退黄灵口服液质量标准研究与提高.doc

退黄灵口服液质量标准研究与提高.doc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。
【关键词】退黄灵口服液;质量标准;稳定性考察
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【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 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 ination of emodin and chrysophanol,simple,accurate and The higher quality standards to better control the quality of this preparation.
【Key ond);高效液相色谱仪(美国l。
制备
大黄照流浸膏与浸膏剂项下的渗漉法(附录10),用50%乙醇作溶剂,浸渍24 h后进行渗漉,减压回收乙醇,得液①,备用。
将处方中其余茵陈等六味,加入热回流循环提取浓缩机组中,加水浸泡30 min后,煮沸,进行回流提取,一边回流一边浓缩,共4 h;~(60℃)的膏体排出,待冷,加入乙醇,调含醇量至60%,充分搅拌均匀,静置24 h;过滤,滤取清液加入酒精回收器,(50℃~60℃)