| Jingfang Huopo Jiedu Mixture is composed of 19 medicinal materials(such as Jingjie,Fangfeng,Chuanxiong,etc),which is recommended in Sichuan Province Guide for Prevention and Control of Novel Coronavirus Infection Pneumonia with Traditional Chinese Medicine(TCM),and Its pungent warming can relieve cold and aromatizing turbidity can remove dampness.Based on the theory of TCM,combined with traditional Chinese medicine technology and modern science and technology,this project intends to develop the original decoction into a compound mixture of TCM,studying its preparation process and quality standards to ensure safe,effective and controllable quality during clinical use.Extraction process: According to the physical and chemical properties of effective components and pre-test results,this prescription will be extracted in three steps.(1)5herbs rich in vol.atile oil we.re extracted by steam distill.ation,collectting the aromatic water and then redistilling it into a mixture of volatile oils,and the amount of volatile oil was used as the eval.uation index to ob.tain the extraction para..meters: no soaking,10 times of water(Contains 2 times water absorption),extraction for 6 hours to get aromatic water;(2)Houpo and Baizhi were extracted by ethanol,using the content of magnolol,honokiol and imperatorin as the evaluation index,the extraction parameters are selected by single factor and orthogonal test method: After soaking in 8 times 65%ethanol for 1.5h,the alcohol absorption rate was supplemented by 1 time,and then extracted by reflux for 2 times,60 minutes each time;The remaining 12 herbs were extracted by water,with the content of amygdalin,cimicifuga glycoside,5-Omethylvisamidol glycoside and dry cream rate for the evaluation index,the best parameters were obtained by single factor and Box-Behnken response surface method:After soaking with 10 times water for 1.5h,the water absorption rate was supplemented by 1 times,and then extracted by reflux for 3 times,each time for 1 hour.Concentration process: Based on the existing equipment conditions of our hospital,the decompression and atmospheric concentration were investigated.The atmospheric concentration significantly reduced the content of amygdalin,and the concentration time was longer.In order to reduce the loss of heat-sensitive substances and save time,the decompression concentration was adopted in this project.Purification process: Centrifugation,chitosan precipitation,gelatin precipitation and ethanol precipitation were investigated respectively.From the component content,clarity and taste comprehensive analysis,ethanol precipitation was selected,and the conditions were optimized by single factor and orthogonal test methods: Concentrate the solution under pressure,and make the relative density to 1.10(±0.01,25℃).Add ethanol slowly while stirring,until the alcohol content of the solution reaches 70%,and refrigerate for 48 h.Molding process: Investigate the range of pH,the type and amount of solubilizer and preservative,determine the p H range of 5.0～6.5,add 1.0% Tween-80,0.15%potassium sorbate.Quality standard research: The product was inspected according to the pharmacopoeia,and they all met the regulations;TLC identification standards for 5herbs(such as Fangfeng,Chuanxiong,Houpo,etc)were established;HPLC method was established to determine the contents of 5 components(such as amygdalin,cohosh glycosides,imperatorin,etc),and the limit of each component was determined;a preliminary study on the fingerprint of this preparation has been carried out,each known ingredient can be traced.It can be used for quality control of the preparation process and product quality evaluation. |
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