1. Evaluation of bioequivalence of sirolimus capsules in healthy Chinese male volunteers
Chinese Pharmaceutical Journal 2012;47(4):296-299
OBJECTIVE: To evaluate the bioequivalence of domestic sirolimus capsules and commercially available sirolimus oral solution in healthy Chinese volunteers. METHODS: Twenty-two healthy Chinese male volunteers were enrolled and orally administered 5 mg sirolimus capsules or oral solution randomly. The concentrations of sirolimus in whole blood were determined by LC-MS/MS. RESULTS: The pharmacokinetic parameters of sirolimus capsules and oral solution were as following: ρmax(26.62 ± 9.97) and (25.28 ± 5.98) ng · mL-1; tmax(2.27 ± 0.55) and. (1.91 ± 2.33) h; t1/2 (73.07 ± 13.81) and (65.49 ± 17.00) h; AUC0-t (372.3 ± 146.2) and (368.2 ± 275.0) ng middot; h middot; mL-1, AUC0-∞ (466.8 ± 194.3) and (442.3 ± 324.4) ng middot; h middot; mL-1, respectively. The relative bioavailability F0-t was (112.4 ± 34.61)% and F0-∞ was (117.2 ± 39.93)%. Two-sided t-test of ρmax, AUC0-t and AUC0-∞ indicated that the preparations were equivalent, and non-parametric test showed that sirolimus capsules had larger tmax than the reference preparation with a significant difference (P < 0.05). CONCLUSION: The domestic sirolimus capsule is bioequivalent to the marketed sirolimus oral solution with significantly different tmax. Copyright 2012 by the Chinese Pharmaceutical Association.
2.Determination of Schaftoside in Jinshaniu Huashi Tablets by HPLC
Zai LIU ; Li ZHANG ; Huizhen KUANG ; Mingguo DONG
China Pharmacist 2016;19(6):1224-1225
Objective:To establish an HPLC method to determine the content of schaftoside in Jinshaniu Huashi tablets .Meth-ods:The separation was performed on an Agilent ZORBAX SB-C18 column(150 mm ×4.6 mm, 5 μm)with 0.2% phosphoric acid-acetonitrile as the mobile phase with gradient elution at a flow rate of 1.0 ml· min-1 .The detection wavelength was set at 272 nm, and the column temperature was set at 25 ℃.Results: The calibration curve of schaftoside had a good linearity within the range of 4.58-183.15 μg· ml-1(r=1.000 0).The average recovery was 99.65%with RSD of 1.09%(n=6).Conclusion:The established method is simple and accurate with high repeatability , which can be used for the content determination of schaftoside in Jinshaniu Hua-shi tablets .
3.Detection and clinical significance of circulating tumor cells and circulating tumor vascular endothelial cells in gastric cancer
Jianming ZHANG ; Zai LUO ; Zhongmao FU ; Tengfei LI ; Yan YANG ; Yuan ZHANG ; Chen HUANG
Chinese Journal of General Surgery 2021;36(4):281-285
Objective:To analyze the role of preoperative circulating tumor cell(CTC) and circulating tumor vascular endothelial cells (CTEC) in the diagnosis of gastric cancer and its correlation with the clinicopathological characteristics of gastric cancer.Methods:Sixty-two gastric cancer patients and 11 patients of benign gastric diseases were enrolled. Subtraction enrichment (SE) and immunofluorescence staining-chromosome fluorescence in situ hybridization (i·FISH) were used to integrate the unique SE-i ·FISH technology platform detecting patients′ CTC and CTEC.Results:The number of CTC in the gastric cancer group was significantly higher than that in the control group ( t=2.693, P=0.009); the number of CTEC in the gastric cancer group was higher than the control group ( t=2.015, P=0.048). With the cut-off value being set at 9 cells/6 ml in blood, the sensitivity of CTC in the diagnosis of gastric cancer is 84%, and the specificity is 82% (AUC=0.876, 95% CI, 0.792-0.963, P<0.01); When set at 6 cells/6 ml, the sensitivity of CTEC in the diagnosis of gastric cancer is 50%, and the specificity is 100%(AUC=0.727, 95% CI, 0.603-0.851, P=0.02). CTC positive is closely related to tumor location(χ 2=4.292, P=0.038 ) and TNM stage(CTC≥10, χ 2=4.848, P=0.028; CTC≥11, χ 2=6.234, P=0.013). CTEC positive is closely related to serum CA19-9(χ 2=4.858, P=0.028) and serum CA724 (χ 2=4.108, P=0.043 ) . Conclusion:SE-i·FISH technology has high sensitivity and specificity in the detection of CTC and CTEC of gastric cancer.
5.Experimental study on effect of jiangya maijing liquid on spontaneous hypertension rats fed with high lipid diet.
Li HUANG ; Zai-xiang SHI ; Jiu-liang ZHANG
Chinese Journal of Integrated Traditional and Western Medicine 2002;22(7):528-530
OBJECTIVETo observe and identify the effect of Jiangya Maijing Liquid (JYMJL) on spontaneous hypertension rats (SHR) fed with high lipid diet in antagonizing hypertension and hyperlipidemia and improving pathological changes of kidney.
METHODSForty-two SHR were divided into 5 groups, except Group A, the Groups B-E were fed with high lipid diet, and Group C, D and E was treated with JYMJL, western drug and Niuhuang Jiangya pill respectively. Besides, Group F was set up for control with normal rats fed by normal diet. The changes of blood pressure (BP), biological indices and renal pathology were observed in the 14 weeks' period of observation.
RESULTS(1) BP raised significantly in Group A and B, it became stable in Group C from the 5th week on and was lower than the BP in other groups (P < 0.01). BP in Group F was not changed; (2) The highest level of nitric oxide (NO) was shown in Group F, and that in Group B and E was lower than that in Group C and D; (3) Level of cholesterol was lower in Group A and F than that in Group C, D and E (P < 0.01), and that in Group C was lower than that in Group B and E (P < 0.01 and P < 0.05 respectively); (4) Pathologic examination on kidney showed that no change was found in Group F, the most severe change was shown in Group B among Group B-E, and the improvement after treatment in Group C was better than that in group B (P < 0.01).
CONCLUSION(1) Condition of disease in rats with hypertension complicated with hyperlipidemia was more severe than that with simple hypertension; (2) JYMJL could restrain the developing of hypertension in SHR, the mechanism may be related with the raising of NO; (3) JYMJL has effect of lowering blood lipid; (4) JYMJL has kidney protective effect, it could alleviate the pathological changes in kidney by way of lowering BP and blood lipid.
Animals ; Antihypertensive Agents ; pharmacology ; Dietary Fats ; administration & dosage ; Drugs, Chinese Herbal ; pharmacology ; Female ; Hyperlipidemias ; etiology ; pathology ; Hypertension ; complications ; pathology ; Hypolipidemic Agents ; pharmacology ; Kidney ; pathology ; Male ; Phytotherapy ; Rats ; Rats, Inbred SHR ; Rats, Inbred WKY
8.A Method for Total DNA Extraction of Sludge Samples from Full-scale Wastewater Treatment Bioreactors
Su ZHANG ; Chun LIU ; Jing-Liang YANG ; Jian-Bo GUO ; Zai-Xing LI ;
Microbiology 2008;0(10):-
According to the characteristics of sludge samples from full-scale wastewater treatment bioreac-tors, the essential total DNA extraction method for most environmental samples, lysozyme-SDS-phenol/ chloroform method, was modified to improve sample pretreatment, intensify cell lysis and enhance the effi-ciency of impurity removal. Obtain a general total DNA extraction method for industrial sludge samples. Such a method was applied for total DNA extraction of sludge samples from several running full-scale an- aerobic or aerobic bioreactors in Shijiazhuang, China. The results indicated that the modified method was suitable for all the sludge samples in this study, showing the satisfying generality. The extracted total DNA of all sludge samples were pure, with about 1.8 of A260/ A280 ratio. The method was also efficient; with average total DNA yield of over 0.7 mg/g and maximum yield of 0.85 mg/g. Moreover, all the extracted to- tal DNA samples could serve as templates directly to amplify 16S rDNA by PCR. The PCR products could be separated well by denaturing gradient gel electrophoresis (DGGE) and the DGGE band patterns were clear enough to be used for further analysis. All these facts indicated that the total DNA extraction method provided in this study could meet the requirements of sludge samples research, from full-scale wastewater treatment bioreactors, using molecular biology technologies.
9.Over-expression and purification of the recombinant p30 antigen of Toxoplasma gondii
Dianbo ZHANG ; Defu ZAI ; Maoqing GONG ; Jin LI ; Qingkuan WEI ; Yong CUI ; Bingcheng HUANG ; Keyi LIU
Chinese Journal of Zoonoses 2005;(12):1089-1093
To provide the basis for preparation of diagnostic kits and vaccines in Toxoplasma gondii infection, the gene coding for the qualified recombinant p30 protein (SAG1) of this parasite was amplified by PCR, and the amplified gene was cloned into prokaryotic expression vector pET-30a(+) to construct the recombinant plasmid, and then transformed to E.coli DH5α. The positive recombinant plasmid was screened by PCR and double enzymes digestion, and the nucleotide sequence of p30 gene was determined by automated DNA sequencing. Meanwhile, the identified recombinant plasmid was transformed to E.coli BL21(DE3) with the expression of p30 on bacteria induced by IPTG and the expressed protein was identified by SDS-PAGE. The protein obtained was then further purified and refolded, and its biological activity was checked by Western blotting. It was shown that the size of the amplified gene was 750 bp with molecular weight of 30 ku, and this protein could specifically react with monoclonal antibody against p30 protein.
10.Genetic and biofilm phenotypic characterization of Candida albicans strains isolated from infectious disease patients
Lyuyin HU ; Jianping QIU ; Bei ZHANG ; Xiangnan HU ; Shubei ZAI ; Jianghua ZHENG ; Min LI
Chinese Journal of Laboratory Medicine 2016;39(3):210-214
Objective To study the molecular epidemiology of C.albicans isolates in infectious disease patients and to explore biofilm phenotypic characterization responsible for biofilm formation in clinical strains.Methods A total of 104 hospital-acquired C.alibcans clinical isolates collected from sterile sites and mucosal lesions of 92 infectious disease patients ( viral hepatitis, tuberculosis and AIDS) in Shanghai Public Health Clinical Center were analyzed.MLST analysis was performed to identify their phylogenetic status.The capability of biofilm formation was measured by [2,3-bis-(2-methoxy-4-nitro-5-sulphenyl)-2H-tetrazolium-5-carboxanilide] XTT assay.The results were compared using Kruskal-Wallis test.Results MLST analysis identified 63 DSTs with a decentralized phylogeny among 104 C.albicans isolates, of which 41 DSTs (65.1%) had not been reported in the online MLST database.The Single Locus Sequence Query from the C.albicans database identified new alleles.MEGA6 analysis of the MLST data assigned the 104 isolates within 14 of the 18 known clades; among them the clade 1 contained the greatest proportion of isolates (26.9%).Of the 43 novel DSTs isolates, 37 ( 86.0%) clustered within 11 of the 18 known clades.16 high biofilm formers were found from a total of 104 clinical isolates.The biofilm formation capabilities differed in strains isolated from different anatomical sites (H =18.23,P=0.0326).Biofilm formation by blood-originated isolates was lower than that of catheter-originated isolates ( Z=-72.20,P<0.001).Genotypes also affected the biofilm formation capability of the C.albicans isolates (H=10.01,P=0.0185).Conclusions A high level of diversity within C.albicans isolates.Microevlution clearly influences C.albicans genetic alterations upon environmental selection.The site of isolation and genotype associates with the biofilm formation capability.