退黄灵口服液质量标准研究与提高.doc

1 退黄灵口服液质量标准研究与提高【摘要】目的拟定退黄灵口服液的质量控制标准, 进行研究与提高。并对大黄素进行含量测定。方法按拟定的质量标准对其进行性状检查等质量研究, 采用薄层色谱法对其有效成分进行鉴别; 采用 HPLC 对大黄素、大黄酚进行测定; 通过加速试验和常温考察两种方法对其初步稳定性进行预测。结果本品分别在 0、1、2、3 个月, 于温度 37℃~40 ℃、相对湿度 75% 和常温下考察, 本品的性状、鉴别、检查等均无明显变化; 大黄素、大黄酚的测定, 操作简便, 准确, 重现性好。结论提高后的质量标准能更有效地控制本制剂的质量。蕌【关键词】退黄灵口服液;质量标准;稳定性考察蕌【 Abstract 】 Objective To the development of the Tuihuangling oral liquid quality control standards and research to carried emodin and chrysophanol To develop quality standards for thEir characters , such as checked the quality of research , used thin-layer chromatography for identification of its active 2 ingredients; used HPLC for the determination of emodin and chrysophanol; by accelerating test and inspection methods at room temperature for its initial Predict 0,1,2,3 in months , the temperature at 37℃~40 ℃, relative humidity of 75%and room temperature inspection , the characters of goods , identification , inspection , and so there was no significant change ; the determination of emodin and chrysophanol , simple , accurate and The higher quality standards to better control the quality of this preparation. 蕌【 Key words 】 Tuihuangling oral liquid ; Quality standards ; Stability 新生儿黄疸是指新生儿体内胆红素过高而引起的一组疾病,严重时可导致新生儿神经系统受损引发胆红素脑病, 影响新生儿智力发育, 是严重威胁新生儿健康的“隐形杀手”。因此及早发现和治疗新生儿黄疸在优育学方面和提高人口素质方面具有极其重要的意义。退黄灵口服液是惠州市中心人