中文摘要：

目的研究鞣质的加入量对中药注射液中不溶性微粒数量的影响，探索鞣质的存在与不溶性微粒形成的相关性。方法通过在经检测合格的茵栀黄注射液中加入不同量的鞣质，制成合不同浓度鞣质的模型注射液，作为测试样品。采用《中国药典》2010年版一部所规定的不溶性微粒检查法（第一法，光阻法），测定各测试样品中的不溶性微粒数量，并比较放置5个月后各注射液样品中微粒的变化情况。结果与0月相比，粒径≥10μm和25μm的微粒数均有较大幅度的增加。结论推测当鞣质浓度达到一定值时，可促使中药注射液中不溶性微粒的形成。

英文摘要：

OBJECTIVE To study the effects of tannin on insoluble particles in TCM injections, and explore the correlation between the existence of tannin and the formation of insoluble particles in TCM injections. METHODS The tannin were added into Yinzhihuang injection products with different amount of tannin. Take the different tannin model injections as the samples. Test method for particular matter in injections, listed in Chinese Pharmacopoeia （2010 edition）, was employed to detect the particle numbers in the samples, and the changes of them in the particle systems after placed for 5 months. RESULTS The amounts of particles with the diameters over 10 μm and 25 μm were both greatly increased after 5 months. CONCLUSION Certain amount of tannin probably induced the formation of insoluble particles in traditional Chinese medk;ine injections.