中国药师
中國藥師
중국약사
CHINA PHARMACIST
2015年
1期
58-62,63
,共6页
覃攀%盘正华%罗单%李其哲%张雁
覃攀%盤正華%囉單%李其哲%張雁
담반%반정화%라단%리기철%장안
压可平Ⅱ胶囊%溶出度%小杯法%高效液相色谱法
壓可平Ⅱ膠囊%溶齣度%小杯法%高效液相色譜法
압가평Ⅱ효낭%용출도%소배법%고효액상색보법
YakepingⅡ capsules%Dissolution%Small glass method%HPLC
目的：：建立压可平Ⅱ胶囊中两种主成分阿替洛尔和硝苯地平的溶出度测定方法。方法：采用小杯法,转速为50 r· min-1,参照日本《医疗用药品品质情报集》中的溶出度试验条件并根据样品实际情况作出相应调整,采用HPLC法分别考察压可平Ⅱ胶囊在pH 1.2的人工胃液(含0.5%十二烷基硫酸钠溶液)、pH 4.0醋酸盐缓冲液(含0.5%十二烷基硫酸钠溶液)、pH 6.8磷酸盐缓冲液(含0.25%十二烷基硫酸钠溶液)及水(含0.25%十二烷基硫酸钠溶液)中的体外溶出行为。结果：阿替洛尔、硝苯地平与压可平Ⅱ胶囊中其他成分分离度良好,阿替洛尔、硝苯地平在10~30μg·ml-1浓度范围呈良好线性关系( r=0.9996和 r =0.9998),两者在四种不同溶出介质中的平均回收率分别为99.64%( RSD =0.73%),99.55%( RSD =0.65%),99.53%(RSD=0.47%),99.54%( RSD =0.51%)和99.52%( RSD =0.61%),99.52%( RSD =0.72%),99.51%(RSD=0.63%),99.61%(RSD=0.59%)(n=9)；压可平Ⅱ胶囊中两种主成分阿替洛尔和硝苯地平在四种不同的溶出介质中溶出度的均一性良好。结论：该方法简便、准确,重复性好,可用于该胶囊的溶出度测定。
目的：：建立壓可平Ⅱ膠囊中兩種主成分阿替洛爾和硝苯地平的溶齣度測定方法。方法：採用小杯法,轉速為50 r· min-1,參照日本《醫療用藥品品質情報集》中的溶齣度試驗條件併根據樣品實際情況作齣相應調整,採用HPLC法分彆攷察壓可平Ⅱ膠囊在pH 1.2的人工胃液(含0.5%十二烷基硫痠鈉溶液)、pH 4.0醋痠鹽緩遲液(含0.5%十二烷基硫痠鈉溶液)、pH 6.8燐痠鹽緩遲液(含0.25%十二烷基硫痠鈉溶液)及水(含0.25%十二烷基硫痠鈉溶液)中的體外溶齣行為。結果：阿替洛爾、硝苯地平與壓可平Ⅱ膠囊中其他成分分離度良好,阿替洛爾、硝苯地平在10~30μg·ml-1濃度範圍呈良好線性關繫( r=0.9996和 r =0.9998),兩者在四種不同溶齣介質中的平均迴收率分彆為99.64%( RSD =0.73%),99.55%( RSD =0.65%),99.53%(RSD=0.47%),99.54%( RSD =0.51%)和99.52%( RSD =0.61%),99.52%( RSD =0.72%),99.51%(RSD=0.63%),99.61%(RSD=0.59%)(n=9)；壓可平Ⅱ膠囊中兩種主成分阿替洛爾和硝苯地平在四種不同的溶齣介質中溶齣度的均一性良好。結論：該方法簡便、準確,重複性好,可用于該膠囊的溶齣度測定。
목적：：건립압가평Ⅱ효낭중량충주성분아체락이화초분지평적용출도측정방법。방법：채용소배법,전속위50 r· min-1,삼조일본《의료용약품품질정보집》중적용출도시험조건병근거양품실제정황작출상응조정,채용HPLC법분별고찰압가평Ⅱ효낭재pH 1.2적인공위액(함0.5%십이완기류산납용액)、pH 4.0작산염완충액(함0.5%십이완기류산납용액)、pH 6.8린산염완충액(함0.25%십이완기류산납용액)급수(함0.25%십이완기류산납용액)중적체외용출행위。결과：아체락이、초분지평여압가평Ⅱ효낭중기타성분분리도량호,아체락이、초분지평재10~30μg·ml-1농도범위정량호선성관계( r=0.9996화 r =0.9998),량자재사충불동용출개질중적평균회수솔분별위99.64%( RSD =0.73%),99.55%( RSD =0.65%),99.53%(RSD=0.47%),99.54%( RSD =0.51%)화99.52%( RSD =0.61%),99.52%( RSD =0.72%),99.51%(RSD=0.63%),99.61%(RSD=0.59%)(n=9)；압가평Ⅱ효낭중량충주성분아체락이화초분지평재사충불동적용출개질중용출도적균일성량호。결론：해방법간편、준학,중복성호,가용우해효낭적용출도측정。
Objective: To establish a dissolution determing method for the two primary ingredients atenolol and nifedipine in YakepingⅡcapsules. Methods:A small glass method was adopted with the rotation rate of 50 r·min-1 . According to the dissolution conditions in Japan “quality of medical drugs information set” with appropriate adjustments in accordance with the actual situation of the samples, different YakepingⅡ capsules were determined by HPLC respectively in pH 1. 2 artificial gastric solution ( containing 0. 5% sodium dodecyl sulfate), pH 4. 0 acetate buffer(containing 0. 5% sodium dodecyl sulfate), pH 6. 8 phosphate buffer(contai-ning 0. 25% sodium dodecyl sulfate) and water(containing 0. 25% sodium dodecyl sulfate). Results:The assay displayed a good lin-earity over the concentration range of 10-30 μg·ml-1 for atenolol and nifedipine(r=0. 999 6 and r=0. 999 8), and the recovery of the two components in the different medium was 99. 64%(RSD=0. 73%), 99. 55%(RSD=0. 65%), 99. 53%(RSD=0. 47%)and 99.54% (RSD=0.51%), 99.52%(RSD=0.67%), 99.52%(RSD=0.72%), 99.51%(RSD=0.63%)and 99.61%(RSD=0. 59%)(n=9). The dissolution of different batches of YakepingⅡcapsules in the four media showed the similar behavior. Conclu-sion:The method is simple, accurate and reproducible in the dissolution determination of atenolol and nifedipine in YakepingⅡ cap-sules.
