Preparation method of lumbrokinase enteric-coated pellets

A technology of lumbrokinase enteric and lumbrokinase, which is applied in the field of preparation of lumbrokinase enteric-coated pellets, can solve the problems of high product cost and high energy consumption

Inactive Publication Date: 2011-07-13
JIANGZHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage is that the freeze-drying process consumes a lot of energy and the product cost is high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0008] Take 10 kg of fresh and live worms, wash them with purified water until the dirt is discharged, add purified water, use a colloid mill to make a homogenate, freeze and thaw twice, and heat to 55°C to remove heat-unstable Miscellaneous protein, after high-speed centrifugation at 4000 rpm, the supernatant was obtained, and the supernatant was passed through a DEAE-anion exchange chromatography column, washed with 0.08M disodium hydrogen phosphate solution and 0.05M sodium chloride solution to obtain the eluate, and then concentrate the eluate with a hollow fiber ultrafiltration device with a standard cut-off molecular weight of 25K until the conductivity is ≤0.1×10 3 At us / cm, pass through folded microporous membranes with a pore size of 0.45um and 0.22um to obtain a concentrated solution. After measuring the potency of the lumbrokinase concentrated solution, add 10% PVPK30, stir and dissolve to obtain a mixed medicinal solution for use. Put the blank pellet core in a flu...

Embodiment 2

[0010] Take 50 kg of fresh and live worms, wash them with purified water until the dirt is discharged, add purified water, use a colloid mill to make a homogenate, freeze and thaw twice, and heat to 55°C to remove heat-unstable Miscellaneous protein, after high-speed centrifugation at 4000 rpm, the supernatant was obtained, and the supernatant was passed through a DEAE-anion exchange chromatography column, washed with 0.08M disodium hydrogen phosphate solution and 0.05M sodium chloride solution to obtain the eluate, and then concentrate the eluate with a hollow fiber ultrafiltration device with a standard cut-off molecular weight of 25K until the conductivity is ≤0.1×10 3 At us / cm, pass through folded microporous membranes with a pore size of 0.45um and 0.22um to obtain a concentrated solution. After measuring the potency of the lumbrokinase concentrated solution, add 15% PVPK30, stir and dissolve to obtain a mixed medicinal solution for use. Put the blank core in a fluidized ...

Embodiment 3

[0012] Take 100 kg of fresh and live worms, wash them with purified water until the dirt is discharged, add purified water, use a colloid mill to make a homogenate, freeze and thaw 3 times, and heat to 65°C to remove heat-unstable Miscellaneous protein, after high-speed centrifugation at 4000 rpm, the supernatant was obtained, and the supernatant was passed through a DEAE-anion exchange chromatography column, washed with 0.08M disodium hydrogen phosphate solution and 0.05M sodium chloride solution to obtain the eluate, and then concentrate the eluate with a hollow fiber ultrafiltration device with a standard cut-off molecular weight of 25K until the conductivity is ≤0.1×10 3 At us / cm, pass through folded microporous membranes with a pore size of 0.45um and 0.22um to obtain a concentrated solution. After measuring the potency of the lumbrokinase concentrated solution, add 20% PVPK30, stir and dissolve to obtain a mixed medicinal solution for use. Put the blank pellet core in a ...

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PUM

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Abstract

The invention relates to a preparation method of lumbrokinase enteric-coated pellets, comprising the following steps of: washing fresh live eisenia foetida with purified water, preparing homogenate by a colloid mill, repeatedly freezing and thawing, heating, centrifuging at high speed to obtain supernatant, separating the supernatant by an anion exchange chromatographic column, eluting, concentrating, filtering to obtain a lumbrokinase concentrated solution, mixing the concentrated solution with an adhesive, spraying onto the blank pellet cores to prepare pellets, coating the pellets with enteric coatings, and screening. The raw materials of the enteric-coated pellets prepared by the method dispense with a freeze drying process, thus simplifying the production process and lowering the production cost.

Description

1. Technical field [0001] The invention relates to a preparation method of lumbrokinase enteric-coated pellets, belonging to the technical field of pharmaceutical production. 2. Background technology [0002] Lumbrokinase is a kind of proteolytic enzyme, which is extracted and separated from artificially cultivated Eisenia chinensis. It has a selective affinity with fibrinogen and can directly hydrolyze fibrinogen to produce soluble fibrinogen for degradation. product, reduce the content of fibrinogen, and prevent thrombosis; lumbrokinase contains components of plasminogen activator and plasmin, which can degrade insoluble fibrin by promoting the conversion of plasminogen into plasmin, It can dissolve the 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 hypercoagulable state before thrombus formation. [0003...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K38/48A61P7/02A61P9/10
Inventor 卢建中李丹吕毅斌张俐伟
Owner JIANGZHONG PHARMA
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