| Objective:To prepare and evaluate the Traditional Chinese Medicine named “Gehuang Capsules” used to treat Carotid Atherosclerosis(CAS)caused by fiery flaming and phlegm and blood stasis,then study on its preparation process,quality standard,preliminary stability and preliminary pharmacodynamics,to provide a basis for its indepth research and development.Methods: 1.The overall desirability of the extraction amount of Tanshinone IIA and paste rate as the evaluation index,to optimization of ethanol extraction process of Salvia miltiorrhiza by the response surface methodology.The overall merit of the extraction amount of Puerarin and Baicalin as the evaluation index on the basis of the single factor experiment,to optimize the water extraction process by the response surface method.The transfer rate of index component by water extracted and the paste rate as the evaluation index,to optimize the alcohol precipitation process.Determination of the best excipient types and dosages of Gehuang Capsules by single factor experiment,then the particles molding rate as the evaluation index to optimize the Gehuang Capsules forming process by the orthogonal test.2.Qualitative identification of Gegen,Scutellariae,Salvia miltiorrhiza,Coptis chinensis Franch and Gastrodia elata in Gehuang Capsules by TLC,and determination of the main active components of Puerarin,Baicalin and Tanshinone IIA in Gehuang Capsules by HPLC,to establish the quality standard draft.3.Preliminary stability test study of Gehuang capsule by accelerated stability test and long-term stability test.4.Preliminary pharmacodynamic test study of Gehuang Capsule by establishing rat CAS.Result: 1.Salvia miltiorrhiza was extracted twice for 1.6h each time with 11 times 90% ethanol,then combined the filtrate and collected the dregs,and to recover the ethanol under reduced pressure;Gegen,Scutellariae,Coptis chinensis Franch,Gastrodia elata and Salvia miltiorrhiza dregs were extraction 2 times for decocting,12.5 times the amount of water for the first time,and 11 times the amount of water for the second time,2 hours each time.Concentrated the water extract to 1.00 g crude drug/m L,and add an appropriate amount of 95% ethanol by gradient increment to make the ethanol content in the extract reach 60% and let stand for 24 hours,to collecte the filtrate and recover the ethanol under reduced pressure,the concentrated solution mixed with the salvia miltiorrhiza extract concentrate solution,and vacuum-dried at 60°C.The powder was added with 15% dextrin to prepare granules by a dry granulator with the roll pressure of 10 MPa,the granulation frequency of 14 Hz,and the feed frequency of 10 Hz,put the granules into the No.0 capsule and 0.48g/grain.2.Establish the TLC qualitative identification method for Gegen,Scutellariae,Salvia miltiorrhiza,Coptis chinensis Franch and Gastrodia elata,and it was determined that in Gehuang Capsule the content of Puerarin is not less less than 9.170mg/grain,Baicalin is not less than 8.350mg/grain,and Tanshinone IIA is not less than 0.698 mg/grain.3.The quality stability of Gehuang capsule was good after 6 months of accelerated stability test and 12 months of longterm stability test.4.Gehuang capsule can significantly reduce the content of TC,TG and LDL-C in serum of CAS model rats,increase the content of HDL-C,and inhibit the intimal thickening of the CAS model rat.Conclusion: The preparation process of Gehuang Capsule is scientific,reasonable and stable,the quality standard control method is accurate and reliable,and has good reproducibility,it can effectively treat CAS caused by fiery flaming and phlegm and blood stasis. |
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