OBJECTIVE: To establish the quality standards of Balaps japanensis yunnanensis Mars. METHODS: Cholesterol was identified by TLC. The contents of heavy metals, moisture, total ash, acid-insoluble ash, water-soluble extract and alcohol-soluble extract were detected according to the standards stated in Chinese Pharmacopoeia. The content of free amino acid was determined by UV. RESULTS: The TLC sports developed were fairly clear and specific. The contents of heavy metals, moisture, total ash, acid-insoluble ash were lower than ten millionth, 10.0% , 4.0% , 0.5% , respectively. The water extract (cold soaking and hot soaking), 95% cold ethanol extract, 95% hot ethanol extract, cold homeopathic ethanol extract and hot homeopathic ethanol extract were more than 21.0% , 17.0% , 20.0% , 20.0% , 25.0% , respectively.The content of free amino acids was no less then 35.00 mg.g-1. CONCLUSION: Established method can be used for the quality control of B. japanensis yunnanensis Mars.%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35.00 mg·g-1.结论:所建标准可用于云南琵琶甲药材的质量控制.
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