今日药学
今日藥學
금일약학
PHARMACY TODAY
2009年
7期
3-7
,共5页
苯磺酸左氨氯地平%分散片%正交试验设计%质量
苯磺痠左氨氯地平%分散片%正交試驗設計%質量
분광산좌안록지평%분산편%정교시험설계%질량
Levoamledipine Besylate%dispersible tablets%orthogonal design%quality
目的 制备苯磺酸左氨氯地平分散片并评价其质量.方法 采用辅料相容性研究和崩解时间为指标筛选崩解剂的种类和用量;采用正交试验设计方案,优化最佳处方和制备工艺,通过初步稳定性考查,认证处方组成的合理性.结果 相容性试验表明:乳糖和苯磺酸左氨氯地平具有配伍禁忌;优化处方组成:主药苯磺酸左氨氯地平3.47 mg,微晶纤维素(MCC)70 mg,磷酸氢钙30 mg,淀粉30 mg,崩解剂交取聚乙烯吡轿咯烷酮(PVPP 8%),矫味剂阿斯巴甜5 mg.2.5%聚乙烯吡咯烷酮(PVP-k30)水溶液制粒,硬脂酸镁1%.采用内外加崩解剂(内加4%,外加4%),片剂崩解效果最好.最佳崩解时间<85 s,10 min溶出百分率明显高于普通片(P<0.05),初步稳定性试验结果表明,加速和室温留样6个月制剂质量稳定,各项指标符合质量标准要求.结论 苯磺酸左氨氯地平分散片处方组成合理,工艺稳定,体外溶出速率明显优于普通片,可适用于工业化生产.
目的 製備苯磺痠左氨氯地平分散片併評價其質量.方法 採用輔料相容性研究和崩解時間為指標篩選崩解劑的種類和用量;採用正交試驗設計方案,優化最佳處方和製備工藝,通過初步穩定性攷查,認證處方組成的閤理性.結果 相容性試驗錶明:乳糖和苯磺痠左氨氯地平具有配伍禁忌;優化處方組成:主藥苯磺痠左氨氯地平3.47 mg,微晶纖維素(MCC)70 mg,燐痠氫鈣30 mg,澱粉30 mg,崩解劑交取聚乙烯吡轎咯烷酮(PVPP 8%),矯味劑阿斯巴甜5 mg.2.5%聚乙烯吡咯烷酮(PVP-k30)水溶液製粒,硬脂痠鎂1%.採用內外加崩解劑(內加4%,外加4%),片劑崩解效果最好.最佳崩解時間<85 s,10 min溶齣百分率明顯高于普通片(P<0.05),初步穩定性試驗結果錶明,加速和室溫留樣6箇月製劑質量穩定,各項指標符閤質量標準要求.結論 苯磺痠左氨氯地平分散片處方組成閤理,工藝穩定,體外溶齣速率明顯優于普通片,可適用于工業化生產.
목적 제비분광산좌안록지평분산편병평개기질량.방법 채용보료상용성연구화붕해시간위지표사선붕해제적충류화용량;채용정교시험설계방안,우화최가처방화제비공예,통과초보은정성고사,인증처방조성적합이성.결과 상용성시험표명:유당화분광산좌안록지평구유배오금기;우화처방조성:주약분광산좌안록지평3.47 mg,미정섬유소(MCC)70 mg,린산경개30 mg,정분30 mg,붕해제교취취을희필교각완동(PVPP 8%),교미제아사파첨5 mg.2.5%취을희필각완동(PVP-k30)수용액제립,경지산미1%.채용내외가붕해제(내가4%,외가4%),편제붕해효과최호.최가붕해시간<85 s,10 min용출백분솔명현고우보통편(P<0.05),초보은정성시험결과표명,가속화실온류양6개월제제질량은정,각항지표부합질량표준요구.결론 분광산좌안록지평분산편처방조성합리,공예은정,체외용출속솔명현우우보통편,가괄용우공업화생산.
Objective To prepare Levoamlodipine Besylate dispersible tablets, and evaluate its quality. Methods Different disintegrates were screened, and the best formulation was optimized by orthogonal experiment design using the disintegration time and dissolution as indexes. The best formulation of Levoamlodipine Besylate dispersible tablets was authenticated by the initial stability experiment. Results Lactose is incompatible with Levoamlodipine Besylate. The best formulation of Levoamledipine Besylate dispersible tablets was composed of Levoamlodipine Besylate 3.47 mg, MCC 70 mg, brushite 30 mg, starch 30 mg, PVPP 8%, aspartame 5 mg, 2.5% polyvidone k30 queous solution quantity sufficient, and 1% Magnesium stearate. The effect of disintegration was much optimized when PVPP were used in coordinationwith exterior addition (4%) and interior addition (4%). The result showed that the disintegration time of optimizedprescription formulation was < 85 s, and the dissolution percent at 10 min was obviously better than that of conventionaltablets (P<0.05), and the quality of the dispersible tablets was very well by stability test. Conclusion The dispersible tablets of Levoamlodipine Besylate have a higher dissolution speed than conventional tablets. Its formulationand technology is simple, reasonable, and is suitable for industrialization production.
