以壳聚糖为基质的盐酸利多卡因凝胶剂的研究

Research on lidocaine hydrochloride gels with chitosan as the matrix

目的：以壳聚糖为基质制备盐酸利多卡因凝胶剂,并建立盐酸利多卡因的含量测定方法。方法：以壳聚糖为基质制备凝胶剂,以HPLC法测定利多卡因的含量;色谱条件为Kromasil C18色谱柱（200 mm×4.6 mm,5μm,）;流动相：甲醇-磷酸缓冲液（加磷酸调节p H=8.00）（75∶25）,流速为0.8 ml/min,检测波长为254 nm,柱温：室温,进样量20μl。结果：盐酸利多卡因在16.24～121.80μg/ml范围内浓度与峰面积线性关系良好（r=0.999 9,n=7）,平均回收率为100.59%,RSD为0.35%。结论：以壳聚糖为基质制备的凝胶剂方法简便,HPLC法测定凝胶剂中的利多卡因方法准确、可靠,可用于对利多卡因凝胶剂进行质量控制、含量控制。

Objectives：Preparation of chitosan as the matrix of lidocaine hydrochloride gels,to establish content determination and methodology of the method. Methods： Design the prescription,according to the prescription preparation gels. To establish HPLC method for determining the content of lidocaine,the chromatographic conditions is Kromasil C18 chromatographic column（200mm × 4. 6 mm,5 μm）; mobile phase： methanol- phosphate buffer（75∶ 25）; add phosphoric acid to adjust p H 8. 0,flow rate of 0. 8 ml / min,λmax= 254 nm;column temperature： room temperat ure,injection amount 20 μl. Results：The calibration curves of lidocaine were linear in the ran ges of 16. 24 ～ 121. 8 μg / ml（ r = 0. 999 9,n = 7）. The recoveries were 100. 59%,and RSD were0. 35%（ n = 3）. Conclusions： The methods of HPLC is specific,effective,sensitive and accurate. It can be used to lidocaine hydrochloride gel agent for quality control,content control.