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目的建立藤菔降压片的质量控制方法。方法采用薄层色谱法(TLC)对藤菔降压片中芥子碱硫氰酸盐、钩藤碱进行定性鉴别;采用高效液相色谱法(HPLC)测定芥子碱硫氰酸盐和钩藤碱的含量。结果 TCL专属性强,简单可行。HPLC法测定芥子碱硫氰酸盐在41.2~412μg·m L-1范围内线性关系良好(r=0.9998),平均加样回收率为100.78%(RSD=3.98%,n=6);钩藤碱在9.54~159μg·m L-1范围内线性关系良好(r=0.9999),平均加样回收率为101.50%(RSD=2.06%,n=6)。限定本品每片含芥子碱硫氰酸盐(C6H24NO5·SCN)含量限量在6.001~7.335 mg之间。限定本品每片含钩藤碱(C22H28N2O4)含量限量在1.182~1.444 mg之间。结论建立的定性、定量方法简单,重复性好,结果准确可靠,可作为藤菔降压片的质量控制方法。
Objective To establish a method for quality control of rattan buckets. Methods TLCs were used for the qualitative identification of sinapine thiocyanate and rhynchophylline in raccoon antihypertensive tablets. The contents of sinapine thiocyanate and rhynchophylline were determined by high performance liquid chromatography (HPLC) Content. The results TCL exclusive strong, simple and feasible. The linearity was good (r = 0.9998) and the average recovery was 100.78% (RSD = 3.98%, n = 6) in the range of 41.2-412μg · m L-1 by HPLC. The linearity of the base ranged from 9.54 to 159 μg · m L-1 (r = 0.9999) with an average recovery of 101.50% (RSD = 2.06%, n = 6). Limit the content of each product containing sinapine thiocyanate (C6H24NO5 · SCN) content limits of 6.001 ~ 7.335 mg. Limit the product each containing rhynchophylline (C22H28N2O4) content limit between 1.182 ~ 1.444 mg. Conclusion The established qualitative and quantitative methods are simple and reproducible, and the results are accurate and reliable, which can be used as the quality control method for Fujifilm hypotensive tablets.