复方替硝唑载体栓的制备及质量考察  

Preparation and Quality Specification of Compound Tinidazole Carrier Suppositories

作　　者：李博[1] 杨兴官[1] 李红玉[2] 

机构地区：[1]辽宁医学院附属第一医院,辽宁锦州121001 [2]辽宁医学院,辽宁锦州121001

出　　处：《中国药房》2012年第37期3502-3504,共3页China Pharmacy

基　　金：辽宁省省级科学技术研究成果获奖项目(20080599)

摘　　要：目的:制备复方替硝唑载体栓并考察其质量。方法:以替硝唑、克霉唑、醋酸氯己定为主药,甘油明胶为基质制备复方替硝唑载体栓;采用高效液相色谱法同时测定3种成分含量;采用桨法、以盐酸为溶出介质进行体外溶出试验,计算溶出参数Td、m并进行相关性检验;考察制剂在市售包装下加速试验6个月的稳定性。结果:制剂含量符合要求,组内、组间溶出参数均无显著性差异(P>0.05),稳定性试验中各指标6个月内无明显变化。结论:该制剂处方设计合理,制备工艺可行,产品质量稳定。OBJECTIVE： To prepare the Compound tinidazole carrier suppositories （CTS） and investigate the quality of it. METHODS： CTS were prepared with tinidazole, clotrimazole and chlorhexidine acetate as main components using glycerogelatin as matrix; the contents of 3 components were determined by HPLC; the dissolution test of suppositories in vitro was conducted by paddle method with hydrochloric acid as medium, and the dissolution parameters Td and m were calculated and tested. The stability of suppositories was detected in 6-month accelerated test. RESULTS： The contents of sample were in line with the standard; there was no significant difference in the interior-group and inter-group （P〉0.05） ; and no obvious change was found in stability test within 6 months. CONCLUSION： CTS are reasonable in formulation, feasible in technology and stable in quality.

关 键 词：复方替硝唑载体栓 克霉唑 醋酸氯己定 制备 含量 溶出参数 稳定性 高效液相色谱法 

分 类 号：R943[医药卫生—药剂学] R944.23[医药卫生—药学]