[关键词]
[摘要]
中药方剂是中医临床治疗的核心手段,而剂型作为方剂的关键构成要素,可能通过改变药物的吸收、分布、代谢及排泄过程,对药效的发挥产生决定性影响。“同方异剂”是指同一方剂经不同制备工艺加工形成的多样化剂型,其“异效”现象已成为中医药领域研究热点与临床关注重点。围绕“同方异剂异效”,首次构建“剂型工艺差异-化学成分谱改变-体内药动学分化-药效及临床疗效差异”完整逻辑链条,系统性梳理了“同方异剂”中药在化学成分、药动学、体外活性与药效、临床应用及不良反应等多方面差异,明确其差异核心在于制备工艺通过影响化学成分谱与溶出行为,进而显著改变其药动学特征和组织分布模式,最终导致药效与临床应用的分化。明确这一逻辑链条,为中药剂型精准设计、质量标准完善及临床合理选药提供理论支撑,推动“同方异剂”中药在精准医疗与国际化进程中的高质量发展。
[Key word]
[Abstract]
Chinese medicine formulas (CMF) are the core means of clinical treatment in traditional Chinese medicine (TCM). As a key component of CMF, dosage forms can exert a decisive impact on the exertion of efficacy by altering the absorption, distribution, metabolism, and excretion processes of drugs. “Same prescription, different dosage forms” refers to the diverse dosage forms formed by processing the same prescription through different preparation technologies, and its phenomenon of “different effects” has become a research hotspot in the field of TCM and a focus of clinical attention. Centering on “same prescription, different dosage forms, different effects”, this paper first constructs a complete logical chain of “differences in dosage form and preparation technology-changes in chemical composition profiles-differentiation of in vivo pharmacokinetic-differences in pharmacodynamic and clinical efficacy”. It systematically sorts out the differences of TCM with “same prescription, different dosage forms” in chemical composition, pharmacokinetics, in vitro activity, pharmacodynamics, clinical application and adverse reactions. It clarifies that the core of these differences lies in the fact that preparation technologies affect chemical composition profiles and dissolution behaviors, thereby significantly altering pharmacokinetic characteristics and tissue distribution patterns, and ultimately leading to the differentiation of pharmacodynamic and clinical application. By establishing this logical chain, this paper aims to provide theoretical support for the precise design of TCM dosage forms, the improvement of quality standards, and the rational clinical drug selection, so as to promote the high-quality development of TCM with “same prescription, different dosage forms” in the process of precision medicine and internationalization.
[中图分类号]
R283
[基金项目]
江西省自然科学基金资助项目(20252BAC200575);江西省教育厅科学技术项目-青年项目(GJJ211266);江西省中医药管理局科技计划项目(2022B1023);江西中医药大学校级科技创新团队发展计划(CXTD22015);六味地黄方的代谢组研究(81525106)