结直肠癌的复发、转移是其治疗中迫切需要解决的关键问题。大量研究表明：中药有效成分能有效抑制肿瘤的复发、转移，但往往因水溶性差、难以进入细胞膜，影响其疗效的发挥。我们提出假说如下：中药采用合理的剂型设计，通过微环境调控上皮细胞通透性，抑制上皮间质转化（EMT），可有效地抑制结直肠癌转移。本研究拟选择难溶性药物人参皂苷Rg3为模型药物，利用课题组在结肠定位与固体自微乳制备的工作基础，通过构建多触发型口服结肠定位给药系统，确保药物达到结肠部位；采用自微乳技术，提高药物溶解度，促进药物进入细胞膜；通过在固体自微乳处方中引入pH敏感高分子聚合物，利用正常组织与肿瘤组织pH值差异，构建在肿瘤特定的pH稳定、可控、长效释药的制剂。课题的实施有利于阐明中药以及制剂抑制肿瘤复发、转移的机制；构建的多触发型OCDDS对结直肠癌等结肠部位疾病的治疗具有广泛适用性和较强的现实指导意义。

Recurrence and metastasis of colorectal cancer are the key problems that need to be solved urgently in the treatment of colorectal cancer. Previous studies have shown that the active ingredients of traditional Chinese medicine can effectively inhibit the recurrence and metastasis of tumors, but often because of poor water solubility, it is difficult to enter the cell membrane, affecting the effectiveness of its play. Our hypothesis is as follows:Chinese herbal medicine can effectively inhibit the metastasis of colorectal cancer by regulating the permeability of epithelial cells and inhibiting epithelial-mesenchymal transition (EMT) through microenvironment with reasonable dosage form design. In this study, the insoluble drug ginsenoside Rg3 was chosen as the model drug, and based on the work of our team in colon localization and solid self-microemulsion preparation, the multi-trigger oral colon-specific drug delivery system was constructed to ensure that the drug reached the colon site; the self-microemulsion technology was used to improve the solubility of the drug and promote the drug to enter the cell membrane; and the solid self-microemulsion prescription was adopted. By introducing pH-sensitive macromolecule polymer, a stable, controllable and long-term drug release formulation with specific pH at the tumor site was constructed based on the difference of pH values between normal tissue and tumor tissue. The implementation of this project is helpful to elucidate the mechanism of Chinese herbs and preparations in inhibiting the recurrence and metastasis of tumors. The construction of multi-triggered OCDDS has the extensive applicability and practical significance for the treatment of colon diseases such as colorectal cancer.