北华大学学报（自然科学版）
北華大學學報（自然科學版）
북화대학학보（자연과학판）
JOURNAL OF BEIHUA UNIVERSITY(NATURAL SCIENCE)
2015年
1期
54-57
,共4页
王喜斌%左红香%王曼力%黄耀林%刘庆波%孙亚楠
王喜斌%左紅香%王曼力%黃耀林%劉慶波%孫亞楠
왕희빈%좌홍향%왕만력%황요림%류경파%손아남
海布胶囊%原料药%稳定性%加速实验
海佈膠囊%原料藥%穩定性%加速實驗
해포효낭%원료약%은정성%가속실험
Haibu capsule%bulk drug%stability%accelerated test
目的：考察海布胶囊原料药的稳定性.方法按药物稳定性实验指导原则进行影响因素实验、加速实验和长期实验.结果海布胶囊原料药在实验前后的外观、鉴别、吸湿性、微生物限度检查等均符合规定，实验前后比较差异无统计学意义(P<0.05).结论海布胶囊于室温条件下保存质量稳定，有效期可达2 a.
目的：攷察海佈膠囊原料藥的穩定性.方法按藥物穩定性實驗指導原則進行影響因素實驗、加速實驗和長期實驗.結果海佈膠囊原料藥在實驗前後的外觀、鑒彆、吸濕性、微生物限度檢查等均符閤規定，實驗前後比較差異無統計學意義(P<0.05).結論海佈膠囊于室溫條件下保存質量穩定，有效期可達2 a.
목적：고찰해포효낭원료약적은정성.방법안약물은정성실험지도원칙진행영향인소실험、가속실험화장기실험.결과해포효낭원료약재실험전후적외관、감별、흡습성、미생물한도검사등균부합규정，실험전후비교차이무통계학의의(P<0.05).결론해포효낭우실온조건하보존질량은정，유효기가체2 a.
Objective The stability of bulk drug in Haibu capsule was investigated. Method Stress test, accelerated test and long-term test were carried out according to the principles referring to the drug stability. Results The quality of the principal agent in Haibu capsule, including appearance, identification, moisture absorption and microorganism limitation, accorded with regulation after the stability tests, and no statistical difference was detected ( P<0 . 05 ) . Conclusion The bulk drug can maintain its stability and feasibility for 2 years at room temperature.
