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Traditional Chinese medicine (TCM) are becoming more and more popular all over the world. However, quality issues of TCM may lead to medical incidents in practice and therefore quality control is essential to TCM. In this review, the state of TCM in European Pharmacopoeia are compared with that in Chinese Pharmacopoeia, and herbal drugs that are not considered as TCM and not elaborated by TCM working party at European Directorate for the Quality of Medicines & Health Care (EDQM) but present in both European Pharmacopoeia and Chinese Pharmacopoeias are also discussed. Different aspects in quality control of TCM including origins, identification, tests and assays, as well as sample preparation, marker selection and TCM processing are covered to address the importance of establishing comprehensive quality standard of TCM. Furthermore, advanced analytical techniques for quality control and standard establishment of TCM are also reviewed.

The analysis of medicinal plants has had a long history, and especially with regard to assessing a plant's quality. The first techniques were organoleptic using the physical senses of taste, smell, and appearance. Then gradually these led on to more advanced instrumental techniques. Though different countries have their own traditional medicines China currently leads the way in terms of the number of publications focused on medicinal plant analysis and number of inclusions in their Pharmacopoeia. The monographs contained within these publications give directions on the type of analysis that should be performed, and for manufacturers, this typically means that they need access to more and more advanced instrumentation. We have seen developments in many areas of analytical analysis and particularly the development of chromatographic and spectroscopic methods and the hyphenation of these techniques. The ability to process data using multivariate analysis software has opened the door to metabolomics giving us greater capacity to understand the many variations of chemical compounds occurring within medicinal plants, allowing us to have greater certainty of not only the quality of the plants and medicines but also of their suitability for clinical research. Refinements in technology have resulted in the ability to analyze and categorize plants effectively and be able to detect contaminants and adulterants occurring at very low levels. However, advances in technology cannot provide us with all the answers we need in order to deliver high-quality herbal medicines and the more traditional techniques of assessing quality remain as important today.

Chinese herbal medicines (CHMs) have unique advantages in the prevention and treatment of diseases, which are widely recognized in the world. More and more CHMs are becoming increasingly popular in the international markets. However, the quality control of CHMs is a significant issue for their acceptance and recognition in the international market. This review mainly focuses on the quality requirements for CHMs to enter the European Union (EU) market. Both Chinese and European regulations and quality controls are compared. Firstly, the EU medicinal regulatory system and relevant regulations were reviewed. Secondly, the key factors of the quality control of CHMs, including Chinese herbal drugs, extracts and products were compared with those of European herbal medicines in the EU market. Subsequently, three main registration routes for herbal medicinal products including Chinese herbal medicinal products entering the EU were introduced. Furthermore, the legal status of traditional Chinese medicine granules in the EU was also discussed. Through the comparison of the key quality factors for CHMs in China and the EU, the similarities and differences in terms of quality requirements and regulations are addressed, which provides a reference for the development of CHMs into the EU market.

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 ChP (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. [Display omitted] •An overview of the classical and modern chromatographic technologies applied in the ChP.•A discussion of the reason why each chromatographic technologies was chosen in the quality control of TCM.•Introduction of the chromatographic technologies applied in the 2020 edition of ChP.

Before 150 years the first Hungarian pharmacopoeia was compiled in 1871 as a result of nearly one century of national efforts. The first four editions were published in two languages, Hungarian and Latin. The second edition (1888) became better than the first one showing significant progress mainly in terms of speciality language.Based on the first edition Prof. Kálmán Balogh, medical doctor, published an encyclopaedic commentary, which is an unparalleled source-work of the contemporary Hungarian pharmacological literature.Geyza Karlovszky and Lajos Winkler issued a pocket edition (“Pocket Commentary”) based on the chemistry articles of the second edition of the pharmacopoeia, which became an important practical handbook of pharmacist education.

Essential oils, although they are effective due to the compounds they contain, are usually high-cost products that are obtained with low efficiency and have stability problems. Many of these oils, which can be found at various prices on the market and are claimed to be natural by manufacturers, are adulterated with other oils or synthetic substances. This study aims to provide samples of the essential oils, which are used in public, namely clove, neroli, tea tree, and cinnamon essential oils belonging to brands known to be sold widely on the market and to evaluate the compliance of these oils with the pharmacopoeia by conducting pharmacopoeia analysis. Among 25 essential oil samples evaluated with reference to the Turkish Pharmacopoeia (2017) within the scope of the study, only 2 of them were found to comply with the pharmacopoeia in terms of all tests. Investigating the compliance of essential oils with quality criteria is of great importance in preventing harm to the health of consumers and preventing them from purchasing unqualified products.

Pharmaceutical manufacturing typically uses batch processing at multiple locations. Disadvantages of this approach include long production times and the potential for supply chain disruptions. As a preliminary demonstration of an alternative approach, we report here the continuous-flow synthesis and formulation of active pharmaceutical ingredients in a compact, reconfigurable manufacturing platform. Continuous end-to-end synthesis in the refrigerator-sized [1.0 meter (width) × 0.7 meter (length) × 1.8 meter (height)] system produces sufficient quantities per day to supply hundreds to thousands of oral or topical liquid doses of diphenhydramine hydrochloride, lidocaine hydrochloride, diazepam, and fluoxetine hydrochloride that meet U.S. Pharmacopeia standards. Underlying this flexible plug-and-play approach are substantial enabling advances in continuous-flow synthesis, complex multistep sequence telescoping, reaction engineering equipment, and real-time formulation.

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. [Display omitted] •The additions and revisions of the Chinese Pharmacopoeia 2020 edition general chapters are introduced.•The applications of advanced techniques have been expanded in the Chinese Pharmacopoeia 2020 edition.•The technical requirements will be better harmonized with ICH in the Chinese Pharmacopoeia 2025 edition.

National, regional and international pharmacopoeias set standards for the quality of medicines and provide instructions for testing to ensure those standards are met. Medicines, tests, standards and methods all vary among the more than 60 pharmacopoeias currently in use. These publications were developed mainly to regulate medicine manufacturing, where safety is essential and methods are generally complex. These methods require sophisticated equipment, specific materials and high levels of skill, and can generate large quantities of pharmaceutical waste. However, pharmacopoeias are also used to guide medicine quality testing for other purposes and in other settings. Notably, they are used in post-marketing surveillance and research on medicine quality in low- and middle-income countries where the prevalence of substandard and falsified medicines is thought to be highest. Regulators and other researchers in these settings may not have access to all the equipment, materials and skills needed to follow pharmacopoeias exactly. Therefore, they often develop work-arounds, which are rarely acknowledged or described when reporting results. Our experience using modified methods for testing amoxicillin tablets in Indonesia suggests that necessary work-arounds can significantly distort study outcomes, potentially leading to misguided policy responses. We argue that standard-setting bodies should recognize challenges to testing in research and surveillance contexts in resource-constrained settings where patient safety is not at immediate risk. These bodies should provide evidence-based guidance on low-cost, environmentally sustainable modifications to industry-standard testing methods for use in these contexts. The research community must inform this guidance, providing details of modifications and their outcomes, both successful and unsuccessful.

Ginseng (Panax ginseng C. A. Meyer), a perennial herb, possesses immunostimulatory, anticarcinogenic, antiemetic, and antioxidative biological activities. In recent years, more and more people have paid attention to the extraction methods and quality evaluation of ginseng. China, the United States, Europe, Japan, and Korea have all had the quality standards and content determination methods of ginseng. The different treatment methods are adopted before the determination of ginseng samples and the content limits of the index components, such as ginsenoside Rb1, ginsenoside Rg1, and ginsenoside Re exist differences. The similarities and differences of ginseng content detection methods in pharmacopoeias of different countries have been analyzed by a research group, but the comparison of the effects of different methods on the ginsenoside content and structural transformation has not been reported. In this paper, ginsenosides in ginseng were extracted according to four national pharmacopoeias and analyzed quantitatively and qualitatively by UPLC-Q-Exactive-MS and HPLC-UV. It was illustrated that the pretreatment method has a significant influence on the content determination of ginseng. The yield of rare saponins was increased by heating concluded from both the qualitative and quantitative comparison. Finally, a simple and feasible extraction method was optimized by response surface method at room temperature. The analysis of the preparation method and process optimization of the four pharmacopoeias can provide important reference information for the revision of ginseng standards.