ABSTRACT
In leading the high-quality development of Chinese medicine preparations, it is an important link to formulate the scientific, reasonable, and feasible guidelines for the change of Chinese medicines in accordance with the change characteristics and principles of the Chinese medicines is an important work to promote the Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines was formed by a broad consensus based on the characteristics and research results of the pharmaceutical changes in Traditional Chinese Medicines(TCM)with the principles of science and risk management. This guideline has clarified the basic principles and requirements for the evaluation of changes in TCM, specified the research and verification work of common change scenarios, defined the boundaries of changes in TCM, and proposed to encourage the use of new technologies, new methods, and new excipients that meet product characteristics. It will definitely promote the quality improvement and the secondary development of TCM. In this article, the revision background and main content of the guideline were introduced, and the main features of the Guideline were analyzed, in order to provide references for the industry.
Subject(s)
Consensus , Drug Compounding , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Pharmaceutical Preparations , Quality ImprovementABSTRACT
Cerebral ischemia/reperfusion injury （CIRI） is a common feature and the main pathophysiological mechanism of ischemic stroke（IS）， which is caused by a blood reperfusion injury in ischemic brain tissues. It can aggravate brain tissue injury and cause irreversible brain damage， seriously affecting the quality of life or even the life of patients. Hence， we must find out the exact mechanism as well as the effective therapeutic drugs and targets for CIRI. The Chinese medicine effective in Xingnao （restoring consciousness） and Kaiqiao （opening orifices） has been widely used in the treatment of CIRI and serves as a classic therapy for IS. In recent years， scholars have conducted extensive and in-depth studies on the mechanism and therapeutic targets of Chinese medicine in Xingnao and Kaiqiao. They found that those drugs could interfere with a series of changes after IS and achieve the remarkable curative effect. This study summarized the effect and mechanism of Chinese medicine in Xingnao and Kaiqiao in the treatment of CIRI， including reducing the inflammatory response and oxidative stress， alleviating brain edema and the toxicity of excitatory amino acids， reducing cell apoptosis， promoting angiogenesis and neurovascular remodeling， and improving blood-brain barrier injury. It is expected to provide references to clarify the mechanism and important targets of those drugs in resisting CIRI and ideas for the in-depth investigation and application of brain protection of Chinese medicine in Xingnao and Kaiqiao.
ABSTRACT
Chinese materia medica (CMM) compound is the quintessence of traditional Chinese medicine culture, the main form in clinic of traditional Chinese medicine, the main categories and direction of research and registration of new CMM products, and an important carrier for traditional Chinese medicine inheritance and innovation. Due to the characteristics of complicated chemical constituents, weak research foundation, unclear effective components and multi-target effects, coupled with the limitations of research methods and evaluation of CMM compound preparation, how to scientifically carry out the design of CMM compound preparation has become a difficult question to answer. In this paper, from the basic attributes and requirements of drugs, combined with the discussion of research and development path, rule, strategy of new CMM compound preparation, it is proposed that the design of CMM compound preparation should be based on clinical value and inheritance and innovation, in the principle of the safety and effectivity of preparations, respecting traditional medicine experience, quality by design, whole quality evaluation, and quality uniformity and stability, etc. The pretreatment, dosage, process, dosage form, formulation design, equipment selection and industrial production in the CMM compound preparation design are also discussed.
ABSTRACT
Chinese materia medica (CMM) compound is the quintessence of traditional Chinese medicine culture, the main form and method of clinical medicine of CMM, the main categories and direction of the research and registration of new CMM products, the important part of “inheritance and development” of CMM culture, and mainly reflects the characteristics of CMM. According to the evaluation practice for many years, the research path and the knowledge of the research rules for new drugs of CMM compound were discussed, and the requirements for pharmaceutical research works of new CMM compound preparation. The pharmaceutical research on new CMM compound preparation is a process of quality design and quality improvement. The evaluation requirements of different stages for new CMM compound preparation were elaborated. It is the conclusion that the discussion of R&D path, R&D law, and R&D strategy on new CMM compound preparation will improve the technical evaluation standard system with the characteristics of CMM, increase the ability of R&D for CMM new products, promote the innovation of CMM, and accelerate the new CMM products to go on market.
ABSTRACT
According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.