| The immune system is an important barrier for human body to protect the body from external diseases.When the immune function is damaged,the human body presents a pathological condition.More and more studies show that the pathogenesis of most malignant tumors is closely related to the damage of immune function.In today’s society,more and more factors affecting the immune ability of the human body.The body’s natural aging,environmental pollution and subhealth conditions caused by various factors will damage the immune function of the body.In recent years,people’s demand for quality of life has increased,and the health care products that enhance immunity have been followed closely,especially the products based on the compound of traditional Chinese medicine gradually become the research and development focus.In this paper,7 groups of Chinese medicine compound were screened by pharmacological experiments,screening may enhance the immune efficacy of combination of traditional Chinese medicine compound,and carries on the extraction,granulating process,to the quality of compound granules to establish evaluation criteria system,provides the material basis for the subsequent product declaration.The results of this paper are as follows:Compound selection:According to the Technical Specification for Health Food Inspection and Evaluation of(2003)edition,this paper adopts normal male BALB/c mice to carry out relevant immune detection.The mice were divided into normal group,positive drug group(letinous edodes polysaccharide capsule content),compound 1 group,compound 2 group,compound 3 group,compound 4 group,compound 5 group,compound 6 group,the compound 7 group,gives the corresponding solution,respectively,based lavage 30 days,the determination of relevant indicators。In the humoral immunity of mice serum hemolysin level and mononuclear macrophage phagocytosis,according to standards for screening compound 3 has more obvious enhance immune function,it can make the normal mice serum hemolysin level rise by 78.60%,and monocyte/macrophage phagocytosis increase about 49.55%less.Therefore,this prescription can be developed as a product of enhancing immunity,and the compound 3 group is named as the HeiJing compound,and the follow-up study is conducted.Extraction process:In this paper,the extraction process of HeiJing compound was investigated by using water as extraction solvent.The content of total polysaccharide,total flavonoids content and paste rate were selected as the test indexes.The comprehensive score of three indexes is calculated by analytic hierarchy process.The comprehensive score was used as the judging index of extraction process,and the extraction time,the number of extraction times and the liquid ratio were investigated by orthogonal experiment.The optimal extraction process of the selected HeiJing compound particles was 10 times.of water,and the extraction time was 0.5 hours.The RSD value was 1.520%,less than 3%,indicating that the process was stable and feasible and reproducible.Granulate forming process:In this paper,granule is selected as the product dosage form of HeiJing compound.By anhydrous lactose,medicinal dextrin and soluble starch,microcrystalline cellulose four complementary makings of the granules made by molding rate,moisture absorption rate,dissolving rate and its comprehensive score of survey,using comprehensive score of 98.9 points of anhydrous lactose and forming rate for 99.3%of the medicinal dextrin unregular to hybrid materials for HeiJing compound particle fillers.And through single factor and orthogonal experiments on hybrid materials in the ratio of anhydrous lactose and medicinal dextrin,medicine auxiliary than filtered,ethanol concentration,dosage of ethanol,ultimately determine the optimal granulating process of HeiJing compound particles are:using anhydrous lactose and medicinal dextrin and the ratio of the configuration of hybrid materials,medicine and auxiliary ratio of 1:1,8,0.5 times the amount of 65%ethanol as adhesives.It is in accordance with the state regulations that the three batches of granules should be inspected according to the granules.Quality Standard:In this paper,the standard of qualitative and quantitative identification of granules is established according to the requirements of health food research and evaluation.In the qualitative identification,based on the Chinese Pharmacopoeia of 2015 edition,the TLC identification method was established for the Polygonatum sibiricum Red.,Ziziphus jujube Mill.,Citrus reticulata Blanco.and Glycyrrhiza uralensis Fisch.of HeiJing compound granules.It has the characteristics of easy operation,and stable method.In quantitative identification,taking the total polysaccharides and total flavonoids in the particles as iconic elements,and through the orthogonal experiment,the screen is suitable for the ultrasonic extraction process,the HeiJing compound particles combined with UV spectrophotometry is used to detect the component content.Finally,a method for determining the signature component content of HeiJing compound particles was established.The content of total polysaccharide and total flavonoids of three batches of HeiJing compound granules was determined by this method,which was 0.8129 mg·mg-1 and 0.0109 mg·mg-1,which provided data basis for the establishment of relevant standards in the future.This paper has the following characteristics and innovation:(1)In this paper,a Chinese herbal prescription with enhanced immunity is selected through pharmacological experiments.(2)In this paper,the content of total polysaccharide,total flavone and extract rate in compound extract powder were evaluated by analytic hierarchy process,and the best extraction technology of HeiJing compound was selected by comprehensive score.Through Single factor-Orthogonal experiment,screened the best granulation process of compound crystal.(3)This paper establishes a quality control system suitable for the HeiJing compound granules,providing quality assurance for the safety and effectiveness of the HeiJing compound granules. |
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