Application of polymerase chain reaction in quality control of biological products
10.13200/j.cnki.cjb.004530
- VernacularTitle:聚合酶链式反应法在生物制品质量控制领域中的应用
- Author:
ZHAO Xuan
- Publication Type:Journal Article
- From:
Chinese Journal of Biologicals
2025;38(07):843-849
- CountryChina
- Language:Chinese
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Abstract:
Polymerase chain reaction(PCR) is a technique for rapid amplification of nucleic acid fragments in vitro, which has a high degree of specificity, stability and reliability, and has an increasingly broad application prospect in the field of pharmaceutical quality control. This paper summarizes the main applications of PCR technology in the quality control of biological products at home and abroad and looks forward to its development prospects. At the same time, considerations for the national drug standard enhancement project:“revision of the PCR method in the Chinese Pharmacopoeia, Volume IV, General Notices1001”were proposed to strengthen quality control in pharmaceutical regulation, providing valuable references for both the revision of the Chinese Pharmacopoeia PCR method and the establishment of industrial quality control protocols.
