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碳酸氢钠注射液生产中易出现小白点和云雾状微粒现象(冒烟现象)而造成澄明度不合格,成品率不高,尤其在贮存期更甚。曾有报道,利用乳酸调节药液pH值,能有效地提高制剂品的澄明度。但其贮存期澄明度如何,最佳生产pH值,室温下的贮存期尚未见有报道。我们在大量生产中利用乳酸调节pH值,并添加了0.01％EDTA-2Na作稳定剂,成品合格率达到93.4％;对留样一年的产品复查,产品合格率为96.5％。本文根据留样考察、着重探讨了pH值对碳酸氢钠注射液稳定性的影响。
Sodium bicarbonate injection prone to white spots and cloud particles phenomenon (smoke phenomenon) caused by the clarity of the unqualified, the yield is not high, especially in the storage period even worse. It has been reported that the use of lactic acid to adjust the liquid pH, can effectively improve the clarity of the preparation. However, the clarity of its storage time, the best production of pH, storage period at room temperature has not been reported. We use a large number of production of lactic acid to adjust the pH, and add 0.01% EDTA-2Na as a stabilizer, the passing rate of finished products reached 93.4%; to retain samples of the product review, the product pass rate of 96.5%. This article based on sample inspection, focusing on the pH value of sodium bicarbonate injection stability.