中国化工贸易
中國化工貿易
중국화공무역
CHINA CHEMICAL TRADE
2013年
10期
175-175
,共1页
孙洋涛%吴双俊%孟爱红%赵海桥
孫洋濤%吳雙俊%孟愛紅%趙海橋
손양도%오쌍준%맹애홍%조해교
辛伐他汀片%工艺优化%技术改进
辛伐他汀片%工藝優化%技術改進
신벌타정편%공예우화%기술개진
Simvastatin Tablets%process optimization%technical improvements
目的：以不同处方及工艺考察辛伐他汀片的稳定性。方法：根据原辅料相容性试验结果，采用正交设计实验，以休止角、溶出度及有关物质综合评分筛选出最合理处方及制备工艺。结果：本法可解决辛伐他汀易氧化及质量不稳定的问题，结论：辛伐他汀片处方合理，工艺可行，符合片剂的质量要求。
目的：以不同處方及工藝攷察辛伐他汀片的穩定性。方法：根據原輔料相容性試驗結果，採用正交設計實驗，以休止角、溶齣度及有關物質綜閤評分篩選齣最閤理處方及製備工藝。結果：本法可解決辛伐他汀易氧化及質量不穩定的問題，結論：辛伐他汀片處方閤理，工藝可行，符閤片劑的質量要求。
목적：이불동처방급공예고찰신벌타정편적은정성。방법：근거원보료상용성시험결과，채용정교설계실험，이휴지각、용출도급유관물질종합평분사선출최합리처방급제비공예。결과：본법가해결신벌타정역양화급질량불은정적문제，결론：신벌타정편처방합리，공예가행，부합편제적질량요구。
Objective: Examine different prescriptions and process stability of Simvastatin Tablets. Methods: According to raw materials compatibility test results, the use of orthogonal design experiments to angle of repose, dissolution and related substances composite score filter out the most reasonable formulation and preparation. Results: This method resolves simvastatin easily oxidized and quality problems of instabili-ty. Conclusions:Simvastatin Tablets reasonable and technology is feasible, consistent with the tablet's quality requirements.
