Development Of Oral Spray Film For Shuanghua Yin

The incidence of head and neck tumors increases year by year due to unhealthy lifestyle caused by modern fast-paced life.Oral inflammation or ulcerative lesions caused by radiotherapy seriously interfere with patients’ normal life and reduce patients’ quality of life.At present,there are few products for radioactive oral mucositis,and the form is single,the development potential is large,and has a good market prospect.In this study,the herbal extract of Shuanghua Yin,a medicinal and edible cognate prescription composed of honeysuckle,dandelion,light bamboo leaves and peppermint,was used as the solvent,combined with chitosan hydrochloride,polyethylpyrrolidone,glycerin and other substances.Through systematic research on extraction technology,raw material ratio,flavor optimization,quality evaluation and other aspects,a medicine with large effect,wide coverage and long contact time with wounds was developed.Protect the wound from external infection,pain relief,antioxidant,safe and assured,good taste,low price,easy to carry,can be taken for a long time to intervene in the treatment of radioactive oral mucosa inflammation Shuang Hua Yin oral spray film.The main research results are as follows:(1)Formulation and verification.Based on the research,the Shuanghua Yin formula was selected,which consisted of honeysuckle,dandelion,light bamboo leaves and mint,to determine its efficacy in the treatment of radioactive oral mucositis.(2)Preparation of stock liquor of Shuanghua Yin.HPLC method for simultaneous determination of rutin,chlorogenic acid and luteolin in Shuanghua Decoction was established to determine the preparation process of Shuanghua Decoction.The results showed that in the chromatographic conditions,the column Compass C18(2)(4.6mm×250mm,5 μm)was in Compassc18.Mobile phase: acetonitrile(A)-0.4%(volume fraction)phosphoric acid(B);Gradient elution(0～20min,10%→20%A;20min～30min,20%→30%A;30min～35min,25%→ 40%A;35min～40min,40% → 40%A);The detection wavelength is239nm(0～21min,22～40min)and 360nm(21～22min).Column temperature 30℃;Volume flow1.0m L/min;The contents of rutin,chlorogenic acid and luteolin could be determined at the same time with the injection volume of 10 μL.Through single factor and orthogonal test,the optimal preparation process of Shuanghua Decoction was obtained: solid-liquid ratio 1:12,extraction times 2,extraction time 60 min.(3)Preparation and flavor optimization of Shuanghua Yin oral spray film.Using spray state,film forming time,film texture and adhesion as evaluation indexes,the preparation process of Shuanghuanyin oral spray film was optimized by single factor experiment combined with response surface test.The optimal technology was 0.48% chitosan hydrochloride,0.29%PVP-K30,1.34% glycerol,and the theoretical comprehensive score was63.43 points.Using color,odor,taste and condition as evaluation indexes,the single factor experiment combined with fuzzy sensory evaluation and response surface test was used to optimize the flavor of Shuanghua Yin oral spray film.The optimal process was determined to be 19.74% maltitol,0.02% DL-malic acid,0.25% menthol,and the theoretical comprehensive score was 88.30 points.(4)Establishment of quality evaluation method and standard for Shuanghua Yin or-al spray film.The quality of the prepared oral spray film of Shuanghua Drink was tested,including p H,hygroscopicity,moisture retention,air permeability and structural characteristics of the film,and the quality evaluation method was established.Shuanghua Yin oral spray film p H 7.00,moisture absorption 29.71%,moisture 31.67%,air permeability 81.08%,the internal showed uniform distribution of spherical structure,no visible impurities.Therefore,the quality standards for oral spray film of Shuanghua Yin were preliminarily established as follows: spray liquid should be sprayed in a mist,and the surface should be free of impurities and bubbles after film formation,with good adhesion.Cool entrance,sweet and sour taste,retain the original taste of traditional Chinese medicine;p H 6.6-7.1,moisture absorption 20.80%-38.62%,moisture 22.17%-41.17%,air permeability 64.86%-97.30%,internal structure is uniform.The detection methods of p H value,hygroscopicity,moisture retention and air permeability of Shuanghua Yin oral spray film were set as the detection methods of Shuanghua Yin oral sprayfilm.(5)Study on antioxidant and bacteriostatic effects of oral spray film of Shuanghua Yin.Shuanghua Yin oral spray film was prepared with the optimal formulation technology.By measuring the scavenging ability of different concentrations of Shuanghua Yin oral spray film on ABTS free radical and DPPH free radical,the antibacterial effect on Staphylococcus aureus and oral streptococcus and the minimum antibacterial concentration,the ability and antibacterial performance of scavenging free radical in vitro were evaluated.The results showed that:(1)Shuanghua Yin oral spray film had good antioxidant activity,and the IC50 values of DPPH and ABTS free radical scavenging were 0.039288mg/m L and 0.594717mg/m L,respectively.(2)Shuanghua Yin oral spray film had antibacterial effect on both oral streptococcus and Staphylococcus aureus,and theantibacterial effect of Staphylococcus aureus was higher than that of oral streptococcus.The minimum inhibitory concentrations for oral streptococcus and Staphylococcus aureus were 0.25g/m L and 0.00625g/m L,respectively.