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目的测定注射用复方甘草酸单铵S分别配伍转化糖电解质溶液、转化糖溶液和0.9%氯化钠注射液的不溶性微粒数。方法模拟临床用药浓度,依据2010年版《中国药典(二部)》规定的不溶性微粒检查法光阻法测定复方甘草酸单铵S与转化糖电解质溶液配合后的不溶性微粒数量。结果转化糖溶液和0.9%氯化钠注射液与其配伍液的不溶性微粒数量未超过2010年版《中国药典(二部)》标准,转化糖电解质与复方甘草酸单铵S配伍明显超过标准,且长时间存放后出现絮状沉淀。结论转化糖电解质与复方甘草酸单铵S配伍可导致微粒超标,两者间存在配伍禁忌,临床应避免混合配伍。
Objective To determine the number of insoluble particles in compound glycyrrhizic acid monoammonium glycyrrhizinate S, which are respectively compatible with invert sugar electrolyte, invert sugar solution and 0.9% sodium chloride injection. Methods The clinical drug concentration was simulated and the amount of insoluble particles of compound glycyrrhizin monoammonium S and invert sugar electrolyte solution was determined by the method of insoluble particle check method according to the 2010 edition of “Chinese Pharmacopoeia (Part II)”. Results The number of insoluble particles in the invert sugar solution and 0.9% sodium chloride injection and its compatibility solution did not exceed the standard of the Chinese Pharmacopoeia (2) in the 2010 edition. The compatibility of the converted sugar electrolyte with the compound monoammonium glycyrrhizinate S significantly exceeded the standard Time deposit after the flocculent precipitation. Conclusion The conversion of sugar electrolyte and compound glycyrrhizin monoammonium S compatibility can lead to excessive particles, there are incompatibility between the two, clinical compatibility should be avoided.