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 PDF

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Publication number
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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parts
softgel shell
interior
chamber
soft capsule
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聂毅
宗有田
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Jiangsu Chenxing Pharmaceutical Ltd By Share Ltd
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Jiangsu Chenxing Pharmaceutical Ltd By Share Ltd
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Priority to CN201811580000.8A priority Critical patent/CN109602718A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)

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

A kind of enteric plant soft capsule and preparation method thereof
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.
CN201811580000.8A 2018-12-24 2018-12-24 A kind of enteric plant soft capsule and preparation method thereof Pending CN109602718A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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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Publication number Priority date Publication date Assignee Title
CN101548961A (en) * 2008-04-03 2009-10-07 单宝华 Novel oral capsule preparation for curing diabetes mellitus and obesity
CN101584679A (en) * 2008-05-21 2009-11-25 单宝华 Novel oral capsule preparation for treating cancer and AIDS
CN101708171A (en) * 2009-12-17 2010-05-19 安徽黄山胶囊有限公司 Enteric plant hollow capsule
CN102552209A (en) * 2012-01-06 2012-07-11 安徽黄山胶囊股份有限公司 Double-layer hollow capsule and multi-layer enteric hollow capsule
WO2013123965A1 (en) * 2012-02-20 2013-08-29 Synthon Bv A fixed dose pharmaceutical formulation
CN204709419U (en) * 2015-06-23 2015-10-21 新疆生命核力高科股份有限公司 Drugs and health care products packaging capsule

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101548961A (en) * 2008-04-03 2009-10-07 单宝华 Novel oral capsule preparation for curing diabetes mellitus and obesity
CN101584679A (en) * 2008-05-21 2009-11-25 单宝华 Novel oral capsule preparation for treating cancer and AIDS
CN101708171A (en) * 2009-12-17 2010-05-19 安徽黄山胶囊有限公司 Enteric plant hollow capsule
CN102552209A (en) * 2012-01-06 2012-07-11 安徽黄山胶囊股份有限公司 Double-layer hollow capsule and multi-layer enteric hollow capsule
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN117159506B (en) * 2023-11-02 2024-02-13 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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