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目的:建立固肠止泻丸平行5波长HPLC指纹谱,鉴定固肠止泻丸及中间体质量,以主成分分析比较固肠止泻丸及中间体主要的药效物质变化。方法:以平行5波长HPLC梯度洗脱方法结合系统指纹定量法对12批固肠止泻丸及中间体的质量进行鉴定。运用主成分分析(PCA)对两者的药效物质特征峰进行区分。结果:以盐酸小檗碱为参照物峰,确定了21个共有峰。系统指纹定量法评价结果显示,除230 nm外,其他4个波长下测到的各批样品质量合格。PCA结果显示,固肠止泻丸制剂和中间体之间仍存在显著差异。与固肠止泻丸中间体特征指纹图谱相比,固肠止泻丸有9个成分峰在成药后含量显著降低。在13.05 min附近有2个峰消失。结论:建立了固肠止泻丸及中间体的HPLC指纹图谱。并比较了两者的差异。以系统指纹定量法评价中药制剂的质量,方法快捷、有效和可靠,为固肠止泻丸的整体质控提供了参考依据。
Objective: To establish a parallel 5-wavelength HPLC fingerprint of Guchang Zhixie Pills, identify the quality of Guchang Zhixie Pills and its intermediates, and compare the main effective substances of Guchang Zhixie Pills and intermediates by principal component analysis. Methods: The quality of 12 batches of solid intestine antidiarrheal pills and intermediates were identified by parallel 5-wavelength HPLC gradient elution method and system fingerprint quantitative method. Principal component analysis (PCA) was used to distinguish the peaks of the potency peaks of the two substances. RESULTS: A total of 21 common peaks were identified with berberine hydrochloride as the reference peak. The results of systematic fingerprint quantification showed that, except for 230 nm, the quality of each batch of samples measured at the other four wavelengths was acceptable. PCA results show that there are still significant differences between the Guchang Zhixue pill preparation and the intermediates. Compared with the fingerprints of Guchang Zhixue Pills, there were 9 peaks in Guchang Zhixie Pills. Two peaks disappeared around 13.05 min. Conclusion: HPLC fingerprints of Guchang Zhixie Pills and its intermediates were established. And compare the difference between the two. The method of systematic fingerprint quantification was used to evaluate the quality of traditional Chinese medicine preparations. The method was fast, effective and reliable. It provided a reference for the overall quality control of Guchang Zhixie pills.