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Preparation method of enteric capsule coating material polyacrylic resin II and method for preparing enteric capsule by using enteric capsule coating material polyacrylic resin II

A technology of polyacrylic acid resin and coating materials, which is applied in the direction of capsule delivery, medical preparations of non-active ingredients, pharmaceutical formulas, etc. It can solve problems such as uneven distribution, large molecular weight, and unqualified capsule friability, and achieve technological The effect of stability, uniform molecular weight distribution, and simple coating formula

Active Publication Date: 2021-04-06
WANNAN MEDICAL COLLEGE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Polyacrylic acid resin II is a commonly used enteric coating material, but the molecular weight of polyacrylic acid resin II prepared by the existing synthetic method is relatively large and the distribution is uneven, and it is easy to cause unqualified friability of the capsule when used in enteric-coated capsules

Method used

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  • Preparation method of enteric capsule coating material polyacrylic resin II and method for preparing enteric capsule by using enteric capsule coating material polyacrylic resin II
  • Preparation method of enteric capsule coating material polyacrylic resin II and method for preparing enteric capsule by using enteric capsule coating material polyacrylic resin II
  • Preparation method of enteric capsule coating material polyacrylic resin II and method for preparing enteric capsule by using enteric capsule coating material polyacrylic resin II

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] A preparation method of enteric capsule coating material polyacrylic acid resin II, comprising the following steps:

[0044] (1) SDS 0.2795g, NaHCO 3 Add 0.1380g, 0.8115g of OP-10 into 180mL of deionized water, sonicate until completely dissolved, then add 0.2750g of potassium persulfate until completely dissolved to obtain reaction solution 1;

[0045] (2) Mix 35mL of MAA, 37.5mL of MMA, and 0.5mL of α-methylstyrene linear dimer, and sonicate until the mixture is uniform to obtain reaction solution 2, which is then heated to 70°C;

[0046] (3) Under the protection of nitrogen, add the reaction solution 1 dropwise to the reaction solution 2, the dropping time is controlled at 2.0h, and after the dropping is completed, keep the temperature at 70°C for 2.5h;

[0047] (4) Obtain a uniform white milky solution after the heat preservation finishes, then place it in a blast drying oven at 60° C. for drying, and then ball mill and pulverize to prepare the white powder of pol...

Embodiment 2

[0053] Others are the same as in Example 1, only changing the temperature in steps (2) and (3) to be 55°C, 60°C, 65°C, 75°C, 80°C, 85°C, 90°C respectively, the polyacrylic resin II prepared finally Productive rate is respectively 41%, 58%, 65%, 68%, 68%, 60%, 55%; The curve figure of reaction temperature and productive rate is as Figure 5 As shown, it can be seen from the figure that the yield of the reaction is higher when the reaction temperature is 70°C, and the yield will decrease if the temperature is lower than or higher than this interval. Considering factors such as energy saving and economy, this paper The optimal reaction temperature for application is 70°C.

Embodiment 3

[0055] Others are the same as Example 1, but the heat preservation time is respectively 0h, 0.5h, 1.0h, 1.5h, 2.0h, 3.0h, 3.5h in the change step (3), and the productive rate of the polyacrylic acid resin II prepared finally is respectively 30 %, 48%, 61%, 64%, 68%, 70%, 70%, the curves of holding time and yield are as follows Figure 6 As shown, it can be seen from the figure that with the increase of the holding time, the yield increases continuously, but the increasing trend decreases to the maximum value and then tends to be stable. This shows that the holding time in the early stage has a great influence on the yield of the product, and the later stage The heat preservation time has less influence on the product yield, and the heat preservation time can be selected to be 2 to 2.5 hours, preferably 2.5 hours, in consideration of economical factors during production.

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Abstract

The invention discloses a preparation method of an enteric capsule coating material polyacrylic resin II and a method for preparing an enteric capsule by using the enteric capsule coating material polyacrylic resin II, the preparation method of the enteric capsule coating material polyacrylic resin II comprises the following steps: adding a compound emulsifier and a pH regulator into deionized water, and carrying out ultrasonic treatment until the compound emulsifier and the pH regulator are completely dissolved; then adding an initiator until the initiator is completely dissolved to obtain a reaction solution I; mixing methyl methacrylate, methacrylic acid and a molecular weight regulator, carrying out ultrasonic treatment until the materials are uniformly mixed to obtain a reaction solution II, and heating the reaction solution II to 65-80 DEG C; dropwise adding the reaction solution I into the reaction solution II under the protection of nitrogen, and keeping the temperature for 2-2.5 hours after dropwise adding is finished; and drying and crushing after heat preservation is finished. The polyacrylic resin II with the weight-average molecular weight of 3.8-4.2 million and uniform molecular weight distribution is prepared, the enteric capsule prepared from the polyacrylic resin II is elastic, neat in appearance, smooth in surface and stable in performance, and the friability of the enteric capsule meets the requirements of enteric acrylic resin coated capsules.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical excipients, and in particular relates to a preparation method of polyacrylic acid resin II, which is an enteric capsule coating material, and a method for preparing enteric capsules by using the polyacrylic resin II. Background technique [0002] At present, capsule types are divided into three categories according to materials: soft capsules (capsules), hard capsules, and enteric-coated capsules. Enteric-coated capsules refer to hard capsules or soft capsules processed from pharmaceutical polymer materials or processed by other suitable methods. Although its capsules cannot dissolve in gastric juice, it can disintegrate in intestinal juice, releasing the active ingredient. Enteric coatings refer to polymeric film coatings that are insoluble under gastric acid conditions and begin to dissolve in the intestinal fluid environment. Common ones are: shellac, alginate, cellulose titanate phtha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08F220/06C08F220/14A61K9/48A61K47/32
CPCC08F220/06A61K9/4816A61K47/32C08F220/14
Inventor 王绍臻王玉松袁琦
Owner WANNAN MEDICAL COLLEGE
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