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目的:通过对本院自制纯中药制剂神衰Ⅲ号口服液中有效组分之一梓醇的分析研究,探索神衰Ⅲ号口服液的稳定性。方法:用HPLC法,对神衰Ⅲ号口服液中梓醇进行定性及定量试验。结果:在对照空白液中未测得梓醇;在生地液及神衰Ⅲ号口服液中可明显测得梓醇组分;梓醇的含量与峰面积呈线性关系;在不同批号的神衰Ⅲ号口服液中梓醇含量稳定。结论:本丈所建立的梓醇测定方法可作为神衰Ⅲ号口服液的质量控制指标之一。
Objective: To investigate the stability of Shenfu III oral liquid by analyzing the sterols, one of the effective components in Shenfu III oral liquid, made in our hospital. Methods: Qualitative and quantitative tests were conducted on sterols in Shenfu III oral liquid by HPLC. RESULTS: No sterols were detected in control blanks; sterols were clearly detected in Shengdiye and Shenfu III oral liquids; the content of sterols was linearly related to the area of the peaks; No. III oral liquid sterol content is stable. Conclusion: The method for determination of sterols established by Ben Zhang can be used as one of the quality control indexes of Shenfu III oral liquid.