A kind of Ailamod slow-release multicomponent composition and preparation method thereof

A composition and multiple technology, applied in the direction of drug combination, drug delivery, pharmaceutical formulation, etc., can solve the problems of multiple release factors, time lag, unstable osmotic pump and so on

Active Publication Date: 2019-01-29
CHINA PHARM UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] There are certain deficiencies in each of the above methods. The preparation process of the double-layer tablet is relatively complicated, and there are many factors affecting the release; the osmotic pump is unstable in the body, and the drug release hole is easily blocked in the body, and there are shortcomings of time lag.

Method used

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  • A kind of Ailamod slow-release multicomponent composition and preparation method thereof
  • A kind of Ailamod slow-release multicomponent composition and preparation method thereof
  • A kind of Ailamod slow-release multicomponent composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Use (spray method) (whether it is a conventional process, if not, it is necessary to explain in detail.) Spray 4.75g of plasticizer dibutyl sebacate into 9.5g of the skeleton carrier material ethyl cellulose 10 superior grade, to ethyl cellulose The base cellulose is plasticized, and then 33.25 g of a release modifier polyoxyethylene (PEO1000000) is added and mixed evenly to prepare a mixed carrier. A physical mixture was prepared by mixing 2.5 g of Iguratimod (source) with mixed carrier uniformly. Set the temperature of the hot-melt extruder (model, manufacturer) at 50°C. After the temperature rises to the set value and balances, the physical mixture is added to the hot-melt extruder, and the material is extruded from the die hole of the head; After cooling to room temperature, the mixture was pulverized and subjected to in vitro release experiments.

Embodiment 2

[0049] Mix 40.5 g of the skeleton carrier material ethylene / vinyl acetate copolymer with 2.25 g of the release modifier xanthan gum and 2.25 g of carbomer 974P to prepare a mixed carrier. Mix Iguratimod 5g with mixed carrier uniformly to prepare physical mixture. Set the temperature of the hot-melt extruder at 70°C. After the temperature rises to the set value and balances, add the physical mixture to the hot-melt extruder, and the material is extruded from the die hole of the head; after cooling the extrudate to room temperature Crush and perform in vitro release experiments.

Embodiment 3

[0051] Mix 21.6 g of the skeleton carrier material ethyl cellulose 10 superior grade with 14.4 g of the plasticizer polyethylene glycol (PEG400) and 4 g of the release modifier carbomer 974P to prepare a mixed carrier. Mix Iguratimod 10g with mixed carrier uniformly to prepare physical mixture. Set the temperature of the hot-melt extruder at 90°C. After the temperature rises to the set value and balances, add the physical mixture into the hot-melt extruder, and the material is extruded from the die hole of the head; after cooling the extrudate to room temperature Crush and perform in vitro release experiments.

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Abstract

The invention belongs to the pharmaceutical field, relates to an igutimod slow release multielement composition and a preparation method thereof, and in particular relates to a medical slow release multielement composition prepared by using igutimod as the active component and a framework carrier material and a release adjustor as a carrier. A plasticizer is added if necessary to reduce the extruding temperature and simplify the extruding process. The preparation method is a thermal melting extruding method which is simple in process and easy for industrial production, and is not involved in organic solvents. The slow release multielement composition consists of severe of dozens of slow release particles which are uniform in grain size, so that the composition is high in safety.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to an iguratimod sustained-release multiple composition and a preparation method thereof. Background technique [0002] Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic erosive arthritis. It is generally believed that it is closely related to genetic, environmental, infection and other factors. How do the above pathogenic factors break immune tolerance? The process of initiating autoimmunity is not well understood. The joint manifestations of rheumatoid arthritis include joint swelling and pain, and morning stiffness. Nervous system and hematopoietic system etc. Rheumatoid arthritis is distributed all over the world, with a prevalence rate of 0.18% to 1.07% among different populations, and its incidence has certain racial differences. The total number of patients in my country exceeds 5 million. Rheumatoid arthritis can occur in all ages, and the peak age ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/52A61K31/352A61K47/38A61K47/34A61K47/32A61K47/44A61K47/12A61K47/10A61P19/02A61P29/00A61P37/02
Inventor 王青松平其能张灿陈玉红李玲许向阳
Owner CHINA PHARM UNIV
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