热毒宁注射液与低硼硅玻璃安瓿瓶的相容性评价

Study on Compatibility of Reduning Injection with Low Borosilicate Glass Ampoule

目的通过提取、浸出及稳定性实验全面考察热毒宁注射液与其包装材料低硼硅玻璃安瓿的相容性。方法首先采用酸性及碱性溶剂对低硼硅玻璃安瓿进行提取,采用电感耦合等离子体质谱仪(ICP-MS)及等离子体发射光谱仪(ICP-OES)检测提取液中的金属元素,采用扫描电子显微镜(SEM)法检测玻璃安瓿内表面可能存在的脱片;然后采用同样的检测方法对热毒宁注射液进行检测,并考察稳定性的影响。结果低硼硅玻璃安瓿提取、浸出实验中可检出33种元素;热毒宁注射液及其稳定性考察样品中各元素均远低于PDE限度值;包装材料内表面均无明显脱片现象。结论热毒宁注射液与低硼硅玻璃安瓿瓶相容性较好,在产品说明书贮藏条件下保存,产品有效期内质量稳定,安全可控。

OBJECTIVE To investigate the compatibility of Reduning injection and lowborosilicate glass ampoule through the elemental analysis of extractables and extracts of Reduning injection products and the analysis of the debonding of the inner surface of glass packaging materials.METHODS Firstly,the low borosilicate glass ampoules were extracted by acid and alkaline solvent.The metal elements in the extract were detected by inductively coupled plasma mass spectrometry(ICP-MS)and plasma emission spectrometry(ICP-OES)and scanning electron microscope(SEM)method for detecting possible splitting on the inner surface of glass ampoules,then the same method was used to detect Reduning injection,and the effect of stability was investigated.RESULTS Thirty-three elements were detected in the extraction and leaching experiments of low borosilicate glass ampoules;all elements in Reduning injection and its stability test samples were far below the PDE limit;no obvious flaking phenomenon was observed on the inner surface of packaging materials.CONCLUSION Reduning injection has good compatibility with low borosilicate glass ampoules.It is preserved under the storage conditions of the product manual.The quality of the product is stable within the validity period,safe and controllable.