雷公藤口服液质量控制方法的研究
Study of the quality control methods on tripterygium oral preparation
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摘要: 目的 建立雷公藤口服液的质量控制方法,研究制剂质量及其稳定性。方法 用TLC法测定雷公藤口服液中总生物碱,采用醇提-氧化铝柱层析净化-紫外分光光度法,以雷公藤甲素为对照,测定雷公藤提取液中总内酯的含量。用控制口服液的 pH 值和相对密度来达到制剂的稳定性。结果 分析 6批口服液的含量,表明该口服液质量稳定,其中总内酯的含量低于市售的该类制剂。产生毒性低服用安全有效,便于患者长期用药。结论 该方法可靠、操作简便,无需贵重仪器,适用于医院中药制剂质量控制。
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关键词:
- 雷公藤口服液 /
- 总内酯 /
- 雷公藤甲素 /
- 薄层色谱法 /
- 柱层析-紫外分光光度法
Abstract: OBJECTIVE To establish the quality control methods of tripterygium oral preparation (TOP) and study the quality and its stability. METHODS The total alkaliod and total triptolide were determined by TLC in tripterygium oral preparation,the total triptolide of tripterygium were determined by UV which alcohol was used as extraction and Al2O3 as purifying column. The stability was reached by control the pH and its relative density. RESULTS 6 batchs of tripterygium oral preparation were determined,the results indicated that the quality were stable and the total triptolides were less than that market product. CONCLUTION The methods are reliable,simple,convenient and can be used in preparation quality control in hospital.-
Key words:
- tripterygium oral preparation /
- total triptolides /
- TLC /
- UV /
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