在制药行业中,质量源于设计(QbD)是一种系统化的方法,用于确保药品的质量和安全性。本文将探讨一种速释片的QbD实例,旨在通过科学的方法优化制剂工艺,提高产品的稳定性和一致性。
中文原文:
在制药行业中,质量源于设计(QbD)是一种系统化的方法,用于确保药品的质量和安全性。本文将探讨一种速释片的QbD实例,旨在通过科学的方法优化制剂工艺,提高产品的稳定性和一致性。
英文翻译:
In the pharmaceutical industry, Quality by Design (QbD) is a systematic approach to ensure the quality and safety of drugs. This article will discuss an example of QbD for an immediate release tablet, aiming to optimize the formulation process through scientific methods to improve product stability and consistency.
通过采用QbD方法,我们能够更好地理解影响药物性能的关键因素,并据此调整配方和生产工艺。例如,在开发速释片时,需要考虑活性成分的溶解度、辅料的选择以及制备过程中的温度和压力条件等因素。这些参数不仅影响最终产品的释放特性,还可能对患者的用药体验产生重要影响。
中文原文:
通过采用QbD方法,我们能够更好地理解影响药物性能的关键因素,并据此调整配方和生产工艺。例如,在开发速释片时,需要考虑活性成分的溶解度、辅料的选择以及制备过程中的温度和压力条件等因素。这些参数不仅影响最终产品的释放特性,还可能对患者的用药体验产生重要影响。
英文翻译:
By adopting the QbD approach, we can better understand the critical factors that affect drug performance and adjust formulations and manufacturing processes accordingly. For instance, when developing an immediate release tablet, factors such as the solubility of active ingredients, the selection of excipients, and the temperature and pressure conditions during preparation must be considered. These parameters not only influence the release characteristics of the final product but may also have a significant impact on the patient's medication experience.
总之,通过实施QbD策略,我们可以实现更高质量的产品,同时降低生产过程中的风险。这对于保障公众健康具有重要意义。
中文原文:
总之,通过实施QbD策略,我们可以实现更高质量的产品,同时降低生产过程中的风险。这对于保障公众健康具有重要意义。
英文翻译:
In conclusion, by implementing QbD strategies, we can achieve higher-quality products while reducing risks in the production process. This is of great significance for ensuring public health.
请注意,以上内容仅为示例性质,实际应用中应根据具体情况进行调整和完善。希望本文能为相关领域的研究人员提供有价值的参考信息。
中文原文:
请注意,以上内容仅为示例性质,实际应用中应根据具体情况进行调整和完善。希望本文能为相关领域的研究人员提供有价值的参考信息。
英文翻译:
Please note that the above content is for illustrative purposes only, and specific adjustments and improvements should be made according to actual circumstances in practical applications. It is hoped that this article can provide valuable reference information for researchers in relevant fields.