| 抗纤胶囊质量标准的研究 |
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| 引用本文： | 朱琳,翟美华.抗纤胶囊质量标准的研究[J].中国医药科学,2011(22):31-32. |
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| 作者姓名： | 朱琳 翟美华 |
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| 作者单位： | 江苏省南通市药品检验所 |
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| 摘 要： | 目的建立抗纤胶囊的质量标准。方法采用薄层色谱法对抗纤胶囊中苦参、赤芍进行定性鉴别;采用高效液相色谱法测定制剂中的粉防己碱,色谱柱为:Diamonsil C18柱(250mm×4.6mm,5μm)分析柱;流动相:甲醇-三乙胺溶液(3.5→500)(80∶20),流速:0.9mL·min;检测波长:283nm。结果薄层色谱法具有专属性,高效液相色谱法准确可靠,粉防己碱在进样量0.09282～2.7846μg范围内线性关系良好,回归方程为Y=735786X-428.14,r=1.0000(n=10),平均回收率为99.11%,RSD为1.89%。结论该法可作为抗纤胶囊的质量控制标准。
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| 关 键 词： | 抗纤胶囊 薄层色谱法 高效液相色谱法 粉防己碱 质量标准 |
The study of standara quality on Kangxian capsules |
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| ZHU Lin,ZHAI Meihua.The study of standara quality on Kangxian capsules[J].China Medicine and Pharmacy,2011(22):31-32. |
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| Authors: | ZHU Lin ZHAI Meihua |
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| Institution: | The Drug Control Institute of Nantong City in Jiangsu Province,Nantong226006,China |
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| Abstract: | Objective To establish the quality standard of Kangxian Capsules. Methods Radix Sophorae Flavescentis,Radix Paeoniae Rubra were identified by TLC.The content of tetrandrine was determined by HPLC RP.HPLC with diamonsil ODS (250 mm×4.6 mm,5 μm)column was used,The mobile phase was a mixture of methanol-trethylamine solution(3.5 → 500)(80:20)with the flow rate of 0.9 mL·min -1 and detection wavelength at 283 nm. Results TLC could identify Radix Sophorae Flavescentis,Radix Paeoniae Rubra.Tetrandrine showed good linear correlation at the range of 0.09282 ～ 2.7846μg,Return equation was Y=735786X-428.14, r=1.0000,the average recovery was 99.11%,RSD was 1.89%.Conclusion The method could be used as the quality control methods of Kangxian Capsules. |
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| Keywords: | Kangxian capsule TLC HPLC Tetrandrine Quality standard |
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