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目的:建立能反映中药饮片内在质量的质量指标,以此质量指标建立的质控指标要达到国际标准化要求,具有可操作性和规范性,并能准确地反应饮片疗效。方法:依据中药炮制原理、药代动力学结论和我国几十年应用化学成分控制中药质量的成功、失败的经验与教训,总结出选定中药饮片质量成分指标的原则。结果:通过对中药饮片质量指标的讨论得出,中药经炮制后,药效增加,毒性减少,而与之对应的化学成分也有增减。这种增减正是中药的药效增加,毒性减少的物质基础。结论:选定的质量指标必须是该中药饮片的主要疗效成分,同时它又符合中药炮制原理,并能用药代动力学的方法对其在体内的代谢规律加以认识。
Objective: To establish quality indicators that can reflect the intrinsic quality of Chinese Herbal Medicine Pieces. The quality control indicators established with this quality index must meet international standardization requirements, have operability and standardization, and can accurately reflect the efficacy of decoction pieces. Methods: According to the theory of Chinese medicine processing, the pharmacokinetics conclusions and the successes and failures of the use of chemical constituents in controlling the quality of traditional Chinese medicines in China for decades, the principles for selecting the quality component indexes of traditional Chinese medicine decoction pieces were summarized. Results: Through the discussion on the quality index of Chinese Herbal Medicine Pieces, it is concluded that after the Chinese medicine is processed, the efficacy is increased, the toxicity is reduced, and the corresponding chemical composition is also increased or decreased. This increase or decrease is the material basis for the increase in the efficacy of Chinese medicine and the reduction of toxicity. Conclusion: The selected quality index must be the main curative component of the Chinese herbal decoction pieces. At the same time, it complies with the principles of Chinese medicine processing and can use pharmacokinetic methods to understand its metabolism in vivo.