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前文曾报导試用塑料涂塞消除注射液灭菌时因瓶塞产生的白点,得到比較滿意的結果。根据文献报导,注射液产生白点的原因大致有五方面:(1)容器附着的污物未洗净,(2)容器玻璃在灭菌时发生水解产物,(3)原料药含杂质,灭菌后形成白点,(4)在注射液灭菌时橡皮塞有脫落物而形成白点,(5)蒸溜水含常水,灭菌后形成白点,(6)长期存放中产生的白点。为了进一步弄清楚注射液灭菌时产生白点的主要原因和設法加以防止,我們进行了如下的实驗观察。白点的来源实驗分四批,每批分实驗和对照两組,每組20个一千毫升的馮瓦氏瓶,在灭菌后的次日作澄明度检查,結果如表1。对长期存放中产生的白点未作观察。从表1批号1两組比較中,未发現因蒸溜水、玻璃水解产物、容器附着污物未洗净而产生
The article previously reported plastic plug test plastic injection to eliminate the white spots caused by the stopper, get more satisfactory results. According to the literature, there are five main reasons for white spots in injection: (1) uncleaned dirt attached to container, (2) hydrolysis of container glass when sterilized, (3) Bacteria form white spots, (4) in the injection sterilization rubber plug off the formation of white spots, (5) distilled water containing water, white spots formed after sterilization, (6) long-term storage of white point. In order to further clarify the main causes of white spots and try to prevent the injection sterilization, we conducted the following experimental observations. The source of the white spots was divided into four batches. Two batches of experimental and control batches were made, each of which contained 20 1000-ml von Vahl’s bottles. The results were as shown in Table 1 after the sterilization. White spots produced during long-term storage were not observed. From Table 1 Lot 1 two groups of comparison, did not find distilled water, glass hydrolysates, containers attached to the dirt generated by cleaning