Study On The Preparation And Quality Standard Of Geranium Dispersible Tablets

Geraniumwilfordii Maxim.,a traditional Chinese herbal medicine,pertains to Geraniaceae Geranium plants of Geranium family.Study showed that the active ingredients of Geranium wilfordii Maxim.are inclusive of the gallic acid,tannins and flavones,which have a good therapeutic effect on ulcerative colitis.But the effective components in Geranium have poor solubility,slow dissolution rate,etc.The dispersible tablets of traditional Chinese medicine is a new dosage forms which can be rapidly disintegrated,evenly dispersed and quickly dissolved.This preparation has the advantages of easy administration,high dissolution efficiency and good stability.The aim of this study is to prepare theGeranium dispersible tablets for improving the dissolution of effective components in vivo,promoting absorption,and increasing clinical efficacy.Phosphomolybdium tungstic acid-casein reaction method was adopted to determine the content of total tannins in the extract.Through comparison of the warm maceration extraction,the super sound extraction method and the reflux extraction of total tannins,the ethanol extraction method was the preferred method.On the basis of single factor experiment,with dry extract rate and total tannin extraction rate as index,the orthogonal test was used to optimize Geranium ethanol reflux extraction process.The optimum extraction process was as follows:18 times the amount of 50%ethanol extracting 3 times,3 hours per time.Single factor experiment method was adopted to investigate the preparation process of Geranium dispersible tablets,initially preferred microcrystalline cellulose as filler,low substituted hydroxypropylcellulose as disintegrating agent,70%ethanol solution of 5%PVP as wetting agent,lubricant selection of micro silica powder.With disintegration time as index,the orthogonal test was used to optimize dispersible tablets.The final prescription of dispersible tablets was as following:extract was 38.5%,microcrystalline cellulose was 50%,low substituted hydroxypropylcellulose was 10%,micro powder silica gel was 1.5%.70%ethanol solution of 5%PVP was used as wetting agent to make soft material.Using internal and external adding method to add the disintegration agent.Wet granulation technique was employed to prepare tablets.The quality standard of Geranium dispersible tablets was studied according to the general principles of the preparation of dispersible tablets in Chinese pharmacopoeia 2010 edition(appendix I D).Weight difference,disperse uniformity and the disintegration time of three batch of Geranium dispersible tablets were within the rules.TLC test were positive.The quantitative content of the gallic acid,total tannins and total flavonoids were respectively determinated by RP-HPLC,phosphomolybdium tungstic acid-casein reaction and UV spectrophotometric.During the assay,the gallic acid,total tannins and total flavonoids were used as indices of dissolution.The results showed that the content of the gallic acid,total tannins and total flavonoids in each tablet were not less than 0.73 mg,14.23 mg and 9.26 mg respectively.The accumulative dissolution in vitro has reached more than 90%in 15 min and achieved the requirements of quick release.The experimental results showed that the reflux method to extracte the effective components in Geranium,the formulation and the preparation process of dispersible tablets were all efficient,reasonable and stable,laying the foundation for industrial production of Geranium dispersible tablets.The quality standard of dispersible tablets,which established in this paper,was simple and reliable.This quality standard will provide basis to control the quality of Geranium dispersible tablets,and provide reference to improve the quality standard of other traditional preparation of Geranium.