肿痛凝胶膏剂制备处方工艺与研究.pdfVIP

肿痛凝胶膏剂制备处方工艺研究 丁江生 王宁 刘石磊 （云南省药物研究所，云南昆明 650111 ） 摘要：目的：优选肿痛凝胶膏剂最佳的制剂处方和工艺，研制性能优良的肿痛凝胶膏剂。方法：选择 部分中和的聚丙烯酸 Viscomate 作为基础聚合物材料，根据药物和溶剂的特点进行处方设计。以凝胶 强度、黏附力和感官质量为指标，通过单因素试验和正交试验法优选处方工艺。结果：最佳制剂处方 为药物溶液36.46%，Viscomate NP700 5.45%，甘油 31.90%，PVP K90 6.38%，卡波姆C940 0.91%， 甘羟铝 0.36%，酒石酸 0.27%，纯化水18.23%。结论：通过优化处方工艺，可制得外观优良、粘附性 能良好的肿痛凝胶膏剂。 关键词：肿痛凝胶膏剂；处方设计；制剂处方；制备工艺 Experimental studies on the preparation techniques of Zhongtong Cataplasma DING Jiang-sheng, WANG Ning, LIU Shi-lei （Yunnan Institute of Materia Medica, Kunming 650111, China ） [Abstract] Objective: To optimize the formula ratio of base to prepare better Zhongtong Poultice. Method: Select varying degree of neutralized polyacrylate Viscomate as the base polymer material preparation, the performulation is tailored to accommodate solvent(s) and drugs.The optimal preparation was selected by 4 single factor experiment and L9( 3 ) orthogonal design with gel strength, ability pasting to skin and sensory quality indexes. Result: The optimal formulation was drug extract solution 36.46%, Viscomate NP700 5.45%, glycerine 31.90%, polyvinyl pyrrolidone 6.38%, carbomer 0.91%, dihydroxyaluminum aminoacetate 0.36%, tartaric acid 0.27%, purified water 18.23%.Conclusion: Zhongtong Poultice with good appearance, viscoelasticity and quality controllable can be prepared by optimizing the optimal formulation and preparation. [Key words ] Zhongtong Poultice; performulation; formulation ; preparation 肿痛凝胶膏剂由肿痛搽剂进行剂型改变而来，含有七叶莲、三七、雪上一枝蒿、金铁 锁、重楼、麝香等多种名贵中药，具有消肿止痛、活血化瘀、舒经活络、化痞散结之功效。 主要用于跌打损伤、风湿关节痛、肩周炎、痛风关节炎、乳腺小叶增生。将其制成以亲水 性高分子材料为基质的凝胶膏剂，具有作用持久，剂量准确，贴敷舒适透气，患者依从性 好等优点[1]，能充分发挥中医药内病外治的优势。 本品研制的关键技术难题是需要在不改变物质基础的条件下将乙醇提取的药物溶液 直接制成凝胶膏剂，需要解决乙醇对凝胶膏剂交联成型和粘附性所带来的