1.Quality Evaluation of Fengshiding Capsules Based on National Drug Sampling and Testing
Lumei GUO ; Tao CHENG ; Donglan LIU ; Xingpeng LIU ; Ming YANG ; Fangfang SI ; Min ZOU ; Jialiang ZHU
Herald of Medicine 2025;44(9):1423-1430
Objective To systematically evaluate the quality of Fengshiding capsules,to analyze existing problems based on national drug sampling and testing,and to offer references and suggestions for improving quality control and regulatory supervision of this product.Methods A total of 136 batches of Fengshiding capsules were subjected to standard quality tests and exploratory analyses.HPLC was used to establish the content determination of Angelica dahurica,Cynanchum paniculatum,and Glycyrrhizae Radix,as well as the limit test for anabasine in the preparation.Additionally,an UPLC method was also employed to establish the characteristic chromatogram of Fengshiding capsules.A screening method for artificial pigments was developed,and UPLC-MS/MS was used to detect the illegal addition of chemical drugs in Fengshiding capsules.Results All 136 batches of samples passed inspection according to the current quality standards.However,based on exploratory study evaluations,the content determination results of Cynanchum paniculatum,Angelica dahurica,and Glycyrrhiza Radix were below the proposed limits.The limit test for anabasine did not exceed the proposed threshold.Furthermore,the characteristic chromatograms revealed missing peaks in several samples,and some batches contained artificial pigments and residues of acetaminophen.Conclusions The overall quality of Fengshiding capsules is rated as"average"based on national drug sampling and testing.To enhance product quality,it is recommended to improve quality standards,ensure the use of high-quality raw herbal materials,promote stronger internal oversight by manufacturers,and intensify regulatory supervision.
2.Self-Prescribed Changning Formula Combined with Mesalazine Regulating PERK/NF-κB Pathway in the Treatment of Ulcerative Colitis
Xuanya HU ; Congjia YANG ; Lumei XU
Acta Medicinae Universitatis Scientiae et Technologiae Huazhong 2025;54(2):255-260
Objective To investigate the effectiveness of self-prescribed Changning Formula combined with Mesalazine in the treatment of ulcerative colitis(UC),and to analyze its effect on protein kinase R-like endoplasmic reticulum kinase(PERK)/nuclear factor κB(NF-κB)pathway.Methods A total of 100 patients with UC admitted to our hospital from January 2021 to January 2024 were selected and divided into control group and combined group by random number table method,with 50 cases in each group.The control group was given Mesalazine,and the combined group was given self-prescribed Changning Formula combined with Mesalazine.After 2 months of treatment,the effectivenesses in two groups were compared.The clinical symp-toms,disease activity(Mayo index score),colonoscopy pathological status(Baron score),mucosal healing status(Geboes index)and PERK/NF-κB pathway-related protein levels in peripheral blood mononuclear cells[phosphorylated PERK(P-PERK),phos-phorylated eukaryotic initiation factor 2α(P-eIF2α),phosphorylated NF-κB(P-NF-κB)],the levels of PERK/NF-κB pathway downstream factors[interleukin-1β(IL-1β),tumor necrosis factor-α(TNF-α),interleukin-6(IL-6),interleukin-8(IL-8)]before and after treatment,as well as adverse reactions were compared between the two groups.Results The total effective rate of the combined group was 96.00%,which was higher than that of the control group(76.00%),and the clinical symptom score was lower than that of the control group(both P<0.05).After treatment,the Mayo index score,Baron score,and Geboes index score in the combined group were(2.32±0.28),(0.51±0.11),and(0.41±0.10),respectively,which were lower than those in the control group[(3.45±0.50),(1.17±0.28),and(1.00±0.22),all P<0.05].After treatment,the levels of P-PERK,P-eIF2α,and P-NF-κB in peripheral blood mononuclear cells in the combined group were(1.07±0.14),(0.88±0.14),and(0.95±0.18),respectively,which were lower than those in the control group[1.85±0.20),(1.29±0.23),and(1.14±0.23),all P<0.05].The levels of serum IL-1 β,TNF-α,IL-6,and IL-8 in the combined group after treatment were(4.02±1.26)pg/mL,(6.15±1.64)pg/mL,(8.52±2.04)pg/mL,and(25.34±5.28)pg/mL,respectively,which were lower than those in the control group[(6.00±1.54)pg/mL,(8.79±2.33)pg/mL,(11.23±3.19)pg/mL,and(41.78±9.34)pg/mL,all P<0.05].The inci-dence of adverse reactions in the combined group was 4.00%,and the difference was not significant compared to the control group(8.00%,P>0.05).Conclusion The effectiveness and safety of self-prescribed Changning Formula combined with Me-salazine in the treatment of UC are confirmed.It can improve clinical symptoms,control disease progression and alleviate inflam-matory response,the mechanism of which may be related to inhibition PERK/NF-κB pathway activation.
3.Self-Prescribed Changning Formula Combined with Mesalazine Regulating PERK/NF-κB Pathway in the Treatment of Ulcerative Colitis
Xuanya HU ; Congjia YANG ; Lumei XU
Acta Medicinae Universitatis Scientiae et Technologiae Huazhong 2025;54(2):255-260
Objective To investigate the effectiveness of self-prescribed Changning Formula combined with Mesalazine in the treatment of ulcerative colitis(UC),and to analyze its effect on protein kinase R-like endoplasmic reticulum kinase(PERK)/nuclear factor κB(NF-κB)pathway.Methods A total of 100 patients with UC admitted to our hospital from January 2021 to January 2024 were selected and divided into control group and combined group by random number table method,with 50 cases in each group.The control group was given Mesalazine,and the combined group was given self-prescribed Changning Formula combined with Mesalazine.After 2 months of treatment,the effectivenesses in two groups were compared.The clinical symp-toms,disease activity(Mayo index score),colonoscopy pathological status(Baron score),mucosal healing status(Geboes index)and PERK/NF-κB pathway-related protein levels in peripheral blood mononuclear cells[phosphorylated PERK(P-PERK),phos-phorylated eukaryotic initiation factor 2α(P-eIF2α),phosphorylated NF-κB(P-NF-κB)],the levels of PERK/NF-κB pathway downstream factors[interleukin-1β(IL-1β),tumor necrosis factor-α(TNF-α),interleukin-6(IL-6),interleukin-8(IL-8)]before and after treatment,as well as adverse reactions were compared between the two groups.Results The total effective rate of the combined group was 96.00%,which was higher than that of the control group(76.00%),and the clinical symptom score was lower than that of the control group(both P<0.05).After treatment,the Mayo index score,Baron score,and Geboes index score in the combined group were(2.32±0.28),(0.51±0.11),and(0.41±0.10),respectively,which were lower than those in the control group[(3.45±0.50),(1.17±0.28),and(1.00±0.22),all P<0.05].After treatment,the levels of P-PERK,P-eIF2α,and P-NF-κB in peripheral blood mononuclear cells in the combined group were(1.07±0.14),(0.88±0.14),and(0.95±0.18),respectively,which were lower than those in the control group[1.85±0.20),(1.29±0.23),and(1.14±0.23),all P<0.05].The levels of serum IL-1 β,TNF-α,IL-6,and IL-8 in the combined group after treatment were(4.02±1.26)pg/mL,(6.15±1.64)pg/mL,(8.52±2.04)pg/mL,and(25.34±5.28)pg/mL,respectively,which were lower than those in the control group[(6.00±1.54)pg/mL,(8.79±2.33)pg/mL,(11.23±3.19)pg/mL,and(41.78±9.34)pg/mL,all P<0.05].The inci-dence of adverse reactions in the combined group was 4.00%,and the difference was not significant compared to the control group(8.00%,P>0.05).Conclusion The effectiveness and safety of self-prescribed Changning Formula combined with Me-salazine in the treatment of UC are confirmed.It can improve clinical symptoms,control disease progression and alleviate inflam-matory response,the mechanism of which may be related to inhibition PERK/NF-κB pathway activation.
4.Quality Evaluation of Fengshiding Capsules Based on National Drug Sampling and Testing
Lumei GUO ; Tao CHENG ; Donglan LIU ; Xingpeng LIU ; Ming YANG ; Fangfang SI ; Min ZOU ; Jialiang ZHU
Herald of Medicine 2025;44(9):1423-1430
Objective To systematically evaluate the quality of Fengshiding capsules,to analyze existing problems based on national drug sampling and testing,and to offer references and suggestions for improving quality control and regulatory supervision of this product.Methods A total of 136 batches of Fengshiding capsules were subjected to standard quality tests and exploratory analyses.HPLC was used to establish the content determination of Angelica dahurica,Cynanchum paniculatum,and Glycyrrhizae Radix,as well as the limit test for anabasine in the preparation.Additionally,an UPLC method was also employed to establish the characteristic chromatogram of Fengshiding capsules.A screening method for artificial pigments was developed,and UPLC-MS/MS was used to detect the illegal addition of chemical drugs in Fengshiding capsules.Results All 136 batches of samples passed inspection according to the current quality standards.However,based on exploratory study evaluations,the content determination results of Cynanchum paniculatum,Angelica dahurica,and Glycyrrhiza Radix were below the proposed limits.The limit test for anabasine did not exceed the proposed threshold.Furthermore,the characteristic chromatograms revealed missing peaks in several samples,and some batches contained artificial pigments and residues of acetaminophen.Conclusions The overall quality of Fengshiding capsules is rated as"average"based on national drug sampling and testing.To enhance product quality,it is recommended to improve quality standards,ensure the use of high-quality raw herbal materials,promote stronger internal oversight by manufacturers,and intensify regulatory supervision.
5.Observation on the effect of nourishing kidney, securing essence and cooling blood on microalbuminuria of patients with incipient diabetic nephropathy
Shuyan LI ; Weiming SONG ; Lumei YANG ; Qing LI ; Yubao ZHU
International Journal of Traditional Chinese Medicine 2010;32(2):115-116
Objective To study the clinical effect of nourishing kidney, securing essence and cooling blood on incipient diabetic nephropathy. Methods A total of 110 patients with incipient diabetic nephropathy were randomly recruited into a treatment group and a control group. The treatment group was treated with the method of nourishing kidney, securing essence and cooling blood and benazepril hydrochloride tablets. The control group was treated with bcnazepril hydrochloride tablets Exclusively. Urina microalbumin was detected in all patients 24 h before and after treatment. Results The effective rate was 94.7% and 86.8% in the treatment group and the control group respectively, showing significant difference (t= 9.31, P<0.01) . Conclusion The method of nourishing kidney, securing essence and cooling blood is effective to decrease urina microalbumin in incipient diabetic nephropathy.

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