| 引用本文: | 张智,乔德龙,李维民,张政,卢英,徐小山,邓月婷.鞣酸不同级分作为合成原料对鞣酸小檗碱膜溶化时限的影响[J].中国现代应用药学,2021,38(10):1201-1204. |
| ZHANG Zhi,QIAO Delong,LI Weimin,ZHANG Zheng,LU Ying,XU Xiaoshan,DENG Yueting.Effects of Different Fractions of Tannic Acid as the Raw Material on the Dissolution Time of Berberine Tannate Pellicles[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(10):1201-1204. |
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| 鞣酸不同级分作为合成原料对鞣酸小檗碱膜溶化时限的影响 |
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张智1,2, 乔德龙1, 李维民1, 张政1,2, 卢英1,2, 徐小山1,2, 邓月婷1,2
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1.甘肃陇神戎发药业股份有限公司, 兰州 730102;2.甘肃省中药固体分散制剂重点实验室, 兰州 730102
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| 摘要: |
| 目的 通过鞣酸小檗碱的合成原料控制改善鞣酸小檗碱膜的溶化时限。方法 通过对73%的粗制鞣酸进行不同极性溶剂的分离提取，得到不同级分的鞣酸，与盐酸小檗碱反应制备鞣酸小檗碱，然后涂膜检测各自的溶化时限，以寻找最佳级分的鞣酸作为鞣酸小檗碱膜合成原料。结果 鞣酸的水级分以及水级分剩余物作为原料制备的鞣酸小檗碱使得鞣酸小檗碱膜的溶化时限缩短至<5 min，完全符合中国药典2015年版膜剂相关要求。结论 经过工艺优化后生产的鞣酸小檗碱原料药可以使鞣酸小檗碱膜溶化时限明显缩短，改善膜剂的分散性能。 |
| 关键词: 鞣酸 级分 溶化时限 小檗碱 膜剂 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.10.008 |
| 分类号:R944 |
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| Effects of Different Fractions of Tannic Acid as the Raw Material on the Dissolution Time of Berberine Tannate Pellicles |
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ZHANG Zhi1,2, QIAO Delong1, LI Weimin1, ZHANG Zheng1,2, LU Ying1,2, XU Xiaoshan1,2, DENG Yueting1,2
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1.Gansu Longshenrongfa Pharmaceutical Industry Co., Ltd., Lanzhou 730102, China;2.Gansu Key Laboratory of Traditional Chinese Medicine Solid Dispersible Preparation, Lanzhou 730102, China
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| Abstract: |
| OBJECTIVE To improve the dissolution time of berberine tannate pellicles by controlling the synthetic material of berberine tannate.METHODS After separation and extraction of 73% crude tannic acid with different polar solvents, different fractions of tannic acid were obtained and reacted with berberine hydrochloride to prepare berberine tannate.Then, the dissolution time of each coating was detected to find the best fraction of tannic acid as the raw material for the synthesis of berberine tannate pellicles.RESULTS The berberine tannate prepared from the water fraction of tannic acid and the remaining water fraction as raw materials shortened the dissolution time of berberine tannate pellicles to <5 min, which fully met the requirements of pellicles of Chinese Pharmacopoeia 2015 Edition.CONCLUSION The berberine tannate active pharmaceutical ingredient produced after the process optimization can shorten the dissolution time of berberine tannate pellicles significantly and improve the dispersive property of film agent. |
| Key words: tannic acid fraction dissolution time berberine membrane |
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