Zhuo Jing-Xian, Qiu Zhen-Wen, Zhou Jie, Wu Yan-Mei, Yang Mao-Lin, Yang Zhong-Qi
Guangzhou Evidence-based Medicine Tech Co., Ltd. Guangzhou 510060, China.
the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510407, China.
Zhongguo Zhong Yao Za Zhi. 2022 Aug;47(15):4256-4260. doi: 10.19540/j.cnki.cjcmm.202204012.601.
Traditional Chinese medicine(TCM) preparations in medical institutions are an important source of research and development(R&D) of TCM new drug. With years of usage in therapy, these preparations' safety and effectiveness have generally been validated in clinic. However, there are still a few disadvantages in TCM new medicine development, such as similar prescriptions, excessive prescription ingredients, too broad clinical orientation, lack of solid clinical data, issue in pharmaceutical quality control, and intellectual property disputes. Nowadays, the Three-Combined Evaluation System has strengthened policy support for the new TCM R&D. In order to improve the success rate of TCM R&D, due to the difficulties within, this paper proposes the process of transforming TCM preparations in medical institutions into new TCM and advocates the evaluation for druggability based on Human Use Experience(HUE). The potencial preparations ought to follow traditional Chinese Medical theory, sufficient HUE data in indication, syndrome type of TCM, target population, usage, dosage, and course of treatment are required. Particular attention should be paid to the source, evolution, and improvement process of prescription, and evaluate the dosage, ingredients, and herb resources of prescription. To assess the feasibility of mass production, it is necessary to determine whether the pharmaceutical process is mostly consistent with the new drug and whether the dosage form is reasonable. By summarizing the clinical application of the preparations, the whole picture of its clinical application would be reveal as much as possible. It is beneficial to evaluate its clinical value and R&D prospect. In consideration of the lack of clinical safety data of preparations, safety profile needs to be collected according to the prescription. The quality of clinical data needs to be evaluated by focusing on the integrity and accuracy of data to reduce bias and confusion. Significant care should be paid to intellectual property protection to avoid legal disputes.
医疗机构中的中药制剂是中药新药研发的重要来源。经过多年临床应用，这些制剂的安全性和有效性已在临床上得到普遍验证。然而，中药新药研发仍存在一些不足之处，如处方相似、处方成分过多、临床定位过宽、缺乏扎实的临床数据、药品质量控制问题以及知识产权纠纷等。如今，“三结合”评价体系加强了对中药新药研发的政策支持。为提高中药研发成功率，鉴于其中存在的困难，本文提出了将医疗机构中药制剂转化为中药新药的流程，并倡导基于人用经验（HUE）进行成药性评价。潜在制剂应遵循中医理论，在适应证、中医证型、目标人群、用法用量及疗程方面需要有充分的人用经验数据。尤其要关注处方的来源、演变及完善过程，对处方的剂量、成分及药材资源进行评价。为评估规模化生产的可行性，有必要确定制药工艺是否与新药基本一致以及剂型是否合理。通过总结制剂的临床应用情况，尽可能全面地揭示其临床应用全貌，这有利于评估其临床价值和研发前景。考虑到制剂临床安全性数据的缺乏，需要根据处方收集安全性资料。临床数据质量需着重从数据的完整性和准确性方面进行评估，以减少偏差和混淆。应高度重视知识产权保护，避免法律纠纷。
