The standardization and improvement of traditional Chinese medicine extract standards are relatively lagging behind. With the implementation and continuous promotion of China's drug standard improvement plan, the national drug standard system has been initially established, the pace of drug regulatory informatization construction has accelerated, and drug standard management has become more standardized and perfect. However, the standardization of traditional Chinese medicine extracts still lags behind, mainly manifested in the following aspects: ① The lack of established standards. Chinese herbal extracts are important raw materials for the production of traditional Chinese patent medicines and simple preparations. According to statistics, about 29.8% of traditional Chinese patent medicines and simple preparations use Chinese herbal extracts as feed materials, but some Chinese herbal extracts have not yet established national standards. Due to the lack of legal standards, production and business activities often adopt demand side standards and enterprise standards, and rely on quality clauses in contracts as the basis for product delivery. The methods for product quality testing are relatively chaotic Inadequate standards. A complete set of standard items is the foundation for effectively controlling the quality of traditional Chinese medicine extracts. However, due to the long time since the issuance of standards for some traditional Chinese medicine extracts, there are situations where the standard items are not sound. For example, some outdated standards for traditional Chinese medicine extracts lack pesticide residue limits and heavy metal determination items, some lack auxiliary material testing standards, and some lack microbial limit testing The situation of non-standard standards. There are numerous standards for traditional Chinese medicine extracts, but there are irregularities in naming, preparation methods, characteristics, and inspection. For example, some traditional Chinese medicine extracts have the same name but different preparation methods. Taking Scutellaria baicalensis extract as an example, it appears 12 times in both the 2010 edition of the Chinese Pharmacopoeia and the Chinese Herbal Formula Preparation. However, there are significant differences in key process parameters that affect the quality of the finished product, such as "whether to add alum solution", "final pH value before drying", and "solution for washing crude products", which can easily cause confusion in production and use The situation of uneven standard levels. The standard level of traditional Chinese medicine extracts approved as new drugs and included in the Chinese Pharmacopoeia is relatively high. But other traditional Chinese medicine extracts still have problems such as outdated processes and lack of core technologies. In addition, the production enterprises of traditional Chinese medicine extracts are mostly small enterprises with relatively poor technical level and production capacity. They rarely seriously optimize and research the production process of products, and lack in-depth development for products, resulting in a low technological threshold for the production of traditional Chinese medicine extracts and disorderly market competition Standard not eliminated. Due to the lack of means to evaluate the implementation of standards for traditional Chinese medicine extracts, some standards for traditional Chinese medicine extracts only exist and do not die. As a result, some standards that have not been updated or revised for many years are still in use, and there is an urgent need to establish a mechanism for phasing out standards.
