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目的:建立金玄痔科熏洗散有效部位新制剂的非挥发性成分的指纹图谱测定方法,指认主要色谱峰,分析比较其与原制剂有效成分的差异,从而为金玄痔科熏洗散传统制剂的二次开发提供依据。方法:采用RP-HPLC,流动相甲醇-0.4%磷酸水溶液梯度洗脱,检测波长335 nm,流速为1.0 mL.min-1,柱温35℃,以指纹图谱计算软件计算相似度并进行图谱的比较及指认。结果:建立了金玄痔科熏洗散及其有效部位新制剂的HPLC标准指纹图谱,各10批次样品的相似度大于0.945,并指认了5个色谱峰。结论:指纹图谱方法可靠、重复性好,能有效比较金玄痔科熏洗散与其新制剂的数量关系,新制剂有效成分的数和量均优于原制剂。
OBJECTIVE: To establish a method for the determination of the non-volatile components of the new preparation of Jinxuan Hemorrhoid Cleansing Powder, identify the main chromatographic peaks, analyze and compare the differences of the active ingredients with the original preparation, The second development of traditional preparations provide the basis. Methods: The mobile phase was eluted with methanol-0.4% phosphoric acid. The detection wavelength was 335 nm, the flow rate was 1.0 mL.min-1 and the column temperature was 35 ℃. The fingerprint similarity Compare and identify. Results: The HPLC fingerprint of Jinxue Hemorrhoid Cleansing Powder and its new active ingredient was established. The similarity of the 10 batches of samples was greater than 0.945 and 5 peaks were identified. Conclusion: The fingerprinting method is reliable and reproducible. It can effectively compare the quantity of Jinxuan Hemorrhoid Washing Powder and its new preparation. The number and amount of active ingredients of the new preparation are better than the original preparation.