The multi-component assay of Kuhuang injection and stability study on its infusion

HE Yuan; SHI Jianli; YAN Liuya

doi:10.3969/j.issn.1006-0111.2019.02.015

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Objective To establish a method for the assay of six active ingredients in Kuhuang injection and study the infusion stability prepared with three different solvents. Methods ①UPLC-MS/MS was used to determine the contents of matrine,dioscin,emodin,rhein,aloe emodin,and saikosaponin A from Sophora flavescens,Rhubarb Artemisia oleracea,and Radix Bupleuri in Kuhuang injection. ②36 hour stability study at room temperature was conducted on the infusions prepared with 5% glucose solution,10% glucose solution and fructose injection. Results ①6 active ingredients in Kuhuang injection were completely separated in 15 minutes and the peak area was linear with the concentration for each component. The stability of the solution was good within 24 hours and the average recovery rate was between 99.86% and 99.92%. ②All three infusion was clear after 36 hours,no turbidity,sedimentation or color change. The pH value of 10% glucose infusion in the minimal dose group with indoor illumination was significantly increased after 8 h. The stability for shading group was better than illumination group. In the maximum dose group,the infusion made with fructose had micro particles after 24 hours and did not meet the requirements. All the rests met the requirements after 36 hours. Conclusion UPLC-MS/MS method is simple,accurate and reliable. It can be used for the determination of active ingredients in Kuhuang injection. Specifically,fructose injection is not a suitable solvent for Kuhuang injection. The infusion should be kept shaded to improve the stability.

The multi-component assay of Kuhuang injection and stability study on its infusion

Department of Pharmacy, Yuyao People's Hospital, Zhejiang Yuyao 315400, China

Received Date: 2018-05-17

Rev Recd Date: 2018-10-23

Key words:

Abstract: Objective To establish a method for the assay of six active ingredients in Kuhuang injection and study the infusion stability prepared with three different solvents. Methods ①UPLC-MS/MS was used to determine the contents of matrine,dioscin,emodin,rhein,aloe emodin,and saikosaponin A from Sophora flavescens,Rhubarb Artemisia oleracea,and Radix Bupleuri in Kuhuang injection. ②36 hour stability study at room temperature was conducted on the infusions prepared with 5% glucose solution,10% glucose solution and fructose injection. Results ①6 active ingredients in Kuhuang injection were completely separated in 15 minutes and the peak area was linear with the concentration for each component. The stability of the solution was good within 24 hours and the average recovery rate was between 99.86% and 99.92%. ②All three infusion was clear after 36 hours,no turbidity,sedimentation or color change. The pH value of 10% glucose infusion in the minimal dose group with indoor illumination was significantly increased after 8 h. The stability for shading group was better than illumination group. In the maximum dose group,the infusion made with fructose had micro particles after 24 hours and did not meet the requirements. All the rests met the requirements after 36 hours. Conclusion UPLC-MS/MS method is simple,accurate and reliable. It can be used for the determination of active ingredients in Kuhuang injection. Specifically,fructose injection is not a suitable solvent for Kuhuang injection. The infusion should be kept shaded to improve the stability.

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The multi-component assay of Kuhuang injection and stability study on its infusion

doi: 10.3969/j.issn.1006-0111.2019.02.015

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