温敏型盐酸达克罗宁胶液的制备及质量评价

Preparation and Quality Evaluation of Temperature-sensitive Dyclonine Hydrochloride Gel

目的制备出温敏型盐酸达克罗宁胶液,建立质量控制方法,并对其进行稳定性考察,评价其作为一种局部麻醉制剂的潜力。方法使用泊洛沙姆为主要温敏基质,制备温敏型盐酸达克罗宁胶液,采用高效液相色谱系统进行含量测定,色谱条件为:Titank Hilic色谱柱(5μm,250 mm×4.6 mm);流动相为乙腈-1‰甲酸溶液50∶50(V∶V);流速为1.0 ml/min;柱温为25℃;检测波长为282 nm;进样量为20μl。以主药含量、外观、胶凝温度、黏度、pH值为指标,考察6个月内的稳定性。结果以泊洛沙姆188和407为主要基质制备了盐酸达克罗宁胶液,该胶液具有良好的理化性质和稳定性。结论温敏型盐酸达克罗宁胶液具有成为新型局部麻醉制剂的前景,所建立的分析方法能够用其质量控制和稳定性研究。

Objective To prepare a temperature-sensitive dyclonine hydrochloride gel,establish a quality control method,and investigate its stability to evaluate its potential as a local anesthetic.Methods Using poloxamer as the main temperature-sensitive matrix,the temperature-sensitive dyclonine hydrochloride gel was prepared,and the content was determined by a high performance liquid chromatography system.The chromatographic conditions are:Titank Hilic chromatographic column(5μm,250 mm×4.6 mm);The mobile phase was acetonitrile-1‰formic acid solution 50∶50(V∶V);The flow rate was 1.0 ml/min;the column temperature was 25℃;The detection wavelength was 282 nm;the injection volume was 20μl.The main drug content,appearance,gelation temperature,viscosity,and pH were used as indicators to investigate the stability within 6 months.Results Dyclonine hydrochloride gel was prepared with poloxamer 188 and 407 as the main matrix.The gel had good physical and chemical properties and stability.Conclusion The temperature-sensitive dyclonine hydrochloride gel has the prospect of becoming a new type of local anesthetic,and the established analytical method can be used for quality control and stability studies.