| With the development of society,the pace of life is accelerating,the immunity is low,and the incidence of chronic fatigue syndrome is gradually increasing,and people’s physical and mental health is being threatened.In view of this,many domestic and foreign researchers have conducted extensive research on traditional Chinese medicinal materials that can improve human immunity and fight fatigue.This article uses ginseng,astragalus and other Chinese herbal medicines to develop a chewable chewable tablet that has the functions of improving immunity and resisting fatigue,and inspects the extraction method,the preparation process,the efficacy research,and the establishment of preliminary quality standards.1.The investigate of extraction methodExacting the saponin and polysaccharose from Ginseng and Astragalus with the method of Water-extraction.Extraction process was optimized by orthogonal experiment.which were designed to examine the four factors affecting the extraction rate:extraction temperature,extraction time,extraction times,and feed-to-liquid ratio The best method was:Under the condition of 100℃,adding 10 times amount of water and extracting the herbs three times,each for 2h.2.Study on preparation technology of Shenqi Chewable TabletsThrough the selection of excipients,the best molding process was obtained.The proportion of extract powder and excipients was 3:1.Based on the percentage hygroscopicity of different excipients,mannitol,aerosil and microcrystalline cellulose Were preliminarily determined as moisture-proof excipients.According to the quality of the pellets and tablets,the proportion between the three excipients was adjusted.The optimum ratio was aerosil:mannitol:microcrystalline cellulose=1:1.5:2.5.The flavoring agent was then examined.when 0.3%aspartame and 0.5%citric acid were added the best taste.The soft material made of 95%ethanol,granulated,and then finally added 1%magnesium stearate as a lubricant,mixed with the particles,tablet weight is about 0.5g.The obtained Shenqi Chewable Tablets have good taste and moderate hardness,which meets the requirement of chewable tablets3.Efficacy of Shenqi Chewable TabletsMTT assay was used to test the proliferation of mouse spleen cells.The results of MTT assay showed that the extract of Shenqi alone had no significant proliferation effect on mouse splenic lymphocytes,but under the synergistic effect of ConA,it could significantly promote the proliferation of mouse splenocytes with a concentration-dependent relationship,and low concentrations favored The proliferation of spleen cells;In addition,the absorbance value of the drug+ConA group was higher than that of the negative control group and the ConA control group,indicating that the Shenqi extract was not immunotoxic.The method blood coagulation was used to study the humoral immunity of Shenqi Chewable Tablets.After immunization of animals with sheep blood(SRBC),anti-SRBC antibodies(hemolysin)are produced and the level of hemolysin is detected by the degree of aggregation of SRBC.The results showed that each dose of Shenqi extract could significantly improve the spleen index and the level of antibodies,They had no influence on the weight of mice.So Shenqi chewable tablets had effect of humoral immunity.The weight-bearing swimming experiment was conducted on Shenqi chewable tablets for anti-fatigue experiments.30 days after intragastric administration of mice,the weight-bearing swimming time,serum lactate and urea nitrogen levels at different time points,and hepatic muscle glycogen content in muscles were measured.The results showed that high-dose Shenqi extract can prolong the swimming time of mice with weight-bearing,reduce the production of blood lactic acid,increase the reserve of hepatic glycogen and muscle glycogen after exercise and reduce the serum urea nitrogen value after exercise,combined with The weight-bearing swimming test and three biochemical indicators of the rats were positive.The initial determination of Shenqi chewable tablets can relieve physical fatigue.4.The content of ginsenoside Rb1 in Shenqi Chewable TabletsA method for the determination of ginsenoside Rb1 in ginseng chewable tablets was established by high performance liquid chromatography and a methodological investigation(including specific investigation,linearity investigation,precision test,stability test,reproducibility test,and sample addition)was carried out.Recovery test)The results show that the method is accurate,reliable,stable,highly specific,and reproducible.Each shenqi chewable tablet contained 0.3307 mg of ginsenoside Rb1. |