不同厂家复方丹参注射液质量考察

目的:考察不同厂家、不同批次复方丹参注射液的质量差异。方法:采用高效液相色谱法进行梯度洗脱得到复方丹参注射液的指纹图谱;测定不同厂家、不同批次样品中丹参素、原儿茶醛、丹酚酸B的含量,并按照《中国药典》2005年版要求检查样品中不溶性微粒、蛋白质、鞣质、树脂等物质。结果:复方丹参注射液指纹图谱特征明显;不同厂家样品中丹参素、原儿茶醛、丹酚酸B含量有显著性差异,部分产品的有关物质不符合规定。结论:不同厂家的复方丹参注射液存在质量差异,应加强和统一复方丹参注射液的质量控制标准,在工艺和技术上对不溶性微粒的控制进行研究和改进。

Quality Investigation of Compound Danshen Injection from Different Manufactures

OBEJECTIVE:To study quality differences of compound danshen injections of different batch numbers from different manufactures.METHODS:The fingerprints of compound danshen injections were obtained through gradient elution by HPLC;The contents of danshensu,protocatechualdehyde and savianolic acid B in samples of different batch numbers and different manufactures were determined,and the insoluble fine particle,protein,tannin,resin etc.in samples were studied ac-cording to the specification of China Pharmacopoeia2005.RESULTS:The fingerprints of compound danshen injections were specific;Great differences were found in the contents of danshensu,protocatechualdehyde and salvianolic acid B of the samples from different manufactures,quality discrepancies were found between some of the related substances in some of the prepara-tions and the specifications.CONCLUSION:Quality differences were found in compound danshen injections from different manufactures,therefore,the quality control standards of compound danshen injections should be enhanced and unified,and with regard to the controlling of the insoluble fine particles,the technics and techniques of which should be improved and given a further study.