Preparation Of Compound Ginseng Effervescent Tablets

Compound Ginseng Effervescent Tablets,it is a health food composed of ginseng,velvet antler and oviductus ranae which can enhance human immune function.Low immunity is manifested by poor appetite,weak constitution and weak spirit.The immune system cannot function properly,not only low quality of life but also easy to cause major diseases.Therefore,it is of great significance to strengthen and improve the immune function of the human body,especially for special groups such as the elderly,children and those who have recovered from the disease.Based on this situation,this thesis designed and developed a compound ginseng effervescent tablet with the effect of enhancing human immunity.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 stability test.The specific results are as follows:1.Research on extraction processThe traditional Chinese medicine of ginseng and velvet antler in the prescription composition was extracted.According to the usage and dosage of ginseng and velvet antler in the Ch.P.,it was determined that both were extracted together in a ratio of3:1.The optimum extraction process was determined by orthogonal test.The optimum extraction process was selected by orthogonal test with the dry weight and total ginsenoside content as the index.Finally determined the extraction process is soak the medicinal materials for 30 minutes,the amount of waters is 8 times of medicinal materials,the extraction time is 3h,and the extraction times is 2 times.2.Research on preparation processOviductus ranae in the formulation was subjected to ultrafine grinding and a small amount of dispersant was added to ensure its efficacy.Determined byprescription screening that xylitol was used as filler,sodium bicarbonate(alkali)and citric acid(acid)were used as disintegrating agent,sodium cyclamate and saccharin were used as flavoring agent,magnesium stearate was added as a lubricant and anhydrous ethanol as a binder,and it was prepared by a non-water granulation method.Determination of the optimal prescription ratio of effervescent tablets by response surface optimization test.The amount of diluent is 1.88 times that of medicinal materials,and the amount of disintegrant is 0.57 times that of medicinal materials,the ratio of acid and alkali is 1:1.31.All indicators of effervescent tablets prepared according to this prescription are in compliance with regulations,the prepared effervescent tablet is smooth and complete and the process is stable.3.Research on quality standardsA series of routine examinations of effervescent tablets according to the Chinese Pharmacopoeia 2015 edition,including weight difference,hardness,friability,disintegration time,pH value and foaming amount.According to GB/T national standards,the effervescent tablets were examined for microbiological and heavy metal limits.Identification of Effervescent Tablets of ginseng and velvet antler by TLC.The contents of ginsenosides Rg1?Re?Rb1?Rc?Rd and 1-methyl hydantoin in the preparations were determined by HPLC and the methodology was examined.The results showed that routine inspections,microorganisms,and heavy metals meet the requirements.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,stability for content determination.4.Preliminary stability studyTo initially explore the stability of effervescent tablets,influencing factor tests,accelerated tests and long-term stability tests were conducted.The results show thatthe stability of effervescent tablets is well,recommended to seal and dry during storage and transportation.Innovation:1.For the first time,the three herbs ginseng,velvet antler and oviductus ranae were properly combined to prepare the new dosage form of Chinese medicine effervescent tablet.2.HPLC was used to qualitatively identify the 1-methyl hydantoin in the oviductus ranae in the 2015 edition Ch.p.In this paper,the first quantitative study of1-methyl hydantoin was carried out by HPLC,the main content was determined accurately.