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CN-122008671-A - Medicinal composite hard tablet and preparation method thereof

CN122008671ACN 122008671 ACN122008671 ACN 122008671ACN-122008671-A

Abstract

The application discloses a medicinal composite hard tablet and a preparation method thereof. The application provides a medicinal composite hard sheet, which comprises an outer layer sheet and an inner layer sheet, wherein the outer layer sheet comprises, by mass, 100 parts of PET resin, 30-40 parts of IPDI polyurethane prepolymer, 6-10 parts of a compatibilizer, 4-8 parts of nano titanium dioxide, 4-8 parts of silicone powder, 30-36 parts of nano montmorillonite and 24-30 parts of carbon black, and the inner layer sheet comprises, by mass, 30-40 parts of medium-density PE resin, 50-60 parts of low-density PE resin and 12-18 parts of nano titanium dioxide. On the other hand, the application also provides a preparation method of the medicinal composite hard tablet. The composite hard sheet has excellent oxygen barrier property, excellent moisture resistance and damp resistance, excellent ultraviolet light barrier property, excellent shading property and low cost.

Inventors

  • HU BIN
  • HU JIANPING
  • YIN RONGLI

Assignees

  • 湖北鹏程药包材有限公司

Dates

Publication Date
20260512
Application Date
20260313

Claims (10)

  1. 1. The medicinal composite hard sheet is characterized by comprising, by mass, 100 parts of PET resin, 30-40 parts of IPDI polyurethane prepolymer, 6-10 parts of a compatibilizer, 4-8 parts of nano titanium dioxide, 4-8 parts of silicone powder, 30-36 parts of nano montmorillonite and 24-30 parts of carbon black, and an inner sheet, wherein the inner sheet comprises, by mass, 30-40 parts of medium-density PE resin, 50-60 parts of low-density PE resin and 12-18 parts of nano titanium dioxide.
  2. 2. The pharmaceutical composite hard sheet of claim 1, wherein the IPDI polyurethane prepolymer is prepared by reacting an IPDI trimer curing agent and a bio-based polyol.
  3. 3. The pharmaceutical composite hard sheet of claim 2, wherein the IPDI trimer curing agent is selected from the group consisting of Z4470-type IPDI trimer curing agents.
  4. 4. The pharmaceutical composite hard sheet according to claim 2, wherein the preparation of the IPDI polyurethane prepolymer comprises the steps of: S1-a, mixing an IPDI trimer curing agent and a bio-based polyol according to a mass ratio of 100:30-38 to obtain a mixed solution; S1-b, adding a mixture of quaternary ammonium salt and quaternary phosphonium salt accounting for 0.25-0.3% of the total mass of the mixed solution into the mixed solution obtained in the step S1-a, and fully stirring and mixing to obtain a reaction solution; S1-C, stirring the reaction liquid obtained in the step S1-b at the temperature of 85-90 ℃ for reacting for 5-5.5 hours, heating to 120-125 ℃, continuously reacting for 0.5-1 hour, and cooling to obtain the IPDI polyurethane prepolymer.
  5. 5. The pharmaceutical composite hard sheet according to claim 4, wherein in step S1-b, the mixture of quaternary ammonium salt and quaternary phosphonium salt is tetrabutylammonium bromide and butyltriphenylphosphine chloride.
  6. 6. The pharmaceutical composite hard sheet according to claim 5, wherein the mass ratio of the tetrabutylammonium bromide to the butyltriphenylphosphine chloride is 1.5-2:1.
  7. 7. The pharmaceutical composite hard sheet according to claim 1, wherein the compatibilizing agent is selected from polyvinylpyrrolidone copolymers.
  8. 8. The pharmaceutical composite hard sheet according to claim 1, wherein each raw material component of the outer sheet further comprises expanded vermiculite micropowder with a particle size of 50-100 μm, and the addition amount of the expanded vermiculite micropowder is 6-8 parts.
  9. 9. The method for preparing a pharmaceutical composite hard sheet according to any one of claims 1 to 8, comprising the steps of: S1, preparing an IPDI polyurethane prepolymer, fully mixing raw materials of other outer sheets except PET resin to obtain a premix, adding the PET resin and the premix into a double-screw extruder, and carrying out hot melt extrusion and granulation to obtain an outer sheet master batch, wherein the temperatures of 6 temperature sections of the extruder are sequentially 175-180 ℃, 180-185 ℃, 185-190 ℃, 180-185 ℃ and 175-180 ℃; S2, mixing raw materials of the inner layer sheet, adding the raw materials into a double-screw extruder, and carrying out hot melt extrusion and granulation to obtain inner layer sheet master batches, wherein the temperatures of 6 temperature sections of the extruder are 160-165 ℃, 165-170 ℃, 165-175 ℃, 170-175 ℃, 175-180 ℃ and 170-175 ℃ in sequence; s3, performing double-layer co-extrusion molding on the outer layer sheet master batch prepared in the step S1 and the inner layer sheet master batch prepared in the step S2 to prepare the medicinal composite hard sheet.
  10. 10. The method for preparing a pharmaceutical composite hard sheet according to claim 9, wherein in the step S3, the double-layer co-extrusion is performed by using the parameters that the temperatures of 6 temperature sections from the feeding end to the connector of the inner layer sheet extruder are 160-165 ℃, 165-175 ℃, 175-180 ℃, 180-185 ℃ and 175-180 ℃ in sequence, the temperatures of 6 temperature sections from the feeding end to the connector of the outer layer sheet extruder and the outer layer extruder are 175-180 ℃, 180-185 ℃, 185-190 ℃, 190-195 ℃, 185-190 ℃ and 175-180 ℃ in sequence, and the die opening temperature of the double-layer co-extruder head is 175-180 ℃.

Description

Medicinal composite hard tablet and preparation method thereof Technical Field The application relates to the technical field of medicinal packaging materials, in particular to a medicinal composite hard tablet and a preparation method thereof. Background The composite hard tablet is one kind of medicine packing material for packing various solid or liquid medicine and is in direct contact with the medicine. For pharmaceutical packaging, barrier properties are critical core properties, directly affecting the shelf life of the pharmaceutical product. The existing high-barrier medicinal composite hard sheet needs to meet the requirements of excellent oxygen barrier property, excellent moisture and humidity resistance and excellent ultraviolet light barrier property, and for part of photosensitive medicines, the composite hard sheet also needs to have excellent visible light barrier property. Based on the excellent oxygen barrier property of PVDC materials, the oxygen barrier property is far superior to other existing thermoplastic materials. Therefore, the existing high-barrier medicinal composite hard sheet basically takes PVDC material as a main material and is compounded with PVC and/or PE material to form a composite material. The PVDC material has complex preparation process, and few manufacturers capable of producing PVDC materials worldwide, which results in extremely high price, far exceeding other thermoplastic materials sold in the prior art. In addition, PVDC materials are homopolymers, have extremely high crystallinity, and do not have thermoplastic processing properties, so that application to pharmaceutical packaging materials generally requires the addition of plasticizers for plasticization modification. The introduction of additives such as plasticizers causes precipitation problems, which affects the safety in use. Therefore, the design of the medical packaging material with the barrier property similar to that of PVDC material, low cost and excellent thermoplastic processability is a technical problem to be solved in the field. Disclosure of Invention In order to solve at least one technical problem, the application provides a medicinal composite hard sheet and a preparation method thereof, wherein the medicinal composite hard sheet has excellent oxygen barrier property, excellent moisture resistance and humidity resistance, excellent ultraviolet light barrier property, excellent shading property and low cost. The application provides a medicinal composite hard sheet, which comprises an outer layer sheet and an inner layer sheet, wherein the outer layer sheet comprises, by mass, 100 parts of PET resin, 30-40 parts of IPDI polyurethane prepolymer, 6-10 parts of a compatibilizer, 4-8 parts of nano titanium dioxide, 4-8 parts of silicone powder, 30-36 parts of nano montmorillonite and 24-30 parts of carbon black, and the inner layer sheet comprises, by mass, 30-40 parts of medium-density PE resin, 50-60 parts of low-density PE resin and 12-18 parts of nano titanium dioxide. Alternatively, the IPDI polyurethane prepolymer is prepared by reacting an IPDI trimer curing agent with a bio-based polyol. Further alternatively, the IPDI trimer curing agent is Z4470 type IPDI trimer curing agent. Further alternatively, the preparation of the IPDI polyurethane prepolymer comprises the following steps: S1-a, mixing an IPDI trimer curing agent and a bio-based polyol according to a mass ratio of 100:30-38 to obtain a mixed solution; S1-b, adding a mixture of quaternary ammonium salt and quaternary phosphonium salt accounting for 0.25-0.3% of the total mass of the mixed solution into the mixed solution obtained in the step S1-a, and fully stirring and mixing to obtain a reaction solution; S1-C, stirring the reaction liquid obtained in the step S1-b at the temperature of 85-90 ℃ for reacting for 5-5.5 hours, heating to 120-125 ℃, continuously reacting for 0.5-1 hour, and cooling to obtain the IPDI polyurethane prepolymer. Still further alternatively, in the step S1-b, the mixture of quaternary ammonium salt and quaternary phosphonium salt is tetrabutylammonium bromide and butyltriphenylphosphine chloride. Still further optionally, the mass ratio of the tetrabutylammonium bromide to the butyltriphenylphosphine chloride is 1.5-2:1. Alternatively to this, the method may comprise, the compatilizer is selected from polymer vinyl pyrrolidone copolymers. Optionally, each raw material component of the outer sheet further comprises expanded vermiculite micropowder, the particle size of the expanded vermiculite micropowder is 50-100 mu m, and the addition amount is 6-8 parts. On the other hand, the application also provides a preparation method of the medicinal composite hard tablet, which comprises the following steps: S1, preparing an IPDI polyurethane prepolymer, fully mixing raw materials of other outer sheets except PET resin to obtain a premix, adding the PET resin and the premix into a double-screw extruder, and