Strategy and challenge of innovative drug research and development from clinically effective ingredients of traditional Chinese medicine / 中国中药杂志

Novel drug discovery from the active ingredients of traditional Chinese medicine is the most distinctive feature and advantageous field of China, which has provided an unprecedented opportunity. However, there are still problems such as unclear functional substance basis, action targets and mechanism, which greatly hinder the clinical transformation of active ingredients in traditional Chinese medicine. Based on the analysis of the current status and progress of innovative drug research and development in China, this paper aimed to explore the prospect and difficulties of the development of natural active ingredients from traditional Chinese medicine, and to explore the efficient discovery of trace active ingredients in traditional Chinese medicine, and obtain drug candidates with novel chemical structure, unique target/mechanism and independent intellectual property rights, in order to provide a new strategy and a new model for the development of natural medicine with Chinese characteristics.

Analysis of innovative drug category 1.2 in traditional Chinese medicine and considerations on quality control of extracts / 中国中药杂志

In this article, the essence of innovative drug category 1.2 extracts and preparations in the new version of the New Drug Registration Category of traditional Chinese medicines(TCM) was analyzed by combing through the history of provisions on drug registration and comparing with other categories of drugs. After analyzing the characteristics of this type of preparations, the author concluded that the quality control objectives of category 1.2 extract should focus on ensuring the quality consistency of the active ingredients/components in batches, so as to guarantee the consistency of drug quality and efficacy. With reference to the relevant technical requirements for herbal medicinal products in European Medicines Agency(EMA) and botanicals in Food and Drug Administration(FDA),the key points in quality control of the extract should include the content and composition of the therapeutic constituents, the type and content of the concomitants, and the influence of exogenous contaminants on drug safety.

Progress in Development of Human Radiolabelled Mass Balance and Biotransformation Studies / 中国药学杂志

Recently, with the rapid development of new drug research in China, the human mass balance and biotransformation (MBB) studies on innovative drugs are on a track to become indispensable during new drug application. However, traditional analysis method, e.g. mass spectrum, is insufficient to elaborately explain the mass balance and the relative biotransformation of the investigated drugs in human bodies. This problem could be solved by applying radiolabelled technique into these MBB studies, which are more and more popular nowadays. The authors' hospital is one of the first a few organizations to conduct the MBB studies, and has completed almost 20 trials. This review mainly focused on the study design from the investigators' viewpoints, involving the related rules and regulations, both at home and abroad, and the protocol design, so as to provide our thinkings for references and benefit to the new drug clinical trial in the future.

Research advancement in natural anti-cancer product / 中国中药杂志

Human health has been severely threatened by malignant tumors continuously.Rational and effective drug use provides an effective means for the treatment of malignant tumors,and is expected to become an important way to solve the problem of tumor treatment in the future.In recent years,with the escalation of new cancer theories and the emergence of clinical drug resistance,innovative research and development of anti-cancer drugs has always been a hot spot and focus in cancer research.Among them,the discovery of novel anti-cancer drugs from natural compound is of top priority due to its strong anti-cancer efficacy and the abundant drug resources.Therefore,it is imperative to systematically summarize the cutting-edge advancements of the natural products and their potential pharmacological mechanisms according to the characteristics of tumor progression,and put forward the new directions and trends for further development of anti-cancer natural products in the future.Specifically,the research advancements on anti-cancer effect of natural products were reviewed,focusing on both the traditional and innovative application.We hope this review could bring the light on the research path of the natural anti-cancer products clearly and comprehensively,and also provide inspirations for innovative,safer and more effective anti-cancer drug development and exploration.

Research Approaches on Discovery R&D of Innovative Drug of Chinese Materia Medica under New Situations / 世界科学技术-中医药现代化

In recent years,with the rapid development of life sciences,changes on the understanding and requirements for innovative drugs of Chinese materia medica (CMM) from the drug approval authorities have been made.In this paper,the discovery,research and development (R & D) approaches for innovative drugs of CMM under new situations were summarized and introduced in details from five aspects as follows.The discovery of innovative drugs from active components of CMMs,active fractions of CMMs and their compound preparations,famous classic prescription,clinically effective prescriptions as well as the famous Chinese patent drugs.This paper puts forward some new ideas for the pharmaceutical researches of innovative drugs of CMM,including the production process,chemical components,quality study,quality standard and stability.This paper provided references for the discovery,R & D of CMM.

Ginkgo biloba leaves history: A model of research and development for Chinese materia medica/phytomedicine / 中草药

Summary in this paper, the active chemical constituents from Ginkgo biloba leaves (GBL), their pharmacological effects, toxicity studies, clinical application, the comparison with the quality standard of the Pharmacopoeia, the history of medicinal development as well as the research and development of GBL in China were described, analyzed, and discussed in detail. GBL began to be recorded the medicinal value from the Song Dynasty in China. The scientists in research and development of GBL in Japanese and German have made significant pioneering contributions. The history of medicinal development of GBL has been fully embodied in the innovation, and has become a model for the research and development of Chinese materia medica and phytomedicine. The innovative drug research of GBL in China has made considerable progress, the significant results have been obtained. But the quality standard of Chinese GBL extract and its preparations have a significant difference with the European and American industries. The industry concentration is low.

Tolerability of baicalein chewable tablets in chinese healthy volunteers: a single-dose dose-escalating study / 中国药学杂志

OBJECTIVE: To evaluate the safety and tolerability of baicalein chewable tablets and establish the maximum tolerated dose in healthy volunteers. METHODS: A randomized, double-blind, dose-escalating, single-center, phase I clinical trial was conducted in 70 healthy male and female subjects. Each subject received oral baicalein only once. Adverse events were identified either by subject self-reporting or evaluation based upon vital signs, physical examination and laboratory parameters. The study was conducted from low to high dose, and the dose escalation was performed only after the safety and tolerability were confirmed favorable. RESULTS: Baicalein chewable tablets were well tolerated and had an acceptable safety profile up to the highest dose of 2800 mg. The vital signs of all subjects were stable, and no QTc interval prolongation was observed during the trial. A total of 11 mild adverse events were reported in 8 subjects. There were no severe adverse events in the study, and none of the adverse events led to withdrawal. CONCLUSION: This study suggests that the innovative drug baicalein chewable tablets are well tolerated in healthy Chinese volunteers within the dose range of 100 to 2800 mg.

Budget Impact Analysis and Cost-effectiveness Analysis / 中国药房

OBJECTIVE:To provide reference information for pharmacoeconomic studies in China.METHODS:To intro?duce the roles of budget impact analysis and financial impact analysis and the connection with cost-effectiveness analy?sis.RESULTS&CONCLUSION:Budget impact analysis can contribute to making innovative drug reimbursement decision.