OBJECTIVE: To better implement Edition 2005 of China Pharmacopeia in order to ensure the safety and rationalization of drug use.METHODS:551 categories of medicinal materials and cut crude drugs in Edition 2005 of China Pharmacopeia(Volume One) was classified on the basis of descriptions of their toxin and precautions.RESULTS:10 categories were classified as extremely poisonous,37 toxic,25 slightly toxic,479 nontoxic.5 categories were classified as contraindication in pregnancy,28 prohibited in pregnancy,38 cautiously used in pregnancy.1 category was classified as prohibited for children.So_me varieties of “Eighteen incompatible medicaments” and “Nineteen medicaments of mutual antagonism” were not mentioned.CONCLUSION:Although there is only small part of categories with toxin and precautions,much attention should be paid to.The use of these materials or drugs should strictly abide by Edition 2005 of China Pharmacopeia.

Objective To detect the reactive samples of enzyme-linked immunosorbent assay (ELISA1) by chemiluminescence microparticle immunoassay (CMIA),and to analyze the application value of CMIA in HCV infection validation of blood donors.Methods Nucleic acid 3-item combined testing (NAT),another ELISA2,HCV antibody supplementary test(Western Blot test,WB) and CMIA test supplemented in blood samples of 102 ELISA1 anti-HCV reactive blood donors were retrospectively analysed.Results Among 102 blood donors of anti-HCV positive,32 cases (31.37%,32/102) were HCV RNA reactive samples,50 cases (49.02%,50/102) were ELISA2/WB reactive simultaneously.With CMIA NAT results as the reference standard,CMIA was poorly correlated with HCV RNA (Spearman correlation coefficient rs=0.395,P<0.01),and the consistency between them was weak by Kappa test (Kappa=0.270,P<0.01).With ELISA2/WB detection results as the reference standard,CMIA was highly correlated with the results(Spearman correlation coefficient rs=0.713,P<0.01),and which showed high consistency by Kappa test (Kappa=0.674,P<0.01).Conclusion CMIA as a detection method of protein label after HCV infection has great value in the HCV infection confirmation in low-risk population.

Objective To evaluated the HCV genotyping results which obtained by genotype diagnostic kit in Shenzhen area. Methods 158 samples which ELISA test of anti-HCV were positive were collected from voluntary blood donors from 2014 to 2015,and were tested by PCR fluorescence probe method for viral load.The samples which viral load were greater than 1.0 ×103 IU/mL were then tested by HCV RNA genotype diagnostic kit.To analysis the proportion of different genotypes and the correla-tion between genotypes with vrial load.Results 54 HCV RNA reactive sample were quantity by PCR fluorescence probe method from 158 anti-HCV positive samples.The genotyping data for 45 cases which vrial load greater than 1.0×103 IU/mL were obtained by HCV RNA genotype diagnostic kit.The frequencies HCV genotype 1b,2,3 and 6 were 57.78%(26/45),6.67%(3/45),8.89%(4/45)and 26.67%(12/45),respectively.One-way ANOVA analysis showed that significant difference in viral loads was found be-tween different HCV genotype 1b and 2(F =2.861,P <0.05),and there was a significant difference in viral loads and anti-HCV S/CO by sex(P <0.05).Fisher′s exact test showed the significance difference between age and genotypes(P <0.05 ).Conclusion HCV 1b and 6 were the most predominant genotypes due to the higher viral load than the other subtypes among volunteer blood do-nors in Shenzhen,while the proportion of HCV 2,3 declined.