| 引用本文: | 李松播,王自强,邵泓,陈钢.PCR鉴定骨肽类制剂中动物源性成分[J].中国现代应用药学,2020,37(10):1203-1207. |
| LI Songbo,WANG Ziqiang,SHAO Hong,CHEN Gang.Identification of Animal-derived Components in Ossotide Preparations by PCR[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(10):1203-1207. |
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| 摘要: |
| 目的 基于分子鉴定技术建立适用于骨肽类制剂的种属鉴定方法，并对部分国内骨肽类制剂生产企业所使用的骨骼原材料的种属来源进行鉴定。方法 以骨肽生产过程中的热压提取中间体作为供试品，采用优化的CTAB法提取核酸，通过PCR扩增、琼脂糖凝胶电泳进行动物源性成分鉴定。结果 采用成功建立的适用于骨骼热压提取中间体的鉴定方法对9家企业的样品进行检测，均只检出猪源性成分，未检出牛或羊源性成分。结论 9家企业均使用猪骨作为骨肽类制剂的原材料，符合相关药品标准规定。 |
| 关键词: 骨肽 生化药物 种属鉴定 聚合酶链式反应 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.10.009 |
| 分类号:R927.11 |
| 基金项目:上海市科学技术委员会科研计划项目（16DZ0500203） |
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| Identification of Animal-derived Components in Ossotide Preparations by PCR |
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LI Songbo1,2, WANG Ziqiang2, SHAO Hong2, CHEN Gang2
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1.China State Institute of Pharmaceutical Industry, Shanghai 201203, China;2.Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China
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| Abstract: |
| OBJECTIVE To establish a method based on molecular biology technology to identify animal-derived components in ossotide preparations, and the species of bone raw materials used by some domestic ossotide preparations enterprises were identified. METHODS The intermediate in the process of ossotide preparations was taken as the sample, and nucleic acid was extracted by optimized CTAB method. The animal-derived components were identified by PCR amplification and agarose gel electrophoresis. RESULTS The samples from 9 enterprises were identified by the method successfully established for ossotide extraction intermediate, and only pig source components were detected, no cattle or sheep source components were detected in all samples. CONCLUSION All the 9 enterprises use pig bone as raw material for ossotide preparations, which is in line with relevant pharmaceutical standards. |
| Key words: ossotide biochemical pharmaceutics species identification polymerase chain reaction |
