| Zhizi Jinhua Pill was composed of gardenia,scutellaria,rhubarbcoptis,phellodendron,rhizoma anemarrhenae,honeysuckle,radixtrichosanthis.The function of the Zhizi Jinhua Pill attended to clear heat,send fire,detoxifi-cation.laxative.But the pill existed the following disadvantage:first,most of pills were made from crude drug,so large dose each time was uncon-vinient.second,pills were easily contaminated by bacteria;third,due to the different place of orgin,the content of effective component of crude drug were different which lead to different effect from different manufacturers,last but most,there were not quality standard for most pill,especially for the honey bolus.Because of these shortages,the pill could be improved to dispersible tablet which was made by extracting all the herb in pres-cription and adding auxiliary materials,Zhizi Jinhua dispersible tablet dis-integrated in 3 minutes.Dissolution means that drugs dissolved out from solid preparations,In this paper,geniposide and berberinehydrochloride and baicalin as the representative components,the dissolution of Zhizi Jinhua pill was compared with Zhizi Jinhua dispersible tablet so that estimate their effects.At the same time determinicng the dissolution of the pills prepared with different partical sizes of the TCM materials by using the dispersable tablets as comparison,to test that whether the difussion effici-ency of pill that is made by superfine power method was the same as the dispersible tablets.Dissllution test needed to determine the content of Zhizi Jinhua pill and dispersible tablet.The Chinese Pharmacopoeia(2010edition)only de-termined the content of geniposide in gardenia which was a monarch d-rug in prescription.In order to control the qualityof other Traditional Chinese Medicine(TCM),a HPLC method was esablished for determining the content of geniposide,berberinehydrochloride and baicalin in ZhiziJin hua pill,thus to control the quality of gardenia,coptis,phellodendron and scutellaria.At the same time the dissolution of geniposide as major com-ponents was investigated in purified water,further to evaluate its quality.In order to control the quality of ZhiziJinhua dispersible tablet,a HPLC method was established to determine eight active components,including geniposide?baicalin?aloeemodin?rhein?emodion?chrysophanol?physcion and berberinehydrochloride in Zhizi Jinhua dispersible tablet.There were three sections in this thesis.The first part:Determination of three active components in Zhizi Jinh ua Pills and dissolution of geniposideObjective:To establish a method for determining the content of geniposide,be-rberinehydrochloride and baicalin in Zhizi Jinhua Pills and the dissoluti-on of geniposide.Methods:A HPLC method was established,the mobile pHase was methan-ol-0.1%phosphoric acid with gradient elution;the flow rate was 0.8 mL/min;The detection wave length was 254nm;and determine the dissolubility of geniposide in purified water,and calculate the cumulati-ve dissolution rate.Results:The linear range of geniposide was between 0.007?0.336?g,r=0.9999:The linear range of berberinehydrochloride was between 0.013?0.624?g,r=0.9998:the linear range of baicalin was between 0.0105?1.734?g,r=0.9998.The average recoveries of geniposide,berberinehydrochlor-ide,baicalin were 99.6%(RSD=2.66%),100.2%(RSD=1.64%),99.0%(RSD=23%)respectively.The cumulative dissol-ution rate of geniposide was 79.9%in 45 min and 92.2%in 120minConclusion:The methods were simple and reproducible.lt can be used to Measu-re the quality evaluation of Zhizi Jinhua Pills.The second part:Determination of eight active components in Zhi zi Jinhua dispersible tabletObjective:To develop a HPLC method for determining eight active components including geniposide?baicalin?aloeemodin?rhein?emodion?chiysopHa nol?pHyscion and berberinehydrochloride in Zhizi Jinhua Dispersible T abletMethods:The determination was performed on a Agilent 1200 HPLC,Dimonsi 1-C18 column,with methanol-0.05%phosphoric acid as the mobile phase in gradient elution mode at the flow rate of 0.8mL/min,The detection wave length was 254nm.Results:Geniposide?baicalin?aloeemodin?rhein?emodion?chrysophanoland physcion could be completely separated from interfacing impurity peaks.The linear range of geniposide was between0.0162?0.1215?g,r=0.9999;the linear range of baicalin was between 0.0334?0.2505?g,r=0.9999;the linear range of aloeemodin was between 0.0006?0.0045?g,r=0.9997;the linear range of rhein was between 0.0020?0.0150?g,r=0.9999;The linear range of emodion was between 0.0060?0.0450?g,r=0.9997;the 1-inear range of chrysophanol was between 0.0012?0.0090?g,r=0.9997;the linear range of physcion was between 0.0002?0.0015?g,r=0.9995.The average recoveries of geniposide?baicalin?aloeemodin?rhein?em-odion?chrysophanol and physcion were 97.27%,100.71%,98.37%99.89%,103.01%,97.07%,101.32%respectively.RSD was 0.65%,4.59%,3.57%,4.05%,3.74%,2.32%,4.66%respectively;The linearrange of b erberinehydrochloride was between2.5?50?g/mL,r=0.9995,The average re covery of berberinehydrochloride was 100.85%,RSD was3.7%.Conclusion:The methods were simple and reproducible.It can be used to meas ure the quality evaluation of Zhizi Jinhua Dispersible Tablet.The third part:study on the diffeerent size of Zhizi Jinhua pill a nd Zhizi Jinhua dispersible tablets dissolution.Objective:By compared the dissolution of Zhizi Jinhua pill which was made in different particle size powder,examined if particle size is the key fac-tors influencing the pill dissolution,and compare the dissolut-ion of Zhizi Jinhua pill and Zhizi Jinhua dispersible tablets in different medium.Methods:According to the 2010 edition Chinese Pharmacopoeia of dissoluti-on test(appendix XC the second method,plasma method),(37±0.5)?,adjust the speed of 50 r/min,900 mL degassing purified water,compared with the dissolution of Zhizi Jinhua pill which were made in different particle size;geniposide,baicalin as the indexes comparedissolution in different medium;in the same dissolution medium,compare Zhizi Jinhua pill with Zhizi Jinhua dispersible tablets.Results:The cumulative dissolution rate of bailey powder,superfine powder,finepowder,powder were 85%,88.3%,79.1%,66%at 45min and were 92%,92.7%,91.9%,70.5%at 120min respectively;0.4%SDS+0.1 MHCL as the dissolution medium,The cumulative dissolutionrate of geniposide?be-rberinehydrochloride and baicalin in Zhizi Jinhua pill were 57.6%,32.2%,32.3%at 60min and were 90.1%,70.4%,60.2%at 120min respectively;0.4%SDS+0.1 MHCL as the dissol-ution medium,the cumulative dissolut-i on rate of geniposideand berberinehydrochloride and baicalin in Zhizi Ji nhua dispersible tablets were 57%,62.1%,20.7%at 5min and were 92.5%,97.9%,27.9%at 30min respectively;purified water as the dissolution m-edium,the cum-ulative dissolution rate of geniposide and berberinehydr-chloride and baicalin in Zhizi Jinhua dispersible tablets were 58.9%,29%,43.1%at 4min and they were 93.9%,63.6%,91.9%at 30min respectively.Conclusion:different particle size of powder was investigated showed that the fine powder was the best;the dissolution of Zhizi Jinhua Dispersible tablet was faster than Zhizi Jinhua pill obviously. |
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