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目的:改进冠心宁注射液的二次醇沉及后续工艺。方法:以滤渣质量为指标,考察二次醇沉后冷藏、过滤步骤的必要性。以丹参素钠、原儿茶醛、迷迭香酸、阿魏酸、丹酚酸B含量为指标,考察加入乙醇的体积分数、药液含醇量及pH对二次醇沉及后续工艺的影响。结果:原标准工艺中“冷藏”可忽略不计。二次醇沉时用90%乙醇调节含醇量至80%,用40%NaOH调pH 8.0~8.2。结论:改进后工艺可有效提高冠心宁注射液中5种特征药效成分的含量,更好地控制药液颜色及成品质量,缩短了生产周期,可推广应用。
Objective: To improve the secondary alcohol precipitation of Guanxinning injection and its subsequent process. Methods: The quality of residue was taken as an index to investigate the necessity of cold storage and filtration after secondary alcohol precipitation. The contents of sodium danshensu, protocatechuic aldehyde, rosmarinic acid, ferulic acid and salvianolic acid B were taken as indexes to investigate the effects of the volume fraction of ethanol, alcohol content and pH on the secondary alcohol precipitation and subsequent processes influences. Results: The original standard process “refrigerated ” is negligible. The second alcohol precipitation with 90% ethanol containing alcohol content to 80%, with 40% NaOH pH 8.0 ~ 8.2. Conclusion: The improved technology can effectively improve the content of five characteristic active ingredients in Guanxinning Injection, and better control the color and product quality of medicinal solution, shorten the production cycle and promote the application.