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CN-122005822-A - Multi-effect synergistic innovative coating material and preparation method thereof

CN122005822ACN 122005822 ACN122005822 ACN 122005822ACN-122005822-A

Abstract

The invention is used in the technical field of pharmaceutical excipients, and discloses a multi-effect synergistic innovative coating material which comprises, by weight, 13% -26% of hypromellose, 10% -16% of polyethylene glycol, 0.07% -0.15% of simethicone, 15% -21% of titanium dioxide, 38% -46% of talcum powder, 3.5% -7.6% of ethyl acrylate-methacrylic acid copolymer aqueous dispersion, 0.7% -2.0% of iron oxide red and 0.6% -1.05% of iron oxide yellow. The multi-effect synergistic innovative coating material realizes the synergistic optimization of the functions of film forming, shading, dampproofing, drug release regulation and control, anti-adhesion, defoaming and the like by precisely regulating and controlling the proportion of each component, forms a composite film forming system by using the hydroxypropyl methylcellulose and the ethyl acrylate-methacrylic acid copolymer aqueous dispersion, and plays a role in film forming cooperatively, thereby not only ensuring the compactness of a coating layer, but also improving the acid resistance and the stability of the coating layer.

Inventors

  • LIU QINGHAI
  • XU YINGFENG

Assignees

  • 上海医精彩生物技术有限公司

Dates

Publication Date
20260512
Application Date
20260305

Claims (10)

  1. 1. A multi-effect synergistic innovative coating material is characterized by comprising, by weight, 13% -26% of hypromellose, 10% -16% of polyethylene glycol, 0.07% -0.15% of simethicone, 15% -21% of titanium dioxide, 38% -46% of talcum powder, 3.5% -7.6% of ethyl acrylate-methacrylic acid copolymer aqueous dispersion, 0.7% -2.0% of iron oxide red and 0.6% -1.05% of iron oxide yellow.
  2. 2. The multi-effect synergistic innovative coating material according to claim 1, wherein the preferable components and contents are, by weight, 19% -26% of hypromellose, 10% -14% of polyethylene glycol, 0.05% -0.15% of simethicone, 15% -17.5% of titanium dioxide, 38% -46% of talcum powder, 3.5% -5.3% of ethyl acrylate-methacrylic acid copolymer aqueous dispersion, 1.4% -2.0% of iron oxide red, and 0.9% -1.05% of iron oxide yellow.
  3. 3. A multi-effect synergistic innovative coating material as claimed in claim 1, characterized in that the viscosity of the hypromellose is between 5 and 100 mPa.s, preferably between 5 and 15 mPa.s.
  4. 4. A multi-effect synergistic innovative coating material as claimed in claim 1, characterized in that the polyethylene glycol has a molecular weight of 4000-10000, preferably 6000-8000.
  5. 5. A multi-effect synergistic innovative coating material as claimed in claim 1, characterized in that the aqueous dispersion of ethyl acrylate-methacrylic acid copolymer has a solids content of 28% to 40%.
  6. 6. The multi-effect synergistic innovative coating material of claim 1, wherein the titanium dioxide is anatase or rutile and has a particle size of 0.1-0.5 μm.
  7. 7. A multi-effect synergistic innovative coating material as claimed in claim 1, characterized in that the particle size of the talc is 5-20 μm, preferably 10-20 μm.
  8. 8. A multi-effect synergistic innovative coating material as claimed in claim 1, characterized in that the viscosity of the simethicone is between 100 and 500 mPa.s.
  9. 9. A process for the preparation of a multi-effect synergistic innovative coating material as claimed in any one of claims 1 to 8, characterized in that it comprises the following steps: S1, preparing a film forming material, namely adding a prescribed amount of hypromellose into purified water, stirring for 20-30min at 40-45 ℃ and 500-1000/minrpm/min until the hypromellose is completely dissolved, adding a prescribed amount of polyethylene glycol, and continuously stirring for 15-20min to obtain a film forming base material solution; s2, dispersing functional components, namely adding the prescribed amounts of titanium dioxide, talcum powder, iron oxide red and iron oxide yellow into the film-forming base material solution obtained in the step S1, heating to 50-60 ℃, and stirring for 30-40min at 600-1500rpm/min to uniformly disperse solid components; S3, constructing a composite system, namely slowly adding a prescribed amount of ethyl acrylate-methacrylic acid copolymer aqueous dispersion into the dispersion liquid obtained in the S2, and stirring for 25-40min at 50-60 ℃ and 700-1500 rpm/min; S4, optimally adjusting, namely adding the simethicone with the prescription amount, cooling to 30-35 ℃, and stirring for 10-15min at 600-1000rpm/min to obtain a coating material finished product.
  10. 10. The method for preparing the multi-effect synergistic innovative coating material according to claim 9, wherein the filtering in the step S4 is carried out by a 200-mesh sieve, and the method further comprises the step of detecting the quality of a finished product, so that the total number of microbial colonies is less than or equal to 10 2 cfu/g and the heavy metal content is less than or equal to 20ppm.

Description

Multi-effect synergistic innovative coating material and preparation method thereof Technical Field The invention relates to the technical field of pharmaceutical excipients, in particular to a multi-effect synergistic innovative coating material and a preparation method thereof, and the coating material is particularly suitable for coating treatment of preparations such as tablets, granules and the like with higher requirements on stability, photosensitivity and drug release regulation. Background The coating technology is one of key technologies in the field of pharmaceutical preparations, and can realize multiple functions of shading, dampproofing, masking taste, improving appearance, regulating drug release and the like by coating a film on the surface of the pharmaceutical preparation, and the existing coating materials have the problems of single function and poor synergism, wherein the partial coating materials have basic film forming property, but poor shading effect, so that photosensitive drugs are easy to degrade in the storage process, the partial materials have good shading property, but the coating films have large brittleness after film forming, are easy to crack and fall off, and the stability and bioavailability of the release rate are difficult to balance when the drug release is regulated, and the technical problems of adhesion, excessive foam and the like are easy to occur in the coating process; At present, most of coating materials commonly used in the market use a single polymer as a film forming base material and are matched with a small amount of auxiliary materials, for example, when hydroxypropyl methylcellulose is used as a film forming agent, the moisture resistance and the mechanical strength of the coating film are insufficient, when an acrylic resin material is adopted, the drug release performance can be regulated, but a large amount of anti-adhesion agents are required to be added in the film forming process, so that the coating film is not uniform, in addition, the proportion of each component of the existing coating material is unreasonable, the mutual interference among functions is often caused, multiple-effect synergy is difficult to realize, for example, the addition of a plasticizer can improve the flexibility of the coating film, but the compactness of the coating film is influenced by excessive addition, the compatibility of a light shielding agent and the film forming agent is poor, the integrity of the coating film is reduced, and the storage stability and the drug release consistency of the drug are further influenced; therefore, an innovative coating material which has excellent film forming property, light shielding property, moisture resistance and drug release regulation function, good synergistic effect of all components and stable coating process is developed, and the novel coating material becomes a technical problem to be solved in the field of current pharmaceutical excipients. Disclosure of Invention The invention aims to provide a multi-effect synergistic innovative coating material and a preparation method thereof, and aims to solve the problems of single function, poor synergistic effect of all components, poor shading and moisture-proof effects, insufficient stability of a coating film and outstanding coating process problems of the conventional coating material in the background art. The invention provides a multi-effect synergistic innovative coating material, which comprises, by weight, 13% -26% of hypromellose, 10% -16% of polyethylene glycol, 0.07% -0.15% of simethicone, 15% -21% of titanium dioxide, 38% -46% of talcum powder, 3.5% -7.6% of ethyl acrylate-methacrylic acid copolymer water dispersion, 0.7% -2.0% of iron oxide red, and 0.6% -1.05% of iron oxide yellow. Preferably, the preferable components and contents by weight percentage are 19% -26% of hydroxypropyl methylcellulose, 10% -14% of polyethylene glycol, 0.05% -0.15% of simethicone, 15% -17.5% of titanium dioxide, 38% -46% of talcum powder, 3.5% -5.3% of ethyl acrylate-methacrylic acid copolymer water dispersion, 1.4% -2.0% of iron oxide red and 0.9% -1.05% of iron oxide yellow. By adopting the technical scheme, the optimal synergistic effect of the film forming base material and the functional auxiliary materials is achieved by optimizing the proportion range of each component, so that the integrity and the mechanical strength of the coating layer are ensured, and the comprehensive performance of shading, dampproofing and drug release regulation is obviously improved. Preferably, the viscosity of the hypromellose is 5 to 100 mPas, preferably 5 to 15 mPas. By adopting the technical scheme, the hydroxypropyl methylcellulose with specific viscosity is selected, so that a compact coating film with proper flexibility is formed, and the problem of insufficient strength of the coating film caused by poor fluidity or low viscosity of the coating film due to high viscosity is avoided. Prefe