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在一次检查0.9％氯化钠注射液(下称盐水)成品时,同一缸pH为6.33的半成品灌装在新输液瓶(出厂未曾使用者。下称新瓶)的500瓶pH为8.70±0.12((?),n=5)不合格;而灌装在旧输液瓶(已使用过一或多次者,下称旧瓶)的500瓶pH为6.90±0.09((?)X,n=3)合格。联想到以往在连续配制数批盐水中,间或出现一批pH不合格品。经查不合格品均为新瓶灌装。为此进行了试验,结果提示,某些厂生产的输液瓶虽中性和耐碱性试验合格,但首次灌装盐水仍可
In a single test of a 0.9% sodium chloride injection (hereinafter referred to as saline) finished product, the 500 bottles of the same bottle with a pH of 6.33 were filled in a new infusion bottle (not used by the manufacturer, new bottle) 8.50 ± 0.12 ((?), n = 5) failed; while the 500 bottles filled in the old infusion bottle (those used more than once, hereinafter referred to as the old bottle) had a pH of 6.90 ± 0.09 3) pass. Associated with the past in the continuous preparation of several batches of salt water, or appear between a batch of pH substandard products. The investigation of substandard products are new bottle filling. To this end, the test results suggest that although some of the factory production of infusion bottles of neutral and alkali resistance test pass, but the first time filling the brine can still