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.

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 .

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.

Animals ; Humans ; Influenza A virus ; genetics ; immunology ; Influenza Vaccines ; administration & dosage ; genetics ; immunology ; Influenza, Human ; prevention & control ; virology ; Vaccines, Virus-Like Particle ; administration & dosage ; genetics ; immunology

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.

Antineoplastic Agents ; adverse effects ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Neoplasms ; drug therapy ; Ondansetron ; therapeutic use ; Phytotherapy ; Vomiting, Anticipatory ; drug therapy

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

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.

Age Factors ; Endometrial Hyperplasia ; pathology ; Endometrial Neoplasms ; pathology ; Endometrium ; cytology ; pathology ; Female ; Humans ; Menstrual Cycle ; Papanicolaou Test ; Postmenopause ; Vaginal Smears

Objective To analyze the clinical characteristics of infants with functional constipation(FC)relating to food allergy(FA)and explore its ways of diagnosis and therapy.Methods The detail clinical information of the patients who corresponded to the criteria of diagnosis of FC and FA simultaneous from Mar.2007 to Dec.2009 were reviewed and analyzed.There were 496 cases of FA,in the FA joint clinic,gastroenterology clinic and pediatric ward,56 cases of them had the symptoms of FC(56/496 cases,11%),diets free and amino acid-based formulae were the treatments of the patients.The 56 cases were analyzed with skin-prick test(SPT),serum special IgE and serum special IgG,and the risk factors attributed to the no response to treatments with Logistic regression.Results Fifty-six cases opened the bowel less than twice a week,and companied with pain,8 patients with soiling once a week at least,10 patients with fecal retention,4 patients with large fecal in rectum.Mother or father with the history of allergy were 22 cases,17 cases,separately,both of mother and father with the history of allergy were 17 cases.The results of SPT,serum special IgE and serum special IgG showed that the patients with different allergens,cow's milk,egg,cod,especially.The patients with FC relating to FA were breast-feed,battle-feed or mix-feed.Treatment relied on amino acid-based formulae,as well as elimination diets in infants,80%of them(45/56 cases)improved.Introducing solid foods,the age of upsetting constipation and premature were the risk factors contributed to the no response to the diet free treatment.Conclusion FA should be consi-dered to contribute to the infants presenting with FC.Diets free and amino acid-based formulae may be effective.