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莱菔子新质量标准的实验研究与修订说明

Editorial Explanation and Experimental Research on New Quality Standard of Semen Raphani

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【作者】 庄明蕊沈霞

【Author】 ZHUANG Ming-rui,SHEN Xia(Shandong Provincial Institute for Drug Control,Jinan 250012,China;Jinan Hongjitang Pharmaceutical Co.,Ltd.,Jinan 250000,China)

【机构】 山东省药品检验所济南宏济堂制药有限公司 济南250012济南250000

【摘要】 目的在中国药典2000年版一部莱菔子质量标准的基础上,测定从全国各地抽取的10批莱菔子的杂质、水分、总灰分、酸不溶性灰分及浸出物等,制定相应的控制范围。方法用数理统计方法对测定项进行分析。结果建议在中国药典莱菔子标准中增加杂质、水分、总灰分、酸不溶性灰分及浸出物等检查项目,控制限度分别为:杂质≤6.0%;水分≤8.0%总灰分≤6.0%;酸不溶性灰分≤2.0%;醇浸出物按干燥品计算≥10.0%。结论对莱菔子的质量标准项目进行了修订和完善,有效地控制了莱菔子质量。

【Abstract】 Objective Based on the initial quality standard of semen raphani in Chinese Pharmacopoeia 2000 Vol.Ⅰ,detections of impurity,moisture,total ash,acid-insoluble ash and extracted matter were carried out by using 10 batches of semen raphani from all over the country.The data were analyzed by statistics and the corresponding contents were defined.Methods Detecting items were analyzed by statistics.Results The contents of impurity,moisture,total ash,acid-insoluble ash and extracted matter measured according to dried ones were not beyond 6.0%,8.0%,6.0%,2.0% and not less than 10.0%,respectively.Conclusion The quality of semen raphani can be controlled effectively by amending and completing the detecting items of semen raphani in Chinese Pharmacopoeia.

  • 【分类号】R282
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