T/TPPA 0005-2023 Quality Standards for High-Quality Products of Huoxiang Zhengqi Decoction

Scope

Main technical content: The establishment of this standard is mainly based on the "Chinese Pharmacopoeia". During the standard-setting process, full consideration is given to the product's effectiveness, safety, consistency, and the comprehensiveness of standard formulation, so as to achieve precise control of quality indicators. This standard is established based on the characteristics of the prescription, with research conducted on the prescription's principal, auxiliary, and adjuvant herbs. For different dosage forms of Huoxiang Zhengqi products, limit standards are scientifically and reasonably set; horizontal comparisons of safety indicators requirements in European and American regulations are conducted, and safety indicator detection items and limits are balanced to ultimately determine high-quality product quality standards. The specific principles are as follows: 1. **Principle of enhancing product effectiveness**: Combined with new technologies in pharmacology and gene networks, target components in the Huoxiang Zhengqi formula are identified, and control indicators for principal and auxiliary herbs are added, ensuring stricter product control. A calculation method for transferring the content of Huoxiang Zhengqi components from raw materials to extracts and formulations is adopted to determine the content limits of the tested components in the formula, raising product control standards and distinguishing high-quality products. 2. **Principle of enhancing product safety**: Increase inspections for aflatoxin, heavy metals, and harmful elements in Huoxiang Zhengqi formulations, and set limit standards. Increase inspections for ethanol residues in formulations other than Huoxiang Zhengqi Water, and set limit standards. 3. **Principle of enhancing product consistency**: Add characteristic chromatograms for Huoxiang Zhengqi formulations, establish a holistic evaluation method based on holographic chemical components, and achieve quality requirements for prod

Development Information

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