CN109602718A - A kind of enteric plant soft capsule and preparation method thereof - Google Patents
A kind of enteric plant soft capsule and preparation method thereof Download PDFInfo
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- CN109602718A CN109602718A CN201811580000.8A CN201811580000A CN109602718A CN 109602718 A CN109602718 A CN 109602718A CN 201811580000 A CN201811580000 A CN 201811580000A CN 109602718 A CN109602718 A CN 109602718A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
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Abstract
The present invention relates to a kind of enteric plant soft capsule and preparation method thereof, including softgel shell, the softgel shell includes interior softgel shell and outer softgel shell, the interior softgel shell and outer softgel shell gap setting, and multiple supporters for maintaining the gap are provided in the gap;The outer softgel shell includes the raw material of following parts by weight: 50 ~ 70 parts of sesbania gums, 10 ~ 15 parts of hydroxypropyl celluloses, 15 ~ 20 parts of konjac glucomannans, 1 ~ 5 part of sour mediator agent;The interior softgel shell includes the raw material of following parts by weight: 50 ~ 70 parts of sesbania gums, 10 ~ 15 parts of hydroxypropyl celluloses, 5 ~ 8 parts of pulullan polysaccharides, 3 ~ 6 portions of modified starches, 15 ~ 20 parts of konjac glucomannans.The present invention can be very good to control decomposition of the outer softgel shell in gastric juice, and the filler in interior softgel shell is avoided to dissolve out because of the decomposition of interior softgel shell, at the same reduce because softgel shell it is damaged caused by content dissolution, capsule has bigger flexibility.
Description
Technical field
The present invention relates to capsulae enterosolubilis technical fields more particularly to a kind of enteric plant soft capsule and preparation method thereof.
Background technique
Soft capsule be using from natural plants plant cellulose or water-soluble polysaccharide as raw material, drug is wrapped up
Sealing and a kind of manufactured soft capsule, sizing material mostly replace gelatin with natural, semi-synthetic and synthetic, can effectively avoid crazy
The propagation of cattle disease and the generation of toxic capsule event, and be able to satisfy vegetarian etc. and require.
Capsulae enterosolubilis is that one kind can be disintegrated in small enteral and discharge the capsule of drug, is typically used as the medicine haveing damage to stomach
Object packaging material.Existing capsulae enterosolubilis, is mostly made with gelatin and enteric-coating material, can make capsule in the acidic environment of stomach not
Disintegration, and small intestine can be entered with gastric emptying, it is disintegrated in the alkaline environment of small intestine, discharges drug.
Enteric plant soft capsule can avoid on the basis of realizing the function of capsulae enterosolubilis by using gelatin to be brought
The drawbacks of, it therefore, is widely noticed in recent years, but the disintegration of enteric plant soft capsule control is need further to be promoted.
Summary of the invention
In view of the above-mentioned problems, the object of the present invention is to provide a kind of enteric plant soft capsules and preparation method thereof.
In order to solve the above-mentioned technical problem, the first aspect of the present invention provides a kind of enteric plant soft capsule, including capsule
Shell, the softgel shell include interior softgel shell and outer softgel shell, the interior softgel shell and outer softgel shell gap setting, are provided with and are used in the gap
Maintain multiple supporters in the gap;
The outer softgel shell includes the raw material of following parts by weight: 50 ~ 70 parts of sesbania gums, 10 ~ 15 parts of hydroxypropyl celluloses, 15 ~ 20 parts
Konjac glucomannan, 1 ~ 5 part of sour mediator agent;
The interior softgel shell includes the raw material of following parts by weight: 50 ~ 70 parts of sesbania gums, 10 ~ 15 parts of hydroxypropyl celluloses, 5 ~ 8 parts it is general
Shandong orchid polysaccharide, 3 ~ 6 portions of modified starches, 15 ~ 20 parts of konjac glucomannans.
Further, the raw material composition of the multiple supporter is consistent with the raw material composition of the interior softgel shell.
Further, the outer softgel shell with a thickness of 2 ~ 3mm.
The second aspect of the present invention provides a kind of preparation method of enteric plant soft capsule, and the method includes following steps
It is rapid:
Step S1, by 50 ~ 70 parts of sesbania gums, 10 ~ 15 parts of hydroxypropyl celluloses, 15 ~ 20 parts of konjac glucomannans be dissolved in 100 parts of room temperature go from
In sub- water, outer softgel shell dispersion liquid is stirred to get;Using capsule shells dispersion liquid described in microwave heating to after 80 ~ 100 DEG C, stirs and protect
Then 30 ~ 90min of temperature is cooled to 50 ~ 60 DEG C, 1 ~ 5 part of sour mediator agent is added, stirs and keeps the temperature 30 ~ 50min, be cooled to 22 ~ 25
DEG C, 60 ~ 120min is stirred and kept the temperature, outer softgel shell colloidal solution is obtained;
Step S2, by 50 ~ 70 parts of sesbania gums, 10 ~ 15 parts of hydroxypropyl celluloses, 5 ~ 8 parts of pulullan polysaccharides, 3 ~ 6 portions of modified starches,
15 ~ 20 parts of konjac glucomannans are dissolved in 100 parts of deionized water at normal temperature, stir to get interior softgel shell dispersion liquid;Using glue described in microwave heating
Softgel shell dispersion liquid stirs and keeps the temperature 30 ~ 90min to after 80 ~ 100 DEG C, be then cooled to 22 ~ 25 DEG C, stir and keep the temperature 60 ~
120min obtains interior softgel shell colloidal solution;
Step S3 pours into outer softgel shell colloidal solution and interior softgel shell colloidal solution in the correspondence chamber of capsule die respectively, described
Capsule die includes first chamber and second chamber, and wherein first chamber is connected to second chamber by support chamber, through the glue
Capsule mold forms to obtain the enteric plant soft capsule.
Further, the frequency of the microwave is 150 ~ 300MHz.
Further, the first chamber is corresponding with the outer softgel shell colloidal solution, the first chamber with a thickness of 2
~3mm。
A kind of enteric plant soft capsule of the invention and preparation method thereof, has the following beneficial effects:
The softgel shell of enteric plant soft capsule of the invention includes interior softgel shell and outer softgel shell, and outer softgel shell includes sour mediator agent, therefore is had
There is certain acid-resisting, can be very good to control decomposition of the outer softgel shell in gastric juice, avoid the filler in interior softgel shell because of capsula interna
The decomposition of shell and dissolve out.
In addition, interior softgel shell and outer softgel shell gap setting, multiple for maintaining the gap are provided in the gap
Support body, the dissolution of the content caused by reducing because of softgel shell breakage, while capsule has bigger flexibility.
In addition, including sesbania gum in capsule shells of the invention, the addition of the sesbania gum can shorten capsule shells in intestinal juice
Disintegration time, accelerate the release of content.
The disintegration time limited of enteric slow release plant capsule of the invention is to be greater than 2 hours in gastric juice, 10 ~ 15 points in intestinal juice
Disintegration, meets the regulation of pharmacopeia in clock.
Specific embodiment
The following is a clear and complete description of the technical scheme in the embodiments of the invention, it is clear that described embodiment
Only a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, the common skill in this field
Art personnel every other embodiment obtained without making creative work belongs to the model that the present invention protects
It encloses.
Embodiment 1
The present embodiment provides a kind of enteric plant soft capsule, including softgel shell, the softgel shell includes interior softgel shell and outer softgel shell, it is described in
Softgel shell and outer softgel shell gap setting are provided with multiple supporters for maintaining the gap in the gap.
The outer softgel shell includes the raw material of following parts by weight: 50 parts of sesbania gums, 10 parts of hydroxypropyl celluloses, 15 portions of konjakus
Glue, 3 parts of sour mediator agents.
The interior softgel shell includes the raw material of following parts by weight: 50 parts of sesbania gums, 10 parts of hydroxypropyl celluloses, 5 parts of Propirams
Polysaccharide, 3 portions of modified starches, 15 parts of konjac glucomannans.
The raw material composition of the multiple supporter is consistent with the raw material composition of the interior softgel shell, and being includes following parts by weight
Raw material: 50 parts of sesbania gums, 10 parts of hydroxypropyl celluloses, 5 parts of pulullan polysaccharides, 3 portions of modified starches, 15 parts of konjac glucomannans.
The outer softgel shell with a thickness of 2mm.
The preparation method of above-mentioned enteric plant soft capsule the following steps are included:
50 parts of sesbania gums, 10 parts of hydroxypropyl celluloses, 15 parts of konjac glucomannans are dissolved in 100 parts of deionized water at normal temperature, stir by step S1
It mixes to obtain outer softgel shell dispersion liquid;Using frequency is capsule shells dispersion liquid described in the microwave heating of 150MHz to after 80 DEG C, and stirring is simultaneously
30min is kept the temperature, is then cooled to 50 DEG C, 3 parts of sour mediator agents are added, stir and keep the temperature 30min, are cooled to 22 ~ 25 DEG C, stirring is simultaneously
60min is kept the temperature, outer softgel shell colloidal solution is obtained.
Step S2, by 50 parts of sesbania gums, 10 parts of hydroxypropyl celluloses, 5 parts of pulullan polysaccharides, 3 portions of modified starches, 15 parts of evil spirits
Taro peptization stirs to get interior softgel shell dispersion liquid in 100 parts of deionized water at normal temperature;Use frequency for the microwave heating of 150MHz institute
Capsule shells dispersion liquid is stated to after 80 DEG C, stirs and keeps the temperature 30min, be then cooled to 22 ~ 25 DEG C, stir and keep the temperature 60min, obtain
Interior softgel shell colloidal solution.
Step S3, takes capsule die, which includes first chamber and second chamber, wherein first chamber and second
Chamber by support chamber connection, first chamber with a thickness of 2mm.First outer softgel shell colloidal solution is poured into first chamber, then
Interior softgel shell colloidal solution is poured into second chamber, forms to obtain the enteric plant soft capsule through the capsule die.
Embodiment 2
The present embodiment provides a kind of enteric plant soft capsule, including softgel shell, the softgel shell includes interior softgel shell and outer softgel shell, it is described in
Softgel shell and outer softgel shell gap setting are provided with multiple supporters for maintaining the gap in the gap.
The outer softgel shell includes the raw material of following parts by weight: 60 parts of sesbania gums, 12 parts of hydroxypropyl celluloses, 18 portions of konjakus
Glue, 1 part of sour mediator agent.
The interior softgel shell includes the raw material of following parts by weight: 60 parts of sesbania gums, 12 parts of hydroxypropyl celluloses, 7 parts of Propirams
Polysaccharide, 5 portions of modified starches, 18 parts of konjac glucomannans.
The raw material composition of the multiple supporter is consistent with the raw material composition of the interior softgel shell, and being includes following parts by weight
Raw material: 60 parts of sesbania gums, 12 parts of hydroxypropyl celluloses, 7 parts of pulullan polysaccharides, 5 portions of modified starches, 18 parts of konjac glucomannans.
The outer softgel shell with a thickness of 3mm.
The preparation method of above-mentioned enteric plant soft capsule the following steps are included:
60 parts of sesbania gums, 12 parts of hydroxypropyl celluloses, 18 parts of konjac glucomannans are dissolved in 100 parts of deionized water at normal temperature, stir by step S1
It mixes to obtain outer softgel shell dispersion liquid;Using frequency is capsule shells dispersion liquid described in the microwave heating of 250MHz to after 90 DEG C, and stirring is simultaneously
60min is kept the temperature, is then cooled to 50 DEG C, 1 part of sour mediator agent is added, stirs and keep the temperature 45min, is cooled to 22 ~ 25 DEG C, stirring is simultaneously
90min is kept the temperature, outer softgel shell colloidal solution is obtained.
Step S2, by 60 parts of sesbania gums, 12 parts of hydroxypropyl celluloses, 7 parts of pulullan polysaccharides, 5 portions of modified starches, 18 parts of evil spirits
Taro peptization stirs to get interior softgel shell dispersion liquid in 100 parts of deionized water at normal temperature;Use frequency for the microwave heating of 250MHz institute
Capsule shells dispersion liquid is stated to after 90 DEG C, stirs and keeps the temperature 60min, be then cooled to 22 ~ 25 DEG C, stir and keep the temperature 90min, obtain
Interior softgel shell colloidal solution.
Step S3, takes capsule die, which includes first chamber and second chamber, wherein first chamber and second
Chamber by support chamber connection, first chamber with a thickness of 3mm.First outer softgel shell colloidal solution is poured into first chamber, then
Interior softgel shell colloidal solution is poured into second chamber, forms to obtain the enteric plant soft capsule through the capsule die.
Embodiment 3
The present embodiment provides a kind of enteric plant soft capsule, including softgel shell, the softgel shell includes interior softgel shell and outer softgel shell, it is described in
Softgel shell and outer softgel shell gap setting are provided with multiple supporters for maintaining the gap in the gap.
The outer softgel shell includes the raw material of following parts by weight: 70 parts of sesbania gums, 15 parts of hydroxypropyl celluloses, 20 portions of konjakus
Glue, 5 parts of sour mediator agents.
The interior softgel shell includes the raw material of following parts by weight: 70 parts of sesbania gums, 15 parts of hydroxypropyl celluloses, 8 parts of Propirams
Polysaccharide, 6 portions of modified starches, 20 parts of konjac glucomannans.
The raw material composition of the multiple supporter is consistent with the raw material composition of the interior softgel shell, and being includes following parts by weight
Raw material: 70 parts of sesbania gums, 15 parts of hydroxypropyl celluloses, 8 parts of pulullan polysaccharides, 6 portions of modified starches, 20 parts of konjac glucomannans.
The outer softgel shell with a thickness of 3mm.
The preparation method of above-mentioned enteric plant soft capsule the following steps are included:
70 parts of sesbania gums, 15 parts of hydroxypropyl celluloses, 20 parts of konjac glucomannans are dissolved in 100 parts of deionized water at normal temperature, stir by step S1
It mixes to obtain outer softgel shell dispersion liquid;Using frequency is capsule shells dispersion liquid described in the microwave heating of 300MHz to after 100 DEG C, and stirring is simultaneously
90min is kept the temperature, is then cooled to 60 DEG C, 5 parts of sour mediator agents are added, stir and keep the temperature 50min, are cooled to 22 ~ 25 DEG C, stirring is simultaneously
120min is kept the temperature, outer softgel shell colloidal solution is obtained.
Step S2, by 70 parts of sesbania gums, 15 parts of hydroxypropyl celluloses, 8 parts of pulullan polysaccharides, 6 portions of modified starches, 20 parts of evil spirits
Taro peptization stirs to get interior softgel shell dispersion liquid in 100 parts of deionized water at normal temperature;Use frequency for the microwave heating of 300MHz institute
Capsule shells dispersion liquid is stated to after 100 DEG C, stirs and keeps the temperature 90min, be then cooled to 22 ~ 25 DEG C, stir and keep the temperature 120min, obtain
To interior softgel shell colloidal solution.
Step S3, takes capsule die, which includes first chamber and second chamber, wherein first chamber and second
Chamber by support chamber connection, first chamber with a thickness of 3mm.First outer softgel shell colloidal solution is poured into first chamber, then
Interior softgel shell colloidal solution is poured into second chamber, forms to obtain the enteric plant soft capsule through the capsule die.
To sum up, a kind of enteric plant soft capsule and preparation method thereof of the invention, has the following beneficial effects:
The softgel shell of enteric plant soft capsule of the invention includes interior softgel shell and outer softgel shell, and outer softgel shell includes sour mediator agent, therefore is had
There is certain acid-resisting, can be very good to control decomposition of the outer softgel shell in gastric juice, avoid the filler in interior softgel shell because of capsula interna
The decomposition of shell and dissolve out.
In addition, interior softgel shell and outer softgel shell gap setting, multiple for maintaining the gap are provided in the gap
Support body, the dissolution of the content caused by reducing because of softgel shell breakage, while capsule has bigger flexibility.
In addition, including sesbania gum in capsule shells of the invention, the addition of the sesbania gum can shorten capsule shells in intestinal juice
Disintegration time, accelerate the release of content.
The disintegration time limited of enteric slow release plant capsule of the invention is to be greater than 2 hours in gastric juice, 10 ~ 15 points in intestinal juice
Disintegration, meets the regulation of pharmacopeia in clock.
Above description sufficiently discloses a specific embodiment of the invention.It should be pointed out that being familiar with the field
Range of any change that technical staff does a specific embodiment of the invention all without departing from claims of the present invention.
Correspondingly, the scope of the claims of the invention is also not limited only to previous embodiment.
Claims (6)
1. a kind of enteric plant soft capsule, which is characterized in that including softgel shell, the softgel shell includes interior softgel shell and outer softgel shell, described
Interior softgel shell and outer softgel shell gap setting are provided with multiple supporters for maintaining the gap in the gap;
The outer softgel shell includes the raw material of following parts by weight: 50 ~ 70 parts of sesbania gums, 10 ~ 15 parts of hydroxypropyl celluloses, 15 ~ 20 parts
Konjac glucomannan, 1 ~ 5 part of sour mediator agent;
The interior softgel shell includes the raw material of following parts by weight: 50 ~ 70 parts of sesbania gums, 10 ~ 15 parts of hydroxypropyl celluloses, 5 ~ 8 parts it is general
Shandong orchid polysaccharide, 3 ~ 6 portions of modified starches, 15 ~ 20 parts of konjac glucomannans.
2. enteric plant soft capsule according to claim 1, which is characterized in that the raw material composition of the multiple supporter with
The raw material composition of the interior softgel shell is consistent.
3. enteric plant soft capsule according to claim 1, which is characterized in that the outer softgel shell with a thickness of 2 ~ 3mm.
4. a kind of preparation method of enteric plant soft capsule, which is characterized in that the described method comprises the following steps:
Step S1, by 50 ~ 70 parts of sesbania gums, 10 ~ 15 parts of hydroxypropyl celluloses, 15 ~ 20 parts of konjac glucomannans be dissolved in 100 parts of room temperature go from
In sub- water, outer softgel shell dispersion liquid is stirred to get;Using capsule shells dispersion liquid described in microwave heating to after 80 ~ 100 DEG C, stirs and protect
Then 30 ~ 90min of temperature is cooled to 50 ~ 60 DEG C, 1 ~ 5 part of sour mediator agent is added, stirs and keeps the temperature 30 ~ 50min, be cooled to 22 ~ 25
DEG C, 60 ~ 120min is stirred and kept the temperature, outer softgel shell colloidal solution is obtained;
Step S2, by 50 ~ 70 parts of sesbania gums, 10 ~ 15 parts of hydroxypropyl celluloses, 5 ~ 8 parts of pulullan polysaccharides, 3 ~ 6 portions of modified starches,
15 ~ 20 parts of konjac glucomannans are dissolved in 100 parts of deionized water at normal temperature, stir to get interior softgel shell dispersion liquid;Using glue described in microwave heating
Softgel shell dispersion liquid stirs and keeps the temperature 30 ~ 90min to after 80 ~ 100 DEG C, be then cooled to 22 ~ 25 DEG C, stir and keep the temperature 60 ~
120min obtains interior softgel shell colloidal solution;
Step S3 pours into outer softgel shell colloidal solution and interior softgel shell colloidal solution in the correspondence chamber of capsule die respectively, described
Capsule die includes first chamber and second chamber, and wherein first chamber is connected to second chamber by support chamber, through the glue
Capsule mold forms to obtain the enteric plant soft capsule.
5. the preparation method of enteric plant soft capsule according to claim 4, which is characterized in that the frequency of the microwave is
150~300MHz。
6. the preparation method of enteric plant soft capsule according to claim 4, which is characterized in that the first chamber and institute
State that outer softgel shell colloidal solution is corresponding, the first chamber with a thickness of 2 ~ 3mm.
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112569204A (en) * | 2020-12-30 | 2021-03-30 | 湖北人福药用辅料股份有限公司 | Pullulan polysaccharide and starch plant enteric-coated capsule and preparation method thereof |
CN112603905A (en) * | 2020-12-30 | 2021-04-06 | 湖北人福药用辅料股份有限公司 | Preparation process of pullulan plant capsules |
CN117159506A (en) * | 2023-11-02 | 2023-12-05 | 江苏海王健康生物科技有限公司 | Enteric plant capsule, preparation process and application |
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CN101548961A (en) * | 2008-04-03 | 2009-10-07 | 单宝华 | Novel oral capsule preparation for curing diabetes mellitus and obesity |
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