RECOGNITION OF THE HERBAL PHARMACOPOEIAS OF THE FRENCH OVERSEAS REGIONS AND COLLECTIVITIES

French overseas departments and territories are known for their rich and diverse tropical floras,associated with traditional health knowledge,skills,and practices.Many people find necessary to further highlight this still very much alive cultural heritage,because transmission to future generations is not assured.Official recognition of

Global Pharmacopoeia Genome Database is an integrated and mineable genomic database for traditional medicines derived from eight international pharmacopoeias

Genomic data have demonstrated considerable traction in accelerating contemporary studies in traditional medicine. However,the lack of a uniform format and dispersed storage limits the full potential of herb genomic data. In this study, we developed a Global Pharmacopoeia Genome Database(GPGD). The database contains 34,346 records for 903 herb species from eight global pharmacopoeias(Brazilian, Egyptian, European, Indian, Japanese, Korean, the Pharmacopoeia of the People’s Republic of China, and U.S. Pharmacopoeia’s Herbal Medicines Compendium). In particular, the GPGD contains 21,872 DNA barcodes from 867 species, 2,203 organelle genomes from 674 species, 55 whole genomes from 49 species, 534 genomic sequencing datasets from 366 species, and 9,682 transcriptome datasets from 350 species. Among the organelle genomes, 534 genomes from 366 species were newly generated in this study. Whole genomes, organelle genomes, genomic fragments, transcriptomes, and DNA barcodes were uniformly formatted and arranged by species. The GPGD is publicly accessible at http://www.gpgenome.com and serves as an essential resource for species identification, decomposition of biosynthetic pathways, and molecular-assisted breeding analysis. Thus, the database is an invaluable resource for future studies on herbal medicine safety, drug discovery, and the protection and rational use of herbal resources.

Physico-Chemical and Mineralogical Characterizations of Tchiky Clays (Thies, Senegal) for Pharmaceutical Uses

Our study focused on the valuation of Tchiky clays. This work aims to evaluate its properties to explore possible uses in pharmacy. Physico-chemical and mineralogical characterizations were carried out, as well as pharmacopoeial tests and an evaluation of the antioxidant activity. Thus, chemical analysis by X-ray fluorescence spectrometry gave silicon (55.65%), iron (15.73%), aluminum (13.53%), potassium (6.05%), titanium (3.98%), magnesium (2.10%), and calcium (0.82%). X-ray diffraction showed the presence of kaolinite, quartz and illite. This study also revealed that the sample studied was essentially a plastic clay of hard consistency, with average flowability. The evaluation of the antioxidant activity gave a percentage inhibition of 62.97% for a concentration of 7.5 g/l with an IC50 of 5.5 g/l. These results should allow use as an excipient in pharmacy, particularly in liquid, semi-liquid and pasty formulations.

Lesions Superimposed by Traditional Medicine on Renal Biopsies in Senegal

Traditional African medicine products are responsible for kidney damage that baffles both nephrologists and pathologists. Renal biopsies reveal acute or chronic inflammatory changes that cannot be explained by the progressive stage of the basic lesion of the nephropathy. The aim of this study is to analyze the lesions superimposed on 73 kidney biopsies from patients who took traditional herbal medications to treat the symptoms of kidney disease.

Chemo-profiling of eucalyptus and study of its hypoglycemic potential

Constant escalations in the number of diabetics worldwide and the failure of conventional therapy to restore normoglycemia without adverse effects,in spite of tremendous strides in modern medicine,calls for naturopathy and alternative medicine.Because diabetes is multi-factorial and has secondary complications,prevention of hyperglycemia is the central dogma for its management.To date,no oral hypoglycemic exists which can achieve tight glycemic control without side effects.Dietary adjuncts,lifestyle interventions and a resurgence of interest in phyto-therapy have consequently gained ground.Natural hypoglycemics have attracted attention due to ease of incorporation in everyday diet,affordability,less adverse effects,and long term safety.Ethno botanical literature reports more than 800 anti-diabetic plants species.Eucalyptus is well represented in the Aboriginal Pharmacopoeias for its various pharmacological activities.Its hot aqueous decoction has been used as a hypoglycemic in various regions of world.This editorial attempts to summarize the data on the hypoglycemic potential of the different eucalyptus species,highlight the value of its natural biomolecules for the prophylaxis and treatment of type2 diabetes,describe their mechanistic actions,shed light on the posology and safety aspects of eucalyptusand assess its applicability as a reinforcement to currently used therapy.

Review on“Long-Dan”,one of the traditional Chinese medicinal herbs recorded in Chinese Pharmacopoeia

“Long-Dan”is an important traditional Chinese medicinal(TCM)herb used widely for the treatment of inflammation,hepatitis,rheumatism,cholecystitis,and tuberculosis.In the Chinese Pharmacopoeia,the roots and rhizomes of four species from the genus Gentiana(Gentianaceae)are recorded as the original materials of“Long-Dan”,called Gentianae Radix et Rhizoma.The species included G.manshurica,G.scabra,G.triflora and G.rigescens,which are distributed in different areas of China.Though iridoid and secoiridoid glucosides were reported as the main constituents in“Long-Dan”,these four different species also resulted in different minor components,which may related to their pharmacological activities.Herein,we summarized the herbal textual study,distribution,chemical constituents,biological investigation and quality control of the recorded“Long-Dan”origins in Chinese Pharmacopoeia during the period 1960 to 2011.

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.

Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations

The aim of this study was to develop and validate a simple,sensitive,precise and cost-effective onelevel agar diffusion（5＋1） bioassay for estimation of potency and bioactivity of Levofioxacin in pharmaceutical preparation which has not yet been reported in any pharmacopoeia.Among 16 microbial strains.Bacillus pumilus ATCC-14884 was selected as the most significant strain against Levofioxacin.Bioassay was optimized by investigating several factors such as buffer pH,inoculums concentration and reference standard concentration.Identification of Levofioxacin in commercial sample Levoflox tablet was done by FTIR spectroscopy.Mean potency recovery value for Levofioxacin in Levoflox tablet was estimated as 100.90%.A validated bioassay method showed linearity（r^2 = 0.988）,precision（Interday RSD=1.05%,between analyst RSD=1.02%） and accuracy（101.23%,RSD=0.72%）.Bioassay was correlated with HPLC using same sample and estimated potencies were 100.90% and 99.37%.respectively.Results show that bioassay is a suitable method for estimation of potency and bioactivity of Levofioxacin pharmaceutical preparations.

Comparison of Sulfur Dioxide Residue in Chinese Me-dicinal Materials by Titration-fluorescence Spectrome-try and Pharmacopoeia Method

With sulphur-fumigated Chinese medicinal materials （Fritillaria thunbergii , Isatis #utigotica , Asparagus cochinchinensis and Poria cocos ） as the test materials, sulfur dioxide or sulfite residue was determined by the method in Chinese Pharmacopoeia （2015 edition） and titration-fluorescence spectrometry, respec- tively. The results showed that there were significant differences in measured value between titration-fluorescence spectrometry and phmmacopoeia method. The t result of titration-fluorescence spectrometry was much closer to the actual content of sulfur dioxide in Chinese medicinal materials. Thus, titration-fluo- rescence spectrometry had higher application value

Quality and Pharmaceutical Equivalence Determinations of Commercially Available Amlodipine Besylate Immediate Release Tablets

Counterfeit and substandard drugs possess serious health risks. Regular quality screening is very important to ensure the standard and efficacy of pharmaceutical products. The study aimed to compare the quality of amlodipine besylate tablets available in the Bangladesh drug market and examine their physical and pharmaceutical equivalence. The various physico-chemical parameters such as diameter, shape, size, weight variation, thickness, hardness, loss on drying (LOD), friability, disintegration, dissolution, and assay have been determined according to the methods mentioned in the United States Pharmacopoeia (USP) and British Pharmacopoeia (BP). Four brands of amlodipine besylate were purchased from different local retail stores and coded as ALT1, AMT2, AMT3, and AST4 on the basis of their market share. All four brands met official USP specifications. Pharmaceutical equivalence was determined from the dissolution profile which gives acceptable difference (f1) and similarity (f2) factor values for all the brands compared with the benchmark brand for its highest market share. All the brands also met the USP criteria for assay of not less than 90.0% and not more than 110.0% of the labeled amount of amlodipine (C20H25N2O5Cl).

Reflections on the Management of Preventing Interest Conflict among Pharmacopoeia Members

Objective To provide reference for strengthening the management of preventing interest conflicts among pharmacopoeia members.Methods The procedures of the United States Pharmacopoeia (USP) Committee,and the actions taken by members or experts of US food and drug administration to prevent interest conflicts were referred to analyze the problems in the management of preventing interest conflicts in China pharmacopoeia committee,and corresponding suggestions were put forward.Results and Conclusion Although the interest and risk avoidance system and dismissal measures were mentioned in the measures for the administration of Chinese pharmacopoeia commissioners,no detailed rules and specific procedures were formulated to prevent interest conflicts of Chinese pharmacopoeia commissioners.It is suggested that preventing the interest conflicts of pharmacopoeia members should be included into the drug formulation and revision system as soon as possible.In addition,the management measures for pharmacopoeia members should be further perfected to avoid the interest conflicts.The scope of publicity for the formulation and revision of drug standards should be expanded and the supervision and implementation must be strengthened.Therefore,the members of pharmacopoeia can participate in the formulation and revision of drug standards in a fair or just manner.

Challenges in Research and Development of Traditional Chinese Medicines

This review is briefly to recall the history of research and development (R&D) of Chinese materia medica (CMM) and to discuss the challenges of Chinese traditional and herbal medicines (CTHM) facing the modern science and technology. The R&D of CTHM is thought to be an important pathway for new drug discovery. Since1949, about 140 approved new drugs have been developed, among which about 80 originated directly or indirectly from medicinal plants. CTHM has gained interest from the international medical, biomedical, and pharmaceutical institutions as a valuable source of potential medicines. For the modernization of CMM and innovative research of CTHM, there are following challenges to be faced: (1) to evaluate the efficacy, pharmacological properties, action mechanism, and active chemical constituents; (2) to develop new methodologies for the quality and safety of CTHM; (3) to apply new '-omics' techniques to accelerate drug discoveries developed from CTHM; and (4) to apply international practices including good agricultural practice, good manufacturing practice, good laboratory practice, and good clinical practice in the R&D of CTHM.

Pharmacopoeia of the People's Republic of China(2010 Edition):A Milestone in Development of China's Healthcare

Compilation of the Pharmacopoeia of the People’s Republic of China (known as the Chinese Pharmacopoeia 2010) has been completed by the Ninth Chinese Pharmacopoeia Commission,which has been officially distributed in January 2010 and implemented

Medicinal plants of Chinese Pharmacopoeia and Daodi:Insights fromphylogeny and biogeography

Objective: The Chinese Pharmacopoeia(2015) includes 584 plant medicines, of which 284 also contain high quality subsets, so called "Daodi" components, where Daodi denotes superior clinical properties compared to non-Daodi counterparts despite being sourced from the same species. Commercial and clinical drivers of selection for Daodi have been described elsewhere. Our objective is to investigate the overall composition of Daodi to determine in what ways medicines with Daodi as a whole differ from the other plants of the Chinese Pharmacopoeia. A further objective is to characterise the Chinese Pharmacopoeia and Daodi in terms of the plant species including their traits and distribution.Methods: We used trait analysis to identify whether Daodi species were significantly different from the remaining Chinese Pharmacopoeia plant species in any traits. We used biogeographic methods and an existing classification of Daodi into 10 regions to identify spatial patterns amongst the species. Regression and binomial analyses were used to test for over-and under-use of plant families and endemic species.Preferences for lineages were visualized using phylogenetic mapping.Results: We found that Daodi species(species with any Daodi subset) were more likely to be roots that are "hot" or "warm", and less likely to be "oxic", according to traditional Chinese medicine(TCM) concepts. Roots were over-represented in the Bei region, and whole plants over-represented in Guang. Both the Chinese Pharmacopoeia and Daodi indicated preferences for families not common in previously studied ethnopharmacopoeias, and fewer endemic species were represented than expected by chance.Conclusion: Using the phylogenetic and biogeographical methods, we highlighted patterns of plant use,and the biological characters of Daodi medicinal plants. Our study points towards cultural preferences in need of scientific explanation.

New Collection of Crude Drugs in Chinese Pharmacopoeia 2010 II.Sankezhen(Berberis spp.)

Sankezhen(Berberidis Radix)is a traditional Chinese materia medica,cold in nature and bitter in taste,for treating syndromes of liver,stomach,and large intestinal meridians,in which berberine and berbamine are the major pharmacological components.Sankezhen has been readmitted in Chinese Pharmacopoeia 2010 following the 1977 version as the roots of Berberis spp.e.g.B.soulieana,B.wilsonae,B.poiretii,B.vernae,etc.Recent studies showed that Berberis spp.were potential phytomedicines with multiple spectrums therapeutic effects and various pharmaceutical parts.Here we reviewed Sankezhen in traditional use and phytochemistry,and its major active components berberine and berbamine with potential bioactivities recently discovered,such as antitumor,antidiabetic, antihyperlipidemic,anti-arrhythmic,and neuro-protective activities.It is necessary to mature the quality assessment of Sankezhen as a new admission of Chinese Pharmacopoeia 2010.Other parts of Berberis spp.should be investigated to better develop this herb in medicinal usage.

The Role of the European Pharmacopoeia(Ph Eur)in Quality Control of Traditional Chinese Herbal Medicine in European Member States

In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Countries which are signatories of the European Pharmacopoeia Convention. Consequently, new Ph Eur TCM herbal drug Monographs should be elaborated, based on preexisting Monographs in the Chinese Pharmacopoeia(Ch P) 2010.Such a program has been inaugurated in 2005 by the Ph Eur Groups of Experts 13 A and B(Phytochemistry). Since then good progress has been made, elaborating of about one third of the originally proposed 100 TCM herbals being identified as important monographs for the European Market. Taking into account the many challenges still laying ahead, the establishment of a specialized Working Party(WP) on TCM with specialists and experts from many EU Member States has been decided by the Ph Eur Commission in 2008 which is highly active ever since in the examination and elaboration of new TCM herbal drug monographs, primarily to assure the safety of the European patient and further to provide quality parameters extremely important for all registration and licensing procedures of the respective National Authorities all over Europe.This paper is a survey of results and difficulties obtained so far which has been encountered meanwhile in the elaboration process by the Ph Eur TCM WP of these monographs and will discuss these in detail. Moreover the role of Ph Eur TCM monographs in the European community is addressed.

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.

INTRODUCTION OF ASIAN HERBAL MEDICINES IN THE EUROPEAN PHARMACOPOEIA: RELEVANCE OF THE CURRENT ASSAY POLICY

Herbal drugs have a long tradition as medicines for the European market.They are recognized within the regulatory framework of the European Union(EU)on medicinal products like all kinds of medicines.All herbal drugs and the products made thereof have to proof their quality and safety prior to gaining access to the market.The concern about the safety of TCM herbal drugs in the