一种HPLC法测定葛兰心宁软胶囊中多种有效成分含量的方法
By optimizing chromatographic conditions and detection wavelength using HPLC, the separation and detection of puerarin and hyperoside in Gelanxinning soft capsules were solved, improving the comprehensiveness and sensitivity of drug quality control and ensuring the safety and efficacy of the product.
CN122409908APending Publication Date: 2026-07-17XIAN CHIHO PHARMA
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- XIAN CHIHO PHARMA
- Filing Date
- 2026-05-18
- Publication Date
- 2026-07-17
AI Technical Summary
Technical Problem
The existing quality control methods for GlaxoSinning soft capsules fail to fully reflect the quality of the drug, especially lacking quality control of hawthorn extract, which cannot effectively guarantee its clinical efficacy.
Method used
The contents of puerarin in total flavonoids of kudzu root and hyperoside in hawthorn extract in Gelanxinning soft capsules were determined simultaneously by HPLC. By optimizing chromatographic conditions and detection wavelength, the two active ingredients were separated and detected.
Benefits of technology
This improved the comprehensiveness and sensitivity of drug quality control, ensuring the product quality and efficacy of GlaxoSmithKline soft capsules, and achieving efficient detection of multiple components simultaneously.
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Figure CN122409908A_ABST
Abstract
本发明公开了一种HPLC法测定葛兰心宁软胶囊中多种有效成分含量的方法，该方法建立多指标成分质量控制模式，对葛根总黄酮中的葛根素、山楂提取物中的金丝桃苷两种有效成分同时进行测定。在原有检测葛根素的基础上，将金丝桃苷活性成分的含量测定引入到葛兰心宁软胶囊的质量控制方法中，能够弥补葛兰心宁软胶囊现有质量控制方法的不足，该含量测定方法灵敏、专属性强、准确、重现性好，有效控制药物的质量，使药物质量与临床治疗有效成分进行关联，从而达到稳定、可控、高效及安全的标准，有效保障葛兰心宁软胶囊的产品质量。
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