Pharmaceutical Research Of New Traditional Chinese Medicine Qianliekangshu Capsule

Qianliekangshu Capsule is pure Chinese herbal oral drug,derived from effective proved recipe which properly disposed according to pharmacological results and clinical practices.The drug is prepared by extracting from six kinds of TCM,Epimedy,Astragalus,Cyathula officinalis Kuan,leonurus heterophyllus sweet and taraxacum mongolicum,which are all recorded in the Chinese Pharmacopoeia(edition 2005) Volume 1.The preparation is organized reasonable,innovative,mainly for the treatment of prostatic and chronic prostatitis.Qianliekangshu Capsules belongs to the Sixth Type of New Traditional Chinese Medicine.We establish preparation process and quality control standards for the content of pharmaceutical research in accordance with the procedures for examination and approval of new drugs,and choose capsule form as the agents and develop further study of preparation process,quality standards,stability,etc.The results are as follows:A.research of the preparation process1.study on ethanol extract processingThe optimum preparation procedure of Epimedy,Cyathula officinalis Kuan,leonurus heterophyllus sweet were studied by 4 factor 3 level orthogonal experiment,containing four factors-ethanol concentration,the amount of ethanol,extraction time and extraction times,testing the content of dry extract amount and icariin as index.2.study on water extract processing The optimum preparation procedure of Astragalu and taraxacum mongolicum were studied by orthogonal experiment,containing four factors-the amount of water,extraction time,extraction times and blank,testing the content of dry extract amount and astragalosideⅣas index.3.study on water extracting-alcohol precipitating processThe optimum water extracting-alcohol precipitating process of Astragalu and taraxacum mongolicum were studied by selecting the relative density of liquid and the alcohol concentration as the investigating factors,testing the content of dry extract and astragalosideⅣas index.4.study on Preraration ProcessThe kinds and usage amount of drug excipient and other aspects were studied in detail.The optimum preparation procedure was established as follow:We take the amount of prescription Epimedy,Cyathula officinalis Kuan,leonurus heterophyllus sweet,following,add seven times 70%ethanol extracted 3 times,1 hour pertimes.Then mixed decoction and filtrated, concentrated to non-alcoholic taste of ethanol as the part 1; Astragalu,taraxacum mongolicum and 70%ethanol extract of medicine residue were extractd with 8 times water,3 times,2 hours pertimes;mixed decoction and concentrated to the relative density of 1.12(80℃)and precipitated by adding 95%alcohol to concentration of 70%;still 24 hours,filtrate,recovery of ethanol to the degree of non-alcohol taste as the part 2:part 1 and part 2 mix with each other to concentrate the thick paste with the relative density of 1.30～1.35(80℃),vacuum drying(control vacuum ≤0.08MPa,temperature:70～80℃).Crushed into fine powder,added starch, mixing with 95%ethanol,granulating,drying,mounted 1000 capsules.B.research of quality standardIn accordance with the Chinese Pharmacopoeia 2005 version of capsule,we detect water test,the gross deviation,disintegration,heavy metals,arsenic salt,microbial limit,the results are in line with the Chinese Pharmacopoeia.The qualitative TLC and quantitative HPLC research were well studied in the dissertation.The medicine of epimedy,astragalus,taraxacum mongolicum herba were differentiated by TLC.The experimental results suggested that the spots on the chromatograms are clear,characteristic,reproducibility,and without interference by negative material.The methods are suitable for the qualitative identification of Qianliekangshu capsule.Icariin was quantitative determined by HPLC.Chromatographic experiments were performed on column Shim-pack Vp-ODS column(4.6mm×250 mm,5μm),the mobile phase was acetonitrile - water(30:70);the detection wavelength was 270 nm,the flow rate was 1.0 ml/min.The linear range for detection of icariin was 0.428～1.712μg/mL(r=0.9996).The average recovery rate of the method was 97.50%,with RSD=1.36%(n=6).The content of icariin is no less than 4.8mg per capusule.The method is simple,accurate,reproducible and can be used as quality control of the preparation.C.research of the stabilityAt the preparation stable aspect,in accordance with the procedures for examination and approval of new drugs,we used the normal temperature test and the acceleration test to detect the preparation character of outward appearance,the gross deviation,disintegration,the microorganism limit,the qualitative distinction,the content determination items.The normal temperature test inspected for 6 months,the acceleration test inspected for 6 months;The results not obviously changed,showed the preparation stable in the storage time,the stability was good.The results showed that the preparation procedure of Qianliekangshu capsule is reasonable in technics,controllable in quality and good in stability.The thesis provided whole pharmaceutical document for the declaration of Qianliekangshu capsule.