| Jinze Paishi Granules consists of Chinese herbal medicines such as Lysimachia,Alisma,Gardenia,Lygodium,Taraxacum,Glycyrrhiza.The subject is developed into a granule that is easy to take,easy to carry,and easy to store.The systematic research on the preparation process,quality standard improvement and diversification of Jinze Paishi Granule and its pharmacy related content were carried out.The Lysimachia was extracted with ethanol.Orthogonal test design method is preferred for extracting part of alcohol extraction.The preferred result is: 8 times the amount of 50% ethanol,extracted 3 times,each time 0.5h.The other herbs were extracted with water.The water extraction part extraction process is preferably carried out by orthogonal test.The optimal extraction process is 10 times water,extracted 3 times,each time 0.5h.The alcohol extract and the water extract are separately purified.The alcohol extract was purified by decomposing water-sinking under reduced pressure.The Box-Behnken response surface method was used to optimize the water-sinking process.The best water-sinking process is a drug solution density of 1.2,a water addition of 30 times,and standing for 20 hours.The water extract adopts the centrifugal impurity removal method,and the optimized impurity removal process parameter is 4000 r/min,the concentrated material-liquid ratio is 1:3,and the centrifugation time is 15 min.After the alcohol extract is filtered and decontaminated,the ethanol is recovered under reduced pressure to an alcohol-free taste,mixed with water to remove the mixed liquid,and concentrated under reduced pressure to a clear paste having a relative density of 1.10(75~85°C).Dry under reduced pressure(80 °C)into a dry paste.Screening auxiliary materials for powder 50%,lactose 15%,dextrin 35%.The granules are packaged.The quality standard of Jinze Paishi Granules was determined by multivariate quality control system,namely qualitative identification,quantitative determination,chemical fingerprinting and biological activity detection.Thin layers were identified for the medicinal herbs such as Lysimachia sinensis and Cape Jasmine,its high resolution and no interference.The content of quercetin,kaempferol and ge niposide was determined by HPLC method.The total amount of querceti and scutellaria per gram of Lysimachia shall not be less than 6mg;tentatively,the Geniposide is not less than 169 mg per gram.Fingerprint analysis of 10 batches of particles was carried out.The similarity of 10 batches of samples was >0.9,and a control fingerprint was generated.At the same time,the HPLC images of the six herbs in the prescription were exported and compared with the control fingerprints.The common fingerprint peaks are assigned separately,and the main chemical composition of the compound preparation is basically clarified.The COX-2 inhibitor screening kit was used to measure the anti-inflammatory biological activity of Granules by fluorescence detection.According to the measurement results,the half-inhibition concentration of particles was tentatively determined to be no more than 10.5 mg/ml.In the stability test,the product was subjected to a 6-month accelerated stability test and a 9-month stability test.The results of the inspection were in compliance with the regulations,indicating that the product was stable and controllable within 18 months. |
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