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随着卫生行业“三项改革”的进行,医药事业在蓬勃发展,但由于医院的条件限制,硬件跟不上,稍有忽疏会造成制剂质量不稳定,往往影响临床疗效,为了医院制剂能符合《医疗机构制剂配制质量管理规范》和《医疗机构制剂许可证》的验收标准,笔者根据多年的工作经验,应从下面两方面加以注意:1生产过程中的质量控制1.1原料药的控制。制剂质量的好坏与原料药有直接的关系。
With the progress of the “three reforms” in the health sector, the pharmaceutical industry is booming. However, due to the limited conditions in hospitals and the inability to keep up with the hardware, a slight overshoot will result in unstable preparation quality and often affect clinical efficacy. For the sake of hospitals The preparation can meet the acceptance criteria of “Quality Management Regulations of Preparation of Medical Institutions” and “Preparation License of Medical Institutions”. Based on years of work experience, the author should pay attention to the following two aspects: 1. Quality Control in Production Process 1.1 Control of Raw Material Drugs . The quality of preparation and raw material medicine has a direct relationship.