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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
OBJECTIVE: To develop ephedrine hydrochloride film for the development of new dosage forms and routes of administration for the treatment of chronic and refractory bronchial asthma. Methods: To study the formulation, preparation and quality control of ephedrine hydrochloride tablets, and to evaluate the effect of sustained-release membrane and animal experiment in vitro release test to evaluate its safety. Results: The drug-loaded membrane matrix containing ephedrine hydrochloride gel was better than gelatin, and PVA17 -99 was the best. Determination of content by UV spectrophotometry. In vitro release test showed that the sustained release effect of this product is good, without any adverse reaction to implant acupuncture points. Clinical application of reliable efficacy, lasting effect, good safety. CONCLUSION: The dual therapeutic effect of ephedrine hydrochloride implants implanted Shuangdingpo point with acupoint therapy and controlled release of drug targets is a promising new preparation