山东省医疗机构中药制剂质量标准现状及标准提高问题分析

目的 规范山东省医疗机构中药制剂质量标准,保障医疗机构中药制剂的安全、有效和质量可控.方法 基于山东省医疗机构中药制剂质量标准现状,通过对《山东省医疗机构制剂规范》(第一版第一册)和标准提高品种的整理和归纳,总结医疗机构中药制剂质量标准存在的问题.结果 《山东省医疗机构制剂规范》(第一版第一册)收载的780个品种的质量...

Analysis on the current situation and improvement of TCM preparation quality standard in Shandong Province medical institutions

Objective To standardize the quality standards of TCM preparations in medical institutions of Shandong Province and ensure the safety, effectiveness and quality control of TCM preparation in medical institutions.Methods Based on the status of TCM preparation quality standards of medical institutions in Shandong Province, this paper summarizes the existing problems of TCM preparation quality standards of medical institutions in Shandong Province by sorting out and summarizing Shandong Provincial Medical Institution Preparation Specification(volume 1, first edition) and the improved varieties.Results The quality standard items of 780 varieties collected in Shandong Provincial Medical Institution Preparation Specification (Volume I, first edition) are relatively simple, and the quality control index is single, comparing the quality standards of 310 varieties in the standard improvement task before and after the improvement, the overall standard control was significantly improved. In the future work, we should strengthen the quality standard of security, integrity and applicability, and improve the quality of preparations to ensure the safe and effective clinical application.Conclusion As the legal standard of Shandong Provincial medical institution preparation, medical institution preparation standard in Shandong Province will be greatly improved after the promulgation and implementation of Shandong Provincial Medical Institution Preparation Specification.