盐酸丙卡特罗口服溶液工艺的研究Study on the stability of Procaterol Hydrochloride Oral Solution
阳志军,杨雅兰,刘文亮
YANG Zhi-jun~1,YANG Ya-lan~2,LIU Wen-liang~3 (1.Development Department of the New Products
摘要(Abstract):
目的确定生产过程中影响新产品稳定性的因素。方法利用正交实验设计制得相应样品,通过加速试验测其含量及pH值的变化。结果配液罐和容器在与药液接触过程中,溶出的某些微量重金属会导致盐酸丙卡特罗含量的降低。结论配液罐和容器的选用对盐酸丙卡特罗口服溶液稳定性的影响大。
Objective To study the factor that influence the stability of the product in the process of amnufacture.Methods Using the cross experiment make the corrrsponding samples,and testing the change of its content and pH by accelerating test.Results Some minimal heavy metal that separated from the mixing liquid tank and container can decrease the content of Procaterol Hydrochloride when the pharmacetic liquid in the mixing liquid tank and container.Conclusion Using different mixing liquid tank and container can decrease the content of Procaterol Hydrochloride Oral Solution.
关键词(KeyWords):
盐酸丙卡特罗;正交试验;稳定性;微量重金属
Procaterol Hydrochloride;cross experiment;Stability;minim heavy metal
基金项目(Foundation):
作者(Author):
阳志军,杨雅兰,刘文亮
YANG Zhi-jun~1,YANG Ya-lan~2,LIU Wen-liang~3 (1.Development Department of the New Products
参考文献(References):
- [1]中川量之,吉崎司郎,谷村薰,等.新型喹诺酮衍生物[J].日本国特许厅.专利第1304078号,1986,2:28.
- [2]八仓隆宝,石山太朗,宫本昭正,等.新β受体刺激性支气管扩张剂Procedural对支气管哮喘药效的检讨[J].现代医疗,1978,10(11):1499.
- [3]佐佐木圣,川合满他,江头洋佑,等.Procedura治疗小儿急性支气管炎的使用经验[J].药理和治疗,1980,8(12):4375.
- [4]师昌绪.材料大辞典[M].北京:化学工业出版社,1994:56.
- [5]黄建中,左禹.材料的耐腐性和腐蚀数据[M].北京:化学工业出版社,2003:140-190.
- [6]田雁晨.塑料配方大全[M].北京:化学工业出版社,2004:201.
- [7]杨明.塑料添加剂应用手册[M].南京:江苏科学技术出版社,2002:218.