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心肌康注射液中黄芪化学成分及其质量标准的研究

Study on Chemical Components and Quality Standard of Radix Astragali in Xinjikang Injection

【作者】 关延彬

【导师】 李永吉;

【作者基本信息】 黑龙江中医药大学 , 药剂学, 2003, 硕士

【摘要】 心肌康注射液是治疗病毒性心肌炎的有效中药复方制剂,由黄芪和丹参两味药组成。其中黄芪的主要成分是总皂苷和总黄酮,以往仅以黄芪甲苷作为质量评价指标,很难全面控制黄芪药材的质量,更无法满足中药注射剂指纹图谱的要求。 本文以心肌康注射液中黄芪为研究对象,对黄芪的化学成分进行了研究,通过运用硅胶柱层析,分离出了几种有效成分,经1H-NMR,13C-NMR,MS-FAB鉴定为黄芪甲苷;9,10-二甲氧基紫檀烷—7—0—β—D—葡萄糖苷;芒柄花苷;2′—OH—3′,4′-二甲氧基异黄烷—7—O—β—D—葡萄糖苷,为心肌康注射液指纹图谱的建立提供了指标性成分。 用比色法测定了心肌康注射液中总皂苷和总黄酮的含量,用HPLC法测定了黄芪甲苷,异黄烷苷的含量,在一定程度上反映了黄芪中皂苷与黄酮的含量,该测定结果可作为判断心肌康注射液质量的依据之一。并根据皂苷部分和黄酮部分的特点,制定了相应的指纹图谱。利用Excel2000,夹角余弦和相关系数原理,进行了色谱峰的匹配,计算了十批指纹图谱的相似度,均达到0.99以上。结果表明,该方法可以有效的控制心肌康注射液的质量。 实验结果证明:通过运用中药指纹图谱和指标成分定量相结合的方式,既可完善表达中药的整体特征,又优于西药单一成分定量的质量控制模式,为心肌康注射液的质量评价工作提供了可靠依据。

【Abstract】 Xinjikang injection is an effective preparation to cure viral myocarditis(VCM).It consists of ingredients of Radix Salvia and Radix Astragali.The total saponin and total flavonind are active compounds in Radix Astragali. So the AstragalosideIV(AGSIV) should not be the only index to assess its quality and satisfy the demand for fingerprint chromatography of TCM injection .By column chromatography with silica-gel four compounds were isolated from Radix Astragali .That is AGSIV,onion, 9,10-dimethoxy-pterocarpan-3-O-β -D-glucopyranoside, 2’ -hydroxy-3 ’ ,4’ -dimethoxy-isoflavan-7-O- β -D-glucopyranoside, Which can be used as the index to set up fingerprint chromatography of xinjikang injection.A colorimetric method was developed for the determination of total saponin and total flavonind. AGSIV and 2’ -hydroxy-3’ ,4’ -dimethoxy-isoflavan-7- O- β-D-glucopyranoside were determined by HPLC. This experiment has set up a fingerprint chromatography of medium and xinjikang injection in Radix Astragali .The similatity was calculated with coefficient of correlation and cosine value of vectorial angel by Excel 2000 and the result is over 0.99 .It showes that the method can be used to control its quality effectively.With the TCM fingerprint chromatography and quantitative analysis of index constituents,the result of this study is showing that the method can reflect all the characteristic of TCM and is better than quantitative analysis of single index in Western medicine,.So it gives information for the quality assessment on xinjikang injection

  • 【分类号】R286.0
  • 【下载频次】298
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