Study On Preparation Process And Quality Standard Of Ginseng Angelica Colla Corii Asini Blood Effervescent Tablets

Anemia has become the most common disease in the world,which affects a wide range of people and has complicated causes.According to the different causes of anemia,it can be divided into aplastic anemia,hemolytic anemia,iron deficiency anemia and megaloblastic anemia.Nutritional anemia is a general term for iron deficiency anemia and megaloblastic anemia.Its general clinical symptoms are poor mental state,easy fatigue and drowsiness,insensitivity,lack of attention,cold numbness and tingling in the hands and feet.The hair is fine and crisp and does not have the gloss sense,easy to lose hair;often feels dizzy,headache,tinnitus,vertigo,the black spots present in eyes,which seriously affects the modern people's quality of life.Based on this situation,this research develops Ginseng Angelica Colla Corii Asini Blood Effervescent,in which the main pharmaceutical ingredients are ginseng,angelica and Colla Corii Asini and it can effectively relieve the symptoms of nutritional anemia and treat illness.Its advantages are that it is relatively convenient to carry,is especially convenient for the elderly,children and dysphagia because of its advantages in dosage form.Therefore,it has the market competitiveness and prospects.This thesis mainly studies the extraction process of the effervescent tablet,the research of the preparation process,the establishment of the quality standard and the preliminary stability test.The specific results are as following:1.Extraction process:the extraction method of this subject was designed by using orthogonal test and measured by the dry ointment weight and the total content of ginsenoside.According to the physical and chemical properties of the effective ingredients in effervescent tablets,the extraction was carried out by alcohol extraction.Finally,the optimum extraction process was determined:70%ethanol concentration,ethanol quantity is 8 times the amount of medicinal material,3 times of extraction and 2 hours per each time.2.The preparation process:through prescription screening,the final determined optimal preparation technology of effervescent tablets is xylitol as filler,sodium bicarbonate,citric acid and sodium carboxymethyl starch as disintegrating agent,cyclamate and saccharin sodium as flavoring agent,magnesium stearate as lubricant.According to the best ratio of prescription,they are uniformly mixed withthe main pharmaceutic and is made to ultrafine powder.The ethanol solution of 20%PEG 6000 is used as binder and then it is process of granulation and tablets.After verification,the the effervescent tablets made by this process has good stability,good taste and fast disintegration.3.Establishment of quality standardsThe qualitative analysis of Angelica was carried out by TLC.The results showed that there were spots in the same position between the samples and the comparison samples,and there was no interference between them.The determination of ginsenosides and its methodological study were performed by HPLC.The results show that the method has good linearity,accuracy,repeatability,stability,good recovery and is simple and accurate.4.Stability assessmentThe influence factor test,accelerated test and long-term stability test were carried out on this preparation.The results showed that the Ginseng Angelica Colla Corii Asini effervescent tablets has good stability and the related properties were basically stable.