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目的采用HPLC指纹图谱及多指标评价方法优选小儿银马口服液澄清工艺。方法建立小儿银马口服液HPLC指纹图谱,比较离心法、乙醇沉淀法、壳聚糖絮凝法、明胶絮凝法、活性炭吸附法的差异,以指纹图谱相似度及特征峰总面积、绿原酸含量、甘草酸含量、固含量、平均粒径、Zeta电位、多分散指数等为评价指标,优选小儿银马口服液的澄清工艺。结果最佳澄清工艺为乙醇沉淀法。结论运用指纹图谱对口服液不同澄清工艺进行考察,可保障澄清前后组分有较好的一致性,多指标评价方法可较全面考察口服液的澄清工艺,为小儿银马口服液的工艺及稳定性研究提供参考。
Objective To adopt the method of HPLC fingerprinting and multi-index evaluation to optimize the process of clarification of oral silver liquid in children. Methods The HPLC fingerprint of Yinma Oral Liquid was established. The differences of the fingerprint, similarities of the fingerprint, the total area of the characteristic peaks, the chlorogenic acid content , Glycyrrhizic acid content, solid content, average particle size, Zeta potential, polydispersity index as the evaluation index, the preferred clarification process of Yinma Oral Liquid. Results The best clarification process was ethanol precipitation. Conclusion Fingerprints of oral liquid different clarification process to inspect, can protect the components before and after clarification have better consistency, multi-index evaluation method can be more comprehensive study of oral liquid clarification process, as the process and stability of infant Yinma oral liquid Provide a reference for sexual research.