安瓿瓶内表面与枸橼酸咖啡因注射液的相容性研究

摘要

OBJECTIVE: To study the compatibility of inner surface of anatomy bottle and Caffeine citrate injection.METHODS: After treated with high temperature (60 ℃, 10 days), light (5 000 Lx, 10 days), freezing and thawing (2 days for freezing at -18 ℃ and 2 days for thawing at 40 ℃ as a circulation, and repeat for 3 times), sterilizing (121 ℃, 2 h), Caffeine citrate injection packed in anatomy bottle was tested in respects of pH value, insoluble particle, glass stripping tendency before test and under the above conditions. The contents of arsenic, cadmium, lead, cobalt, manganese, vanadium, copper, lithium, barium, chromium, antimony, aluminum, boron, calcium, iron, potassium, magnesium, silicon and titanium that may dissolve by inner surface of anatomy bottle were tested by ICP method, and compared with analysis evaluation threshold (AET) of each element. RESULTS: Before the test, under high temperature, light, freezing and thawing, sterilization, and pH values of Caffeine citrate injection installed with ampoule were 4. 58, 4. 60, 4. 61, 4. 58, 4. 58. The insoluble particles were all in line with 0903 provisions stated in (four) general provisions of Chinese Pharmacopoeia (2015 edition). The inner surface of ampoule bottle glass had no stripping tendency. The arsenic, cadmium, lead, cobalt, manganese, vanadium, copper, lithium, barium, chromium, antimony, iron, magnesium and titanium were not detected in caffeine citrate injection, and the contents of aluminum, boron, calcium, potassium and silicon were far below its AET value. CONCLUSIONS: Caffeine citrate injection has no effect on inner surface of ampoule bottle.%目的:研究安瓿瓶内表面与枸橼酸咖啡因注射液的相容性.方法:将安瓿瓶装枸橼酸咖啡因注射液分别进行高温(60 ℃, 10 d)、光照(5000 Lx,10d)、冻融(-18 ℃冷冻放置2d、40℃融化放置2 d为1个循环,按此循环处理3次)、灭菌(121 ℃, 2 h)处理,检测试验前及上述条件下枸橼酸咖啡因注射液的pH值、不溶性微粒、安瓿瓶玻璃脱片趋势,并采用电感耦合等离子光谱法(ICP)检测安瓿瓶内表面玻璃可能浸出的砷、镉、铅、钴、锰、钒、铜、锂、钡、铬、锑、铝、硼、钙、铁、钾、镁、硅、钛元素的含量,与各元素分析评价阈值(AET)进行比对.结果:在试验前及高温、光照、冻融、灭菌的情况下,安瓿瓶装枸橼酸咖啡因注射液的pH值分别为4.58、4. 60、4. 61、4. 58、4. 58,不溶性微粒均符合2015年版《中国药典》(四部)通则0903规定范围,安瓿瓶内表面玻璃没有脱片趋势,枸橼酸咖啡因注射液中砷、镉、铅、钴、锰、钒、铜、锂、钡、铬、锑、铁、镁、钛元素等均未检出,铝、硼、钙、钾、硅含量均低于其 AET.结论:枸橼酸咖啡因注射液对安瓿瓶内表面没有影响.