| ObjectiveIt is composed of cassia seed,hawthorn and lotus leaf.The heat and blood,the turbidity of the purge.It can also be used to prevent atherosclerosis in patients with high blood pressure and hyperlipidemia.There are more than 30 years of clinical use history,and in addition to the appearance and appearance of the standard,only the thin layer of the decile has been identified.The quality control method is too simple to meet the development requirements of modern Chinese medicine.Therefore,this research group improved its quality standard:the content determination of 3 active ingredients and a fingerprint map were added.Combined with the application of fingerprint and multi-index evaluation process improvements on the original process,hoping to solve large dose,patients’ compliance bad problem and found that the effective components in the experimental process transfer rate is low.MethodsThe whole project mainly includes the establishment of the test method,the establishment of the fingerprint,the improvement of the water extraction process and the improvement of the alcohol extraction process.The main methods are as follows:(1)Establishment of the method for the determination of lotus leaf base:establish a method for the determination of lotus leaf alkaloids in HPLC heights.Chromatographic conditions:the chromatographic column is Agilent 5HC C18(4.6mm×250mm,5 m),with acetonitrile-water-trimethylamine-glacial acetic acid(25:72.5:1.65:0.85)as mobile phase;The velocity was 1ml/min,the column temperature was 30,and the detection wavelength was 270nm.The preparation of test sample solution:take this product to coating powder is about 0.5 g,precision said,with a plμg in the conical flask,precision add 25 ml of methanol,said weighty heating reflux 2.5 hours,put cold,again according to weight,make up the weight loss reduction with methanol,shake well,filtration,quick.(2)Establishment of fingerprint map:establishment of HPLC mountain lipid profile fingerprint.Chromatographic conditions:chromatographic column is Agilent 5 hc-c18(2)(250mm×4.6mm,5 mu m)flow phase A methanol-b(0.2%trimethylamine phosphate)aqueous solution,gradient elution:0-2min,10%methanol;2-30min,10%-35%methanol;30-40min,35%methanol;40-90min,35%-90%methanol;90-100min,90%methanol.Column temperature 30℃ detection wavelength of 274 nm,the flow rate of 1.0 ml/min,10 microliter sample quantity.Preparation of the test product solution:the granule lipids to the sμgar coating,the research of fine,precise weighing of 0.5g,methanol 25ml,ultrasound 60 minutes,weight,0.45 mu m microporous filter membrane filtration,ready.(3)the water extraction process improvement:fixed extraction times 3 times,extracting time and adding water two times the amount respectively single factor,by comparing the extract rate and lotus leaf alkaloid,orange tree,rhubarb phenol method of transfer rate,it is concluded that the optimal extraction process.(4)Improvement of alcohol extraction process:first screen the concentration of ethanol,then determine the number of extraction,and finally determine the best technology by orthogonal test.The evaluation method is the combination of fingerprint and multi-index.Results(1)the establishment of quality standard system,established the heights of lipid-lowering lotus leaf alkali content determination and fingerprint,throμgh the methodology,the method is stable and feasible,and can be applied to quality control and technology in the study.(2)the water extraction process improvement:the original process water extracting 3 times,times of water quantity respectively for 8 times,six times,six times,extracting time is 2 h,the improved process for the extraction of water 3 times,times of water quantity respectively for 6 times,four times,four times,extracting time 2 h,1 h,1 h,respectively.The effective component transfer rate has not changed much,and it has reduced the yield.This reduces the dosage.(3)the alcohol extraction process improvement:the final optimization of extraction process of 30%ethanol extract 3 times,add alcohol amount of times for 8 times,extracting time 2 h,1.5 h,1.5 h,respectively,the extraction technology of effective components transfer rate is higher.Under Chinese study,the transfer rate of lotus leaf base increased by 40%.The metastasis rate of orange was increased by 24%.The rhubarb transfer rate increased by 8%.ConclusionThis topic to improve the quality of the villa lipid-lowering piece of standards,set up the heights of lipid-lowering piece of lotus leaf alkali measuring method and the fingerprint,method can be repeated,good precision and accuracy,and can achieve the goal of control product quality.The improved water extraction process reduces the paste rate,reduces the dosage and improves patient compliance.The improved alcohol extraction process improves the transfer rate of the active ingredients,but it has a large change in the process,and the effectiveness of the drμg requires clinical trials to be determined.Therefore,follow-up studies are needed. |
PDF Full Text Request