Study On Compound Hawthorn Effervescent Tablets

Dyspepsia,gastric hypomotility,is a common gastrointestinal disease with the main clinical manifestations including abdominal pain,abdominal distension,nausea,loss of appetite and other symptoms.Long term indigestion and lack of gastric motility will not only affect the intake of food and nutrients,but also induce gastritis and other gastrointestinal diseases.Gastritis can cause gastric motility disorders and vicious cycle of disease,which affects the patient’s normal life and work seriously.Based on this situation,this paper developed the Compound Hawthorn effervescent tablets.The prescription was composed of ginseng,Poria,Radix Aucklandiae,hawthorn and malt.It is a kind of health care products which can promote digestion,enhance the efficacy of gastric motility.The effervescent tablets have broad market prospects because it is convenient to take,rapid to absorb and easy to carry.This paper mainly studied the preparation technology,quality standards,stability and pharmacodynamics of the effervescent tablets.The results are showed as follows:1.The study on preparation technologyExtraction process: According to the physical and chemical properties of the active ingredient,we used the alcohol to extract effective components.The optimum extraction process was selected by orthogonal test with the dry weight and total ginsenoside content as the index.The best extraction process was confirmed on the basis of results of orthogonal test,which was displayed as follows: ethanol concentration is 50%,the amount of alcohol is 10 times of medicinal materials,the extraction time is 2h,and the extraction time is 3 times.Preparation technology: Appropriate filler,effervescent disintegratings,flavoring agent and binder was chosen as excipients.Then the proportion of main drugs and excipients was screened by test.Finally,the optimum technology of the effervescent tablets was determined as follows: xylitol was used as filler,sodium bicarbonate(alkali)and citric acid(acid)were used as disintegrating agent,sodium cyclamate andsaccharin were used as flavoring agent.Then those excipients were mixed with main drugs in proportion and pulverized into ultrafine powde.18%PEG(6000)ethanol solutionwas used as binder for granulation.Finally,compound hawthorn effervescent tablets with good taste and quick disintegrating were prepared after sieving and tabletting.2.The establishment of quality standardsIn this study,the quality standard for the effervescent tablets were investigated according to requirements in tablet item of China Pharmacopoeia 2015 edition "(four)".The routine examination of the disintegration time and the brittleness of the preparation was carried out,and the qualitative analysis of woody,Poria,hawthorn,malt were carried out by TLC method.We determined the content of Ginsenoside in preparation and studied methodological investigation by High performance liquid chromatography(HPLC)method.The results showed that the routine examination results were in accord with the standard.The results of TLC showed that the samples were in the same position as the control samples,and the negative ones had no interference.The results of the methodological investigation showed that the HPLC was a good method with strong specificity,good repeatability,good stability for content determination.3.Stability investigationThe traits,identification,disintegration time limit,p H value,content determination and microbial limit were investigated in influencing factor test,accelerated test and long-term stability test.The results showed that Compound Hawthorn effervescent tablet has good stability.4.Pharmacodynamics studyThe pharmacodynamics study of the preparation was carried out via animal experiments.The experimental results showed that the Compound Hawthorn effervescent tablets can promote digestion,enhance the efficacy of gastric motility.