[Crystal form issues and development prospects of TCM solid preparations]

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Traditional Chinese Medicine (TCM) Research

Background:

• Solid dosage forms are dominant in TCM clinical practice, yet face challenges in quality stability and consistent therapeutic efficacy.
• Variations in TCM efficacy are linked to physicochemical states of active ingredients, with crystal forms identified as a critical influencing factor.
• Understanding TCM crystal forms is crucial for addressing the 'identical composition but heterogeneous activity' phenomenon.

Purpose of the Study:

• To comprehensively review the current research landscape of Traditional Chinese Medicine (TCM) crystal forms, from single components to compound preparations.
• To systematically elucidate the technical systems and category characteristics associated with TCM crystal forms.
• To propose an innovative crystal form-based strategy for quality control of TCM solid preparations.

Main Methods:

• Review of existing literature on TCM crystal form preparation, characterization, and property analysis.
• Systematic analysis of technical frameworks and category characteristics of TCM crystal forms.
• Development of a novel strategy for quality control centered on crystal forms.

Main Results:

• Significant progress has been made in studying TCM crystal forms for single components and compound preparations, establishing a technical framework.
• Research on crystal forms within TCM solid preparations, particularly Chinese patent medicines, remains largely unexplored.
• The study highlights the critical role of crystal forms in TCM quality fluctuations and efficacy variations.

Conclusions:

• Crystal forms are fundamental to the physicochemical properties and biological activities of TCM drugs, directly impacting quality and efficacy.
• A crystal form-based strategy offers a novel research framework for enhancing TCM solid preparation quality control and developing new nanoparticle drugs.
• Further investigation into TCM crystal forms is essential for standardization, ensuring clinical efficacy, and advancing TCM nanoscience.