能力六合图在医院制剂硫酸镁口服溶液质量分析中的应用

Application of capability sixpack in quality analysis of hospital preparation magnesium sulfate oral solution

目的应用能力六合图对医院制剂硫酸镁口服溶液进行质量分析。方法运用Minitab软件中能力分析的"六合图"功能,以硫酸镁口服溶液的硫酸镁含量为指标,判断生产过程中硫酸镁含量是否达到控制状态,硫酸镁口服溶液的生产工艺是否稳定。结果硫酸镁含量及硫酸镁口服溶液的生产工艺处于受控状态,但存在潜在缺点。基于风险管理理念,应用失败模式和效应分析(FMEA)进行了潜在风险的前瞻性管理。结论应用能力六合图于医院制剂硫酸镁口服溶液的质量分析,有助于我们发现生产工艺受控状态下的潜在风险,有利于制剂生产过程的改进以及制剂质量的保证。

Objective To analyze the quality of the hospital preparation magnesium sulfate oral solution by using capability sixpack.Methods By using the capability sixpack of Minitab,the content of magnesium sulfate in the magnesium sulfate oral solution was used as an indicator to determine whether the magnesium sulfate composition reached a controlled state during the production process and whether the production process of magnesium sulfate oral solution was stable.Results The content of magnesium sulfate and the production process of magnesium sulfate oral solution was under control,but there were potential disadvantages.Based on the concept of risk management philosophy,The failure model and effect analysis(FMEA)were applied to the prospective management of potential risks.Conclusion The application of the capability sixpack in the quality analysis of the hospital preparation of magnesium sulfate oral solution is helpful for us to discover the potential risks under the controlled state of the production process,which is beneficial to the improvement of the preparation production process and the assurance of the quality of the preparation.