| OBJECTIVE:1)To establish method for determination the content of Berberine and Palmatine in Xianghe suppository. 2)To select proper pharmaceutical technology of Xianghe suppository.3)To choose suitable carrier.4)To prepare Xianghe suppository.5)To study on the preparation of Xianghe suppository and to discuss its releasing mechanism.6)To study on the quality of Xianghe suppository. 7)To study on the pharmacodynamics of Xianghe suppository.METHOD:1)HPLC method was used for the determination of Xianghe suppository. Column: BDS C18, (4. 9mm X 250mm, 5 ii m),mobile phase: acetonitrile ater(1:1,containing 3.4g KI~I2P04 and 1.7g CH3(CH2)SO4Na per l000ml), mobile speed:1. Om I/mi n, detectedwavelength:345nm, paperspeed:O.5iyvti/min, the method was simple rapid and sensitive. 2)The effects of the extraction methods, the extraction time, the different dosage of extraction medium, and the different concentration of ethanol were studied. Final ly the pharmaceutical technology of Xianghe suppository was achieved by employing the orthogonal design with the indexes of the content of bererine and of the yield of extract.3)ln the studies on thebacter ia--i nh ib it ion, the effects of thepharrecodynami cs concentrat ion of ethanot extract, thedifferent dosage of borneol and menthol were studied.The best bacter iostat ic cond it ion of Xi anghesuppos itory was ach ieved by us ing the orthogonal des i gnwi th the index of the M I C. 4) Xi anghe suppos itory wasproduced by carr ier, bases and drug. Determi ned thereIoase of the suppository and studied the factorswh ich affected release of suppository. ln the studieson the properties of the Xianghe suppository in v itrore Iease. the effects of the release med ium, thed i fferent temperature of med ium, the factors o+pharreceut ica I preparat ion on the drug re l ease wereinvestigated. 5) A HPLC rethod was deveIoped to separateand determi ne berber ine and pa fmat ino in X ianghesuppos itory. 6) The stab i I ity test of Xi anghesuppos itory was carr ied out by the methods ofacce l erat i ng destruct ion and samp I e reserv i ngobservat ion. 7) The Ioca I st imu I at ion of the X ianghesuppos itory was carr ied out by the methods of anima lexper iment to research the chang ing of pathomorpho logyof v ig ina I mycoderma. B) An ima I exper imenta l method wasused to eva luate the Xianghe suppos itory effect toant i -- i nf I ammat i on.6R.8U Itt t 1 ) The op itma I techno l ogy was cho iced asdecoct ing in tenfoI d 65% a Icohol three t imes for twohours by orthogonal test. 2)The kind and temperature ofrelease med ium, the proport ion of bases affectedrelease of Xianghe suppository. The resuIts showed thatthe drug re Iease froo the Xianghe suppos itory was s lowand the re Iease profi Ies in v itro can be descr ibed bythe two--phas6 dynami c model. The matron idzo I eaccumulat ion was 61. 94% and 94. 22% at 2hour and 12hourrespect i ve l y. 3) The l i near ity equat ion' corre l at ioncoeffic ient and I inear ity range of the two const ituentswere @ berber inet Y=1. 41 X 105 +5. 46 X10', r=0. 9999, I inear ity range 0. 07--2' 24 p g; @ pa Imat ineY=1. 96 X 10sX+6. 81 X 10', r=0. 9997, l inear ity range 0. 07-2. 24 P g, The average recover ies of the two const ituentswere 98. 23 f 2. 17% and 97. 14% i 2. 85% respect ive Iy. 4) Itwas showed that the samp I e was re I at ive I y stab I e atroom temperature (25 t ). According to the changes ofberber ine in the samp Ie, its effect ive storage per iodat room temperature is one year. 5)The results showedthat tho pathonorphoIogy of gi na l wa I l hav6n't changedobv ious I y between the two group an ima I s. 6) The act ionof inhibit ing bacter ia is obv ious in vitro. lt showedthat Xianghe suppository possessed the effects ofant in f I amatory and bacter iostas i s.op0LUSlpe: It is indicated in this articIe thatX ianghe i s a good susta ined--re Iease suppos itory.Xiangh... |
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