中药固体制剂吸湿性评价及其实践应用

Hygroscopic Evaluation and its Practical Application of Solid Preparation of Chinese Materia Medica

从产品质量设计的角度,在文献综述及理论计算的基础上,以达到控制水分上限的平衡吸湿量对应的相对湿度,作为关键相对湿度(KRH)较临界相对湿度(CRH)更有实际意义;可通过计算明确相关的工艺操作时限、相关变更的有效性,以及内包装材料防潮性能要求;此外,目前药品内包装材料的防潮性能指标低,应制订相应的内控标准。

On the basis of QBD, literature review and theoretical calculations, hygroscopic was evaluated by absorbent balanced; within defining indicators, process control and storage parameters were calculated; packaging material was then chosen. Relative humidity while preparation reached moisture equilibrium at the maximum water standard, is called key relative humidity （KRH） ,which is more practical significance than CRH; time limit of process operation, effectiveness of changes and packaging material moisture-proof per- formance requirements can be calculated; current standards of moisture-proof performance indicators of phar- maceutical packaging materials should be developed appropriate, and internal control standards should be given.