构建医院内中药饮片质量控制体系的必要性与探索研究

Necessity and exploration of constructing quality control system of Chinese herbal pieces in hospital

中药饮片是中医临床防治疾病的处方药,医院作为应用中药饮片的主体之一,医院内中药饮片质量的优劣直接影响着中药临床疗效,关系到患者切身健康。但是目前中药饮片市场较为混乱,中药材种植或养殖、生产加工、贮藏管理、流通经营等方面均有不规范的问题出现。同时,中药饮片供应方式隔绝了医院对所用中药饮片来源和生产过程的知情权,医院受制于中药饮片供应企业,被动接受供应企业提供的中药饮片产品,这对医院购进的中药饮片质量的可控形成了很大障碍。为解决以上问题,应从中药饮片进入医院的源头和医院的质量管理两方面出发,探索构建以中药饮片采购管理、入库验收、储存养护、人员能力提升等措施为内容的中药饮片质量控制体系。同时,应积极发挥中药临方炮制的重要作用、中药产品全过程追溯体系与中药材市场监管体系的保障作用,加强医院在中药饮片质量控制体系中的主导地位。

The hospital is one of the main subjects for application of Chinese herbal pieces（CHP） which is the prescription drug for Chinese medicine clinical prevention and treatment of disease. The quality of CHP in hospital has a direct impact on clinical effect and is related to the health of the patients. But presently the market of CHP is chaotic with the prominent issue. The cultivation, the production and processing, the storage management and operation of CHP are not standardized. Simultaneously, the supply method of CHP is cut off from the right of the hospital to know the source and production process of CHP. The hospital is restricted to the supply enterprises of CHP. This situation makes a great obstacle to the quality control of CHP in hospital. The quality control system of CHP in hospital is composed of the source and the quality management of CHP. The quality control system of CHP includes the measures such as the purchasing management, acceptance of storage, storage and maintenance, and personnel capacity improvement. The prescription-based processing of Chinese materia medica should play an important role in this system. The whole process traceability system and the guarantee function of the market supervision system of Chinese medicinal materials should also be taken effect. In this way, the dominant position of hospital in the quality control system of CHP is strengthened.