The Study On Preparation And Quality Evaluation Of Compound Lingxian Spray

Compound lingxian spray is made up by ginger,clematis root ginger,cinnamon and acorus gramineus.The efficacy of the spray is huoxue-liyan-tongqiao.It is used on oropharyngeal topical treatment of dysphagia after stroke,eating or drinking water choking cough.Ginger is used as monarch drug.CIematis root and cinnamon are used as associate drugs.In the medicine,altogether plays dissipate phlegm,activating blood,relieving sore throat and tongqiao.According to its own the prescriptions and the clinical application experience and under the guidance of TCM theory,it developed into spray.Because its can act directly on the lesion site,local treatment role.The main aim of this study was to research the preparation technology,rule of permeation mucosa and quality standard of compound lingxian spray.Firstly,the preparation process of this drug was studied.Content of active ingredient,clarity of pharmaceutical and efficacy experiment were used as evaluation index to choose extraction technology.The single factor method was optimized through throat spray oil extraction process.L9(34)orthogonal experiment,BP neural network,genetic algorithm and support vector machine(SVM)were used to optimize the water extraction process.The alcohol refining process and molding process was examined.The dosage of solubilizer and the concentration of the solution was identified.The best extraction technology is the oil extraction with 12 times water of drug,and the time of extraction with 7h.Combine the water decoction and concentrate until the density of 1.05 g·mL-1.Then adding ginger,continue to concentrate density of 1.075 g-mL-1.95%ethanol was added until ethanol concentration in the solution of 75%.The suction filter is used to remove sediment.Twain-80 is used as solubilizer.The propotion of naphtha and twain-80 is 1:1.Second,we research on in vitro experiment of through mucosa.Modified Franz diffusion cell methods was applied to investigatein vitro mucosa absorption of Compound lingxian spray and the content of in receptor fluid composed of PEG400%-95%ethanol-water(1:3:6)were determined by HPLC.The results were processed and different equations were fitted.The transdermal actions of cinnamic acid and cinnamaldehyde were in accordance with Higuchi equation and the fitting equation was Q=77.277t1"2-20.577;Q=2.0244ti1/2-0.9166.In 8 hours,the release rate of was 33.93μg·cm-1h-1 and 813.59 μg·cm-1h-1.The results show that the compound lingxian spray has a good performance through mucosa.Finally,to control the product quality,the quality standards of the spray was studied.High performance liquid chromatography was used to determine the content of cinnamic acid,cinnamic aldehyde,ivy saponins and oleanolic acid in the finished product.Systemic methodology was researched on the assaying method,and the blank was no interferential.It indicated that,with the concerntration of reference substance as the abscissa and peak area as the ordinate,cinnamic acid has a good linear relationship at a range of 1.08～17.28 μ.g·ml-1.The regression equation of is γ=97857x + 2578.6，R R2= 0.9999.The average recovery is 98.88%(RSD1.26%).Cinnamaldehyde has a good linear relationship at a range of 24.24～387.80μg·ml-1.The regression equation of is y = 96528x-80764(r=1).The average recovery is 99.54%(RSD1.61%).Hederagenin has a good linear relationship at a range of 22.16～554.00μg·ml-1 the regression equation of is y = 6077.8x-573.93(r =1).The average recovery is 101.99%(RSD2.28%).Oleanolic acid has a good linear relationship at a range of 16.24～406.OOμ.g·mlr-1.The regression equation of is y=5785.6x +617.74(r = 1)).The average recovery is 96.42%(RSD1.31%).Thin layer chromatography(TLC)was also used to identify each other effective components of drugs in the medicine.The results show that the spots in the established TLC methods were clear and blank no interference.In addition,we also check the minimum load of our product,injection test,heavy metals,arsenic salts and microbial limit inspection.The quality standards can control the compound lingxian spray quality fairly.