ABSTRACT
Following the Chinese-led global standardization of Chinese medicine, the 9 th edition of the European Pharmacopoeia, published in 2016, listed 66 kinds of crude drugs that are used in traditional Chinese medicine. By the spread of dietary supplements in the United States, the number of herbal medicines listed in United States Pharmacopoeia is tended to be increasing. In this article, we compare the names and origins of crude drugs listed in the European and American Pharmacopoeias and used in ethical Kampo extract formulation with those described in the pharmacopoeias of Japan, China, Taiwan, and South Korea. There were 4 crude drugs that had the same origins and names in the pharmacopoeia of these 6 countries, but only Coix Seed had the same English name. The pharmacopoeia of the 5 countries except the United States had 19 crude drugs with the same origin, but only Platycodon Root and Eucommia Bark had the same English and Latin names. For other crude drugs, the names and origins in the pharmacopoeia of each country were different. When scientists in each country disseminate the information about crude drugs used in their own countries to the world, it is necessary for them to describe the original plant scientific names and their medicinal parts that are unified by International Code of Nomenclature for plants instead of English or Latin names of crude drugs.
ABSTRACT
Atractylodis Macrocephalae Rhizoma is a common traditional Chinese medicine with huge demand. In this paper, quality standards of Atractylodis Macrocephalae Rhizoma in Chinese Pharmacopoeia, Japanese Pharmacopoeia, Korean Pharmacopoeia, European Pharmacopoeia and Hong Kong Chinese Materia Medica Standards were compared and analyzed. It aims to understand the similarities and differences of the quality standards of Atractylodis Macrocephalae Rhizoma between Chinese Pharmacopoeia and other pharmacopoeias, and learn the advantages of them to provide the reference for improving the quality standard of Atractylodis Macrocephalae Rhizoma.
ABSTRACT
OBJECTIVE:To provide ideas for revise and improve the standard and related method of the quality control of ben-zalkonium chloride in Chinese Pharmacopoeia (2015 edition,Ⅱ). METHODS:The standards and related methods of the quality control of benzalkonium chloride in Chinese Pharmacopoeia(2015 edition,Ⅱ),British Pharmacopoeia(2013 edition),European Pharmacopoeia (7.0 edition) and United States Pharmacopoeia (36 edition) were comprehensively compared. RESULTS:Com-pared with Chinese Pharmacopoeia(2015 edition,Ⅱ),the standards abroad provided the component and the ratio of the benzalko-nium chloride substituted homolog,the method for ammonia compound test had higher sensibility,it also added the test for benzyl alcohol,benzaldehyde and benzyl chloride impurity,as well as the component ratio test and average relative molecular mass calcu-lation. CONCLUSIONS:The standard and related method of the quality control of benzalkonium chloride in Chinese Pharmacopoe-ia(2015 edition,Ⅱ)still need to be further improved.
ABSTRACT
Monographs of Chinese medicine into the United States Pharmacopeia and the European Pharmacopoeia is the prerequisite and foundation for the aim of Chinese medicine standards leading the international standard-set-ting. By comparative analysis of the key issues of quality standards among Chinese, American and European Phar-macopoeia, thoughts and suggestions are proposed on how to implement the construction of international quality stan-dard of traditional Chinese medicine. Meanwhile, under the pressure of the present international environment, the pa-per can also provide some reference and advices which can help to break down the difficult situation for the process of internationalization of traditional Chinese medicine.
ABSTRACT
OBJECTIVE: An international collaborative study involving fourteen laboratories has taken place, organized by the European Directorate on Quality of Medicines (EDQM) and National Institute for Biological Standards and Control(NIBSC) to provide supporting data for the establishment of replacement batches of calibration chemical reference substance (CRS) for low molecular weight heparin (LMWH). METHODS: The study was organized in two phases: A prequalification (phase 1, performed in three laboratories in 2005) followed by an international collaboration study (phase 2). Our institute (National Institutes for Food and Drug Control, NIFDC) took part in the phase 2 study started in March 2006. The molecular mass parameters were determined for seven different LMWH samples using the current CRS (CRS1) and two batches of candidate replacement material (cCRS2 and cCRS3) with a defined number average molecular mass (Mn) of 3700 determined in phase 1. RESULTS: The calculated values of cCRS2 and cCRS3 were systematically different from the values calculated using CRS1 with its assigned Mn of 3700. Using the raw data supplied by other participants, the molecular mass parameters were recalculated using cCRS2 and cCRS3 with values for Mn of 3800 and 3900. The calculated values using these Mn values agreed more closely with those calculated using CRS1, supporting the fact that the candidates, though similar in view of the production processes, differed slightly from CRS1 in terms of molecular mass distribution. CONCLUSION: The establishment of cCRS2 and cCRS3 could be recommended with an assigned Mn value of 3 800 that is consistent with both the phase 1 results and the determination result of current CRS1.