单采猪血浆的质量研究

研究单采猪血浆的质量情况,为建立猪血浆的质量标准提供参考依据。参照中国药典、欧洲药典及猪源性生物制品相关要求检测血浆的外观、pH、渗透压、总蛋白含量、枸橼酸盐含量、钠钾钙离子含量、是否无菌以及对猪细小病毒进行PCR检测方法的建立与应用。结果显示单采血浆外观正常,渗透压、总蛋白含量、枸橼酸盐含量、钾离子、钙离子、钠离子分别为315±34 mOsnlol/kg、53.7±3.2 g/L、15.98±4.88 mmol/L、3.00±0.45 mmol/L、2.35±0.38 mmol/L、151.3±22.4 mmol/L,检测结果均符合人血浆制品或者人血浆标准,但pH 7.81±0.21,其与人血浆规定含量稍有差异。单采血浆样品中只有1个样品检出细菌阳性。建立了猪细小病毒特异敏感的PCR检测方法,检测结果显示单采猪血浆猪细小病毒阳性率为0。实验为单采猪血浆质量基本符合现有人血浆或血浆制品质量标准。

Study on the Quality of Apheresis Porcine Plasma

To analyze and study the quality of apheresis porcine plasma. Visual check, pH, osmolality, content of total protein, sodium citrate, biochemical indicator ,sterility test were detected of apheresis porcine plasma,with the reference to the Chinese Pharmacopoeia, European Pharmacopoeia and related requirements of porcine source biological products. PCR method for the determination of porcine parvovirus(PPV) was developed. Apheresis porcine plasma varied in colour from yellow to light yellow. The mean value of all the sample of osmolality, total protein, sodium citrate and concentration of potassium, sodium and calcium were 315.25±34.06 mOsmol/kg, 53.75±3.23 g/L, 15.98±4.88 mmol/L, 3.00±0.45 mmol/L, 2.35±0.38 mmol/L, 151.31±22.44 mmol/L, which were up to the standards of human plasma. The mean value of pH was 7.81±0.21, which was above the standard of human plasma. Only one sample of apheresis porcine plasma contained bacteria. The developed PCR method had good sensitivity and specificity. By the method, no PPV was detected in all samples. The quality of apheresis porcine plasma corresponded basically with the standards of human plasma or human blood products.