| Compound rhinitis rather nasal drops, it is consists of three Chinese herbs(Herbs Aã€Herbs Bã€Licorice)。And it is provided with nasal orifices, liver lungs, detoxification xuan fei, the effect of divergent cold. Mainly used for acute rhinitis and acute exacerbation of chronic rhinitis. this issue is under the theory of Chinese medicine, Physicochemical properties and clinical needs of the prescription drug, select the dosage form of nasal drops, application of modern pharmaceutical technology, a systematic study of the preparation process of the preparation, quality standards and stability.The best optimum conditions were:Herbs A pulverized into particles, soak1hour, water was added, with distillation of the volatile oil6hours, after distillation of an aqueous solution of another collection; The dregs Add GL, herbs B, extracted twice with75%ethanol,1.5hours each; Recovering ethanol and Added to the above aqueous solution after the distillation, mixing, concentrated to the relative density of about1.07, Adding10%of the volume of the drug solution with chitosan solution At80℃.(Provisional dubbed with1%acetic acid solution in a colloidal solution of1%(W/W)),Stirring was continued for20min, Standing24h and Filtration, Volatile oil, polysorbate-8010ml,20ml of glycerol,sodium benzoate,5g sodium citrate7.5g were added to the filtrate. The filtrate was heated and stirred to dissolve At80℃and add water to1000ml. Adjusting the pH from6.3to6.8with10%sodium carbonate solution, filtration, Aseptic filling.This study lays down the product quality standards, using the TLC identification to distinguish Herbs Aã€Herbs Bã€Licorice. The results show that the TLC identification was good at Resolution, reproducibility, and negative non-interference, using HPLC to survey and evaluate the contents of Herbs A〠Licorice. To determine the content limits:This product per lml of the licorice acid shall not be less than0.99mg; Per lml liquiritin the shall not be less than0.458mg; The this product lml of magnolin shall not be less than0.334mgUsing acceleraty test and long-term satability test to research the product stability. The results show that:Three batches of test products meet the standard requirements traits, TLC examination, microbial limit test content determination.The preparation of pharmaceutical research results show that the preparati process is reasonably practicable, quality control, good stability. |