盐酸美西律滴鼻剂的制备及质量控制  

Preparation and Quality Control of Mexiletine Hydrochloride Nasal Drops

作　　者：金伟华 邓凯文 蒲志强 廖艳 JIN Weihua;DENG Kaiwen;PU Zhiqiang;LIAO Yan(The General Hospital of Western Theater Command of Chinese PLA,Chengdu,Sichuan,China 610083;School of Pharmacy,Southwest Medical University,Luzhou,Sichuan,China 646000)

机构地区：[1]中国人民解放军西部战区总医院,四川成都610083 [2]西南医科大学药学院,四川泸州646000

出　　处：《中国药业》2022年第21期52-54,共3页China Pharmaceuticals

摘　　要：目的探讨盐酸美西律滴鼻剂的制备方法,并建立其质量控制标准。方法采用溶解法制备盐酸美西律滴鼻剂;通过视觉观察制剂的性状;采用pH计考察制剂的pH;采用高效液相色谱法测定滴鼻剂中盐酸美西律含量,色谱柱为Eclipse XDB-C_(18)柱(150 mm×4.6 mm,5μm),流动相为0.1 mol/L醋酸钠溶液[醋酸调节pH为(5.8±0.1)]-甲醇(49∶51,V/V),流速为1.0 mL/min,检测波长为262 nm。结果盐酸美西律滴鼻剂为无色透明澄清溶液;pH为5.60~5.72。盐酸美西律质量浓度在0.2502~1.2510 mg/mL范围内与峰面积线性关系良好(r=0.9999,n=5);精密度、稳定性、重复性试验结果的RSD均小于2.0%(n=6);平均加样回收率为100.84%,RSD为1.05%(n=9)。结论该制剂处方合理、工艺可行,所建立的质量控制方法可靠。Objective To investigate the preparation method of Mexiletine Hydrochloride Nasal Drops,and to establish the standard of its quality control.Methods The Mexiletine Hydrochloride Nasal Drops were prepared by the dissolution method,the properties of the preparation were observed by the vision,and the pH of the preparation was investigated by the pH meter.The content of mexiletide hydrochloride in the nasal drops was determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was Eclipse XDB-C_(18) column(150 mm×4.6 mm,5μm),the mobile phase was 0.1 mol/L sodium acetate solution[adjusted to pH(5.8±0.1)with acetic acid]-methanol(49∶51,V/V),the flow rate was 1.0 mL/min,and the detection wavelength was 262 nm.Results The Mexiletil Hydrochloride Nasal Drops were colorless,transparent and clear solution with pH 5.60-5.72.The linear range of mexiletide hydrochloride was 0.2502-1.2510 mg/mL(r=0.9999,n=5).The RSDs of precision,stability and repeatability tests were lower than 2.0%(n=6).The average recovery rate of mexiletide hydrochloride was 100.84%with an RSD of 1.05%(n=9).Conclusion The prescription of the Mexiletine Hydrochloride Nasal Drops is reasonable,the process is feasible,and the established quality control method is reliable.

关 键 词：盐酸美西律滴鼻剂 高效液相色谱法 制备工艺 含量测定 质量控制 

分 类 号：R987[医药卫生—药品] TQ460.6[医药卫生—药学]