| Objective: Sanwei Jianghuang Tangsan is recorded in the ancient books of Tibetan medicine.This study will study the formulation reform of Sanwei Jianghuang Tangsan,and use modern extraction and preparation technology to make Sanwei Jianghuang Tangsan into capsules,and establish quality control methods to provide basis for further development and research of this preparation.Methods: This subject was studied from the following aspects.1.Extraction and purification process research: Check the relevant data to determine the indicator components in the three herbs.The extraction process of turmeric adopts the results of previous research;in the previous research group,the ethanol extraction and macroporous adsorption resin purification of the mink skin were carried out.On this basis,the water extraction of the mink skin was carried out and the stone thiol method water extract was used.Purification,preferably extraction and purification process;the extraction process of Phyllanthus emblica L.was studied by single factor test combined with response surface method,and the extract of Phyllanthus emblica L.was purified by water extraction and alcohol precipitation process,extraction method and macroporous adsorption resin method.The gallic acid,Corrida,ellagic acid,total polyphenol content and amount of ointment are used as indicators to optimize the extraction and purification process.In addition,DPPH antioxidant research was carried out on the purified extract of Phyllanthus emblica.2.Study on Forming Technology: According to the nature and characteristics of different pharmacodynamic substances in the prescription,capsules are the best dosage form for the prescription.The properties of the final granules(difficulties in granulation and fluidity of the granules)were investigated.Combining literature and experiments to screen out suitable excipients and dosages,etc.,in order to optimize the optimal formulation process.3.Quality control research: To ensure the stability of the capsule,it is easy to control its quality.TLC was used to identify the turmeric,mink skin and Phyllanthus emblicaL.in Sanwei Jianghuang Capsule;the content of 7 active ingredients in capsules was determined by HPLC;in the determination of dissolution,curcumin,berberine hydrochloride,gallic acid,As the dissolution index,the dissolution medium and dissolution rate were investigated.The in vitro dissolution of Sanwei Jianghuang capsule was investigated by HPLC.The experimental basis for evaluating and controlling the quality of Sanwei Jianghuang capsule was established,and the quality control method was established.Result: 1.Extraction and purification process:Turmeric is selected by ethanol percolation method,10 times 70% ethanol is used as extraction solvent,turmeric needs to be immersed for 12 h first,and percolate is collected;small mink is extracted by 15 times 75% ethanol,extracted twice,each time 2 In the hour,the extract is purified by macroporous adsorption resin method,and the extraction and purification effect is better than water extraction and stone mercaptan method;the optimal water extraction process of Phyllanthus emblica L.: extraction with 20 times of water for 3 times,each time for 3 hours;combined extract Filtered,concentrated under reduced pressure to 0.1 g/ml containing crude drug,extracted with ethyl acetate,extraction time was 10 min,extractant ratio was 1:5,and extracted 3 times.In addition,the antioxidant activity of the extract of Phyllanthus emblica L.was about 3.8 times that of ascorbic acid,indicating that it has strong antioxidant activity.2.Molding process results: The turmeric dry paste is mixed with the small suede and the purified powder of the emblica,and the 25% microcrystalline cellulose of the drug ratio is used as the auxiliary material,and the wet granulation is used,95% ethanol is used as the wetting agent,and the mesh is made by the 24 mesh sieve.The granules after granules were dried in an oven at 60 ° C for 2 h,granulated by a 24-mesh sieve,and filled into a No.1 capsule shell,which was obtained.3.Quality Control Study: A thin-layer chromatographic identification of turmeric,mink skin and Phyllanthus emblica L.in Sanwei Jianghuang Capsule was established.The spots were clear and the specificity was good.The method for determining the content of seven components in capsules by HPLC method was established.Calculated as dry product,per gallon containing gallic acid(C7H6O5),magnolia(C20H24NO4),ellagic acid(C14H6O8),jatrorrhizine hydrochloride(C20H20Cl NO4),palmatine hydrochloride(C21H22Cl NO4),berberine hydrochloride([C20H18NO4]+),curcumin(C21H20O6)were 76.75,88.85,9.95,5.76,6.17,59.13,17.19 mg respectively.In the dissolution measurement,the dissolution medium was selected to contain 0.1%/L hydrochloric acid solution of 1% SDS.When the dissolution rate was 100 r/min,the dissolution effect was good.The cumulative dissolution of gallic acid and berberine hydrochloride reached within 30 minutes.More than 90%,the cumulative dissolution of curcumin reached 76.3% at 480 minutes.Referring to the relevant literature and actual production,with 80% as the limit,it is tentatively set that there should be no less than 61.4 mg,71.08 mg,7.96 mg,4.61 mg,4.94 mg,47.30 mg and 13.75 mg of seven components per g.The dissolution of gallic acid and berberine hydrochloride should not be less than 59.45 mg and 44.07 mg respectively within 30 minutes.Conclusion: This project through the research on the preparation process of Sanwei Jianghuang Capsule,the process is stable and feasible;the establishment of relevant quality control methods provides a basis for ensuring the quality of the preparation. |
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