| ObjectiveThe topic studied the preparation process,quality standard,preliminary stability,and the preliminary effficacy of mouthwash which is made by Fructus xanthii and Radix paeoniae alba.Methods1. We determined the ratio of Fructus xanthii and Radix paeoniae alba with the minimum bacteriostasis concentration in vitro experiment.2. Determined the content of paeoniflorin and chlorogenic acid by High performance liquid chromatography. We selected the best extraction technology by means of orthogonal test method.3. According to QB/T2945-2012 and the Chinese pharmacopoeia,we checked the fragrance, clarity,stability,pH, and microbial limit of the mouthwash. Determined the content of paeoniflorin and chlorogenic acid of the mouthwash by High performance liquid chromatography.4. According to the result of accelerated stability test for the mouthwash, we can know the validity of the mouthwash.5. Determined the content of extracellular water insoluble polysaccharide of Streptococcus mutans with Anthrone method,and according to this,we can know if the mouthwash can inhibit streptococcus mutans syntheting extracellular water insoluble polysaccharide.6. Determined the content of total protein with Coomassie brilliant blue method, determined the content of reducing sugar with Somogyi method.Then,we can calculated than the enzyme activity,and according to this,we can know if the mouthwash can inhibit the activity of streptococcus mutans enzymes.Result1. According to the minimum bacteriostasis concentration, We determined the ratio of Fructus xanthii and Radix paeoniae alba as 1:1.The mouthwash was made up of traditional Chinese medicine extract, ethanol, glycerin, Citric acid, Water soluble menthol, Arcelormittal honey, the surfactant, preservatives and water. The proportion of them was 6.25%,15%, 10%,0.02%,0.8%,0.02%,0.3%,0.02%respectively.2. According to the result of means of orthogonal test method,we determined the preparation process. Fructus xanthii and radixpaeoniae alba were dried, crushed, throughed 80 mesh sieve. Extracted the powder for times under reflux with 55% ethanol for 1 hour,the ethanol volume was 6 times more than that of the material.Concentrate the combined fitrate.Put Citric acid, Water soluble menthol, Arcelormittal honey in water,mixed thoroughly.Put twain in it,mixed thoroughly.We get the clear solution. Put ethylparaban in ethanol,mixed thoroughly.Then put glycerin in it,mixed thoroughly. We got clear alcohol solution. Joined the extraction, mixed two kinds of solutions, used water constant volume, shaked well, high pressure sterilization.3. Set up a simple and accurate method for the determination of paeoniflorin and chlorogenic acid by HPLC.The calibration curves of paeoniflorin and chlorogenic acid were in good linearity over the range of 0.7～0.00175mg/ml and 0.3～0.0015mg/ml respectively.The average content of chlorogenic acid and paeoniflorin was 0.090mg/ml and 0.641mg/ml respectively.The average recovery of chlorogenic acid and paeoniflorin was 98.71% and 97.59%.The mouthwash is clean and fresh.The range of pH was 6.74～7.23.Stored at 4℃ for 24 hours, the mouthwasb was not frozen, colour and luster was stable.Stored at 40℃ for 24 hours,the mouthwash was no condensation and not cloudy.Microbial limited conform to the rules.4. According to the result of accelerated stability test for the mouthwash,We calculated the one over ten failure period of chlorogenic acid and paeoniflorin.The validity of the mouthwash was 11months.5. The mouthwash and when the concertration of the solution was lower half can inhibit streptococcus mutans syntheting extracellular water insoluble polysaccharide.6. The mouthwash and when the concertration of the solution can inhibit the activity of streptococcus mutans enzymes.ConclusionThe preparation technology we selected is feasible.The mouthwash we maked was perfect.The quality can be control,the stability was good,and bacteriostatic effect was obvious.It laied a foundation for the development of chinese mouthwash. |
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