冻干粉针剂、治疗用生物制品（注射用重组人白介素-2）的生产；保健食品的生产；食品、日用化学品的销售；二类6840体外诊断试剂的生产；药品技术的开发、转让、咨询；自营和代理各类商品及技术的进出口业务（国家限定企业经营或禁止进出口的商品和技术除外）。（依法须经批准的项目，经相关部门批准后方可开展经营活动）
Objective To establish a sterility test method for thymopentin for injection (TP-5).Methods The membrane filtration method was adopted according to the provision of sterility test method in Chinese Pharmacopoeia(Edition 2010,Vol Ⅱ) ,doing methodology validation with different flushing dose,to make sure the optimal flushing dose for eliminate bacteriostasis components.Results The optimal flushing dose for eliminate bacteriostasis component was 600 ml through the verification test of 60 bottles*1 mg TP-5 for injection.Conclusion The TP-5 sterility test of using membrane filtration method is feasible and effective.
Objective To establish a method for the determination of bacterial endotoxin of lansoprazole for injection through interference test of lansoprazole for injection. Methods According to method of determination of bacterial endotoxin approved by Chinese Pharmacopoeia (Edition 2010,Vol Ⅱ) . Results The interference on the determination of bacterial endotoxin can be excluded when Lansoprazole for injection was diluted the concentration of 50μg/ml. Conclusion It is feasible to detect the bacteria endotoxin of lansoprazole for injection by the method of determination of tachypleus amebocyte lysate.
Objective:To establish the bacterial eudotoxins testing method of mycophenolate mofetil for injection (MMF).Method:Using two tachypleus amebocyte lysate(TAL)from different producers,the interference test of MMF was conducted according to bacteria endotoxin test in China Pharmacopeia 2005,second section.Result:The density of diluted solution of MMF has reached 0.625 mg·mL~(-1)will not interfere with bacteria endotoxin test.The limitation of bacteria endotoxin was 0.4 EU·mg~(-1).Conclusion:Bacteria endotoxin test is accurate and suitable for detection of bacteria endotoxin in mycophenolate mofetil for injection.
To establish a method for the determination of acetonirrile residue in Recombinant Human Interleukin-2,the head-space GC method was used with PEG-20000 Quartz Capillary column(30 m×0.25 mm×0.25 μm),high pure N2 as carrier gas and FID detector.Acetonirrile showed good linearity in the range of 1.014～5.070 μg/mL in sample solution(r=0.997 3).The average recovery rate was 97.2 %(RSD=2.8%).The minimum detective limit of acetonirrile was 0.6 μg/mL.This method is sensitive,repeatable and easy to operate and is suitable for determining acetonitrile residual of recombinant human interleukin-2.
Three lots of shaker tests were conducted in a 2 L flask. To observe the influence of the different culture time,the density of bac terium and the different induction time on the yield of the recombinant bacteria l strain and the recombinant human brain natriuretic peptide(BNP) expression. Af ter recombinant bacterial strain was cultured at 37℃ for 3～3.5 h, the g r owth density (OD 600) of bacterium was 0.8～1.0. As the recombinant bac t erium strain was induced and cultured with IPTG for 4 h, the yield of the wet weight of bacterium and the BNP protein expression would be more satisfactory. The average wet weight of the bacterium and the BNP protein expression were 10.3 g/L fermented liquid and 25.8%, respectively.It is the same as the report of data abroad(8～10 g/L fermented liquid and 25%). Before the induction, the d i fferent bacterium density and after,the different induction time can significant ly influence the yield of BNP recombinant bacterium strain and the BNP protein e xpression.
