兽用复方聚甲酚磺醛凝胶的制备及质量控制  

Preparation and Quality Control of Veterinary Used Compound Policresulen Gel

作　　者：李园[1,2] 刘丹[2] 李会芳[2] 刘一霖[2] 汪坊 李引乾[2] 

机构地区：[1]陕西子长县史家畔乡政府,陕西子长717300 [2]西北农林科技大学动物医学院,陕西杨凌712000

出　　处：《动物医学进展》2013年第12期149-151,共3页Progress In Veterinary Medicine

摘　　要：为了有效治疗母畜子宫内膜炎,制备了兽用复方聚甲酚磺醛凝胶剂,并建立了其质量控制方法。以聚甲酚磺醛为主药,羧甲基纤维素钠等为基质制备凝胶。采用滴定法测定聚甲酚磺醛的含量。并分别将其在30℃±2℃、相对湿度65%±5%条件下进行加速3个月,室温避光条件下放置半年,2 500r/min离心30min进行稳定性考察试验。采用家兔同体左右侧自身对比滴眼法观察该药对眼黏膜的刺激性。所制制剂质地均匀、细腻,主药鉴别、pH测定均符合阴道用凝胶制剂的规定。聚甲酚磺醛含量测定平均实际含量为39.83mL/L(n=3)。复方聚甲酚磺醛凝胶对家兔的眼黏膜无明显刺激性。该制剂制备工艺简单可行,质量稳定、安全,符合黏膜用药制剂的规定,质控方法简单且结果可靠。The veterinary used compound policresulen gel was prepared in this study,and the quality control method was established.To effectively treat dam endometritis,the gel was prepared with policresulen as the main drug and sodium carboxymethyl cellulose as matrix.The policresulen was quantified by titration method.The preparation was accelerated for 3 months at 30℃±2℃,with a relative humidity of 65% ± 5%,stored at room temperature avoiding light for half a year,centrifuged with 2 500r/min for 30min for the stability test.The drug was dropped in rabbit′s eyes to observe its irritation to eye mucous membrane by the means of comparing the two eyes that comes from one rabbit.The preparation was uniform texture,delicate,the main drug identification and pH determination were measured in accordance with the relevant provisions.The average actual content of policresulen was 39.83mL/L（n=3）.Compound policresulen gel had no obvious irritation to rabbit′s eye mucous membrane.This preparation method is feasible,stable,complying with the provisions of the mucosa drug preparations,and the quality control method is simple,with accurate results.

关 键 词：聚甲酚磺醛 凝胶剂 质量控制 

分 类 号：S859.799.1[农业科学—临床兽医学]