20%甘露醇注射液常温下为过饱和溶液,易析出结晶。文献报道析出结晶是贮温过低所致。我们在试验中发现,难溶性微粒也是导致甘露醇结晶析出的重要因素。为找出影响结晶析出的主次因素,本文拟用正交法作一探讨。一、制定因素水平表根据不同因素对结晶析出的影响程度,我们选择贮存温度、不溶性微粒、振摇情况三项主要因素。每个因素取两个水平,见表1。 Mannitol 20% at room temperature for supersaturated solution, easy to precipitate crystallization. Reported crystallization crystallization is due to low storage temperature. We found in the experiment, insoluble particles also lead to mannitol crystallization of the important factors. In order to find out the primary and secondary factors that affect the crystallization, this paper intends to use orthogonal method to make a discussion. First, set the level of factors According to different factors on the degree of crystallization of the degree of impact, we choose the storage temperature, insoluble particles, shake the three major factors. Take two levels for each factor, see Table 1.