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为保证医院自制中药制剂安全、有效,除应建立严格的生产质量检验程序外,还应建立产品的留样观察制度。留样观察是中药制剂稳定性研究的一项重要内容,也是提高中药制剂质量、为临床提供安全有效的中药制剂的保证。国家药品监督管理局2000年印发的“《医疗机构制剂许可证》验收标准”中第76条规定:“药检室应按制剂室规模、品种设立化学、生物、仪器等检测室和留样观察室”;第77条“药检室必要时制订制剂的中间品、成品检验操作规程,建立取样、留样制度。”但目前不少医疗单位不重视自制产品的留样观察,没有建立留样观察制度,即使设置了留样柜,也是为了应付检查,平时用作产品的陈列柜。本文针对目前医院的情况,提出建立自制中药制剂留样观察制度的必要性,并结合我院实际,就如何开展中药制剂留样观察进行探讨。
In order to ensure that the hospital’s self-made TCM preparations are safe and effective, in addition to establishing strict production quality inspection procedures, a sample retention observation system for products should also be established. Retention observation is an important part of the study on the stability of TCM preparations. It is also a guarantee for improving the quality of TCM preparations and providing safe and effective TCM preparations for clinical use. Article 76 of the “Acceptance Criteria for the Preparation of Medical Institutions” published and issued by the State Drug Administration in 2000 stipulates: “The drug testing room shall set up testing rooms and sample keeping rooms for chemical, biological, and instrumentation according to the scale and variety of the preparation room. “Article 77 “The drug testing room shall formulate the test procedures for intermediate products and finished products when necessary, and establish a sampling and sample retention system.” However, many medical units do not pay attention to the sample retention of self-made products and do not establish a sample observation system. Even if a sample retention cabinet is set up, it is also used to meet inspections and is usually used as a showcase for products. In this paper, according to the current situation of the hospital, the necessity of setting up an observation system for the retention of self-made Chinese medicine preparations is proposed. Combined with the actual situation in our hospital, we will discuss how to carry out the observation of preserved samples of traditional Chinese medicine preparations.