1.Expert Consensus on Clinical Application of Qidong Yixin Oral Liquid
Changkuan FU ; Xiaochang MA ; Mingjun ZHU ; Yue DENG ; Hongxu LIU ; Mingxue ZHANG ; Ying CHEN ; Yan ZHOU ; Ling ZHANG ; Jianhua FU ; Wei YANG ; Yu'er HU ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):147-158
The prescription of Qidong Yixin oral liquid is derived from the experience of national medical master Ren Jixue in treating viral myocarditis (VMC). It has the functions of tonifying Qi, nourishing the heart,calming the mind, and relieving palpitations. It is used to treat VMC and angina pectoris of coronary heart disease caused by deficiency of both Qi and Yin. However,the understanding of its efficacy evidence, advantageous aspects, dosage and administration, and medication safety remains insufficient in clinical practice. Therefore,the development of the Expert Consensus on the Clinical Application of Qidong Yixin Oral Liquid (hereinafter referred to as consensus) was initiated. Consensus strictly followed the process and methods of the expert consensus on the clinical application of Chinese patent medicines of the China Association of Chinese Medicine,successively completing multiple tasks such as the consensus project initiation,determination of clinical problems,evidence search and evaluation,formation of recommendation opinions and consensus suggestions,solicitation of opinions,peer review, submission for review and release, and so on. Consensus formed a total of 10 recommendation opinions and 12 consensus suggestions,clarifying the clinical positioning,efficacy advantages,syndrome differentiation,dosage and administration,combination therapy,timing of medication,adverse reactions,contraindications, and precautions of Qidong Yixin oral liquid,indicating that it has good clinical advantages and safety in the treatment of VMC and angina pectoris of coronary heart disease,providing norms and references for physicians to safely and rationally apply Qidong Yixin oral liquid. Consensus was reviewed and approved for release by the Standardization Office of the China Association of Chinese Medicine on December 23, 2024. Standard number:GSCACM-376-2024.
2.The introduction on the new standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; CHEN Ying ; TU Jiasheng ; LIU Yanming ; ZHENG Luxia ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):058-066
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 Edition has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, an increase of 15.5% compared with the 2020 Edition, and the total number has reached 387. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
3.Analysis of national external quality assessment results for transfusion compatibility test, 2018 to 2023
Junhua HU ; Peng ZHANG ; Jiali LIU ; Zhiguo WANG ; Yanming LIU ; Shengchen TIAN ; Wanru MA ; Xiang LI ; Xuebin ZHAO ; Feng XUE ; Yuntian WANG ; Dong LIN ; Zheng SUN ; Jiwu GONG ; Lin ZHOU
Chinese Journal of Blood Transfusion 2025;38(12):1720-1727
Objective: To analyze the results of national external quality assessment (EQA) for transfusion compatibility test from 2018 to 2023, with the aim of providing references for improving laboratory testing quality and ensuring the safety of clinical blood transfusion. Methods: Three EQA programs were conducted annually, each distributing 22 quality assessment samples. Participating transfusion laboratories were required to complete testing within specified deadlines and to submit results along with documentation of testing methodologies, reagents, and equipment used. National Center for Clinical Laboratories (NCCL) conducted statistical analysis of laboratory results, evaluated testing outcomes and related circumstances, and provided feedback to participating laboratories. EQA data from transfusion laboratories across China from 2018 to 2023 were collected and systematically analyzed. Results: From 2018 to 2023, the qualification rates for all five items (ABO forward typing, ABO reverse typing, Rh blood group typing, antibody screening, and cross-matching) were 67.59%, 77.11%, 77.38%, 72.78%, 79.96%, and 85.16%, respectively. The mean qualification rates for ABO forward typing, ABO reverse typing, RhD blood group typing, antibody screening, and cross-matching over the past six years were 96.25%±0.59%, 90.45%±4.52%, 96.05%±0.71%, 90.88%±2.86%, and 88.34%±3.48%, respectively. The qualification rates in 2019, 2020, 2022, and 2023 all showed a stable trend of "blood stations>tertiary hospitals>secondary hospitals". The mean qualification rate of laboratories in secondary hospitals from 2018 to 2023 was significantly lower than those of laboratories in tertiary hospitals and blood stations (P<0.05), while no significant difference was observed between laboratories in tertiary hospitals and blood stations (P>0.05). The micro column agglutination method was the most widely used in all five tests. In the four test items, namely ABO forward typing, ABO reverse typing, antibody screening, and cross-matching, there was a statistically significant difference in the qualification rate of micro column agglutination method compared to other methods (P<0.05). There was a statistical difference in the qualification rate between manual and automated detection using micro column agglutination method in the cross-matching tests (P<0.05), whereas no significant difference was noted for the other test items (P>0.05). Conclusion: From 2018 to 2023, the number of laboratories participating in EQA activities has been increasing year by year, and the qualification rate has shown an overall upward trend. The type of laboratory is a key factor affecting the qualification rate, and the testing capabilities of some laboratories still need to be improved. The micro column agglutination method is widely used in transfusion compatibility tests. The established EQA program effectively monitors quality issues in laboratories, drives continuous improvement, and ensures sustained enhancement of testing standards to safeguard clinical blood safety.
4. Determination of docusate sodium by ion-pair high-performance liquid chromatography
Lirong CAI ; Haiping SHU ; Sha XIAO ; Yue TAN ; Jinfeng ZHENG ; Changliang LI ; Yanming LIU
Journal of China Pharmaceutical University 2025;56(2):183-187
To reduce the dependency on high-carbon-load chromatographic columns,a new method has been established for the determination of the content of docusate sodium using ion-pair high-performance liquid chromatography (IP-HPLC). Tetrapropylammonium chloride was used as the ion-pair reagent with a mobile phase, composition of acetonitrile:10 mmol/L tetrapropylammonium chloride solution = 66∶34, adjusting pH to 6.5 with 0.1% phosphoric acid solution,flow rate of 1.5 mL/min, detection wavelength of 214 nm,column temperature of 35 °C, and an injection volume of 25 μL,and quantified by an external standard method. The main peak of docusate sodium exhibited a tailing factor of 1.34. The method showed good linearity within the range of 0.02 mg/mL to 0.40 mg/mL, with a correlation coefficient (r) of 0.999 9. It also demonstrated good repeatability, with recovery ranging from 97.0% to 98.2% (n=6). The quantification limit was 3.31 μg/mL, and the detection limit was 2.76 μg/mL.In summary,the new method shows good durability, a wide linear range, and high sensitivity, it is suitable for the determination of docusate sodium.
5.miR-582-5p regulates DUSP1 to modulate Mycobacterium tuberculosis infection in macrophages.
Yanming SUN ; Fengxia LIU ; Tingting CHANG
Chinese Journal of Cellular and Molecular Immunology 2025;41(5):406-412
Objective To explore the effect of miR-582-5p on Mycobacterium tuberculosis (Mtb)-infected macrophages by regulating dual specificity phosphatase 1 (DUSP1). Methods THP-1 macrophages were divided into six groups: control group, Mtb group, inhibitor-NC group, miR-582-5p inhibitor group, miR-582-5p inhibitor+si-NC group, and miR-582-5p inhibitor+si-DUSP1 group. QRT-PCR was applied to detect the gene expression of miR-582-5p and DUSP1 in cells. ELISA kit was used to detect the levels of interferon γ (IFN-γ), interleukin 6 (IL-6), tumor necrosis factor α (TNF-α), and interleukin 1β (IL-1β). CCK-8 method was applied to detect cell proliferation. Flow cytometry was applied to detect cell apoptosis rate. Western blot analysis was used to measure the protein expression levels of B-cell lymphoma 2 (Bcl2), Bcl2-associated X (BAX), and cleaved-caspase 3 (c-caspase-3) in cells. In addition, the target relationship between miR-582-5p and DUSP1 was verified. Results Compared with the control group, the expression of miR-582-5p, levels of IFN-γ, IL-6, TNF-α, IL-1β, bacterial load and OD450 values (24 h, 48 h), and the protein expression of Bcl2 in macrophages were higher in the Mtb group, while the mRNA expression of DUSP1, apoptosis rate, and the protein expression levels of c-caspase-3, BAX and DUSP1 were lower. Compared with the Mtb group and the inhibitor-NC group, the above-mentioned indicators in the miR-582-5p inhibitor group were partially reversed. Down-regulation of DUSP1 expression partially reversed the inhibitory effect of down-regulation of miR-582-5p expression on Mtb-infected macrophages. Conclusion Inhibiting the expression of miR-582-5p can up-regulate DUSP1, thereby inhibiting the proliferation and inflammatory response of Mtb-infected macrophages and promoting cell apoptosis.
Humans
;
Macrophages/metabolism*
;
Dual Specificity Phosphatase 1/metabolism*
;
MicroRNAs/metabolism*
;
Mycobacterium tuberculosis/physiology*
;
Tuberculosis/microbiology*
;
Apoptosis/genetics*
;
THP-1 Cells
;
Cell Proliferation/genetics*
;
Interferon-gamma/genetics*
;
Tumor Necrosis Factor-alpha/genetics*
;
Interleukin-1beta/genetics*
6.hAMSCs repair endometrial injury through suppressing endometrial EMT and fibrosis via TGF-β1/Smad signaling pathway
Ting XIE ; Yanming HUANG ; Jiaying NIU ; Rongxia LIU ; Siyu LIANG ; Yao ZHANG ; Lu CHEN ; Binyue SHENG
Journal of Army Medical University 2025;47(21):2688-2697
Objective To explore the repair effect and mechanism of human amniotic mesenchymal stem cells(hAMSCs)on endometrial injury.Methods hAMSCs were isolated using a two-enzyme digestion and then cultured.The third-passage(P3)cells were harvested to detect the surface markers by flow cytometry and to identify their trilineage differentiation potentials.Eighteen nulliparous female SD rats(8~9 weeks old,weighing 250~280 g)were randomly divided into 3 groups(n=6):normal control group,model group,and hAMSCs group.A rat model of intrauterine adhesions(IUA)was established in SD rats by using curettage combined with lipopolysaccharide(LPS)infection.In 2 weeks after modeling,the hAMSCs group received a bilateral uterine horn transplantation of 0.2 mL hAMSCs(1.0×10? cells/mL),while the model group received a same volume of PBS into both uterine horns.All rats were sacrificed in 2 weeks after transplantation.HE and Masson staining was used to observe endometrial thickness and gland number as well as endometrial fibrosis area.RT-qPCR and Western blotting were performed to detect the mRNA and protein levels of TGF-β1,Smad3,Smad7,epithelial-mesenchymal transition(EMT)markers(E-cadherin,Vimentin),fibrosis factor α-SMA,and endometrial estrogen receptor(ER)and progesterone receptor(PR)in endometrial tissues.Results The obtained cells were identified as hAMSCs due to the characteristics of surface markers and differentiation potentials.Compared with the normal control group,the model group showed decreased endometrial thickness,reduced gland number,increased fibrosis area,and enhanced mRNA and protein levels of fibrosis-related factors TGF-β1,Smad3,Vimentin,and α-SMA(P<0.01),while down-regulation of fibrosis-inhibiting molecule Smad7,the EMT marker E-cadherin,and endometrial receptors ER and PR at both mRNA and protein levels(P<0.01).hAMSCs transplantation increased endometrial thickness and gland number,decreased fibrosis area,and down-regulated mRNA expression of the aforementioned fibrosis-related factors(P<0.01),and up-regulated the mRNA expression levels of Smad7,E-cadherin,ER,and PR(P<0.01).The hAMSCs group also exhibited obviously down-regulated protein levels of TGF-β1,Smad3,and α-SMA(P<0.05),while enhanced protein levels of Smad7 and PR(P<0.05).Conclusion Intrauterine transplantation of hAMSCs can promote the repair of endometrial injury,and inhibits endometrial EMT and fibrosis through the TGF-β1/Smad7 signaling pathway.
7.Predictive value of T cell subtype characteristics and peripheral blood inflammatory indicators in patients with liver cancer for myelosuppression after hepatic artery infusion chemotherapy
Rongrong ZHANG ; Yanming LIU ; Xiangyan CHEN ; Jing LING
Journal of International Oncology 2025;52(7):426-431
Objective:To explore the predictive value of T cell subtype characteristics and peripheral blood inflammatory indicators in patients with liver cancer for myelosuppression after hepatic artery infusion chemotherapy.Methods:A total of 115 patients with primary hepatocellular carcinoma who received transcatheter arterial chemoembolization (TACE) treatment in the Department of Oncology of Taizhou Jiangyan Traditional Chinese Medicine Hospital from May 2022 to May 2024 were enrolled as the research subjects. According to whether myelosuppression occurred after TACE treatment, the patients were divided into a non-myelosuppression group ( n=93) and a myelosuppression group ( n=22). The clinical data, the proportions of T cell subsets before TACE treatment, and the differences in the levels of peripheral blood inflammatory indexes were compared between the two groups. Spearman correlation analysis and multivariate logistic regression analysis were used to screen out the influencing factors of myelosuppression after TACE treatment in patients with primary hepatocellular carcinoma. The receiver operator characteristic (ROC) curve was used to analyze the efficacy of each influencing factor in predicting the myelosuppression of patients. Results:There were no statistically significant differences in age, sex, history of hypertension, body mass index, type of hepatitis virus infection, status of hypersplenism, Barcelona staging, Child-Pugh classification of liver function, number of TACE treatments, and the proportion of CD8 + T cells between the patients in the myelosuppression group and non-myelosuppression group (all P>0.05). However, there were statistically significant differences in diabetes ( χ2=3.94, P=0.047), history of alcohol consumption ( χ2=5.47, P=0.019), the longest diameter of the tumor ( Z=2.31, P=0.021), the presence of ascites ( χ2=4.10, P=0.043), the proportion of CD4 + T cells ( t=4.66, P<0.001), the ratio of CD4 +/CD8 + ( t=4.98, P<0.001), the neutrophil/lymphocyte ratio (NLR) ( t=4.98, P<0.001), the monocyte/lymphocyte ratio (MLR) ( t=2.31, P=0.023), and the systemic immune inflammation index (SII) ( t=5.31, P<0.001). Spearman correlation analysis showed that diabetes ( r=0.19, P=0.048), history of alcohol consumption ( r=0.22, P=0.019), the presence of ascites ( r=0.19, P=0.043), the longest diameter of the tumor ( r=0.22, P=0.020), NLR ( r=0.39, P<0.001), MLR ( r=0.30, P=0.001), and SII ( r=0.36, P<0.001) were all positively correlated with myelosuppression after TACE treatment in patients with primary hepatocellular carcinoma, while the proportion of CD4 + T cells ( r=-0.37, P<0.001) and the ratio of CD4 +/CD8 + ( r=-0.40, P<0.001) were negatively correlated with myelosuppression after TACE treatment in patients with primary hepatocellular carcinoma. Multivariate logistic regression analysis showed that the ratio of CD4 +/CD8 + ( OR=0.01, 95% CI: 0.01-0.11, P=0.002) was an independent protective factor for myelosuppression after TACE treatment in patients with primary hepatocellular carcinoma, and NLR ( OR=1.82, 95% CI: 1.31-5.60, P=0.013) and SII ( OR=1.03, 95% CI: 1.01-1.05, P=0.002) were both independent risk factors for myelosuppression after TACE treatment in patients with primary hepatocellular carcinoma. ROC curve analysis showed that the areas under the curve (AUCs) of the ratio of CD4 +/CD8 +, NLR, and SII for predicting myelosuppression after TACE treatment in patients with primary hepatocellular carcinoma alone were 0.79 (95% CI: 0.70-0.89), 0.78 (95% CI: 0.65-0.92), and 0.76 (95% CI: 0.65-0.87), respectively. The AUC of the combined prediction of the three was 0.91 (95% CI: 0.83-0.99), which was higher than that of the ratio of CD4 +/CD8 + ( Z=4.21, P<0.001), NLR ( Z=4.36, P<0.001), and SII ( Z=4.48, P<0.001) for prediction alone. Conclusions:The ratio of CD4 +/CD8 +, as well as NLR and SII levels before TACE treatment are independent factors influencing the occurrence of myelosuppression after treatment in patients with primary hepatocellular carcinoma, and are expected to be important indicators for predicting myelosuppression after hepatic artery infusion chemotherapy in patients with primary hepatocellular carcinoma.
8.Comparing the effects of dual-task training and single-task training on walking, balance and cognitive functions in individuals with Parkinson’s disease: A systematic review
Xiaoying LIN ; Yanming ZHANG ; Xiaowei ZHANG ; Xi CHEN ; Jianhua LIU ; Lei YANG ; Pang Marco Yiu Chung
Chinese Medical Journal 2024;137(13):1535-1543
Background::This systematic review aimed to examine whether dual-task (DT) training was superior to single-task (ST) training in improving DT walking, balance and cognitive functions for individuals with Parkinson’s disease (PD).Methods::Literature search was performed in the following electronic databases: PubMed, the Cochrane Library, Web of Science, and Metstr covering inception to May 10, 2023. And in order to facilitate comparison across trials, we calculated the effect size (Hedges’ g) of gait, balance, cognitive, and other parameters under both ST and DT conditions, using the mean change score and standard deviation (SD) of change score of the experimental and control groups. Randomized controlled trials that examined the effects of DT motor and cognitive training in individuals with Parkinson’s disease were included for this systematic review.Results::A total of 214 participants recruited from six articles (actually five trials) were involved in this review. In terms of walking ability, only double support time and stride time variability showed significant between-group difference (Hedges’ g = 0.34, 0.18, respectively). Compared to ST training group, DT training group had a more improvement effect in laboratory balance measurement (Hedges’ g = 0.18, 1.25), but no significant improvement in clinical balance measurement. No significant between-group differences were observed, thus its training effect on cognitive function was inconclusive.Conclusions::The DT training failed to achieve promising results better than ST training in improving DT walking and balance functions for individuals with PD. Any firm conclusion cannot be drawn at present, due to the limited number of eligible publications. Larger sample size and high-quality studies are needed to investigate the effectiveness of DT training in individuals with PD.
9.Study on the compatibility between pharmaceutical excipient polyethylene glycol 6000 and antiepileptic active pharmaceutical ingredients levetiracetam
Yun JIANG ; Ying ZHOU ; Yong ZHAO ; Jinfeng ZHENG ; Yanming LIU
China Pharmacist 2024;27(1):57-65
Objective To investigate the compatibility between antiepileptic active pharmaceutical ingredient(API)levetiracetam and binder polyethylene glycol 6000,and provide a basis for evaluating and ensuring the safety of drugs.Methods Levetiracetam and polyethylene glycol 6000 from different producers were mixed in a certain proportion,and placed under different conditions according to the test method of stability influencing factors.The compatibility of levetiracetam and polyethylene glycol 6000 was analyzed by differential scanning calorimetry and HPLC,respectively,and the thermal variations,changes of levetiracetam appearance and related substances were investigated.Results After being placed under high humidity(relative humidity of 90%)and light(4 500 Lx)for 10 days,the compatibility between API and pharmaceutical excipients was proved good,while under the conditions of high temperature of 50℃ and 60℃,polyethylene glycol 6000 interacted with levetiracetam,resulting in the growth of levetiracetam related substances including impurity A and total amount of impurities,along with the production of two unknown impurities.Polyethylene glycol 6000 from different producers and different batches had different effects on the related substances of levetiracetam.Conclusion There is a risk of compatibility between levetiracetam and polyethylene glycol 6000 under elevated temperatures,and it is recommended that preparation producers optimize product prescriptions and improve the quality and safety of drugs.
10.Determination of related substances in the pharmaceutical excipient triacetin by gas chromatography
Yue ZHANG ; Rong SHI ; Jinfeng ZHENG ; Yanming LIU ; Yingying XIE ; Ying LI
China Pharmacist 2024;27(2):227-232
Objective To determine the related substances in the pharmaceutical excipient triacetin by gas chromatography(GC).Methods Rtx-1701 and DB-1701 chromatographic column(30 m×0.25 mm,0.25 μm)was used,with nitrogen as the carrier gas,the flow rate was 1.5 mL/min,the inlet temperature was 200℃,the hydrogen flame ionization detector was used,the temperature of the measuring instrument was 250℃,and the program heating was used.Results Under this chromatographic condition,each substance could be effectively separated,and showed good linearity at 2-40 μg/mL(r>0.99).The recovery rates of acetic acid,glycerol,1-monoglyceryl acetate,1,2-diglyceryl acetate and 1,3-diglyceryl acetate were 100.7%(RSD=3.12%),95.1%(RSD=3.66%),99.43%(RSD=4.62%),103.66%(RSD=5.88%)and 103.15%(RSD=4.17%)(n=6),respectively.Conclusion This method has high accuracy and good reproducibility,which can be used for the determination of related substances in the triacetin,and provides a reference for the quality standard of triacetin.

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