| 摘要: |
| 目的：研究复方清痹片糖衣片改薄膜衣片的质量标准。方法：将原由滑石粉、糖浆、川蜡等辅料包糖衣片改为由胃溶型薄膜包衣预混剂包薄膜衣片，对薄膜衣片质量标准进行研究，对赤芍、防己、黄柏、甘草等进行薄层鉴别研究，并对赤芍中芍药苷进行含量测定方法学研究。结果：赤芍、防己、黄柏、甘草薄层鉴别斑点清晰，专属性强；芍药苷在2.9858～29.8584μg/ml之间有良好的线性关系，平均回收率98.33%，RSD%为1.70%。结论：糖衣片改薄膜衣片工艺可行，质量控制可靠、准确，可用于复方清痹片的质量控制。 |
| 关键词: 复方清痹片 薄膜衣片 质量标准 |
| DOI： |
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| Quality standard for compound Qingbi tablets changed from sugar-coated tablets to film-coated tablets |
| LIU Hui,TANG Wei,PENG Yanmei |
| (The Affiliated Hospital of Hunan Academy of Chinese Medicine，Changsha 410006，Hunan，China;Institute of Chinese Materia Medica，Hunan Academy of Chinese Medicine，Changsha 410013，Hunan，China) |
| Abstract: |
| Objective：To investigate the quality standard for compound Qingbi tablets changed from sugar-coated tablets to film-coated tablets.Methods：The sugar-coated tablets with the excipients of talcum powder，syrup，and Chinese insect wax were changed to the film-coated tablets with stomach-type thin film coating soluble premixes.The quality standard for the film-coated tablets was analyzed；thin-layer chromatography (TLC) was used for the identification of Radix Paeoniae Rubra，Stephania tetrandra，Phellodendri Chinensis Cortex，and Radix Glycyrrhizae，and the method for determining the content of paeoniflorin in Radix Paeoniae Rubra was analyzed.Results：Radix Paeoniae Rubra，Stephania tetrandra，Phellodendri Chinensis Cortex，and Radix Glycyrrhizae had clear TLC spots.Paeoniflorin had a good linear relationship within 2.9858～29.8584μg/ml，with an average recovery rate of 98.33% (relative standard deviation=1.70%).Conclusion：It is feasible in process to change from sugar-coated tablets to film-coated tablets，and the quality control standard is reliable and accurate and can be used for the quality control of compound Qingbi tablets. |
| Key words: compound Qingbi tablets film-coated tablet quality standard |
