Lumbrukinase enteric-coated pellet capsule and preparation method thereof

Abstract

The invention provides a lumbrukinase enteric-coated pellet capsule and a preparation method of the lumbrukinase enteric-coated pellet capsule. According to the preparation method, the centrifugal granulation technology is adopted, the lumbrukinase is prepared into pellet and is coated by low-temperature-filmed enteric coating and then is filled into a gastric soluble capsule; and a dried-powder wrapping method is adopted, which has the advantages of being short in preparation time, high in drug loading rate, high in yield of target pellet (20 to 30 meshes), and smooth and round in appearance of the target pellet. By adopting the lumbrukinase enteric-coated pellet capsule, the pellet can be dissolved and absorbed by the small intestine, so that the lumbrukinase can be effectively prevented from being damaged by gastric acid, and the treatment effect can be ensured; compared with common capsule, the capsule provided by the invention has the advantage that the pellet is filled in the gastric soluble capsule, so that the shortcomings that the powdered medicine flies and is adhered on the capsule can be avoided, the acting efficiency can be remarkably improved, the quality and output of the capsule can be obviously increased, and the producing cost can be reduced; compared with tablets, the capsule has the advantages that the pellet is small in granularity, hardly influenced by the food delivery frequency of the alimentary canal, and is high in bioavailability; and by adopting the lumbrukinase enteric-coated pellet capsule, the controllability of the quality is improved.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a lumbrokinase enteric-coated pellet capsule and a preparation method thereof. Background technique [0002] Lumbrokinase is a multi-component enzyme preparation extracted and purified from the open-air red worm Eisenia. It has dual properties of kinase and plasmin. It can not only directly degrade fibrinogen, but also increase the activity of t-PA in the body and activate fiber Lysozyme can increase plasmin, dissolve thrombus, reduce blood viscosity, improve microcirculation, and improve blood rheology, so as to achieve the purpose of treatment. It is mainly used for the prevention and treatment of cerebral thrombotic diseases, endocrine, respiratory system and other diseases, with obvious curative effect. [0003] Lumbrokinase is easily destroyed in gastric acid, and its curative effect can be significantly reduced when heated above 40°C. At present, lumbrokinase enteric-coated capsule...

AI Technical Summary

Problems solved by technology

However, the common lumbrokinase enteric-coated capsules currently have the following problems: ①Low production yield of lumbrokinase raw materials, large amount of acid, alkali and water used, high production cost

②Gastric acid can penetrate into the capsule through the interface and damage of the capsule, destroying the active ingredients and significantly reducing the efficacy of the medicine

③The quality of blank enteric-coated capsules is not stable, it is easy to become brittle when stored, and the probability of loading is low (sometimes less than 70%), and it is easy to break when taking out the capsules from aluminum platinum, which affects the accuracy of dosage and patient compliance

④The lumbrokinase adhering to the surface of the capsule is difficult to remove after polishing, which not only causes a lot of waste of powder, increases the chance of bacterial contamination, but also obviously affects the appearance

⑤Dust flying during powder filling, which obviously affects the health of operators and brings difficulties to workshop cleaning

[0006] Commonly used enteric coating materials mostly use organic solvents as solvents, and the film-forming temperature is high, which is not suitable for enteric coating of lumbrokinase pellets