中国药物评价
中國藥物評價
중국약물평개
Chinese Journal of Drug Evaluation
2015年
2期
65-68
,共4页
阿莫西林%溶出曲线%相似性%f2相似因子%Weibull分布
阿莫西林%溶齣麯線%相似性%f2相似因子%Weibull分佈
아막서림%용출곡선%상사성%f2상사인자%Weibull분포
Amoxicillin capsules%Dissolution curve%Comparability%F2 similarity factor%Weibull′s distribution
目的：考察4家企业生产的阿莫西林胶囊在4种溶出介质中的溶出情况，并对溶出曲线相似性进行评价。方法：分别以水、pH 1.2盐酸溶液、pH 4.0醋酸盐缓冲液及pH 6.8磷酸盐缓冲液为溶出介质，按《中华人民共和国药典》（2010年版）阿莫西林胶囊项下方法进行溶出曲线测定。选择非模型依赖法f2相似因子法和模型依赖法Weibull分布模型评价溶出曲线的相似性。结果：A、B、C样品均为国产样品，其T50、Td值相差小，溶出曲线相似；D样品为ICH成员国进口样品，其T50、Td值约为A、B、C样品的2倍，与A、B、C样品累计溶出曲线的相似因子均小于50，溶出曲线存在显著差异。结论：f2相似因子法和Weibull分布模型法二者互为补充，适用于固体制剂体外溶出曲线相似性评价。
目的：攷察4傢企業生產的阿莫西林膠囊在4種溶齣介質中的溶齣情況，併對溶齣麯線相似性進行評價。方法：分彆以水、pH 1.2鹽痠溶液、pH 4.0醋痠鹽緩遲液及pH 6.8燐痠鹽緩遲液為溶齣介質，按《中華人民共和國藥典》（2010年版）阿莫西林膠囊項下方法進行溶齣麯線測定。選擇非模型依賴法f2相似因子法和模型依賴法Weibull分佈模型評價溶齣麯線的相似性。結果：A、B、C樣品均為國產樣品，其T50、Td值相差小，溶齣麯線相似；D樣品為ICH成員國進口樣品，其T50、Td值約為A、B、C樣品的2倍，與A、B、C樣品纍計溶齣麯線的相似因子均小于50，溶齣麯線存在顯著差異。結論：f2相似因子法和Weibull分佈模型法二者互為補充，適用于固體製劑體外溶齣麯線相似性評價。
목적：고찰4가기업생산적아막서림효낭재4충용출개질중적용출정황，병대용출곡선상사성진행평개。방법：분별이수、pH 1.2염산용액、pH 4.0작산염완충액급pH 6.8린산염완충액위용출개질，안《중화인민공화국약전》（2010년판）아막서림효낭항하방법진행용출곡선측정。선택비모형의뢰법f2상사인자법화모형의뢰법Weibull분포모형평개용출곡선적상사성。결과：A、B、C양품균위국산양품，기T50、Td치상차소，용출곡선상사；D양품위ICH성원국진구양품，기T50、Td치약위A、B、C양품적2배，여A、B、C양품루계용출곡선적상사인자균소우50，용출곡선존재현저차이。결론：f2상사인자법화Weibull분포모형법이자호위보충，괄용우고체제제체외용출곡선상사성평개。
Objective:To investigate the dissolution of amoxicillin capsules which came from 4 pharmaceutical companies in 4 kinds of dissolution media,and to evaluate the comparability of dissolution curves.Methods: According to ChP 2010, water, pH 1.2 hydrochloric acid solution,pH 4.0 acetate buffer solution and pH 6.8 phosphate buffer solution were respectively used to deter-mine the accumulative dissolution of the samples.The model independent method -f2 similarity factor method and model dependent method-Weibull′s distribution model were selected to evaluate the comparability of dissolution curves.Results:A, B, and C came from domestic pharmaceutical companies,their value of T50 and Td were very close and their dissolution curves were similar.D came from pharmaceutical company of ICH members, its value of T50,Td double than that of A,B,and C, in addition,the dissolution curve was significantly different from that of A, B, and C, the similarity factors were all less than 50.Conclusion: f2 similarity factor and Weibull′s distribution model method complement each other.Both of them were suitable to evaluate the dissolution curve similarity of solid preparation.
