【摘要】 高浓度卡介苗临床用于膀胱癌术后化疗已有数十年。经临床使用其抑制浅表型膀胱癌术后复发效果显著。为满足临床患者的使用，需研制一种适合的治疗用卡介苗制剂。本文报道了三批治疗用卡介苗的研制过程及本所质管处，中检所的检定结果。样品现已通过检定，正申请试生产文号更多还原

【Abstract】 Higher concertration BCG vaccine which used in chemotherapy of superficial bladder cancer after transurethral resection have been applied clinically for several ten years.It very curative by chinical studying that therapetic BCG can suppress incidence of recurrence of superficial bladder cancer after surgical treatment. However,there is a need to prepare a kind of therapeutic BCG product for meeting the demands of clinical pationts. This paper reports the procedures of preparation of three batch samples of therapeutic BCG and the results of test for quality control by our institute quality control department and the National Institute for the Control of Pharmaceutical and Biologicsal Products.Three batch samples have been passed the test for quality control,and applying for trial licence of manufacture from Minictry of Health.更多还原