国产尼莫地平注射液稳定性影响因素试验

目：考察国产尼莫地平注射液稳定性影响因素。方法：考察本产品对温度和光照稳定性，湿度分为低温（4℃）、高温（40℃、60℃、80℃）考察10天，光照考察3000Ix强光试验和室温自然光暴露试验24h。主要考察项目为尼莫地平含量以及有关物质变化。结果：尼莫地平注射液对 低温、高温稳定性良好；尼莫地平注射液对光敏感，置于3000Ix强光照射5h含量下降2．6％，有关物质接近超标为2．93％，第10h明显变化含量降至69．5％、有关物质相应增多，第24h含量仅为40．2％、有关物质为27．33％，色泽明显加深；但在室温自然光暴露24h，含量无明显变化。结论：国产尼莫地平注射液与尼莫通注射液影响因素试验研究文献报道结果基本相符。本品应该避光贮存，输注需避免阳光等强光直射。

The stable factors on nimodipine injection

OBJECTIVE：To invesitigate efects of temperature and light on content and the related substances Nimodipine lnject ion.METHODS:Put them into different conditions(4℃,40℃,60℃,80℃,st rong light of 3000Ix,nature light),detemine its content and related substances b y HPLC.RESULTS:on the condition of strong light,the Nimodipine lnjec tion is not stable.After 5,10,24 hours,the content becomes 96.6%,69.5%,40.2% res pectively and the related substances.increase,but on other conditions,it is rath er stable.CONCLUSION:It should be avoided strong light when store an d use.