正交试验优选复方甘草酸单铵氯化钠注射液制备工艺

Optimum Techniques for Complex Ammonium Glycyrrhizinate Sodium Chloride Injection by Orthogonal Test

目的用正交试验方法优选复方甘草酸单铵氯化钠注射液的制备工艺。方法采用正交试验,选择活性炭用量、中间体pH、微孔滤芯孔径、活性炭吸附温度4个因素,每个因素安排4个水平,按L16(45)安排正交试验,用2个指标的加权评分值判定工艺优劣,试验结果进行方差分析。结果活性炭对甘草酸单铵有明显吸附作用,影响成品率的主要因素为活性炭及pH。在主药浓度、吸附时间固定时,加炭0.05%、中间体pH=6.5、吸附温度70℃、滤芯孔径0.22μm的优化条件下,活性炭对甘草酸单铵吸附较少、产品热原检查合格、澄明度、成品率最高。结论配制复方甘草酸单铵氯化钠注射液时要对各影响因素进行控制,避免原料损失,提高成品率及产品质量。

Objective To seek the optimum techniques for preparing Complex Ammonium Glycyrrhizinate Sodium Chloride Injection by orthogonal test. Methods The influencing factors such as dosage of aeticarbon, pH of intermediate product, membrane aperture of mieropore filter and adsorption temperature were studied and each of them was arranged for 4 levels according to L16（45） orthogonal table, using weighted- count mark with 2 indexes to decide whether the technique was well and using variance analysis to analyze the results of the experiment. Results Acticarbon could adsorb ammonium glycyrrhizinate greatly. The factors influencing the rate of final products were pH and acticarbon. There was a lower adsorption of ammonium glycyrrhizinate by acticarbon under the condition that the acticarbon concentration was 0. 05%, intermediate product＇s pH was 6.5, adsorbing temperature was 70 ℃ and the membrane aperture of micropore filter was 0.22μm. Within a confirmed concentration of principal agent and adsorption time, and we could also obtain good result of pyretogen test and highest rates of clarity and final products. Conclusion The various influencing factors should be controlled when preparing Complex Ammonium Glycyrrhizinate Sodium Chloride Injection in order to avoid the loss of the row material and to improve the final products＇ rate and quality.