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目的建立医院制剂鼻窍通颗粒中黄芪、黄芩的质量控制方法,为质量标准的制定提供依据。方法采用单因素试验方法,对影响黄芪、黄芩的薄层色谱因素(包括不同的展开系统、显色剂、温度、湿度、点样量和不同厂家薄层板)进行系统考察,筛选出最佳的薄层色谱条件。结果黄芪采用硅胶G薄层板,以三氯甲烷-甲醇-水(13∶7∶2)的下层溶液为展开剂,取出,晾干,喷以10%硫酸乙醇溶液,在105℃加热至斑点显色清晰;黄芩采用硅胶G薄层板,以甲苯-乙酸乙酯-甲酸-甲醇(9∶3∶2∶2)为展开剂,取出,晾干,日光下放置30 min后检视斑点显色清晰。结论薄层色谱特征斑点清晰、分离效果好,专属性强,重复性好,阴性对照品无干扰。该方法简单方便、准确灵敏,可有效控制鼻窍通颗粒的质量。
Objective To establish a method for quality control of Astragalus and Scutellaria baicalensis Georgi in nostrils and capsules of hospital preparations and provide basis for the establishment of quality standards. Methods The single factor test method was used to systematically investigate the effects of TLC on Astragalus membranaceus and Scutellaria baicalensis Georgi (including different development systems, developer, temperature, humidity, spotting amount and different manufacturer laminates) TLC conditions. Results Astragalus using silica gel G plate with chloroform - methanol - water (13: 7: 2) of the lower solution as the developing agent, remove, dry, spray 10% sulfuric acid ethanol solution, heated to 105 Clear color; Scutellaria using silica gel G plate with toluene - ethyl acetate - formic acid - methanol (9: 3: 2: 2) as developing solvent, dried and placed in sunlight for 30 minutes after the inspection spot color Clear. Conclusion TLC features spots clear, good separation, specificity, good repeatability, negative control without interference. The method is simple and convenient, accurate and sensitive, which can effectively control the quality of the nasal block.