There are many problems in the standardization of Chinese medicine excipients

Traditional Chinese medicine preparation is different from western medicine preparation It needs to be processed by traditional Chinese medicine, extraction, concentration, separation and purification, drying, comminution, mixing and preparation, sterilization and other production processes It is difficult to define the specific role of pharmaceutical excipients in each stage However, in the process of preparation, extraction of effective components and preparation molding, Chinese medicine preparation needs to add pharmaceutical excipients The effectiveness of the excipients used in different production stages is different, which increases the difficulty of further clarifying the role of Chinese medicine excipients In addition, it is more difficult to determine the chemical reaction between these components and pharmaceutical excipients because of the complexity of the components of traditional Chinese medicine, the difficulty of research, the low requirements of quality standards and the lack of detection indicators Pharmaceutical excipients may react with or cross-linked with components of traditional Chinese medicine to form allergens, which may cause allergic reactions However, it is difficult to understand that pharmaceutical excipients react with or cross-linked with a certain component, a certain component or a variety of components in traditional Chinese medicine, and the research in this field is essential to ensure the safety of drugs The pharmaceutical excipients and preparation technology in chemical preparations have a certain foundation, and can be used for reference by foreign inspection, but the pharmaceutical excipients and technology related to traditional Chinese medicine have not really started, and foreign countries have not taken this as the main research direction, only relying on our research Traditional Chinese medicine, as a traditional medicine in China, has no clear and unified requirements of varieties, specifications and pharmaceutical quality standards since ancient times It mainly depends on the experience of pharmaceutical manufacturers to grasp its quality The mastery of pharmaceutical excipients and technology is mostly empirical, and systematic theory is few To a certain extent, it increases the difficulty of establishing and improving the standards of Chinese medicine excipients Most of the excipients in traditional Chinese medicine have no specific dosage There are steps in the extraction process of traditional Chinese medicine preparation In the extraction process, because of the influence of the origin, harvest season and extraction equipment of traditional Chinese medicine, the paste yield of different origin and different batches of traditional Chinese medicine is bound to be different In this case, in order to make the quantity of each batch of finished products reach the quantity specified in the drug standard, enterprises often add appropriate auxiliary materials to adjust, so as to ensure the accuracy of each dose (calculated by the original medicine) taken by patients In the case of uncertain quantity of herbal extracts, it is necessary to survive to produce quantitative finished products, which leads to the inability to specify the specific dosage of pharmaceutical excipients of traditional Chinese medicine preparations "There are some difficulties in improving the standards of Chinese medicine excipients, but it is of great significance to establish the standards of excipients with Chinese medicine characteristics to promote the modernization of Chinese medicine preparations Competent departments at all levels and industry associations should attach great importance to and take effective measures to strengthen this work." Liang Yi stressed Last year, the State Administration of traditional Chinese medicine set up a special scientific research project to carry out "Research on screening and evaluation of solubilized pharmaceutical excipients in line with the characteristics of traditional Chinese medicine", aiming to study the screening method and evaluation mode of solubilized excipients in traditional Chinese medicine injection, optimize solubilized excipients in line with the safety requirements of traditional Chinese medicine injection, explore the suitability of solubilized excipients in traditional Chinese medicine preparation, and establish the characteristics of traditional Chinese medicine Quality standard of solubilized excipients This measure shows that the relevant management departments have begun to solve the problems in the standards of Chinese medicine excipients.