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目的:建立云南琵琶甲药材的质量标准。方法:采用薄层色谱(TLC)法对云南琵琶甲中胆甾醇成分进行鉴别,按《中国药典》方法检测其重金属、水分、总灰分、酸不溶性灰分、水溶性浸出物及醇溶性浸出物含量;采用紫外分光光度法测定游离氨基酸的含量。结果:TLC斑点清晰,专属性强;重金属、水分、总灰分、酸不溶性灰分含量分别不超过百万分之十、10.0%、4.0%、0.5%,水(冷浸和热浸)浸出物、95%乙醇冷浸浸出物、95%乙醇热浸浸出物、稀乙醇冷浸浸出物、稀乙醇热浸浸出物不得少于21.0%、17.0%、20.0%、20.0%、25.0%;游离氨基酸的含量不得少于35.00mg.g-1。结论:所建标准可用于云南琵琶甲药材的质量控制。
Objective: To establish the quality standard of Pipa armor in Yunnan Province. Methods: Cholesterol was identified by TLC. The content of heavy metals, water, total ash, acid-insoluble ash, water-soluble extract and alcohol-soluble extract were determined by Chinese Pharmacopoeia ; Determination of free amino acids by UV spectrophotometry. Results: The TLC spots were clear and specific. The contents of heavy metals, moisture, total ash and acid insoluble ash were not more than 10 ppm, 10.0%, 4.0%, 0.5%, water (cold soak and hot soak) 95% ethanol cold extract, 95% ethanol hot extract, diluted ethanol cold extract, dilute ethanol hot-extract not less than 21.0%, 17.0%, 20.0%, 20.0%, 25.0%; free amino acid The content of not less than 35.00mg.g-1. Conclusion: The proposed standard can be used for the quality control of Pipa drug in Yunnan.