Studies On Production Technology And Stability Of Mulberry Sesame Oral Liquid

Mulberry sesame oral liquid is made by mulberry leaves and black sesameseeds(fried). It has the effects of nourishing liver and kidney, expelling wind andimproving eyesight, which is mainly used for liver and kidney deficiency, dizziness,blurred vision, epipHora induced by wind and other symptoms. The main medicinalingredient of mulberry oral liquid is rutin. Rutin is also known as rutoside, which is akind of flavonoids compounds widely existing in plants. Its content is higher inmulberry leaves. But it is not easy to be extracted, water solubility is poor andoxidation degeneration easily occurs. The production process, quality standard andstability etc. of mulberry oral liquid were mainly studied in this paper, whichintensively solved the problems of content, water soluble, stability of Rutin oral liquid.Mulberry sesame oral liquid was prepared. And the studies on the quality standard andstability were completed. The concrete content included:1. Study on preparation technology of mulberry sesame oral liquidFirstly the extraction process of mulberry sesame oral liquid was optimized inthis experiment. The previous extraction method of common Rutin included decoctionmethod, percolation method, alkali extraction and acid precipitation method, alkaliextraction and acid precipitation+antioxidant method, Tris alkali extraction and acidprecipitation, Tris alkali extraction and acid precipitation+antioxidant method. Thecontent of rutin oral liquid obtained by above methods could not meet the productionneeds. At last, a new Rutin extraction route was proposed by the summary andinnovation of the above test methods, namely direct acid extraction method. And thecontent of rutin oral liquid was taken as the index. The medicinal materials soak time,extraction time, extraction times, ratio of material to liquid, acid concentration weretaken as investigation factors for single factor L18（35）orthogonal test. The optimumextraction technology of mulberry sesame oral liquid rutin: soaked for2hours, waterof15times of medicinal materials was added. The extraction time was1hour. The extraction times were3times. The extraction acid concentration was3.75%. Thecontent of mulberry sesame oral liquid rutin was up to187.47μg/ml under theprocessing conditions so as to meet the requirements of rutin content of mulberrysesame oral liquid (160μg/ml). Considering the on-site production amplification oforal liquid might affect the content of rutin to some extent, the process was furtheroptimized based on the production process. The inclusion agent and hydroxypropyl-β--cyclodextrin and tert-Butylhydroquinone were added. Its amount was taken as theinvestigation indicator for single factor experiment. The final best productiontechnology of mulberry oral liquid was: soaked for2hours, water of15times ofmedicinal materials was added. The extraction time was1hour. The extraction timeswere3times. The extraction acid concentration was3.75%. The content ofhydroxypropyl-β-cyclodextrin was15%of medicinal materials. The content oftert-Butylhydroquinone was5‰of medicinal materials. The content of mulberry oralliquid rutin was up to272.83μg/ml under the processing conditions, which wasgreatly improved than that of previous optimization extraction process.2. Quality standard of mulberry sesame oral liquidThe high performance liquid chromatograpHy detection method on the content ofrutin oral liquid was successfully established. And the detection method on pH valuerelative density was established. The content standard of rutin in mulberry oral liquidwas not lower than160μg/ml. pH value was during4.5~6.5. The relative density wasnot less than1.06. The accuracy and precision of detection method were high, whichwas in conformity with the provisions of annex I G in《Chinese pharmacopoeia》2010edition.3. Study on the stability of mulberry sesame oral liquidAccording to the provisions of 《Chinese pharmacopoeia》2010edition, theacceleration test, light test, high temperature test and long-term stability test at roomtemperature were performed to investigate the stability of mulberry oral liquid. Theresults showed that the content of rutin oral liquid in light test and high temperaturetest was reduced, and varied little in the acceleration test and long-term stability test.So the storage condition of mulberry oral liquid was shading airtight preservation at room temperature.