中国药师
中國藥師
중국약사
CHINA PHARMACIST
2014年
12期
2033-2036
,共4页
袁园%张莉%张金安%郭均平
袁園%張莉%張金安%郭均平
원완%장리%장금안%곽균평
尼美舒利%温敏凝胶%泊洛沙姆407%稳定性
尼美舒利%溫敏凝膠%泊洛沙姆407%穩定性
니미서리%온민응효%박락사모407%은정성
Nimesulide%Thermo-sensitive hydrogels%Poloxamer 407%Stability
目的：：建立温敏凝胶中尼美舒利的含量测定方法并考察其各种条件下的稳定性。方法：采用HPLC法,色谱柱为岛津Shim-Pack C18-ODS柱(150 mm ×4.6 mm,5μm),甲醇-水-冰醋酸(65∶35∶0.8)为流动相,流速为1.0 ml·min-1；检测波长：299 nm；柱温：30℃,进样量为10μl。结果：凝胶中尼美舒利与各杂质及降解产物分离良好,在2.43~24.37μg·ml-1范围内线性关系良好(r=0.9998),平均回收率为100.02%(RSD=1.12%,n=5)。最低检测限为0.098μg·ml-1,最低定量限为0.25μg·ml-1。强光照射试验、破坏性试验及长期稳定性试验结果表明,尼美舒利温敏凝胶长期稳定性良好,但在高温碱性、高温酸性、高温强氧化溶液和强光照条件下不稳定。结论：该方法可用于温敏凝胶中尼美舒利含量测定及稳定性研究,方法准确、可靠。制剂对热和光照的稳定性较差,宜阴凉避光保存。
目的：：建立溫敏凝膠中尼美舒利的含量測定方法併攷察其各種條件下的穩定性。方法：採用HPLC法,色譜柱為島津Shim-Pack C18-ODS柱(150 mm ×4.6 mm,5μm),甲醇-水-冰醋痠(65∶35∶0.8)為流動相,流速為1.0 ml·min-1；檢測波長：299 nm；柱溫：30℃,進樣量為10μl。結果：凝膠中尼美舒利與各雜質及降解產物分離良好,在2.43~24.37μg·ml-1範圍內線性關繫良好(r=0.9998),平均迴收率為100.02%(RSD=1.12%,n=5)。最低檢測限為0.098μg·ml-1,最低定量限為0.25μg·ml-1。彊光照射試驗、破壞性試驗及長期穩定性試驗結果錶明,尼美舒利溫敏凝膠長期穩定性良好,但在高溫堿性、高溫痠性、高溫彊氧化溶液和彊光照條件下不穩定。結論：該方法可用于溫敏凝膠中尼美舒利含量測定及穩定性研究,方法準確、可靠。製劑對熱和光照的穩定性較差,宜陰涼避光保存。
목적：：건립온민응효중니미서리적함량측정방법병고찰기각충조건하적은정성。방법：채용HPLC법,색보주위도진Shim-Pack C18-ODS주(150 mm ×4.6 mm,5μm),갑순-수-빙작산(65∶35∶0.8)위류동상,류속위1.0 ml·min-1；검측파장：299 nm；주온：30℃,진양량위10μl。결과：응효중니미서리여각잡질급강해산물분리량호,재2.43~24.37μg·ml-1범위내선성관계량호(r=0.9998),평균회수솔위100.02%(RSD=1.12%,n=5)。최저검측한위0.098μg·ml-1,최저정량한위0.25μg·ml-1。강광조사시험、파배성시험급장기은정성시험결과표명,니미서리온민응효장기은정성량호,단재고온감성、고온산성、고온강양화용액화강광조조건하불은정。결론：해방법가용우온민응효중니미서리함량측정급은정성연구,방법준학、가고。제제대열화광조적은정성교차,의음량피광보존。
Objective:To establish the method for determining nimesulide in thermo-sensitive hydrogels and study the stability of the preparation. Methods:An HPLC method was adopted with a Shim-Pack C18-ODS (150 mm × 4. 6 mm,5 μm) column, the mobile phase was composed of menthol-water-acetic acid (65∶35∶0. 8) with the flow rate of 1. 0 ml·min-1 at 30℃, the detection wavelength was at 299 nm, and the injection volume was 10 μl. Results:The separation of nimesulide, impurities and degradation products was good. The linear range of nimesulide was 2. 43-24. 37μg·ml-1(r=0. 999 8), the average recovery was 100. 02%(RSD=1. 12%, n=5). The lowest detectable limit and the lowest quantitation limit was 0. 098μg·ml-1 and 0. 25μg·ml-1, respectively. The stabil-ity results of hard-light exposure, destructive testing and long-term testing showed that the preparation was basically stable at room tem-perature, while under high temperature with hard light, strong basicity, acidicity or oxidation solution, the preparation was unstable. Conclusion:The method is accurate and reliable in the determination and stability study of nimesulide thermo-sensitive hydrogels. The hydrogels should be stored in shady, cool and dark place.
