CAJ | 학술논문

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。
종산품질량설계적각도，재문헌종술급이론계산적기출상，이체도공제수분상한적평형흡습량대응적상대습도，작위관건상대습도（KRH）교림계상대습도（CRH）경유실제의의；가통과계산명학상관적공예조작시한、상관변경적유효성，이급내포장재료방조성능요구；차외，목전약품내포장재료적방조성능지표저，응제정상응적내공표준。
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 .