| Objective: Tidy grain is a clinical experienced prescription which has time-honored function such as expel wind and remove dampness,benefiting qi and nourishing blood.It is inconvenient to carry and has bad stability,becauseit was decoction.So it is necessary to changer the form of the drug.The article is aimed to make a safe,stability,effective and controlled compound granule under the guidance of the theory of Chinese Medicine by using Modern pharmaceutical technology to screen the appropriate method and preparation technology respectively according to various active ingredient in different medicine.Method:1.As far as preparation method is concerned,the article use the orthogonal test and set the rate of extraction,polydatin,puerarin,total flavonoids as its index in order to screen the best preparation method by using aqueous extract、ethanol extraction,water extraction-alcohol precipitation.2.On the side of quality controlled,the article build the TLC identification method of lignum et folium trachelospermi,tu-chung,rhizomacibotii,determine the content of polydatin by the HPLC method,using the HPLC-ELSD method to measure the content of astragaloside iv,determine the content of total flavonoids by the UV method.The result has showed that the method can be used as the index to the quality inspection for its convenient,accuratecharacteristics.3.The article also conduct the irrelevance check.Result:1.he ideal contraction condition forpolydatin and rhizomacibotii is three times with eight times 50% ethanol reflux based on the index of polydatin,total flavonoids,dry extract percent one hour for each time.The best condition to extract other six drugs is to add six times water for three times.The optimum conditions for thogonal experiment of water extraction and alcohol precipitationis after twelve hours when the liquid medicine is concentrate to 1.15 times relative density with 50% ethanol content.The process of making medicine grain include alcohol extract,concentrate and add accessories.The inspection of three different group samples show that the preparation technology is safe,reliability and good repeatability.2.The article established the identification method of rhizomacibotii,tu-chung,lignumet folium trachelospermi.The chromatograph of sample has showed the distinct the spots of the same color.The negative fluid medicine of control group has no spot in the same position.3.The polydatin content is determined by HPLC,when the concentration of the refer-ence ranged from 0.01008 to 0.06048mg/ml,the peak area has a good linear relationship with it.The average recovery is 100.30% and RSD is 1.98%.The polydatin content is determined by HPLC,when the concentration of the reference ranged from 5.2 to 26.0ug/ml,the peak area has a good linear relationship with it.The average recovery is 99.84% and RSD is 2.08%.The astragaloside content is determined by HPLC-ELSD,when the concentration of the reference ranged from 1.048 to 6.288 ug,the peak area has a good linear relationship with it.The average recovery is 98.57% and RSD is 1.71%.The general flavone content is determined by UV,when the concentration of the reference ranged from 0.212 to 50.88 mg,the peak area has a good linear relationship with it.The average recovery is 101.07% and RSD is 1.9%.Conclusion: The results show that the extraction technongy is reasonable,stable and feasible.The content determination and TLC have strong specific.The repeatability,precision,stability and sample recovery rate all meet the requirements.Meanwhile they all comply with the granules checks in pharmacopoeia of China(2015). |
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