接骨七厘散软胶囊内容物加 PEG400湿法超微粉碎工艺讨论【摘要】 目的湿法超微粉碎技术对接骨七厘散工艺改进和剂型改革,考察接骨七厘散软胶囊内容物的最佳湿法超微粉碎工艺参数。方法以物料粒度、物料稳定性等作考察指标,采纳单因素考察法分别对分散介质、介质用量等工艺参数进行筛选。结果软胶囊内容物的最佳湿法超微粉碎工艺为:加倍量预保温 PEG400, 40 ℃以下超微粉碎 35 min,出料,即得。结论湿法超微粉碎工艺简便,效率高,不仅使物料粒度变细提高了药物生物利用度,节约药源,同时使物料均质化程度更高,便于制剂,具有宽阔的前景。 【关键词】 接骨七厘散软胶囊; 湿法超微粉碎; PEG400; 生物利用度 Abstract:ObjectiveTo explore the optimal ultra-fine pulverization procedure for the content of Jie Gu Qi Li San soft capsule by wet processing. MethodsUsing the particle size (D50 and D90), station and so on of the contents from Jie Gu Qi Li San soft capsule as main indicators, the pulverization progress was studied by single factor method. In this way, the effects of such conditions as pulverizing time, mediator consumption, pulverizing temperature and so on extracting rate were optimal pulverization procedure for the content of Jie Gu Qi Li San soft capsule was times of PEG400, vibrating frequently 35 minutes under 40℃.ConclusionThe optimum pulverizing procedure is convenient, and applicable to the preparation of Jie Gu Qi Li San Soft should have a good future. Key words:Jie Gu Qi Li San soft capsule; Frequent vibrating pulverization by wet processing; PEG-400; Bioavailability 接骨七厘散收载于《国家中成药标准汇编》骨伤科分册[1],疗效确切,但由于处方中含大量树脂类药材导致散剂易板结、吸潮、剂量不准、服用不便。而对于矿物类、树脂类和贵细类药物等有效成分不明确、受热破坏或无适宜溶剂提取的药物,增大其表面积是提高药物生物利用度最有效的方式之一,超微粉碎是增大药材表面积的常用方法,但本处方中各药物超微粉碎后表面积急剧增加导致板结和吸潮问题更加严重。本文采纳加...