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碳酸氢钠注射液的主要问题是:澄明度不好,易出现小白点和云雾状微粒现象(“冒烟”)。在贮存过程中,这些现象更为严重。本品通CO_2或用乳酸均能使药液的pH值稳定已得到确认,但操作麻烦,费时。近3年来我们采用改进的配制法,不通CO_2,也不用乳酸调pH(采用重庆制药六厂生产的原料),也能制得合格产品,合格率达到了94%左右,留样观察8个月,澄明度仍在合格范围内。其配制过程如下: 将15～20℃的注射用水配成4%NaHCO_3溶液,加入0.06%EDTA-2Na,并加0.1%针用活性炭,每次
Sodium bicarbonate injection of the main problems are: clarity is not good, prone to white spots and cloud particles phenomenon ( “smoke ”). These phenomena are even more serious during storage. The goods through CO_2 or lactate can make liquid pH stability has been confirmed, but the operation is cumbersome and time-consuming. In the past three years, we have adopted an improved formulating method, failing in CO 2 and adjusting the pH value with lactic acid (using the raw materials produced by Chongqing No. 6 Pharmaceutical Factory), and can also produce qualified products with a passing rate of 94% , Clarity is still within the scope of the eligibility. The preparation process is as follows: 15 to 20 DEG C of water for injection is dubbed 4% NaHCO3 solution, 0.06% EDTA-2Na is added, and 0.1% acupuncture needle activated carbon is added, each time