Preparation and Quality Evaluation of Carbinoxamine Maleate Sustained-release Suspension
10.6039/j.issn.1001-0408.2017.07.24
- VernacularTitle:马来酸罗托沙敏缓释混悬液的制备及质量评价
- Author:
Yifan WANG
;
Shuhan LOU
;
Yonglu WANG
;
Xiaotong GU
;
Xueming LI
- Keywords:
Carbinoxamine maleate;
Sustained-release suspension;
Cation exchange resin;
Surface coating;
HPLC
- From:
China Pharmacy
2017;28(7):947-950
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To prepare Carbinoxamine maleate sustained-release suspension,and evaluate its quality. METH-ODS:Using carbinoxamine maleate as raw material,drug-loaded resin was prepared by cation exchange resin;surface coating method was used to finally prepare sustained-release suspension,using Eudragit RS100 as sustained-release coating material to pre-pare sustained-release microparticles. HPLC was conducted to determine the content of carbinoxamine maleate,release degree of original preparations and self-made suspensions was compared,drug-loading capacity was calculated. RESULTS:The drug amount in preparing drug-loaded resin was 2%,reaction temperature was 25 ℃,and reaction time was 4 h;the drug-loading capacity in surface coating was 35%,amount of coating material was 10%,and reaction temperature was 40 ℃. The drug-loading capacities of sustained particles before and after coating were 35.23%,32.72%,respectively;the yield was 96.82%. The carbinoxamine ma-leate in prepared sustained-release suspension accounted for 98.76% of the labeled amount;release degree in 10 h reached about 80%,f2 was 65.73. CONCLUSIONS:Carbinoxamine maleate sustained-release suspension is prepared successfully,and its release is similar to the original preparation.