| Due to the rapid development of China's social economy,increasing job stress and life pressure tend to make people tired.According to the WHO survey,more than 35% of the world's people are in fatigue.The middle aged men's fatigue state is 60%.A study shows that elderly people,especially those over 60 years old,have the highest risk of fatigue.There is a strong correlation between health and fatigue.The poorer the health is,the easier it is to feel tired.Fatigue not only affects people's physical and mental health,reduce the quality of people's life,while the fatigue problem of this broad,but also because many unhealthy way of life and work,such as the lack of physical exercise,irregular diet,environmental pollution,not net,low immunity has become a social phenomenon of Guangdong,the not only destroyed people's health in China,also will be the development of all aspects of social and economic stability,etc..In recent years China's hematopoietic stem cell and solid organ transplantation has made a breakthrough,the number of transplants have been among the highest in the world;thanks to radiotherapy and chemotherapy and treatment progress,cancer patients survival period is prolonged;the level of diagnosis and treatment of rheumatism and other immune related diseases,improve the patients,in order to maintain long-term remission of symptoms and even the lifetime use of corticosteroids and immunosuppressive agents;with the epidemiological trend changes,the Asian patients with acquired immunodeficiency syndrome and the number is in a period of rapid growth.Due to these factors,our immunocompromised population is growing,and the large population base,the absolute number of the immune function of patients with low ranking first in the world.It has a good market prospect to develop the drugs to improve the immunity and relieve fatigue.Therefore,this paper is to develop a kind of health food with horse deer antler as raw material,which can improve the immunity and fast fatigue effect.The basic research ideas in this paper are based on the research from preparation process to quality standard,and then to stability research.Finally,the logical route of pharmacodynamics research is researched and designed.1.The process of design and preparationThe prescription design: antler deer animal notochord mammalia animal Cervuslaphus elaphus Linnaues Red Deer stag immature ossification densely hairy,only contained in the "Shen Nong's herbal classic" as the product is a kind of traditional Chinese medicine of china.Zhuang Yang,velvet antler essence and blood,strong bones and muscles,regulating Chongren,supporting Chuangdu effects for kidney yang deficiency,blood deficiency,impotence,spermatorrhea,palace cold infertility,win thin,fatigue,chills,dizziness,tinnitus,deafness,cold pain in the lumbar spine,flaccidity,bones,and metrorrhagia and metrostaxis gangrene.Antler has the effect of enhancing the cellular and humoral immunity of the body.Antler polypeptide has a very good anti-hypoxia and anti-fatigue effect.Preparation process: This product uses polyethylene glycol 4000 as adhesive,sodium carboxymethyl starch sodium as disintegration agent,select tablet as the basic dosage form.Compared with other dosage forms,tablets are accurate and uniform in content,and the number of tablets as a dose unit is easy to carry and transport,and the degree of production mechanization is high,so that the content of tablets is uniform,and the content of drugs in tablets is small.Compared with the pills,the dissolution rate and bioavailability are relatively high.Pure Chinese medicine preparations contain no sugar and high effective components.They enter the gastrointestinal tract rapidly and disintegrate and are absorbed,with less dosage and convenient portability.The technology of this product adopts conventional tablets production process:(medicine,excipient)comminution,sieving,mixing(adding binder,wetting agent to make soft material),then granulation,sieving,drying,and whole grain(disintegrating agent,lubricant mixing),then tabletting and packaging.2,making quality standardsAccording to the Chinese pharmacopoeia standard(2015 Edition)and the national standard(GB),we designed and inspecting methods and standard ranges for improving the indexes of immunity,anti fatigue pilose antler,and finally determined that the protein contained less than 15 g per 100 g in the preparation.3,stability investigationTo improve the stability of the non immunity anti fatigue velvet,designed three months accelerated and twelve months of normal test to study performance of pilose antler slice stability in five subjects in the project,five projects are characters,load difference,disintegration time,content and microbial limit,results show that the preparation stable and reliable.4,pharmacodynamic studySix experiments were designed for the pharmacodynamic study of this preparation.The results proved that the preparation has the effect of improving immunity and anti fatigue. |
PDF Full Text Request