The multi-component assay of Kuhuang injection and stability study on its infusion
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摘要: 目的 建立测定苦黄注射液中4个组分6种有效成分含量的方法，并比较3种溶媒配制的苦黄成品的输液稳定性，为苦黄注射液的质量控制和临床合理用药提供参考依据。 方法 ①采用超高效液相色谱-质谱法（UPLC-MS/MS）测定苦参、大黄、茵陈蒿、柴胡4组分中苦参碱、槐国碱、大黄素、大黄酸、芦荟大黄素、柴胡皂苷a的含量；②苦黄注射液采用最大剂量、最小剂量，以5%葡萄糖溶液、10%葡萄糖溶液、果糖注射液为溶媒，配制成品输液，并测定其在室温下放置36 h的稳定性。 结果 ①15 min内苦黄注射液中6种有效成分完全分离，峰面积与各个成分浓度呈线性关系；24 h内溶液的稳定性好，平均加样回收率在99.86%~99.92%之间；②各个成品输液在36 h均澄清，无混浊、沉淀产生，颜色无变化。最小剂量室内光照组10%葡萄糖注射液的成品输液pH值在8 h显著升高，遮光组比光照组稳定性更好；最大剂量组中果糖注射液的成品输液24 h后微粒值不符合规定，其余均在36 h内符合规定。 结论 UPLC-MS/MS法测定苦黄注射液中有效成分的含量，是一种操作简单、结果准确可靠的方法；苦黄成品输液在储存和输注过程中应予以遮光，以保持成品输液质量的稳定；果糖注射液可能降低苦黄成品输液的质量，不宜作为苦黄注射液的溶媒。
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关键词:
- 苦黄注射液 /
- 超高效液相色谱-质谱 /
- 稳定性
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.-
Key words:
- Kuhuang injection /
- UPLC-MS/MS /
- stability
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