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Method of preparing pancreatin pellets, in particular pancreatin micropellets, and pancreatin pellets prepared thereby

机译:制备胰酶小丸特别是胰酶微丸的方法以及由此制备的胰酶小丸

摘要

Pancreatin pellet (1) formed only of pancreatin without auxiliaries and binding agents, is claimed. Independent claims are also included for: (1) a pharmaceutical composition comprising the pancreatin pellets in a pharmacologically effective amount; and (2) a pancreatin pellet prepared by: (a) comminuting the pork or beef derived pancreatic tip and subjecting it to autolysis, (b) obtaining a sieve filtrate by filtering the intermediates obtained after (a), (c) precipitating the enzymes from the sieve filtrate, (d) filtering the mixture obtained after (c) to obtain the filter cake, (e) grinding and vacuum drying the filter cake to a residual moisture of 0.1-0.3 wt.%, where the pancreatin product is formed with 0.1-0.3 wt.% of residual moisture in the dried end product, where the extrudable filter cake mass comprises more residual moisture and organ solvent residue which is present in a magnitude of 50%, (f) subjecting the filter cake to heat treatment at 80[deg] C or at a temperature below 80[deg] C, extruding the heat-treated and a sufficient plasticity exhibiting filter cake without the auxiliaries and/or binding agents to form strands, and (h) spheronizing the strands without the auxiliaries and/or binding agents to obtain the spherical, elliptical or drop shaped pellets. ACTIVITY : Anabolic; Metabolic; Gastrointestinal-Gen. No biological data given. MECHANISM OF ACTION : None given.
机译:本发明要求仅由胰酶形成的胰酶沉淀物(1),而没有助剂和粘合剂。还包括以下独立权利要求:(1)一种药物组合物,其包含药理学有效量的胰酶小丸; (2)通过以下方法制备的胰酶沉淀物:(a)粉碎猪肉或牛肉来源的胰头并使其自溶,(b)通过过滤(a),(c)沉淀酶后得到的中间体获得筛滤液。从筛滤液中,(d)过滤(c)后获得的混合物以获得滤饼,(e)将滤饼研磨并真空干燥至残留水分为0.1-0.3重量%,在其中形成胰酶产物。在干燥的最终产品中具有0.1-0.3 wt。%的残留水分,其中可挤出的滤饼物料包含更多的残留水分和含量为50%的有机溶剂残留物,(f)对滤饼进行热处理在80℃或低于80℃的温度下,挤出热处理并具有足够塑性的显示出滤饼的滤饼,而没有助剂和/或粘合剂以形成股线,以及(h)将股线球化而没有助剂和/或粘合剂以获得球形,椭圆形或水滴状的颗粒。活动:合成代谢;新陈代谢;胃肠源。没有给出生物学数据。作用机理:未给出。

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