摘要
目的对富马酸依美斯汀滴眼液进行处方优化,制备出质量合格、性质稳定的样品。方法以氯化钠作为渗透压调节剂;羟丙甲纤维素作为增稠剂;苯扎氯铵作为抑菌剂制备样品。结果与0月相比,自制样品放置9个月后的外观性状、pH、渗透压、有关物质及含量等指标均无明显变化。结论自制滴眼液处方设计合理,质量合格、性质稳定。
Objective To optimize the formulation of emedastine difumarate eye drops and obtain stable qualified preparations. Methods Emedastine difumarate eye drops were prepared with sodium chloride as osmotic regulator, hypromellose as thickener and benzalkonium chloride as bacteriostatics. Results Compared with 0 month, the main parameters including appearance, pH value, osmotic pressure, related substances and the content of the self-produced preparation after storage for 9 months showed no significant differences. Conclusion The preparation with reasonable formulation is stable and qualified.
作者
颜东
陈超
孙倩倩
YAN Dong1,2 CHEN Chao3, SUN Qian-qian4(1. Shandong Standard Test Technology Co., Ltd., Jinan 250101; 2. Shandong Shenlian Pharmaceutical Co., Ltd., Jinan 250101; 3. Shandong Academy of Pharmaceutical Sciences, Jinan 250101; 4. Shandong Freda Bioengineering Co., Ltd., Jinan 25010)
出处
《中南药学》
CAS
2018年第7期931-934,共4页
Central South Pharmacy
