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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,制成含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。
Objective To study the effect of the addition of tannin on the number of insoluble particles in Chinese injection and to explore the correlation between the presence of tannin and the formation of insoluble particles. Methods Different concentrations of tannin were added into Yinzhihuang injection which was tested to make model injection with different concentrations of tannin as the test sample. The number of insoluble particles in each test sample was determined using the Insoluble Particle Check method (first method, photo-resist method) as specified in a 2010 edition of the Chinese Pharmacopoeia. The amount of fine particles in each injection sample after 5 months of storage Changes. Results Compared with that of 0 months, the number of particles with particle size of 10μm and 25μm increased significantly. Conclusions When the concentration of tannin reaches a certain value, it can promote the formation of insoluble particles in Chinese medicine injection.