1.Establishment of a method for determining the key parameters of hydrolysis kinetics of acid α -glucosidase for injection by ion chromatography
Xin-yue HU ; Jia-hao KONG ; Yue SUN ; Lü-yin WANG ; Xiao-ming ZHANG ; Ping LÜ ; Cheng-gang LIANG ; Jing LI
Acta Pharmaceutica Sinica 2024;59(12):3361-3366
The Dionex CaboPacTM PA10 BioLCTM Analyical 2 mm × 250 mm column was used with a protective column (Dionex CaboPacTM PA10 BioLCTM Guard 2 mm × 50 mm). 100 mmol·L-1 sodium hydroxide solution was used as eluent; the flow rate was 0.25 mL·min-1. Sample tray temperature: 35 ℃. The pulse amperometric detector was adopted, and the waveform was Gold CWE, Ag-AgCl RE, Carbo, Quad. The samples were cultured with 8 concentrations of glycogen substrates (0.31, 1.25, 2.5, 5, 10, 20, 30, and 40 mg·mL-1).
2.The research of a SEC-UV-RI method to determine the modifiction degree of PEG-rhGH
Yi LI ; Xiao-ming ZHANG ; Xin-yue HU ; Yue SUN ; Lü-yin WANG ; Du-yu CHEN ; Ping LÜ ; Cheng-gang LIANG ; Jing LI
Acta Pharmaceutica Sinica 2024;59(12):3367-3373
According to the requirements of the regulatory authorities, degree of modification (DP) should be included in the characterisation of the PEGylated protein drug substance, and is one of the critical quality attributes for quality control. In this study, based on the fundamental assumption that the refractive index (RI) signal and the ultraviolet (UV) signal of PEGylated protein are equal to the sum of the corresponding signal produced by the polyethylene glycol (PEG) and protein parts of the conjugates in their uncoupled state, we developed a method to determine the DP of PEGylated recombinant human growth hormone (inpegsomatropin). In this method, 20 μL of 1 mg·mL-1 human growth hormone (hGH) standard, 2 mg·mL-1 PEG reference substance and 1 mg·mL-1 drug substance solution were each injected to size exclusion chromatographic (SEC) column for separation, detected with ultraviolet and refractive index (UV-RI) detectors in series. Finally, the DP was calculated as the formula derived from the fundamental assumption. The developed SEC-UV-RI method showed good specificity, repeatability (RSD = 0.63%,
3.Analysis of the new WHO guideline to accelerate the progress towards elimination of schistosomiasis in China.
Zhao Yu GUO ; Jia Xin FENG ; Li Juan ZHANG ; Yi Biao ZHOU ; Jie ZHOU ; Kun YANG ; Yang LIU ; Dan Dan LIN ; Jian Bing LIU ; Yi DONG ; Tian Ping WANG ; Li Yong WEN ; Min Jun JI ; Zhong Dao WU ; Qing Wu JIANG ; Song LIANG ; Jia Gang GUO ; Chun Li CAO ; Jing XU ; Shan LÜ ; Shi Zhu LI ; Xiao Nong ZHOU
Chinese Journal of Schistosomiasis Control 2022;34(3):217-222
On February 2022, WHO released the evidence-based guideline on control and elimination of human schistosomiasis, with aims to guide the elimination of schistosomiasis as a public health problem in disease-endemic countries by 2030 and promote the interruption of schistosomiasis transmission across the world. Based on the One Health concept, six evidence-based recommendations were proposed in this guideline. This article aims to analyze the feasibility of key aspects of this guideline in Chinese national schistosomiasis control program and illustrate the significance to guide the future actions for Chinese national schistosomiasis control program. Currently, the One Health concept has been embodied in the Chinese national schistosomiasis control program. Based on this new WHO guideline, the following recommendations are proposed for the national schistosomiasis control program of China: (1) improving the systematic framework building, facilitating the agreement of the cross-sectoral consensus, and building a high-level leadership group; (2) optimizing the current human and livestock treatments in the national schistosomiasis control program of China; (3) developing highly sensitive and specific diagnostics and the framework for verifying elimination of schistosomiasis; (4) accelerating the progress towards elimination of schistosomiasis and other parasitic diseases through integrating the national control programs for other parasitic diseases.
China/epidemiology*
;
Disease Eradication
;
Humans
;
Public Health
;
Schistosomiasis/prevention & control*
;
World Health Organization
4.Contribution to global implementation of WHO guideline on control and elimination of human schistosomiasis by learning successful experiences from the national schistosomiasis control program in China.
Xin Yao WANG ; Jian Feng ZHANG ; Jia Gang GUO ; Shan LÜ ; Min Jun JI ; Zhong Dao WU ; Yi Biao ZHOU ; Qing Wu JIANG ; Jie ZHOU ; Jian Bing LIU ; Dan Dan LIN ; Tian Ping WANG ; Yi DONG ; Yang LIU ; Shi Zhu LI ; Kun YANG
Chinese Journal of Schistosomiasis Control 2022;34(3):230-234
Schistosomiasis is a parasitic disease that seriously hinders socioeconomic developments and threatens public health security. To achieve the global elimination of schistosomiasis as a public health problem by 2030, WHO released the guideline on control and elimination of human schistosomiasis on February, 2022, with aims to provide evidence-based recommendations for schistosomiasis morbidity control, elimination of schistosomiasis as a public health problem, and ultimate interruption of schistosomiasis transmission in disease-endemic countries. Following concerted efforts for decades, great achievements have been obtained for schistosomiasis control in China where the disease was historically highly prevalent, and the country is moving towards schistosomiasis elimination. This article reviews the successful experiences from the national schistosmiasis control program in China, and summarizes their contributions to the formulation and implementation of the WHO guideline on control and elimination of human schistosomiasis. With the progress of the "Belt and Road" initiative, the world is looking forward to more China's solutions on schistosomiasis control.
China/epidemiology*
;
Disease Eradication
;
Humans
;
Public Health
;
Schistosomiasis/prevention & control*
;
World Health Organization
5.A new disubstituted succinate from the roots of Tagetes erecta
Guo-yu LI ; Xin-yu LÜ ; Ji-ping JIAN ; Dan-dan ZHU ; Ying LIU ; Chun-yan LÜ ; Yu-yan GUO ; Shao-wa LÜ
Acta Pharmaceutica Sinica 2019;54(8):1457-1460
Nine compounds were isolated from 95% ethanol extract of the roots of
6.Response of human triple-negative breast cancer to paclitaxel after vascu-lar normalization in nude mice
zhao Rong LÜ ; yu Lu ZHAO ; zheng Chang SHI ; Wei LI ; ping Ze WENG ; Xin HUANG ; xia Ning WANG ; long Yun PAN
Chinese Journal of Pathophysiology 2017;33(10):1819-1824
AIM:To explore whether there is synergistic effect of recombinant human endostatin ( rh-Endo ) and paclitaxel (Pac) in the time window of vascular normalization and the role of magnetic resonance imaging (MRI) in early assessment of chemotherapy by observing the response of human triple -negative breast cancer ( TNBC) to Pac after vascular normalization in nude mice .METHODS:The human TNBC MDA-MB-231 cells were planted in the subcutaneous region of right lower abdomen of BALB/c-nu female nude mice .These nude mice were randomly divided into 4 groups (n=7).rh-Endo was given for 17 consecutive days in rh-Endo group and rh-Endo+Pac group.Pac was given on the 6th and 12th days in Pac group and rh-Endo+Pac group.The dosage of both drugs was 10 mg· kg-1· d-1(ip).On the day before the treatment and the 5th, 11th and 17th days after treatment, all the transplanted tumors were examined by MRI . All the mice were killed by cervical dislocation and their transplanted tumors were taken down for examinations after the last MRI on the 17th day.The changes of pathology, immunohistochemisty, microvessel density (MVD) and Ki67 expression were measured.RESULTS:On the 17th day, the volume of transplanted tumor in rh-Endo+Pac group was smaller than that in model group and rh-Endo group ( P<0.05 ) , and no difference between rh-Endo+Pac group and Pac group was found.On the 17th day, the tumor inhibitory rates in rh-Endo group, Pac group and rh-Endo+Pac group were 14.61%, 39.08%and 54.79%, respectively.The slow diffusion coefficient in Pac group was increased compared with model group , while it was decreased compared with rh-Endo+Pac group (P<0.05).No distant metastatic lesion in the tumor-bearing mice was observed .The necrotic rates in rh-Endo+Pac group and Pac group were higher than those in model group and rh-Endo group.The MVD in model group was higher than that in the other 3 groups.The MVD in rh-Endo+Pac group was decreased compared with Pac group and rh-Endo group .The Ki67 level in rh-Endo+Pac group was decreased compared with rh-Endo group , and no difference between rh-Endo+Pac group and Pac group was detected .CONCLUSION:In the time window of vascular normalization , the combination of Pac and rh-Endo has a significant antitumor effect on TNBC , but this study did not observe a significant synergistic effect of the 2 drugs.The change of slow diffusion coefficient can predict the therapeutic effect in advance .
7.Expressions of ODF2 mRNA and protein are down-regulated in the sperm of asthenospermia patients.
Bin LUO ; Wei HE ; Shi-Heng WANG ; Hong-Ping XIONG ; Xin LIANG ; Xu-Dong SHAN ; Zi-Li LÜ
National Journal of Andrology 2017;23(11):1002-1006
Objective:
To investigate the mRNA and protein expressions of outer dense fiber 2 (ODF2) in the sperm of the asthenospermia patient and their differences from those in normal healthy men.
METHODS:
According to the WHO criteria, we collected semen samples from 45 asthenozoospermia patients and 15 normal healthy volunteers. Using computer-assisted sperm analysis (CASA), we divided the semen samples from the asthenospermia patients into a mild, a moderate and a severe group, and determined the mRNA and protein expressions of ODF2 in different groups by RT-PCR and Western blot.
RESULTS:
Compared with the normal healthy men, the expression of the ODF2 gene showed no statistically significant difference in the mild asthenospermia group (1.112 0 ± 0.525 5 vs 0.688 0 ± 0.372 0, P >0.05) but remarkably decreased in the moderate (0.483 3 ± 0.186 3, P <0.05) and severe asthenospermia patients (0.448 3 ± 0.340 8, P <0.01). The OD value (ODF2/β-actin) of the ODF2 protein in the normal men exhibited no statistically significant difference from that in the mild asthenospermia group (0.458 7 ± 0.052 1 vs 0.326 1 ± 0.071 4, P >0.05), but markedly lower than in the moderate (0.145 4 ± 0.053 6, P <0.05) and severe asthenospermia patients (0.122 7 ± 0.045 7, P <0.01), which was consistent with the results of RT-PCR.
CONCLUSIONS
Decreased mRNA and protein expressions of ODF2 in the sperm are positively correlated with declined sperm motility of the asthenospermia patient, which is suggestive of the involvement of the ODF2 gene in the regulation of sperm motility.
Asthenozoospermia
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metabolism
;
physiopathology
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Case-Control Studies
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Down-Regulation
;
Heat-Shock Proteins
;
genetics
;
metabolism
;
Humans
;
Male
;
RNA, Messenger
;
metabolism
;
Semen Analysis
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Sperm Motility
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Sperm Tail
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Spermatozoa
;
metabolism
8.Expression of SKP2 and Thr187 phosphorylated p27(kip1) proteins in human breast carcinoma and their prognostic significance.
Zhi-qin GUO ; Qing-shan LÜ ; Yan-ping ZHANG ; Zhen WANG ; Zheng-ying TANG ; Yi ZHANG ; Wei WANG ; Hong-jie YANG ; Ning LU ; Xiao-wei WEN ; Cai-ping CHEN ; Wan-xin WU
Chinese Journal of Pathology 2013;42(3):197-198
Adult
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Aged
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Aged, 80 and over
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Breast Neoplasms
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metabolism
;
pathology
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Carcinoma
;
metabolism
;
pathology
;
Cyclin-Dependent Kinase Inhibitor p27
;
metabolism
;
Female
;
Humans
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Lymphatic Metastasis
;
Middle Aged
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Neoplasm Staging
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Phosphorylation
;
Prognosis
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S-Phase Kinase-Associated Proteins
;
metabolism
;
Threonine
;
metabolism
9.Coronary stenting versus bypass surgery in heart failure patients with preserved ejection fraction.
Zeng-ming XUE ; Wei-ju LI ; Chang-sheng MA ; Shao-ping NIE ; Jian-zeng DONG ; Xiao-hui LIU ; Jun-ping KANG ; Qiang LÜ ; Xin DU ; Xiao WANG ; Fang CHEN ; Yu-jie ZHOU ; Shu-zheng LÜ ; Fang-jiong HUANG ; Cheng-xiong GU ; Xue-si WU
Chinese Medical Journal 2012;125(6):1000-1004
BACKGROUNDThe optimal revascularization strategy in patients with heart failure with preserved ejection fraction (HFPEF) remains unclear. The aim of the present study was to compare the effects of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with HFPEF.
METHODSFrom July 2003 through September 2005, a total of 920 patients with coronary artery disease (CAD) and HFPEF (ejection fraction ≥ 50%) underwent PCI (n = 350) or CABG (n = 570). We compared the groups with respect to the primary outcome of mortality, and the secondary outcomes of main adverse cardiac and cerebral vascular events (MACCE), including death, myocardial infarction, stroke and repeat revascularization, at a median follow-up of 543 days.
RESULTSIn-hospital mortality was significantly lower in the PCI group than in the CABG group (0.3% vs. 2.5%, adjusted P = 0.016). During follow-up, there was no significant difference in the two groups with regard to mortality rates (2.3% vs. 3.5%, adjusted P = 0.423). Patients receiving PCI had higher MACCE rates as compared with patients receiving CABG (13.4% vs. 4.0%, adjusted P < 0.001), mainly due to higher rate of repeat revascularization (adjusted P < 0.001). Independent predictors of mortality were age, New York Heart Association (NYHA) class and chronic total occlusion.
CONCLUSIONAmong patients with CAD and HFPEF, PCI was shown to be as good as CABG with respect to the mortality rate, although there was a higher rate of repeat revascularization in patients undergoing PCI.
Aged ; Angioplasty, Balloon, Coronary ; mortality ; Coronary Artery Bypass ; mortality ; Female ; Heart Failure ; physiopathology ; therapy ; Hospital Mortality ; Humans ; Male ; Middle Aged ; Stents
10.Catheter directed thrombolysis for early left lower extremity deep venous thrombosis without vena cava filters protection.
Le XIAO ; Kun-mei GONG ; Kun-hua WANG ; Yan-jiao LÜ ; Zhi-song CHEN ; Yi-ming OUYANG ; Ping LING ; Ya-xin LONG ; Lin-hai LI
Chinese Journal of Surgery 2012;50(1):15-18
OBJECTIVETo investigate the indications, safety and efficacy of catheter directed thrombolysis for early left lower extremity deep venous thrombosis (DVT) without vena cava filters protection.
METHODSClinical data of 54 cases of early left lower extremity DVT received catheter directed thrombolysis without vena cava filters from July 2008 to June 2010 were retrospectively analyzed. The thrombosis was entire without free floating clots and no thrombosis in vena cava detected with ultrasound scan. Twenty-five patients were male and 29 were female with the average age of 52.8 years. Fifty-one of which were iliofemoral and popliteal, the other 3 were iliofemoral. The course were ≤ 7 d in 45 cases and these were 8 to 30 d in 9 cases. Urokinase of 300 000 U was infused through catheters per 2 h twice a day. Meanwhile 4000 U of low weight heparin was administered subcutaneously per 12 h, or heparin infusion at dosage of 18 U×kg(-1)×h(-1).
RESULTSThe procedure technically succeeded in all patients. In total cases venous score decreased to 4.6 ± 2.1 post 6 to 10 d of thrombolysis from 10.8 ± 1.0 with thrombolysis rate of 58% ± 18% which was not significantly different between groups of ≤ 7 d and 8 to 30 d (t = 1.02, P = 0.34). On 14(th) day, 11 patients (20.4%) completely recovered, 35 cases (64.8%) experienced large improvement, 8 patients (14.8%) had mild improvement and nobody was failed, resulting in total efficacy of 100%. No patient developed clinical symptomatic pulmonary embolism. SpO2 did not alter markedly post thrombolysis [(91.0 ± 2.6)% vs. (90.8 ± 2.4)%, t = 2.03, P = 0.05]. No patients suffered from cerebral hemorrhage and haemoturia, and catheter induced inflammation occurred in 4 cases (7.41%). There was mild bleeding in puncture sites in 11 patients (20.4%) during the course. There were 36 patients (66.7%) had been followed up with the time of 6 to 21 months. In which 31 cases had no lower extremity edema or had mild edema after activities. Two patients developed serious edema after activities for deep venous insufficiency. Three cases combined with malignant tumor or renal failure recurred.
CONCLUSIONSFor early left extremity DVT which is entire without free floating clots and no thrombosis in vena cava, catheter directed thrombolysis without filter protection maybe administered with safety, efficiency and lower expense.
Catheterization, Peripheral ; Female ; Fibrinolytic Agents ; administration & dosage ; therapeutic use ; Follow-Up Studies ; Humans ; Lower Extremity ; blood supply ; Male ; Middle Aged ; Pulmonary Embolism ; prevention & control ; Retrospective Studies ; Thrombolytic Therapy ; methods ; Urokinase-Type Plasminogen Activator ; administration & dosage ; therapeutic use ; Vena Cava Filters ; Venous Thrombosis ; complications ; therapy

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