摘要
目的 建立替考拉宁及其注射用制剂的含量测定方法。方法 管碟法。中国药典Ⅱ号培养基 ,pH 6 .5～ 6 .6 ;pH 6 .0磷酸盐缓冲液 ;检定菌为枯草芽孢杆菌 [CMCC(B) 6 35 0 1];培养温度为 (36± 1)℃ ;培养时间 14～ 16h ;高、低剂量分别为 40和 2 0u·mL-1。结果 抑菌圈大小适中、边缘清晰 ;在 17.17～ 41.91u·mL-1范围内 ,线性关系良好 (r =0 .99996 ) ;重现性好 (RSD=0 .6 % ,n =6 ) ;回收率为 10 0 .2 % (RSD =1.9% ,n =6 )。
OBJECTIVE To develop a bioassay for determing the content of teicoplanin in teicoplanin for injection.METHODS The cylinder-plate method with Medium No.2,Ph 6.5～6.6 and pH 6.0 phosphate buffer (Chinese Pharmacopeia Ⅱ,2000 Edition Appendix) was used.The test organism was Bacillus subtilis [CMCC(B) 63501];Incubation lasted 14～16 hours at the temperature (36±1)℃.The high and low doses were 40 and 20 teicoplanin units per mL respectively.RESULTS The size of circular area (zone) of growth inhibition aroud the cylinder was moderate and the brim of ones was clear.The linearity was achieved over the range of 17.17～41.91 μ·mL -1(r=0.999 96).The reproducibility and recovery were acceptable.CONCLUSION It provided a suitable method to determin the contents of teicoplanin in injection.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2002年第4期302-304,共3页
Chinese Pharmaceutical Journal
