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| 清热降糖颗粒剂的质量标准研究 | |
| 引用本文： | 仲跻云,时文祥,仲珊珊,李瑾,张乃元.清热降糖颗粒剂的质量标准研究[J].药学进展,2012,36(8):373-376. |
| 作者姓名： | 仲跻云 时文祥 仲珊珊 李瑾 张乃元 |
| 作者单位： | 1. 南京海鲸药业有限公司,江苏南京,210061 2. 中国药科大学制药有限公司,江苏南京,210009 3. 中国药科大学药物制剂研究所,江苏南京,210009 |
| 摘 要： | 目的：建立清热降糖颗粒的质量标准。方法：采用薄层色谱法对制剂中黄连、葛根及黄芩进行定性鉴别,以HPLC法对制剂中黄芩苷进行定量测定。结果：黄连、葛根及黄芩薄层色谱斑点清晰,阴性对照无干扰。黄芩苷进样量在0.069 28～1.385 6μg范围内与色谱峰面积积分值呈良好线性关系（r=0.999 7）,平均回收率为99.21%,RSD为0.40%（n=5）。测得3批样品中的黄芩苷含量分别为30.46、32.68和31.54 mg.g-1。结论：所建标准可用于清热降糖颗粒的质量控制。 |
| 关 键 词： | 清热降糖颗粒 质量标准 黄芩苷 薄层色谱 高效液相色谱 |
Study on Quality Standard of Qing-Re-Jiang-Tang Granules |
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| ZHONG Ji-yun , SHI Wen-xiang , ZHONG Shan-shan , LI Jin , ZHANG Nai-yuan.Study on Quality Standard of Qing-Re-Jiang-Tang Granules[J].Progress in Pharmaceutical Sciences,2012,36(8):373-376. | |
| Authors: | ZHONG Ji-yun SHI Wen-xiang ZHONG Shan-shan LI Jin ZHANG Nai-yuan |
| Institution: | 1(1.Nanjing Hai-jing Pharmaceutical Co.,Ltd.,Nanjing 210061,China;2.China Pharmaceutical University Pharmaceutical Co.,Ltd.,Nanjing 210009,China;3.Institute of Pharmaceutics,China Pharmaceutical University,Nanjing 210009,China) |
| Abstract: | Objective:To establish the quality standard of Qing-Re-Jiang-Tang Granules.Methods:The thin layer chromatography(TLC) method was used to identify Coptidis Rhizoma,Puerariae Lobatae Radix and Scutellariae Radix in the recipe qualitatively.The content of baicalin in the recipe was determined by HPLC.Results:The TLC spots were clear without the interference from negative sample.Baicalin showed a good linear relationship at a range of 0.06928~1.3856 μg(r=0.999 7).The average recovery was 99.21%,and RSD was 0.40%(n=5).The content of baicalin in 3 batches of samples was 30.46,32.68 and 31.54 mg ·g-1,respectively.Conclusion:The established standard can be used for the quality control of Qing-Re-Jiang-Tang Granules. |
| Keywords: | Qing-Re-Jiang-Tang Granules quality standard baicalin thin layer chromatography HPLC |
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