正交试验法优化参芪通脉口服液制备工艺  

Optimization of Preparation Process of Shenqi Tongmai Oral Liquid by Orthogonal Test

作　　者：李倩 吴冰 裴京楠 王莉 李秋萍 张洪平 LI Qian;WU Bing;PEI Jing-nan;WANG Li;LI Qiu-ping;ZHANG Hong-ping(Graduate School of Guangxi University of Chinese Medicine,Nanning 530200,China;Department of Pharmacy,Liuzhou Traditional Chinese Medicine Hospital,Liuzhou 545001,China;Liuzhou Engineering Research Center for Preparation Technology of Chinese Materia Medica(Zhuang and Yao),Liuzhou 545001,China)

机构地区：[1]广西中医药大学研究生院,广西南宁530200 [2]柳州市中医医院(柳州市壮医医院)药学部,广西柳州545001 [3]柳州市中药(壮瑶药)制剂开发工程技术研究中心,广西柳州545001

出　　处：《中国现代中药》2024年第10期1773-1781,共9页Modern Chinese Medicine

基　　金：广西壮族自治区中医药管理局科技项目(GZZC2020421);广西中医药大学校级科研项目(2020MS056);广西壮族自治区中医药管理局中药壮瑶药医院制剂质量提升项目(GZZJ202026)。

摘　　要：目的:优化参芪通脉口服液的制备工艺。方法:在单因素试验的基础上采用正交试验,分别以总皂苷、总黄酮含量和干浸膏得率为评价指标,加权评分优化处方中红参的醇提、复方水提工艺;以总皂苷、总黄酮含量结合沉淀状态、澄清度为评价指标,加权评分优化复方醇沉工艺。以总皂苷、总黄酮含量,澄清度为评价指标对不同pH进行考察,建立参芪通脉口服液的制备工艺,确定主要技术参数及辅料的种类、用量。结果:红参单独醇提最佳工艺为加20倍量60%乙醇,提取3次,每次2.5 h;复方水提最佳工艺为加10倍量水,提取2次,每次提取1.5 h;醇沉最佳工艺为水提液相对密度1.25(80℃),醇沉体积分数80%,醇沉温度35℃。矫味剂为木糖醇,防腐剂为0.1%苯甲酸和0.03%羟苯乙酯,pH调至4.0~5.0,总皂苷和总黄酮质量浓度分别提高至131.050、9.765 mg·mL^(-1)。结论:参芪通脉口服液优选工艺中总皂苷和总黄酮的含量大幅度提升,方法稳定可行、可操作性强,适于批量生产。Objective:To optimize the preparation process of Shenqi Tongmai Oral Liquid.Methods:Basis on of single factor tests,the orthogonal test was employed to optimize the ethanol extraction conditions of Ginseng Radix et Rhizoma Rubra and water extraction conditions of the prescription with total saponins,total flavonoids,and extract yield as the evaluation indexes.With total saponins,total flavonoids,precipitation status,and clarity as the evaluation indexes,the weighted scoring method was used to optimize the ethanol precipitation process of the prescription.With total saponins,total flavonoids,and clarity as the evaluation indexes,the effects of different pH values were investigated.The main technical parameters and the type and dosage of pharmaceutical excipients were determined,and the preparation process of Shenqi Tongmai Oral Liquid was then established.Results:The optimal ethanol extraction process of Ginseng Radix et Rhizoma Rubra was extraction with 20 volumes of 60%ethanol for 3 times(2.5 h each time).The optimal water extraction process of the prescription was extraction with 10 volumes of water twice(1.5 h each time).The optimum ethanol precipitation process was precipitation of water extract(relative density of 1.25 at 80℃)with 80%ethanol at 35℃.The flavoring agent was xylitol,and the preservatives were benzoic acid(0.1%)and hydroxyphenyl ethyl ester(0.03%).The system was adjusted to reach pH 4.0-5.0.Under the conditions above,the concentrations of total saponins and total flavonoids were increased to 131.050 and 9.765 mg·mL^(-1),respectively.Conclusion:The optimization significantly increases total saponins and total flavonoids in Shenqi tongmai Oral Liquid.The method is stable,feasible,and operable and it is thus suitable for mass production.

关 键 词：参芪通脉口服液 提取工艺 成型工艺 正交试验 总黄酮 总皂苷 

分 类 号：R286[医药卫生—中药学]