CN1947709A - Vegetative hard capsule casing material and its prodn. method - Google Patents
Vegetative hard capsule casing material and its prodn. method Download PDFInfo
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- CN1947709A CN1947709A CN 200510030530 CN200510030530A CN1947709A CN 1947709 A CN1947709 A CN 1947709A CN 200510030530 CN200510030530 CN 200510030530 CN 200510030530 A CN200510030530 A CN 200510030530A CN 1947709 A CN1947709 A CN 1947709A
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Abstract
A vegetative shell of capsule is prepared from hydrophilic vegetative gel, adhesive, plasticizer and water. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to the material field, relate more specifically to the component and the production method of hard capsule case.
Background technology
At present, the film of hard capsule is that the gelatin that extracts with materials such as animal bone such as cattle, pig or skins is that raw material makes.Although gelatin has good characteristic when the preparation hard capsule, yet gelatin has antigenicity as heterologous protein.For example, the cattle source property gelatin materials of import may contain Protein virus, uses its soft capsule that makes as raw material may cause the diffusion of bovine spongiform encephalopathy.Along with the increase of market to the botanical material demand, the vegetative hard capsule material beyond the exploitation gelatin is extremely urgent.
For avoiding the infection of the human diseases that the animal proteinum protein may cause, this area press for the new non-gelatin of exploitation, vegetal hard capsule casing material and production technology thereof.
Summary of the invention
The purpose of this invention is to provide a kind of new vegetative hard capsule casing material and with the vegetative hard capsule casing of this material preparation;
Another object of the present invention provides the method with this material preparation vegetative hard capsule casing.
In a first aspect of the present invention, a kind of vegetative hard capsule casing material is provided, described vegetative hard capsule casing material contains vegetalitas hydrophilic gel, binding agent and water, the parts by weight of wherein said vegetalitas hydrophilic gel are 0.01-18 part, the parts by weight of described binding agent are 62-96 part, the parts by weight of described water are 3-10 part, and plasticizer is 0.01-5 part.
In the preference of the present invention, wherein also contain flocculation aid or its combination of 0.01-5 weight portion.
In the preference of the present invention, the parts by weight of described vegetalitas hydrophilic gel are 0.1-18 part, and the parts by weight of described binding agent are 62-96 part, and the parts by weight of described water are 3-10 part.
In the preference of the present invention, described gel is selected from down the hydrophilic gel of group: high acetylation gellan gum, low acetylation gellan gum, κ type carrageenan, ι type carrageenan, β type carrageenan, agar, pectin, sodium alginate, xanthan gum, tragacanth, POLY-karaya or its combination;
Described binding agent is selected from down the binding agent of group: hypromellose, methylcellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, high amylopectin starch, dextrin, polyvinylpyrrolidone, sodium carboxymethyl cellulose or its combination.
In the preference of the present invention, described plasticizer is selected from down the plasticizer of group: glycerol, Sorbitol, Polyethylene Glycol and composition thereof, ethylene glycol, ethyl acetate, 1,3-butanediol, 1,4-butanediol, xylitol, Glycerine 1,3-diacetate, triacetin, monoacetin, mannitol, inositol, maltose alcohol, glucose, polypropylene glycol or its combination.
In the preference of the present invention, described flocculation aid is selected from down the flocculation aid of group: potassium chloride, calcium chloride, potassium phosphate, potassium citrate and composition thereof.
In the preference of the present invention, form by hydrophilic gel, binding agent, plasticizer, flocculation aid and water basically,
The parts by weight of wherein said hydrophilic gel are 0.01-18 part, the parts by weight of described binding agent are 62-96 part, and the parts by weight of described water are 3-10 part, and the parts by weight of plasticizer are 0.01-5 part, the weight portion of described flocculation aid is 0.01-5 part, and wherein:
Described gel is selected from down the hydrophilic gel of group: high acetylation gellan gum, low acetylation gellan gum, κ type carrageenan, ι type carrageenan, β type carrageenan, agar, pectin, sodium alginate, xanthan gum, tragacanth, POLY-karaya or its combination;
Described binding agent is selected from down the binding agent of group: hypromellose, methylcellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, high amylopectin starch, dextrin, polyvinylpyrrolidone, sodium carboxymethyl cellulose or its combination;
Described plasticizer is selected from down the plasticizer of group: glycerol, Sorbitol, Polyethylene Glycol and composition thereof, ethylene glycol, ethyl acetate, 1,3-butanediol, 1,4-butanediol, xylitol, Glycerine 1,3-diacetate, triacetin, monoacetin, mannitol, inositol, maltose alcohol, glucose, polypropylene glycol or its combination;
Described flocculation aid is selected from down the flocculation aid of group: potassium chloride, calcium chloride, potassium phosphate, potassium citrate and composition thereof.
Another aspect of the present invention discloses a kind of hard capsule, make by vegetative hard capsule casing material, described vegetative hard capsule casing material contains vegetalitas hydrophilic gel, binding agent, plasticizer and water, the parts by weight of wherein said vegetalitas hydrophilic gel are 0.01-18 part, the parts by weight of described binding agent are 62-96 part, the parts by weight of described water are 3-10 part, and plasticizer is 0.01-5 part.
A further aspect of the invention discloses a kind of production method of vegetative hard capsule casing, comprises step:
(a) hydrophilic gel, the binding agent of 10-40 weight portion, the plasticizer of 0.01-5 weight portion and the water of 60-90 weight portion of mixing and stirring 0.01-5 weight portion obtain dissolved glue;
(b) glue that obtains of step (a) makes vegetative hard capsule casing with dip in glue method (preferably can simply describe) in description;
(c) vegetative hard capsule casing that step (b) is obtained obtains the vegetative hard capsule in vegetative hard capsule gross weight water content 3-10% through 30-45 ℃ of oven dry.
In the preference of the present invention, in step (a), also comprise: the flocculation aid that in glue, is added into the 0.01-5 weight portion.
The specific embodiment
The inventor is through going deep into and extensive studies for a long time, from solving the snap fit capsule defective, according to vegetalitas colloid properties of materials, discovery is composite by a certain percentage with binding agent and hydrophilic gel, form the hard capsule casing material that mouthfeel is good, clarity is high, and make ideal vegetative hard capsule casing.Finished the present invention on this basis.
The main component of vegetative hard capsule casing material of the present invention is hydrophilic gel, binding agent, plasticizer, He Shui.In addition, also can add various additives in the vegetative hard capsule casing material of the present invention.For example, contain the additive that is selected from down group: flocculation aid and composition thereof.Also can further add antiseptic, antioxidant or its mixture.
Hydrophilic gel
Can be used for hydrophilic gel of the present invention and be all the vegetalitas gel, representative example comprises (but being not limited to): high acetylation gellan gum or low acetylation gellan gum, κ type carrageenan, ι type carrageenan, β type carrageenan, agar, pectin, sodium alginate, xanthan gum, tragacanth, POLY-karaya.
In vegetative hard capsule casing material of the present invention or the vegetative hard capsule casing that makes, the content of hydrophilic gel is generally 0.01-18 part, preferred 0.1-2 part.
If by weight percentage, in vegetative hard capsule casing material or the vegetative hard capsule casing that makes, the content of hydrophilic gel is generally 0.01-18%, preferably is 0.05-10 part, more preferably is 0.1-2%.
Binding agent
Binding agent among the present invention is hypromellose, methylcellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, high amylopectin starch, dextrin, polyvinylpyrrolidone, sodium carboxymethyl cellulose etc.
The content of binding agent is generally 62-96 part, and preferable is 75-95 part, more preferably 90-95 part.
Water
The content of the water in the vegetative hard capsule casing of the present invention is generally 3-10 part, preferred 5-8 part.
Plasticizer
Representational plasticizer comprises (but being not limited to): glycerol, Sorbitol, Polyethylene Glycol and composition thereof, ethylene glycol, ethyl acetate, 1,3-butanediol, 1,4-butanediol, xylitol, Glycerine 1,3-diacetate, triacetin, monoacetin, mannitol, inositol, maltose alcohol, glucose, polypropylene glycol or its combination.
The content of plasticizer is generally 0.01-5 part.Preferred 0.1-4 part.Usually, plasticizer dosage is relevant with capsule finished product soft or hard degree, and generally increases with the consumption of hydrophilic gel.
Flocculation aid
Representational flocculation aid comprises (but being not limited to): potassium chloride, calcium chloride, potassium phosphate, potassium citrate and composition thereof.
The content of flocculation aid is generally 0.01-5 part.Preferred 0.1-4 part.Substantially, the consumption of flocculation aid and hydrophilic gel consumption are inversely proportional to.
Other additives
In vegetative hard capsule casing material of the present invention, also can contain other complementary additives, for example antiseptic, antioxidant, pigment, flavoring agent, flavouring agent etc.
Usually the consumption of these complementary additives is 0.01-3 part, more preferably 0.1-1 part.
Antiseptic
Representational antiseptic comprises (but being not limited to): sodium benzoate, methyl parahydroxybenzoate, propyl p-hydroxybenzoate and composition thereof.The content of antiseptic is generally 0.001-0.2 part.Preferably be about 0.01-0.19 part.The antiseptic consumption is directly proportional substantially with binder dosage.
Antioxidant
Representational antioxidant comprises (but being not limited to): propyl gallate, tea polyphenols, phytic acid, phospholipid, L-ascorbic acid and composition thereof.The content of antioxidant is generally 0.001-0.2 part.Preferably be about 0.01-0.19 part.
Preparation method
The present invention adopts hydrophilic gel and binding agent to mix, and adds water and adds flocculation aid, plasticizer, makes vegetative hard capsule casing material after the heating and melting.Its step is as follows: (a) mix and stir hydrophilic gel, the binding agent of 10-40 weight portion, the plasticizer of 0.01-5 weight portion and the water of 60-90 weight portion of 0.01-5 weight portion, obtain dissolved glue; Preferably, 0.01 part of the defoamer that also can add in the whipping process, as glycerol polyethenoxy ether, glycerol polyoxyethylene or its combination, for example commercially available bubble enemy (north, Jiamusi star organic chemical industry company limited is produced);
(b) glue that obtains of step (a) makes vegetative hard capsule casing with dipping in glue method or pressing;
(c) vegetative hard capsule casing that step (b) is obtained obtains the vegetative hard capsule in vegetative hard capsule gross weight water content 3-10% through 30-45 ℃ of oven dry.
In another preference, can mix the hydrophilic gel of 1-6 parts by weight, the binding agent of 5-40 parts by weight earlier, the plasticizer of 3-15 parts by weight forms mixture; The water of 28.8-94 parts by weight is heated to 75-95 ℃, mixture is dissolved in make the colloid uniform dissolution then, obtain the liquid material; After insulation, the glue legal system is dipped in the feed liquid employing and get hard capsule case.After drying, softgel shell still contains a certain amount of water, the general about 3-10% of finished product water content.
The preparation method of vegetative hard capsule casing of the present invention can be carried out on the equipment of existing preparation gelatin hard softgel shell.Need not set in addition under the condition that is equipped with, as long as can make required vegetative hard capsule casing according to parameters such as the corresponding adjustment baking temperature of prescription, humidity, coating thickness, running speeds.
Compared with prior art, major advantage of the present invention is:
(1) preparation capsule shells used colloidal materials does not contain animal protein and fat based on hydrophilic plant colloid, thereby has avoided the pollution that may be caused by the animal proteinum protein.
(2) can add the plasticizer of enumerating among the present invention according to circumstances.
(3) agent of hydrophilic plant gel is easy to dissolving, can save the imbibition stage necessary when making gelatine capsule, saves the production time.
(4) tolerance to humiture makes it very convenient in use, storage and transportation.And the gelatin hard softgel shell is relatively stricter to the toleration of humiture, so its application is restricted.
(5) in the advantage that keeps the gelatin hard softgel shell, overcome the gelatin hard softgel shell meet high temperature, heat easily decompose and can not load the aldehyde medicine etc. shortcoming.And regulate prescription as required and can make hard capsule cases such as being applicable to quick-acting, slow release, controlled release, enteric, gastric solubleness.
Below in conjunction with specific embodiment, further illustrate the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.The experimental technique of unreceipted actual conditions in the following example, usually according to normal condition, or the condition of advising according to manufacturer.Ratio and percentage ratio are based on weight, unless stated otherwise.
Embodiment 1
Vegetative hard capsule casing material 1
| Composition of raw materials | Consumption (content in per 100 gram gross weights) |
| Hypromellose | 25 grams |
| κ type carrageenan | 1 gram |
| Deionized water | 72 grams |
| Glycerol | 2 grams |
Manufacture method is: take by weighing κ type carrageenan 1 gram, glycerol 2 grams are poured 72 gram deionized waters into, are heated to 90 ℃, dissolving is evenly poured hypromellose into again, stirs, and behind the bubble of cooling down feed liquid is cooled to 55 ℃, adopts to dip in the glue legal system and get capsule shells.In about 35 ℃ of oven dry, the capsule water content of membrane is controlled in the 3%-10%, obtain 27.5 gram vegetative hard capsule casings altogether.Transparent, the good springiness of the vegetative hard capsule casing that finally obtains.
Embodiment 2
Vegetative hard capsule casing material 2
| Prescription | Consumption (content in per 100 gram gross weights) |
| κ type carrageenan | 0.5 gram |
| Polyvidone | 9.5 gram |
| Hypromellose | 18 grams |
| Polyethylene Glycol | 2 grams |
| Deionized water | 70 grams |
Manufacture method is: take by weighing κ type carrageenan 0.5 gram, polyvidone 9.5 grams, Polyethylene Glycol 2 grams and pour 70 gram deionized waters into, be heated to 90 ℃, dissolving is evenly poured hypromellose into and is stirred evenly, and dips in the glue legal system and gets capsule through insulation, the bubble back employing of cooling down.In about 30 ℃ of oven dry, the capsule water content of membrane is controlled in the 3%-10%, obtain 32 gram vegetative hard capsule casings altogether.The vegetative hard capsule casing that finally obtains is transparent, flexible, mouthfeel is good.
Embodiment 3
Vegetative hard capsule casing material 3
| Prescription | Consumption (content in per 100 gram gross weights) |
| Gellan gum | 1 gram |
| Hypromellose | 20 grams |
| Polyethylene Glycol | 0.8 gram |
| Calcium chloride | 0.2 gram |
| Deionized water | 78 grams |
Manufacture method is: get gellan gum 1 gram, and Polyethylene Glycol 0.8 gram, calcium chloride 0.2 gram is poured in the 78 gram deionized waters, is heated to 100 ℃.Dissolve evenly, hypromellose 20 gram addings are stirred again, behind insulation, froth breaking, employing is dipped in glue and is obtained hard capsule case, and 40 ℃ of oven dry, the capsule shells water content obtains 23.5 gram vegetative hard capsule casings altogether at 3-10%.The vegetative hard capsule casing that makes is bright, flexible, mouthfeel is good.
All quote in this application as a reference at all documents that the present invention mentions, just quoted as a reference separately as each piece document.Should be understood that in addition those skilled in the art can make various changes or modifications the present invention after having read above-mentioned teachings of the present invention, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Claims (10)
1. vegetative hard capsule casing material, it is characterized in that: described vegetative hard capsule casing material contains vegetalitas hydrophilic gel, binding agent, plasticizer and water, the parts by weight of wherein said vegetalitas hydrophilic gel are 0.01-18 part, the parts by weight of described binding agent are 62-96 part, the parts by weight of described water are 3-10 part, and plasticizer is 0.01-5 part.
2. hard capsule casing material as claimed in claim 1 is characterized in that, wherein also contains the flocculation aid of 0.01-5 weight portion.
3. hard capsule casing material as claimed in claim 1 is characterized in that, the parts by weight of described vegetalitas hydrophilic gel are 0.1-18 part, and the parts by weight of described binding agent are 62-96 part, and the parts by weight of described water are 3-10 part.
4. hard capsule casing material as claimed in claim 1 is characterized in that,
Described gel is selected from down the hydrophilic gel of group: high acetylation gellan gum, low acetylation gellan gum, κ type carrageenan, ι type carrageenan, β type carrageenan, agar, pectin, sodium alginate, xanthan gum, tragacanth, POLY-karaya or its combination;
Described binding agent is selected from down the binding agent of group: hypromellose, methylcellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, high amylopectin starch, dextrin, polyvinylpyrrolidone, sodium carboxymethyl cellulose or its combination.
5. hard capsule casing material as claimed in claim 1, it is characterized in that, described plasticizer is selected from down the plasticizer of group: glycerol, Sorbitol, Polyethylene Glycol and composition thereof, ethylene glycol, ethyl acetate, 1,3-butanediol, 1,4-butanediol, xylitol, Glycerine 1,3-diacetate, triacetin, monoacetin, mannitol, inositol, maltose alcohol, glucose, polypropylene glycol or its combination.
6. hard capsule casing material as claimed in claim 1 is characterized in that, described flocculation aid is selected from down the flocculation aid of group: potassium chloride, calcium chloride, potassium phosphate, potassium citrate and composition thereof.
7. hard capsule casing material as claimed in claim 1 is characterized in that, forms by hydrophilic gel, binding agent, plasticizer, flocculation aid and water basically,
The parts by weight of wherein said hydrophilic gel are 0.01-18 part, the parts by weight of described binding agent are 62-96 part, and the parts by weight of described water are 3-10 part, and the parts by weight of plasticizer are 0.01-5 part, the weight portion of described flocculation aid is 0.01-5 part, and wherein:
Described gel is selected from down the hydrophilic gel of group: high acetylation gellan gum, low acetylation gellan gum, κ type carrageenan, ι type carrageenan, β type carrageenan, agar, pectin, sodium alginate, xanthan gum, tragacanth, POLY-karaya or its combination;
Described binding agent is selected from down the binding agent of group: hypromellose, methylcellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, high amylopectin starch, dextrin, polyvinylpyrrolidone, sodium carboxymethyl cellulose or its combination;
Described plasticizer is selected from down the plasticizer of group: glycerol, Sorbitol, Polyethylene Glycol and composition thereof, ethylene glycol, ethyl acetate, 1,3-butanediol, 1,4-butanediol, xylitol, Glycerine 1,3-diacetate, triacetin, monoacetin, mannitol, inositol, maltose alcohol, glucose, polypropylene glycol or its combination;
Described flocculation aid is selected from down the flocculation aid of group: potassium chloride, calcium chloride, potassium phosphate, potassium citrate and composition thereof.
8. a hard capsule is characterized in that, it is made with the described vegetative hard capsule casing material of claim 1.
9. the production method of a vegetative hard capsule casing is characterized in that, comprises step:
(a) hydrophilic gel, the binding agent of 10-40 weight portion, the plasticizer of 0.01-5 weight portion and the water of 60-90 weight portion of mixing and stirring 0.01-5 weight portion obtain dissolved glue;
(b) glue that obtains of step (a) makes vegetative hard capsule casing with dipping in glue method or pressing;
(c) vegetative hard capsule casing that step (b) is obtained obtains the vegetative hard capsule in vegetative hard capsule gross weight water content 3-10% through 30-45 ℃ of oven dry.
10. method as claimed in claim 9 is characterized in that, also comprises in step (a): the flocculation aid that is added into the 0.01-5 weight portion in glue.
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| CN 200510030530 CN1947709A (en) | 2005-10-14 | 2005-10-14 | Vegetative hard capsule casing material and its prodn. method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510030530 CN1947709A (en) | 2005-10-14 | 2005-10-14 | Vegetative hard capsule casing material and its prodn. method |
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| WO2009021377A1 (en) * | 2007-08-10 | 2009-02-19 | Shanghai Huiyuan Vegetal Capsule Co., Ltd | Non-gelatin shell material of hard capsule and process for preparing thereof |
| WO2009062356A1 (en) * | 2007-11-13 | 2009-05-22 | Shanghai Huiyuan Vegetal Capsule Co., Ltd | Non-gelatin enteric hard capsule shell and preparation method thereof |
| CN102100681A (en) * | 2011-01-28 | 2011-06-22 | 广东仙乐制药有限公司 | Vegetal shell of soft capsule |
| CN101708171B (en) * | 2009-12-17 | 2011-12-07 | 安徽黄山胶囊有限公司 | Enteric plant hollow capsule |
| CN101433526B (en) * | 2007-11-13 | 2012-04-18 | 上海慧源植物胶囊股份有限公司 | Non-gelatine enteric hard capsule shell material and method for producing the same |
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