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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。
To study the quality of single pig plasma, to provide a reference for the establishment of pig plasma quality standards. With reference to the requirements of Chinese Pharmacopoeia, European Pharmacopoeia and pig-derived biological products, the appearance, pH, osmotic pressure, total protein content, citrate content, sodium-potassium-calcium content, plasma sterility and PCR Establishment and Application of Testing Methods. The results showed that the appearance of apheresis plasma was normal. The osmotic pressure, total protein content, citrate content, potassium ion, calcium ion and sodium ion were 315 ± 34 mOsnlol / kg, 53.7 ± 3.2 g / L and 15.98 ± 4.88 mmol / L, 3.00 ± 0.45 mmol / L, 2.35 ± 0.38 mmol / L and 151.3 ± 22.4 mmol / L respectively. The results were in line with human plasma or human plasma, but the pH value was 7.81 ± 0.21, which was slightly different from that of human plasma . Only one sample in the apheresis plasma was positive for the bacteria. A porcine parvovirus-specific PCR assay was established. The results showed that the positive rate of porcine plasma parvovirus was 0. Experiments for the piglet plasma quality basically consistent with existing human plasma or plasma product quality standards.