基于质量源于设计理念的上市冰硼散质量评价研究

Quality evaluation of marketing Bingpeng powder based on quality by design

目的以质量源于设计(QbD)理念为指导,对冰硼散的质量状况进行分析与评价。方法按法定标准检验与探索性研究相结合,对评价工作进行详细的设计和落实。结果通过对收集来的样品进行现行法定标准检验,发现部分生产企业存在不严格执行生产工艺的情况,如存在过量投料的问题。根据冰硼散的实际质量情况,采用探索性研究的形式,对其安全性、有效性和稳定性进行评价,发现冰硼散存在可溶性汞元素含量过高及有人工合成色素染色等安全性问题;部分样品中存在主要成分硼砂(煅)和玄明粉含量过低引起的有效性问题。此外,不合适的包装材料会降低冰硼散的受热稳定性。最后,针对所发现的问题,分别对冰硼散的生产环节及质量标准提出了相关建议。结论本研究对于冰硼散药品的质量提升具有一定的意义,同时也是QbD理念指导药品质量评价的有益尝试。

Objective To evaluate the quality of marketing Bingpeng powder based on quality by design(QbD). Methods Combination the official standard tests and exploratory research, we evaluated the quality of marketing Bingpeng powder with careful design and strict implementation based on QbD. Results In the test of current official standard for collected samples, the production process of some manufacturers was not strictly followed, and excessive feeding of raw materials in some manufacturers was found. The safety, effectiveness and stability of Bingpeng powder were evaluated in the form of exploratory research and some problems were revealed. First, the high content of soluble mercury and synthetic dyes in some samples affected the safety of this drug. Second, the low content of borax(calcined) and compound of glauber-salt and liquorice influenced the effectiveness of this drug. Finally, the stability of Bingpeng powder depended on the medicinal packaging materials. For these problems, we gave suggestions on the production procession and quality standard in this paper. Conclusion The research helps promote the quality of marketing Bingpeng powder, and it is a meaningful try for the application of QbD in the quality evaluation of drugs.