目的 完善中药醇沉前浓缩液质控指标,并建立浓缩液质量标准。方法 制备多批次党参浓缩液,研究密度与浓缩液其他性质间的关系。将党参炔苷保留率、与乙醇充分混合的浓缩液质量百分比以及单位质量浓缩液产生沉淀质量作为醇沉工艺评价指标,开展膜分散醇沉实验研究,筛选浓缩液关键性质并建立其与上述评价指标的定量模型。基于所建模型,采用预测误差传播的方法建立党参浓缩液的质量标准,并进行实验验证。结果 浓缩液密度与固含量之间具有良好的线性关系。相比密度,浓缩液黏度能更灵敏地体现出不同批次浓缩液的性质差异。筛选出浓缩液的黏度和固含量为浓缩液关键性质。建立的二阶多项式模型R²大于0.97。建立了不等式组作为浓缩液质量控制标准,实验验证结果表明,模型预测性能较好,建立的党参浓缩液的质量标准较为可靠。结论 建议增加黏度作为浓缩液品质的控制指标,并建立综合考虑密度和黏度的浓缩液质量标准,通过放行控制提高醇沉工艺效果及批次间一致性。

Objective To improve the quality control index of concentrate before ethanol precipitation of traditional Chinese medicine and establish the quality standard of concentrate.Methods Multiple batches of Dangshen (CodonopsisRadix) concentrates were prepared to study the relationship between density and other properties of the concentrates.The lobetyolin recovery,mass percentage of concentrate fully mixed with ethanol solution and precipitate mass generated per gram concentrate were used as indicators of ethanol precipitation process.The membrane dispersion ethanol precipitation experiments were carried out to screen the critical properties of concentrates.The quantitative models between the above evaluation indicators and critical properties of concentrates were established.Based on the established models,the quality standard ofCodonopsisRadix concentrates was established by using a prediction error propagation method and verified by experiments.Results There was a good linear relationship between density and solid content of concentrate.Compared with density,viscosity of concentrate could more sensitively reflect the property differences of different batches of concentrates.The viscosity and solid content were selected as the critical properties of the concentrates.R² values of the established second-order polynomial models were greater than 0.97.The verification experimental results showed that the prediction performance of the models was good,and the established quality standard ofCodonopsisRadix concentrates was reliable.Conclusion It was recommended to increase the viscosity as a quality control index of concentrates.By establishing the quality standard of concentrates that comprehensively consider density and viscosity,batch-to-batch consistency of ethanol precipitation process is expected to be improved.

R283.6

国家中医药管理局创新团队与人才支持计划项目(ZYYCXTD-D-202002)