间苯三酚氯化钠注射液处方工艺优化及质量控制

Formula and Technology Screening and Quality Control of Phloroglucinol and Sodium Chloride Injection

目的根据临床需要,研究开发间苯三酚氯化钠注射液,并建立其质量控制方法。方法拟订处方组成与制备工艺,制备中试样品,用高效液相色谱法测定间苯三酚含量,用容量法测定氯化钠含量,并通过影响因素试验、加速试验和长期试验考察该注射液的稳定性。结果按照优化出来的最佳处方及工艺制备的3批中试样品,其质量均合格。结论制剂处方合理,制备工艺简便可行,产品稳定性良好,质量可控。

Objective To research and develop phloroglucinol and sodium chloride injection in order to meet the clinical request, and to build up the methods of the quality control. Methods Designing the formulation and manufacturing technique, to determine the content of phloroglucinol by HPLC and sodium chloride by volumetric method, and to investigate the stability by influencing factor test, accelerated test and long- term test. Results According to the optimized fomula and manufacturing technique, the three batchs of phloroglucinol and sodium chloride injection were prepared. The quality of the products was investigated and the results were qualified. Conclusion The design of the preparation and manufacturing technique is rational. The quality can be controlled and the stability is achieved.