淫羊藿提取物 质量标准
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检测项目Items |
标准Standards |
检测方法Method |
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理化分析Physical and chemical analysis： |
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性状Description |
棕色至淡黄色粉末 Brown to yellow Powder |
Visual |
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含量Assay |
淫羊藿单甙Icariin |
5%-98% |
HPLC（CP2010） |
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粒径Mesh Size |
80目 100％pass 80mesh |
CP2010 |
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鉴别 Identification |
(+) |
TLC（CP2010） |
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炙灼残留Ash Content |
≤5.0％ |
CP2010 |
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干燥失重Loss on Drying |
≤5.0％ |
CP2010 |
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提取溶剂 Extraction solvent |
70%乙醇 70% Ethanol |
/ |
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松密度Bulk density |
40~60g/100mL |
CP2010 |
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紧密度Tap density |
60~90g/100mL |
CP2010 |
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残留物分析Residue analysis： |
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重金属Heavy Metal |
≤10ppm |
CP2010 |
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铅（Pb） |
≤2ppm |
GB/T 5009.12-2003 |
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砷（As） |
≤2ppm |
GB/T 5009.11-2003 |
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汞（Hg） |
≤2ppm |
GB/T 5009.15-2003 |
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镉（Cd） |
≤2ppm |
GB/T 5009.17-2003 |
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溶剂残留Solvents Residue |
Meet Eur.Ph.7.0 <5.4> |
Eur.Ph 7.0<2.4.24> |
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农药残留Pesticides Residue |
Meet USP Requirements |
USP34 <561> |
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微生物Microbiological： |
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细菌总数Total Plate Count |
≤1000cfu/g |
AOAC990.12,16th |
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霉菌及酵母菌Yeast&Mold |
≤100cfu/g |
AOAC996.08、991.14 |
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大肠杆菌E.coil |
无Negative |
AOAC2001.05 |
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沙门氏菌Salmonella |
无Negative |
AOAC990.12 |
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一般状态General Status： |
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灭菌方法sterilization method |
高温灭菌 High temperature sterilization |
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包装Packing |
外包装为纸板桶，内包装为双层塑料袋，25kg纸板桶尺寸为直径35cm，高51cm； Packed in paper-drums and two plastic-bags inside. N.W:25kgs .I.D.35×H51cm; |
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存储条件Storage |
请存放在阴凉干燥的地方，远离强光和热源。 Keep in cool & dry place. Keep away from strong light and heat. |
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保质期Shelf life |
原包装状态保质期24个月。 24 months under the conditions above and in its original packaging. |
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【功能与主治】 补肾阳，强筋骨，祛风湿。用于阳痿遗精，筋骨痿软，风湿痹痛，麻木拘挛；更年期高血压。
