Fermentation is a technology,validation is a management.Technology and management could not be seperated trom each other.The basic theory of the validation was introduced,the idea of the validation was fused into the ferment technology.The idea of the validation of the ferment system was set forth the whole process of the validation of the ferment system from personal qualification,operation procotol,validation implement,and sum-up reports.It was proved that implementing validation and constructing validation system throughout ferment processing is indispensable for completing a successful fermentation.the validated fermentation system is just a dependable system,the validated ferment technique is a stable technique.

Objective To investigate the significance of human cyomeg Movirus(HCMV)pp65 IgG antibody avidity index(AI)for the clinical diagnosis of HCMV primary infection through the experimental model of HCMV primaly infection in BALB/c mice.Methods 6～8 weeks,female,specific-pathogen-free BALB/c mice were divided into 5 groups.6 mice in each group. And he mice were injected with 2×106 PFU/m1,2×105 PFU/mi,2×104 PFU/ml,2×103 PFU/ml and 2×102 PFU/ml of HCMV intraperitoneally respectively. Another 6 mice were injected intraperitoneally with the maximum dose of HCMV kept at 56℃ for 30 min as inactivated virus group.And HF negative control group was established at same time. All the mice ere sacrificed to obtain brain and lung tissues for the following experiments after 1 montll.(1)Tissue samples obtained from mice were inoculated in human embryo fibroblasts(HF)monolayers after routine treatment for virus isolation.HCMV specific eytopathie effect(CPE) was observed bv inverted phase-contrast microscopy.HCMV UL83 DNA in the ultures as tested by PCR and pp65 antigen was detected by indirect immunofluorescence.(2)Extracted mRNA from tissue samples and HCMV pp67 mRNA were analyzed by reverse transcriptase PCR(RT-PcR).(3)Immunoglobulin M(IgM)antibody and immunoglobulin G(1gG)antibody avidity Was investigated for their usefulness in distinguishing primary genital HCMV infections rom nonprimary infections with ELISA kit using truncated pp65 protein.ResultsHCMV can be isolated in the tissues from the mice injected with 2×106 PFU/ml and 2×105 PFU/m1.RT- PCR and ELISA showed positive results in the same groups.The infective rates were 100%.The analysis of the low doses groups,inactivated group and HF negative ontrol group all showed negative results.Conclusions BALB/c mice can be infected with HCMV and appeared as primary infection after1 month.Determination of HCMV pp65 IgM and HCMV p065 IgG-AI by ELISA incorporated with virus isolation and RT-PCR are helpful for distinguishing primary infections from nonpfimary infections.The detection of HCMV p65 IgM and HCMV pp65 IgG-AI by ELISA utilizing recombinant protein pp5 as antigens can be used for preliminary screening.

Objective　To investigate the effect of congenital human cytomegalovirus（HCMV） infection on the growth of embryo and cerebral cortex. Methods　HCMV (6.0 log TCID50 in 1.0 ml/mice) was separately injected into the intraperitoneum of 10-week-old female mice on pre-mating, 3, 7, 15 gestation days. Cerebral cortices of fetuses were collected by laparotomy on 19th gestation-day just before delivery. The specimens were fixed with 4% buffered solution of paraformal dehyde. And then sectioned and stained with HE. Meanwhile, part of the specimens was used for viral isolation and HCMV DNA test by PCR. Results　In the cerebral cortex of fetal mice, it was found that the capillary was dilated and congested, and the parenchyma was infiltrated with neutrophils, monocyte for experimental group and not for control group. The degeneration, necrosis and apoptosis of neurons co-existed. The rates of virus isolation for the fetal cerebral cortex among pre-mating, 3-, 7-, 15-gestation-day groups were 60%、62%、67%、25%,respectively （χ2=13.475，P＜0.05) and the rate for 15 gestation-day group was significantly lower than others. Average weight of experimental mice for 15-gestation-day was significantly lower than control group and those for other gestation groups were not significantly different on group t-test. Conclusion　HCMV can replicate in the cerebral cortex of ICR mice, infect fetal and initiate congenital infection of cerebral cortex of fetus. In addition, embryo of different gestation stages can be infected by HCMV on experiment. HCMV delays embryo growth and causes the cerebral cortex damage.

Objective:To survey the continuous change features of cusp angle in anatomic artificial teeth,and to investigate their effects on occlusal balance.Methods:28 artificial teeth of a complete denture were measured by optical three-dimensional(3D)scan-ner and the corresponding digital models were constructed using the reverse engineering software Surfacer 1 0.5.The working side cusp slopes of lateroprotrusive movement including the maxillary buccal cusp distal slopes and the mandibular buccal cusp mesial slopes were studied.The straight lines from bottom to top of cusp were constructed and the corresponding projected curves in occlusal surface were generated.The angulation values of straight line and the continuous change values of projected curve were calculated.Results:The angulation values of artificial teeth cusp inclination including straight line and corresponding projected curve were obtained.The maxillary working cusp inclination varied from 1 3.7°to 25.6°,and the mandibular working cusp inclination varied from 1 1 .3°to 37.7°.Conclusion:The relatively large differences of the cusp inclination among traditional anatomic artificial teeth and the convex form of the cusp are disadvantage factors to set up stable centric stop and unhindered chew course.

Objective To investigate the effects of valsartan on experimental left cardiac function and the vasoactive substance in rats with acute myocardial infarction (AMI).Methods Seventy Wistar rats were randomly divided into 6 group:①Sham groups: including Sham 1(n=5) and Sham 4(n=5).The pericardium of rats in Sham groups were cut open and sutured immediately.The rats were routinely breeded for 1 week and 4 weeks,1.5 mL saline was poured into stomach once a day.②Control groups: AMI 1 (n=10) and AMI 4 (n=10).Anterior descending branches of coronary artery of Wistar rats were ligated to establish models of AMI.The rats with AMI were poured into stomach with 1.5 mL saline once a day after AMI for 1 week and 4 weeks.③Valsartan groups: VAS 1 (n=10) and VAS 4 (n=10).The rats with AMI were poured into stomach with valsartan 10 mg?kg-1 and 1.5 mL saline for 1 week and 4 weeks(once a day).Cardiac function was assayed by arterial cannulatio.Angiotensin Ⅱ(Ang Ⅱ),aldosterone (ALD),endothelin (ET),thromboxane A2(TXA2) and prostacyclin I2 (PGI2) in serum were measured by radioimmunoassay.Results ① Valsartan could evidently improve cardiac function on the 1st and 4th week after experimental AMI.+dp/dtmax and-dp/dtmax were both increased on the 1st and 4th week and more evidently on the 4 week.②Compared with control groups,valsartan decreased the levels of ALD,ET and TXA2 in plasma and increased the levels of AngⅡ and PGI2 in plasma.Conclusion Valsartan could improve left cardiac function on late stage of infarction,the effect improve not only systolic function,but also diastolic function.

Objective: To realize the requirement of adjacent area accuracy,axial surface physical contour and smoothness in the process of inlay computer-aided design(CAD).Methods:A compromised method was brought forward that some assistant 3-D constraint lines from occlusion to gingiva were used to lead the inlay contour on axial corner and other characterized areas,and two perpendicular 3-D constructing lines at adjacent area were used to construct accurate 3-D configuration of this area.The axial surface was completely defined by the network of specified curves which were two constructing lines and four borders.Results:Inlay axial surface was smooth,the contour was consistent with the residual tooth body and the 3-D configuration in adjacent area was accurate.Conclusion:It is feasible to realize the inlay axial surface accuracy,smoothness,and consistency using the method of special distributed 3-D B-Spline curve network.

Objective To investigate the relationship between axon degeneration of Goll’s column system and Amyloid ? protein (A?) deposit sludge. Methods A? protein deposition in area of axon degeneration of Goll’s columns was measured by using immunohistochemical method.Results There was found strong positive round like A? deposit in the area of axon degeneration of Goll’s column system of GAD mouse. Spheroid appeared in the area of medullar nucleus of the Goll's column system at an age of 4 weeks. However the A? was negative and 9 weeks later, it became positive in partial spheroid and formed a strong round like material and became more and more standing up with age increase. The material mentioned above appeared consistently progressive in degeneration of axon in sequence.Conclusion It was suggested that the deposition of A? should be the result secondary to degeneration of nervous axon and be closely correlated with axon degeneration.

Objective:We estimated the effect of Xinxuetong on the left ventricular function in hyperten-sion. Methods :Transaortic and transmitral flow velocity was studied by pulsed Doppler echo cardiographybefore and after vein administration of Xinxuetong. Results: It was shown that Peak A, IRP andPeak A/Peak E decreased after administration of Xinxuetong. Conclusion:This study suggests that Xinx-uetong can significantly improve the diastolic function and the treatment of hypertension.

Objective To investigate the prevalence of Helicobacter pylori (Hp) infection among health checkup population in Xiamen area during 2012-2014,and evaluate the potential predictors for Hp infection.Methods A cross-sectional study was conducted among health checkup population in the Zhongshan Hospital during 2012-2014.Potential participants completed 13C breath tests for helicobacter pylori infection.An epidemiological questionnaire was used to collect data on socio-demographic characteristics,the awareness of Hp-related information,the history of gastrointestinal diseases or symptoms,life styles and relevant data for each participant.Univariate and multivariate logistic regression analyses were performed to evaluate the associations of Hp infection with potential predictors.Results Three groups of individuals with 1 631,1 766,and 5 257 persons who underwent health checkup were screened for Hp infection,and Hp prevalence was 48.9％,49.8％,and 50.5％ during 2012-2014,respectively.No significant difference in Hp prevalence was found between both sexes.A total of 1444 acceptible questionnaires were used to evaluate the associations between Hp infection and potential predictors and Hp infection was 47.9％ among 1 444 eligible participants.In the multivariate logistic regression model,Hp infection was found to be associated significantly with having ever tested for Hp infection (OR,0.67;95％CI:0.51-0.88;P=0.004),the history of stomachache or gastrectasia (OR,2.19;95％ CI:1.73-2.78;P＜0.001),and alcohol drinking (OR,1.38;95％ CI:1.11-1.71;P=0.004).The higher the severity of Hp infection,the higher the prevalence of stomachache or gastrectasia,and smoking and alcohol drinking.However,the prevalence of smoking and alcohol drinking decreased among those with the highest severity of Hp infection.Conclusion The prevalence of Hp infection in Xiamen area was slightly lower than the national Hp prevalence among natural population,but this prevalence reached 50％.The awareness rate of Hp infection was still low.The prevalence of stomachache or gastrectasia among our study population presented positive correlation with the severity levels of Hp infection.More attention should be paid to Hp screening and treatment among those with gastrointestinal diseases or symptoms.

Objective To evaluate the protective effect of Ulinastatin on pathological changes of lung induced by paraquat (PQ) intoxication in rats. Method Sixty female SD rats were randomly and equally divided into three groups ( n = 20 in each group). On the experimental day, the rats of group A (control group) received 1 mL of saline intragastrically; the rats of group B (PQ, group) received 1 mL of PQ intragastrically (40 mg/kg diluted in saline) and then treated with saline injected intraperitoneally once a day, and the rats of group Group C (Ulinastatin treatment group) received 1 mL of PQ intragastrically (40 mg/kg,diluted in saline) and then treated with 1 mL of Ulinastatin ( 120 000 IU/kg) intraperitoneally twice a day. The rats ( n = 5 in each subgroup) were sacrificed on the 7th, 14th, 21st, and 28th day for observing the histopathological changes of the lung stained with hematoxylin-eosin stain (HE) and Masson's trichrome stain. Data were semi-quantitatively analyzed by SPSS10.0 software. Hierarchical data were analyzed by rank and inspection. The data that have significance analyzed by comparison test (Bonferroni methods). Results Paraquat intoxication resulted in significant alveolitis and lung fibrosis. Ulinastatin treatment alleviated lung edema, hemorrhage, inflammatory cell infiltration, and fiber aggregation. Conclusions These data demonstrated the Ulinastatin exerted protective effects against PQ-induced lung injury. Ulinastatin could to be used in clinical management for PQ intoxication.