栓剂.docVIP

阿司匹林栓剂制备工艺 姓名：刘怡娟 石河子大学药学院 ，石河子 832002 ［摘要］ 目的：改进阿司匹林栓剂热熔法制备工艺。方法：固定处方，改变制备过程中润滑剂涂着、冷凝方式、灌模温度等条件控制。结果：润滑剂涂着、冷凝方式、灌模温度等条件对栓剂成形有直接影响。阿司匹林（Aspirin） 又名乙酰水杨酸（Acetylsalicylic acid），化学名为2-（ 乙酰氧基）苯甲酸，系白色结晶或结晶性粉末，熔点135~140℃，无臭或略带醋酸味，水中微溶，乙醇中易溶，氯仿或乙醚中溶解，遇湿气缓慢水解生成水杨酸，具弱酸性，最稳定ph值2.5。1899年开始药用，至今仍为一常用解热镇痛抗炎药。目前剂型众多，中国药典2005版二部收载有阿司匹林片、阿司匹林肠溶片、阿司匹林栓.在此我们对阿司匹林栓剂热熔法制备工艺条件控制作研究，以期解决制备中经常发生的一些问题。 ［关键词］阿司匹林；栓剂；制备；热熔法Aspirin suppositories preparation technology [abstract] objective: to improve the legal system for aspirin suppositories hot melt process. Methods: fixed a prescription, change during the preparation of lubricant with, condensing way, irrigation mode on the conditions of temperature control. Results: with a lubricant, condensing way, filling mold temperature conditions on the suppositories has a direct impact on the forming. Aspirin Aspirin name and Acetylsalicylic acid Acetylsalicylic acid , chemical called 2- acetyl oxygen radicals benzoic acid, is the white crystalline or crystal powder, melting point 135 ~ 140 ℃, odourless or with acetic acid taste, slightly soluble in water, ethanol, ethyl ether easily dissolved chloroform or dissolved in slow hydrolysis, moisture generated with weak acidity, salicylic acid, the most stable ph 2.5. Started in 1899, is still a medicinal for commonly used antipyretic anti-inflammatory drug. At present, China pharmacopoeia many dosage form the 2005 version has two parts of aspirin, aspirin posted enteric-coated metformin hydrochloride, aspirin bolt. Here we about aspirin suppositories hot melt method for process condition control, to solve the preparation happen in some problems. [key words] aspirin; Suppositories; Preparation; Melt method 1　实验材料 1. 1　仪器 电子天平; 电热恒温鼓风干燥箱; 电热恒温水浴锅；栓剂融变仪；栓模。 1. 2　试剂 混合脂肪酸甘油酯；阿司匹林；润滑剂（液体石蜡） 2　实验方法 2. 1　置换价的测定 2. 1. 1　纯基质栓的制备 分四个小组用四种方法制备，每小组制9粒。 一组：称取混合脂肪酸甘油酯10g置蒸发皿中，于50℃水浴加热熔化，备用。栓模合页分开，用棉签均匀涂上一层润滑液，合拢，将上述熔化基质倾入栓模中， 液面稍溢出模口平面1~2mm，待自然冷却至凝固，用裁纸刀削平，开启栓模，取出即得。 二组：栓模置干燥箱内预热至50℃后灌模，其余操作同一组。 三组：栓模置干燥箱内预热至5