退黄灵口服液质量标准研究与提高

Improve the quality control standards of the Tuihuangling oral liquid

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。

Objective To the development of the Tuihuangling oral liquid quality control standards and research to improve. And carried emodin and chrysophanol determination. Methods To develop quality standards for their characters, such as checked the quality of research, used thin-layer chromatography for identification of its active ingredients ; used HPLC for the determination of emodin and chrysophanol; by accelerating test and inspection methods at room temperature for its initial Predict stability. Results 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 ehrysophanol, simple, aceurate and reproducible. Conclusion The higher quality standards to better control the quality of this preparation.