Study On Process And Quality Standard Of Jing Kang Tablet

Cervical spondylisis refers to a disease in which degenerative changes of cervical intervertebral discs and its secondary pathological changes in adjacent structures involve surrounding tissue structures(nerves,blood vessels,etc.),and clinical manifestations corresponding to imaging changes appear.Common upper limb pain,numbness,weakness and dizziness.With the accelerating pace of life,the increasing pressure of modern people and the popular use of electronic products,the number of patients with cervical spondylosis in China is 18% higher in the population.This has become a number that cannot be ignored,and the incidence of cervical spondylosis has also increased from the middle and old People tend to gradually grow younger.The theory of traditional Chinese medicine believes that the formation of cervical spondylosis is due to the deficiency of liver and kidney yang,and the lack of essence.In the study of ancient books,existing health foods and literature,the three medicinal materials of rehmannia,pueraria,and notoginseng Method of granulating.After the tablets are compressed,a cervical spondylopathy with liver and kidney deficiency is made into a Jingkang tablet to treat the cervical spondylopathy with liver and kidney deficiency and improve people’s quality of life.When optimizing the formulation process,this topic first selects four different fillers to mix with the extract particles,and determines that corn starch is the most suitable auxiliary material through the moisture absorption rate during the observation period.Afterwards,the PVP anhydrous ethanol solution of different concentrations and proportions was tested,and the adhesive of this product was determined to be a 5% pvp60% anhydrous ethanol solution.Considering the fluidity and subsequent disintegration of the powder,0.5% magnesium stearate was selected as the lubricant for this topic.The most determined and best process is: adding 1times the amount of corn starch,using 5% PVPk3060% ethanol as a binder for wet granulation,adding 0.5% magnesium stearate before tableting,tableting.After consulting the literature,it is determined that the three medicinal materials are extracted by water.Secondly,take the ratio of material to liquid,the number of extractions and the extraction time as independent variables,and the dry paste yield after extraction and the content of notoginsenoside Rb1 in the extracts are used as inspection indicators to design a single factor test and optimize the extraction process by response surface methodology.After that,by observing the optimization results of the concentration and drying process,the optimal process was finally determined as follows: when the material-to-liquid ratio is 1:8,extract 2times,2h each time,combine the filtrate of the two extractions at a constant temperature of 80°,0.06 Concentrate under reduced pressure in the pressure range of-0.08 MPa,and when concentrated to the relative density of the thick paste in the range of 1.30 to 1.35,place it at a constant temperature of 60° and dry in the pressure range of 0.06-0.08 MPa.In accordance with the provisions of the Pharmacopoeia,this product is subject to routine inspections of appearance properties,weight difference,friability,disintegration time limit,and microbiological inspection.This product is a light green film-coated tablet with a smooth,bright appearance,suitable hardness,and no special taste or smell.The remaining routine inspection items are in compliance with the relevant requirements of the Pharmacopoeia.The thin-layer identification item was used to identify the Panax notoginseng and Pueraria lobata in Jingkang tablets according to the pharmacopoeia.As a result,spots of the same color appeared on the corresponding position of the control medicinal material in the thin-layer plate of the test product.In the subsequent methodological experiments,this topic first screens the column,column temperature and experimental conditions.Afterwards,the content was determined by high performance liquid chromatography to determine the content of notoginsenoside saponins R1 and two ginsenosides Rg1 and Rb1 respectively.The linear range was established,and a feasible method for determining the content of Jingkang tablets was determined.It also stipulates that each tablet of this product contains not less than 0.80 mg based on the total amount of notoginsenoside R1,ginsenoside Rg1 and ginsenoside Rb1.Check the stability of the final pellets.Tests show that the inspection results are within the index range,indicating that the properties of the particles are relatively stable,which can provide a certain scientific basis for the establishment of its production,storage,transportation conditions and shelf life.