The quality management of drug research,development,registration,production and marketing strengthened by good practice for pharmaceuticals ensure the drag safety,effectiveness and quality control.Teaching of new drug research and evaluation in compliance with good practice for pharmaceuticals will be of value in making teaching content close to actual work,extending the students'knowledge and training student's good habits in scientific study.

OBJECTIVE:To establish the quality standards for Fufang ningshen granule. METHODS:TLC was used for the qualitative identification of Radix angelicae and White paenoy;HPLC was adopted for the contents determination of spinosin and verbascoside:the column was Kromasil C18 with the mobile phase of acetonitrile-0.1% acetic acid(16∶84,V/V)at a flow rate of 1.0 ml/min,detection wavelength was 330 nm,column temerpature was 30 ℃. RESULTS:The TLC spots of R. angelicae and W. pae-noy were clear with good separation,negative control without interference. The linear range was 0.055 44-0.277 2μg for spinosin(r=0.999 4)and 0.055 98-0.279 9 μg for verbascoside(r=0.999 5);RSDs of precision,stability and reproducibility tests were lower than 3.0%;recoveries were 95.62%-100.53%(RSD=1.77%,n=9) and 95.63%-102.57%(RSD=2.74%,n=9). CONCLU-SIONS:The standard can be used for the quality control of Fufang ningshen granule.

ObjectiveTo investigate the clinical,myopathological and molecular changes in two Chinese families with oculopharyngodistal myopathy ( OPDM).MethodsWe performed muscle biopsy and histopathologic study on the probands of two families,and further examined molecular genetic testing on PABPN1 and GNE gene. Results Family 1 included 3 affected brothers in the same generation and family 2 involved 4 patients in 2 generations. Dysarthria rather than external ophthalmoplegia was the prominent oculopharyngeal symptoms for Chinese patients. No intranuclear inclusions were observed in ultrastructural examination.The number of GCG repeats in the PABPN1 gene was within normal range and no mutations were identified in the GNE gene.ConclusionsFamily 1 is the first publication on autosomal recessive OPDM in China.The age of onset of two families was comparable with Japanese patients and the pattern of muscle involvement was different. OPDM is a distinct phenotypical,histological,and genetic entity.

Objective To explore the mucosal healing quality of hydrotalcite combined with esomeprazole in gastric ulcer.Methods Forty-two patients visiting from June 2014 to December 2015 and diagnosed with gastric ulcer were selected and divided into combination therapy group and single therapy group with 21 patients in each group.The patients of combination therapy group received esomeprazole combined with hydrotalcite,and the patients of single therapy group received esomeprazole alone.The total therapeutic course was eight weeks.At the same period,21 health check-up participants were enrolled as normal control group.The healing of gastric ulcer was observed under white light endoscopy.The morphological changes of gastric pits and microvessel of mucosal at peripheral mucosa around ulcer and normal gastric mucosal were observed under narrow band imaging magnifying endoscopy.The gastric mucosa tissues of the two groups before and after treatment,and normal gastric mucosa of healthy control group were taken.The amount of deposition and composition of collagen fibers,the expression level of factor Ⅷ,the level of transforming growth factor (TGF)-beta1 and the content of hydroxyproline were analyzed by Masson,immunofluorescent and immunohistochemistry staining as well as enzyme linked immunosorbent assay.Chi square test,one-way analysis of variance (ANOVA),least significant difference (LSD) method,Dunnett's T3 and Kruskal-Wallis test and other method were used for comparison.Results After treatment,18 patients of combination therapy group (21 patients) had regular microvessel nets (85.7％),which was significantly more than those of single therapy group (12 cases,57.1％) and healthy control group (10 cases,47.6 ％),and the differences were statistically significant (x2 =4.200,P=0.040).In the comparison of maturity of regenerative mucosa between combination therapy group and single therapy group after treatment,the ration between collagen type Ⅰ and Ⅱ,deposition of collagen fibers,the number of factor Ⅷ positive cells,the level of TGF-beta1 and the content of hydroxyproline were 36.05 and 23.14;269 375.63.± 171 608.63 and 137 693.14±98 330.93;34.91±8.40 and 28.24±6.93;104 498.71±40 487.96 and 70 757.11±19 323.95;(1 897.80±879.35) and (1 230.57±536.05) μg/L,respectively;while in healthy control group,the above parameters were 36.81,245 696.90 ± 224 687.00,23.10 ± 8.40,94 048.04 ±41 306.55 and 1 681.20 ± 423.61 μg/L,and the differences were statitically significant among these three groups (H=7.375,F=3.465,11.680,5.190,5.160;all P＜0.05).Those parameters of combination therapy group were significantly higher than those of single therapy group (H=2.416,LSD method;all P＜0.05).Conclusion Hydrotalcite combined with esomeprazole in the treatment of gastric ulcer could significantly improve microvessel morphology,maturity degree of regenerative mucosal structure and function,and the mucosal healing quality was also superior to single esomeprazole group.

Objective To investigate the number and activation status of circulating mucosal associated invariant T (MAIT) cells in patients with sepsis.Methods Flow cytometric method was used to determine the number and percentage of MAIT cells and their expression of activation molecule CD69.Results The circulating MAIT cells dropped significantly at early stage of sepsis in septic patients.The MAIT cells in the sepsis group continued to express high levels of CD69 on day 1 and day 3 after admission to ICU.Conclusions Remarkable decrease of circulating MAIT cells may portend the possibility of sepsis in patients with severe infection.

Objective To investigate the influence of total progressively motile sperm count(TPMSC) after treatment on clinical outcomes of intrauterine insemination(IUI) with the husband′s sperm in ovulation-promoting cycles.Methods The clinical data in 4179 cases undergoing IUI with the husband′s sperm in ovulation-promoting cycles were retrospectively analyzed.The correlation between clinical pregnancy rate and TPMSC was analyzed.Results Among all the clinical data,TPMSC was to 100×106 in occasional live sperm.TPMSC<0.15×106 was in 15 cases,1 case had pregnancy (live sperm was occasionally seen on IUI day after sperm processing).Ten cases of TPMSC >60×106 had no pregnancy.A total of 4 154 cases of TPMSC (0.15-60.00)×106 were analyzed.The female age,duration of infertility,number of follicles and endometrial thickness(EDM) had no statistical differences among various groups.The clinical pregnancy rate was 13.5%(576/4 154),the group with the highest clinical pregnancy rate was (5.00-<10.00)×106.But there was no statistically significant difference in clinical pregnancy rate among groups(P=0.133).Conclusion Performing IUI in PMSC (0.15-60.00)×106 after processing can get preferable pregnancy rates.

Objective To investigate the clinical effects of the Viscoat viscoelastic combined with soft corneal contact lens for central corneal perforation.Methods Six cases were collected and treated with corneal local debridement of which diameter were less than 2.0 mm.Six cases received Viscoat viscoelastic injection into their anterior chamber.And then soft corneal contact lens were worn.The curative effect indicators such as patients' symptom,visual acuity,slit lamp examination,intraocular pressure,confocal microscope and corneal endothelial cell counts were recorded in the follow-up periods.Results All the cases were healed with the recovery time of 1 month to 2 months;After treatment,the best corrected visual acuity of patients were increased to 0.6-0.8 and average corneal endothelial cell count was (3415.5 ±279.5)mm-2.No obvious scar was left in the cornea and no serious complicatious occurred during treatment.Conclusion For traumatic corneal central perforation with diameter is 2.0 mm or less can be treated with Viscoat viscoelastic combined with soft corneal contact lens.This therapy is worthy of popularize since it's satisfied prognosis and less economic burden.

Objective To evaluate permissive hypocaloric intake in postoperative patients by a prospective, randomized, controlled trial. MethodsForty-two postoperative patients were randomly assigned to receive 117kJ?kg~ -1?d~ -1in control group, and 75kJ?kg~ -1?d~ -1in experimental group intravenously. Blood routine, liver and renal functions were measured one day before and day 1, 3, 5 post operation. Blood glucose level, insulin intervention, infectious complications, hospital stay, and relevant cost were also evaluated. ResultsHypocaloric intake in the experimental group post-operatively did not influence the hemoglobin level, liver function, and other indicators in the serum. The fasting blood glucose and glucose levels after infusion, as well as the volume of insulin intervention were significantly higher in the control group during 4 days of parenteral nutrition. Experimental group had lower relevant hospital cost, while two groups had similar duration of hospital stay. ConclusionPermissive hypocaloric intake shortly after surgery does not influence the patient nutritional status, besides it avoids to some extent the hyperglycemia, reduces the need for insulin intervention .

Objective To investigate the effect of Ulinastatin, a urinary trypsin inhibitor on the outcome of patients undergoing liver resection. Methods In this prospective, randomized, and controlled clinical study, 42 patients undergoing hepatectomy were randomly divided into treatment group and control group. In treatment group Ulinastatin was given on the day of surgery and the three consecutive days. Blood was tested for biochemistry. ResultsSerum ALT and AST levels in treatment group were significantly lower than those in control group 12 hours post-operation, especially in patients undergoing multisegmentectomy. Difference became insignificant at the time point of 60 hours post-operation. Administration of Ulinastatin resulted in faster decrease of serum bilirubin level in patients undergoing small volume hepatectomy, and no effect on coagulative function was observed. Conclusions The protective effects of urinary trypsin inhibitor exist mainly in early stage of major liver resection.

Objective To study the effect of urinary trypsin inhibitor (UTI) on the release of inflammatory media and oxidation reaction and the mechanism by which UTI protects postoperative liver function following hepatectomy. Methods This was a prospective, randomized, controlled clinical trail, in which cases undergoing hepatectomy were divided into control group (n = 15) and treatment group (n = 15). UTI was administered beginning the day of operation and three days post-op consecutively in the treatment group. Serum CD4, CD8, C-reactive protein(CRP), and gene expressions of IL-1, Il-6, TNF-alpha, iNOS were measured. Results TNF-alpha and iNOS levels significantly decreased in treatment group compared with control 12 hours after surgery (0. 053?0. 02 & 0. 12?0. 04 vs. 0. 084?0. 01 & 0. 21?0. 02, all P