| 高纯度胰岛素的研制与临床试用 |
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| 引用本文： | 杨继虞,方芳,祝小元,邓尚平,周文碧,熊中云.高纯度胰岛素的研制与临床试用[J].四川大学学报(医学版),1991(2). |
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| 作者姓名： | 杨继虞 方芳 祝小元 邓尚平 周文碧 熊中云 |
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| 作者单位： | 药学院生物化学教研室
(杨继虞，方芳，祝小元)，华西医大临床免疫中心
(邓尚平，周文碧)，华西医大临床免疫中心(熊中云) |
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| 基金项目： | 卫生部及商业部资助课题 |
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| 摘 要： | 胰岛素制剂的免疫原性与其纯度密切相关。作者研制的高纯度胰岛素(HP-I)其主要大分子杂质胰岛素原、胰高血糖素和胰多肽的含量分别为76.00、2.11和0.11ppm。产品的纯度显著优于国产普通结晶胰岛素,并超过国外单峰胰岛素(SP-I)的质量标准。临床试用结果,病人血清中胰岛素、胰岛素原和胰多肽等三种特异抗体的阳性率分别为37.5％、0％和0％。其免疫原性也明显低于国产普通结晶胰岛素、接近丹麦单组分胰岛素(MC-I,Nordisk)的水平。
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| 关 键 词： | 高纯度胰岛素 胰岛素原 糖尿病 免疫原性 |
The Preparation or Highly Purified Insulin and Its Clinical Use |
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| Yang Jiyu,Fong Fang,Zhu Xiaoyuan,Deng Shangpin,Zhou Wenbi,Xing Zhongyun.The Preparation or Highly Purified Insulin and Its Clinical Use[J].Journal of West China University of Medical Sciences,1991(2). |
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| Authors: | Yang Jiyu Fong Fang Zhu Xiaoyuan Deng Shangpin Zhou Wenbi Xing Zhongyun |
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| Institution: | Yang Jiyu,Fong Fang,Zhu Xiaoyuan,Deng Shangpin,Zhou Wenbi,Xing Zhongyun Department of Biochemistry,School of Pharmacy Clincal Immunological Centre Insulin Cooperative Study Group |
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| Abstract: | Antigenicity of insulinpreparations is obviously related to theirpurity. The average contents of proinsu-lin. glucagon and pancreatic polypeptidein highly purified insulin (HP-I) producedby us are 76.0, 2.11 and 0.11 ppm respec-tively. These results are superior to thosefor domestic conventional crystalline insu-lin and single peak insulin (SP-I). The antibodies to insulin, proinsulinand pancreatic polypeptide in erum wereexamined in 24 diabetic patients treatedwith HP-I for more than 6 months. Thepositive rates for the above three antibod-ies were 37.5%, 0% and 0% respectively.the results showed that the antigenicityof HP-I was much lower than that of do-mestic conventional crystalline insulin andalmost the same as that of MC-I fromNordisk, Denmark. |
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| Keywords: | Highly purified insulin Proinsulin Diabetes Antigenicity |
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