CN104434870A - Enteric-coated gelatine empty capsules and preparation method thereof - Google Patents
Enteric-coated gelatine empty capsules and preparation method thereof Download PDFInfo
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- CN104434870A CN104434870A CN201410582510.4A CN201410582510A CN104434870A CN 104434870 A CN104434870 A CN 104434870A CN 201410582510 A CN201410582510 A CN 201410582510A CN 104434870 A CN104434870 A CN 104434870A
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Abstract
The invention discloses enteric-coated gelatine empty capsules. The enteric-coated gelatine empty capsules comprise the following components in parts by weight: 100 parts by weight of gelatine, 3-8 parts by weight of water, 8-15 parts by weight of sodium alginate, 8-15 parts by weight of acrylic resin, 20-45 parts by weight of n-butyl acetate, 5-25 parts by weight of sodium lauryl sulphate and 0-8 parts by weight of colorant. The invention further discloses a preparation method of the enteric-coated gelatine empty capsules. The preparation method disclosed by the invention is capable of effectively solving the technical problems of solvent evaporation during a forming process, resource waste, cost increase and air pollution, thus the capsule shell performance of the produced capsules is more excellent, and the pass percent of finished products is greatly increased.
Description
Technical field
The invention belongs to pharmaceutic adjuvant technical field, relate to a kind of enteric gelatin hollow capsule, also relate to the preparation method of this kind of enteric gelatin hollow capsule.
Background technology
Enteric hollow capsule, also known as softgel shell, refers to that softgel shell is insoluble in gastric juice, but can disintegrate or dissolving and discharge medicine in capsule in intestinal juice, and softgel shell is also the major auxiliary burden of processing medicament capsule preparation.The enteric hollow capsule of current use is by the enteric-coating material of the anti-gastric acid of outsourcing after gelatin machine-shaping.Gelatin is first with purified water immersion, swelling rear glue, after send capsule production line through dipping in gum forming, dry solidification, obtaining gelatin hollow capsule capsule material, after enteric coating process is carried out on gelatin hollow capsule capsule material surface, form enteric hollow capsule capsule material again, then the operation such as dry solidification cooling, cutting obtains enteric hollow capsule.Described glue is exactly dropped in mixing kettle to heat up by the gelatin after swelling together with water surface activating agent etc. to stir, and after filtration, obtains sizing material after bubble removing, tune proportion.
Current enteric hollow capsule is primarily of the enteric-coating material of anti-gastric acid and gelatin composition.The enteric-coating material of anti-gastric acid mostly is CAP or acrylic resin, and must use ethanol and acetone as solvent when coating, solvent volatilization in forming process, on the one hand wastes resource, raises the cost, contaminated air, also has residual on the other hand in softgel shell.
Summary of the invention
The object of this invention is to provide a kind of enteric gelatin hollow capsule, effectively can control the water content of products material, the softgel shell performance that production is obtained is more excellent, and product qualified rate improves greatly.
Another object of the present invention is to provide the preparation method of this kind of enteric gelatin hollow capsule.
For technical solution problem, the present invention adopts following technical scheme:
A kind of enteric gelatin hollow capsule, comprise following component, each component is respectively according to weight portion:
The preparation method of this kind of enteric gelatin hollow capsule, its preparation process comprises: add gelatin and water in a kettle., pass into steamed 30 ~ 40min, temperature controls, at 20 ~ 30 DEG C, to be warming up to 70 ~ 85 DEG C, after stirring, slowly add sodium lauryl sulphate, continue stirring 25 ~ 40min, add sodium alginate, continue to stir, standing and reacting 2 ~ 3h; Then send into capsule production line to carry out dipping in glue, molding, obtain gelatin hollow capsule capsule material; Cotton seeds is carried out on the gelatin hollow capsule capsule material surface that the mixed liquor of acrylic resin, n-butyl acetate and coloring agent is obtaining, strong agitation, dry again, bake out temperature is 60 ~ 80 DEG C, drying time is 0.5 ~ 2h, constantly vibrate through vibrosieve in drying course, final curing cooling, cutting, obtain enteric gelatin hollow capsule.
Through steamed after gelatin and water mix by the present invention, about steaming half an hour under first keeping low temperature, gelatin can be made swelling, and have certain Fermentation, then heating up makes gelatin reach ripening, add Surfactant SDS again, and flocculation aid sodium alginate, then carry out dipping in the operations such as glue, molding, coating, oven dry, solidification cooling, cutting.Wherein during coating, by acrylic resin and n-butyl acetate mixing, after stirring, glue Capsules capsule material is soaked in the mixed liquor of acrylic resin and n-butyl acetate, strong agitation, adopt spraying method to spray glue Capsules capsule material after 20 ~ 30min, in spraying process, glue Capsules capsule material constantly vibrates in vibrosieve, dries after twice spraying again.
The present invention adopts n-butyl acetate to substitute acetone solvent in tradition, n-butyl acetate is non-volatile, effectively can solve solvent volatilization in forming process, waste resource, raise the cost, air-polluting technical problem, through strong agitation during Cotton seeds, and vibrate in drying course, residual in softgel shell of solvent can be made to greatly reduce.Meanwhile, n-butyl acetate has happy fruit aroma, can regulate the mouthfeel of enteric gelatin hollow capsule product very well, and crowd's likability on probation increases by 15 ~ 20% than in prior art.Sodium alginate, as flocculation aid, is conducive to solidifying of products material, is conducive to dipping in glue, the carrying out smoothly of molding, in addition, enteric gelatin hollow capsule product can also be made to obtain good printing performance unexpectedly.
Preferably, enteric gelatin hollow capsule comprises following component, and each component is respectively according to weight portion:
Wherein, when not adding coloring agent, the enteric gelatin hollow capsule obtained is transparent.
Preferably, enteric gelatin hollow capsule comprises following component, and each component is respectively according to weight portion:
Preferably, enteric gelatin hollow capsule comprises following component, and each component is respectively according to weight portion:
Compared with prior art, the present invention has following beneficial effect:
1, during coating of the present invention, by acrylic resin and n-butyl acetate mixing, after stirring, glue Capsules capsule material is soaked in the mixed liquor of acrylic resin and n-butyl acetate, strong agitation, adopt spraying method to spray glue Capsules capsule material after 20 ~ 30min, in spraying process, glue Capsules capsule material constantly vibrates in vibrosieve, dries after twice spraying again, can ensure that coating is even, smooth surface, excellent appearance, is more conducive to printing.
2, the present invention adopts n-butyl acetate to substitute acetone solvent in tradition, n-butyl acetate is non-volatile, effectively can solve solvent volatilization in forming process, waste resource, raise the cost, air-polluting technical problem, through strong agitation during Cotton seeds, and vibrate in drying course, residual in softgel shell of solvent can be made to greatly reduce.Meanwhile, n-butyl acetate has happy fruit aroma, can regulate the mouthfeel of enteric gelatin hollow capsule product very well, and crowd's likability on probation increases by 15 ~ 20% than in prior art.
3, in the present invention, sodium alginate, as flocculation aid, is conducive to solidifying of products material, is conducive to dipping in glue, the carrying out smoothly of molding, in addition, enteric gelatin hollow capsule product can also be made to obtain good printing performance unexpectedly.
Below in conjunction with detailed description of the invention, the invention will be further described:
Detailed description of the invention
A kind of enteric gelatin hollow capsule embodiment 1 of the present invention, comprise following component, each component is respectively according to weight portion:
The preparation method of this kind of enteric gelatin hollow capsule is as follows: add gelatin and water in a kettle., pass into steamed 30 ~ 40min, temperature controls at 20 ~ 30 DEG C, be warming up to 70 ~ 85 DEG C, after stirring, slowly add sodium lauryl sulphate, continue stirring 25 ~ 40min, add sodium alginate, continue to stir, standing and reacting 2 ~ 3h; Then send into capsule production line to carry out dipping in glue, molding, obtain gelatin hollow capsule capsule material; Cotton seeds is carried out on the gelatin hollow capsule capsule material surface that the mixed liquor of acrylic resin, n-butyl acetate is obtaining, strong agitation, dry again, bake out temperature is 60 ~ 80 DEG C, drying time is 0.5 ~ 2h, constantly vibrate through vibrosieve in drying course, final curing cooling, cutting, obtain enteric gelatin hollow capsule.
A kind of enteric gelatin hollow capsule embodiment 2 of the present invention, comprise following component, each component is respectively according to weight portion:
The preparation method of this kind of enteric gelatin hollow capsule is identical with embodiment 1.
A kind of enteric gelatin hollow capsule embodiment 3 of the present invention, comprise following component, each component is respectively according to weight portion:
The preparation method of this kind of enteric gelatin hollow capsule is identical with embodiment 1.
Enteric gelatin hollow capsule comparative example of the prior art, comprises following component, and each component is respectively according to weight portion:
The preparation method of this kind of enteric gelatin hollow capsule is as follows: gelatin and water are stirred, and is heated to 70 ~ 75 DEG C, then adds sodium lauryl sulphate, stir, standing and reacting 4 ~ 5h, then sends into capsule production line and carries out dipping in glue, molding; Then be soaked in the mixed liquor of acrylic resin, acetone and coloring agent, then dry, bake out temperature is 30 DEG C, and drying time is 3 ~ 4h, and final curing cooling, cutting, obtain enteric gelatin hollow capsule product.
The disintegration, friability, printing, fertility performance etc. of the enteric gelatin hollow capsule product that embodiment 1 ~ 3 obtains are detected, judge whether the standard meeting enteric hollow capsule in " Chinese Pharmacopoeia ", be compared with the prior art example to compare, testing result is as shown in table 1 simultaneously.
The detection method of disintegration: get this product 6, fill Pulvis Talci, according to the method under disintegration inspection technique (annex X A) capsule item, add baffle plate inspection, each grain all should dissolve or disintegrate in 10 minutes.All can not dissolve or disintegrate if any 1, separately should get 6 retrials, all should conform with the regulations.
The detection method of friability: get this product 50, put in surface plate, moving into fills in the exsiccator of magnesium nitrate saturated solution, put 25 DEG C ± 1 DEG C constant temperature 24 hours, take out, (internal diameter is 24nm to put into by grain the glass tubing stood upright on plank (thickness 2cm) respectively immediately, long is 200nm) in, by cylindrical counterweight, (material is politef, diameter is 22mm, weighs 20g ± 0.1g) freely fall from the glass mouth of pipe, whether break depending on capsule, if any breaking, must not more than 5.
Table 1
Test result shows, the 2010 editions disintegration > 2hs of " Chinese Pharmacopoeia " hollow core capsule in gastric juice, < 10min disintegration in intestinal juice, enteric gelatin hollow capsule product of the present invention all meets the standard of " Chinese Pharmacopoeia ", disintegration in gastric juice is obviously greater than comparative example, more ensure that and can not dissolve under one's belt or disintegrate, the content in capsule is avoided to cause stimulation to stomach, and be significantly less than comparative example the disintegration in intestinal juice, can ensure to absorb rapidly at enteral at medicine, make drug effect more remarkable.The grain number broken in the detection of friability is fewer, illustrate that capsule pliability is better, as can be seen from Table 1, the grain number that enteric gelatin hollow capsule product of the present invention breaks minimizing more obvious than comparative example, and obtain more excellent printing performance unexpectedly, the outward appearance of product is also obviously better than prior art, and yield rate is also significantly improved.The capsule that the present invention finally obtains is described, the combination property of product is all significantly improved than prior art.
The foregoing is only specific embodiments of the invention, but technical characteristic of the present invention is not limited thereto, any those skilled in the art is in the field of the invention, and the change done or modification are all encompassed among the scope of the claims of the present invention.
Claims (5)
1. an enteric gelatin hollow capsule, is characterized in that: comprise following component, and each component is respectively according to weight portion:
2. a kind of enteric gelatin hollow capsule as claimed in claim 1, it is characterized in that: comprise following component, each component is respectively according to weight portion:
3. a kind of enteric gelatin hollow capsule as claimed in claim 1, it is characterized in that: comprise following component, each component is respectively according to weight portion:
4. a kind of enteric gelatin hollow capsule as claimed in claim 1, it is characterized in that: comprise following component, each component is respectively according to weight portion:
5. the preparation method of a kind of enteric gelatin hollow capsule as claimed in claim 1, it is characterized in that: its preparation process comprises: add gelatin and water in a kettle., pass into steamed 30 ~ 40min, temperature controls, at 20 ~ 30 DEG C, to be warming up to 70 ~ 85 DEG C, after stirring, slowly add sodium lauryl sulphate, continue stirring 25 ~ 40min, add sodium alginate, continue to stir, standing and reacting 2 ~ 3h; Then send into capsule production line to carry out dipping in glue, molding, obtain gelatin hollow capsule capsule material; Cotton seeds is carried out on the gelatin hollow capsule capsule material surface that the mixed liquor of acrylic resin, n-butyl acetate and coloring agent is obtaining, strong agitation, dry again, bake out temperature is 60 ~ 80 DEG C, drying time is 0.5 ~ 2h, constantly vibrate through vibrosieve in drying course, final curing cooling, cutting, obtain enteric gelatin hollow capsule.
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| CN201410582510.4A CN104434870B (en) | 2014-10-27 | 2014-10-27 | A kind of enteric gelatin hollow capsule and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108451920A (en) * | 2018-03-14 | 2018-08-28 | 绍兴康可胶囊有限公司 | A kind of suction mist formula capsule and preparation method thereof |
| CN112107562A (en) * | 2019-06-04 | 2020-12-22 | 绍兴康可胶囊有限公司 | Suction type hollow capsule and preparation process thereof |
| CN112472680A (en) * | 2020-12-15 | 2021-03-12 | 江苏力凡胶囊有限公司 | Anti-crisp capsule and preparation method thereof |
| EP4169503A1 (en) | 2021-10-20 | 2023-04-26 | Tessenderlo Group NV | Composition comprising gelatin, gelatin films and capsules |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108451920A (en) * | 2018-03-14 | 2018-08-28 | 绍兴康可胶囊有限公司 | A kind of suction mist formula capsule and preparation method thereof |
| CN112107562A (en) * | 2019-06-04 | 2020-12-22 | 绍兴康可胶囊有限公司 | Suction type hollow capsule and preparation process thereof |
| CN112472680A (en) * | 2020-12-15 | 2021-03-12 | 江苏力凡胶囊有限公司 | Anti-crisp capsule and preparation method thereof |
| EP4169503A1 (en) | 2021-10-20 | 2023-04-26 | Tessenderlo Group NV | Composition comprising gelatin, gelatin films and capsules |
| WO2023067092A1 (en) | 2021-10-20 | 2023-04-27 | Tessenderlo Group Nv | Composition comprising gelatin, gelatin films and capsules |
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| CN104434870B (en) | 2017-10-10 |
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Denomination of invention: Enteric gelatin hollow capsule and preparation method thereof Effective date of registration: 20191104 Granted publication date: 20171010 Pledgee: Xinchang Zhejiang rural commercial bank Limited by Share Ltd. Pledgor: SHAOXING KANGKE CAPSULE Co.,Ltd. Registration number: Y2019330000164 |
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Date of cancellation: 20220711 Granted publication date: 20171010 Pledgee: Xinchang Zhejiang rural commercial bank Limited by Share Ltd. Pledgor: SHAOXING KANGKE CAPSULE Co.,Ltd. Registration number: Y2019330000164 |
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