[1]司佩茹,周红建,杨显伟,等.温敏型盐酸达克罗宁胶液的制备及质量评价[J].医学信息,2021,34(14):66-69.[doi:10.3969/j.issn.1006-1959.2021.14.019]
　SI Pei-ru,ZHOU Hong-jian,YANG Xian-wei,et al.Preparation and Quality Evaluation of Temperature-sensitive Dyclonine Hydrochloride Gel[J].Medical Information,2021,34(14):66-69.[doi:10.3969/j.issn.1006-1959.2021.14.019]
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温敏型盐酸达克罗宁胶液的制备及质量评价()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
34卷
期数:
2021年14期
页码:
66-69
栏目:
论著
出版日期:
2021-07-15

文章信息/Info

Title:
Preparation and Quality Evaluation of Temperature-sensitive Dyclonine Hydrochloride Gel
文章编号:
1006-1959（2021）14-0066-03
作者:
司佩茹; 周红建; 杨显伟; 等
（1.西安交通大学药学院，陕西 西安 710061； 2.遂成药业股份有限公司，河南 新郑 451150）
Author(s):
SI Pei-ru; ZHOU Hong-jian; YANG Xian-wei; et al.
(1.School of Pharmacy,Xi’an Jiaotong University,Xi’an 710061,Shaanxi,China; 2.Suicheng Pharmaceutical Co.,Ltd.,Xinzheng 451150,Henan,China)
关键词:
温敏盐酸达克罗宁胶液; 泊洛沙姆; 质量评价
Keywords:
Temperature-sensitive dyclonine hydrochloride gel; Poloxamer; Quality evaluation
分类号:
TQ460.4
DOI:
10.3969/j.issn.1006-1959.2021.14.019
文献标志码:
A
摘要:
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（5 μm, 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20 μl。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。
Abstract:
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 (5 μm, 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 20 μl.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.

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更新日期/Last Update: 1900-01-01