镇痛灵粘贴膏制备工艺与质控标准

Study on the Quality Standard and Preparation Process of Zhengtongling Adhesive Plaser

目的 :探索新材料在镇痛灵粘贴膏中的应用及制订出镇痛灵粘贴膏的质量标准。方法 :进行粘性强度测试、抗老化试验、剥离强度测试、含膏量试验、耐热试验、耐寒试验。结果 :粘性强度为 2 .3 7g/ s;温度在( 3 0～ 60 )℃ ,相对湿度在 85 %区间内粘性不变 ,此后每增加 10℃或 10 %湿度时 ,粘性呈下降趋势 ;剥离强度值为 0 .5± 0 .1kg/ cm2 ,比橡皮膏剥离值小 ( 1.8± 0 .2 kg/ cm2 ) ;每 10 0 cm2 含膏量不低于 1.6g。结论 :镇痛灵粘贴膏采用高分子胶粘剂作基质 ,可达到反复粘贴 ,药物释放快 ,透皮吸收好 ,疗效确切。通过质量控制试验 ,该粘贴膏质量可控 。

OBJECTIVE:To study the application of new materials in Zhengtongling adhesive plaster,and to establish its the quality control standard.METHODS:Engage in the experiments about stickiness intensity,antiage,stripp intensity,the content of plasters,heat resistance and cold resistance.RESULTS:Stickiness intensity is 2.37 g/s;when the temperature is 30 ℃～60 ℃ and relative humidity is about 85% stickiness kepps stable,it will come down when the temperature goes up 10 ℃ or the humidity rises 10%;stripp intensity is smaller than the rubplaster stripping number,it is 0.5±0.1 kg/cm 2;the content of plasters every 100 cm 2 is no lower than 1.6 g.CONCLUSION:Zhengtongling adhesive plaster uses macromolecular adhesive material as basis and it can be pasted for many times.The plaster is popular for its good transdermal absorption and notable curative effect.Through quality control experiment Zhengtongling adhesive plaster is tested safe and effective.