Re-evaluation of bioequivalence of generic drugs is one of the key research focus currently. As a means to ensure consistency of the therapeutic effectiveness of drug products, clinical bioequivalence has been widely accepted as a gold standard test. In vitro dissolution testing based on the theory of the BCS is the best alternative to in vivo bioequivalence study. In this article, the conventional dissolution method and flow-through cell method were used to investigate the dissolution profiles of domestic amoxicillin capsules in different dissolution media, and the absorption behavior of the drugs with different release rates (t85% = 15-180 min) in the gastrointestinal tract was predicted by Gastro Plus. The flow-through cell method was thought better to reflect the release characteristics in vivo, and amoxicillin capsules with regard to the release rates up to 45 min (t85% = 45 min) were having a satisfied bioequivalence with the oral solution according to the C(max) and AUC. Although two different dissolution profiles of domestic amoxicillin capsules were found by flow-through cell methods, prediction results revealed that domestic capsules were probably bioequivalent to each other.
Amoxicillin ; pharmacokinetics ; Capsules ; Computer Simulation ; Gastrointestinal Tract ; Humans ; Software ; Solubility ; Therapeutic Equivalency

Powder X-ray diffraction (PXRD) technology combined with cluster analysis method was used to classify 75 batches of crystalline ceftriaxone sodium into subtypes, the crystalline characteristics of each subtype were measured with scanning electron microscope (SEM). By comparing some parameters of these subtypes correlated to crystallization process of ceftriaxone sodium, such as salification rate, water content in different subtypes, as well as by studying different lattice stabilities, different compatibilities with rubber closures during accelerated stability tests, the key point to improve the quality of domestic ceftriaxone sodium was disclosed. The results of this paper indicated that the fine structure of the products could be controlled well by improving the salification and crystallization process. As a result, the subtype II of ceftriaxone sodium with high stability can be produced.
Ceftriaxone ; chemistry ; classification ; Crystallization ; Microscopy, Electron, Scanning ; Powders ; Water ; X-Ray Diffraction

OBJECTIVETo investigate the effect of sea cucumber cerebroside(SCC) and its long-chain base(LCB) on lipid and glucose metabolism in obese mice.

METHODSThe mouse obese model was established by feeding high fat diet. The mice were randomly assigned to 4 groups: control group, model group, SCC group and LCB group. After 4 weeks, the glucose tolerance test was undertaken. After 5 weeks, the body fat content, organic indexes, serum lipid level, glycemic index and liver lipid level were determined.

RESULTSCompared with the model group, the glucose tolerance in the SCC group and LCB group was ameliorated significantly (P<0.01, P<0.05); glycemic index (P<0.01, P<0.01), the weight of adipose tissue (P<0.05, P<0.01) and the hepatic TG were reduced significantly (P<0.05, P<0.05).

CONCLUSIONSea cucumber cerebroside and its long-chain base can improve the glucose and lipid metabolism in obese mice.

Animals ; Blood Glucose ; metabolism ; Cerebrosides ; pharmacology ; Lipid Metabolism ; Lipids ; blood ; Male ; Mice ; Mice, Inbred C57BL ; Mice, Obese ; Obesity ; blood ; drug therapy ; Sea Cucumbers ; chemistry

Objective To investigate the dynamics and development trends of drinking water type of endemic fluorosis after water improvement in Xinbaerhuyouqi of Hulunbeir city, Inner Mongolia and to provide a scientific evidence for the development of countermeasures. Methods We mainly selected Adunchulusumu and Kerlunsumu in Xinbaerhuyouqi of Hulunbeir city as the two monitoring points after water improvement in 2000 -2009. Of these, 1 sample of centralized water supply source water and 3 samples of tap water and 5 samples of noncentralized water supply source water according to water well locations of east, west, south, north and center were collected and the levels of water fluoride were tested; the prevalence of dental fluorosis of school children aged 8 to 12 were examined; from 2002 onwards, the urine samples of 30 children aged 8 to 12(five age groups, six urine samples for each age group) were collected, and all urine samples were collected in the case of less than 30, and urine fluoride was tested. Dental fluorosis was diagnosed using Dean method; water fluoride was tested using fluoride ion selective electrode(WS/T 106-1999); urinary fluoride was tested by determination of fluoride in urine using ion-selective electrode(WS/T 89-1996). Results In 2000 - 2009, the mean levels of fluorine in drinking water in Adunchulusumu and Kerlunsumu were 1.79 - 4.35 mg/L and 1.38 - 3.18 mg/L, respectively; the detection rate of dental fluorosis of children aged 8 to 12 were 45.24％(19/42) - 89.78％(123/137) and 40.00％ (28/70) - 74.47％ (70/94), respectively; the median urinary fluoride of them were 2.30 - 4.15 mg/L and 2.73 - 4.55 mg/L, respectively. ConclusionsThe detection rate of children's dental fluorosis remains high in Xinbaerhuyouqi during the past 10 years after changing water. The endemic fluorosis remains a serious disease. Effective prevention and control measures must be taken to control the occurrence of fluorosis in the future.

Objective To establish a method to determine the contents of total flavonoids and shikimic acid in pine needles of Pinus massoniana Lamb.in Wudang Area.Methods Rutin was used as reference standard,and the content of total flavonoids in pine needles of Pinus massoniana Lamb. was determined by UV spectrometry at wavelength of 500 nm. The content of shikimic acid was determined by HPLC-DAD. The Fortis Xi C8 column (5 μm, 250 mm × 4.6 mm) was adopted with acetonitrile - 0.4% phosphoric acid solution (8:92, V/V) as mobile phase at the flow rate of 0.9 mL/min. The detection wavelength was 213 nm; the column temperature was 30 ℃; the injection volume was 20 μL. Results The linear range was 8.26-49.54 μg for rutin (r=0.999 4) with an average recovery of 99.2%, RSD=1.94%. The linear range was 10.26-61.56 μg for shikimic acid (r=0.999 4) with an average recovery of 99.5%,RSD=1.93%.The contents of total flavonoids in pine needles of Pinus massoniana Lamb.was 28.33 mg/g, and shikimic acid was 15.25 mg/g, respectively. Conclusion The method is simple, rapid, accurate and reproducible. It can be used for the content determination of total flavonoids and shikimic acid in pine needles of Pinus massoniana Lamb. in Wudang Area.

0.05)in the former part of the surgery that was before the beginning of the surgery via anterior route.But in group B,only propofol for sedation was used for the patients during the latter part of the surgery via the anterior route or while the nerve plexus was blocked; during this time in group A,the addition of fentanyl and vecuronium were still intermittently necessary to maintain the general anesthesia.The duration between the completion of surgery and the recovery of spontaneous breathing,times for initial conscious reaction such as opening the eyes following an order, extubation and from extubation to complete recovery were significantly shorter in group B than those in group A(all P

Objective To investigate the feasibility of rat sodium/iodide symporter (rNIS) as a reporter gene monitoring rat bone marrow mesenchymal cells (rBMSC) transplanted to rat myocardium in vivo.Methods Recombinated adenovirus vector was constructed by rNIS/enhanced green fluorescence protein (EGFP) (Ad-rNIS/EGFP).rBMSC transfected by Ad-rNIS/EGFP were studied using fluorescence microscope.Fifteen rats were transplanted with rBMSC and randomly divided into three groups:rNIS group (with rNIS transfection), blocked group (with rNIS transfection) by oral intake of perchloric sodium before planar imaging(GE Millennium MPR SPECT), and control group (without rNIS transfection).All rats underwent 99Tcm-pertechnetate planar imaging.The biological distribution of 99Tcm-pertechnetate was studied.The expressions of rNIS gene and protein in myocardium were measured by real time polymerase chain reaction (PCR) and western blot, respectively.The expressions of CD29, CD44, CD90, CD11b, CD34 and CD45 were measured by immunohistochemistry.Results rBMSC transfected by Ad-rNIS/EGFP showed EGFP expression under fluorescence microscope.The transplanted rat myocardium could be visualized on 99Tcm-pertechnetate planar imaging in rNIS group.The relative uptake ratio( Rheart/Rhmb, RUR) was 6.7 ±0.4.RUR in control group (3.0 ±0.2) was lower than that in rNIS group (t =2.78, P=0.03).The percentage injection dose per gram of tissue (% ID/g) of the transplanted myocardium was 60.2 ± 20.8 in rNIS group,which was higher than that (2.5 ± 0.4) % ID/g of control group ( t = 7.13, P＜0.001 ).rNIS gene and protein were highly expressed in transplanted myocardium in rNIS group but less expressed in control group.The expressions of CD29, CD44 and CD90 were positive, CD45 and CD45 negative CD11b mildly positive in the myocardium transplanted with infective rBMSC.Conclusion rNIS can efficiently monitor rBMSC transplanted to rat myocardium.

Objective To investigate the prognostic sequelae in neontes with hypoxic-ischemic encephalopathy (HIE) and ven-tricnlar dilatation.Methods Seventy-six full term newborns infants with HIE were followed up at the age from 3 to 19 months after therapy. Twenty-five infants among them were followed up by telephone in the epidemic period of SARS.Results Among 76 infants of 88 newborn infants with HIE(84.6%), 73 infants were normal (96.1% ). 1 infant had cerebral palsy (1.3%), 2 infants died (2.6 %).Among 39 cases with mild HIE, none of them had cerebral sequelae; among moderate HIE. 1 infant had cerebral palsy (2.9%) 1 infant died (2. 9 %), interlenkin-4 among severe HIE 50 % died (P00.5 The poor outcome of HIE in those infants were related to intrauterine growth retardation,severe birth asphyxia;and inadequate treatment.Cranial ultra-sonography of 49 infants were done on follow-up,and 12 of them (24.5 % ) had ventricular dilatations, which appeared after birth with 6 infants. Others occurred on follow-up with 1 infant had cerobral palsy,all ventricular dilatations recovered to normal at 12- 19 months except the cerebral palsy.Conclusions The poor outcome of HIE depends on the infants with intranterine growth relarda-tion,severe birth asphyxia and inadequate treatment.The prognosis of transient ventrealar ddatation are good except cerebral palsy.J Appl Clin pediatr,2004,19(12) : 1045- 1047

Amino Acids ; blood ; Amino Acids, Branched-Chain ; blood ; Capsules ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Hepatitis B, Chronic ; blood ; drug therapy ; Humans ; Liver Cirrhosis ; blood ; drug therapy ; Male ; Phytotherapy

OBJECTIVETo construct a replication-defective recombinant adenovirus expressing the ORF2 (112-660aa) antigen of hepatitis E virus (HEV) and evaluate its immunization effect in BALB/c mice by mucosal inoculation.

METHODSThe HEV ORF2 gene encoding for 112-660aa was amplified from plasmid pUC-HEV and inserted into the transfer vector pTrack-CMV. The recombinant plasmid and adenoviral backbone plasmid pAdEasy-1 were co-transformed into E. coli strain BJ5183. Taking the advantage of the high efficient homologous recombination machinery presented in bacteria, the recombinant adenovirus backbone plasmid was generated in BJ5183, and then was transfected into 293 cells. Recombinant Adenoviruses were propagated in 293 cells with high titers. 8-week-old BALB/c mice were inoculated intraperitoneally and intranasally with 10(7) pfu recombinant adenovirus each on weeks 0, 3, 5, 7, 10.

RESULTSBoth groups of mice induced humoral IgG immune response with the highest titers 1:1,000 and 1:10,000 each. Only the group inoculated intranasally could induce mucosal IgA immune response.

CONCLUSIONSThe adenoviral recombinant can stimulate specific humoral and mucosal immune response in mice and is potentially to be used as a candidate vaccine for the treatment of HEV infection.

Adenoviruses, Human ; genetics ; Animals ; Hepatitis Antigens ; genetics ; immunology ; Immunoglobulin A ; immunology ; Immunoglobulin G ; immunology ; Male ; Mice ; Mice, Inbred BALB C ; Nasal Mucosa ; immunology ; Peritoneum ; immunology ; Recombinant Proteins ; biosynthesis ; genetics ; immunology ; Viral Hepatitis Vaccines ; Viral Proteins ; biosynthesis ; genetics ; immunology