蒲地蓝消炎口服液醇沉环节质量标志物的有效传递研究  

Effective delivery of quality markers in alcohol precipitation of Pudilan Xiaoyan Oral Liquid

作　　者：黄然 姜梦华 孙娥[2] 李超 朱法根 邵建国 封亮 贾晓斌 HUANG Ran;JIANG Meng-hua;SUN E;LI Chao;ZHU Fa-gen;SHAO Jian-guo;FENG Liang;JIA Xiao-bin(the Affiliated Haspital of Nanjing University of Chinese Medicine,Nanjing 210029,China;Key Laboratory of New Drug Delivery System of Chinese Materia Medica,Jiangsu Prorince Academy of Traditional Chinese Medicine,Nanjing 210028,China;Jiangsu Key Laboralory of Chinese Medicine and Characteristic Preparations for Paediatrics,Jumpcan Pharmaceutical Co.,Itd.,Taixing 225400,China;School of Traditional Chinese Pharmacy,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]南京中医药大学附属医院,江苏南京210029 [2]江苏省中医药研究院国家中医药管理局中药口服释药系统重点研究室,江苏南京210028 [3]济川药业集团有限公司江苏省儿科中药与特色制剂重点实验室,江苏泰兴225400 [4]中国药科大学中药学院,江苏南京211198

出　　处：《中国中药杂志》2022年第21期5757-5764,共8页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划项目(2018YFC1706902);江苏省儿科中药与特色制剂重点实验室开放课题项目(BM2019011);江苏省科技成果转化专项(BA2020077);江苏省医学创新团队项目(CXTDB2017003);国家中医药管理局基于重点研究室研究领域的中医药多学科研究能力提升项目(2022GJJZDYJS-01);2021年度江苏省研究生实践创新计划项目(SJCX21-0716)。

摘　　要：以蒲地蓝消炎口服液为例,研究中药口服液体制剂醇沉环节质量标志物的有效传递。采用Plackett-Burman试验设计,以腺苷、紫堇灵、菊苣酸、黄芩苷和汉黄芩素转移率为指标,考察醇沉前浓缩液密度、加入乙醇体积分数、搅拌速度、浓缩液温度、搅拌时间、醇浓度、醇沉时间、醇沉静置温度、加醇速度及浓缩液pH对醇沉工艺的影响,得出影响醇沉工艺的关键因素。再通过Box-Behnken试验对关键因素进行优化,得到最佳醇沉工艺参数。当醇沉前浓缩液密度为1.12 g·mL-1,浓缩液pH为6.86,醇浓度为50.00%时,黄芩苷和汉黄芩素的转移率分别为91.86%和87.78%;当醇沉前浓缩液密度为1.13 g·mL-1,醇浓度为74.50%,醇沉静置温度为17.0℃时,腺苷、紫堇灵和菊苣酸的转移率分别为85.95%、71.62%和83.19%。采用响应面法优化蒲地蓝消炎口服液醇沉工艺确定工艺参数的方法合理可行,同时为中药口服液体制剂中质量标志物的有效传递提供指导和经验。Taking Pudilan Xiaoyan Oral Liquid as a demonstration, the effective delivery of quality markers in alcohol precipitation of Chinese medicine oral liquid preparations was studied. With the transfer rates of adenosine, corynoline, cichoric acid, baicalin, and wogonin as evaluation indexes, the effect of the density of concentrate before alcoholic precipitation, volume fraction of ethanol, stirring speed, temperature of concentrated solution, stirring time, alcohol concentration, alcohol precipitation time, alcoholic precipitation temperature, alcohol addition rate, and the pH of concentrate on the alcohol precipitation process was investigated by Plackett-Burman trial design, thus obtaining the key factors that influenced the alcohol precipitation process. The key factors were further optimized by Box-Behnken design to determine the optimal alcohol precipitation conditions. When the density of concentrate before alcoholic precipitation was 1.12 g·mL-1, the pH of concentrate was 6.86, and the alcohol concentration was 50.00%, the transfer rates of baicalin and wogonin were 91.86% and 87.78%, respectively. When the density of concentrate before alcoholic precipitation was 1.13 g·mL-1, the concentration of alcohol was 74.50%, and the alcoholic precipitation temperature was 17.0 ℃, the transfer rates of adenosine, corynoline, and cichoric acid were 85.95%, 71.62% and 83.19%, respectively. The method of optimizing alcohol precipitation techniques and determining the parameters of Pudilan Xiaoyan Oral Liquid by response surface methodology is reasonable and feasible, which provides guidance and experience for the effective delivery of quality markers in Chinese medicine oral liquid preparations.

关 键 词：中药口服液体制剂 醇沉环节 质量标志物 有效传递 蒲地蓝消炎口服液 

分 类 号：R283.6[医药卫生—中药学]