香砂养胃胶囊的质量标准改进研究

目的:改进香砂养胃胶囊的质量控制标准。方法:修定木香、厚朴、广藿香的薄层鉴别项目,增加陈皮、枳实中橙皮苷的含量测定项目。结果:改进后的薄层鉴别方法专属性强且效率更高,用一个薄层方法即能鉴别木香、厚朴两种药材;广藿香的薄层鉴别结果斑点清晰;采用正交试验优化并最终建立了陈皮、枳实中橙皮苷的HPLC含量测定方法;参照药典方法,改原有的厚朴酚单指标HPLC质控方法为厚朴酚、和厚朴酚双指标HPLC质控方法。结论:改进后的方法快速、专属性强、准确,能够更有效的控制香砂养胃胶囊的质量。

Improvement Research on the Quality Standard of Costusroot and Amomum Stomach-Nourishing Capsules

Objective:To improve the quality standard of Costusroot and Amomum Stomach-Nourishing Capsules.Methods:The thin-layer identifications of Muxiang (Radix Aucklndiae),Houpu (Cortex Magnoliae Officinalis) and Guanghuoxiang (Herba Pogostemonis) were revised,and the content determination of hesperidin in Chenpi (Periearpium Citri Reticulatae) and Zhishi (Fructus Aurantii Immaturus) were added.Results:After irrprovement,the thin-laver identification method become more specific and effective.One thin-layer identification method can identify Muxiang (Radix Aucklandiae) and Houpu (Cortex Magnoliae Officinalis).The spots were clear in the thiu-laver identifications of Guanghuoxiang (Herba Pogostemonis).The content determination method of HPLC of hesperidin in Chenpi (Pericarpium Citri Reticulatae) and Zhishi (Fructus Aurantii Immaturus) was established by optimizing orthogona] test.Referring to the method of pharmacopeia,the primary quality control method of HPLC with single index of magnolol was changed into double indicators.Conclusion:The improved method was efficient,specific,exact and effective to control the quality of Costusroot and Amomum Stomach-Nourishing Capsules.