清热颗粒质量标准研究

STANDARD FOR ASSESSING THE QUALITY OF FEVER-REDUCING GRANULES

目的评价自制清热颗粒制剂的质量,建立其标准的鉴定方法。方法采用薄层色谱法对自制清热颗粒的主药板蓝根、黄芩、栀子、枳壳、赤芍进行鉴别,发现问题及时采取措施进行修正;对其他指标按照2005年版《中华人民共和国药典》(一部)中药材标准亦进行了评定。结果通过修改提取方法、调整展开剂等,采用薄层色谱法能准确鉴别板蓝根、黄芩、栀子、枳壳、赤芍等主药;其他指标均符合国家标准,并且能建立相应的评定方法。结论自制清热颗粒制剂符合国家有关标准,并且能有简便易行、阴性亦无干扰的鉴别方法以及可行的评定方法。

Objective To evaluate the quality of thel self-made fever-reducing granules and to establish relative identifying method for the assessment. Methods The quality of radices isatidis, baikal skullcap root, fructus aurantii and radices paeoniae rubra were identified and the effetes were assessed according to the identification standard prescribed in the Phramacopoeia in Chuna. The quality of radices isatidis, baikal skullcap root, fruetus aurantii and radices paeoniae rubra were identified by adjusting the extraction methods and adopting thin-layer chromatography （TLC） and according to the Phramacopoeia jn Chuna. ResultsThe quality of radices isatidis, baikal skullcap root, fructus aurantii and radices paeoniae rubra were identified successfully according to the above methods. Conclusion The self-made fever-reducingl granules conforms to the national standard and can be used conveniently with being affected by negative bacteria.