ABSTRACT
Chinese medicine preparations in medical institutions are an important reservoir for new traditional Chinese medicines. The management basis for the registration and filing of Chinese medicine preparations in medical institutions are sorted out, and the general situation is analyzed, and the current filing information and technical requirements of Chinese medicine preparations in medical institutions and new traditional Chinese medicine compound preparations are compared. The purpose is to understand the variety of Chinese medicine preparations in medical institutions and the potential issues in the application materials, and to provide reference for better application of human experience and exemption from the application materials of new traditional Chinese medicines derived from Chinese medicine preparations in medical institutions.
ABSTRACT
OBJECTIVE: To discuss the technical requirements of scored tablets combining with the current situation of clinical use of scored tablets and the domestic and national technical requirements. METHODS: The FDA guidance on tablet scoring was introduced in detail, on this basis, the general considerations on the technical requirements of generic scored tablets were put forward. RESULTS: AND CONCLUSION: It was suggested that the evaluation criteria should be established on the basis of taking a full consideration on product characteristics in the process of research and development, scored tablets should be developed in accordance with clinical needs, and specification description should be standardized for clarifying the clinical use of the scored tablets.
ABSTRACT
Traditional Chinese medicine (TCM) reference drug is a new form of TCM standard reference substance. The purpose of this guideline is to guide the establishment of the reference drug and standardize its investigation and application in national drug standards. Definition of TCM reference drug was specified and relating guideline and technical requirement were introduced in this paper. Its application in quality control of TCM was analyzed and the developing train was proposed. There is a wide prospect for the application of reference drug in quality control of TCM. Thus it has practical significance to explore and conduct the quality evaluation system by using TCM reference drug as the reference substance.