中国医药导报
中國醫藥導報
중국의약도보
CHINA MEDICAL HERALD
2014年
28期
4-6,10
,共4页
刘玉明%钱甜甜%蒋定文%何颖%沈先荣%江叔奇
劉玉明%錢甜甜%蔣定文%何穎%瀋先榮%江叔奇
류옥명%전첨첨%장정문%하영%침선영%강숙기
海洋星虫多糖胶囊%稳定性%加速试验%长期试验
海洋星蟲多糖膠囊%穩定性%加速試驗%長期試驗
해양성충다당효낭%은정성%가속시험%장기시험
Sipunculus nudus Polysaccharide Capsules%Stability%Accelerated test%Long-term test
目的研究海洋星虫多糖胶囊的稳定性。方法按照《中国药典》2005年版二部附录原料药与药物制剂稳定性试验指导原则，以胶囊剂重点考察项目性状、鉴别、水分、崩解时限、微生物限度、含量测定为评价指标，进行加速试验和长期试验。结果三批样品经过6个月的加速试验和12个月的长期试验，各项指标均符合质量标准规定。结论海洋星虫多糖胶囊药物性质稳定。
目的研究海洋星蟲多糖膠囊的穩定性。方法按照《中國藥典》2005年版二部附錄原料藥與藥物製劑穩定性試驗指導原則，以膠囊劑重點攷察項目性狀、鑒彆、水分、崩解時限、微生物限度、含量測定為評價指標，進行加速試驗和長期試驗。結果三批樣品經過6箇月的加速試驗和12箇月的長期試驗，各項指標均符閤質量標準規定。結論海洋星蟲多糖膠囊藥物性質穩定。
목적연구해양성충다당효낭적은정성。방법안조《중국약전》2005년판이부부록원료약여약물제제은정성시험지도원칙，이효낭제중점고찰항목성상、감별、수분、붕해시한、미생물한도、함량측정위평개지표，진행가속시험화장기시험。결과삼비양품경과6개월적가속시험화12개월적장기시험，각항지표균부합질량표준규정。결론해양성충다당효낭약물성질은정。
Objective To investigate the stability of Sipunculus nudus Polysaccharide Capsules. Methods According to the stability testing of pharmaceutical preparations and guiding principles in Appendix of Chinese Pharmacopeia (2005 edition, 2 volume), with the major investigation items of character, identification, moisture, disintegration time, micro-bial limit test, the content of polysaccharide as the evaluation indexes, the accelerated test and long-term test were performed. Results All indexes in 3 batches of samples after 6-month accelerated testing and 12-month long trial were in line with the quality standard requirements. Conclusion The drug properties of Sipunculus nudus Polysaccharide Capsules are stable.
