炼蜜栓成型工艺研究

Study on the Forming Technology of Honey-refining Suppository

目的:实验优化得到炼蜜栓的最佳成型工艺,为其规模生产提供理论和实验依据。方法:通过单因素实验考察,采用对比试验,摸索不同的基质,按照药典标准以外观、性状、重量差异、融变时限等为综合指标,优选出炼蜜栓剂的最佳成型工艺。结果:炼蜜栓的最佳成型工艺为采用热熔法制备,以聚乙二醇6000为基质,注模温度为70℃,最大含药量为46.6%,本品外观为淡橙色,硬度适中,完整无缺的鱼雷形,重量差异稳定控制在±7.5%以内,融变时限测定于35~40min内完全溶出。结论:通过工艺优化,炼蜜栓的成型工艺简单,稳定可行,栓剂稳定性好,适合工业化生产。

Objective:To experimentally optimize the best forming process for hemorrhoidal suppositories made from refined honey,and to provide a theoretical and experimental basis for their large-scale production.Methods:The optimum moulding process of the honey suppositories was optimised by single-factor experimental investigation,,using comparative tests to find out different substrates,and according to the pharmacopoeia standard with the comprehensive indexes of appearance,character,weight variation and time limit of melting change.Resul:ts The best forming process for hemorrhoidal suppositories with refined honey was prepared by the hot-melt method,using polyethylene glycol 6000 as the base,with a moulding temperature of 70℃ and a maximum drug content of 46.6%.The product had a light orange appearance,moderate hardness and intact torpedo shape,and the weight variation was controlled within±7.5%.Conclusion:Throughprocess optimization,the molding process of the hemorrhoidal suppository with refined honey is simple,sstable and feasible,and the suppository is stable and suitable for industrial production.