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目的:通过对医疗机构中药制剂存在问题的整理探讨,为医疗机构研发、配制中药制剂提供一些建议,同时为监管部门实施相关监管提供参考。方法文献检索有关医疗机构中药制剂的文章,分析其中存在的问题,并将其进行分类,对出现频率较高的问题进行分析和讨论。结果主要存在的问题有制剂质量控制、制剂室软硬件配备、制剂经济效益和制剂配制工艺等。结论医疗机构与监管部门协作,从技术上、法规上为医疗机构中药制剂把好质量关,从而保障人民用药安全有效。“,”Objective Through ar anging and exploring the existing problems in (of) the Hospital TCM Preparations , to provide some suggestions for the research and development about the Hospital TCM Preparations , and provide a reference for the regulatory authorities to implement the relevant regulatory. Methods Articles of the Hospital TCM Preparations were searched, then analyzed and classified the existing problems, analyzed and discussed the problems with high frequency. Results The main existing problems are quality control of the preparation, hardware and software of preparation room, economic ef iciency and the preparation process of the Hospital TCM Preparations. Conclusion Medical institutions should cooperate with the regulatory authorities, make sure the quality of the Hospital TCM Preparations from the technology, laws and regulations form, so as to ensure the safety and ef ectiveness of drugs.