| Objective:The aim of this research is to develop Licorzinc and Amlexanox oral compound film, establish transdermal absorption model, quality control standards, and stability evaluation.This new oral compound film can used to treat oral ulcers, maintain a higher concentration of local treatment, and play a better therapeutic effect.Method:This preliminary study of the amount of film-forming materials, according to literature, in accordance with uniform design approach to PVA, HPMC and propylene glycol dosage of three factors,and to each factor is divided into nine levels, the softness of membrane (study stripping the difficulty, the more likely the higher the score), uniformity (the overall thickness of the film are the same), smoothness (with or without a small pimple), transparency of the indexes, the use of stepwise regression of the quadratic polynomial model for statistical data processing, filtering out the best prescription. And conduct penetration testing, penetration rate obtained.Preparation of composite membrane for a series of quality assessment, including the appearance of smoothness, color uniformity, no obvious bubbles, transdermal absorption rate, content, and other related substances. Reference to the Food guiding principles of New Drug Stability and the actual situation with the experiments to study composite film in strong acid, alkali, strong oxidation under the conditions of stability and humidity, high temperature effects on the preparation and conduct some of the accelerated experiments and long-term experiment.Results:Unifom design method to be the best prescription composite membrane amount of each component, respectively PAV:6.5g,HPMC;0.1g, propyleneglycol:6.0g; Kunming mice using the back of the skin with saline soaked overnight to remove the impurites, to pH=6.8phosphate buffer solution as the release of medium to high-performance liquid chromatography (HPLC) on the skin of the drug concentrations were measured, chromatography conditions are:Column: Kromasil-C18column (F200mm×4.6mm,5μm); Mobile phase:methanol-0.2mol·l-1ammonium acetate solution-glacial acetic acid (67:33:1); detection wavelength:250nm; flow rate:0.8ml·min-1; injection volume:20μl; column temperature:room temperature. Calculated after the first two hours of licorzinc skin penetration rate is2.49, Amlexanox to Tie Snow skin penetration rate is0.10.Assay, related substances are selected by RP-HPLC mobile phase was methanol-0.2mol·1-1ammonium acetate solution-glacial acetic acid (67:33:1), flow rate:0.8ml·min-1, detection of wavelength:250nm, measured when the preparation of small quantities of this product licorice labeled amount of zinc content of100.14%, Amlexanox to Tie promise of the labeled amount of98.56%.Composite film, as well as blank Remover of strong base and strong oxidation of stability, compound Fihnogen in humidity (75%and92.5%) and high temperature40℃, under experimental conditions, no content, related substances changed significantly. However, taking into account Remover at higher temperatures may occur characteristics change, so the preparation recommended in the shade to save. Preparation6months accelerated test appearance, content and results of the stability related substances.Conlclusion:Selected under this topic the optimization of the composite film prescription and process conditions, the system obtained Remover color uniform, smooth complete, the thickness of consistent, rapid transdermal absorption. Quality control method is accurate, simple. The preparation of this product in strong base and oxidative conditions is stable, unstable in acidic conditions, a serious breakdown, the system obtained Filmogen need to save in the shade. |
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