复方连翘滴鼻液制备工艺优化及质量控制  

Optimization of Preparation Technology and Quality Control of Compound Lianqiao Nasal Drops

作　　者：金伟华 于波涛 张明 蒲志强 龚婵 JIN Weihua;YU Botao;ZHANG Ming;PU Zhiqiang;GONG Chan(Department of Pharmacy,The General Hospital of Western Theater Command of PLA,Chengdu,Sichuan,China;Department of Pharmacy,North Sichuan Medical College,Nanchong,Sichuan,China637000)

机构地区：[1]中国人民解放军西部战区总医院药剂科,四川成都612083 [2]川北医学院药学部,四川南充637000

出　　处：《中国药业》2021年第6期32-35,共4页China Pharmaceuticals

摘　　要：目的研究复方连翘滴鼻液的提取工艺和质量标准。方法采用正交试验优选提取工艺。采用薄层色谱(TLC)法定性鉴别样品中连翘和知母。采用高效液相色谱法测定连翘苷的含量,色谱柱为YMC-Triart C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(23∶77,V/V),流速为1.0 m L/min,检测波长为277 nm,柱温为30℃,进样量为10μL。结果最佳提取工艺为加10倍水,煎煮3次,每次1 h,最佳醇沉体积分数为60%。连翘苷进样质量浓度在0.0366~0.1830 mg/m L范围内与峰面积线性关系良好,精密度、稳定性、重复性试验的RSD均小于2.1%,平均加样回收率为101.48%,RSD为1.55%(n=9)。结论优选的提取工艺科学合理,质量标准有效可控,可用于该制剂的质量控制。Objective To study the extraction process and quality standard of Compound Lianqiao Nasal Drops.Methods Orthogonal test was used to optimize the extraction process.Thin-layer chromatography(TLC)was used for the qualitative identification of Forsythia suspensa and Anemarrhena asphodeloides in the samples,and High-performance liquid chromatography(HPLC)was used for the content determination of forsythin,the chromatographic column was YMC-Triart C18 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-water(23∶77,V/V),the flow rate was 1.0 m L/min,the detection wavelength was 277 nm,the column temperature was 30℃,and the injection volume was 10μL.Results The optimal extraction process was as follows:the water addition was 10 times,decocted for 3 times,1 h each time,the optimal alcohol precipitation volume fraction was 60%.The linear range of forsythin was 0.0366-0.1830 mg/mL.The RSDs of precision,stability and repeatability tests were less than 2.1%.The average recovery of forsythin was 101.48%with RSD of 1.55%(n=9).Conclusion The optimized extraction process is scientific and reasonable,and the quality standard is effective and controllable,which can be used for the quality control of the preparation.

关 键 词：复方连翘滴鼻液 提取工艺 连翘苷 质量标准 

分 类 号：R932[医药卫生—生药学] R283[医药卫生—药学]