| 摘要: |
| 目的：制备肝喜片薄膜衣片并制定其质量标准。方法：一部分药材采用水提、浓缩、减压干燥后与另一部分药材粗粉混合制粒、压片、包薄膜衣，薄膜衣材料由羟丙甲纤维素、二氧化钛、滑石粉及适量色淀混合组成。以TLC法对桃仁、陈皮、黄芪、薏苡仁、大黄和苏木进行鉴别，按《中国药典》2015年版薄膜衣片项下要求进行检查，HPLC法测定大黄素含量。结果：桃仁、陈皮、黄芪、薏苡仁、大黄和苏木TLC色谱斑点清晰，专属性强，重复性良好，检查项均符合规定，大黄素含量与糖衣片无明显差别。结论：薄膜衣制备工艺简单可行，制剂质量稳定，质量控制方法简便、可靠、准确，可用于肝喜片薄膜衣片的质量控制。 |
| 关键词: 肝喜片 薄膜衣片 工艺研究 质量标准 |
| DOI： |
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| Change from sugar-coated tablets to film-coated tablets for Ganxi tablets：A process study and quality control |
| CHEN Linglong，,TIAN Qixue，,LI Qinwen |
| (The Affiliated Hospital of Hunan Academy of Chinese Medicine，Changsha 410006，Hunan，China) |
| Abstract: |
| Objective：To investigate the film-coated tablets of Ganxi tablets and its quality standard.Methods：A part of the medicinal materials were treated with water extraction，concentration，and vacuum drying and were then mixed with the crude powder of the remaining medicinal materials for granulation，tableting，and film coating.The film coat was made by the mixture of hydroxypropyl methylcellulose，titanium dioxide，talcum powder，and an appropriate amount of lake.Thin layer chromatography（TLC) was used for the identification of peach kernel，tangerine peel，Astragalus membranaceus，coix seed，Rheum officinale，and hematoxylon；examination was performed according to the requirements in the section of film-coated tablets in Chinese Pharmacopoeia（2015)；high-performance liquid chromatography was used to measure the content of emodin.Results：Peach kernel，tangerine peel，Astragalus membranaceus，coix seed，Rheum officinale，and hematoxylon had clear TLC spots with strong specificity and good reproducibility.The results of examination met related requirements.There was no significant difference in the content of emodin between film-coated tablets and sugar-coated tablets.Conclusion：The preparation process of film-coated tablets is simple and feasible and can achieve stable quality.The quality control measures are simple，reliable，and accurate and can be used for the quality control of the film-coated tablets of Ganxi tablets. |
| Key words: Ganxi tablet film-coated tablet process study quality standard |
