Study On Preparation Process And Quality Standard Of Chimu Fuyan Capsules

Chimu Fuyan Capsules is a new compound preparation of pure Traditional Chinese Medicine,which consists of Herba fibraureae recisae,Moutan bark,Engelhardia roxburghiana wall,Radix paeoniae rubrathe.The prescription has been used clinically for many years.Chimu Fuyan Capsules has the function of clearing heat and removing toxin,activating blood circulation to remove blood stasis.It is used for chronic pelvic inflammatory disease of damp and hot type.According to Chinese medicine,natural medicine new drug registration requirements of category 6.1,the preparation process and quality standard of Chimu Fuyan Capsules 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 main effective components hydrochloride palmatine,paeonol,astilbin,paeoniflorin transfer rate as the evaluation index.By preliminary test and orthogonal design test and combined pharmacophore test results,finally determined the extraction process of Chimu Fuyan capsules: Take Herba fibraureae recisae,plus six times the amount of 0.3% sulfuric acid solution soak 3 times,each time for 24 hours,filtered,and the filtrate was combined with 50% sodium hydroxide solution to adjust PH to 12,plus salting to 10%,and then standing 48 hours,filtered,residues 70? drying,Herba fibraureae recisae was crude extract.The Herba fibraureae recisae crude extracts pulverized,plus 20 times 85% ethanol extracted for 30 minutes,the combined filtrate was concentrated to 15 times and then standing 48 hours,residues 70? drying,to obtain Herba fibraureae recisae refined dry paste.Take Moutan bark herbs,plus 12 times the amount of water,by steam distillation is distilled five times the amount collected fractions at 4? refrigerator overnight,filtered,residues 45? drying,to obtain Moutan volatile oil.Paeonia steam distillation of the filtrate was collected and set aside.Take Radix paeoniae rubrathe herbs,plus 10 times the amount of water extracted 3 times,each time 1 hour,combined filtrate,and the filtrate was mixed with the peony bark,80? concentrated under reduced pressure to a relative density of 1.12(60?),cooled,add 95% ethanol alcohol precipitation,containing alcohol amounted to 70%,for 12 hours,filtered,and ethanol precipitation was concentrated under reduced pressure to 80? relative density 1.30(60?)thick paste,80? dried under reduced pressure into a dry paste.Take Moutan volatile oil,add 6 times amount 95% ethanol and dissolved,and slowly added dropwise to 10 volumes of a saturated solution of ?-cyclodextrin,the reaction was stirred for 1 hour at 80?,cooled to room temperature,at 4? refrigerated overnight,filtered,residues 45? drying,Moutan volatile oil inclusion compound.Take Engelhardia roxburghiana wall herbs,plus 10 times the amount of 60% ethanol reflux extraction 2 times,each time 1 hour,combined filtrate,80? concentrated under reduced pressure to a relative density 1.15(60?),plus 1.0% alum,standing for 36 hours,filtered,the filter residue was washed 4 times the amount of water twice,80? drying,the Engelhardia roxburghiana wall purified dry extract.Each part of the dry extract and peony peel volatile oil inclusion compound mixed evenly,tnamely.The Prepation Process: By investing the influence of different excipients,wetting agent and the consumption on the granulation,using many experiment study,then determine the forming process of Chimu Fuyan Capsules: the dry paste powder(80 mesh)and Starch(41:4)was mixed,then added the appropriate amount of water,made into soft material,palletized by 20 mesh,dried,sieved by 18 mesh,add 0.4% magnesium stearate,mix well,filled into the capsule,aluminum plastic packed,namely.2.Study on quality standardStudy on TLC identification: TLC was adopted for the identification of Herba fibraureae recisae,Moutan bark,Engelhardia roxburghiana wall in Chimu Fuyan Capsules.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 Palmatine chloride,which exists in Herba fibraureae recisae of Chimu Fuyan Capsules was determined by HPLC.The chromatographic conditions are as follows: Eighteen alkyl silane bonded silica as filling agent;Acetonitrile-0.4% phosphoric acid(25:75)as mobile phase;detection wavelength is 345nm;column temperature is 40?;flow rate is 1.0ml/min.Through the ten batch of pilot and the three batch of pilot study to determine the content of tetrahydropalmatine in the finished product,that is not less than 45.0mg in each capsule.