Objective:To prepare N-trimethyl chitosan (TMC)-coated sparfloxacin (SL) nanoliposomes in situ gels(ISG)and in-vestigate the drug release in vitro.Methods:SL liposomes were prepared by a pH gradient method , and then homogenized to nanolipo-somes by high pressure .TMC was used as the coating material to prepare TMC-coated SL nanoliposomes .Poloxamer 407 was used as the gel base, and the optimal amount was selected according to the gelation temperature .TMC-coated SL nanoliposomes ISG was pre-pared using a cold method , and the morphology , size, zeta potential and entrapment efficiency of TMC-coated SL nanoliposomes were studied.A membraneless model was used to study the drug release in vitro, and the result was compared with that of TMC-coated SL nanoliposomes.Results:The optimal amount of poloxamer 407 in the formula was 25%, and the gelation temperature was 23.6℃in the artificial tears and 33 .5℃in the diluted artificial tears .The morphology of TMC-coated SL nanaoliposomes in the ISG was spherical with the mean diameter of (96.8 ±1.5) nm, zeta potential of (46.2 ±1.4) mV and entrapment efficiency of (76.6 ±2.4) %, and the indices had no significant difference when compared with those of TMC-coated SL nanoliposomes .Both the drug release in vitro and gel dissolution profile of TMC-coated SL nanoliposomes ISG exhibited the characteristics of zero-order kinetics, and compared with that of TMC-coated SL nanoliposomes , the sustained release property of the ISG was more significant .Conclusion:TMC-coated SL nanoli-posomes ISG has promising gelation temperature and notable sustained release property .

Objective To establish a method for determination of allicin(diallyl trisulfide) in the ultrafine garlic powder by gas chromatography(GC) . Methods Allicin injection was extracted by supersonic wave with a mixed solvent hexane-anhydrous ethanol(1:4) in GC by capillary column and detected by hydrogen flame ionization detector(FID) ,using nitrogen as the carrier gas. Results The peak areas were proportional to the allicin concentrations and the standard curve showed good linearity,y=190 282.5x-11 734.5(r=0.999 3) within the range of 0.30～3.00 mg/ml,the average recovery was 84.6%-98.6 % with RSD of 1.85%～3.27%. Conclusion The method is simple,accurate with good repeatability,and it is applicable to the determination of allicin in the ultrafine garlic powder.

ObjectiveTo evaluate the significance of ankler-brachial index (ABI) to predict the extent of intracranial artery stenosis in ischemic stroke patients. Methods243 ischemic stroke patients were enrolled, brain angiography were examined and all of the ABI and basic data were collected. ResultsABI≤0.9 was associated with a specificity of 84.6% and a sensitivity of 16.8% for predicting the presence of severe stenosis in intracranial artery. The area under receiver operating characteristic curve was (0.591±0.046) (P<0.05). ConclusionABI≤0.9 has a relative specificity and sensitivity for predicting the presence of severe stenosis of intracranial artery.

Objective To investigate the clinical effects,feasibility,points for attention and complications of treating distal radial fractures through minimally invasive palmar locking plate.Methods A total of 22 patients with distal radial fractures managed by minimally invasive palmar locking plate from August 2009 to August 2010 were enrolled in the study.According to AO classification,there were five patients with type A2 fractures,three with type A3,four with type B1,seven with type B3,two with type C1 and one with type C2.Two vertical or parallel palmar incisions of 2 cm long were performed.The distal transverse incision was along the proximal wrist crease,while the distal and proximal vertical incisions were close to the radial side of flexor carpi radialis.Then,palmar locking plate was inserted through deep pronator quadratus.Results Follow-up period was 10-18 months(mean,12 months).According to Dienst function evaluation criteria,the results were excellent in 13 patients,good in six,fair in three and poor in zero,with excellence rate of 86％.Complications were as follows:one patient had delayed healing of proximal wrist crease incision;one patient had numbness of thenar eminence and the symptom was disappeared three months postoperatively;two patients remained pain on ulnar side of the wrist joint;two patients had limited function of the wrist joint.Conclusions Minimally invasive palmar locking plate is safe,mini-invasive and reliable when treating distal radial fractures,which is conducive to early functional exercise.Furthermore,the method achieves satisfactory appearance of the incision which meets the minimal invasion and thus deserves clinical practice.

Objective To develop a PCR-ELISA assay for the rapid, specific and sensitive detec-tion of human seasonal influenza virus ( H1, H3 and B) by using molecular biological and immunological methods in combination.Methods The primers were designed according to the genes encoding the matrix protein ( M) , the H1 and H3 hemagglutinin ( HA) of influenza A virus and the nonstructural proteins ( B-NS) of influenza B virus and then were labeled with biotin.The PCR products were detected by ELISA by use of an internal catching probe labeled with DIG.Results The minimum copy numbers of genes encoding the M, H1, H3 and B-NS proteins detected by the established assay were 1.43?103 , 8.67?102 , 3.86?103 and 5.45?103 copies/μl, respectively, which indicated that the PCR-ELISA assay was about 10 times more sensitive than agarose gel electrophoresis in the detection of PCR products.No cross-reactions between the different subtypes of influenza virus or different species of virus were observed.Moreover, a total of 104 clin-ical specimens of influenza virus were examined by the PCR-ELISA assay, the results of which were consist-ent with those of the virus isolation method.Conclusion The newly developed PCR-ELISA assay was a highly sensitive and specific method for the rapid detection and subtyping of influenza virus, suggesting the possibility of using it in laboratory for the surveillance and detection of influenza virus.

Intellectual property protection is an indispensable management measure in the process of knowledge innovation in the National Traditional Chinese Medicine (TCM) Clinical Research Bases. Longhua Hospital, a National TCM Clinical Research Base , has actively participated in studies and construction of TCM intellectual property policy , laws and regulations , and endeavored to enhance international research cooperation and broaden the international repercussions of TCM . Longhua Hospital made great efforts to strengthen management on intel-lectual property management team and measures, advocacy training, property rights formation and transactions. Intellectual property protection played an important role in the construction of the National TCM Clinical Re-search Base in Longhua Hospital .

Objective To explore the association between the polymorphism rs671 site of the acetaldehyde dehydrogenase 2 (ALDH2) gene and H-type hypertension in the elderly in Han nationality in Qingdao.Methods Totally 406 patients aged 60-90 years with primary hypertension were randomly selected in the study.Serum levels of homocysteine(Hcy),folate and vitamin B12 were determined and all patients were divided into H-type hypertension group and non H-type hypertension group.Gene chip technology was used to analyze the ALDH2 (rs671) polymorphism,and the association between ALDH2 gene and H type hypertension was evaluated.Results Of all hypertensive participants,82.0％ (333/406) were in H-type hypertension,87.4％ (221/253) in male and 73.2％ (112/153) in female.The GA/AA genotype and A allele frequency were higher in H-type hypertension group than in non H-type hypertension group [37.2 ％ (124/333) vs.16.4 ％ (12/73) and 21.3％(71/333) vs.9.6％(7/73),P=0.001and 0.021].Serum Hcyleveland the prevalence of H type hypertension were higher in GA/AA genotype group than in GG genotype group(both P＜ 0.05).Logistic regression analysis showed that GA/AA genotype,gender (male),drinking,folate deficiency and increased systolic pressure were the risk factors for H-type hypertension (OR=3.17,2.14,2.37,0.75,1.03,respectively,all P＜ 0.05).Conclusions The genetic variation of ALDH2(rs671) may increase Hcy level by decreasing the levels of folate and vitamin B12.GA/AA genotype is a risk factor for H-type hypertension,and it contributes to H-type hypertension together with gender,drinking history,folate levels and systolic pressure.

Objective: To study the solubilization of sulfonated butyl ether-β-cyclodextrin (SBE-β-CD) and hydroxypropyl-β-cyclodextrin (HP-β-CD) for voriconazole (VCZ) to lay basis for the preparation of inclusion compounds of VCZ.Methods: The phase-solubility method was used, and the solubilization of SBE-β-CD and HP-β-CD at different concentrations for VCZ was studied at various temperatures and the inclusion constant (K) and such inclusion parameters as ΔG, ΔH and ΔS were calculated.Results: Both SBE-β-CD and HP-β-CD could improve the solubility of VCZ in water, while the solubilization of SBE-β-CD was more significant than that of HP-β-CD at the same concentration under the same temperature.The equilibrium phase-solubility diagram of SBE-β-CD vs VCZ was AN type, and that of HP-β-CD vs VCZ was AL type.With the increase of temperature, K of both β-CD decreased.ΔG, ΔH and ΔS were all negative for the inclusion process.Conclusion: Compared with that of HP-β-CD, the solubilization of SBE-β-CD for VCZ is better.The inclusion is spontaneously formed with exothermic process, and the main acting force is Van der Waals'' force.

ObjectiveTo establish the reference intervals of serum triiodothyronine (TT3),the thyroxine ( TT4 ),free triiodothyronine ( FT3 ),free thyroxine ( FT4 ) and thyroid-stimulating hormone (TSH)in the apparently healthy individuals of Beijing and Shanghai.Methods According to the requirement for laboratory support for the diagnosis and monitoring of thyroid diseases in the National Academy ofClinicalBiochemistry(NACB)laboratorymedicinepracticeguidelines, therewere 390 apparently healthy individuals tested (221 male,169 female,18 -65 years old) from Beijing and Shanghai for serum TT3,TT4,FT3,FT4 and TSH on American Beckman UniCel DXI 800 Automatic Chemiluminescent Analyzer.All markers were analyzed between gender,region,age group using t test and ANOVA.The reference intervals of all markers were determined by P2.5 - P97.5.ResultsTT3,TT4,FT3,FT4,TSH levels in the male group were ( 1.90 ± 0.32) nmol/L,( 116.77 ± 18.02) nmol/L,( 5.28 ±0.67) pmol/L,( 11.54 ± 1.97) pmol/L,( 1.92 ± 1.12 ) mIU/L,respectively,while the above indicators in the female group were ( 1.82 ± 0.32) nmol/L,( 115.73 ± 14.39 ) nmol/L,(5.04 ± 0.59 ) pmol/L,( 10.94 ± 1.45) pmol/L,( 2.37 ± 1.86 ) mIU/L,respectively.When comparing the results in genders,statistical significance was shown in TF3,FT3,FT4 and TSH of two gender groups( t =2.377,3.642,3.471,2.520,all P ＜ 0.05 ).When comparing different regions,statistical significance was only shown in FT3 ( t =6.410,P ＜ 0.05 ),in which Beijing group was (5.01 ± 0.63) pmol/L,and Shanghai group was (5.41 ±0.61 ) pmol/L,and no significant difference were shown in other four markers.Correlation analysis showed that TT4 was positively correlated with age (r =0.22,P ＜ 0.001 ) while TSH was negatively correlated with age ( r =- 0.12,P ＜ 0.05 ).TT3,TT4,FT3,FT4,TSH reference intervals were ( 1.22 - 2.50 ) nmol/L,(83.37 - 149.37 ) nmol/L,( 3.88 - 6.48 ) pmol/L,( 7.70 - 14.86) pmol/L,( 0.38 - 5.58 ) mIU/L,respectively.ConclusionDifferences of serum thyroid hormones were observed in different areas of China,It is important to establish reference intervals of the serum thyroid hormones in Chinese population.

Objective:To prepare sirolimus ( SRL) dropping pills to improve SRL solubility and dissolution. Methods:The base of SRL dropping pills was screened. The optimal formula and preparation process were also optimized by orthogonal design. The equi-librium solubility, hygroscopicity and drug release in vitro of SRL dropping pills were studied. Results: PEG6000 was chosen as the base. The optimal preparation conditions of SRL dropping pills were as follows: the ratio of SRL and base was 1∶10, the dropping speed was 65 drops/min, the dropping temperature was 95℃ and the temperature of cooling solvent was 5℃. The equilibrium solubili-ty of SRL dropping pills in different solvents was increased significantly compared with that of SRL. The hygroscopicity of the dropping pills was notable. The drug release in vitro of SRL dropping pills was similar to that of the marketed tablets with quick and complete re-lease. Conclusion:SRL dropping pills exhibit increased solubility and improved dissolution, which are valuable to be studied further.