A kind of preparation method of sea-plant fucoidin enteric hard capsules
Technical field
The present invention relates to a kind of preparation method of sea-plant Capsules, particularly relate to a kind of preparation method of sea-plant fucoidin enteric hard capsules.
Background technology
Capsule is usually used in loading medicine and health food, has beautiful outward appearance, but the abnormal flavour of masking agents, be easy to swallow, make consumer be easy to accept the bioavailability height of functional factor, supplementary product consumption is few, in gastrointestinal tract disintegrate fast, general clothes back was a disintegratable release function material in 3-10 minute; Compare with tablet with pill, capsule has advantages such as produce effects is fast, good absorbing, good stability, longer shelf-life, thereby very popular.
Existing empty hard capsule is many to be the wall material with the animal gelatin.Gelatin adopts the animality leather-solid waste to produce, and causes the accumulation of some heavy metals in these leftover bits and pieces raw materials itself and the collection process thereof easily, therefore exists materials safety poor, problems such as heavy-metal residual.During traditional gelatine capsule molding is with gelatin drying film forming and sclerosis, and cyst material this physicochemical change does not take place in preparation process.But because gelatin belongs to protein matter, hygroscopicity is strong, and can give the content medicine water transport that absorbs, and make the medicine moisture absorption rotten, cause off quality and effect duration short, and protein substance is met aldehyde material cross-linking and curing reaction is easily taken place.These have all limited the scope of application of animal gelatin hard capsules, as the unsuitable easy moisture absorption of filling, easy-weathering and the implant that reacts with the capsule material material of aldehyde radical (as contain), gelatine capsule disintegrating property in vivo fluctuates easily in addition, tend to make the effective ingredient of medicine to be difficult to accurate release, the viscosity temperature influence of gelatin solution is very big, be easy in process of production change because of variations in temperature causes viscosity, make the control of capsules preparation technique that difficulty take place, as wall thickness change, drying and moulding condition variation etc., and then influence the performance of capsule finished product, as mechanical strength, disintegration properties etc.In addition, there are two potential safety hazards in the Capsules that with the gelatin is raw material: the quality and safety problem of (1) gelatin raw material is serious: gelatin is to adopt the animality leather-solid waste to produce, and causes the accumulation of some heavy metals (chromium, arsenic, hydrargyrum, lead etc.) in these leftover bits and pieces raw materials itself and the collection process thereof easily.Excessive heavy metal can cause nervous system to be poisoned, and symptoms such as dizziness, insomnia, diarrhoea, dermatitis occur, and easily in liver, kidney accumulation.(2) capsule finished product is anticorrosion: because gelatin itself can be utilized by many microorganisms, therefore generally adopt the inhibitor of Nipagin ester as mycete in the capsule manufacture at present, be used to suppress the microbial reproduction of gelatine capsule.But in view of its contained harmful chemical component, be used for medicine strict limit requirement is arranged, Chinese Pharmacopoeia parabens (Nipagin ester) antiseptic is defined as 0.05% to greatest extent in medicine, and in Japan, its human body that has been under an embargo is taken, another potential safety hazard of gelatine capsule is the sterilization process of capsule oxirane, because the carcinogenesis of oxirane, forbid being used for medicated disinfecting in areas such as America and Europes, the problem of Capsules quality and safety, in the industry in addition the image title " eating capsule preparations is not to take medicine, but is eating poison ", yet this problem is ignored by " out of trade " common people always, becomes the Chinese Medicine industry and not should bear pain.The outburst of animality epidemics such as more Eurasian in recent years geographic " bovine spongiform encephalopathys ", " foot and mouth disease " and popular in addition is to being that the biological safety of the gelatin capsule formulation of raw material brings impact with the animal sebum.China is preparation big export country, but the more annual product that capsule formulations are all arranged is many markets of letting sth. slip by because capsular safety index does not reach the requirement of importer, and because particular culture faith requirement, the hard capsules and the preparation thereof that with the gelatin are raw material exist serious resistance emotion in Islamic country and area and vegetarian, so, the quality of the raising capsule softgel shell of people's effort always and seek that a kind of quality is safer, aboundresources, cheap novel capsule raw material.
Summary of the invention
The purpose of this invention is to provide a kind of preparation method of sea-plant fucoidin enteric hard capsules, it can remedy the above-mentioned deficiency of prior art.
A kind of preparation method of sea-plant fucoidin enteric hard capsules, it is characterized in that taking by weighing sodium alginate and add the deionized water and stirring dissolving, be configured to the hydrosol that mass percentage concentration is 0.1-30%, add purity then greater than 96% glycerol, making its mass percentage concentration is 0.1-10%, stir, deaeration, again 00#-5# capsule die tringle is immersed in the water-soluble glue of deaeration, the about 4-15 of submergence tringle second, tringle is mentioned, overturn and then in coagulating bath, solidify for 3-5 time, dry under the condition of constant temperature and humidity, pull out shell, make fucoidin enteric hard capsules of the present invention.
The sea-plant fucoidin enteric hard capsules that the present invention makes has good film property, slow-releasing, safety, stability, plurality of advantages such as biocompatibility and biological degradability, fucoidin itself has wide biological activity simultaneously, as antitumor and immunological enhancement, antiinflammatory, antiviral, the antibiotics blood coagulation, blood sugar lowering, the defying age isoreactivity, particularly conventional antibacterial, microorganisms such as mycete seldom can be decomposed and utilized alginate, overcome the defective that traditional gelatine capsule need add antiseptic and ethylene oxide sterilizing, improve capsule quality and safety, be slow releasing pharmaceutical, condition has been created in the high-valued application of health product and food.
The specific embodiment
The preparation method of sea-plant fucoidin enteric hard capsules of the present invention, it is characterized in that taking by weighing sodium alginate and add the deionized water and stirring dissolving, be configured to the hydrosol that mass percentage concentration is 0.1-30%, add purity then greater than 96% glycerol, making its mass percentage concentration is 0.1-10%, stir, deaeration, again 00#-5# capsule die tringle is immersed in the water-soluble glue of deaeration, the about 4-15 of submergence tringle second, tringle is mentioned, overturn and then in coagulating bath, solidify for 3-5 time, dry under the condition of constant temperature and humidity, pull out shell, make fucoidin enteric hard capsules of the present invention.Described sodium alginate is the sodium alginate that extracts in Thallus Laminariae (Thallus Eckloniae) sodium alginate, Alga Sgrgassi Enerves sodium alginate, Macrocystis pyrifera (L.) Ag. sodium alginate, Macrocystis pyrifera (L.) Ag. sodium alginate, Thallus Laminariae sodium alginate or other Brown algaes; The viscosity of described sodium alginate is 1.0-30.0mps; Described coagulating bath is the aqueous solution of calcium salt, zinc salt, magnesium salt, aluminum salt, mantoquita, selenium salt or iron salt, and the mass percentage concentration of salt ion is 0.01-20% in this aqueous solution.
Embodiment
Take by weighing 12 kilograms of dried sodium alginates, add 88 kilograms of deionized waters, stirring and dissolving, add purity then greater than 3 kilograms of 96% glycerol, stir deaeration, again 5# capsule die tringle is immersed in the water-soluble glue of deaeration, the about 4-15 of submergence tringle second, tringle is mentioned, overturn after 3-5 time, in being 2% calcium chloride water, mass percentage concentration solidifies, dry under the condition of 60 ℃ of constant temperature and humidities, pull out shell, make 40,000 of fucoidin enteric hard capsules of the present invention.
The fucoidin enteric hard capsules color and luster of the present invention's preparation is even, glossy, does not have obvious aberration, no trachoma, and no stain, disintegration time is 43 ± 1min in the intestinal juice, meets the requirement of pharmacopeia to the enteric hard capsules fully.