| In this thesis, yacon leaf, scaphium lychnophorum, flos albizzia and bupleurum were using as raw medicine to develop the buccal tablets with throat-clearing function, and the determination and extraction technology of active ingredient of formula, the drug loading and related mechanism of diluents, technology research of preparing buccal tablets, and quality analysis were studied. Results as below:Taking chlorogenic acid as representative of active ingredient, analysis method of active ingredient was established by HPLC. The best chromatographic conditions as follow: Chromatographic experiments were performed on Agilent C8 column(4.6×150mm,5μm); the column temperature was 35℃; the flow rate was 1.0 mL/min, the mobile phase was 4%o acetic acid and acetonitrile(9:1) in 0～10min, 4‰acetic acid and acetonitrile(1:9) in 10-17min, 4‰acetic acid and acetonitrile(9:1) in 17-20min; the detection wavelength was 325nm. This method has high precision, good stability, high recovery rate and easy to repeat.In the study of extraction technology, the effect of extractant species, extraction temperature, extraction time, and liquid-to-solid ratio on active ingredient extraction amount was studied, and the best extraction technology was determined. The results show that ethanol concentration of extractant has significant impact on the product of chlorogenic acid and extractant. active ingredient can be fully extracted by 80% ethanol Orthogonal experiment found that liquid-to-solid ratio, extraction time and extraction temperature has no significant effects on extraction of chlorogenic acid, the best extraction condition as follows:the extractant is 80% ethanol, liquid-solid ratio is 30:1, extraction temperature is 80℃, extract 1 hour and extract three times. Under this condition, the average extracted amount of chlorogenic acid is 0.2779mg/g and extractant 0.1479g/g.Five diluents usually used in buccal tablets were studied on their drug loading and loading mechanism. The results showed that the drug loading sequence of the five kinds on extactum is microcrystalline cellulose>dextrin>lactose>mannitol>sucrose; All kinds of diluents had the same loading mechanism, that is the concurrent result of disperse-embed and adsorption, and disperse-embed method is the main way. The method of improve drug loading as follows:according to need, select the diluents which had good fluidity high critical humidity; decrease the diluents particle size; increase non-uniformity of particle size moderately; extract the raw medicine with weak polar extractant and concentrated the extract to high density, while controlled air humidity of production areas at a low level.In technology research of preparing buccal tablet, the effect of additive species, dosage and different technology condition on product quality and stability was studied, and the formula was determined as follow:20% raw medicine extractum (1.2g/cm3),69% diluents (mannitol:lactose=1:1),3.5%o lubricants (magnesium stearate),4‰flavoring agent (Menthol), proper amount of binder (8% starch slurry). The optimum preparing processes were as follows:blended the extractum into diluents, adding proper amount of starch slurry to produce damp mass, granulated with 18 mesh screen, dried at 50℃for 25min, unified with 18 and 20 mesh screen and weighted, spray menthol in PVP ethanol solution in proportion, sealed for 30 min, added magnesium stearate in proportion, tablet after mixed, preserved products in sealed container. The product of this technology is yellow round tablet,4mm thickness, and had the aroma of menthol. According to National pharmacopoeia and food sanitation standards, various indexes of the product can meet the limitation. |
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