安神口服液澄明度及其影响因素分析  

The analysis of clarity influencing factors of Anshen oral liquid

作　　者：韩月芝[1] 冯莎[1] 王岳[1] 苏平菊[1] 赵书勇[1] 

机构地区：[1]石家庄以岭药业股份有限公司,050035

出　　处：《中国现代药物应用》2013年第2期4-5,共2页Chinese Journal of Modern Drug Application

摘　　要：目的以优化醇沉及制剂工艺制备安神口服液,解决产品澄明度随放置时间延长而下降的问题。方法以成品单位体积内的10μm和25μm总微粒数为考察指标,采用正交试验方法优选出醇沉及制剂工艺条件。结果安神口服液最佳制备工艺为醇沉浸膏搅拌频率15Hz,3～4℃静置,稀配液pH4.5,灭菌温度100℃。结论以优化醇沉及制剂工艺制备的安神口服液澄明度明显提高,该工艺合理可行,为工业化生产提供了实验依据。Objective This paper uses the optimization of alcohol precipitation process and preparation process to solve the problem of Anshen oral liquid which clarity decreased with storage time. Methods This paper uses 10μm and 25μm total particle number as indexes, and uses the method of orthogonal test for alcohol precipitation process and preparation process. Results The optimal preparation technology of Anshen oral liquid was 15 Hz mixing frequency,3℃~4℃ static storage during alcohol preparation process, and dilute solution with pH 4.5, sterilization temperature 100 ℃.Conclusion The clarity of Anshen oral liquid which using optimized alcohol preparation process and preparation process was improved, so the process is reasonable and feasible, and provides the experimental basis for industrialized production.

关 键 词：安神口服液 澄明度 醇沉 正交试验 

分 类 号：R286.0[医药卫生—中药学]