多西他赛注射液的制备及质量控制.pdfVIP

2010 4 25 2 121 # # 1, 2 1( 1. , 200030; 2. , 201203) 朱 雷 , 沈 琦 : 制备一种稳定的多西他赛注射液, 并对其进行相应质量控制和稳定性考 通过对多西他赛注射液的处方 工艺的系统研究, 制备一种稳定的多西他赛注射液, 参照注射用多西他赛的国家试行标准和安万特的多西他赛注射液( 泰索帝) 的内控标准, 制定相应标准并对其质量进行控制和稳定性考 以酒石酸为 pH 调节剂, 当溶液的 pH 为3. 5 左右时, 注 射液稳定性最好通过 12 个月的稳定性考 , 注射液的各项指标均符合要求 制备工艺比较简单, 制成的多西他赛注射 液稳定性好, 质量符合标准要求 : 多西他赛注射液; 制备; 质量控制 doi: 10. 3969/ j. issn. 1004-2407. 2010.02. 025 : R94 :A : 1004-2407(2010) 02-0121-03 Preparation and quality control of Docetaxel Injection 1, 2 1 ZHU Lei , H EN Qi ( 1. School of P har macy , S hang hai J iaotong Univ ers ity , S hang hai, 200030; 2. Shanghai D esano M edi- cine D evelop ment Co . , Ltd, Shang hai, 201203 Abstract: Objective To make a better formulation of Docetaxel Injection by using a simple preparation met hod, and to establish a better quality standard w hich can control the samples. Method The prescript ion process of Docetaxel Inject ion was established and compared w ith the national standards and the internal cont rol st andards of Taxotere from Avent is company. Results The injection was stable when the pH , adjusted by t artaric acid, of the solution is about 3. 5; the qualit y of the samples was consist ent w ith t he standard. after 12 months. Conclusion The preparing t hchnique is simple; the quality of the samples is consistent w ith the stand- ard. Key words:Docetaxel injection; preparation; quality 1995 ( MILLIPORE ) ; ( ) ; ( N CLC) , ( ) ; 51 , 24 ( ) ; pH ( , N CLC ) 2004 FDA 1. 2 试药 ( ) ; ( ) ; 80( ) ; N CLC ( ) ; ( , , ) 2 , 20 g 1. 25 g , , 121 e 15 min 20 mg B 0. 5 mL 80 500 mL, , 1 000 mL, [ 1]