Study On Preparation Technology And Quality Standard Of "Total Ginsenoside Capsule"

With the rapid development of economy and the improvement of living standards,people’s definition of health is no longer confined to the state that the body is not sick,but is in a good state in physical,mental and social aspects.However,the improvement of living standards is bound to be accompanied by the increase of life pressure.Long-term high-pressure living conditions and irregular living habits will make the health state in sub-health state,while sub-health state will lead to attention loss,fatigue,immunity decline and other diseases that can not be considered as diseases.It seems unnecessary to use drugs to solve this situation,so the health food is more meaningful.Ginseng,as a valuable traditional Chinese herbal medicine in China,is now used as both medicine and food.It is widely used in health food.Therefore,the product studied in this paper is a health food with ginseng as the main raw material,and its main function is to improve immunity.This paper includes the following aspects: 1.By consulting the literature and relevant regulations,he prescription of this product is determined,including the basis for the use of ginseng and auxiliary starch.The dosage is equivalent to 5 grams of ginseng per day.At the same time,the degradation of total ginsenosides in artificial gastric juice and artificial intestinal juice is investigated.The results showed that the degradation rate of total ginsenosides in artificial gastric juice is 70% in 2 hours and 29% in artificial intestinal juice.It is proved that the intestinal solvent type was the better choice for this product.Therefore,the dosage form of this product was enteric-coated capsule.2.Complete the preparation process of this product.Firstly,the ginseng medicinal material is determined.After TLC,moisture determination and content determination,the ginseng meet the requirements and could be used as the original medicinal material of this product.Secondly,choosing the best preparation process needs the reference basis,that is the content of total ginsenosides.Therefore,the determination method of total ginsenosides is determined by referring to the 15 th edition of Chinese Pharmacopoeia.In the research of preparation technology,the extraction process,purification process and moulding process are determined.According to the preparation of ginseng products in Chinese Pharmacopoeia,the decocting time and times are defined,but the specific parameters of water addition are lacked.The influence of specific parameters is investigated through experiments and verified,and the amount of water extracted is determined to be 10 times as much as that in the purification process.In order to prevent blockage of macroporous adsorption resin,ginsenosides are treated by alcohol precipitation.Therefore,when investigating the factors affecting the separation and purification of ginsenosides by macroporous adsorption resin,the factors affecting the alcohol precipitation of ginseng liquid were also investigated,including the density of ginseng liquid during alcohol precipitation,the content of ethanol during alcohol precipitation,the adsorption amount of macroporous adsorption resin,the concentration of sample,the flow rate of sample,the amount of eluent and the flow rate of eluent.The density of ginseng solution is 1.1 gram per milliliter,the content of ethanol is 60%,the concentration of macroporous adsorbent resin is 0.08 gram per milliliter,the amount of sample is 800 milliliter,the flow rate of sample is 3 column volume per hour,the dosage of eluent is 6 column,and the flow rate of eluent is 3 column volume per hour.In the forming process,the preparation of granules and the filling of capsules are included.The bulk density,fluidity,relative humidity and content of granules are investigated.The bulk density is 0.5 gram per milliliter,relative humidity is 69.81 percent,total ginsenoside content is 10 percent,and the fluidity is good.3.Complete the drafting of quality standards,and accurately determine the quality standards of this product through the experimental results and relevant national standards,including the appearance,content,physical and chemical indicators,pollutant limits and microbial limit determination methods and standards.4.Complete the pilot-scale study,produce according to the best preparation process and test the quality of the products.The appearance,content,physical and chemical indexes,pollutant limits and microbial limits of the three batches of "Total Ginsenoside Capsule" produced in the pilot-scale conform to the draft quality standards.5.The stability test is completed,and the stability of the product is determined by three months accelerated test.The appearance,content,physical and chemical indexes and microbial limit of the product are tested within three months,all meet the draft quality standard,and the shelf life of the product can be tentatively set as two years.