Study On The Preparation And Quality Standard Of Bauhinia Championi (Benth.) Benth. Dispersible Tablets

Objective: Bauhinia championii (Benth.) Benth. is the plant from leguminous of thegenus sheep hoof nail, its Medicinal part is the dry stem. Bauhinia championii (Benth.) Benth.have the function of dispelling the wind and dehumidification and promoting flow of qi and bloodcirculation. It is usually used for the treatment of traumatic injury,hemiplegia, iagnosis pain, injuries,infantile malnutrition, diarrhea and so on. Some tests about Bauhinia championii (Benth.) Benth.were did in the paper, such as extraction, purification,in tablets and so on.The study aim at reducingthe drug dose,improving the relative content of the effective component,improving drug bioavailability.Methods:①Study of Fingerprints of Bauhinia championii (Benth.) Benth. The studyestablished the fingerprint of11batches of Bauhinia championii (Benth.) Benth. aiming toidentification and quality standard of Bauhinia championii (Benth.) Benth.②Extraction technologyresearch of Bauhinia championii (Benth.) Benth. single-factor experiment and Central CompositeDesign-Response Surface Methoclology was carried out for the optimization of reflux extraction inBauhinia championii (Benth.) Benth.③Purification technology research ofBauhiniachampionii (Benth.) Benth. Purification technology of the D101macroporous resin was optimizedusing single factor and Central Composite Design-Response Surface Methoclology.④Study onthe preparation process of Bauhinia championii (Benth.) Benth. dispersible Tablets according to theindex of differences in the appearance of tablets or disintegration time by single factor and CentralComposite Design-Response Surface Methoclology.⑤Study on quality standardThe quality standardwas developed according to Chinese pharmacopoeia2010edition of the general principles of thepreparation of dispersible tablets under (appendix ⅠD);TLC was carried out toidentify the true and falseof dispersible tablets; By RP-HPLC method, the content of3,4,5,5,7-5methoxy flavone (flavonoid 1),3,4-5-methylene two oxygen radicals,5,6-4methoxy flavone (flavonoid2) were tested indispersible tablets.Results:①The similarity of11different sources ofBauhinia championii (Benth.)Benth. in addition to the Guangdong Huizhou was more than,15common chromatographicpeaks were identified and two chromatographic peak were marked.②The optimumExtraction condition is14times45%ethanol, extracting2times of each time116min. Themass fraction of3’,4’,5’,5,7-methoxy flavone is0.046%,mass fraction of3’,4’-methylenetwo oxygen radicals-5’,5,6,7-methoxy flavone is0.027%, the extract yield is21.21%.③The optimum Purification condition is as the following:recycling to extract without alcoholflavor, sample concentration was0.11g·mL-1,the sample rate is2BV·h-1, First with5times body volume (BV) distilled water to wash to polar components,following with13.94BV84.41%ethanol elution at a rate of about2BV·h-1, eluent was concentrated intoextract; the purity of3’,4’,5’,5,7-methoxy flavone was increased from0.22%to1.14%,and the purity of3’,4’-methylene two oxygen radicals-5’,5,6,7-methoxy flavone from0.13%to0.67%,the purpose of the content of relative components were raised,it has thevalue to popularization and application.④The final prescription of dispersible tablets wasas following:extract is22%,MCC58%,L-HPC9.2%,PVPP9.8%,magnesium stearate1.0%.The preparation technology of dispersible tablets was as following: the extract was driedunder60℃and crashed to pieces reaching the aim of geting through100mesh sieve;accessory had the same handling method with the extract;MCC as filler,L-HPC and PVPPas disintegrating agent, mixed evenly,and the wetting agent of85%alcohol was joined tomake into soft material,the soft material must get through20mesh granulating,60dried;lubricant magnesium stearate was joined in the soft material, mixed evenly.Dispersible tablets was made from the above material under the same pressure.Theappearance of tablets is rounding,and sepia;and the disintegration time was40s.⑤Weightdifference and disperse uniformity were within the rules; the disintegration time was40s;TLC test was positive; the accumulative dissolution in vitro was30min reaching90%andmeet the requirements of quick release;The content of3’,4’,5’,5,7-methoxy flavone and 3’,4’-methylene two oxygen radicals-5’,5,6,7-methoxy flavone in each tablet wererespectively are0.700mg,and0.412mg.Conclusions:①Fingerprints of Bauhinia championii Benth from differencesbatches was studied in this paper,and the method is simple and good repeatability;it has thereference value of the use and quality evaluation of Bauhinia championi (Benth.)Benth.②The extraction condition and purification process by D101macroporousadsorption resin were developed;The preparation technology and prescription were filteredwhich technology is simple and robustness.③Quality standard which method iseasy and simple to handle and high accuracy was established in order to control thestand or fall of Bauhinia championii Benth.