基于中药TDX105研究的质控标准数据

数据内容包括对制剂含量测定方法及薄层鉴别方法进行了开发优化及确定，同时按药典要求对颗粒剂粒度、水分、溶化性、装量差异、微生物限度等进行检查，建立TDX105的质量控制标准。此数据为TDX105的后续新药研发奠定基础，也为中药复方的进一步研发提供制剂学基础

The data content includes the development, optimization, and validation of the content determination method and thin-layer identification method for the preparation. Meanwhile, inspections on the particle size, moisture content, dissolution property, weight variation of contents, microbial limit, etc. of the granules were carried out in accordance with pharmacopoeial requirements to establish the quality control standards for TDX105. This data lays a foundation for the subsequent new drug development of TDX105 and also provides a pharmaceutical basis for the further research and development of Chinese medicine compound prescriptions.