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.
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)
出处
《中国药业》
CAS
2021年第6期32-35,共4页
China Pharmaceuticals
关键词
复方连翘滴鼻液
提取工艺
连翘苷
质量标准
Compound Lianqiao Nasal Drops
extraction technology
forsythin
quality standard
