CAJ | 학술논문

目的：分析右旋糖酐40氯化钠注射液沉淀物的来源，查找影响因素，并提出控制措施。方法通过分析产品中沉淀物的性质及其产生的因素，并结合试验及生产经验，确定控制措施。结果右旋糖酐40氯化钠注射液沉淀物为右旋糖酐40结晶析出；产品的原料药质量、运输和储存条件对右旋糖酐40氯化钠注射液沉淀物产生有直接的关系。结论通过提高原料质量及保证运输和储存条件等可减少析出结晶，并修订药品说明书明确结晶的处理方式。
목적：분석우선당항40록화납주사액침정물적래원，사조영향인소，병제출공제조시。방법통과분석산품중침정물적성질급기산생적인소，병결합시험급생산경험，학정공제조시。결과우선당항40록화납주사액침정물위우선당항40결정석출；산품적원료약질량、운수화저존조건대우선당항40록화납주사액침정물산생유직접적관계。결론통과제고원료질량급보증운수화저존조건등가감소석출결정，병수정약품설명서명학결정적처리방식。
Objective To analyze the precipitate source of Dextran 40 Sodium Chloride Injection and find the factors affecting,propose control measures. Methods By analyzing the factors in the nature of the product precipitate,and com-bined test,production experience,to determine the control measures. Results Dextran 40 Sodium Chloride Injection precip-itate was crystallized dextran 40;API product quality,transport and storage conditions on the Dextran 40 Sodium Chloride Injection precipitate had a direct relationship. Conclusion By improving the quality of API and to ensure that transport and storage conditions can reduce precipitation crystallization,and revise the package insert to identify the approach of crystal clear.