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葡萄糖酸鈣注射液是一种过飽和溶液,因葡萄糖酸鈣在水中的溶解度仅为3.3%,而其注射液为10%,因此在貯藏期間极易析出沉淀。过去国內有的药厂在生产葡萄糖酸鈣注射液时,常由于药液产生小白点或大量沉淀,致使废品率高达30%以上。对于这一产品的稳定性,目前虽有了一些改进,但問題尚未得到彻底解决。有关这方面的研究,在各国文献中已有不少介紹,解决的方法不外:选择一种助溶剂以增加葡萄糖酸鈣在溶液中的稳定性;采用純度較高的原料;調整溶液的pH值;在制造过程中避免与空气中的二氧化碳接触;注意安瓿的质量以及某些操作方法的改进,等等。茲根据各国文献記載以及国內生产单位的实际經驗,对葡萄糖酸鈣注射液的稳定性問題,从下列几方面
Calcium gluconate injection is a supersaturated solution, since calcium gluconate has a solubility in water of only 3.3% and its injection is 10%, thus precipitating easily during storage. In the past, some domestic pharmaceutical companies in the production of calcium gluconate injection, often due to liquid white spots or a large number of precipitation, resulting in rejection rate as high as 30%. The stability of this product, although some improvements, but the problem has not yet been completely resolved. The research in this field has been introduced in many countries and the solution is nothing more than the following: Choose a cosolvent to increase the stability of calcium gluconate in solution; Use high purity raw materials; Adjust the pH of the solution Value; Avoid contact with carbon dioxide in the air during manufacturing; Pay attention to the quality of the ampoules and improvements in certain operating methods, and so on. It is based on documented in various countries and the actual experience of domestic production units, calcium gluconate injection stability issues, from the following aspects