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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 develop the quality control standard of Jhuangling oral liquid and to study and improve it. And emodin content determination. Methods According to the quality standards, the quality traits were checked and the effective components were identified by TLC. The emodin and chrysophanol were determined by HPLC. The preliminary tests were carried out by accelerated test and room temperature test Stability prediction. Results This product was observed at 0, 1, 2 and 3 months respectively at 37 ℃ ~ 40 ℃, relative humidity 75% and room temperature. The properties, identification and examination of this product showed no significant changes. Emodin, rhubarb Determination of phenol, easy to operate, accurate, reproducible. Conclusion The improved quality standard can more effectively control the quality of the preparation.