A Study On Preparation Process And Quality Standard Of Compound Huangbo Fuyan Capsules

Compound Huangbo Fuyan Capsules is a new compound preparation of pure Traditional Chinese Medicine,which consists of Cortex phellodendri,radix paeoniae rubra,smilax,rhizoma corydalis,angelica,motherwort.The prescription has been used clinically for many years.Compound Huangbo Fuyan Capsules has the function of clearing away heat and drying dampness,Scattering stasis pain,promoting blood circulation for regulating menstruation,Clearing damp and relieving the leucorrhea.It for the treatment of chronic inflammation of department of gynaecology has good curative effect.According to Chinese medicine,natural medicine new drug registration requirements of category 6.1,the preparation process and quality standard of Compoud Huangbo 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 process.The extraction process: with the dry extract yield and the transfer rate of the main effective components: berberine,phellodendrine,peoniflorin,tetrahydropalmatine,ferulaic acid,astilbin and engelitin,hydrochloric stachydri as the evaluation index,through preliminary test and orthogonal design expriment,then combined with thepharmacodynamic test results,ultimately determine the extraction process of Compound Huangbo Fuyan capsule as follows: Radix Paeoniae Rubra,Smilax China,Tail of Angelica sinensis,Motherwort,Added water extract 3 times,each time 1 hour,10 times the amount for the first time,the second and third time 6 times the volume,filtered the liquid,then combined the filtrate,Condensed the filtrate with pressure relief to the relative density of 1.14(60 ℃)clear cream,added 95% alcohol to make the alcohol content was 80%,keep it static overnight,take supernatant,spare.Cortex phellodendri,Corydalis ambigua added 50% ethanol and extracted for 3 times,1 hours each time,then combined the extract,the extracted liquid was filtered,then then combined the extract,spare.Contentration and drying process: With the transfer rate of peoniflorin and Berberine as the evaluation indicator,through the investigation of concentration and drying methods and temperature,eventually determine the water extraction liquid 80℃ stress concentration to the relative density of 1.14(60℃)clear cream and added ethnol to make the content of ethanol was 80%;The supernatant alcohol was concentrated with 80℃ and under reduced pressure to paste to relative density of 1.32~1.34(60℃)for later use;The alcohol extracting was concentrated with 70℃ and under reduced pressure to paste to the relative density of 1.24(60℃),spare;Combined the acohol sink thick paste with alcohol extraction thick paste and mixed fully,vacuum drying into dry extract under 80℃.Preparation for molding 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 Compoud Huangbo Fuyan Capsules: the dry paste powder(80mesh)and starch(2.75:1)was mixed,then added theappropriate amount of 95% ethanol,made into soft material,palletized by30 mesh,dried,sieved by 24 mesh,blending,filled into the capsule,aluminum-plastic packed,namely.2.Study on quality standardStudy on TLC identification: TCL was adopted for the identification of Cortex phellodendri,red peony,smilax,rhizoma corydalis,angelica,motherwort in Compoud Huangbo Fuyan capsule.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 berberine,which exists in Cortex phellodendri of Compoud Huangbo Fuyan Capsules was determined.The chromatographic conditions are as follows:Eighteen alkyl silane bonded silica as filling agent;Acetonitrile-0.1%phosphoric acid solution(50:50)(per 100 ml add sodium dodecyl sulfate0.1g)as mobile phase;detection wavelength is 265nm;column temperature is 30℃;flow rate is 1ml/min.Through the ten batch of pilot and the three batch of pilot study to determine the content of berberine in the finished product,that is not less than 9.0mg in each capsule.