusion: Tripterygium glycosides combined with compound -keto acid tablets can effectively reduce the inflammatory response, oxidative stress and renal interstitial fibrosis in patients with chronic renal failure.展开更多
Objective: To study the effect of compound α-ketoacid combined with routine nutritional intervention on the inflammatory response and oxidative stress response in patients with maintenance hemodialysis. Methods: A to...Objective: To study the effect of compound α-ketoacid combined with routine nutritional intervention on the inflammatory response and oxidative stress response in patients with maintenance hemodialysis. Methods: A total of 78 patients with uremia who received maintenance hemodialysis in Dangyang Changbanpo Hospital between February 2014 and November 2016 were collected and divided into control group and observation group according to the random number table method, 39 cases in each group. The control group received routine nutritional intervention, and the observation group underwent compound α-ketoacid combined with routine nutritional intervention. The serum levels of inflammatory factors and oxidative stress indicators in two groups of patients were detected before dialysis and 6 months after dialysis. Results: Before dialysis, differences in serum levels of inflammatory factors and oxidative stress indexes were not statistically significant between two groups of patients. After dialysis, serum CRP, IL-6, TNF-α, MDA and AOPP levels of both groups of patients were significantly higher than those before dialysis while SOD and GSHPx levels were significantly lower than those before dialysis and serum CRP, IL-6, TNF-α, MDA and AOPP levels of observation group after dialysis were significantly lower than those of control group while SOD and GSHPx levels were significantly higher than those of control group. Conclusions:Compound α-ketoacid combined with routine nutritional intervention can effectively reduce the systemic microinflammatory state and inhibit the oxidative stress response in patients with maintenance hemodialysis.展开更多
Compound Shenhua Tablet,a medicine comprising seven herbs,is employed in treating IgA nephropathy.This study aimed to meticulously analyze its chemical composition.Based on a list of candidate compounds,identified thr...Compound Shenhua Tablet,a medicine comprising seven herbs,is employed in treating IgA nephropathy.This study aimed to meticulously analyze its chemical composition.Based on a list of candidate compounds,identified through extensive literature review pertinent to the tablet’s herbal components,the composition analysis entailed the systematic identification,characterization,and quantification of the constituents.The analyte-capacity of LC/ESI-MS-based and GC/EI-MS-based assays was evaluated.The identified and characterized constituents were quantified to determine their content levels and were ranked based on the constituents’daily doses.A total of 283 constituents,classified into 12 distinct categories,were identified and characterized in the Compound Shenhua Tablet.These constituents exhibited content levels of 1−10982μg·g^(−1),with daily doses of 0.01−395μmol·d^(−1).The predominant constituents,with daily doses of≥10μmol·d^(−1),include nine organic acids(citric acid,quinic acid,chlorogenic acid,cryptochlorogenic acid,gallic acid,neochlorogenic acid,isochlorogenic acid C,isochlorogenic acid B,and linoleic acid),five iridoids(specnuezhenide,nuezhenoside G13,nuezhenidic acid,secoxyloganin,and secologanoside),two monoterpene glycosides(paeoniflorin and albiflorin),a sesquiterpenoid(curzerenone),a triterpenoid(oleanolic acid),and a phenylethanoid(salidroside).Additionally,there were 83,126,and 55 constituents detected in the medicine with daily doses of 1–10,0.1–1,and 0.01–0.1μmol·d^(−1),respectively.The combination of the LC/ESI-MS-based and GC/EI-MS-based assays demonstrated a complementary relationship in their analyte-capacity for detecting the constituents present in the medicine.This comprehensive composition analysis establishes a solid foundation for further pharmacological research on Compound Shenhua Tablet and facilitates the quality evaluation of this complex herbal medicine.展开更多
Objective:A typical case of Xianling Gubao(XLGB)Tablets-induced liver injury was systematically studied in the clinic and the laboratory.Methods:A patient with herb-induced liver injury(HILI)and a history of taking XL...Objective:A typical case of Xianling Gubao(XLGB)Tablets-induced liver injury was systematically studied in the clinic and the laboratory.Methods:A patient with herb-induced liver injury(HILI)and a history of taking XLGB Tablets before disease onset was engaged as the study subject,and the case was diagnosed according to the updated Roussel Uclaf Causality Assessment Method(RUCAM)and the integrated evidence chain(iEC)method recommended by the Guidelines for Diagnosis and Treatment of Herb-induced Liver Injury(HILI Guidelines).Results:Clinical history,biochemical indexes and imaging tests were used to exclude the influence of fundamental diseases and confusing liver diseases such as viral,alcoholic and autoimmune liver diseases on the diagnosis.Based on an investigation of the patient’s medication history,she was suspected to have HILI caused by XLGB Tablets,as the patient was only taking an oral preparation of XLGB Tablets,and the influence of other drugs on the diagnosis was excluded.This patient with alanine aminotransferase(ALT)3 upper limit of normal(ULN)and a calculated R of 6 was diagnosed with possible acute drug-induced hepatocellular injury.The relationship was considered“highly probable”(score of 9)using the updated RUCAM of 2016.Moreover,the fingerprint similarity between the preparation taken by the patient and a commercially available preparation was 0.99,suggesting that the patient was consuming XLGB Tablets rather than another drug.LC-MS technology and the Agilent Fake TCM-Drugs database were used to investigate the drug,and no chemical additions were found.Examination of the drug for pesticide residues,heavy metals,aflatoxins and other exogenous substances indicated compliance with the content limits of the Chinese Pharmacopoeia.Conclusion:In summary,the final diagnosis of XLGB-induced liver injury reached the clinical diagnosis of HILI and was acute severe hepatocellular injury type by the updated RUCAM and iEC.Therefore,this study provides scientific evidence regarding the causality evaluation of compound preparations of traditional Chinese medicines-induced liver injury.展开更多
文摘Objective: To investigate the effects of Compound α-Ketoacid Tablets on renal function, renal fibrosis indexes and oxidative stress in patients with diabetic nephropathy. Methods: A total of 180 patients with diabetic nephropathy admitted to Nephrology Department of our hospital were randomly divided into control group and observation group, 90 cases in each group. The patients in the control group were given conventional treatment, such as antihypertensive drugs, diet and blood glucose control, and the patients in the observation group were given Compound α-Ketoacid Tablets on the basis of the control group. Renal function, renal fibrosis index and oxidative stress levels were compared between the two groups before and after treatment. Results: After treatment, the levels of serum ALB, BUN, Cr, Hcy, VEGF and MDA in two groups were significantly decreased than those before the treatment, and the levels of ALB, Hcy, VEGF and MDA in the observation group were significantly lower than those in the control group, the difference was statistically significant. After treatment, the levels of serum GFR, HGF, T-AOC and SOD in two groups were significantly increased than that before the treatment, and the levels of HGF, T-AOC and SOD in the serum of the observation group were significantly higher than that in the control group, the difference was significant. Conclusion:The Compound α-Ketoacid Tablets has good effect in the treatment of diabetic nephropathy. It can effectively improve the state of renal fibrosis and reduce the oxidative stress reaction of the patients, so as to achieve the protection of the kidney.
基金supported by the Bureau of Traditional Chinese Medicine of Guangdong Province, No. 2010463the National Science and Technology"12~(th) Five-years"Major Special-purpose Foundation,No.2011ZX09201-201-01
文摘After gene mutation, the pcDNA3.1/APP595/596 plasmid was transfected into HEK293 cells to establish a cell model of Alzheimer's disease. The cell model was treated with donepezil or compound Danshen tablets after culture for 72 hours. Reverse transcription-PCR showed that the mRNA expression of amyloid protein precursor decreased in all groups following culture for 24 hours, and that there was no significant difference in the amount of decrease between donepezil and compound Danshen tablets. Our results suggest that compound Danshen tablets can reduce expression of the mRNA for amyloid protein precursor in a transgenic cell model of Alzheimer's disease, with similar effects to donepezil.
文摘[ Objective ] This study was conducted to improve quality standard of Compound Danshen tablets. [ Method] Tanshinones in Compound Danshen tab- lets were determined by HPLC method. [ Result] A good linear relationship was found in the range of 0.10 -0.50 μg, and the average recovery rate was 100.59% (RSD = 1.38% ). [ Conclusion] The method is simple, rapid and reproducible, and could be used as a method for quality control of Compound Danshen Tablets.
基金The authors would like to acknowledge the support of the Ph.D.research startup foundation of Guangdong Medical University (2XB14006).
文摘The content of berberine hydrochloride(BH)in compound berberine tablets(CBTs)is subject to strict requirements.Its content is usually measured based on chemical analysis.In this paper,the fluorescence spectral imaging method was used to study the relative content of BH from a physics perspective.By comparing the relative fluorescence intensity of self-made CBTs with di®erent mass percentages of BH,a linear positive relationship was observed between the BH content and the relative fluorescence intensity,and accordingly the quality of CBTs of different brands was evaluated.The results indicate that the fluorescence spectral imaging method can be a simple,fast and nondestructive semi-quantitative analysis method to determine the content of BH in CBTs,and this method has great potential in the quality control of CBTs.
文摘Compound glycyrrhizin tablets(CGT)is a glycyrrhizin-containing preparation for the treatment of chronic hepatic diseases,it contained Glycyrrhizin,Monoammonium Glycyrrhizinate,Aminoacetic Acid and Methionine.CGT has been shown to have anti-inflammatory,anti-oxidative,and anti-viral effects.Although pseudo-hyperaldosteronism was reported as its important side effects,the frequency was unknown.A 59-year-old male patient with tuberculous pleurisy received CGT to prevent impairment in liver function which was caused by antituberculosis drugs.After more than one month,it appeared edema in the lower extremity,blood pressure increased,serum potassium lowed,serum sodium raised at the normal high limit.Finally,it was improved by suspending the CGT and diuretic treatment.
文摘Objective:To study the effect of Compound Biejiaruangan Tablets combined with entecavir therapy on liver fibrosis process and immune response state in patients with chronic hepatitis b.Methods: Patients with chronic viral hepatitis b who were treated in the Affiliated Hospital of Inner Mongolia Medical University between May 2015 and March 2017 were selected as the research subjects and divided into the combined group who accepted Compound Biejiaruangan Tablets combined with entecavir therapy and the control group who accepted entecavir monotherapy. The contents of collagen metabolism indexes and inflammatory response molecules in serum as well as the contents of immune cells in peripheral blood were determined before treatment and 24 weeks after treatment.Results: 24 weeks after treatment, PC-III, C-IV, MMP1, MMP2, TIMP1, IL-1β, IL-18, MIF, RANTES, MIP-1 and MIP-1β contents in serum as well as Th2, Treg and Th17 contents in peripheral blood of both groups of patients were significantly lower than those before treatment whereas Th1 contents in peripheral blood were significantly higher than those before treatment, and PC-III, C-IV, MMP1, MMP2, TIMP1, IL-1β, IL-18, MIF, RANTES, MIP-1 and MIP-1β contents in serum as well as Th2, Treg and Th17 contents in peripheral blood of combined group of patients were significantly lower than those of control group whereas Th1 content in peripheral blood was significantly higher than that of control group.Conclusion: Compound Biejiaruangan Tablets combined with entecavir therapy can delay the liver fibrosis process and improve the immune response state in patients with chronic hepatitis b.
文摘Objective:To investigate the effects of tripterygium glycosides combined with compoundα-ketoacid tablets on inflammatory response, oxidative stress and urinary TGF-β1 and IV-C levels in patients with chronic renal failure.Methods: 102 patients with chronic renal failure admitted to Shuguang hospital from January 2017 to June 2018 were randomly divided into observation group (51 cases) and control group (51 cases). In the control group, the tripterygium glycosides tablets were orally administered, and the observation group was orally administered with tripterygium glycosides tablets and compoundα-keto acid tablets. The inflammatory response, oxidative stress index and urinary TGF-β1, IV-C levels were compared between the two groups.Results: There was no significant difference in CRP and TNF-α levels between the two groups before treatment (P>0.05). After treatment, the levels of CRP and TNF-α in the observation group were (9.32±1.10) mg/L and (3.14±0.36) ng/L, respectively, and the levels of CRP and TNF-α in the control group were (15.34±1.31) mg/ L, (5.01±0.53) ng / L. The CRP and TNF-α levels in the two groups were lower than those before treatment, and the CRP and TNF-α in the observation group were significantly lower than those in the control group (P<0.05). Before treatment, there was no significant difference in MDA, SOD and GSH-PX levels between the two groups (P>0.05). After treatment, the MDA level of the observation group was (3.01±0.32) μmol/L, and the MDA level of the control group was (5.17±0.61) μmol/L. The MDA of the two groups was lower than that before treatment, and the MDA of the observation group was significantly lower than that of the control group (P<0.05). After treatment, the levels of SOD and GSH-PX in the observation group were (101.45±13.16) U/L and (94.83±7.17) U/L, respectively. The levels of SOD and GSH-PX in the control group were (88.87±12.05) U/L, (87.38 ± 6.32) U/L. The SOD and GSH-PX of the two groups were higher than those before treatment, and the SOD and GSH-PX of the observation group were significantly higher than the control group (P<0.05). Before treatment, there was no significant difference in TGF-β1 and IV-C levels between the two groups (P>0.05). After treatment, the levels of TGF-β1 and IV-C in the observation group were (1.05±0.24) ng/L and (5.05±1.13) μg/L, respectively, and the levels of TGF-β1 and IV-C in the control group were (1.36±, respectively). 0.26) ng/L, (7.07±1.24) μg/L. The levels of TGF-β1 and IV-C in the two groups were lower than those before treatment, and the TGF-β1 and IV-C in the observation group were significantly lower than those in the control group (P<0.05).Conclusion: Tripterygium glycosides combined with compound -keto acid tablets can effectively reduce the inflammatory response, oxidative stress and renal interstitial fibrosis in patients with chronic renal failure.
文摘Objective: To study the effect of compound α-ketoacid combined with routine nutritional intervention on the inflammatory response and oxidative stress response in patients with maintenance hemodialysis. Methods: A total of 78 patients with uremia who received maintenance hemodialysis in Dangyang Changbanpo Hospital between February 2014 and November 2016 were collected and divided into control group and observation group according to the random number table method, 39 cases in each group. The control group received routine nutritional intervention, and the observation group underwent compound α-ketoacid combined with routine nutritional intervention. The serum levels of inflammatory factors and oxidative stress indicators in two groups of patients were detected before dialysis and 6 months after dialysis. Results: Before dialysis, differences in serum levels of inflammatory factors and oxidative stress indexes were not statistically significant between two groups of patients. After dialysis, serum CRP, IL-6, TNF-α, MDA and AOPP levels of both groups of patients were significantly higher than those before dialysis while SOD and GSHPx levels were significantly lower than those before dialysis and serum CRP, IL-6, TNF-α, MDA and AOPP levels of observation group after dialysis were significantly lower than those of control group while SOD and GSHPx levels were significantly higher than those of control group. Conclusions:Compound α-ketoacid combined with routine nutritional intervention can effectively reduce the systemic microinflammatory state and inhibit the oxidative stress response in patients with maintenance hemodialysis.
基金supported by the National Natural Science Foundation of China(Nos.82192912,82074273)the Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine(No.ZYYCXTD-C-202009)the Program of State Key Laboratory of Drug Research(No.SIMM2103ZZ-06).
文摘Compound Shenhua Tablet,a medicine comprising seven herbs,is employed in treating IgA nephropathy.This study aimed to meticulously analyze its chemical composition.Based on a list of candidate compounds,identified through extensive literature review pertinent to the tablet’s herbal components,the composition analysis entailed the systematic identification,characterization,and quantification of the constituents.The analyte-capacity of LC/ESI-MS-based and GC/EI-MS-based assays was evaluated.The identified and characterized constituents were quantified to determine their content levels and were ranked based on the constituents’daily doses.A total of 283 constituents,classified into 12 distinct categories,were identified and characterized in the Compound Shenhua Tablet.These constituents exhibited content levels of 1−10982μg·g^(−1),with daily doses of 0.01−395μmol·d^(−1).The predominant constituents,with daily doses of≥10μmol·d^(−1),include nine organic acids(citric acid,quinic acid,chlorogenic acid,cryptochlorogenic acid,gallic acid,neochlorogenic acid,isochlorogenic acid C,isochlorogenic acid B,and linoleic acid),five iridoids(specnuezhenide,nuezhenoside G13,nuezhenidic acid,secoxyloganin,and secologanoside),two monoterpene glycosides(paeoniflorin and albiflorin),a sesquiterpenoid(curzerenone),a triterpenoid(oleanolic acid),and a phenylethanoid(salidroside).Additionally,there were 83,126,and 55 constituents detected in the medicine with daily doses of 1–10,0.1–1,and 0.01–0.1μmol·d^(−1),respectively.The combination of the LC/ESI-MS-based and GC/EI-MS-based assays demonstrated a complementary relationship in their analyte-capacity for detecting the constituents present in the medicine.This comprehensive composition analysis establishes a solid foundation for further pharmacological research on Compound Shenhua Tablet and facilitates the quality evaluation of this complex herbal medicine.
基金supported by the National Natural Science Foundation of China(No.82174071).
文摘Objective:A typical case of Xianling Gubao(XLGB)Tablets-induced liver injury was systematically studied in the clinic and the laboratory.Methods:A patient with herb-induced liver injury(HILI)and a history of taking XLGB Tablets before disease onset was engaged as the study subject,and the case was diagnosed according to the updated Roussel Uclaf Causality Assessment Method(RUCAM)and the integrated evidence chain(iEC)method recommended by the Guidelines for Diagnosis and Treatment of Herb-induced Liver Injury(HILI Guidelines).Results:Clinical history,biochemical indexes and imaging tests were used to exclude the influence of fundamental diseases and confusing liver diseases such as viral,alcoholic and autoimmune liver diseases on the diagnosis.Based on an investigation of the patient’s medication history,she was suspected to have HILI caused by XLGB Tablets,as the patient was only taking an oral preparation of XLGB Tablets,and the influence of other drugs on the diagnosis was excluded.This patient with alanine aminotransferase(ALT)3 upper limit of normal(ULN)and a calculated R of 6 was diagnosed with possible acute drug-induced hepatocellular injury.The relationship was considered“highly probable”(score of 9)using the updated RUCAM of 2016.Moreover,the fingerprint similarity between the preparation taken by the patient and a commercially available preparation was 0.99,suggesting that the patient was consuming XLGB Tablets rather than another drug.LC-MS technology and the Agilent Fake TCM-Drugs database were used to investigate the drug,and no chemical additions were found.Examination of the drug for pesticide residues,heavy metals,aflatoxins and other exogenous substances indicated compliance with the content limits of the Chinese Pharmacopoeia.Conclusion:In summary,the final diagnosis of XLGB-induced liver injury reached the clinical diagnosis of HILI and was acute severe hepatocellular injury type by the updated RUCAM and iEC.Therefore,this study provides scientific evidence regarding the causality evaluation of compound preparations of traditional Chinese medicines-induced liver injury.