Medicinal resin material and preparation method thereof
By mixing functional polyacrylates with polylactic acid and antioxidants to form a composite network and flexible segments, the problems of insufficient viscosity and toughness of polyacrylates are solved, the viscosity and toughness of pharmaceutical resin materials are improved, and the compressibility and mechanical integrity of drug particles are enhanced.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- HANGZHOU INSTITUTE OF MEDICAL SCIENCES CHINESE ACADEMY OF SCIENCES
- Filing Date
- 2026-02-12
- Publication Date
- 2026-05-19
AI Technical Summary
Existing polyacrylate materials, when used as granulation binders, have insufficient viscosity and toughness, resulting in brittle particles that affect the mechanical integrity and compressibility of pharmaceutical formulations.
Pharmaceutical resin materials are prepared by mixing functional polyacrylates with polylactic acid and antioxidants. A composite network is formed by the reaction of starch, dicarboxylated polyethylene glycol and chitosan, which enhances viscosity and toughness. The synergistic effect of polyether segments and oleic acid improves molecular chain fluidity and extensibility.
It improves the viscosity and toughness of pharmaceutical resin materials, enhances the compressibility and mechanical integrity of drug particles, prolongs the drug's residence time in the body, and achieves biodegradability after drug release.
Smart Images
Figure SMS_1
Abstract
Description
Technical Field
[0001] This invention relates to the field of pharmaceutical polymer materials, specifically to a pharmaceutical resin material and its preparation method. Background Technology
[0002] Polyacrylic acid resin is a class of polymeric materials copolymerized from methacrylic acid and its ester monomers. It has broad application prospects in the pharmaceutical field, particularly as a drug carrier, sustained-release material, and biomedical material. Among these, polyacrylates used for coating, which are less prone to sticking, generally have a viscosity of less than 20 mPa·s. However, when used as a binder in granulation, a higher viscosity is often necessary to improve granule compressibility, isolate granule components, and reduce the hygroscopicity of granules and tablets. Furthermore, when polyacrylic acid resin is used to bind drug granules, the rigid carbon-carbon bonds in the polyacrylate backbone and its high glass transition temperature restrict molecular chain movement, resulting in insufficient toughness. This makes it prone to cracking and fragmentation during tableting and transportation, reducing the mechanical integrity and breakage resistance of the granules.
[0003] Therefore, how to improve the viscosity of pharmaceutical-grade polyacrylate while enhancing its toughness, so that polyacrylate is more suitable as a binder for granulation, requires further investigation. Summary of the Invention
[0004] To address the aforementioned technical problems, this invention provides a pharmaceutical resin material and its preparation method.
[0005] The objective of this invention can be achieved through the following technical solutions: A pharmaceutical resin material comprises the following raw materials in parts by weight: 65-75 parts of functional polyacrylate, 25-35 parts of polylactic acid, and 0.1-0.3 parts of antioxidant; Furthermore, the antioxidant is obtained by mixing antioxidant 1010 and antioxidant 168 in a mass ratio of 1-2:1.
[0006] The preparation method of the pharmaceutical resin material includes the following steps: The functional polyacrylate is dried for 3-4 hours to obtain dried functional polyacrylate; polylactic acid is dried for 4-5 hours to obtain dried polylactic acid; the dried functional polyacrylate and antioxidant are mixed for 10-15 minutes to obtain mixture 1; mixture 1 and dried polylactic acid are heated and melted in a protective gas atmosphere, extruded and granulated, and dried at room temperature for 24-30 hours to obtain pharmaceutical resin material. Furthermore, the functional polyacrylate is vacuum dried at a temperature of 60-70°C; the polylactic acid is vacuum dried at a temperature of 80-85°C; the mixing speed for 10-15 minutes is 500-600 rpm. Furthermore, during the heating and melting process, the temperature control of each section is as follows: feeding section 170-175℃, compression section 180-185℃, homogenization section 185-190℃, screw speed 100-120rpm, residence time 3-5min; Furthermore, the particle size of the granulated particles is 3-5 mm.
[0007] Furthermore, the functional polyacrylate is prepared by the following steps: Step (1): Add starch and dicarboxylated polyethylene glycol to phosphate buffer, heat and stir, cool, add chitosan solution and activator, stir to react, dialyze, freeze dry to obtain product a; Step (2): Add methacrylic acid and methacrylate to an ethanol aqueous solution and stir. Then add an initiator, heat and stir to react. Pour into deionized water, filter, wash with ethanol, and dry to obtain product b. Step (3): After mixing and stirring product a and ethanol, add oleic acid, stir, then add p-toluenesulfonic acid, heat and stir, then add product b, continue stirring to obtain a reaction solution, and then post-process the reaction solution to obtain functional polyacrylate.
[0008] Furthermore, the preparation method of the functional polyacrylate includes the following specific steps: Step (1): Add starch and dicarboxylated polyethylene glycol to phosphate buffer, heat to 37-40℃, stir for 14-15h, cool to 25℃, add chitosan solution and activator, stir reaction for 12-14h, dialyze (MWCO 3.5 kDa) for 48-49h, freeze dry for 24-25h to obtain product a; Furthermore, the ratio of starch, dicarboxylated polyethylene glycol, phosphate buffer, chitosan solution, and activator is 1-1.5g: 1-1.2g: 30-40mL: 18-22mL: 0.4-0.5g; Furthermore, the pH of the phosphate buffer solution is 7.5-8.0; the chitosan solution is prepared by mixing chitosan and acetic acid solution at a ratio of 1-1.2g:10mL; the mass fraction of the acetic acid solution is 1-1.5%; the activator is prepared by mixing EDC and NHS at a molar ratio of 1.5-2:1-1.5. In step (1), product a is obtained by reacting the dicarboxyl group of dicarboxylated polyethylene glycol with some of the hydroxyl groups in starch and the amino groups in chitosan. Step (2): Add methacrylic acid and methacrylate to an ethanol aqueous solution and stir for 10-15 min. Add the initiator and stir the reaction at 80-85℃ for 2-2.5 h. Pour into deionized water, filter, wash with ethanol, and dry to obtain product b. Furthermore, the ratio of methacrylic acid, methacrylate, ethanol aqueous solution, and initiator is 20-22g: 20-22g: 200-220mL: 0.2-0.25g; the methacrylate is methyl methacrylate or ethyl methacrylate; the mass fraction of the ethanol aqueous solution is 35-40%; and the initiator is benzoyl peroxide. In step (2), methacrylic acid and methacrylate are polymerized to obtain polyacrylate; Step (3): Mix product a and ethanol and stir for 30-40 min, add oleic acid and stir for 35-45 min, then add p-toluenesulfonic acid and stir at 60-80℃ for 10-12 h, add product b and continue stirring for 24-25 h to obtain a reaction solution, stir the reaction solution and add it to cold methanol, let it stand for 3-4 h, centrifuge, wash with cold methanol, dialyze (MWCO 3.5 kDa) for 72-73 h, freeze dry for 48-49 h to obtain functional polyacrylate; Furthermore, the ratio of product a, ethanol, oleic acid, p-toluenesulfonic acid, and product b is 9-10g: 100-110mL: 3-4g: 50-60mg: 18-20g; the cold methanol is methanol at -25℃ to -20℃. In step (3), oleic acid reacts with the unreacted hydroxyl groups in product a to form an ester, and then polyacrylate is added. Through physical bonding and chemical esterification with the hydroxyl groups, functional polyacrylate is obtained.
[0009] This invention discloses a pharmaceutical resin material and its preparation method, wherein the pharmaceutical resin material is prepared from raw materials such as functional polyacrylate, polylactic acid, and antioxidants.
[0010] The beneficial effects of this invention are: 1. The functional polyacrylate used in this invention is obtained by reacting starch, dicarboxylated polyethylene glycol, and chitosan to produce product a, which is then reacted with oleic acid and product b (obtained by polymerization of methacrylic acid and methacrylate). In the preparation of product a, starch and dicarboxylated polyethylene glycol are thoroughly mixed to increase their contact area, facilitating full contact between the carboxyl groups of the dicarboxylated polyethylene glycol and the hydroxyl groups of the starch. Then, chitosan solution and an activator are added to graft the dicarboxylated polyethylene glycol, starch, and chitosan together.
[0011] 2. In the functional polyacrylate prepared by this invention, starch enhances molecular chain entanglement through hydrogen bonding, and chitosan forms a composite network through electrostatic interactions. The starch and chitosan synergistically enhance the viscosity and stability of the functional polyacrylate, which helps to improve the compressibility of drug particles prepared using pharmaceutical resin materials as binders, thereby increasing the retention time of drugs in oral or transdermal formulations. Blending the functional polyacrylate with polylactic acid to prepare pharmaceutical resins allows polylactic acid, chitosan, starch, etc., to form a biodegradable framework. After drug release, this synergistically enhances the biodegradability of the pharmaceutical resin, expanding its applicability.
[0012] 3. In the functional polyacrylate prepared by this invention, the polyether segments in the dicarboxylated polyethylene glycol have high segmental freedom, which improves molecular chain fluidity through flexible spacing, inhibits the tight stacking of polymer chains, reduces stress concentration points, and provides resistance to crack propagation; the flexible unsaturated alkane long chains in oleic acid weaken the inter-chain forces through van der Waals forces, expand the free volume, and improve the material's ductility and deformation capacity; the synergistic effect of dicarboxylated polyethylene glycol and oleic acid enhances the toughness of the functional polyacrylate; blending the highly tough functional polyacrylate with polylactic acid can improve the brittleness of polylactic acid, thereby obtaining a pharmaceutical resin material with strong toughness. Detailed Implementation
[0013] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0014] Example 1 Functional polyacrylates are prepared by the following steps: Step (1): Add starch (supplier: Aladdin, item number S104454) and dicarboxylated polyethylene glycol (supplier: Zhengzhou Aikem Chemical Co., Ltd., 1kg) to phosphate buffer (pH 7.6, supplier: Aladdin, item number P299410), heat to 37°C, stir for 14h, cool to 25°C, add chitosan solution and activator, stir reaction for 12h, dialyze with deionized water (MWCO 3.5 kDa) for 48h, freeze dry for 24h (specifically: cool to -50°C at a rate of 2°C / min, keep warm for 2h, then keep warm at -30°C for 18h, and finally keep warm at 20°C for 4h) to obtain product a; The ratio of starch, dicarboxylated polyethylene glycol, phosphate buffer, chitosan solution, and activator is 1g:1g:30mL:18mL:0.4g; the chitosan solution is obtained by mixing chitosan (supplier: Xi'an Jinxiang Pharmaceutical Excipients Co., Ltd., pharmaceutical grade chitosan) and a 1% acetic acid solution at a ratio of 1g:10mL; the activator is obtained by mixing EDC and NHS at a molar ratio of 1.5:1. Step (2): Add methacrylic acid and methyl methacrylate to an ethanol aqueous solution and stir for 10 min. Add benzoyl peroxide and stir at 80 °C for 2 h. Pour into 150 mL of deionized water, filter, wash six times with ethanol, and dry at 75 °C for 4 h to obtain product b. The ratio of methacrylic acid, methyl methacrylate, ethanol aqueous solution, and benzoyl peroxide is 20 g: 20 g: 200 mL: 0.2 g; the mass fraction of the ethanol aqueous solution is 35%; and the volume fraction of ethanol is 95%. Step (3): Mix product a and ethanol and stir for 30 min, add oleic acid and stir for 35 min, then add p-toluenesulfonic acid and stir at 60℃ for 10 h. Add product b and continue stirring for 24 h to obtain a reaction solution. Stir the reaction solution into 120 mL of cold methanol, let it stand for 3 h, centrifuge at 1000 rpm, wash six times with cold methanol, dialyze with deionized water (MWCO 3.5 kDa) for 72 h, and freeze dry for 48 h (specifically: cool to -50℃ at a rate of 2℃ / min, keep warm for 5 h, then keep warm at -30℃ for 35 h, and finally keep warm at 30℃ for 8 h) to obtain functional polyacrylate; the ratio of product a, ethanol, oleic acid, p-toluenesulfonic acid and product b is 9 g: 100 mL: 3 g: 50 mg: 18 g; the cold methanol is methanol at -20℃; the volume fraction of ethanol is 95%.
[0015] Example 2 Functional polyacrylates are prepared by the following steps: Step (1): Add starch (supplier: Aladdin, item number S104454) and dicarboxylated polyethylene glycol (supplier: Zhengzhou Aikem Chemical Co., Ltd., 1kg) to phosphate buffer (pH 7.6, supplier: Aladdin, item number P299410), heat to 39℃, stir for 14.5h, cool to 25℃, add chitosan solution and activator, stir reaction for 13h, dialyze with deionized water (MWCO 3.5 kDa) for 48.5h, freeze dry for 24.5h (specifically: cool to -50℃ at a rate of 2℃ / min, keep warm for 2h, then keep warm at -30℃ shelf temperature for 18.5h, and finally keep warm at 20℃ shelf temperature for 4h) to obtain product a; The ratio of starch, dicarboxylated polyethylene glycol, phosphate buffer, chitosan solution, and activator is 1.3g:1.1g:35mL:20mL:0.45g; the chitosan solution is obtained by mixing chitosan (supplier: Xi'an Jinxiang Pharmaceutical Excipients Co., Ltd., pharmaceutical grade chitosan) and a 1.3% acetic acid solution at a ratio of 1.1g:10mL; the activator is obtained by mixing EDC and NHS at a molar ratio of 1.8:1.2. Step (2): Add methacrylic acid and methyl methacrylate to an ethanol aqueous solution and stir for 13 min. Add benzoyl peroxide and stir at 83 °C for 2.3 h. Pour into 150 mL of deionized water, filter, wash six times with ethanol, and dry at 75 °C for 4 h to obtain product b. The ratio of methacrylic acid, methyl methacrylate, ethanol aqueous solution, and initiator is 21 g: 21 g: 210 mL: 0.23 g; the mass fraction of the ethanol aqueous solution is 37%; and the volume fraction of ethanol is 95%. Step (3): Mix product a and ethanol and stir for 35 min. Add oleic acid and stir for 40 min. Then add p-toluenesulfonic acid and stir at 70 °C for 11 h. Add product b and continue stirring for 24.5 h to obtain the reaction solution. Add the reaction solution to 120 mL of cold methanol and let it stand for 3.5 h. Centrifuge at 1000 rpm, wash six times with cold methanol, and dialyze using deionized water (MWCO 3.5). The product (kDa) was subjected to 72.5 h of freeze drying for 48.5 h (specifically: cooling to -50 °C at a rate of 2 °C / min, holding for 5 h, then holding at -30 °C on a shelf for 35.5 h, and finally holding at 30 °C on a shelf for 8 h) to obtain functional polyacrylate; the ratio of product a, ethanol, oleic acid, p-toluenesulfonic acid, and product b was 9.5 g: 105 mL: 3.5 g: 55 mg: 19 g; the cold methanol was methanol at -23 °C; and the volume fraction of ethanol was 95%.
[0016] Example 3 Functional polyacrylates are prepared by the following steps: Step (1): Add starch (supplier: Aladdin, item number S104454) and dicarboxylated polyethylene glycol (supplier: Zhengzhou Aikem Chemical Co., Ltd., 1kg) to phosphate buffer (pH 8.0, supplier: Aladdin, item number P299411), heat to 40℃, stir for 15h, cool to 25℃, add chitosan solution and activator, stir reaction for 14h, dialyze with deionized water (MWCO 3.5 kDa) for 49h, freeze dry for 25h (specifically: cool to -50℃ at a rate of 2℃ / min, keep warm for 2h, then keep warm at -30℃ shelf temperature for 19h, and finally keep warm at 20℃ shelf temperature for 4h) to obtain product a; The ratio of starch, dicarboxylated polyethylene glycol, phosphate buffer, chitosan solution, and activator is 1.5g:1.2g:40mL:22mL:0.5g; the chitosan solution is obtained by mixing chitosan (supplier: Xi'an Jinxiang Pharmaceutical Excipients Co., Ltd., pharmaceutical grade chitosan) and a 1.5% acetic acid solution at a ratio of 1.2g:10mL; the activator is obtained by mixing EDC and NHS at a molar ratio of 2:1.5. Step (2): Add methacrylic acid and methyl methacrylate to an ethanol aqueous solution and stir for 15 min. Add benzoyl peroxide and stir at 85 °C for 2.5 h. Pour into 150 mL of deionized water, filter, wash six times with ethanol, and dry at 75 °C for 4 h to obtain product b. The ratio of methacrylic acid, methyl methacrylate, ethanol aqueous solution, and initiator is 22 g: 22 g: 220 mL: 0.25 g; the mass fraction of the ethanol aqueous solution is 40%; and the volume fraction of ethanol is 95%. Step (3): Mix product a and ethanol and stir for 40 min. Add oleic acid and stir for 45 min. Then add p-toluenesulfonic acid and stir at 80 °C for 12 h. Add product b and continue stirring for 25 h to obtain the reaction solution. Stir the reaction solution into 120 mL of cold methanol and let it stand for 4 h. Centrifuge at 1000 rpm and wash six times with cold methanol. Dialyze with deionized water (MWCO 3.5 kDa) for 73 h and freeze dry for 49 h (specifically: cool down to -50 °C at a rate of 2 °C / min, keep warm for 5 h, keep warm at -30 °C for 36 h, and finally keep warm at 30 °C for 8 h) to obtain functional polyacrylate. The ratio of product a, ethanol, oleic acid, p-toluenesulfonic acid and product b is 10 g: 110 mL: 4 g: 60 mg: 20 g. The cold methanol is methanol at -25 °C. The volume fraction of ethanol is 95%.
[0017] Example 4 A pharmaceutical resin material comprises the following raw materials in parts by weight: 65 parts of functional polyacrylate obtained in Example 1, 25 parts of polylactic acid, and 0.1 parts of antioxidant; the antioxidant is obtained by mixing antioxidant 1010 and antioxidant 168 in a mass ratio of 1:1.
[0018] The preparation method of pharmaceutical resin materials includes the following steps: The functional polyacrylate obtained in Example 1 was vacuum dried at 60°C for 3 hours to obtain dried functional polyacrylate; polylactic acid (supplier: Wuhan Lanabai Pharmaceutical Chemical Co., Ltd., pharmaceutical grade) was vacuum dried at 80°C for 4 hours to obtain dried polylactic acid; the dried functional polyacrylate and antioxidant were mixed at 500 rpm for 10 minutes to obtain mixture 1; mixture 1 and dried polylactic acid were heated and melted in a nitrogen atmosphere, extruded and granulated, and dried at room temperature for 24 hours to obtain pharmaceutical resin material; during the heating and melting process, the temperature of each section was controlled as follows: feeding section 170°C, compression section 180°C, homogenization section 185°C, screw speed 100 rpm, residence time 3 minutes; the particle size of the granulated particles was 3 mm.
[0019] Example 5 A pharmaceutical resin material comprises the following raw materials in parts by weight: 70 parts of functional polyacrylate obtained in Example 2, 30 parts of polylactic acid (supplier: Wuhan Lanabai Pharmaceutical Chemical Co., Ltd., pharmaceutical grade), and 0.2 parts of antioxidant; the antioxidant is obtained by mixing antioxidant 1010 and antioxidant 168 in a mass ratio of 1.5:1.
[0020] The preparation method of pharmaceutical resin materials includes the following steps: The functional polyacrylate obtained in Example 2 was vacuum dried at 65°C for 3.5 h to obtain dried functional polyacrylate; polylactic acid was vacuum dried at 83°C for 4.5 h to obtain dried polylactic acid; the dried functional polyacrylate and antioxidant were mixed at 550 rpm for 13 min to obtain mixture 1; mixture 1 and dried polylactic acid were heated and melted in a nitrogen atmosphere, extruded and granulated, and dried at room temperature for 27 h to obtain pharmaceutical resin material; during the heating and melting process, the temperature of each section was controlled as follows: feeding section 173°C, compression section 183°C, homogenization section 188°C, screw speed 110 rpm, residence time 4 min; the particle size of the granulated particles was 4 mm.
[0021] Example 6 A pharmaceutical resin material comprises the following raw materials in parts by weight: 75 parts of functional polyacrylate obtained in Example 3, 35 parts of polylactic acid (supplier: Wuhan Lanabai Pharmaceutical Chemical Co., Ltd., pharmaceutical grade), and 0.3 parts of antioxidant; the antioxidant is obtained by mixing antioxidant 1010 and antioxidant 168 in a mass ratio of 2:1.
[0022] The preparation method of pharmaceutical resin materials includes the following steps: The functional polyacrylate obtained in Example 3 was vacuum dried at 70°C for 4 hours to obtain dried functional polyacrylate; polylactic acid was vacuum dried at 85°C for 5 hours to obtain dried polylactic acid; the dried functional polyacrylate and antioxidant were mixed at 600 rpm for 15 minutes to obtain mixture 1; mixture 1 and dried polylactic acid were heated and melted in a nitrogen atmosphere, extruded and granulated, and dried at room temperature for 30 hours to obtain pharmaceutical resin material; during the heating and melting process, the temperature of each section was controlled as follows: feeding section 175°C, compression section 185°C, homogenization section 190°C, screw speed 120 rpm, residence time 5 minutes; the particle size of the granulated particles was 5 mm.
[0023] Comparative Example 1 Compared with Example 6, product a used in the preparation of the functional polyacrylate was replaced with product a-1, and the rest was exactly the same as in Example 6, to obtain a pharmaceutical resin material. Preparation method of product a-1: Starch, chitosan solution, and dicarboxylated polyethylene glycol (supplier: Zhengzhou Aikem Chemical Co., Ltd., 1 kg) were added to phosphate buffer, heated to 40℃, stirred for 15 h, cooled to 25℃, an activator was added, and the reaction was stirred for 14 h. Dialysis was performed with deionized water (MWCO 3.5). The product a-1 was obtained by freeze-drying for 49 hours (specifically, by cooling to -50°C at a rate of 2°C / min, holding for 2 hours, then holding at -30°C for 19 hours, and finally holding at 20°C for 4 hours) for 25 hours. The ratio of starch, dicarboxylated polyethylene glycol, phosphate buffer, chitosan solution, and activator was 1.5g:1.2g:40mL:22mL:0.5g. The pH of the phosphate buffer was 8.0. The chitosan solution was obtained by mixing chitosan (supplier: Xi'an Jinxiang Pharmaceutical Excipients Co., Ltd., pharmaceutical grade chitosan) and acetic acid solution with a mass fraction of 1.5% at a ratio of 1.2g:10mL. The activator was obtained by mixing EDC and NHS at a molar ratio of 2:1.5.
[0024] Comparative Example 2 Compared with Example 6, the dicarboxylated polyethylene glycol used in the preparation of the functional polyacrylate was replaced with succinic acid, and the rest was exactly the same as in Example 6, to obtain a pharmaceutical resin material.
[0025] Comparative Example 3 Compared with Example 6, the functional polyacrylate used was replaced with functional polyacrylate-1, and the rest was exactly the same as in Example 6, to obtain a pharmaceutical resin material; The specific steps are as follows: Product a and ethanol were mixed and stirred for 40 min, oleic acid and product b were added, and stirred for 45 min. Then p-toluenesulfonic acid was added, and the mixture was stirred at 80℃ for 37 h to obtain a reaction solution. The reaction solution was stirred and added to cold methanol, allowed to stand for 4 h, centrifuged at 1000 rpm, washed with cold methanol, dialyzed with deionized water (MWCO 3.5 kDa) for 73 h, and freeze-dried for 49 h (specifically: cooled to -50℃ at a rate of 2℃ / min, kept at that temperature for 5 h, then kept at a shelf temperature of -30℃ for 36 h, and finally kept at a shelf temperature of 30℃ for 8 h) to obtain functional polyacrylate-1. The ratio of product a, ethanol, oleic acid, product b, and p-toluenesulfonic acid was 10 g: 110 mL: 4 g: 20 g: 60 mg; the cold methanol was methanol at -25℃; and the volume fraction of ethanol was 95%.
[0026] The effects of the pharmaceutical resin material prepared by this invention are further tested below, and the test results are shown in the figure.
[0027] Viscosity test: 10g of the pharmaceutical resin material obtained in Examples 4-6 and Comparative Examples 1-3 of this invention was mixed with 90mL of ethyl acetate and stirred at 60℃ for 2.5h to obtain the sample to be tested. The viscosity of the sample to be tested was measured using an NDJ-1 type rotary viscometer.
[0028] Elongation at break determination: The test sample was prepared according to the above preparation method. The test sample was dried at 90℃ for 4h to form a film. The dumbbell-shaped sample was prepared according to GB / T 1040.1-2025, and the elongation at break was determined to evaluate the toughness of the pharmaceutical resin material.
[0029] The results are recorded in Table 1; Table 1: Test Results According to the data in Table 1, the pharmaceutical resin material of the present invention has good viscosity and toughness.
[0030] A comparison of Example 6 and Comparative Example 1 shows that replacing product a in the preparation of the functional polyacrylate with product a-1 indicates that the pharmaceutical resin material prepared using product a in this invention has higher viscosity and stronger toughness.
[0031] A comparison of Example 6 and Comparative Example 2 shows that replacing the dicarboxylated polyethylene glycol used in the preparation of the functional polyacrylate with succinic acid demonstrates that the pharmaceutical resin material prepared using dicarboxylated polyethylene glycol in this invention has higher viscosity and stronger toughness.
[0032] A comparison of Example 6 and Comparative Example 3 shows that replacing the functional polyacrylate with functional polyacrylate-1 demonstrates that the pharmaceutical resin material prepared by the present invention using functional polyacrylate has higher viscosity and stronger toughness.
[0033] The above description is merely an example and illustration of the concept of the present invention. Those skilled in the art can make various modifications or additions to the specific embodiments described or use similar methods to replace them, as long as they do not deviate from the concept of the invention or exceed the scope defined in the claims, they should all fall within the protection scope of the present invention.
Claims
1. A pharmaceutical resin material, characterized in that: It includes the following raw materials in parts by weight: 65-75 parts of functional polyacrylate, 25-35 parts of polylactic acid, and 0.1-0.3 parts of antioxidant.
2. The pharmaceutical resin material according to claim 1, characterized in that: The functional polyacrylate is prepared by the following steps: Step (1): Add starch and dicarboxylated polyethylene glycol to phosphate buffer, heat and stir, cool, add chitosan solution and activator, stir to react, dialyze, freeze dry to obtain product a; Step (2): Add methacrylic acid and methacrylate to an ethanol aqueous solution and stir. Then add an initiator, heat and stir to react. Pour into deionized water, filter, wash with ethanol, and dry to obtain product b. Step (3): After mixing and stirring product a and ethanol, add oleic acid, stir, then add p-toluenesulfonic acid, heat and stir, then add product b, continue stirring to obtain a reaction solution, and then post-process the reaction solution to obtain functional polyacrylate.
3. The pharmaceutical resin material according to claim 2, characterized in that: In step (1), the ratio of starch, dicarboxylated polyethylene glycol, phosphate buffer, chitosan solution and activator is 1-1.5g: 1-1.2g: 30-40mL: 18-22mL: 0.4-0.5g.
4. The pharmaceutical resin material according to claim 3, characterized in that: The chitosan solution is obtained by mixing and stirring chitosan and acetic acid solution at a ratio of 1-1.2g:10mL; the activator is obtained by mixing EDC and NHS at a molar ratio of 1.5-2:1-1.
5.
5. The pharmaceutical resin material according to claim 2, characterized in that: In step (2), the ratio of the amount of methacrylic acid, methacrylate, aqueous ethanol solution and initiator is 20-22g: 20-22g: 200-220mL: 0.2-0.25g.
6. The pharmaceutical resin material according to claim 2, characterized in that: In step (3), the ratio of product a, ethanol, oleic acid, p-toluenesulfonic acid and product b is 9-10g: 100-110mL: 3-4g: 50-60mg: 18-20g.
7. A method for preparing a pharmaceutical resin material according to any one of claims 1-6, characterized in that: Includes the following steps: The functional polyacrylate is dried for 3-4 hours to obtain dried functional polyacrylate; polylactic acid is dried for 4-5 hours to obtain dried polylactic acid; the dried functional polyacrylate and antioxidant are mixed for 10-15 minutes to obtain mixture 1; mixture 1 and dried polylactic acid are heated and melted in a protective gas atmosphere, extruded and granulated, and dried at room temperature for 24-30 hours to obtain pharmaceutical resin material.
8. The method for preparing a pharmaceutical resin material according to claim 7, characterized in that: The functional polyacrylate is vacuum dried at a temperature of 60-70°C; the polylactic acid is vacuum dried at a temperature of 80-85°C; and the mixing speed for 10-15 minutes is 500-600 rpm.
9. The method for preparing a pharmaceutical resin material according to claim 7, characterized in that: During the heating and melting process, the temperature control of each section is as follows: feeding section 170-175℃, compression section 180-185℃, homogenization section 185-190℃, screw speed 100-120rpm, and residence time 3-5min.