Study On Preparation Process And Quality Standard Of Zhicao Relin Granules

Zhicao Relin Granules is a new compound preparation of pure Traditional Chinese Medicine,which consists of Gardenia jasminoides,plantagoasiatieal,Justicia procumbens,Mahonia bealei,Polygonum aviculare,Glycyrrhizauralensis Fischand.The prescription has been used clinically for many years.Zhicao Relin Granules has the function of clearing heat,removing dampness,treating stranguria.According to Chinese medicine,natural medicine new drug registration requirements of category 6.1,the preparation process and quality standard of Zhicao Relin Granule are studied experimentally on system by applying modern science and technology,with the guidance of traditional Chinese Medicine theory,to ensure the scientific and reasonable preparation process and the quality is stable and controllable.1.Study on preparation processThe extraction process: With the dry extract was rate and the transfer rate of main active components gardenin,myricoside,plantarine,glycyrrhizin and ammonium glycyrrhizinate were used as the evaluation index.By preliminary test and orthogonal design test and combined pharmacophore test results,finally determined the extraction process of Zhicao Relin Granules as follows : Add 12 times amount water in the Gardenia jasminoides,Jiebeiao,Radix Meristem,Glycyrrhiza uralensis,for 1 times of decoction(each decoction takes 1 hour).Then add 10 times amount water for 1 time of decoction(each decoction takes 1 hour),filtered,combined with filtrate,ready for use;add 8 times the amount 70% alcohol in the plantain and palygonum aviculare for 3 times of extraction(each extraction takes 1 hours),filter,gather filtrate,ready for use.Concentration process: Taking the transfer rates of geniposide and myricoside as evaluating indexes,through the study of the concentration method,thickening degree and drying temperature,Finally,the thick cream of water extract was concentrated to the relative density of 1.26 ~ 1.30(60?)and the alcohol extract part to 1.24 ~ 1.28(60?).Combining vacuum drying to dry paste(80?).Preparation forming process: Through the researching the influence of the different excipients,wetting agents and their dosage to the granulation and by a number of small tests.Finally,the forming process of compound Zhicao Relin granules was determined as follows: the dry paste powder(80 mesh)and amount of sugar powder-maltodextrin(1:1)was mixed,then added the appropriate amount of 95% alcohol,made into soft material,palletized by 18 mesh,65?dried,sieved by 16 mesh,add 0.2% sucralose,mix well,canned,that is.2.Study on quality standardStudy on TLC identification: TLC was adopted for the identification of Polygonum aviculare,Gardenia jasminoides,Mahonia bealei Carr,Justicia procumbens in Zhicao Relin Granules.The results show that the sample displays the same spots with control drug or control in the corresponding position,and has no negative interference.Study on content of HPLC determination: The content of Geniposide,which exists in Gardenia jasminoides of Zhicao Relin Granules was determined by HPLC.The result shows that eighteen alkyl silane bonded silica as filling agent;Acetonitrile-water(11:89)as mobile phase;detection wavelength is 238nm;column temperature is 35?;flow rate is 1.0ml/min.Through the ten batch of pilot the content of Zhicao Relin Granule in the finished product is not less than 31.6mg in each bag.