ABSTRACT
OBJECTIVEP: To explore the necessity and feasibility of organic combination of the national drug sampling and testing for quality evaluation and national drug standards improvement. METHODS: Through analysis of the similarities and differences of the two working modes and their complementarity, the problems that may arise in the connection of work were identified. The mechanism and counter measures to promote the organic combination of the two working modes were put forward. RESULT AND CONCLUSION: It was suggested that a communication mechanism should be established in time to strengthen the connection and interaction between the national drug sampling and testing for quality evaluation and national drug standard improvement, thus to avoid wasting resources and timely translate feasible suggestions into national drug standards.
ABSTRACT
There are many problems in the use of Bupleurum medicinal materials such as confusion in variety, unclearness in origin and quality problems, e.g., adulteration of authentic Bupleurum and mixing of non-medicinal parts. Therefore, the quality of Chinese patent medicines containing Bupleurum chinense is variable, and it is necessary to establish targeted quality control methods. Based on the quality control methods of Bupleurum and its Chinese patent medicines, combined with the example of Xiaochaihu granules, this paper discussed the quality standard improvement and supplementary test methods of Bupleurum and its Chinese patent medicines, aiming to provide reference for the quality control, quality supervision and standardized production of Chinese patent medicines containing Bupleurum and promote the improvement of its intrinsic quality.
ABSTRACT
OBJECTIVE: To evaluate the quality status and current standard of cytochrome C injection and to carry out exploratory research on its standard. METHODS: Samples were tested according to the current quality standard in the Pharmacopoeia of the People's Republic of China (2010) Volume II- Exploratory researches including peptide mapping analysis, activity determination by TMB substrate ehromogenic method, and related substances detection by HPLC were carried out. RESULTS: The passing rate of cytochrome C injection was 100%, and that of freeze-dried cytochrome C powder for injections was 50%. CONCLUSION: There existed some problems with both the quality status and current standard of cytochrome C injection. The exploratory researches indicate that it is necessary to improve the statutory standard of cytochrome C.