1.HPLC fingerprint and three main components determination of Modified Zengye Decoction
Shiqi LIU ; Chuang WU ; Zhimin ZHU ; Feng XU ; Yaowen CHANG ; Haiyan ZHANG ; Xiaojun GOU
China Pharmacist 2024;27(6):928-936
Objective To establish a method for HPLC fingerprint analysis and determine three main components of Modified Zengye Decoction.Methods The chromatographic column was Shimadzu WondaSil C18 column(250 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.3%aqueous phosphoric acid with a gradient elution procedure,the volume flow rate was 1.0 mL/min,the detection wavelengths were 265,203,310 and 290 nm,the column temperature was 25 ℃,and the injection volume was 20 μL.The HPLC fingerprints of the 10 batches of Modified Zengye Decoction were established,and the similarity analysis was performed by using the similarity evaluation system of chromatographic fingerprint of traditional Chinese medicine(version 2012A).The common peaks were identified and assigned,and the contents of the three main components were quantitatively determined.Results There were 17 common peaks in the fingerprints of 10 batches of Modified Zengye Decoction with similarities ranging from 0.872-0.989.The fingerprints recognized peak 9,14 and 17 as ferulic acid,aurantiamarin and harpagoside,respectively.The contents of ferulic acid,aurantiamarin and harpagoside were 0.067 3-0.174 8,0.498 8-1.522 7,0.270 9-0.802 4 mg/g,and the transfer rate were 30.74%-55.63%,11.77%-35.94%,23.15%-68.56%,respectively.Conclusion The established HPLC fingerprint analysis method combined with main components quantitative analysis method can be used for the quality analysis and control of Modified Zengye Decoction with simple analysis method and reliable results.
2.Simultaneous determination of 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material and its formulations by GC-MS/MS
Shangying LI ; Qingyang YUE ; Yaowen ZHANG ; Wankui XU
China Pharmacy 2023;34(15):1830-1834
OBJECTIVE To establish a method for simultaneous determination of the contents of 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material and its formulations. METHODS GC-MS/MS was adopted to determine 6 kinds of N-nitrosamines genotoxic impurities in losartan potassium raw material, Losartan potassium tablet, Losartan potassium capsule and Losartan potassium hydrochlorothiazide tablets, such as N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), N-ethyl-N-nitroso-2-propanamine (NEiPA), N-nitrosodiisopropylamine (NDiPA), N-nitrosodipropylamine (NDPA) and N-nitrosodibutylamine (NDBA). The separation was performed on SHIMADZU SH-L-17Sil MS capillary column by temperature- programmed GC, with injector temperature of 250 ℃ , sample size of 1 μL, carrier gas of helium, and carrier flow rate of 1 mL/min. Electron ionization and multiple reaction monitoring (MRM) data acquisition mode were used, with an ion source temperature of 250 ℃ and solvent delay time of 3.1 min. RESULTS The separation among NDMA, NDEA, NEiPA, NDiPA, NDPA, NDBA and adjacent chromatographic peaks was good, and the separation rate was higher than 3.8; the linear ranges of them were 4.9-486.0, 4.9-488.5, 4.5-451.5, 6.8-683.5, 5.2-525.0 and 5.2-520.0 ng/mL(all r≥0.999 8). The limits of quantitation were 4.86, 4.88, 4.52, 6.84, 5.25 and 5.20 ng/mL; the limits of detection were 0.97, 0.98, 0.90, 1.37, 1.05 and 1.04 ng/mL. RSDs of repeatability tests were 2.2%-5.6%(n=6), those of precision tests were 0.5%-1.4%(n=6), and those of stability tests were 1.5%-3.4%(n=5), respectively. Average recoveries of low-, medium- and high-concentration solution were 83.4%-103.0% (RSDs were 1.2%-6.3%, n=3), respectively. No one among the 6 kinds of N-nitrosamines genotoxic impurities was detected in both losartan potassium raw material and formulations. CONCLUSIONS The method is good in separation effect, highly accurate, sensitive and simple. It can be used in the determination of the 6 kinds of N-nitrosamines genotoxic impurities.
3.Analysis of imaging features of bronchopulmonary dysplasia
Yaowen LI ; Shumin XU ; Hongwu ZENG
Chinese Pediatric Emergency Medicine 2022;29(6):412-417
Bronchopulmonary dysplasia(BPD)is a chronic respiratory disease characterized by alveolar and pulmonary microvascular dysplasia.It happens in premature infants, which is a major cause of death and long-term complications in premature infants.Chest radiology examination is essential for BPD, which not only reveals main radiological features such as pulmonary hyperinflation, pulmonary fibrosis and atelectasis, but also evaluates the severity and progression.These provide significant information for clinical treatment and follow-up study of children with BPD.
4. Effects of individual differences on the pharmacokinetics of capecitabine in cancer patients
Guofang XU ; Pan GAO ; Ping LIU ; Yaowen LAI ; Guanghui LI ; Yue ZHAO ; Yongling ZHANG ; Xiaosu LI ; Qi QI
Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(3):305-311
AIM: To study the effects of individual differences (gender, age, body surface area, and body weight) on the pharmacokinetics of capecitabine in cancer patients in hoping of providing evidence for the rational use of capecitabine in clinic. METHODS: A total of 76 patients with various solid tumors were given a single dose of 0.6 g (0.15 g, 4 tablets) capecitabine in postprandial and blood samples were collected at multiple time points. The plasma concentration of capecitabine and its active metablolite, 5-fluorouracil (5-FU) were analyzed by HPLC-MS/MS and the pharmacokinetic parameters of the drugs were calculated by Phoenix WinNonlin7.0 software. RESULTS: Following oral administration, the C
5.Content Determination of 20 Element Impurities in Aminomethylbenzoic Acid Injections and Its Compatibility Investigation
Hai HUANG ; Yaowen ZHANG ; Jiaxuan SONG ; Ming YU ; Wankui XU
China Pharmacy 2021;32(11):1330-1336
OBJECTIVE:To establish a m ethod to determine the cont ents of 20 elements impurities in Aminomethylbenzoic acid injection ,and to investigate its compatibility in low-borosilicate glass ampoules. METHODS :The sample was diluted with 5% nitric acid solution ,and then determined by ICP-MS using scandium ,indium and bismuth as internal standards. The nebulizer flow(argon)was 0.92 L/min,collision gas flow (helium)was 4.5 L/min,RF power was 1 895 W,plasma flow was 18 L/min, pump speed was 40 r/min,injection delay time was 65 s. The collision mode was used as measurement mode ,the data sampling adopted peak skipping mode ,and repeated for 3 times. The accelerated test was carried out after sample was stored at 70 ℃ for 1 and 3 months,and the compatibility was investigated by comparing the change trend of element impurity content. RESULTS :The linear range of vanadium ,cobalt,chromium,arsenic,cadmium,antimony,mercury,thallium and lead were 0.01-20 μg/L;those of magnesium ,aluminium,ferrum,nickel,copper,zinc,barium were 0.1-200 μg/L;those of boron ,silicon,potassium and calcium were 1-2 000 μg/L(r≥0.999 8). RSDs of precision ,intermediate precision ,stability(8 h)and repeatability test were all lower than 6%. The limits of quantitation were 0.000 7-2.986 3 μg/L;the limits of detection were 0.000 2-0.895 9 μg/L. The average recoveries were 88.50%-111.00%(RSDs were 0.52%-2.33%,n=9). The minimum content of 20 element impurities was less than detection limits ,the maximum contents were 3 835.9 μg/L(0 month),10 448.4 μg/L(1 month),17 261.2 μg/L(3 month) in Aminomethylbenzoic acid injection from 8 manufacturers. Among the 20 elements impurities ,except that boron , aluminum,magnesium,silicon,calcium and potassium were not specified ,the contents of other elements were less than the threshold. The research of compatibility showed that the impurity contents of seven elements such as boron ,aluminum,silicon, potassium,zinc,arsenic and barium showed an increasing trend. The silicon concentration ,silicon/aluminum concentration ratio and silicon/boron concentration ratio in the accelerated samples after stored for one and three months were significantly different from those stored for 0 month. CONCLUSIONS :The established method is sensitive ,reproducible and accurate ,and can be used for the content determination of 20 element impurities in Aminomethylbenzoic acid injection. The interaction between low-borosilicate ampoule and Aminomethylbenzoic acid injection is obvious.
6.Molecular epidemiology of drug resistance genes and carbapenem resistance of Pseudomonas aeruginosa in rural well water
Shuang WANG ; Liuchen XU ; Yaowen PEI ; Mei WANG ; Zhenqiang BI ; Huaning ZHANG ; Lu LIU ; Ming FANG ; Zengqiang KOU
Chinese Journal of Epidemiology 2021;42(5):898-902
Objective:To analyze molecular epidemiological characteristics of drug resistance genes and carbapenem resistance of Pseudomonas aeruginosa (PA) in rural well water. Methods:According to Citation of Natural Mineral Water Inspection (GB 8538-2016), a total of 112 well water samples were tested in Juye county of Shandong province, and PFGE and drug susceptibility test were conducted for the identified PA strains. After PCR identification of carbapenem resistance genes, S1-PFGE and Southern blotting were used to determine the location of drug resistance genes, and combined experiments were used to determine gene transferability. Results:The detection rate of PA in rural well water samples in Juye county of Shandong province was 54.46% (61/112). The 61 strains could be divided into 56 PFGE types. There were 2 strains with 100.00% consistent band types, and there was no obvious predominant band type. The results of drug susceptibility experiments showed that 93.44% (57/61) were multi-drug resistant strains, and there were 2 strains carrying blaVIM-2, both of which were located on the plasmid, and both of them were transferred horizontally with the plasmid. Conclusion:PA carrying carbapenem resistance genes was detected in well water of rural communities in Juye country, and there is the possibility of horizontal transmission of such resistance genes.
7.Risk factors analysis of initial high peritoneal solute transport status in peritoneal dialysis patients
Tao LIN ; Geping YU ; Jingyuan XIE ; Xiaomin HUANG ; Tian XU ; Li WANG ; Xiao LI ; Chunyan ZHANG ; Yaowen XU ; Hong REN ; Nan CHEN
Journal of Shanghai Jiaotong University(Medical Science) 2017;37(8):1090-1093
Objective · To investigate the clinical characteristics of initial peritoneal dialysis (PD) patients with different peritoneal transport status, and analyze risk factors of high peritoneal transport status in PD patients. Methods · A total of 455 consecutive PD patients newly starting PD between January 2007 to October 2015 were retrospectively analyzed. According to the results of the first sPET, patients were divided into H/HA (4h D/Pcr ≥ 0.65) and L/ LA (4h D/Pcr<0.65) groups. Clinical and biochemical characteristics between the two groups were compared. Multivariate logistic regression model was established to investigate risk factors of higher peritoneal transport status of incident PD patients. Results · The study included 372 incident PD patients. The L/LA group and H/HA group had 264 cases (71.2%) and 108 cases (28.8%) respectively. The H/HA group had higher proportion of male patients (63.0% vs 50.8%, P=0.03), lower residual renal function [RRF, (4.26±2.77) mL/min vs (5.79±4.53) mL/min, P<0.01], lower serum albumin level [(29.34±6.89) g/L vs (32.08±5.86) g/L, P=0.00], and more frequent diabetic nephropathy (19.4% vs 9.5%, P=0.00), compared with L/LA group. Univariate and multivariate logistic regression analysis showed that higher peritoneal transport status was associated with lower serum albumin level (OR=0.96, 95% CI 0.28-0.99; P=0.02), male (OR=1.92, 95% CI 1.19-3.12; P=0.00), presence of diabetic nephropathy (OR=2.52, 95% CI 1.26-5.05; P=0.00) and lower residual renal function (OR=0.90,95% CI 0.83-0.96; P=0.00). The level of hsCRP in patients with hypoalbuminemia was higher than that in patients with normal albumin level (1.69 mg/L vs 0.69 mg/L, P=0.00). Conclusion · Low and low average peritoneal transport status accounted for the majority of the patients in this study. Low serum albumin levels, male, diabetic nephropathy, RRF were risk factors of initial high peritoneal solute transport status. Chronic inflammatory status might partially explain for the correlation between hypoalbuminemia and high peritoneal solute transport status in PD patients.
8.Genetic characteristics of coxsackievirus A16 strains isolated in Liaocheng city in Shandong province ;during 2013
Guangyin XU ; Yaowen PEI ; Shiying ZHANG ; Zhiyu WANG
Chinese Journal of Microbiology and Immunology 2015;(4):253-257
Objective To study the etiological agent of hand, foot and mouth disease ( HFMD) and the genetic characteristics of coxsackievirus A16 ( CVA16 ) strains isolated from clinical specimens of patients with HFMD in Liaocheng city in 2013.Methods Throat swab and stool specimens were collected from patients with HFMD in the disease surveillance hospitals in Liaocheng city from January to December 2013.Samples pos-itive for CVA16 strains were screened out for the isolation of virus strains with rhabdomyosarcoma ( RD) cells and Vero cells.The entire VP1 coding regions of 9 randomly selected CVA16 isolates were amplified and se-quenced.BioEdit and MEGA4 softwares were used for homology analysis.A phylogenetic tree among the 9 CVA16 isolates and 56 CVA16 representative strains of known genotypes and subgenotypes was constructed.Re-sults The results of PCR analysis showed that 747(77.73%) out of 961 specimens were positive for HFMD and among them, 74 samples (9.91%) were positive for EV71 strains, 130(17.40%) were CVA16 strains and 543(72.69%) were other enterovirus strains.The 9 CVA16 strains clustered into the B2b evolution branch of B genotype with the representative strains, sharing 97.7%to 100%homologies in nucleotide sequences and 99.3%to 100%in amino acid sequences.Conclusion Although EV71 and CVA16 strains were identified, other enteric viruses were the predominant pathogens causing HFMD in Liaocheng city in 2013.The CVA16 iso-lates belonged to B2b subgenotype.The pathogen spectrum of HFMD had already changed.It is necessary to strengthen the surveillance for EV71, CVA16 and other enteric viruses and understand their genetic characteriza-tions, which would be of great significance for the prevention and control of HFMD.
9.Effect of metallothionein on the renal injury induced by chronic intermittent hypoxia in mice
Weixia SUN ; Xia YIN ; Yaowen FU ; Zhonggao XU
Chinese Journal of Nephrology 2014;30(5):384-388
Objective To investigate the mechanism of chronic intermittent hypoxia (CIH)-induced renal injury and the protection of metallothionein (MT).Methods 8-10 weeks old male MT-1 transgenic (MT-TG) mice (n=12) and the wide type (WT) mice (n=12) were randomly divided into two groups respectively,Air mimic control(Ctrl) group (n=6) and CIH group (n=6).The period of chronic intermittent hypoxia was continued for 8 weeks.The CIH paradigm consisted of 20.9% O2 and 8% O2 fraction of inspiration O2 (FiO2) alternation cycles (30 episodes per hour) with 20 seconds at the nadir FiO2 for 12 hours/day during daylight.The nadir hemoglobin oxygen saturations mainly ranged from 60% to 70%.Urine,blood,kidney were collected at the end of study respectively.Histopathology,Western blotting and colorimetric method for related target were performed respectively.Results In WT mice,renal fibrosis,the expression of connective tissue growth factor (CTGF),type-1 plasminogen activator inhibitor (PAI-1),hypoxia-inducible factor 1α (HIF-1α),transforming growth factor β1 (TGF-β1),phosphorylated Smad2 and the MDA content were significantly increased by CIH (P < 0.01).In WT mice,the expression of MT detected by using Western blotting was significantly decreased by CIH (P < 0.01).However,in MT-TG mice,above-mentioned indicators showed no significant difference between CIH and Ctrl group.Conclusions Oxidative stresses is the main mechanism of CIH-induced renal injury.The possible molecular mechanism of CIH-induced renal injury is that CIH increases the expression of HIF-1α in kidney tissue,then activate the TGF-β1-Smad2 signaling pathway and lead to the renal fibrosis.The protection of MT on CIH-induced renal injury may be via its antioxidant effect.
10.The application of delayed skin grafting combined traction in severe joint cicatricial contracture.
Zihan XU ; Zhenxin ZHANG ; Benfeng WANG ; Yaowen SUN ; Yadong GUO ; Wenjie GAO ; Gaoping QIN
Chinese Journal of Plastic Surgery 2014;30(6):424-427
OBJECTIVETo investigate the effect of delayed skin grafting combined traction in severe joint cicatricial contracture.
METHODSAt the first stage, the joint cicatricial contracture was released completely with protection of vessels, nerves and tendons. The wound was covered with allogenetic skin or biomaterials. After skin traction for 7-14 days, the joint could reach the extension position. Then the skin graft was performed on the wound. 25 cases were treated from Mar. 2000 to May. 2013.
RESULTSPrimary healing was achieved at the second stage in all the cases. The skin graft had a satisfactory color and elasticity. Joint function was normal. All the patients were followed up for 3 months to 11 years with no hypertrophic scar and contraction relapse, except for one case who didn' t have enough active exercise on shoulder joint.
CONCLUSIONDelayed skin grafting combined traction can effectively increase the skin graft survival rate and improve the joint function recovery.
Biocompatible Materials ; therapeutic use ; Cicatrix, Hypertrophic ; Combined Modality Therapy ; methods ; Contracture ; surgery ; Female ; Humans ; Male ; Recovery of Function ; Recurrence ; Skin Transplantation ; methods ; Tendons ; Traction ; methods ; Wound Healing

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