青梅复方口服液制备工艺及初步质量标准研究

Study on Preparation Technology and Preliminary Quality Standard of Olive and Plum Compound Oral Liquid

目的：优选青梅复方口服液的制备工艺并进行初步质量标准研究,为口服液进一步开发提供基础性依据。方法：以芦丁为标准品,选取提取时间、料液比值、提取次数为考察因素,以总黄酮含量和浸膏得率为评价指标,采用正交试验法优选水提工艺。以水提工艺的最佳条件为基础,进行醇沉工艺的优选。以芦丁为标准品,选取醇沉浓度、醇沉时间、药液浓度为考察因素,以总黄酮含量和浸膏得率为评价指标,采用正交试验法优选醇沉工艺。采用薄层色谱法分析口服液中乌梅、青果、稻香陈成分。结果：最佳水提工艺为：料液比值1∶10,加热提取3次,提取时间90 min。最佳醇沉工艺为：药液浓度0.35 g·mL^-1,醇沉浓度60%,醇沉时间12 h。薄层色谱中,口服液样品与药物对照品在相对应的位置上显现出相同颜色的斑点。结论：采用水提总黄酮时具有耗时短、提取效率高、安全方便、操作简单、不需要高温条件等优点,适合大规模的生产和应用。醇沉正交试验,醇沉浓度较小且醇沉时间短,考虑成本、工时等因素,适合工厂实际生产。

Objective：To optimize the preparation process of olive and plum compound oral liquid,and to study the preliminary quality standard,so as to provide the basic basis for further development of oral liquid. Methods：Taking rutin as the standard,the extraction time,the ratio of liquid to liquid and the times of extraction were selected as the research factors. The total flavonoids content and the yield of extract were used as evaluation indexes,and the water extraction process was optimized by orthogonal test. Based on the optimum conditions of water extraction process,the optimization of alcohol precipitation process was carried out. Taking rutin as the standard,the concentration of alcohol,the time of alcohol precipitation and the concentration of liquid medicine were selected as the research factors. The total flavonoids content and the yield of extract were taken as the evaluation indexes. The orthogonal test was used to optimize the alcohol precipitation process. TLC analysis of oral liquid in plum,olive,rice aroma component. Results：The optimum water extraction process is：the ratio of liquid to liquid at 1∶10,heating 3 times,and extraction time of 90 min. The optimum alcohol precipitation process was as follows：concentration of 0.35 g·mL^-1,alcohol concentration 60%,alcohol precipitation time 12 h. In thin layer chromatography,the sample of the oral liquid and the reference substance of the medicine show the same color spots at the corresponding position. Conclusion：The total flavonoids extracted by water have the advantages of short time consumption,high extraction efficiency,safety,convenience,simple operation,no need of high temperature and so on. It is suitable for large-scale production and application. In the orthogonal test of alcohol precipitation,the concentration of alcohol is small and the time of alcohol precipitation is short. Considering the cost,working hours and other factors,it is suitable for the actual production of the factory.