CN101708173A - Soft capsule and application thereof - Google Patents
Soft capsule and application thereof Download PDFInfo
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- CN101708173A CN101708173A CN200910241482A CN200910241482A CN101708173A CN 101708173 A CN101708173 A CN 101708173A CN 200910241482 A CN200910241482 A CN 200910241482A CN 200910241482 A CN200910241482 A CN 200910241482A CN 101708173 A CN101708173 A CN 101708173A
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Abstract
The invention discloses a soft capsule, which consists of a soft capsule content and a soft capsule capsule wall material, wherein the main raw material for preparing the soft capsule capsule wall material is seaweed polysaccharide gum. The invention further discloses a motherwort herb soft capsule, which consists of the soft capsule content and the soft capsule capsule wall material, wherein the main raw material for preparing the soft capsule content is a motherwort herb extract, and the main raw material for preparing the soft capsule capsule wall material is the seaweed polysaccharide gum. The soft capsule provided by the invention has the advantages of rapid disintegration, high bioavailability, good stability, low water content, accurate dosage, convenient administration, good mouthfeel, easy storage, convenient carrying and the like.
Description
Technical field
The present invention relates to a kind of soft capsule preparation and application thereof.
Background technology
Existing soft capsule is all made by animal gelatin, have three difficult problems that can't overcome: thus one, the vegetable tannin composition in the content of the albumen composition of animal gelatin and soft capsule can take place cross-linking reaction slowly form can't disintegrate tannin albumen, thereby existing soft capsule preparation usually 6～9 months after production promptly occur can't disintegrate a difficult problem, have a strong impact on the quality and the quality guarantee period of this medicine, this has become the professional technical barrier of Chinese patent medicine soft capsule preparation development.Two, the content of soft capsule is a high-hydroscopicity, and the water content height of animal gelatin (the gelatin water content is about 15% when 50%R.H.), the soft capsule of making like this can be drawn moisture content from gelatin in storage process, thereby cause content oil-water separation.Three, animal gelatin is mainly made by compositions such as the skins of animals such as pig cattle and bones, exists the religious taboo problem when using in the Islam area.
Herba Leonuri is the Chinese medicine material, has clearing away heat and cooling blood, and the effect of blood stasis dispelling regulating menstruation is used for the accumulation of heat blood stasis, menorrhagia, puerperal metrorrhagia, uterus meromorphosis is seen above-mentioned patient.This kind has good clinical effectiveness, is widely used clinically.Traditional motherwort formulation has Herba Leonuri extractum, Herba Leonuri capsule, Herba Leonuri granule, YIMUCAO PIAN etc., not only all has the mouthfeel bitter in the mouth, the olfactory sensation discomfort smell defectives such as flavor; And the quality of fluid extract and oral liquid is stable inadequately, is easy to generate precipitation, transports, carries inconvenience; Tablet then dissolves in the stomach slowly, the effect of gathering waits problem more slowly.Thereby people change it into soft capsule in recent years for a kind of more selection is provided to the patient.But all there is above-mentioned problem in existing Herba Leonuri soft capsule preparation.
Summary of the invention
The purpose of this invention is to provide a kind of new soft capsule preparation, and its application is provided.
For achieving the above object, technical scheme of the present invention provides a kind of soft capsule preparation, is made up of soft capsule content and soft capsule material, and the primary raw material that wherein is used to prepare described soft capsule material is a Sargassum polysaccharides glue.Sargassum polysaccharides (glue) is various natural polysaccharide carbohydrates contained in the Sargassum.They all are water miscible, and most of Sargassum polysaccharides have high viscosity or coagulation ability.
Soft capsule preparation of the present invention, wherein said Sargassum polysaccharides glue preferably derives from red algae.
Further, the present invention especially provides a kind of Herba Leonuri soft capsule preparation, is made up of soft capsule content and soft capsule material, and the primary raw material that wherein is used to prepare described soft capsule content is the Herba Leonuri medicinal substances extract; The primary raw material that is used to prepare described soft capsule material is a Sargassum polysaccharides glue.Described Sargassum polysaccharides glue preferably derives from red algae.
Above-mentioned Herba Leonuri soft capsule preparation, the raw material components and the parts by weight thereof that are used to prepare described soft capsule content are: Herba Leonuri medicinal substances extract pressed powder 35～65; Edible vegetable oil 35～65; Cera Flava 1～5;
The raw material components and the parts by weight thereof that are used to prepare described soft capsule material are: Sargassum polysaccharides glue 8.5～11.5; Glycerol 3.5～5.5; Hydroxypropyl emthylcellulose 0.005～0.015.
Above-mentioned Herba Leonuri soft capsule preparation, the raw material components and the parts by weight thereof that wherein are used to prepare described soft capsule content are preferably: Herba Leonuri medicinal substances extract pressed powder 40; Soybean salad oil 60; Cera Flava 3; The raw material components and the parts by weight thereof that are used to prepare described soft capsule material are preferably: Sargassum polysaccharides glue 10; Glycerol 4.5; Hydroxypropyl emthylcellulose 0.01.The fine powder that the Herba Leonuri clear paste that Herba Leonuri medicinal substances extract pressed powder wherein can adopt conventional method to make or sell is spray dried to.
A kind of preparation method of above-mentioned Herba Leonuri soft capsule preparation may further comprise the steps:
1) preparation of feed liquid: Herba Leonuri medicinal substances extract pressed powder sieves, oven dry; Get Cera Flava and add in the soybean salad oil, make the soft capsule disperse medium; The Herba Leonuri extractum dry powder of getting after sieving adds in the disperse medium, and mixing and stirring is regulated the colloid mill fineness and refluxed under 5～10 μ m conditions, crosses colloid mill, becomes finely dispersed suspension, evacuation, and soft capsule Herba Leonuri feed liquid is made in cooling, stablizes stand-by;
2) glue preparation: Sargassum polysaccharides glue, glycerol, hydroxypropyl emthylcellulose in changing glue pot, heat 50～60 ℃, stir, evacuation, the soft capsule material glue, steady glue is stand-by;
3) system capsule: the soft capsule Herba Leonuri feed liquid of above-mentioned preparation and soft capsule material glue are dropped into soft capsule produce in the filling machine and prepare the Herba Leonuri soft capsule.
Herba Leonuri medicinal substances extract pressed powder is crossed 100～150 mesh sieves in the wherein said step 1), puts 50～60 ℃ of oven dry; Regulate the colloid mill fineness 10～30min that under 5～10 μ m conditions, refluxes.
Technique scheme has following advantage:
1, compares with the soft capsule dosage form made from animal gelatin in the past, it is accurate that soft capsule preparation provided by the invention has disintegrate rapidly, bioavailability height, good stability, water content low (water content is 5～8% when 50%R.H.), dosage, taking convenience, mouthfeel are good, easily storage and advantage such as easy to carry, and in the whole nation in addition the whole world do not have the restriction of religious taboo when using.
2, the Herba Leonuri soft capsule preparation that the present invention further provides, active chemical is clear and definite, has the effect of clearing away heat and cooling blood, change silt regulating menstruation.Be used for the accumulation of heat blood stasis, menorrhagia; Puerperal metrorrhagia, uterus meromorphosis is seen above-mentioned sign person, is the new varieties of a determined curative effect, application safety.Its compare with dosage form in the past have good stability, disintegrate is rapid, bioavailability is high, water content is low, content of dispersion is accurate, bitterness that dosage is few, can cover medicine and the uncomfortable flavor of smelling, security seal, taking convenience, outward appearance are good, instant effect, easily storage and advantage such as easy to carry are not subjected to religious restriction during use.
The specific embodiment
Below in conjunction with embodiment, the specific embodiment of the present invention is described in further detail.Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
Get Herba Leonuri extractum dry powder 40kg, cross 120 mesh sieves, put 60 ℃ of oven dry; Get Cera Flava 5kg, join among the salad oil 60kg, make the soft capsule disperse medium; Get the Herba Leonuri extractum dry powder after sieving, add in the disperse medium, put mixing and stirring in the ingredients pot, regulate the colloid mill fineness 10min that under 5 μ m conditions, refluxes, cross colloid mill, become finely dispersed suspension, evacuation, the barrelling capping that takes the dish out of the pot, cooling, promptly make soft capsule Herba Leonuri feed liquid, stablize stand-by.
Weigh up raw material Sargassum polysaccharides glue 10kg and (buy the Sargassum polysaccharides glue that Qinhuangdao Medicinal Capsule Co., Ltd. produces.The accurate word F20050001 of traditional Chinese medicines), glycerol 4.5kg, hydroxypropyl emthylcellulose 0.01kg the Sargassum polysaccharides glue that this factory produces obtains the authentication code of State Food and Drug Administration:; Drop in the change glue pot of preheating, heat 50～60 ℃, stir, evacuation is put the mucilage binding bucket after qualified by inspection, steady glue is stand-by, promptly gets the soft capsule material glue.
The soft capsule content and the soft capsule material glue of above-mentioned preparation are dropped in the soft capsule production filling machine, 35～40 ℃ of sprinkler body temperature, adopt the rotating mould platen press to prepare the Herba Leonuri soft capsule, the system skin, fill, go out ball, typing, drying is to finish on production line, feed liquid enters the glue box automatically, the rubber wheel rotates and forms rubber, both sides rubber enters and rolls mould formation glue shell, feed liquid forms soft capsule by charging pump injection glue shell simultaneously, soft gelatin capsule enters by conveyer belt and rolls cage enforcement typing drying, through washing ball, select ball, obtain finished product after wiping pill package, promptly get the Herba Leonuri soft capsule.
Embodiment 2
Get Herba Leonuri extractum dry powder 60kg, cross 100 mesh sieves, put 50 ℃ of oven dry; Get Cera Flava 1kg, add among the salad oil 40kg, make the soft capsule disperse medium; Get the Herba Leonuri extractum dry powder after sieving, add in the disperse medium, put mixing and stirring in the ingredients pot, regulate the colloid mill fineness 20min that under 5 μ m conditions, refluxes, cross colloid mill, become finely dispersed suspension, evacuation, the barrelling capping that takes the dish out of the pot, cooling, promptly make soft capsule Herba Leonuri feed liquid, stablize stand-by.
Weigh up raw material Sargassum polysaccharides glue 11.5kg, glycerol 3.5kg, hydroxypropyl methyl fiber 0.005kg; Drop in the change glue pot of preheating, heat 50～60 ℃, stir, evacuation is put the mucilage binding bucket after qualified by inspection, steady glue is stand-by, promptly gets the soft capsule material glue.
The soft capsule content and the soft capsule material glue of above-mentioned preparation are dropped in the soft capsule production filling machine, 40～45 ℃ of sprinkler body temperature, adopt the rotating mould platen press to prepare the Herba Leonuri soft capsule, the system skin, fill, go out ball, typing, drying is to finish on production line, feed liquid enters the glue box automatically, the rubber wheel rotates and forms rubber, both sides rubber enters and rolls mould formation glue shell, feed liquid forms soft capsule by charging pump injection glue shell simultaneously, soft gelatin capsule enters by conveyer belt and rolls cage enforcement typing drying, through washing ball, select ball, obtain finished product after wiping pill package, promptly get the Herba Leonuri soft capsule.
Embodiment 3
Get Herba Leonuri extractum dry powder 35kg, cross 150 mesh sieves, put 60 ℃ of oven dry; Get Cera Flava 3kg, add among the salad oil 65kg, make the soft capsule disperse medium; Get the Herba Leonuri extractum dry powder after sieving, add in the disperse medium, put mixing and stirring in the ingredients pot, regulate the colloid mill fineness 30min that under 10 μ m conditions, refluxes, cross colloid mill, become finely dispersed suspension, evacuation, the barrelling capping that takes the dish out of the pot, cooling, promptly make soft capsule Herba Leonuri feed liquid, stablize stand-by.
Weigh up raw material Sargassum polysaccharides glue 8.5kg, glycerol 5.5kg, the foster 0.015kg of hydroxypropyl emthylcellulose; Drop in the change glue pot of preheating, heat 50～60 ℃, stir, evacuation is put the mucilage binding bucket after qualified by inspection, steady glue is stand-by, promptly gets the soft capsule material glue.
The soft capsule content and the soft capsule material glue of above-mentioned preparation are dropped in the soft capsule production filling machine, 45～50 ℃ of sprinkler body temperature, adopt the rotating mould platen press to prepare the Herba Leonuri soft capsule, the system skin, fill, go out ball, typing, drying is to finish on production line, feed liquid enters the glue box automatically, the rubber wheel rotates and forms rubber, both sides rubber enters and rolls mould formation glue shell, feed liquid forms soft capsule by charging pump injection glue shell simultaneously, soft gelatin capsule enters by conveyer belt and rolls cage enforcement typing drying, through washing ball, select ball, obtain finished product after wiping pill package, promptly get the Herba Leonuri soft capsule.
As can be seen from the above embodiments, the embodiment of the invention is compared as follows with existing animal glue soft capsule by its Herba Leonuri soft capsule that makes is concrete by adopting the capsule material raw material of Sargassum polysaccharides glue as soft capsule:
| The animal gelatin soft capsule | Sargassum polysaccharides glue soft capsule | |
| Chemical analysis | Animal collagen | Vegetable polysaccharides |
| The source | The skin of animal such as pig, cattle, bone, tendon, ligament etc., the composition complexity | The sea-plant red algae, simple |
| The animal gelatin soft capsule | Sargassum polysaccharides glue soft capsule | |
| Chemical property | Easy degraded, changeableness | Do not degrade, invariance |
| Water content | 12.5～17.5%, the water content height | 5～8%, water content is low |
| Hygroscopicity | Easily moisture absorption adhesion | Be difficult for the moisture absorption |
| Air slaking | Easy-weathering becomes fragile, frangible | Non-efflorescing cementitious, flexible |
| Elasticity | Prolong the elasticity variation in time | The elasticity lasting stability, |
| Viscosity | Lower, 15% concentration is not less than 60mm 2/ s | Higher, be not less than 50mm during 8% concentration 2/ s |
| Disintegration | Instability, surpassing can not disintegrate after 9 months in 20 minutes disintegration in 6 months. | Be stabilized in 10 minutes |
| Shelf-life | 9 months | 18 months |
Soft capsule preparation provided by the invention is preferred for preparing the Herba Leonuri soft capsule, and it can certainly be applied to other Chinese patent medicine soft capsule preparations, and its preparation effect can directly be known by inference from the present invention and obtains.
The above only is a preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the technology of the present invention principle; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (9)
1. a soft capsule preparation is made up of soft capsule content and soft capsule material, it is characterized in that, the primary raw material that is used to prepare described soft capsule material is a Sargassum polysaccharides glue.
2. soft capsule preparation as claimed in claim 1 is characterized in that, described Sargassum polysaccharides glue derives from red algae.
3. a Herba Leonuri soft capsule preparation is made up of soft capsule content and soft capsule material, it is characterized in that, the primary raw material that is used to prepare described soft capsule content is the Herba Leonuri medicinal substances extract; The primary raw material that is used to prepare described soft capsule material is a Sargassum polysaccharides glue.
4. Herba Leonuri soft capsule preparation as claimed in claim 3 is characterized in that, described Sargassum polysaccharides glue derives from red algae.
5. as claim 3 or 4 described Herba Leonuri soft capsule preparations, it is characterized in that the raw material components and the parts by weight thereof that are used to prepare described soft capsule content are: Herba Leonuri medicinal substances extract pressed powder 35～65; Edible vegetable oil 35～65; Cera Flava 1～5; The raw material components and the parts by weight thereof that are used to prepare described soft capsule material are: Sargassum polysaccharides glue 8.5～11.5; Glycerol 3.5～5.5; Hydroxypropyl emthylcellulose 0.005～0.015.
6. Herba Leonuri soft capsule preparation as claimed in claim 5 is characterized in that, the raw material components and the parts by weight thereof that are used to prepare described soft capsule content are: Herba Leonuri medicinal substances extract pressed powder 40; Edible vegetable oil 60; Cera Flava 3; The raw material components and the parts by weight thereof that are used to prepare described soft capsule material are: Sargassum polysaccharides glue 10; Glycerol 4.5; Hydroxypropyl emthylcellulose 0.01.
7. as claim 5 or 6 described Herba Leonuri soft capsule preparations, it is characterized in that described edible vegetable oil comprises soybean salad oil, Petiolus Trachycarpi oil and Oleum Arachidis hypogaeae semen.
8. the preparation method of each described Herba Leonuri soft capsule preparation of claim 3-7 is characterized in that, may further comprise the steps:
1) preparation of feed liquid: Herba Leonuri medicinal substances extract pressed powder sieves, oven dry; Get Cera Flava and add in the soybean salad oil, make the soft capsule disperse medium; The Herba Leonuri extractum dry powder of getting after sieving adds in the disperse medium, and mixing and stirring is regulated the colloid mill fineness and refluxed under 5～10 μ m conditions, crosses colloid mill, becomes finely dispersed suspension, evacuation, and soft capsule Herba Leonuri feed liquid is made in cooling, stablizes stand-by;
2) glue preparation: Sargassum polysaccharides glue, glycerol, hydroxypropyl emthylcellulose in changing glue pot, heat 50～60 ℃, stir, evacuation, the soft capsule material glue, steady glue is stand-by;
3) system capsule: the soft capsule Herba Leonuri feed liquid of above-mentioned preparation and soft capsule material glue are dropped into soft capsule produce in the filling machine and prepare the Herba Leonuri soft capsule.
9. preparation method as claimed in claim 8 is characterized in that, Herba Leonuri medicinal substances extract pressed powder is crossed 100～150 mesh sieves in the described step 1), puts 50～60 ℃ of oven dry; Regulate the colloid mill fineness 10～30min that under 5～10 μ m conditions, refluxes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009102414829A CN101708173B (en) | 2009-12-03 | 2009-12-03 | Soft capsule and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009102414829A CN101708173B (en) | 2009-12-03 | 2009-12-03 | Soft capsule and application thereof |
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| Publication Number | Publication Date |
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| CN101708173A true CN101708173A (en) | 2010-05-19 |
| CN101708173B CN101708173B (en) | 2012-11-07 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2009102414829A Active CN101708173B (en) | 2009-12-03 | 2009-12-03 | Soft capsule and application thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102670563A (en) * | 2012-06-05 | 2012-09-19 | 江南大学 | Preparation method of soft capsule without gelatin |
| CN102696942A (en) * | 2012-05-24 | 2012-10-03 | 海南大学 | Method for preparing nutrient capsules containing marine organism polysaccharide |
| CN103070917A (en) * | 2013-01-29 | 2013-05-01 | 沈阳永大制药有限公司 | Novel leonurus capsule and preparation method thereof |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1528422A (en) * | 2003-10-01 | 2004-09-15 | 浙江天一堂集团有限公司 | Motherwort soft capsule and preparing method thereof |
| CN1552422A (en) * | 2003-12-18 | 2004-12-08 | 华东中药工程集团有限公司 | Motherwort soft capsule and preparing method thereof |
| CN100531700C (en) * | 2005-07-26 | 2009-08-26 | 黄族和 | Method for producing hollow capsules dissoluble in stomach by using seaweed polysaccharide as raw material |
-
2009
- 2009-12-03 CN CN2009102414829A patent/CN101708173B/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102696942A (en) * | 2012-05-24 | 2012-10-03 | 海南大学 | Method for preparing nutrient capsules containing marine organism polysaccharide |
| CN102670563A (en) * | 2012-06-05 | 2012-09-19 | 江南大学 | Preparation method of soft capsule without gelatin |
| CN103070917A (en) * | 2013-01-29 | 2013-05-01 | 沈阳永大制药有限公司 | Novel leonurus capsule and preparation method thereof |
| CN103070917B (en) * | 2013-01-29 | 2017-09-19 | 沈阳永大制药有限公司 | A kind of new Yimucao capsule and its preparation method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101708173B (en) | 2012-11-07 |
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