| Malignant tumor,as one of the major global public health problems,does great harm to human health.It is no longer a severe in developed industrial countries,but also a greater disease burden to developing countries.In china,death from tumor accounts for 25% of the total death toll.To find an antineoplastic or compound preparation that has accurate efficacy and less side effects is one of the most urgent problems awaiting to be solved.China is rich in traditional medicine resources.With accurate curative effects,various types of Chinese medicinal formulae play a vital role in preventing and curing of diseases.The object of this research——Fufang Liuqing Mixture,is a self-made herbal compound preparation by Beijing University of Chinese Medicine Affiliated Hospital.Composed of more than 15 kinds of herbal medicine including Panacis quinquefolii radix,Curcumae rhizome,Citrl reticulate pericarpium,astragali radix,Angelicae sinensis radix,Corni fructus and Lycii fructus,it has gone through refined processing.Guided by basic theories of herbal medicine,it is a clinically proved recipe.Aided by chemotherapy and one-to-one prescription,it was effective in dealing with multiple types of cancer,elongating the life-span of cancer patients,improving their life quality.Having been applied to clinical cases for years,it has been proved excellent,yet not a complete quality-control standard has been established.Therefore,this thesis takes Fufang Liuqing Mixture as study object,traditional Chinese medicine as theoretical guiding lines,modern Chinese medicinal theories and methodologies as basis.Additionally,it has improved the pharmaceutical technology,adopting ingredient discriminating and active ingredient concentration methods,proposing quality standard and ascertaining an applicable standard control method as well as its working mechanism.Thus,this study is of theoretical and practical importance and will lay foundation for the extensive application of this medicine.Objective: According to the differences in active constituent of traditional Chinese herbal medicine in this prescription,different extracting methods are used for each group in preparation in order to keep the effective constituents to the largest extent.Methods: There are six constituents in Group One: Panacis quinquefolii radix,astragali radix,Lycii fructus,rehmanniae radix,Trionycis carapax,Eupolyphaga steleophaga,the active ingredients of which are mainly water soluable,so extracted water decocting method is used;three ingredients in Group Two: Angelicae sinensis radix,Citrl reticulate pericarpium,Curcumae rhizome,of which the volatile oils is extracted first.Then the dregs of decoction will be mixed with Group Three for extracting effective ingredients using ethanol precipitation;six ingredients in Group Three: spatholobi caulis,Scutellariae barbatae herba,Cremastrae pseudobulbus pleiones pseudobulbus,and the dregs of decoction from Group Two.Together,they go through water decoction process,and alcohol precipitation to keep the effective elements and get rid of the impurities as much as possible;six ingredients in Group Four: Bruceae fructus,Corni fructus,coicis semen,of which the effective elements are mainly alcohol soluble,thus the approach of circumfluence extraction of ethanol is adopted.The extraction processes for each group are determined by orthogonal tests.Having determined the extraction processes,the types of preparations are compared.Then three preparation processes including mixture,granular formulation and syrup before orthogonal test.Quality-control center observes,first of all,the thin layer chromatography(TLC)method was established to identify angelicae sinensis radix,curcumae rhizome,panacis quinquefolii radix,astragali radix,lycii fructus,corni fructus,citrl reticulate pericarpium and spatholobi caulis;then the density ratio,p H level,microbial limit,heavy metal and arsenic salt are examined;as for content determination,HPLC is used to determine the Rgl,Rbl of ginsenoside in panacis quinquefolii radix,and the curdione,curcumenol,germacron in curcumae rhizome.Results: the optimized conditions in preparation technology are: for Group One: Add eight times of the water into Panacis quinquefolii radix,astragali radix,Lycii fructus,rehmanniae radix,Trionycis carapax,Eupolyphaga steleophaga and decoct it for three times,one hour each until the filtrate turns into clear paste of which the density is from 1.25 to 1.30(50-55 ?);for Group Two: Add eight times of the water into Angelicae sinensis radix,Citrl reticulate pericarpium,Curcumae rhizome and extract the volatile oil for four hours.The volatile oil is then collected and dissolved by 10 ml of ethyl alcohol for future use.The dregs of them are mixed with spatholobi caulis,Scutellariae barbatae herba,Cremastrae pseudobulbus pleiones pseudobulbus,with ten timese of water added,being decocted three times,two hours each till its density becomes 1.10(50?).Then it will be cooled and alcoholized till 70%,and put still for48 hours.The clear solution will be taken and filtered for later;for Group Four:Bruceae fructus,Corni fructus,coicis semen will be reflux extracted three times by ethanol at 75% density,one hour each.The filtrate will be mixed with the above-mentioned alcoholic solution to recycle the ethanol,till it becomes a clear paste at a density of 1.25-1.30(50-55?).The above filtrate will be mixed with the clear paste and concentrated.Take 3.00 g sodium benzo and dissolve it with 20 ml water;weigh 0.3g menthol and 1ml volatile oil and dissolve them with 10 ml dried methyl alcohol.The mixed paste is added with volatile oil and alcohol corrigent and sodium benzoate and is mixed up by water till the constant volume tunrs 1000 ml.The liquor is mixed up,filtered and finally sealed.The relative density,p H level,microbial limit,heavy metal and arsenic salt all abide by the requirements of pharmacopeia.For content measuring,Rgl,Rbl from ginsenosidem,hesperidin,curdione,curcumenol and germacron are used as the index for measuring using HPLC.Rgl from ginsenosidem in a density range of 0.06024-0.6024 mg/ml demonstrates a positive lineal relation(r=0.9997,n=6)and peak area,with an average recovery of97.83%,and RSD of 1.28%(n=9);Rbl from ginsenosidem in a density range of0.03369-0.3369 mg/ml presents a a positive lineal relation(r=0.9997,n=6)and peak area,with an average recovery of 98.01%,and RSD of 1.15%(n=9);hesperidin in a density range of 0.0092-0.0920 mg/ml shows a a positive lineal relation(r=0.9995,n=6)and peak area,with an average recovery of 100.02%,and RSD of 1.25%(n=9);curdione in a density range of 0.1398 – 1.398 mg/ml shows a a positive lineal relation(r=0.9998,n=6)and peak area,with an average recovery of 99.12%,and RSD of 1.16%(n=9);curcumenol in a density range of 0.0304 – 0.304 mg/ml shows a a positive lineal relation(r=0.9998,n=6)and peak area,with an average recovery of 98.56%,and RSD of 0.72%(n=9);germacron in a density range of0.0968 – 0.968 mg/ml shows a a positive lineal relation(r=0.9998,n=6)and peak area,with an average recovery of 99.00%,and RSD of 1.15%(n=9)Conclusion: The preparation technology of Fufang Liuqing Mixture is reasonable and applicable,and the mixture quality can be effectively controlled.Also,the pilot study of medicine effects prove it to be effective in anti-tumor. |
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