Objective To establish the 3rd national standard for un-fractionated heparin for National Institutes for Food and Drug Control(NIFDC).MethodsFour candidate heparin samples(code ampoule 1,2,3,4)were assayed against the International Standard(07/328)and National Standard(150509-200912).Jiangsu Institute for Food and Drug Control(JSIFDC)determined the potency of anti-FXa and anti-FIIa by chromogenic substrate methods and the potency of anticoagulation by whole rabbit blood of Chinese Pharmacopoeia(2015).Results All of the data from our institute were adopted to calculate the 3rd national standard for un-fractionated Heparin.NIFDC analyzed the data from 13 laboratories.The geometric coefficient of variation of inter-laboratory and intra-laboratory were both below 10％.Conclusion Approved by the national drug standards material Committee,the candidate(140817-201501)was recommended to be the 3rd national standard for un-fractionated Heparin with an assigned value of 2011IU per ampoule.

Objective To compare the license issuance and status of administration of laboratory animals in Jiangsu and Zhejiang provinces in the last five years, and to study the status of laboratory animal license management and industry development level in the two provinces.Methods Taking a combination of current status investigation, literature search, information collection and comparative analysis, to study the similarities and differences in the annual issuance of laboratory animal licenses, level of environmental facility, type of institution division, regional distribution of institutions, etc.in the two provinces over the last five years.Results Over the past five years, the total number of the issued laboratory animal licenses and approved institutions in Jiangsu province are significantly more than in Zhejiang province.The proportion of barrier environmental facilities in Jiangsu is slightly higher than that in Zhejiang.Laboratory animal institutions cover most areas of the provinces, relatively concentrated in the capital cities and economically developed cities.The business type institutions account for the highest percentage in the two provinces.Animal species in the two provinces are approximately the same.Conclusions The industrial structure of the laboratory animals in Jiangsu province is more perfect than that in Zhejiang province.Industrialization and socialization get a higher degree in Jiangsu province.The range of regular species of the laboratory animals needs to be further expanded.The competent departments need further optimize and promote license management system of the laboratory animals.

Objective To evaluate the sensitizations of Hydroxyethyl Starch 40 Sodium Chloride Injection . Methods Active systemic anaphylaxis ( ASA) test, internal sensitive index ' s determination and screening and Passive Cutaneous Anaphylaxis ( PCA) test are carried out .Observe the allergy safety of the samples .Results We use guinea pigs to carry on ASA test and PCA test with Hydroxyethyl Starch 40 Sodium Chloride Injection from 45 batches of 3 companies and no changes have occurred .Measuring and comparing the sensitive index of HIS ,IgG, IgM and IgE in plasma, IgM and IgE are not obvious variation;HIS and IgG positive group and negative group and sample groups are different .Conclusions It is suggestion that Hydroxyethyl Starch 40 Sodium Chloride Injection safety evaluation should include allergic reactions , HIS and IgG sensitive index monitoring in clinical application of hydroxyethyl starch .