注射用间苯三酚的制备、质量控制及稳定性考察

Phloroglucinol for Injection:Preparation,Quality Control and Stability Study

目的；制备注射用间苯三酚，建立其质量控制方法并考察其稳定性。方法：对处方中填充荆的种类、用量进行选择，并制备注射用间苯三酚；采用高效液相色谱法测定其中间苯三酚的含量，并对制荆进行稳定性试验。结果：确定了以甘露醇100．0g为填充剂的制剂处方；间苯三酚检测浓度在0．13～1．04mg·mL^-1范围内线性关系良好（r=1．0000）；恒温加速试验6mo及长期留样试验12mo时主药含量及有关物质检测未见明显改变。结论：该制剂处方工艺合理可行，质量可控，稳定性良好；所建立的含量测定方法重现性好、专属性强，测定结果在规定限度内。

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 pre pared, 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.