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作 者:李冰韶 康倩[1] 陈柽 王永洁 赵颖 何斌源 吴清[1] LI Bing-shao;KANG Qian;CHEN Cheng;WANG Yong-jie;ZHAO Ying;HE Bin-yuan;WU Qing(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 10248;Beijing KangyiMedicine,Beijing 100021)
机构地区:[1]北京中医药大学中药学院,北京102488 [2]北京康益医药投资控股有限公司,北京100021
出 处:《中南药学》2019年第3期414-419,共6页Central South Pharmacy
摘 要:目的优化复方双花口服液(FS)醇沉工艺的关键工艺参数,改善产品的澄明度,保证产品质量的安全有效、稳定可控。方法以(R,S)-告依春保留率(GY)、蛋白质清除率(DB)、多糖清除率(DT)、鞣质清除率(RZ)和出膏率(CG)为考察指标,采用模糊层次分析法(FAHP)、熵权法、FAHP-熵权法确定各指标的权重系数,优化FS醇沉工艺的关键工艺参数。结果 FAHP-熵权法较单一赋权法更加科学、合理、全面,根据所得权重系数进行综合评价,优化后的FS醇沉关键工艺参数为药液浓缩至相对密度1.00~1.05,加入乙醇使含醇量为80%,静置12 h。结论 FAHP法结合熵权法可用于FS醇沉工艺多指标权重的建立,优化后的醇沉工艺稳定可行,除去了水提液中较多的大分子物质,使该产品的澄明度得到了较大的改善,为其工业化大生产的适应性提供参考。Objective To optimize the critical parameters of alcohol precipitation of Fufang Shuanghua oral liquid, and improve its clarity to ensure the safety and effectiveness of product quality and make it stable and controllable. Methods The(R, S)-goitrin retention rate, the precipitation rate of protein/polysaccharide/tannin and the solid content were chosen as indicators. Fuzzy analytic hierarchy process(FAHP), entropy method and FAHP-entropy method were used to determine the weight coefficients of each indicator, to optimize the critical process parameters of alcohol precipitation process. Results FAHP-entropy method was more scientific, reasonable and comprehensive than the single weighting method. According to the obtained weighting coefficients, comprehensive evaluation was conducted. Optimal alcohol precipitation critical technical parameters were as follows: the relative density of the drug concentration was 1.00-1.05;adding ethanol until treaching 80% and resting in cold storage for 12 h. Conclusion FAHP-entropy method can be used to establish the multi-index weights of alcohol precipitation process of Fufang Shuanghua oral liquid. The optimized alcohol precipitation process is stable and feasible. The clarity of the oral liquid is greatly improved after the macromolecules are removed in the extraction, providing a reference for the industrialized large-scale production.
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