正交实验法优化栀子豉汤口服液中栀子苷和染料木素的提取工艺和制备工艺的研究

Orthogonal Experiment to Optimize the Extraction Technology and Preparation Technology of Geniposide and Genistein in Zhizichi Decoction Oral Liquid

确立栀子豉汤口服液中栀子苷和染料木素的最佳提取工艺和制备工艺。以栀子豉汤的栀子苷含量、染料木素含量作为评价指标,通过正交实验法对加水量、提取时间、提取次数进行考察,选取最佳提取工艺,以栀子苷和染料木素的含量作为水提取条件选定的指标,以回收乙醇后制剂的澄清度作为醇沉工艺选定的指标;通过对蔗糖用量的考察确立成型工艺。经实验最终确定栀子豉汤口服液的最佳制备工艺是300g栀子和200g豆豉粉碎后加入3000m L水浸泡75min、回流提取3次、每次1h,将3次药液合并,浓缩至相对密度1.05~1.15(80℃)的清膏,加乙醇使药液中乙醇浓度达到70%进行醇沉,后取上清液加150g蔗糖后定容至1000m L,灌装,湿热灭菌法灭菌,即得成品。该工艺既保证了有效成分的提取效果,又符合了现代制剂工艺的要求,为栀子豉汤口服液的量化生产以及高质量标准化制备流程的建立提供坚实的数据基础。

The best extraction and preparation technology of geniposide and genistein in Zhizichi decoction are established.The geniposide con-tent and genistein content of Zhizichi decoction are used as the evaluation indicators,the water addition,extraction time and extraction times are in-vestigated through;the orthogonal experiment method to select the best extraction process,and the contents of geniposide and genistein are used as in-dicators for the selection of water extraction conditions,and the clarity of the preparation after the recovery of ethanol is used as the indicators for the selection of the alcohol precipitation process;the molding process is established by investigating the amount of sucrose.According to the experiment,the best preparation process of Zhizichi decoction oral liquid is determined as follows:firstly,300g gardenia and 200g tempeh are crushed,then3000mL water is added to soak for 75min,after that refluxes and extracts for 3 times,each time for 1h,then combines the three medicines and con-centrates to obtain a clear ointment with a relative density of 1.05 ~1.15(80℃),next the ethanol is added to make the ethanol concentration in the drug solution reach 70% for alcohol precipitation,then gets the supernatant,adds 150g sucrose and dilute the volume to 1000mL,at last fills and sterilizes with the moist heat sterilization to obtain the finished product.This process not only guarantees the extraction effect of active ingredients,but also meets the requirements of modern preparation technology,and it provides solid data support for the quantitative production of Zhizichi decoction oral liquid and the establishment of high-quality standardized preparation processes.