安中通便胶囊质量标准提升研究

Investigating quality standard improvement of Anzhong Tongbian Capsules

为完善和提升安中通便胶囊的质量标准,文章以薄层色谱法鉴别方中姜厚朴及肉苁蓉;以高效液相色谱(high performance liquid chromatography,HPLC)法测定君药中大黄素及大黄酚的质量,并以现行版中国药典方法进行微生物限度检查验证试验。试验结果表明:姜厚朴及肉苁蓉的薄层特征斑点清晰,分离度好,阴性无干扰;安中通便胶囊中大黄素、大黄酚质量浓度线性范围分别为0.006~0.144 mg/mL(r=0.9997)、0.018~0.420 mg/mL(r=0.9996),大黄素平均加样回收率为98.95%,相对标准偏差(relative standard deviation,RSD)为0.97%;大黄酚的平均加样回收率为96.77%,RSD为0.84%。安中通便胶囊各菌的回收率在0.5~2.0区间。该试验新增的薄层鉴别、含量测定及微生物限度检查方法操作简便、专属性强,重复性好,可为进一步提升该制剂的质量标准提供依据。

To improve the quality standard of Anzhong Tongbian Capsules,Magnolia Bark slices stir-baked with ginger juice and Cistanche deserticola Ma were qualitatively identified by using thin layer chromatography(TLC)method.The content of Rheum emodin and Chrysophanol was determined by using high performance liquid chromatography(HPLC)method.Microbial limit inspection verification test was also carried out according to the current Chinese Pharmacopoeia method.The results showed that the TLC spots of Magnolia Bark slices stir-baked with ginger juice and Desertliving Cistanche were clear,the resolutions were good,and the negative controls were no interference.The linear ranges of Rheum emodin and Chrysophanol were 0.0060.144 mg/mL(r=0.9997)and 0.0180.420 mg/mL(r=0.9996),respectively.The average recovery of Rheum emodin was 98.95%(RSD=0.97%),and the average recovery of Chrysophanol was 96.77%(RSD=0.84%).The bacteria recovery rates of Anzhong Tongbian Capsules were all within the range of 0.52.0.The new added thin-layer identification,content determination,and microbial limit inspection methods are simple to operate,highly specific and repeatable,providing a basis for further improving the quality standard of Anzhong Tongbian Capsules.