Objective To develop and validate size exclusion column-high performance liquid chromatography(SEC-HPLC)for determination of the purity of bulk material of freeze-dried rabies vaccine for human use.Methods Chromatography column TSK-gel G6000PW_(XL)(7.8 mm × 30 cm,13 μm)was used for the determination(column temperature 30 ℃)with mobile phase of 0.1 mol/L PB buffer(pH 7.8)at a flow rate of 0.5 mL/min.The detection wavelength was 280 nm and injection volume was 20 μL.The method was validated for system suitability,specificity,precision and durability and determined for detection limit and quantitation limit,which was applied to analyze bulk material purity of freeze-dried rabies vaccine for human use of 3 batches of Vero cells and 1 batch of human diploid cells.Results The resolution of target protein spectrum peak of bulk material of reference sample and freeze-dried rabies vaccine for human use prepared with two substrates was more than 1.5 with a tailing factor less than 1.5;The blank solvent showed no absorption peak at the position of target protein peak with no interference in the determination;The RSDs of retention time and peak area in precision verification were both less than 2.0%;The quantitative limit was 10 μg/mL,and the detection limit was 4 μg/mL;The reference sample was injected three times continuously at three different detection wavelengths of 278,280 and 282 nm,and the RSDs of retention time and peak area were also less than 2.0%.The purity of 4 batches of freeze-dried rabies vaccine bulk material for human use was all more than 97%.Conclusion The developed SEC-HPLC for determination of the purity of freeze-dried rabies vaccine bulk material for human use showed good specificity,precision and durability,which provided a reliable method for the quality control of human rabies vaccine.

China ; Humans ; Infant, Newborn ; Metabolism, Inborn Errors ; diagnosis ; therapy ; Neonatal Screening ; Phenylketonurias ; diagnosis ; Tandem Mass Spectrometry

OBJECTIVE:To establish the quality standard for Qiwei kangti powders.METHODS:Radix Astragali,Angelica sinensis,Salvia miltiorrhiza were identified by TLC.The content of tanshinone Ⅱ A(the chief content in Salvia milti-orrhiza) was determined by HPLC.RESULTS:The TLC spots developed were fairly specific.Tanshinone Ⅱ A showed a good linear relationship at a range of 5.44～32.64 ?g?mL-1(r=0.999 8),and its average recovery was 99.54%(RSD=0.955%,n=9).CONCLUSION:The established quality standard is applicable for the quality control of Qiwei kangti powders.

Objective To investigate clinical characteristics of aerobic vaginitis AV) and its mixed infections for diagnosis efficiently. Methods From April 2008 to December 2008, 516 patients with vaginitis treated in Tianjin Medical University General Hospital were enrolled in this study. AV, bacterial vaginosis (BV) , vulvovaginal candidiasis (VVC), trichemonal vaginitis (TV) , and cytolytic vaginosis (CV) were diagnosed based on symptoms, sign and vaginal discharge examination. Results Among 516cases, AV cases were found in 14. 7% (76/516), and AV was common vaginal infection. AV mixed infections was diagnosed in 58% (44/76), including mixed with BV (45%, 20/44), mixed with VVC (30% , 13/44) , and mixed with TV (25% , 11/44). Those common symptom of AV were yellow vaginal discharge (63%, 20/32), more vaginal discharge (44%, 14/32). Vaginal pH value was usually more than 4. 5 (84% , 27/32). Vaginal cleanliness mainly was grade Ⅲ - V (88% , 28/32). Six cases with enterococcus faecium and 4 cases with streptococci were frequently isolated. The symptom and sign of mixed AV infection was atypical. Conclusions Aerobic vaginitis is a common lower vaginal infection and easily mixed with other pathogens, especially with BV, VVC or TV. When patients were diagnosed with AV or other vaginal infection, it should be mentioned whether those patients have mixed vaginal infection or AV.

Objective To observe the changes of malondialdehyde (MDA), superoxide dismutase (SOD-1) in serum and plasma endothelin (ET)and angiotensin II(AⅡ) in patients with severe closed head injury before and after being treated with hyperbaric oxygenation (HBO). Methods Fifty patients were recruited. Thirty-two patients were treated with HBO in addition to the conventional management (HBO group) and the other eighteen patients without HBO except for conventional management served as the controls (control group). Thirty healthy volunteers served as normal controls (normal group). Activities of MDA ,SOD-1,ET and AII were measured with spectrometry and radioimmunoassay in all the subjects, respectively, during the study. Results Before treatment, there was a significant difference between the normal group and HBO group as well as the control group in regard to the activities of the 4 parameters(P0.05) as the 4 parameters were concerned. The patients scored 3-5 with GCS in the control group were significantly different from those scored the same with GCS in the normal group in terms of the SOD-1 and MDA. Higher GCS was found in patients with low activities of MDA, ET and AII but high SOD-1 levels. Favourable changes of GCS and GOS were observed in patients in the HBO group as compared with those in the control group (P

Acute appendicitis is the most common general surgical problem encountered during pregnancy, which may be associated with serious maternal and /or fetal complications such as appendiceal perforation or premature delivery.Clinical presentation and imaging remains vital in the diagnosis of appendicitis.As a general rule,the clinical suspicion of acute appendicitis during pregnancy is an indication for an urgent surgical intervention.Appendectomy is the preferred treatment.Laparoscopic appendicectomy(LA)can also be performed safely and effectively in pregnant patients without bringing additional maternal complications.

Objective To explore the relationship between serum levels of unconjugated estriol (uE3)and human placental lacto-gen (hPL)and preeclampsia.Methods 123 cases of pregnant women diagnosed as preeclampsia were enrolled into observational group,and 1 50 cases of healthy pregnant women were enrolled into control group.Blood specimen were collected from the two groups in 28-<32 gestational weeks and 32-36 gestational weeks.Serum levels of uE3 and hPL were determined and compared between the two groups.Results The pregnancy outcomes of the control group were better than those of the observation group. With the increase of gestational age,there was increasing trend of serum levels of uE3 and hPL in the two groups.However,com-pared with the observation group,the serum levels of uE3 and hPL were higher in the control group,and the differences were statis-tically significant(P <0.05).Conclusion The decrease of serum levels of uE3 and hPL in pregnant women with preeclampsia may be associated with the pregnancy outcomes.

Adult ; Age of Onset ; Citrullinemia ; Humans

Humans ; Lysosomal Storage Diseases ; prevention & control ; therapy ; Lysosomes ; metabolism

Humans ; Polymorphism, Genetic ; Pulmonary Fibrosis ; genetics ; physiopathology ; Transforming Growth Factor beta ; genetics ; physiology