Study On Preparation Process And Quality Standard Of Fufang Baishaochangkang Granules

Fufang Baishaochangkang Granules formerly known as Baishao changkang soup,is a new pharmaceutical preparation of TCM,which consists of Radix paeoniae alba,Magnolia officinals,Rhizoma cor ydalis,Evodia rutaecarpa,Radix glycyrrhizae and other herbs.It has the function of clearing heat and detoxicating,invigorating spleen for eliminating dampness,regulating qi-flowing for relie ving pain,thick intestine and relieving diarrheal.It,s mainly used in the treatment of ulcerative colitis.This research is ba sed on the definite effect of Clinical experience prescription,under the guidance of TCM theory,with applying the modern pharm aceutical technology and analysis method.Researched prescriptio n of extracting process,pharmaceutical technology and its quali ty standard was established.The project developed the decoction into granules,aimed at keeping the curative effect of the orig inal drugs under the condition of invariable composition and do sage ratio.To provide a pharmacy experimental basis for the fur ther development of Fufang Baishaochangkang Granules.During the researching of extraction technology,theory of modern pharmaceutics,pharmaceutical chemistry and pharmacology was employed to analysis various kinds of medicinal prescription in the compatibility and major effective component physico chemical properties.Taking content of index components and dry extract rate as evaluation index,orthogonal test was employed to investigate influence the factors of herbs extraction.Optimum water extraction process: extracted twice with 10 times the volume of water 1.5h per time;Optimum alcohol extraction process:extracted twice with 8 times the amount of 60% ethanol for 1.5h time;According to optimal process conditions for prepa ring 3 batches of sample to test,the results:the content of pae oniflorin is 24.28 mg.g-1,RSD 0.90%;rate of the dry extract is 34.05%;RSD 1.47%;the content of honokiol and magnolol is 26.98 m g.g-1,dry extract rate is 19.71%;RSD 1.96%,It,s consistent with the results of orthogonal experiments.It proved that the best extraction process is reasonable,stable and feasible.To investigate the influence of different concentration temperature on content of index components,optimizated the best concentration and dry process conditions :decompression enrich ment to the relative density is 1.10(60?).Mixture water extrac tion and a Lcohol extraction,decompression enrichment to thick paste with a relative density of 1.25(60?),then join the 10% of the weight of the paste,60? vacuum drying into dry paste used qualified percentage of particle size,appearance shape etc as index to investigated the influence of accessories,wetting agent,flavorings and other factors on the forming process,opti mum the best molding process :According to the dry extract and material by 1:1-1:1.5 to add the dextrin,steviosid,mixing,use 60% ethanol make of soft material,granulating(16 mesh),60? dr y,14 mesh sieve granulation,spray the volatile oil(volatile oil and ethanol by 1:6),get granules.In order to validate the pr ocess and establish the quality control parameters suitable for production,we made three batches of pilot samples for inspecti on,results showed that the process condition is stable,feasibl e and suitable for industrialized production.In the study of the quality standard,the techniques of HPLC is adopted in the studies of content determination and the system study of analysis method for the Fufang Baishaochang kang Granules.Magnolol standard curve regression equation: Y =14630X+9332.1(R2=1.00),show that the Linear relationship of magnolol in the range of 8.11?g.m L-1~121.68?g.m L-1 is good.Honokiol standard curve regression equation :Y =16541X+5851.3(R2=1.00),reveal that The Linear relationship of magnolol in the range of 5.05?g.m L-1~101.00?g.m L-1 is good;Precision experiment measured magnolol area values RSD:0.072%,honokiol area values RSD:0.051%,suggest that the instrument with good precision.Determination of magnolol and honokiol in repeated experiments of RSD 0.85%,indicate that the method has good repeatability.Stability experiments show that within 24 hours for trial in the standard solution of magnolol and honokiol con tent RSD is 0.21%,show that for the test solution within 24 hours stability is good.Average recovery is 100.23%,RSD 0.76%.Show that content determination method has good accuracy,It can be suitable for the preparation of testing requirements.Using thin layer chromatography optimized method for the identifica tion of Radix paeoniae alba,Magnolia officinals and Rhizoma Cor ydalis together into the preparation of thin layer identifica tion of quality standards.Studies show that the extraction and forming processes of Fufang Baishaochangkang Granules are simple,reasonable and practicable.TLC determination method are simple,specific.The quality standards of the preparation are stable and controllabl e which could provide a reference for rational development of Fufang Baishaochangkang Granules.