The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People’s Republic of China in July 2020.The current edition w...The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People’s Republic of China in July 2020.The current edition was officially implemented on December 30,2020.The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines,which are the common requirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia.Owing to adherence to the principles of scientificity,versatility,operability,and sustainable development,there is an improvement in the general chapters of the 2020 edition over those of the previous editions.Further,the application of advanced and mature analytical techniques has expanded,the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened,and technical requirements are now better harmonized with international standards.The updated edition provides technical and methodological support to ensure safety,effectiveness,and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technologies,improving the quality control of medicines,and strengthening the means of drug regulation in China.This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.展开更多
Nanosilver particles are used in various clinical settings because of their antibacterial properties.However,their safety evaluation when used for gynaecological disorders has not been established.Nanosilver particles...Nanosilver particles are used in various clinical settings because of their antibacterial properties.However,their safety evaluation when used for gynaecological disorders has not been established.Nanosilver particles were administrated in the vagina of New Zealand rabbits,and the pathological appearance of the surrounding tissue was examined by hematoxylin–eosin staining and transmission electron microscopy(TEM)after 1 and 3 days of treatment.The nanosilver content was assessed by plasma mass spectrometry,and the presence of particles in the hepatic portal vein blood was assessed by TEM.The results of our study show that the vaginal administration of nanosilver particles caused ultrastructural changes to the vaginal mucosa,urethra and rectum,with accumulation of particles in all tissues.These results demonstrate a new migration route of nanosilver particles following vaginal administration.They also demonstrate,for the first time,that the vaginal administration of nanosilver particles can enter the blood circulation system by examining the hepatic portal vein blood under the TEM which is the most direct visualized evidence.展开更多
基金financial support from the Chinese Pharmacopoeia Commission Drug Standard Promoting Funds and Comprehensive Reform of the Chinese Drug and Medical Device Review and Approval System Funds(2015e2020)。
文摘The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People’s Republic of China in July 2020.The current edition was officially implemented on December 30,2020.The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines,which are the common requirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia.Owing to adherence to the principles of scientificity,versatility,operability,and sustainable development,there is an improvement in the general chapters of the 2020 edition over those of the previous editions.Further,the application of advanced and mature analytical techniques has expanded,the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened,and technical requirements are now better harmonized with international standards.The updated edition provides technical and methodological support to ensure safety,effectiveness,and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technologies,improving the quality control of medicines,and strengthening the means of drug regulation in China.This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.
基金Funding This research is funded by Science and Technology Support Program of National 12th Five Year Plan(grant number:2012BAI22B01).This project is investigation and safety evaluation of medical devices with high-risk level。
文摘Nanosilver particles are used in various clinical settings because of their antibacterial properties.However,their safety evaluation when used for gynaecological disorders has not been established.Nanosilver particles were administrated in the vagina of New Zealand rabbits,and the pathological appearance of the surrounding tissue was examined by hematoxylin–eosin staining and transmission electron microscopy(TEM)after 1 and 3 days of treatment.The nanosilver content was assessed by plasma mass spectrometry,and the presence of particles in the hepatic portal vein blood was assessed by TEM.The results of our study show that the vaginal administration of nanosilver particles caused ultrastructural changes to the vaginal mucosa,urethra and rectum,with accumulation of particles in all tissues.These results demonstrate a new migration route of nanosilver particles following vaginal administration.They also demonstrate,for the first time,that the vaginal administration of nanosilver particles can enter the blood circulation system by examining the hepatic portal vein blood under the TEM which is the most direct visualized evidence.