Compatibility Study of Inner Surface of Anatomy Bottle and Caffeine Citrate Injection / 中国药房

ABSTRACT

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.