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消骨增贴质量标准研究

         

摘要

Objective: To explore the quality standards of Xiaoguzeng Patch. Methods: Semen Strychni, Cortex Phel-lodendri Chinensis, Rhizoma et Radix Rhei Officinalis in Xiaoguzeng Patch were identified by TLC, the contents of Aconi -tine were analysed, the contents of Strychnine in Xiaoguzeng Patch were analysed quantitatively by dual wavelength scan -ning. Results: The TLC had a good specific and separation. The content limit to Aconitine had not more than 0.4 mg/ patch. Quantitative analysis of Strychnine in the volume of sample linear range was 0.61-3.05 μg (r=0.998 0, n=5), the average recovery was 100.73%, RSD=l.90% (n=6). Conclusion: The method is reliable, accurate and specific. It can control the quality of the preparation.%目的:探讨消骨增贴的质量标准.方法:用薄层色谱法鉴别消骨增贴中的马钱子、川黄柏和大黄;检查乌头碱含量;用双波长薄层扫描法对制剂中士的宁进行定量分析.结果:薄层色谱鉴别专属性强,分离度好.乌头碱限量检查不超过0.4 mg/贴,定量分析中士的宁点样量线性范围为0.61~3.05 μg(r=0.998 0,n=5),平均回收率为100.73%,RSD=1.90%(n=6).结论:所建立的方法可靠、准确、专属性强,可控制该制剂的质量.

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