中国药师
中國藥師
중국약사
CHINA PHARMACIST
2014年
12期
2053-2056
,共4页
奥氮平双羟萘酸盐长效注射剂%体外溶出度%高效液相色谱法
奧氮平雙羥萘痠鹽長效註射劑%體外溶齣度%高效液相色譜法
오담평쌍간내산염장효주사제%체외용출도%고효액상색보법
Olanzapine pamoate long-acting injections%In vitro dissolution%HPLC
目的：：建立奥氮平双羟萘酸盐长效注射剂的体外溶出度方法。方法：采用HPLC法测定奥氮平双羟萘酸盐长效注射剂的溶出度,采用浆法测定药物溶出度,溶出介质为0.5%十二烷基硫酸钠(SLS)模拟肌液(pH 7.0±0.05),体积为500 ml,分别考察不同转速(25,50,75 r·min-1)对自制制剂溶出行为的影响。结果：双羟萘酸在2.15~107.40 mg·L-1(r=0.9999)内,奥氮平在1.75~87.40 mg·L-1(r=0.9999)内浓度与峰面积呈良好的线性关系。奥氮平双羟萘酸盐的平均回收率为99.80%(RSD=0.55%, n=9)；自制制剂和原研制剂在溶出介质中溶出度相似因子f2为70.80。结论：溶出度测定方法能够有效控制该奥氮平双羟萘酸盐长效注射剂的产品质量。
目的：：建立奧氮平雙羥萘痠鹽長效註射劑的體外溶齣度方法。方法：採用HPLC法測定奧氮平雙羥萘痠鹽長效註射劑的溶齣度,採用漿法測定藥物溶齣度,溶齣介質為0.5%十二烷基硫痠鈉(SLS)模擬肌液(pH 7.0±0.05),體積為500 ml,分彆攷察不同轉速(25,50,75 r·min-1)對自製製劑溶齣行為的影響。結果：雙羥萘痠在2.15~107.40 mg·L-1(r=0.9999)內,奧氮平在1.75~87.40 mg·L-1(r=0.9999)內濃度與峰麵積呈良好的線性關繫。奧氮平雙羥萘痠鹽的平均迴收率為99.80%(RSD=0.55%, n=9)；自製製劑和原研製劑在溶齣介質中溶齣度相似因子f2為70.80。結論：溶齣度測定方法能夠有效控製該奧氮平雙羥萘痠鹽長效註射劑的產品質量。
목적：：건립오담평쌍간내산염장효주사제적체외용출도방법。방법：채용HPLC법측정오담평쌍간내산염장효주사제적용출도,채용장법측정약물용출도,용출개질위0.5%십이완기류산납(SLS)모의기액(pH 7.0±0.05),체적위500 ml,분별고찰불동전속(25,50,75 r·min-1)대자제제제용출행위적영향。결과：쌍간내산재2.15~107.40 mg·L-1(r=0.9999)내,오담평재1.75~87.40 mg·L-1(r=0.9999)내농도여봉면적정량호적선성관계。오담평쌍간내산염적평균회수솔위99.80%(RSD=0.55%, n=9)；자제제제화원연제제재용출개질중용출도상사인자f2위70.80。결론：용출도측정방법능구유효공제해오담평쌍간내산염장효주사제적산품질량。
Objective:To develop a dissolution method for olanzapine pamoate long-acting injections. Methods:The in vitro dis-solution profile of olanzapine pamoate was detected by an oar method and an HPLC method. The stirring speed respectively was 25, 50 and 75 r·min-1, and 500 ml of sodium lauryl sulfate simulated muscle fluid [0.5% , with pH of (7.0 ±0.05)] at (37 ±0.5)℃was used as the bio-relevant dissolution media. Results: The linearity between the peak areas and the concentrations was observed within the range of 2. 15-107. 40 mg·L-1(r=0. 999 9) for pamoate and 1. 75-87. 40 mg·L-1(r=0. 999 9) for olanzapine, respec-tively, and the average recovery of olanzapine pamoate was 99. 80%(RSD=0. 55%, n=9). The f2 for the dissolution in the dissolu-tion medium of shelf-prepared products and the innovation preparations was 70. 80. Conclusion:The dissolution method can be utilized to control the quality of olanzapine pamoate long-acting injections.
