CN106265592A - Hypromellose empty hard capsule and preparation method thereof - Google Patents
Hypromellose empty hard capsule and preparation method thereof Download PDFInfo
- Publication number
- CN106265592A CN106265592A CN201610867681.0A CN201610867681A CN106265592A CN 106265592 A CN106265592 A CN 106265592A CN 201610867681 A CN201610867681 A CN 201610867681A CN 106265592 A CN106265592 A CN 106265592A
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- Prior art keywords
- hypromellose
- hard capsule
- capsule
- empty hard
- acid
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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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)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention belongs to capsule preparing technical field, be specifically related to a kind of hypromellose empty hard capsule and preparation method thereof.Hypromellose empty hard capsule is made up of the raw material of following percentage by weight: hypromellose 95 98.4%, gellant 0.05 2.0%, flocculation aid 0.05 1.0%, disintegrate controlling agent 0 1.0%, PH regulator 0 1.0%.In the present invention 30 minutes, the Discrete control of capsule disintegration time can be realized, for pharmacy corporation, more more options be provided for the demand of capsule；The hard capsule water content produced is low, uniformity is high, and extraneous humiture is little on its impact, indeformable in storage, transportation.
Description
Technical field
The invention belongs to capsule preparing technical field, be specifically related to a kind of hypromellose empty hard capsule and preparation thereof
Method.
Background technology
Along with the development of pharmaceuticals industry, capsule becomes one of wide variety of dosage form, is broadly divided into gelatin empty hard capsule
And plant hollow hard capsule.
The traditional material of preparation animal capsule is gelatin, is that one utilizes the connective groups such as animal skin, bone, sarolemma, flesh evil spirit
The native biopolymer material of the collagenous portion degraded in knitting.The gelatin hollow capsule stable in physicochemical property prepared,
Disintegration is stable.The disintegration of gelatin empty hard capsule is affected by the character of gelatin and content so that disintegration deposits
In uncontrollable situation.
It is empty that plant hollow hard capsule is broadly divided into starch empty hard capsule, Pullulan empty hard capsule and hypromellose
Hard-hearted capsule, hypromellose empty hard capsule, because of its stability in terms of raw material sources and product property, obtains
Develop widely.
The stability of its good film property of hypromellose procatarxis and film dissolution time thereof becomes making hypromellose
The desirable plants material of element empty hard capsule, but hypromellose indefiniteness effect own, need to add certain adjuvant
Can shape, in the R&D process of hypromellose empty hard capsule, find that different auxiliary material has certain minimizing to disintegration time
And retarding action.
Summary of the invention
It is an object of the invention to provide a kind of hypromellose empty hard capsule, disintegration time controllable, water content is low,
Uniformity is high, and extraneous humiture is little on its impact, indeformable in storage, transportation；Invention also provides hydroxypropyl first
The preparation method of cellulose hollow hard capsule, scientific and reasonable, simple.
Hypromellose empty hard capsule of the present invention, is made up of the raw material of following percentage by weight:
The methoxyl content 27.0-30.0wt% of described hypromellose, hydroxypropyl content 4.0-12.0wt%, solidifying
Glue temperature 58-68 DEG C, viscosity 3.0-15.0mpa.s；Preferably methoxyl content 28.0-29.5wt%, hydroxypropyl content 8.0-
10.0wt%, gelling temp 61-68 DEG C, viscosity 4.0-6.0mpa.s.
Described gellant is one or more in low-acyl gellan gum, carrageenin, alginate jelly or pectin, preferably less than
Acyl gellan gum；Gellant quality is the 0.05-2.0% of raw material gross mass, preferably 0.1-1.8%.
Low-acyl gellan gum is the outer special-shaped polysaccharide of extracellular microbial, and the basic structure of molecule is a main chain, by four repeated
Sugar unit is constituted, and the monosaccharide participating in being formed has glucose, glucuronic acid and rhamnose, and mol ratio is 2:1:1, in recent years, with
The characteristics such as its safety non-toxic, physicochemical property are excellent are increasingly paid close attention to by all conglomeraties such as food, pharmacy and cosmetics, by
International food legislative bodies allow to be used as the microbial polysaccharide of food additive.
Low-acyl gellan gum function admirable, the most just can form high-quality gel, is a kind of very effective gelling
Agent；Stable in physicochemical property, heating and low pH are the least on the impact of its gelling performance；Heat-convertible gel can be formed with sodium, potassium ion, with
Calcium, magnesium ion form irreversible gel；The control to capsule disintegration time is realized by the type forming gel.
Described flocculation aid is one or more in potassium carbonate, potassium bicarbonate or potassium citrate, preferably potassium carbonate；Help solidifying
Agent quality is the 0.05-1.0% of raw material gross mass, preferably 0.1-0.9%.
Described disintegrate controlling agent is in sodium carboxymethyl cellulose, hydroxypropyl cellulose, calcium citrate or magnesium citrate
One or more, preferably carboxymethyl cellulose sodium or calcium citrate；Disintegrate controlling agent quality is the 0-1.0% of raw material gross mass,
Preferably 0-0.75%.
Described PH regulator is one or more in carbonic acid, acetic acid, citric acid, boric acid, lactic acid or phosphoric acid, preferably second
Acid；PH regulator quality is the 0-1.0% of raw material gross mass, preferably 0-0.70%.
Described raw material also includes pharmaceutical grade or food grade colorant, and addition is the 0-5.0% of raw material gross mass.
The preparation method of hypromellose empty hard capsule of the present invention, step is as follows:
(1) take hypromellose, gellant, flocculation aid, disintegrate controlling agent and PH regulator, be added to the water, stirring
It is formed uniformly glue；
(2) on full-automatic or semi-automatic capsule production line, the production method of snap fit capsule is used to produce hydroxypropyl first fine
Dimension element hard capsule.
The quality of the water described in step (1) is that hypromellose, gellant, flocculation aid, disintegrate controlling agent and PH adjust
The 400-600% of joint agent gross mass.
When adding pigment, the preparation method of hypromellose empty hard capsule of the present invention, step is as follows:
(1) take hypromellose, gellant, flocculation aid, disintegrate controlling agent, PH regulator and pigment, be added to the water,
Stir formation glue；
(2) on full-automatic or semi-automatic capsule production line, the production method of snap fit capsule is used to produce hydroxypropyl first fine
Dimension element hard capsule.
The quality of the water described in step (1) is hypromellose, gellant, flocculation aid, disintegrate controlling agent, PH regulation
Agent and the 400-600% of pigment gross mass.
The water content of hypromellose empty hard capsule prepared by the present invention is 2-8%.
The present invention can use automatic production line to dip in glue method to prepare capsule.
The hard capsule that the present invention is produced complies fully with the regulation of state-promulgated pharmacopoeia Capsules standard.
The present invention compared with prior art, has the advantages that
In the present invention 30 minutes, the Discrete control of capsule disintegration time can be realized, for pharmacy corporation for the demand of capsule
Provide more more options.
The hard capsule water content that the present invention is produced is low, uniformity is high, and extraneous humiture is little on its impact, is storing, is transporting
During defeated indeformable.
The hard capsule that the present invention is produced, main material hypromellose cellulose content is high, and capsule light transmittance is high, raw material type
Few, use safer, constant product quality.
The non-animal derived material of hard capsule that the present invention is produced, is suitable for vegetarian diet and Moslem crowd eats, and exports unrestricted
System.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described further.
Embodiment 1
In glue pot, add temperature purified water 550kg, add low-acyl gellan gum 975g, stir, be warming up to 75 DEG C,
Add 100kg hypromellose, keep more than 75 DEG C, stir 30 minutes, form uniform glue, be subsequently adding flocculation aid: carbon
Acid potassium 780g, sodium carboxymethyl cellulose 560g, acetic acid 400g, negative pressure eliminates bubble in glue, ultimately forms homogeneous glue.
According to tradition snap fit capsule production method.Through dipping in glue, drying, pull out capsule, fixed length, cutting, fit process, obtain
Transparent hypromellose hard capsule.
Embodiment 2
In glue pot, add temperature purified water 550kg, add low-acyl gellan gum 1025g, stir, be warming up to 75
DEG C, add 100kg hypromellose, keep more than 75 DEG C, stir 30 minutes, form uniform glue, be subsequently adding potassium carbonate
870g, acetic acid 400g, negative pressure eliminates bubble in glue, ultimately forms homogeneous glue.
According to tradition snap fit capsule production method.Through dipping in glue, drying, pull out capsule, fixed length, cutting, fit process, obtain
Transparent hypromellose hard capsule.
Embodiment 3
In glue pot, add temperature purified water 550kg, add low-acyl gellan gum 1150g, stir, be warming up to 75
DEG C, add 100kg hypromellose, keep more than 75 DEG C, stir 30 minutes, form uniform glue, be subsequently adding potassium carbonate
550g, calcium citrate 300g, acetic acid 400g, negative pressure eliminates bubble in glue, ultimately forms homogeneous glue.
According to tradition snap fit capsule production method.Through dipping in glue, drying, pull out capsule, fixed length, cutting, fit process, obtain
Transparent hypromellose hard capsule.
Embodiment 4
In glue pot, add temperature purified water 550kg, add low-acyl gellan gum 1150g, stir, be warming up to 75
DEG C, add 100kg hypromellose, keep more than 75 DEG C, stir 30 minutes, form uniform glue, be subsequently adding potassium carbonate
550g, calcium citrate 300g, acetic acid 400g, negative pressure eliminates bubble in glue, adds light blue pigment 300g (opening with water-soluble), stirring
Uniformly, homogeneous glue is formed.
According to tradition snap fit capsule production method.Through dipping in glue, drying, pull out capsule, fixed length, cutting, fit process, obtain
The hypromellose hard capsule of blue-tinted transparent.
The embodiment 1-4 gained each index parameter of hypromellose hard capsule is shown in Table 1.
The table 1 embodiment 1-4 gained each index parameter of hypromellose hard capsule
| Project | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 |
| Friability | 0 | 0 | 0 | 0 |
| Loss on drying | 4.23% | 4.83% | 4.65% | 5.15% |
| Residue on ignition | 1.42% | 1.67% | 1.94% | 2.12% |
| Heavy metal | ＜ 0.0010% | ＜ 0.0010% | ＜ 0.0010% | ＜ 0.0010% |
| Arsenic salt | ＜ 0.0002% | ＜ 0.0002% | ＜ 0.0002% | ＜ 0.0002% |
| Disintegration | 4 points 05 second | 7 points 12 seconds | 15 points 35 seconds | 16 points 08 second |
| Upper probability | 99% | 99% | 99% | 99% |
Claims (10)
1. a hypromellose empty hard capsule, it is characterised in that be made up of the raw material of following percentage by weight:
Hypromellose empty hard capsule the most according to claim 1, it is characterised in that described hypromellose
Methoxyl content 27.0-30.0wt%, hydroxypropyl content 4.0-12.0wt%, gelling temp 58-68 DEG C, viscosity 3.0-
15.0mpa.s。
Hypromellose empty hard capsule the most according to claim 1, it is characterised in that described gellant is low acyl
One or more in base junction cold glue, carrageenin, alginate jelly or pectin.
Hypromellose empty hard capsule the most according to claim 1, it is characterised in that described flocculation aid is carbonic acid
One or more in potassium, potassium bicarbonate or potassium citrate.
Hypromellose empty hard capsule the most according to claim 1, it is characterised in that described disintegrate controlling agent is
One or more in sodium carboxymethyl cellulose, hydroxypropyl cellulose, calcium citrate or magnesium citrate.
Hypromellose empty hard capsule the most according to claim 1, it is characterised in that described PH regulator is carbon
One or more in acid, acetic acid, citric acid, boric acid, lactic acid or phosphoric acid.
Hypromellose empty hard capsule the most according to claim 1, it is characterised in that described raw material also includes medicine
By level or food grade colorant, addition is the 0-5.0% of raw material gross mass.
8. the preparation method of the arbitrary described hypromellose empty hard capsule of claim 1-6, it is characterised in that step
Rapid as follows:
(1) take hypromellose, gellant, flocculation aid, disintegrate controlling agent and PH regulator, be added to the water, stir
Form glue；
(2) on full-automatic or semi-automatic capsule production line, the production method of snap fit capsule is used to produce hypromellose
Hard capsule.
The preparation method of hypromellose empty hard capsule the most according to claim 8, it is characterised in that in step (1)
The quality of described water is hypromellose, gellant, flocculation aid, disintegrate controlling agent and the 400-of PH regulator gross mass
600%.
10. the preparation method of the hypromellose empty hard capsule described in a claim 7, it is characterised in that step is such as
Under:
(1) take hypromellose, gellant, flocculation aid, disintegrate controlling agent, PH regulator and pigment, be added to the water, stirring
It is formed uniformly glue；
(2) on full-automatic or semi-automatic capsule production line, the production method of snap fit capsule is used to produce hypromellose
Hard capsule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610867681.0A CN106265592A (en) | 2016-09-30 | 2016-09-30 | Hypromellose empty hard capsule and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610867681.0A CN106265592A (en) | 2016-09-30 | 2016-09-30 | Hypromellose empty hard capsule and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106265592A true CN106265592A (en) | 2017-01-04 |
Family
ID=57715695
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610867681.0A Pending CN106265592A (en) | 2016-09-30 | 2016-09-30 | Hypromellose empty hard capsule and preparation method thereof |
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| Country | Link |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107929258A (en) * | 2018-01-02 | 2018-04-20 | 上海祺宇生物科技有限公司 | A kind of plant hollow capsule |
| CN108553444A (en) * | 2018-04-25 | 2018-09-21 | 常州市阿曼特医药科技有限公司 | A kind of health care Capsules and preparation method thereof |
| CN109528678A (en) * | 2019-01-14 | 2019-03-29 | 武汉海吉亚生物科技有限公司 | A kind of hydroxypropyl methylcellulose capsules and its preparation method and application |
| CN111303493A (en) * | 2020-03-05 | 2020-06-19 | 上海祺宇生物科技有限公司 | Cellulose composition and molded product thereof |
| WO2021145296A1 (en) * | 2020-01-14 | 2021-07-22 | カプスゲル・ジャパン株式会社 | Hard capsule containing cellulose derivative as base material and having improved mechanical strength and oxygen permeability |
| CN114010616A (en) * | 2021-12-06 | 2022-02-08 | 江苏力凡胶囊有限公司 | Rapidly disintegrating hollow capsule and preparation method thereof |
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| CN1292261A (en) * | 1999-09-28 | 2001-04-25 | 上海大众凌伟生化股份有限公司 | Plant hard capsule and its production process |
| US20020081331A1 (en) * | 1999-07-07 | 2002-06-27 | R.P. Scherer Technologies, Inc. | Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same |
| CN103301086A (en) * | 2013-06-05 | 2013-09-18 | 绍兴康可胶囊有限公司 | Plant cellulose hard empty capsule preparation method |
| CN103432096A (en) * | 2013-08-11 | 2013-12-11 | 重庆衡生药用胶囊有限责任公司 | Hydroxypropyl methylcellulose enteric empty capsule jellied by carrageenan and potassium citrate |
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| US20020081331A1 (en) * | 1999-07-07 | 2002-06-27 | R.P. Scherer Technologies, Inc. | Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107929258A (en) * | 2018-01-02 | 2018-04-20 | 上海祺宇生物科技有限公司 | A kind of plant hollow capsule |
| CN108553444A (en) * | 2018-04-25 | 2018-09-21 | 常州市阿曼特医药科技有限公司 | A kind of health care Capsules and preparation method thereof |
| CN109528678A (en) * | 2019-01-14 | 2019-03-29 | 武汉海吉亚生物科技有限公司 | A kind of hydroxypropyl methylcellulose capsules and its preparation method and application |
| WO2021145296A1 (en) * | 2020-01-14 | 2021-07-22 | カプスゲル・ジャパン株式会社 | Hard capsule containing cellulose derivative as base material and having improved mechanical strength and oxygen permeability |
| JP7397886B2 (en) | 2020-01-14 | 2023-12-13 | キャプシュゲル・ベルジウム・エヌ・ヴィ | Hard capsules with improved mechanical strength and oxygen permeability based on cellulose derivatives |
| CN111303493A (en) * | 2020-03-05 | 2020-06-19 | 上海祺宇生物科技有限公司 | Cellulose composition and molded product thereof |
| CN114010616A (en) * | 2021-12-06 | 2022-02-08 | 江苏力凡胶囊有限公司 | Rapidly disintegrating hollow capsule and preparation method thereof |
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