| 摘要: |
| 本文通过对人用鱼腥草注射液新标准（公示稿）的解读，从标准减少辅料聚山梨酯80的用量并通过检测控制含量、用专属性较高的薄层鉴别取代理化鉴别并增加对照品至3个、含量测定检测4个组分（其中2个组分有上、下限控制量）、增加指纹图谱和原料药材贮藏时间不宜超过24小时等规定的理解和分析，认为 “成分可知可控”已是中药注射液质量标准的努力方向，提出兽用鱼腥草注射液应借鉴人药的研究成果修订质量标准。 |
| 关键词: 鱼腥草注射液 质量标准 指纹图谱 |
| DOI： |
| 投稿时间：2012-03-05修订日期：2012-05-19 |
| 基金项目: |
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| discussion and interpretation about the new quality specification of Houttuynia Herb Injection for human |
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| (Guangxi Zhuang Autonomous Region Institute of Veterinary Drug Control) |
| Abstract: |
| According to the discussion and interpretation about the new quality specification of Houttuynia Herb Injection (Draft showed in public), more specifically, in the new quality specification,the less amount of minor ingredient of Polysorbate 80, detecting the control content, replacing the physical and chemical identification with thin-layer chromatography with significant specificity, increasing to three reference substances, quantitative analysing four components in two of which exist upper and lower limits quantity, and adding fingerprint and the rule which the medicinal materials storage should not be more than 24 hours, etc, this article propose that the conception of which the ingredient should be knowable and controllable is the striving direction of quality specification of Chinese medical injection.This article also considered of the related revision details of the quality specification of Houttuynia Herb Injection,and propose relevant working ideas. |
| Key words: Houttuynia Herb Injection quality specification fingerprint |
