| Visual fatigue is a comprehensive symptom based on the patient's eye symptoms,which is intertwined by eye or systemic factors and mental factors(psychological factors),and belongs to the psychosomatic medicine category.Clinically,it often manifests as dryness,swelling,soreness,ghosting,blurred vision,etc.In severe cases,it can also cause systemic symptoms such as headache,nausea,dizziness and cervical soreness.There is no clear definition of fatigue in the literature of ancient Chinese medicine,but according to the theory of traditional Chinese medicine that“the liver is open to the eye and the liver can be seen by blood”,it is considered that visual fatigue is very similar to“liver labor”.Nowadays,with the continuous advancement of science and technology,the work of close-range fine-eyed use is becoming more and more popular.The emergence of electronic products such as computers and smart phones has led to an increase in the incidence of visual fatigue,and people's quality of life has been seriously affected.Therefore,it is of great significance to develop a safe and effective product to alleviate visual fatigue.Prescription argument:Traditional Chinese medicine emphasizes the overall concept,syndrome differentiation and treatment,and highlights the advantages in treating visual fatigue.Shikang Capsule was a capsule made of radix rehmannia 148 g,chrysanthemum 36.7 g,medlar 36.7 g,salvia miltiorrhiza 55.05 g and cassia seed 55.05 g.Rehmannia glutinosa was a medicinal herb with the effect of nourishing blood and nourishing yin,and replenishing the essence of the marrow;scorpion could refine the eyesight,nourish the liver and nourish the kidney,mainly used for the deficiency of the labor,dizziness,waist and knee pain,internal heat too;Chrysanthemum had the functions of calming liver and eyesight,evacuating wind heat,clearing away heat and detoxifying.It was suitable for clearing liver and diarrhea,dispelling wind and clearing heat,and could also benefit Yinyin and eyesight.It could be used to treat liver and wind,or to cause redness and swelling caused by liver fire attack.They were compatible with the drug;Cassia could not only clear the liver and gallbladder stagnation,but also evacuated the wind and heat,for the treatment of red eyes and swelling and pain,Danshen could activate blood stasis,clear heart and trouble,solve local choroidal obstruction,they were adjuvant.The combination of various medicines had the effects of nourishing yin and tonifying the kidney,clearing the liver and improving eyesight,and promoting blood circulation and collaterals.On the basis of prescription demonstration,this subject carried out research on the preparation process and quality standard of Shikang Capsule,and evaluated the efficacy.Extraction and capsule preparation process research:Through literature analysis,it was determined that rehmannia glutinosa,chrysanthemum and alfalfa were extracted by water extraction,and cassia seed and salvia miltiorrhiza were extracted by ethanol.According to the hygroscopicity of the powder,the pellet forming rate and other indicators,the suitable excipients were screened out,and the effects of the amount of excipients,the concentration of the wetting agent and its dosage,drying time,temperature,and the critical relative humidity of the particles on the preparation process were investigated.Results:Rehmannia glutinosa 148 g and chrysanthemum 36.7 g added 10 times the amount of water,reflux extraction for 3 h,filtration,filter residue added to chrysanthemum 36.7 g,8 times water reflux extraction for 2 h,filtration,filter residue added 8 times water reflux extraction 1 h,the filtrates were combined,concentrated to a relative density of 1.05-1.10,The first dry extract was obtained by freeze-drying,and the yield was 54.65%.Salvia miltiorrhiza 55.05 g added 8 times the amount of 95%ethanol reflux extraction for 1.5 h,filtration,filter residue added cassia 55.05 g and 6 times the amount of 50%ethanol reflux extraction for 1.5 h,filter,the filtrate was concentrated to a density of 1.05-1.10.The second dry extract is obtained by freeze-drying,and the yield was 26.16%.Then,the two dry extracts were evenly mixed,and lactose was used as an auxiliary material.The ratio of the medicine was 1.15:1,and the soft material was made of 90%ethanol of one-fifth of the total amount of the medicine.The wet granules were passed through a 24 mesh sieve at 60°C for 2 h,and filled the capsules after sizing.Study on the quality standard of Shikang Capsule:This study identified Rehmannia glutinosa,Chrysanthemum,Salvia miltiorrhiza,Radix Scutellariae and Cassia sinensis by TLC method and determined the content of Verbascoside,chlorogenic acid,orange cassia,chrysophanol,salvianolic acid B,tanshinone IIA by using high performance liquid chromatography,and determined the content of crude polysaccharide using UV spectrophotometry.Aaccording to the inspection items under the capsules of the Chinese Pharmacopoeia in 2015,The moisture,difference in the volume,and the time limit for disintegration were examined to establish quality standards.The results of the study:TLC identification of Rehmannia glutinosa,Chrysanthemum,Chinese wolfberry,Salvia miltiorrhiza,Cassia showed the same color fluorescent spots at the corresponding positions of the reference substance,and the spots were clear,the negative control had no interference;The linear regression equation of mullein in the range of 10~100?g/mL was Y=23310X-61910(R~2=0.9991,n=6),and the linear regression equation of chlorogenic acid in the interval 2.50-80?g/mL was Y=8250.5X+2205.8(R~2=0.9997,n=6),the linear regression equation of orange cassia and chrysophanol in the range of 0.03~0.75?g was Y=2E+07X-145455(R~2=0.9993,n=6),Y=5E+06X-40146(R~2=0.9997,n=6),the linear regression equation of salvianolic acid B in the range of0.4-4?g was Y=937194X-212556(R~2=0.9993,n=6),and tanshinone IIA was linear in the range of 5-50?g/mL,and the regression equation was Y=152664X-500071(R~2=0.9992,n=6),and the linear regression equation of crude polysaccharide in 10-90?g/mL was Y=0.0089X+0.0008(R~2=0.9994,n=6).The precision,stability,reproducibility and sample recovery rate of the six content determination methods were in accordance with the methodological requirements.It was stipulated that each 1 g of Shikang capsule containing verbascoside,chlorogenic acid,orange cassia,chrysophanol,salvianolic acid B,tanshinone IIA and crude polysaccharide should not be less than0.015%,0.017%,0.007%,0.007%,1.163%,0.045%,19.701%.The water content,weight difference and disintegration time limit of the three batches of capsules were all in compliance with the pharmacopoeia standards.The extraction process of five medicinal materials and capsule preparation process were simple and easy,and the quality was controllable.and it provided a powerful basis for its development to relieve visual fatigue products. |
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