生脉拆方系列注射液的制备及质量标准研究_药学论文.docVIP

生脉拆方系列注射液的制备及质量标准研究_药学论文 生脉拆方系列注射液的制备及质量标准研究_药学论文 作者：李国信,张会宗,刘晶,刘君 【摘要】 目的 对生脉注射液不同拆方配伍制备的注射液进行制备工艺及质量标准研究,为生脉注射液在体药物配伍关系研究提供物质基础及质量保证。方法 参照生脉注射液制备方法,规范了7种注射液的制备工艺,并采用HPLC及TLC法分别对系列注射液人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、五味子醇甲及麦冬药材进行定量或定性分析。结果 人参皂苷Rg1、人参皂苷Re在0.942 4～9.424 μg与0.624～6.24 μg范围内,进样量与峰面积呈良好的线性关系(r1＝0.999 5、r2＝0.999 7),平均回收率为97.0%～100.4%,RSD为0.45%～3.44%。TLC检出人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、五味子醇甲成分及麦冬对照药材主斑点。结论 本试验确定的制备工艺稳定,质量控制方法便捷,结果准确可靠、重现性好,可为生脉注射液在体药物配伍关系研究提供试验基础与保证。 【关键词】 生脉注射液；人参皂苷Rg1；人参皂苷Re；人参皂苷Rb1；五味子醇甲；高效液相色谱法；薄层色谱法 Abstract：Objective To study the preparation and quality standard of series of Shengmai Injection, and supply substantial basis and quality assurance for compatibility relation research on traditional Chinese medicine in vivo. Methods According to the preparing process of Shengmai Injection, preparing processes for 7 dismantlement injections were established. HPLC and TLC methods were used for qualitative analysis and quantitation determination of Ginsenoside Rg1, Ginsenoside Re, Ginsenoside Rb1, Schisandrin and Radix Ophiopgonis. Results The linear ranges of Ginsenoside Rg1 and Ginsenoside Re were 0.942 4～9.424 μg (r＝0.999 5) and 0.624～6.24 μg (r＝0.999 7). The average recovery was 97.0%～100.4%, and RSD was 0.45%～3.44%. The main spots of Ginsenoside Rg1, Ginsenoside Re, Ginsenoside Rb1, Schisandrin and Radix Ophiopgonis were identified by TLC method. Conclusion The preparation processes are stable. The method of quality control was showed rapid, reliable and well reproducible. It set a good basis for the compatibility study on Shengmai Injection in vivo. 　　Key words：Shengmai Injection；Ginsenoside Rg1；Ginsenoside Re；Ginsenoside Rb1；Schisandrin；HPLC；TLC 探讨中药复方发挥整体效应的物质基础及药味配伍关系是现代中药学研究的热点。为了开展此方面的研究工作,本试验选定生脉注射液为示范性研究制剂。在统一药材批次、固定处方比例、规范制备条件的前提下,参照《卫生部药品标准》(中药成方制剂)“生脉注射液”项下制备方法[1],分别制备7种注射液,并制定其质量控制标准,为方中红参、麦冬、五味子3味中药群体组分在体研究的均一性和可比性提供基本保障,同时为方中药味在体生脉注射液指纹谱的识别与归属、色谱峰的消长变化与药物配伍关系的评定提供良好的物质基础和技术保证。 　　1 仪器与试药 Waters高效液相色谱仪(美国),LC-10UV检测器,JS-3030型色谱工作站。人参皂苷R