目的 确定制备复方黄连注射剂的最佳脱色工艺方法和条件。方法 以复方黄连注射剂未脱色药液为原料，以脱色率、工艺成本、脱色后药液的气味变化及对耐药金黄色葡萄球菌的最低抑菌浓度（MIC）等为评价指标，对活性炭吸附法、铅盐沉法、氧化铝吸附法、石灰乳沉淀法、硅胶吸附法5种方法进行综合评价。结果 经过综合分析，确定最佳脱色方法为硅胶吸附法。通过正交试验，确立硅胶吸附法的最佳工艺条件为硅胶用量35%，温度40 ℃，时间30 min，在该条件下脱色率为35.98%，复方黄连注射剂对耐药金黄色葡萄球菌的MIC值为7.8 mg/mL。结论 用正交设计确定的硅胶吸附法最适脱色条件可实现复方黄连注射剂的有效脱色。

Objective To prepare the Compound Huanglian Injection (CHI) and to optimize the decolorization process of CHI. Methods The comprehensive effect of five decolorization processes (active carbon adsorption, lead salt precipitation method, aluminum oxide adsorption method, lime milk precipitation, and silica gel adsorption) was evaluated by the decolorization rate, cost of the process, chemical odor after bleaching, and minimuminhibitory concentration (MIC) to Staphylococcus aureus. Results The optimal method was silica gel adsorption method, and the optimum conditions calculated by orthogonal test were as follows: 35% of silicone, adsorption time for 30 min at 40 ℃, and decolorization rate of 35.98%. The MIC of CHI to drug resistantive S. aureus was 7.8 mg/mL. Conclusion The silica gel adsorption in optimal decolorization process could achieve the effective decolorization of CHI.

科技部国际科技合作专项基金（2011DFA30490）；湖南省科技重大专项（2012FJ1004）