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Low molecule heparin sustained-release controlled-release capsule preparations and preparation method thereof

A low-molecular-weight heparin and capsule technology, used in pharmaceutical formulations, blood diseases, extracellular fluid diseases, etc., can solve the problems of inconvenient administration, pain and possible infection at the injection site, reducing the number of administrations, affirming the curative effect, Easy-to-use effects

Inactive Publication Date: 2008-06-04
周长海
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

By making oral low-molecular-weight heparin sustained-release and controlled-release capsule preparations, it overcomes the shortcomings of the current low-molecular-weight heparin injections, such as inconvenient administration, pain during injection, and possible infection at the injection site. patient compliance

Method used

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  • Low molecule heparin sustained-release controlled-release capsule preparations and preparation method thereof
  • Low molecule heparin sustained-release controlled-release capsule preparations and preparation method thereof
  • Low molecule heparin sustained-release controlled-release capsule preparations and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0036] The weight composition of low-molecular-weight heparin pellet core includes (dosage per 1000 sustained-release capsules)

[0037] Lactose or fructose or sucrose 40g

[0038] Starch or microcrystalline cellulose 40g

[0039] Hydroxypropyl methylcellulose or macrogol or tragacanth 2g

[0040] The weight composition of the drug-containing layer of low-molecular-weight heparin pellets includes (consumption per 1000 sustained-release capsules)

[0041] Low molecular weight heparin 40g

[0042] Lactose or fructose or sucrose 40g

[0043] Starch or microcrystalline cellulose 40g

[0044] Hydroxypropyl methylcellulose or macrogol or tragacanth 2g

[0045] The weight composition of coating layer of low-molecular-weight heparin pellets includes (per 1000 sustained-release capsules dosage)

[0046] Polyacrylic resin or ethyl cellulose 30g

[0047] Plasticizer: castor oil or diethyl phthalate 5g

[0048] 95% ethanol 1000g

[0049] Static remover talcum powder 10g.

example 2

[0051] The weight composition of low-molecular-weight heparin pellet core includes (dosage per 1000 sustained-release capsules)

[0052] Lactose or fructose or sucrose 160g

[0053] Starch or microcrystalline cellulose 160g

[0054] Hydroxypropyl methylcellulose or polyethylene glycol or tragacanth gum 10g

[0055] The weight composition of the drug-containing layer of low-molecular-weight heparin pellets includes (consumption per 1000 sustained-release capsules)

[0056] Low molecular weight heparin 160g

[0057] Lactose or fructose or sucrose 160g

[0058] Starch or microcrystalline cellulose 160g

[0059] Hydroxypropyl methylcellulose or polyethylene glycol or tragacanth gum 10g

[0060] The weight composition of coating layer of low-molecular-weight heparin pellets includes (per 1000 sustained-release capsules dosage)

[0061] Polyacrylic resin or ethyl cellulose 100g

[0062] Plasticizer: castor oil or diethyl phthalate 15g

[0063] 95% ethanol 1500g

[0064] Antis...

example 3

[0066] The weight composition of low-molecular-weight heparin pellet core includes (dosage per 1000 sustained-release capsules)

[0067] Lactose or fructose or sucrose 100g

[0068] Starch or microcrystalline cellulose 100g

[0069] Hypromellose or macrogol or tragacanth 6g

[0070] The weight composition of the drug-containing layer of low-molecular-weight heparin pellets includes (consumption per 1000 sustained-release capsules)

[0071] Low molecular weight heparin 100g

[0072] Lactose or fructose or sucrose 100g

[0073] Starch or microcrystalline cellulose 100g

[0074] Hypromellose or macrogol or tragacanth 6g

[0075] The weight composition of coating layer of low-molecular-weight heparin pellets includes (per 1000 sustained-release capsules dosage)

[0076] Polyacrylic resin or ethyl cellulose 80g

[0077] Plasticizer: castor oil or diethyl phthalate 10g

[0078] 95% ethanol 1200g

[0079] Static remover talcum powder 20g.

[0080] The preparation method of ...

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Abstract

The invention provides a sustained release and controlled release capsule preparation with low molecular weight heparin, which is a micro-pill containing low molecular weight heparin and is a sustained release and controlled release preparation. The invention includes a pill core, a drug layer and a coating film; two parts of the micro-pills containing drug with coating films and the micro-pills containing drug without coating films are mixed according to a certain proportion, and then are filled into capsules. The effective dosage of the low molecular weight heparin is 40mg-160mg, the grain diameter of the micro-pill is 405Mu m-180Mu m. The pill cores with diameters of 400Mu m-800Mu m and bulk densities of 0.7g / ml-0.9g / l are selected are wetted by adhesive; the mixed powder of the low molecular weight heparin powder and excipient are evenly scattered on the pill cores under wetting condition, and fast-release micro-pills containing drug can be obtained after being dried; the fast-release micro-pills containing drug are coated with coating films, and sustained release micro-pills containing drug can be obtained after being dried; and finally the fast-release micro-pills containing drug and the sustained release micro-pills containing drug are mixed according to a certain proportion and filled into capsules. The effect of the invention has no significant difference compared with the injection of the low molecular weight heparin with same dosage. The invention is characterized by definite efficacy, convenient administration, reducing times of administration, safety and reliability and is a new preparation for treating hyperlipoidemia, thrombotic disease and coronary heart disease.

Description

technical field [0001] The invention belongs to the solid oral dosage form of low-molecular-weight heparin (including low-molecular-weight heparin calcium and low-molecular-weight heparin sodium), and particularly relates to an oral low-molecular-weight heparin sustained-release and controlled-release capsule preparation and a preparation method thereof. Background technique [0002] Low molecular weight heparin (LMWH) was discovered in the 1980s when studying the molecular structure of unfractionated heparin (UFH), and it is a mixture of sulfated polysaccharides with non-uniform molecular weight. It is obtained by chemical or enzymatic depolymerization of unfractionated heparin, with a relative molecular mass of 4000~6500. LMWH is widely used clinically. It has biological activities such as anticoagulant, antithrombotic, regulating blood lipid, reducing blood viscosity, enhancing capillary permeability and improving microcirculation. It can be used to prevent and treat deep...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/16A61K31/727A61P7/02A61P9/10
Inventor 周长海
Owner 周长海
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