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.
出处
《实用药物与临床》
CAS
2008年第3期185-187,共3页
Practical Pharmacy and Clinical Remedies
关键词
卡络磺钠
制备工艺
注射剂
Carbazochrome Sodium Sulfonate
Preparative process
Injection
