Lumbrokinase enteric-coated tablet and preparation method thereof

Abstract

The invention provides a lumbrokinase enteric-coated tablet and a preparation method thereof. The lumbrokinase enteric-coated tablet comprises following components in parts by weight: 5 to 15 parts of lumbrokinase, 7.5 to 22.5 parts of hydroxy propyl cellulose, 3.8 to 11.4 parts of powdered steatile, 1.5 to 4.5 parts of magnesium stearate, 2.3 to 6.9 parts of carboxy methyl starch sodium, and 63.9 to 185.7 part of cane sugar, wherein the titer of the lumbrokinase is between 0.9 multiply 104 and 2.7 multiple 104 unit / milligram. Compared to the conventional lumbrokinase preparation and the preparation technology thereof, the lumbrokinase enteric-coated tablet and the preparation method thereof are improved, the quality and curative effect of the lumbrokinase enteric-coated tablet are more stable and reliable, each parameter of the product reaches or exceeds the national drug standards, furthermore, the lumbrokinase stability of the active components is prominently improved, the technical defect that the titer of the thermal sensitive components reduces during the preparation and storage processes is overcome, so that the curative effect of the lumbrokinase on corresponding diseases in clinic is largely improved.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to an enteric-coated tablet and a preparation method thereof, in particular to a lumbrokinase enteric-coated tablet and a preparation method thereof. Background technique [0002] Lumbrokinase is a kind of proteolytic enzyme extracted and isolated from the artificially cultivated Eisenia chinensis. It has a selective affinity for fibrinogen, can directly hydrolyze fibrinogen, produce soluble fibrinogen degradation products, and reduce fibrin The original content, preventing thrombosis. Lumbrokinase contains plasminogen activator, plasmin and other components, which can degrade insoluble fibrin by promoting the conversion of plasminogen into plasmin, and can dissolve thrombus in early cerebral infarction. A large number of clinical studies have shown that lumbrokinase has a strong role in dissolving thrombus, inhibiting platelet aggregation, reducing fibrinogen and improving the hypercoagulabl...

AI Technical Summary

Problems solved by technology

However, the quality of lumbrokinase enteric-coated capsules is unstable, and they tend to become brittle when stored, and the probability of capsules being used is very low.

The drug powder in the damaged capsule is easy to stick to the surface of other intact capsules. Although most of the drug powder can be removed by polishing, the drug powder at the interface is difficult to remove, which not only causes a lot of waste of drug powder, but also increases the chance of pollution and prolongs production. cycle

In addition, gastric acid may penetrate into the capsule through the interface, destroying the active ingredients and reducing the efficacy of the medicine.

The preparation process of lumbrokinase enteric-coated pellets is to freeze-dry the lumbrokinase concentrated solution to obtain lumbrokinase dry powder, and wrap the mixed powder of dry powder and starch on the blank pellet core through the action of adhesive. The drying process requires a lot of energy and the product cost is high

Relatively speaking, the preparation of lumbrokinase enteric-coated tablets can avoid these defects, but in the production of lumbrokinase enteric-coated tablets, the type and amount of excipients, drying time and temperature of granules will all affect the product quality

For example, Xu Jian (“Research on Lumbrokinase Enteric-Coated Tablets”, Xu Jian, Proceedings of the Fourth China New Medicine Doctor Forum, pp. 242-246) proposed a preparation process for lumbrokinase enteric-coated tablets, However, this preparation process causes fragmentation and capping of the tablets during the tableting process, and the disintegration time limit does not meet the requirements, so it cannot be applied to the industrial production of lumbrokinase enteric-coated tablets.

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