The evolution of drug delivery systems has progressed from traditional routes and dosage forms to long-acting, sustained-release, controlled-release, and targeted formulations in modern medicine. Today, we have entered the era of intelligent drug delivery systems. With a deeper understanding of pharmaceutical preparations, these are no longer merely "formulations" of drugs with specific dosages, but rather "devices" for precise drug delivery [1]. This shift brings new opportunities and challenges to traditional Chinese medicine (TCM). However, due to the unique nature of TCM, its preparation is still in the early stages of transitioning from conventional methods.
To address the limitations of traditional Chinese medicine, nanotechnology has introduced innovative approaches and methodologies for the development of nano-preparations. Both domestic and international research has recognized the potential and future applications of nano-medicine. Yet, TCM consists of numerous herbs, complex prescriptions, and diverse ingredients, making it challenging to apply nanotechnology effectively under the framework of TCM theory.
Several nano-preparation techniques have already been reported. For instance, Xu Huibi used high-energy ball milling under vacuum or inert gas, along with supersonic airflow pulverization, to produce realgar particles as small as 50–80 nm [2]. Luo Guoan developed carboplatin liposomes and breviscapine polyacrylate nanoparticles using microemulsion polymerization [3]. Zui, a pioneering technology, applies nanotechnology to herbal processing, producing nano-level powders such as licorice and Gynostemma [4].
Currently, several methods are used in nano-preparation of TCM:
1.1 **Superfine Pulverization Technology**: Using specialized mechanical equipment, raw materials or extracts are reduced to the nanoscale. China's high-turbulent pulverizer can achieve particle sizes below 1 μm for herbs and less than 100 nm for minerals.
1.2 **Solid Dispersion Technology**: The drug is dispersed in a carrier material at the molecular level, forming nano-sized particles. Techniques like melting, solvent evaporation, and grinding are commonly used.
1.3 **Microemulsification Technology**: A colloidal system formed by dispersing emulsion droplets (10–100 nm) in another liquid, using oil, water, emulsifiers, and co-emulsifiers.
1.4 **Chemical Vapor Deposition**: A gaseous chemical reaction leads to the formation of nano-particles through rapid condensation.
1.5 **Supercritical Fluid Technology**: Utilizes supercritical COâ‚‚ to create nano-drug particles via rapid expansion or anti-solvent processes.
1.6 **Supersonic Jet Technology**: High-pressure fluid jets cause strong collisions, leading to immediate nano-dispersion and surface coating of particles.
1.7 **High-Pressure Homogenization**: Produces nano-emulsions by passing a mixture through a homogenizer, resulting in smaller, more stable particles.
1.8 **Encapsulation Technology**: Uses β-cyclodextrin as a carrier to improve solubility, reduce irritation, and enhance stability of volatile components.
The choice of method depends on the material properties, desired particle size, and drug characteristics. Over 145 TCM nano-preparations have been patented, mainly involving microwave extraction and supersonic jet technology.
Despite progress, challenges remain. These include ensuring the stability of nano-formulations, selecting appropriate surface modifiers, meeting GMP standards, and achieving scalable production. While some institutions have invested in basic research, further efforts are needed to advance this field.
Basic research into nano-TCM is still in its infancy. Most studies are in vitro or in vivo, lacking solid theoretical foundations. Safety concerns also arise, as nano-formulations may alter efficacy or introduce new toxicities. It is crucial to maintain or enhance the original therapeutic effects while minimizing side effects.
Quality control and testing of nano-TCM remain underdeveloped. How to assess particle size, ensure consistency, and establish evaluation criteria are critical issues that require further study.
In summary, the advancement of preparation technologies has transformed TCM from passive delivery to active, targeted drug release. Despite the complexity of TCM composition and mechanisms, multidisciplinary collaboration is essential for developing effective nano-delivery systems. As China continues to invest in this area, it holds great potential for globalizing TCM and improving public health worldwide.
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