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目的:研究丹参注射剂生产中1次醇沉中浓缩液水含量、加入乙醇的浓度和乙醇加入量等3个重要工艺参数的相关性及其对醇沉上清液品质的影响。方法:以中心组合设计进行试验,建立了浓缩液水含量、加入乙醇的体积分数和醇料比等工艺条件和醇沉中总固体去除率、丹参素保留率和丹参素纯度等3个指标的数学模型,并对模型进行了验证。通过模型分析各个工艺参数对3个指标的影响。结果:所建立的数学模型具有良好的准确性,预测结果和实测值的相对偏差在3%以下。浓缩液水含量下降和加入乙醇的体积分数提高都有利于沉淀固体和提高丹参素纯度,但会造成丹参素损失更多。醇料比的增加有利于产生沉淀,但是对于丹参素保留率和纯度都会有先增加后下降的效果。结论:为了取得更好的醇沉效果,生产中应该根据浓缩液含水量和待用乙醇的体积分数适当调整加醇量。
OBJECTIVE: To study the correlation between three important parameters, such as the water content of concentrated alcohol concentrate, the concentration of ethanol and the amount of ethanol added during the production of Salvia miltiorrhiza injectio and its effect on the quality of alcohol precipitation supernatant. Methods: The central composite design was used to test the water content of concentrated solution, the volume fraction of ethanol and the ratio of ethanol to ethanol, the total solid removal rate, the retention rate of Danshensu and the purity of Danshensu Mathematical model, and verify the model. Through the model analysis of the impact of various parameters on the three indicators. Results: The mathematical model was established with good accuracy. The relative deviation between the predicted result and the measured value was less than 3%. Decreased water content of the concentrate and the increase of the volume fraction of the added ethanol all contribute to the precipitation of the solid and increase the purity of the danshensu, but cause more loss of the danshensu. The increase of alcohol ratio is conducive to the precipitation, but for the retention and purity of Danshensu will increase first and then decrease. Conclusion: In order to obtain a better alcohol sink effect, the production should be based on the concentration of water content and the volume fraction of ethanol to be appropriate to adjust the volume of alcohol.