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Aqueous enteric coating solution and preparation method thereof

An enteric coating, water-based technology, applied in enteric coating liquid and its preparation, water-based enteric coating liquid in the field of preparation of enteric-coated preparations, can solve the problem of insufficient combination of polymer particles and plasticizers, organic solvents Problems such as high viscosity of the coating liquid and leakage loss of plasticizers, etc., to achieve the effect of tight combination, dense coating film, and less leakage loss

Active Publication Date: 2015-06-17
ZHEJIANG UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The coating film formed by the organic solvent enteric coating solution is relatively dense and uniform, and the film-forming polymer material is closely combined with the plasticizer. In an acidic environment, the plasticizer is not easy to leak and lose, and the water permeability is low. Enteric-coating function, but the organic solvent coating liquid has a high viscosity, low solid content, easy to produce adhesion during the coating process, and the coating time is long, and the residual amount of organic solvent in the product must be controlled, and there is potential environmental pollution, etc. shortcoming
The water-based enteric coating solution has the advantages of high solid content, low viscosity, short coating time and high efficiency, but the formed coating film is formed by the combination of polymer particles, and the combination of polymer particles and plasticizer is not enough Tight, plasticizer leakage loss is prone to occur in an acidic environment, resulting in the loss of plasticizer coating film due to the difficulty of tolerating osmotic pressure and rupture, so the film has high water permeability, and thus causes the drug to be released in gastric juice Increased and rapid release in intestinal fluid

Method used

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  • Aqueous enteric coating solution and preparation method thereof
  • Aqueous enteric coating solution and preparation method thereof
  • Aqueous enteric coating solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] The preparation of embodiment 1 aqueous enteric coating solution

[0047] Take 1.3g of sodium hydroxide and add it into distilled water to make a sodium hydroxide solution for use; mix 100g Slowly add L100-55 powder to 210g ethanol in batches, stir while adding to avoid agglomeration or precipitation, stir for 2 hours to a clear solution; add plasticizer to the clear solution, stir for 30 minutes, then slowly drop The above sodium hydroxide solution is used to obtain a milky white liquid; the milky white liquid is distilled off under reduced pressure to remove ethanol to obtain an aqueous enteric coating solution. The plasticizers used in the examples are triethyl citrate (TEC) and dibutyl phthalate (DBP) as examples, and the amounts of distilled water and plasticizers used in the preparation process are shown in Table 1 and Table 2.

[0048] Amounts of Distilled Water and TEC in Examples F1-F5 of Table 1

[0049]

F1

F2

F3

F4

F5

...

Embodiment 2

[0052] The preparation of embodiment 2 free films

[0053] The water-based enteric coating solution prepared by F1-F8 in Example 1 is poured into the bottom placed horizontally. In a rectangular box (15cm×15cm×1.0cm) of the material, age at 40°C until the polymer forms a dense and uniform film; move the film to a container filled with saturated KNO 3 Put the solution in a desiccator with a relative humidity of (92.5±5)%, place it at room temperature for 10 hours to soften the film by absorbing moisture, so as to facilitate the complete removal of the film; then remove the film and dry it again at 40°C for 24 hours ; Finally, store in a desiccator with a relative humidity of 45-50%. The aqueous enteric coating solutions of F1-F8 all obtained uniform coating films.

Embodiment 3

[0054] Embodiment 3 film dry weight loss rate investigation

[0055] When the film is prepared from the F4 water-based enteric coating solution in Example 2, the film is softened after absorbing moisture and cut into a rectangle of 3 cm × 1.5 cm with a scalpel, and then through subsequent drying steps, the obtained film is used as the water-based enteric coating solution of the present invention. Coating film.

[0056] Take 10g of triethyl citrate and add it to 333g of water and stir for 10min, then add 333g of coating material L30D55, stir to mix well. Prepare the film according to the preparation method of Example 2. After the film absorbs moisture and softens, cut it into a rectangle of 3cm×1.5cm with a scalpel, and then go through the subsequent drying step to make L30D55 ​​water-based film, as comparative example 1.

[0057] 100g Slowly pour L100-55 into 600g of 95% ethanol solution in batches to avoid agglomeration or precipitation. Stir for 30-60 minutes to form ...

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Abstract

The invention discloses a preparation method of an aqueous enteric coating solution. The preparation method comprises the steps of: preparing all raw materials; adding copolymer powder of methacrylic acid and ethyl acrylate into an organic solvent at first to obtain a settled solution; adding a plasticizer into the settled solution, and then adding an alkaline solution into the settled solution to obtain a latex dispersion liquid; and removing the organic solvent from the latex dispersion liquid to obtain the aqueous enteric coating solution. The invention also discloses the aqueous enteric coating solution prepared according to the preparation method, a preparation coated with the coating solution, pantoprazole sodium pellets coated with the coating solution, and the application of the coating solution in the preparation. By virtue of a coating membrane formed by the aqueous enteric coating solution disclosed by the invention, the plasticizer is unlikely to leak and get lost in an acidic environment of gastric juice, the water permeability is low, and simultaneously the advantages of the aqueous coating solution in a coating process are retained.

Description

technical field [0001] The invention belongs to the technical field of coating of pharmaceutical preparations, in particular to an enteric coating solution and a preparation method thereof, preparations coated with the enteric coating solution, pellets coated with the enteric coating solution, And the application of the aqueous enteric coating solution in the preparation of enteric preparations. Background technique [0002] Enteric coating is a coating technology for oral enteric-coated film-controlled release preparations to improve the chemical stability of pH-sensitive drugs and reduce gastric irritation caused by drugs, and can be used for small intestine and colon targeting treat. Commonly used enteric coating film-forming materials include acrylic resin, polyvinyl acetate phthalate (PVAP) and hypromellose phthalate (HPMCP), among which methacrylic acid in acrylic resin and Copolymer of ethyl acrylate (1:1) (such as produced by Rohm in Germany L30D55 ​​water disper...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/32A61K9/16A61K31/4439
Inventor 胡富强吴晖袁弘欧阳亚华韩敏陈眉眉李海杰杜永忠游剑赵川平
Owner ZHEJIANG UNIV
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