盐酸麻黄素植入膜剂的研制与临床应用

目的 :研制盐酸麻黄素植入膜剂 ,为临床治疗慢性、顽固性支气管哮喘开发新剂型与给药途径。方法 :研究盐酸麻黄素植入膜剂的处方、制备、质量控制 ,并通过体外释药试验评价缓释膜作用及动物试验考查其安全性。结果 :盐酸麻黄素植入膜剂的含药膜基质以明胶为佳 ,延缓释药膜基质以PVA17 -99 为佳。含量测定用紫外分光光度法。体外释药试验表明 ,本品缓释效果好 ,植入穴位无任何不良反应。临床应用疗效可靠、作用持久、安全性好。结论 :盐酸麻黄素植入膜剂植入双定喘穴具穴位疗法和药物靶区定向缓释的双重治疗作用 ,是一个有前途的新制剂

Preparation and Clinical Use of Implanted Film of Ephedrine Hydrochloride

OBJECTIVETo develop an implanted film of ephedrine hydrochloride so as to provide a new preparationand therapeutic method for chronic and obstinate bronchial asthma.METHODS Theformula,preparation technique and quality control of the implanted film were studied.Therelease characteristic in vitro was determined and the safety was observed on animalexperiment.RESULTS Gelatin was the best drug-base and PVA17～ 99 the bestsustained-release base.The content of ephedrine was determined by UV-spectrophotometry.Ithad satisfactory sustained-release action without any side-effect at implantedacupoint.The results of clinical use showed that this preparation waseffective,long-action and safe.CONCLUSION The film is valuable to be futher studied asa nes preparation with dual therapeutic effects of point-treatment and targetsustained-release action.