茱萸丸制备工艺与质量控制方法研究  

Study on preparation technology and quality control method of Zhuyu pil

作　　者：何小芳 李敏敏 周昕[2] 张小波 杨乐乐 宋玮 沈涛[2] 何瑶[1] HE Xiaofang;LI Minmin;ZHOU Xin;ZHANG Xiaobo;YANG Lele;SONG Wei;SHEN Tao;HE Yao(State Key Laboratory of Southwestern Chinese Medicine Resources,School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,Sichuan;School of Basic Medicine,Chengdu University of Traditional Chinese Medicine,Chengdu 610075,Sichuan)

机构地区：[1]西南特色中药资源国家重点实验室,成都中医药大学药学院,四川成都611137 [2]成都中医药大学基础医学院,四川成都610075

出　　处：《中药与临床》2024年第6期20-24,37,共6页Pharmacy and Clinics of Chinese Materia Medica

基　　金：四川省科技计划项目(2022YFS0381)。

摘　　要：目的:优化茱萸丸塑制法制备工艺并建立质量控制方法。方法:以溶散时限、水分、指标成分含量为评价指标,筛选茱萸丸的最佳制备工艺,并对制备的5批次样品进行HPLC含量测定、薄层鉴别、溶散时限的质量控制研究。结果:茱萸丸制备工艺为:炒吴茱萸、酒黄连均粉碎成100目细粉,加0.5倍药粉量的纯化水润湿,闷润30 min,再加0.3倍药粉量的纯化水制软材,全自动制丸机中制丸,选丸,55℃干燥8 h,即得。建立茱萸丸指标成分HPLC含量测定方法,测得茱萸丸中的吴茱萸碱和吴茱萸次碱总量、表小檗碱、黄连碱、巴马汀、小檗碱质量分数分别为4.0686~4.4927,0.8731~1.0830,1.4008~1.7601,2.2402~2.7281,7.4301~8.8474 mg·g^(-1);薄层色谱鉴别中,茱萸丸样品在与黄连对照药材、小檗碱对照品、吴茱萸对照药材、吴茱萸次碱对照品色谱相应位置显相同颜色的荧光斑点,主斑点清晰,分离度好;茱萸丸溶散时限均符合2020年版《中国药典》“丸剂”项下规定。结论:优选的茱萸丸制备工艺简便稳定,质量控制方法准确、可靠,可为茱萸丸医院制剂研究开发提供参考。Objective:To optimize the preparation process of Zhuyu pill and establish the quality control method.Methods:The optimal preparation process of Zhuyu pill was screened based on the evaluation indexes of dissolution time,moisture and index component content.HPLC content determination,thin layer identification,and quality control of dissolution time of 5 batches of samples were studied.Results:The preparation process of Zhuyu pill was as follows:Fried Euodiae Fructus Coptidis Rhizoma(Wuzhuyu)and Coptis rhizoma(Huanglian)prepared with yellow rice wine were crushed into 100 mesh fine powder.then added 0.5 times the amount of medicinal powder to the purified water for 30 minutes,then added 0.3 times the amount of medicinal powder to the purified water to make soft material,Purified water of o.5 times the amount of medicinal powder was added to wet,and made moist for 30 minutes.Then 0.3 times the amount of medicinal powder of purified water was added to make soft material which was put into the automatic pill-making machine to make pills.The pills was selected,dried at 55°C for 8 hours,and removed.The HPLC content determination method of Zhuyu pill was established.The contents of evodiamine and rutaecarpine,berberine,coptisine,palmatine and epberberine in Zhuyu pills were 4.0686-4.4927,0.8731-1.0830,1.4008-1.7601,2.2402-2.7280 and 7.4301-8.8474 mg·g^(-1),respectively.In the thin-layer chromatography identification,Zhuyu pill samples showed fluorescent spots of the same color in the corresponding positions of the chromatogram of Huanglian,berberine hydrochloride reference substance,Wuzhuyu control substance,and rutaecarpine reference substance.The main spots were clear and the separation was good.The dissolution time in line with the provisions under the"pil"in the Chinese Pharmacopoeia(2020 edition).Conclusion:The preparation process of the optimized Zhuyu pill is simple and stable,and the quality control method is accurate and reliable,which can provide reference for the research and development of Zhuyu pill hospit

关 键 词：茱萸丸 制备工艺 质量控制 溶散时限 HPLC含量测定 薄层鉴别 

分 类 号：R283.6[医药卫生—中药学]