Phloroglucinol for Injection:Preparation,Quality Control and Stability Study / 中国药房

ABSTRACT

OBJECTIVE:To prepare phloroglucinol for injection,establish its quality control and determine its stability.METHODS:The type and dosage of the adjuvant in the formula were optimized and the phloroglucinol for injection was prepared,with its content determined by HPLC.Meanwhile its stability was tested.RESULTS:Mannitol 100.0g was determined as the adjuvant in the formula.The linear range of phloroglucinol was 0.13～ 1.04mg.mL-1(r=1.000 0).No obvious changes were observed at 6 month of an accelerated test or 12 month of long-term storage test.CONCLUSIONS:The preparation is reasonable and feasible in techniques,controllable and stable in quality;and the established method is recurrent,specific and the determination results are within defined margin.