注射用灰树花倍他葡聚糖的含量测定方法研究

目的建立注射用灰树花倍他葡聚糖的含量测定方法。方法分别采用甲醇提取法、透析法、凝胶过滤法和超滤离心法去除供试品中的辅料后采用硫酸-苯酚法进行含量测定,并将结果与不去除辅料直接采用硫酸-苯酚法,分别以葡萄糖及含处方量甘露醇的葡萄糖制作标准曲线进行含量测定的结果进行比较。结果各种供试品前处理方法在去除辅料时,都会造成灰树花倍他葡聚糖主药的损失,其中超滤离心法操作简便,主药的损失量最小。在不去除辅料的情况下,采用以含处方量甘露醇的葡萄糖制作标准曲线的方法更能真实地反映供试品的含量。结论采用硫酸-苯酚法以含处方量甘露醇的葡萄糖制作标准曲线,可消除辅料的干扰,并具有良好的精密度和重现性,适合于注射用灰树花倍他葡聚糖的含量测定。

Studies on determination of grifola frondosa beta-glucan for injection

Purpose To establish determination method of grifola frondosa beta-glucan for injection(GFGI).MethodsMannitols as excipient were removed from GFGI by methanol extraction,dialysis,gel filter and ultrafilter-centrifugation methods respectively,and then the contents of grifola frondosa beta-Glucan(GFG) in GFGI were compared with the results of GFG in GFGI determined directly by sulfuric acid-phenol method based on glucose and the glucose containing formulated-amount mannitol as standard curve separately.ResultsGFG was lost at different degree when mannitols were removed from GFGI using pretreatment methods mentioned-above,and the ultrafilter-centrifugation method was very simple and the losing of GFG was the least.Contents of GFGI determined directly by sulfuric acid-phenol method based on glucose containing formulated mannitol as standard curve were in accordance with the true contents of GFGI.ConclusionThe sulfuric acid-phenol method based on glucose containing formulated mannitol as standard curve is suitable to GFGI determination.It can eliminate the interference of mannitol and has good accuracy and reproducibility.