摘要
目的探讨复方柴胡栓的处方、制备工艺,并拟定其质量标准。方法采用水蒸气蒸馏法提取柴胡挥发油,将挥发油与牛磺酸混合后采用熔融法制备复方柴胡栓;参照2020年版《中华人民共和国药典》(四部)通则0107项下的质量检查项目拟定该制剂的质量标准;采用气相色谱-质谱法(GC-MS)测定该制剂中正己酸和正庚酸的含量,采用高效液相色谱法(HPLC)测定该制剂中牛磺酸的含量。结果优化后柴胡挥发油精馏时间为1.5 h,正己酸、正庚酸、牛磺酸质量浓度的线性范围分别为23.1750~115.8750μg·mL^(-1)(R^(2)=0.9994),4.5900~68.8500μg·mL^(-1)(R^(2)=0.9989),15~125μg·mL^(-1)(R^(2)=0.9996);平均加样回收率分别为99.83%、101.96%、98.89%;相对标准偏差(RSD)分别为2.84%、1.36%、2.88%;精密度、稳定性、重复性实验的RSD均<5%。该制剂性状、质量差异、融变时限、微生物限度、稳定性考察等均符合《中华人民共和国药典》规定。结论复方柴胡栓的制备工艺合理可行,符合质量标准。
Objective To explore the prescription and preparation technology of compound Bupleurum suppository and draft its quality standard.Methods The volatile oil of Bupleurum was extracted by steam distillation,and the compound Bupleurum-based suppository was prepared by mixing the volatile oil with taurine using the melting method.The quality standard of the preparation was formulated according to the quality inspection items of the general rule 0107 of the Pharmacopoeia of the People's Republic of China(2020 Edition,Volume IV);The contents of n-hexanoic acid and n-heptanoic acid in the preparation were determined by gas chromatography-mass spectrometry(GC-MS).The content of taurine in the preparation was determined by high-performance liquid chromatography(HPLC).Results The optimized distillation time of the volatile oil was 1.5 h,The linear ranges of n-hexanoic acid,n-heptanoic acid and taurine are 23.1750^(-1)15.8750μg·mL^(-1)(R^(2)=0.9994),4.5900-68.8500μg·mL^(-1)(R^(2)=0.9989)and 15^(-1)25μg·mL^(-1)(R^(2)=0.9996),respectively.The average recoveries are 99.83%,101.96%,98.89%with RSDs of 2.84%,1.36%,2.88%,respectively.The RSDs of precision,stability,and repeatability tests are less than 5%.The properties,mass difference,melting time,microbial limit,and stability assessment of the preparationwere all in accordance with the Pharmacopoeia of the People's Republic of China.Conclusion Compound Bupleurum suppository preparation technology is reasonable and feasible,which meets the quality standard.
作者
虞至真
刘泽干
王莉博
黄良永
叶方
朱海涛
徐子俨
杜士明
YU Zhizhen;LIU Zegan;WANG Libo;HUANG Liangyong;YE Fang;ZHU Haitao;XU Ziyan;DU Shiming(College of Pharmacy,Hubei University of Medicine,Shiyan 442000,China;Department of Pharmacy,Affiliated Taihe Hospital of Hubei University of Medicine,Shiyan 442000,China)
出处
《医药导报》
北大核心
2025年第9期1482-1489,共8页
Herald of Medicine
基金
湖北省卫生健康委员会中医药科研项目[ZY2021M005]
十堰市科技局科研项目[16Y21]。
关键词
复方柴胡栓
柴胡挥发油
牛磺酸
制备工艺
质量标准
Compound Bupleurum suppository
Volatile oil of Bupleurum
Taurine
Preparation technology
Quality standard
