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为了有效去除痛安注射液中无效杂质,优化配液过程中除杂工艺的最佳参数,该文以痛安注射液为研究对象,以白屈菜碱的质量浓度、青藤碱的质量浓度、固含物减少率、有关物质检查结果等为评价指标,考察冷藏、热处理、碳吸附等工艺对药液中杂质及有关物质的去除情况,优化工艺参数并确定除杂方法的可行性。结果表明,冷藏时间36 h,热处理时间15 min,活性炭用量0.3%,100℃吸附10 min,能够有效的去除痛安注射液中鞣质等杂质,保证成品的质量和安全性。
In order to effectively remove the unnecessary impurities in Tongan injection and optimize the optimal parameters of the impurity removal process in the process of liquid preparation, the paper takes Tong’an injection as the research object, and takes the mass concentration of chelidonine, the mass concentration of sinomenine , The reduction rate of solid content, the results of the relevant substances as the evaluation index, to investigate the removal of impurities and related substances in the liquid chemicals by refrigeration, heat treatment, carbon adsorption and the like, and to optimize the process parameters and determine the feasibility of the impurity removal method. The results showed that the chilling time of 36 h, the heat treatment time of 15 min, the amount of activated carbon 0.3% and adsorption of 100 ℃ for 10 min can effectively remove the impurities such as tannin in Tongan Injection and ensure the quality and safety of the finished product.