T/TPPA 0006-2023 Active

Main technical content: The establishment of this standard was primarily conducted on the basis of the "Chinese Pharmacopoeia". During the standard-setting process, full consideration was given to the applicability and specificity of the methods. Ultimately, analytical methods for items such as the thin-layer identification of Huoxiang Zhengqi Decoction, safety index inspection, characteristic fingerprinting, and content determination were established. These methods were validated in accordance with the Guidelines for Method Validation in Part IV of the "Chinese Pharmacopoeia". During the method development process, combined with the expert review opinions at the project initiation stage, the differences in dosage forms and laboratory conditions were fully considered, and various types of analytical methods for different dosage forms were added. In practical applications, users can select methods based on their specific scenarios and actual situations to ensure the scientificity, applicability, and selectivity of the methods. Specifically: 1. **Principle of scientifically reasonable methods**: Based on the characteristics of the product's dosage forms, analytical methods were established for different dosage forms of Huoxiang Zhengqi products, taking into account the actual situation of the samples to ensure that the final methods are scientifically reasonable. For example, in content determination, solid samples were added with 25ml methanol, and liquid samples were diluted to 25ml volumetric flasks, which also ensured the operability of the test process. 2. **Principle of enhancing method applicability**: In addition to the methods in the "Chinese Pharmacopoeia", the newly established analytical methods for different dosage forms underwent method validation to ensure their applicability. 3. **Principle of enhancing method selectivity**: Considering the differences in dosage forms and laboratory conditions, we provided multiple methods for certain detectio