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The Preparation of Alginate Enteric-coated Hard Capsules

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Tutor: GaoZuo
School: Ocean University of China
Course: Aquatic Products Processing and Storage Engineering
Keywords: Enteric,Hard capsules,Alginate,Film-forming
CLC: TQ460.6
Type: Master's thesis
Year:  2010
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Alginate is a polysaccharide extracted from brown algae, seaweed, kelp sargassum carbohydrates, 1,4 - poly-¦Â-D-mannuronic acid and ¦Á-L-guluronic uronic acid a linear polymer. Alginate is generally present In the form of the sodium salt of alginic acid, sodium alginate is a water-soluble alginate of monovalent, and has a good film-forming properties. When the effect of the hydration of the alginate with a small amount of calcium ion, it will greatly increase the viscosity of the solution to improve film forming properties, and suitable for the preparation of enteric-coated capsules. Enteric-coated capsules are generally divided into soft and hard capsules in two forms. Enteric soft gelatin capsules commonly used alginate as raw material, the corresponding process preparation technology is more mature; currently listed enteric hollow hard capsules are gelatin capsules made of outsourcing enteric coating, but due to the special nature of gelatin (absorbent short shelf life, etc.), this traditional coating is difficult to achieve the desired results, or to influence the nature of the drug, or affect the overall stability of the capsule. Alginate was prepared from enteric hard capsules, which take full advantage of alginic resources, while expanding the product selectivity of enteric-coated capsules, reduce production costs, but also to meet the special requirements of specific populations, such as the Nation of Islam, has a significant social and economic significance. The main purpose of the present paper in research gelatin the hollow hard capsule preparation process, the film-forming property on the basis of the rheological properties of the algin and alginate, the alginate and the metal cation crosslinking alginate was prepared enteric hollow hard capsules. The main contents are as follows: an optimal preparation of gelatin hard hollow capsules by orthogonal experiments into cystic indicators to determine the glue, the sol and dry conditions, gelatin the hollow hard capsules prepared the best conditions for the glue concentration 30%, the CMC content of 0.2%, the sol temperature of 65 ¡ã C, sol time 70min, drying temperature 40 ¡ã C, the drying time is 60min. Prepared capsules into cystic excellent in aqueous disintegration time of 2.51 ¡À 0.12min disintegration time in the acid solution to 2.14 ¡À 0.2 min, 14.2 ¡À 1.3% Loss on drying Residue on ignition 1.2 ¡À 0.33%, and in full compliance with the requirements of the GB and the Pharmacopoeia of hard gelatin capsules capsules. Low viscosity alginate rheological properties and film study static rheological measurement results show that: the ultra-low viscosity alginate solution is shear thinning pseudoplastic fluid, the viscosity of the solution with the increasing mass fraction increased gradually decrease as the shear rate increases, the shear force is gradually increased with the increase of mass fraction; concentration of less than 14% of the alginate solution having thixotropic properties: the impact of temperature on the viscosity of the alginate solution to compare large, as the temperature increases the viscosity decreased, but at low temperatures is not a gel; have a good correlation with the Arrhenius model. Dynamic rheology measurement results showed that: the alginate was dissolved. Having viscoelasticity in the low frequency region system mainly viscous system of high frequency region to the elastic; low viscosity alginate has good film-forming properties, and with gum solution concentration increased, the film forming property is enhanced. Glue concentration is too small to be less than 4%, it is not film, the optimum the forming interval is 8% -12%; the mechanical properties of the alginate film rigidity larger and less flexible, the tensile strength is 28MPa or more, while the the breaking elongation of 10% -37%. Since a dense structure of the alginate film so that its gas barrier properties, barrier oily and rent aqueous high water vapor permeability of about 0.16g ¡¤ mm/m2 ¡¤ h ¡¤ kPa, water droplets permeation time 800min or more, and air permeability coefficient 7.2cm3 ¡¤ cm/cm2 ¡¤ s ¡¤ kPa or less, the coefficient of permeability oil below the 0.02g ¡¤ mm/m2 ¡¤ d. And a light transmittance of the film is more than 85%, and good organoleptic properties. The nature of the extremely low viscosity alginic film makes it an ideal wall material for enteric hard capsules. Enteric hard capsules of alginate plant preparation process reference to hard gelatin capsules Production and fucoidan calcification nature determine Fucoidan Production of enteric-coated slow-release hard capsules for the sol system embryo, calcification, dry, pull the shell. And selection 8cp alginate as raw rubber, by orthogonal experiment, as cystic indicators to determine the glue dry conditions algin plant enteric hard capsules best preparation conditions for the liquid concentrations of 12% glycerol content %, CaCl2 concentration of 2%, capsule moisture content of 15%. Prepared capsules two hours immersed in artificial gastric juice had no cracks or disintegration phenomenon in artificial intestinal fluid disintegration time 43 ¡À lmin, in full compliance with the requirements of the pharmacopoeia of enteric-coated capsules.
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