【作者】 杨伟；

【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】 在中药现代化的前提下，要求药品质量控制与国际要求接轨的中药质量标准，将从研究阶段推向实用阶段，国家药品监督管理局(SDA)首拟以中药注射剂为突破口，明确要求截止到2004年，中药注射剂必须提供指纹图谱。 本文严格按照《中药注射剂指纹图谱研究的技术要求》(暂行)要求，采用HPLC方法以十批样品进行梯度洗脱，分别建立了心肌康注射剂、丹参药材及中间体指纹图谱的分析方法，结果表明本研究建立的指纹图谱分析方法有较好的重现性，应用简便快速，可以有效控制心肌康注射剂及丹参药材的质量，同时，应用Excel2002统计软件，以相关系数和夹角余弦的方法，对成品、药材和中间体的十批指纹图谱作了相似性研究，其指纹图谱间的相似性均在99％以上，为指纹图谱的可靠性与实用性提供了很好的依据。在此基础上，以丹参中含量最大的丹酚酸B、迷迭香酸，原儿茶醛和丹参素为标准品对注射液、中间体和药材中的色谱峰进行了归属，并分别测定其含量。在成品中含量为56.88％，已完全符合中药注射剂中有效成分含量的要求，为下一步的研究打下了坚实的基础。更多还原

【Abstract】 With the development of TCM modernization, the quality criterion qualified for the international request will go ahead from study to practice. Our SDA took Chinese injection as a model at first, requesting explicitly by the end of 2004 that Chinese injection must provide fingerprint chromatography.According to the request strictly, the fingerprints of every ten batches of Xinjikang injection, Radix Salvia miltiorrhiza and the substances were set up by HPLC of gradation technology. It proved this method was easy, convenient and could be repeated simply. The studies are useful for the quality control of Radix Salvia miltiorrihiza and its injection. Furthermore, The similarity of the fingerprint chromatography about Xinjikang injection, Radix Salvia miltiorrhiza and the substance of Xinjikang injection are all above 99%. It proved the fingerprints were stable and practical.On the basic of this, salvianolic acidB, Rosmarinic acid, protocatechualdehyde and Danshensu having the highest amounts in Radix Salvia miltiorrhiza were used as index contents, the chromatography peaks of Xinjikang injection, the substance of Xinjikang injection and Radix Salvia miltiorrhizairrhiza were identified and analyzed quantitatively, their amounts added up to 56.88%,which coincide with the request of active components in the Chinese injection and is a stable basic for the next study.更多还原