卡络磺钠葡萄糖注射液制剂处方及工艺的研究  

Study on preparative process of Carbazochrome Sodium Sulfonate and glucose injection

作　　者：林瑞红[1] 马大中[2] 

机构地区：[1]沈阳市药品快速检验所,沈阳110013 [2]东北制药集团公司沈阳第一制药厂,沈阳110023

出　　处：《实用药物与临床》2008年第3期185-187,共3页Practical Pharmacy and Clinical Remedies

摘　　要：目的研究卡络磺钠葡萄糖注射液的制备工艺。方法对抗氧剂和金属螯合剂用量、pH值、活性炭用量和灭菌条件进行了筛选。用高效液相色谱法测定卡络磺钠的含量和有关物质。结果加入0.1%甲硫氨酸和0.005%依地酸钙钠,调pH值在4.5-5.5,加入0.05%的活性炭,115℃热压灭菌30 min。制剂质量符合药典有关注射剂的质量标准。结论本品制备工艺可靠,适于工业化生产,质量可控。Objective To study the preparative process of Carbazochrome Sodium Sulfonate and glucose injection. Methods In the experiment, the ratio of antioxidant and metal chelate compound, pH value, the ratio of activated charcoal and sterlization condition experiment were selected respectively. The contents and related substances of carbazochrome Sodium Sulfonate were determined by HPLC. Results The optimal conditions were established as follows： Methionine 0.1%, calcium disodium edetate 0. 005 %, pH 4.5 -- 6.5, activated charcoal 0.05 %, press heat sterlization 115 ℃ for 30 rain. The quality of the injection conformed to the standard for injection in Chinese pharmacopoeia. Conclusion The preparation of Carbazochrome Sodium Sulfonate and glucose injection is reliable and suitable for the industrial manufacture. Its quality can be controlled.

关 键 词：卡络磺钠 制备工艺 注射剂 

分 类 号：R94[医药卫生—药剂学] TQ463[医药卫生—药学]