Thermoplastic elastomer styrene-isoprene-styrene (SIS) framework material extruded and coated by extruder

A framework material and content technology, applied in the field of thermal elastomer SIS framework material, can solve the problems of insufficient cohesion, backing glue penetration, low drug loading, etc., and achieve the effect of improving curative effect

Active Publication Date: 2011-02-09
侯玉庆 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] 1. The molding process of the transdermal absorption patch has a high temperature and serious damage to the active ingredient: the existing hot-melt molding process is above 130°C, coupled with long-term mixing, coating and heating, resulting in serious drug damage, especially heat sensitivity and volatility Drugs, cannot apply "hot melt molding process"
Therefore, at present, most of the transdermal absorption patches are based on the "solvent molding process". This process not only consumes a lot of energy, is high in cost, poor in safety, and has solvent residues, but also has serious organic solvent pollution.
[0004] 2. Poor biocompatibility between SIS adhesives and skin: due to poor moisture absorption and poor air permeability, "sweat retention syndrome" is prone to occur; at the same time, the biomechanical properties adapted to human skin need to be improved, such as the adhesives made of SIS currently on the market agent, there are phenomena such as skin lifting and pain
Or there is insufficient cohesion, resulting in residual glue, overflow glue, backing glue seepage, etc.
[0005] 3. Poor compatibility between SIS adhesives and drugs: Due to the different polarity of drugs, especially the ingredients of traditional Chinese medicine, the compatibility is poor and the paste volume is large
It leads to low drug loading, low release rate and low transdermal rate, which seriously affects the efficacy of the drug
[0006] 4. At present, commercially available SIS contains a large amount of styrene monomer and lithium (Li + ) impurities, which are toxic to human skin and are not suitable for medical applications

Method used

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  • Thermoplastic elastomer styrene-isoprene-styrene (SIS) framework material extruded and coated by extruder
  • Thermoplastic elastomer styrene-isoprene-styrene (SIS) framework material extruded and coated by extruder
  • Thermoplastic elastomer styrene-isoprene-styrene (SIS) framework material extruded and coated by extruder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Preparation of novel SIS: SIS was synthesized by a three-step method.

[0034] 1: Recipe calculation

[0035] Design: styrene / isoprene = 15 / 85; molecular weight: 120000; concentration of n-butyl lithium is 1mol / L; [THF] / [active center] = 2

[0036] Note: Styrene and isoprene are polymer grade; THF is the activator, which requires analytical purity. Calculation: The triblock monomer weight ratio is as follows:

[0037] Styrene:isoprene:styrene=7.5:85:7.5

[0038] The amount of styrene in the first section: m×7.5%=m 1 ;Molecular weight: 120000×7.5%=M 1 .

[0039] The amount of isoprene in the second stage: m×85%=m 2 ;Molecular weight: 120000×85%=M 2 .

[0040] The amount of styrene in the third stage: m×7.5%=m 3 ;Molecular weight: 120000×7.5%=M 3 .

[0041] active center = m 1 / M 1 =m 2 / M 2 =m 3 / M 3 = a mol

[0042] Then the added volume of n-butyllithium is: V=a mol / l (mol / L)=a L

[0043] Organic solvent: cyclohexane, analytically pure.

[0044] Spe...

Embodiment 2

[0054] To prepare a transdermal patch adhesive:

[0055] The SIS used to synthesize the adhesive in the present invention is the SIS claimed in this patent, and its content ranges from 1% to 55% of the adhesive system;

[0056] Softener, plasticizer: one or more of naphthenic oil, hydrogenated naphthenic oil, liquid paraffin, castor oil, hydrogenated castor oil, epoxy soybean oil, the content range is 30%-60% of the adhesive system %;

[0057] Tackifier: including C 5 Petroleum resin and its hydride, C 9 Petroleum resin and its hydride, C 5 -C 9 One or more of petroleum resin and its hydrogenated products, hydrogenated rosin resin, rosin resin, and other rosin derivatives, the content of which ranges from 10% to 60% of the adhesive system;

[0058] Antioxidant: include one or both of antioxidant 1010 (trade name) and antioxidant 264 (trade name), the content range of which is 0.1%-5% of the adhesive system.

[0059] Additives with special functions: such as ingredients t...

Embodiment 3

[0065] Biomechanical studies of different structures:

[0066] At present, it is difficult to prepare an ideal transdermal absorption patch with commercially available SIS, because the initial adhesion, holding force, and peeling force (three forces) of the transdermal patch not only affect the adhesive performance of the patch, but also directly Affect the compliance of people's medication, through a large number of human body application tests, the present invention has explored the best mechanical properties of the transdermal patch suitable for human skin as (tested by the Pharmacopoeia method of the People's Republic of China):

[0067] Initial viscosity / ball number

Holding force / min

Peel strength / (N / mm)

[0068] 16-35

8-30

0.02-0.6

[0069] At present, it is difficult for commercially available SIS models to prepare adhesives to meet the above requirements. Or the initial adhesion is too small, it is not easy to bond t...

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Abstract

The invention relates to a thermoplastic elastomer styrene-isoprene-styrene (SIS) framework material extruded and coated by an extruder. The material is particularly suitable for medical external preparations, is linear triblock copolymer (styrene-isoprene-styrene) which is prepared from 15 to 25 weight percent of styrene and 75 to 85 weight percent of isoprene serving as monomer raw materials, wherein the middle of the triblock copolymer is a polyisoprene chain segment, while the two ends are polystyrene chain segments; the molecular weight of the triblock copolymer is between 120,000 and 150,000; and molecular weight distribution is narrow. The framework material is characterized by also comprising 15 to 50 mass percent of diblock copolymer which consists of the styrene and the isoprene. In application to medicament transdermal patches, health care patches and cosmetic masks, the copolymer has large medicament loading rate and good transdermal absorption effect, adapts to pasting on the skins of human bodies, and lowers the volatilization and damage of volatile components and thermal unstable components during high temperature forming.

Description

technical field [0001] The invention relates to a thermal elastomer SIS framework material extruded by an extruder, especially as a framework material for a transdermal patch, which has a certain molecular weight range and a linear structure and contains triblock and diblock The new SIS polymer structure is more suitable for the preparation of transdermal patches containing active ingredients such as medical, health care, and cosmetics. Background technique [0002] The quality of the transdermal patch is mainly determined by the properties of the adhesive in addition to the drug factor, and the skeleton material is the main factor determining the properties of the adhesive. Styrene-isoprene-styrene block copolymer (Styrene-isoprene-styrene is called for short SIS) has been used in the transdermal absorption patch as framework material, JP 2000-136128 (P2000-136128A), CN 1197389A, CN 1252005A and other foreign patents, but the focus is on the preparation and application of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C09J153/02A61K8/90A61K9/70C08L53/02A61K47/32A61K8/02
Inventor 侯玉庆史关正
Owner 侯玉庆
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