文献类型：期刊文献

中文题名：蓉参通便口服液的制备工艺及中试生产研究

英文题名：Study on preparation technology and pilot production of Rongshen Tongbian oral liquid

作者：王丹[1];马冬妮[2];张文广[1];贾春艳[1];张云鹤[1];杜小正[1];范凌云[1];何贵山[3];李芸[1]

第一作者：王丹

机构：[1]甘肃中医药大学,甘肃兰州730000;[2]甘肃省敦煌市中医院,甘肃敦煌736200;[3]甘肃天然源生物科技有限公司,甘肃兰州730000

第一机构：甘肃中医药大学

年份：2022

卷号：37

期号：6

起止页码：613

中文期刊名：华西药学杂志

外文期刊名：West China Journal of Pharmaceutical Sciences

收录：CSTPCD;;CSCD:【CSCD_E2021_2022】；

基金：全国中药特色技术传承人才培训项目(T20184828005);甘肃省高等学校产业支撑引导项目(2020C-26);兰州市人才创新创业项目(2018-RC-086)。

语种：中文

中文关键词：蓉参通便口服液;提取工艺;纯化工艺;成型工艺;正交试验;均匀设计试验;AHP-CRITIC法;中试生产

外文关键词：Rongshen Tongbian oral liquid;Extraction process;Molding process;Purification process;Orthogonal design test;Uniform design test;AHP-CRITIC method;Pilot production

摘要：目的优化蓉参通便口服液的制备工艺并研究其中试生产工艺。方法以出膏率、总多糖、阿魏酸、松果菊苷的含量为考察指标,采用AHP-CRITIC混合加权法确定权重系数,结合正交试验优选蓉参通便口服液提取工艺的最佳参数。以澄明度、总多糖、阿魏酸、松果菊苷等含量为考察指标,采用AHP-CRITIC混合加权法确定权重系数,结合均匀设计试验优化纯化的工艺,单因素试验优选矫味剂的种类,经浓缩、配液、分装、灭菌后制备得到蓉参通便口服液。在中试生产研究中,根据实际生产条件,对制备工艺进行调整。结果蓉参通便口服液的最佳提取工艺为:全方药材加10倍量水(第二次8倍量)浸泡8 h,提取(3 h×3)。经实验室与中试研究,确定最佳成型工艺为采用管道过滤器过滤(160目),浓缩至相对密度为1.11~1.13(20℃),加0.02%甜菊糖苷进行矫味,0.3%苯甲酸钠防腐剂,在100℃、<0.1 MPa的参数下,在杀菌釜中蒸汽灭菌10 min。结论所用制备工艺简便可行,可为蓉参通便口服液的开发提供依据。
OBJECTIVE To optimize and study the preparation process and pilot production of Rongshen Tongbian oral liquid(RTOL).METHODS Dry paste rate,total polysaccharide,ferulic acid and echinoside contents were taken as the evaluation indexes.Weight coefficients were determined by AHP-CRITIC mixed weighting method,and the optimal extraction parameters of RTOL were optimized by orthogonal experiment.Clarity,total polysaccharide,ferulic acid and echoloside contents were taken as the evaluation indexes,the weight coefficient was determined by AHP-CRITIC mixed weighting method,the purification process was optimized by uniform design experiment,and the type of taste stabilizer was optimized by single factor experiment.RTOL was prepared by concentration,liquid mixing,packaging and sterilization.According to the actual production conditions,the preparation technology was further adjusted.RESULTS The optimal extraction process of RTOL was to soak the whole medicinal material in 10 times water(8 times water for the second time)for 8 h,and extracted it for 3 times and 3 h for each time.Through laboratory and pilot scale studies,the best molding process was determined as follows:pipe filter(160 mesh)was used for filtering,concentrated to the relative density of 1.11-1.13(20℃),adding 0.02%stevia glycoside for taste rectification,0.3%sodium benzoate preservative,at 100℃,<0.1 MPa parameter,steam sterilization in sterilization kettle for 10 min.CONCLUSION The preparation process is simple and feasible,which can provide scientific basis for the subsequent development of RTOL.