Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review

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.

Development of chromatographic technologies for the quality control of Traditional Chinese Medicine in the Chinese Pharmacopoeia

As an important branch of medicine, Traditional Chinese Medicine(TCM) has been applied for the treatment of diseases for thousands of years in China and other countries in East Asia. The Chinese Pharmacopoeia(ChP) is a drug code formulated by the Chinese government, and it includes a special volume for the monographs of TCM, which plays an important role in ensuring the quality of drugs. The use of quality control technology has always been a complex and important factor in TCM. Owing to the chemical diversity of TCM, chromatography technology has been proven to be a comprehensive strategy for the assessment of the overall quality of TCM and has become the main analytical method in the ChP.This article provides an overview of the classical and modern chromatographic technologies applied in the ChP, and summarizes the advantages and disadvantages of each technique in the TCM monographs.In 2020, the new edition of the Ch P(the 2020 edition) has been implemented at the end of 2020. This paper also contains a brief introduction about the application of chromatographic technologies in the new edition of the ChP.

Discrimination of polysorbate 20 by high-performance liquid chromatography-charged aerosol detection and characterization for components by expanding compound database and library

Analyzing polysorbate 20(PS20)composition and the impact of each component on stability and safety is crucial due to formulation variations and individual tolerance.The similar structures and polarities of PS20 components make accurate separation,identification,and quantification challenging.In this work,a high-resolution quantitative method was developed using single-dimensional high-performance liquid chromatography(HPLC)with charged aerosol detection(CAD)to separate 18 key components with multiple esters.The separated components were characterized by ultra-high-performance liquid chromatography-quadrupole time-of-flight mass spectrometry(UHPLC-Q-TOF-MS)with an identical gradient as the HPLC-CAD analysis.The polysorbate compound database and library were expanded over 7-time compared to the commercial database.The method investigated differences in PS20 samples from various origins and grades for different dosage forms to evaluate the composition-process relationship.UHPLC-Q-TOF-MS identified 1329 to 1511 compounds in 4 batches of PS20 from different sources.The method observed the impact of 4 degradation conditions on peak components,identifying stable components and their tendencies to change.HPLC-CAD and UHPLC-Q-TOF-MS results provided insights into fingerprint differences,distinguishing quasi products.

Revision and Improvement of Criterion on Traditional Chinese Medicines in Chinese Pharmacopoeia 201 5

Chinese Pharmacopoeia is updated every five years, of which traditional Chinese medicine （TCM） is the most important part. The 2015 version completed by the 10th Pharmacopoeia Commission has come into operation since December 1, 2015. Here we introduced the revision and improvement of quality evaluation and control standards of TCMs in Chinese Pharmacopoeia 2015.

Genome-wide pan-GPCR cell libraries accelerate drug discovery

G protein-coupled receptors(GPCRs)are pivotal in mediating diverse physiological and pathological processes,rendering them promising targets for drug discovery.GPCRs account for about 40%of FDA-approved drugs,representing the most successful drug targets.However,only approximately 15%of the 800 human GPCRs are targeted by market drugs,leaving numerous opportunities for drug discovery among the remaining receptors.Cell expression systems play crucial roles in the GPCR drug discovery field,including novel target identification,structural and functional characterization,potential ligand screening,signal pathway elucidation,and drug safety evaluation.Here,we discuss the principles,applications,and limitations of widely used cell expression systems in GPCR-targeted drug discovery,GPCR function investigation,signal pathway characterization,and pharmacological property studies.We also propose three strategies for constructing genome-wide pan-GPCR cell libraries,which will provide a powerful platform for GPCR ligand screening,and facilitate the study of GPCR mechanisms and drug safety evaluation,ultimately accelerating the process of GPCR-targeted drug discovery.

Overview of the quality standard research of traditional Chinese medicine

Traditional Chinese medicine(TCM)has been widely used for the prevention and treatment of various diseases for a long time in China.Due to its proven efficacy,wide applications,and low side effect,TCM has increasingly attracted worldwide attention.However,one of the biggest challenges facing the clinical practice of TCM is the uncontrollable quality.In this review,the progress of the development and the current status of quality standard as well as new quality control techniques introduced in Chinese Pharmacopoeia(2010 edition),such as liquid chromatography hyphenated mass spectrometry(LC-MS),fingerprint,quantitative analysis of multi-components by single-marker(QAMS),thin layer chromatography bio-autographic assay(TLC-BAA),and DNA molecular marker technique,are briefly overviewed.

A microRNA encoded by HSV-1 inhibits a cellular transcriptional repressor of viral immediate early and early genes

Viral microRNAs are one component of the RNA interference phenomenon generated during viral infection. They were first identified in the Herpesviridae family, where they were found to regulate viral mRNA translation. In addition, prior work has suggested that Kaposi＇s sarcoma-associated herpesvirus （KSHV） is capable of regulating cellular gene transcription by miRNA. We demonstrate that a miRNA, hsvl-mir-H27, encoded within the genome of herpes simplex virus 1 （HSV-1）, targets the mRNA of the cellular transcriptional repressor Kelch-like 24 （KLHL24） that inhibits transcriptional efficiency of viral imme- diate-early and early genes. The viral miRNA is able to block the expression of KLHL24 in cells infected by HSV-1. Our dis- covery reveals an effective viral strategy for evading host cell defenses and supporting the efficient replication and prolifera- tion of HSV- 1.