丹参1次醇沉中3个重要工艺参数的相关性研究

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。

Correlations of three important technological parameters in first ethanol precipitation of Danshen

Objective :Water content in concentrated extract(WCCE), the concentration of ethanol used in precipitation(CEA)and the quantity of ethanol added(QEA)are three important variables in the first ethanol precipitation of Danshen injection. In this work, the relationships between the three variables and total solid removal, Danshensu(DSS)retention and DSS purity were investigated. Method : Experiments according to central composite design were carried out and mathematical models were developed. Result : The models were accurate and predictive. The relative deviations between prediction results and experimental results were less than 3%. The influences of the three variables were discussed with a response surface method. The decrease of WCCE and the increase of CEA both caused more precipitation and increase the purity of DSS. However, more loss of DSS was observed. The increase of QEA increased total solid removal. DSS retention and DSS purity increased first and then decreased when QEA increased. Conclusion : This result suggests the addition of ethanol should be optimized according to WCCE and CEA to obtain better supernatant.