摘要
目的:比较A、B、C厂头孢羟氨苄制剂的溶出度,为临床选择用药提供参考。方法:含量测定采用紫外分光光度法,测定波长为263nm;溶出度考察统一采用桨法,其溶剂为水,转速为50r/min,并以威布尔分布模型拟合参数Td、m、β的值,再对参数进行方差分析;另对C厂头孢羟氨苄胶囊同时采用桨法和转篮法进行溶出度考察,并将结果做t检验。结果:头孢羟氨苄片与胶囊的Td、β值比较具有显著性差异(P<0.01),不同厂家、规格、批号片剂间的Td值比较均无显著性差异(P>0.05),A厂2批片剂间的m值比较具有显著性差异;C厂2批胶囊分别以桨法和转篮法测定在10、20min以下时的溶出度有显著性差异(P<0.05)。结论:桨法药物释放的前期要比转篮法快;头孢羟氨苄片的溶出要快于胶囊,临床可根据需要选用。
OBJECTIVE:To compare the dissolution rates of cefadroxil preparations from A,B and C3manufacturers and to provide references for rational clinical drug use.METHODS:The contents were determined by UV-spectrophotometry with the detection wavelength at263nm;The dissolution was determined by oar method with water as the solvent and with rotation speed at50r/min,the stripping curves were drawn,the parameters of T d ,m andβwere figured out,and on which ANOVA was conducted;Besides,the dissolution tests were conducted on cefadroxil capsules that from manufacturer C by oar method and baskets-rotating methods simultaneously and the results of which were subjected to t-tests.RESULTS:The values of T d andβof cefadroxil capsules and cefadroxil tablets had significant differences(P<0.01),no significances were found in T d among cefadroxil tablets that from different manufacturers,of different specifications and batch Nos(P>0.05),but sigˉnificances were found in m value between2batches of cefadroxil tables;The dissolution values of2batches of capsules from manufacturer C were signficances determined by oar method and rotation basket method respectively for less than10min and20min(P<0.05).CONCLUSION:At an early stage,drug releasing by oar method was quicker than that by basket-rotation method;The dissolution rate of cefadroxil tablets were quicker than that of its capsules,the clinic can choose different dosage forms based on different needs.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第14期1100-1102,共3页
China Pharmacy
关键词
头孢羟氨苄
片剂
胶囊
溶出度
Cefadroxil
Tablets
Capsule
Dissolution rate
