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目的在制剂配制过程中,加强物料平衡的检查与管理以保证制剂质量。方法从物料平衡的概念、制剂配制过程中各个工序的物料平衡检查等方面阐明了物料平衡管理的重要性和检查方法,从而为保证制剂质量提供一种手段。结果在制剂配制过程中物料平衡检查虽不是唯一的质量控制措施,但是必要的,物料平衡控制数据不合理必定会给制剂质量控制带来矛盾和困惑。结论贯彻实施GPP势在必行,加强物料平衡管理更是保证和提高制剂质量的必要手段之一。
Purpose In the preparation of the preparation process, to strengthen the material balance inspection and management to ensure the quality of preparation. Methods The importance of material balance management and inspection methods were clarified from the concept of material balance, the material balance check of each process during preparation of formulation and so on, so as to provide a means to ensure preparation quality. Results In the process of preparation, the material balance inspection is not the only quality control measure. However, if necessary, the unreasonable material balance control data will inevitably bring contradiction and confusion to preparation quality control. Conclusion It is imperative to implement the GPP and to strengthen material balance management is one of the necessary measures to ensure and improve the quality of preparation.