1.Bacterial Endotoxin Test for Huangy angning Injection
Genglun ZHANG ; Zhiyun FAN ; Qingfen ZHU
Traditional Chinese Drug Research & Clinical Pharmacology 1993;0(01):-
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.
2.Biological Safety Test Methods for Reduced Glutathione for Injection
Na LIU ; Xia WEI ; Fengjia ZHENG ; Chunfang WANG ; Qingfen ZHU
China Pharmacist 2016;19(6):1208-1211
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 .
3.Daily intake and concentrations of 15 kinds of rare earth elements in foods for adult men in four areas in China
Quan WU ; Qingfen LIU ; Tiqiang FAN ; Hongda ZHU
Chinese Journal of Radiological Medicine and Protection 2013;(2):166-169
Objective To obtain the concentrations and daily intakes of 15 rare earth elements in foods for adult men in four areas in China.Methods With duplicate portion study,120 mixed diet samples were collected from adult men in cities of Tianjin,Chengdu,Zhenjiang and Taiyuan,which belong to 4 areas with different dietary types in China.The concentrations of cerium,dysprosium,erbium,gadolinium,lanthanum,lutetium,holmium,neodymium,praseodymium,scandium,samarium,terbium,thulium,yttrium and ytterbium in these samples were determined by Inductively Coupled Plasma Mass Spectrometry(ICP-MS) after pretreatment,and the daily intakes of them were also calculated.Results The concentrations of 15 rare earth elements and their daily intakes in foods for adult men were obtained.Conclusions The concentrations of these elements in each area are consistent with normal distribution.The total rare earth element concentration in the diet of adult men ranges from 24.68 to 109.27 μg/g.The daily intake of total rare earth elements is about 24 μg/d.Reference values of the rare earth element concentrations in the diet and daily intake of Chinese adult men were updated.
4.Detection of Bacterial Endotoxin in Hemocoagulase Atrox for Injection by Kinetic Turbidimetric Assay
Guojin WANG ; Gang CHEN ; Juan ZHANG ; Jiansong QU ; Qingfen ZHU
China Pharmacist 2014;(4):684-685
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.
5.Effects of combined use of heparinoid,aspirin,and losartan on the experimental vascular intima hyperplasia in rats
Liyan PANG ; Xubin ZHOU ; Lixiang WANG ; Qingfen ZHU ; Hongyan XU
Chinese Pharmacological Bulletin 1986;0(05):-
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
6.Main technical points of quarantine inspection of Beagle dogs used for drug GLP experiment
Changhua SUN ; Yi LIU ; Ying XIAO ; Xia WEI ; Qingfen ZHU
Chinese Journal of Comparative Medicine 2017;27(6):63-67
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.
7.Prenatal diagnosis of chromosome abnormalities and nine microdeletion syndromes using both traditional karyotyping and BoBs
Xinhua TANG ; Bicheng YANG ; Shu ZHU ; Jie SU ; Jinman ZHANG ; Yifei YIN ; Yan FENG ; Dongmei LI ; Qingfen ZHAO ; Rui YU ; Baosheng ZHU
Chinese Journal of Obstetrics and Gynecology 2016;51(5):325-330
Objective To evaluate a new prenatal diagnosis model of chromosomal abnormalities and nine microdeletion syndromes by using both traditional karyotyping and a newly-developed rapid prenatal diagnosis technology, BACs-on-Beads (BoBs) technique. Methods From June 2012 to December 2014, 807 pregnant women with high risk after screening or with other indicators, were performed amniocentesis. Traditional karyotyping and BoBs were employed simultaneously for prenatal diagnosis. Results Thirty-two cases with chromosome aneupoidies were successfully detected both by BoBs and karyotyping, including 18 cases of trisomy 21, 6 cases of trisomy 18, 1 case of trisomy 13, and 7 cases with sex chromosome abnormality. All 8 fetuses with chromosome structural abnormalities detected by karyotyping were missed by BoBs;while BoBs contributed more in detection of five microdeletion syndrome cases, including 3 cases of DiGeorge syndromes (two with microduplication and one with microdeletion), one case of Miller-Dieker syndrome, and one case of Wolf-Hirschhorn syndrome. Conclusion Combined use of traditional karyotyping and BoBs, is a rapid and effective prenatal diagnosis model that may enlarge our horizon on chromosomal diseases and should be widely used in future clinical service.