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The quarantine inspection and acceptance of laboratory animals is an important work, which can protect animals from pollution, occurrence and spread of diseases in the surounding area, and it is the key point to realize the quality standardization of laboratory animals.Beagle dogs are acknowledged widely as specialized laboratory dogs which is widely employed in experiments of drug safety evaluation because of the good genetic stability, environmental adaptability, disease resistance and consistency testing in the experiments.Establishment of standard operating procedures of beagle dog quarantine acceptance check for drug GLP organization tests, refining technical points, strengthen the technical training of quarantine officers, and efforts to improve the level of quarantine are needed to finally ensure the quality of laboratory animals.
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Objective:To establish the bacterial endotoxin test method and the abnormal toxicity test method for reduced glutathi -one for injection.Methods:According to the requirements and methods in Chinese Pharmacopoeia (2015 edition, part IV), the bacte-rial endotoxin test and the abnormal toxicity test for reduced glutathione were studied .Results:The limit of bacterial endotoxin for re-duced glutathione was 0.125 EU· mg-1 , and the limit of abnormal toxicity was 1.0 g· kg-1 .Conclusion: The bacterial endotoxin test method and the abnormal toxicity test method are feasible .The abnormal toxicity should be supplemented in the quality standard for reduced glutathione , and the bacterial endotoxin test can replace the pyrogen test .
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Objective:To establish the criterion of bacterial endotoxins test for hemocoagulase atrox for injection and measure the endotoxin concentration in hemocoagulase atrox for injection by the kinetic turbidimetric technique. Methods:The limit of bacterial en-dotoxins in the product was designed according to ChP 2010. Four endotoxin concentrations were prepared to obtain the standard curve. The interfering test was done by measuring the concentration of endotoxin added into the sample solution. The endotoxin concentration in the sample solution was measured. Results:The absolute value of the correlation coefficient was 0. 988 6 (must be above or equal to 0. 980), suggesting the standard curve was valid. The recovery of the added endotoxin in the sample solution was within 50 to 200%when the concentration of the product sample was 0. 25 KU·ml-1 . The measured endotoxin concentration in the sample met the re-quirements for bacterial endotoxins. Conclusion:The bacterial endotoxins assay method for milrinone injections is established, and the kinetic turbidimetric technique is suitable for the bacterial endotoxin test of the product.
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Objective To study the interference of Huangyangning Injection in bacterial endotoxin test and to establish bacterial endotoxin test method for this specimen.Methods According to China Pharmacopoeia 2000,inhibition or en-hancement test for bacterial endoto xins test was carried out for Huangyangning Injection.Results l ∶150solution of Huangyangning Injection had no inte rference on the test.Conclusion Reliable data and result are obtained and bacterial endotoxin test method for Huangyangning Injection has been established.
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AIM To observe the effects of the combination of heparinoid, aspirin and losartan on the experimental vascular intima hyperplasia induced by squeezing carotid artery in rats. METHODS Rats except the normal control group were under operation after two days oral administration once a day. At the second hour after injury, blood coagulation time(CT), time of arterial thrombus formation by electrical stimulus(ATFTES) and the level of TXB_2 in plasma were measured. At the fourteenth day after the surgery, the following indexes were examined: intima/media ratio, intima area ratio, PDGF-B and PCNA immunohistochemistry in carotid artery. RESULTS CT, TATFES increased and the level of TXB_2 decreased in the groups of Hep, Asp and Hep+Asp. The PDGF-B content, the positive ratio of PCNA and the inti- ma/media ratio also decreased in the groups of Hep, Asp, Los, Hep+Asp, Hep+Los and Asp+Los. Compared with single drug or two drugs combination, PDGF-B, positive ratio of PCNA, intima/media ratio and intima area ratio decreased significantly in the group of three drugs combination( P