CN109908103A - A kind of composition being used to prepare soft capsule - Google Patents
A kind of composition being used to prepare soft capsule Download PDFInfo
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- CN109908103A CN109908103A CN201811626327.4A CN201811626327A CN109908103A CN 109908103 A CN109908103 A CN 109908103A CN 201811626327 A CN201811626327 A CN 201811626327A CN 109908103 A CN109908103 A CN 109908103A
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- soft capsule
- hydroxypropul starch
- gelling agent
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Abstract
The invention belongs to pharmaceutical technology fields, and in particular to a kind of composition for being used to prepare soft capsule and its application.The composition includes hydroxypropul starch acetate, and gelling agent, plasticizer, surplus is water.The present invention is by using hydroxypropul starch acetate with the gelling agent in a small amount of natural plant gum source, plasticizer and water are mixed to get composition, because of the introducing of acetyl group in hydroxypropul starch acetate, so that hydroxypropul starch acetate and phyteral polysaccharide gelling agent have good compatibility, synergistic effect can even be generated, composition is set to obtain the higher gel rubber of toughness through sol-gel process, to reduce the cost of raw material, it ensure that the efficiency and product quality of soft capsule production, so that being provided with economic benefit and promotional value with this composition production soft capsule.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of composition for being used to prepare soft capsule and its answer
With.
Background technique
Soft capsule belongs to a kind of manner of packing of capsule, is common in drug or health food, means a certain amount of liquid
Body drug is directly encapsulated, or solid drugs are dissolved or dispersed in suitable excipient be made solution, suspension, lotion or
Semisolid, the capsule being sealed in spherical or ellipse soft capsule material.The advantages of soft capsule, is that is embedded is interior
It is tolerant to completely cut off completely with extraneous factors such as air, avoid the effective component in content from being destroyed by extraneous factor;To easily waving
Hair, the ingredient being easily oxidized can effectively be kept, and each active constituent content or net content of single capsule grain can remain steady
It is fixed, guarantee the value of the medicinal and health care of content;The peculiar smell of part functional drug or food can be effectively covered, is dropped
Repulsion of the low consumption person on sense organ.The rubber of common soft gel products is from animal skeleton or leather at present
For gelatin as primary raw material, gelatin is a kind of excellent thermal reversibility gelling agent, has fabulous elasticity, toughness and gel-
Colloidal sol transition temperature is widely used in food and medicine field.And the end of last century, the outburst of rabid ox disease finally produce gelatin
Product have been dragged in a unprecedented trust crisis.In addition, there is also many disadvantages for gelatine capsule itself, such as: being easy to breed
Microorganism, the easy moisture absorption, the low then flexibility of ambient humidity is poor and frangible, and ambient humidity is then prone to greatly adhesion, thus cannot
Load drug easy to moisture absorption or to water sensitive;Gelatin chains contain a large amount of reactive groups, are easy to filling drug response.
Soft capsule is prepared using plant base raw material is undoubtedly the effective ways to solve the above problems.But at present for planting
Research in terms of composition soft capsule rubber is still fewer, although having some patent reports, it is described formula it is still in need after
In place of continuous improve and perfect.
United States Patent (USP) US 5,342,626, which is described, prepares soft capsule with revolving die method, and wherein capsule shell is pitched by angle
Dish, mannosan, gellan gum are made of the polysaccharide mixture derived from plant.
Chinese patent CN 201610677342.6 discloses a kind of composition that can be made into soft capsule capsule material,
In, the composition includes agar-agar, locust bean gum, plastotype agent and adjuvant.
It is well known that phyteral derived polysaccharide extract is often expensive, often using it as capsule material source consumer
It is difficult to bear, therefore numerous patents consider to introduce cheap starch raw material, are mixed with using phyteral polysaccharide with starch raw material
Soft capsule material.
Chinese patent CN 201110271792.2 discloses a kind of Konjak polysaccharide compound soft capsule shell, including by weight
Following components, 0.5~8 part of konjac polysaccharide, 2~10 parts of wheaten starch, 3~15 parts of kappa-carrageenan, 0.2~4 part of xanthan gum,
7~45 parts of swelling agent, 6~30 parts of plasticizer, 0.5~3 part of other additives.
Chinese patent CN 201410258075.X discloses a kind of soft capsule, it is characterised in that the weight of materials composition
Amount proportion are as follows: 100 parts of purified water, 1~30 part of sesbania gum, 10~60 parts of pregelatinized starch, 0.5~19 part of film forming agent, surface is living
0.01~1 part of agent of property, 3~50 parts of plasticizer, pigment and opacifier are respectively 0~3 part.
Chinese patent CN 201410546365.4 discloses a kind of formula of non-soft-gelatin softgel shell, including modified shallow lake
Powder, carragheen, plasticizer, water, thickener, the weight percent of each component are as follows: modified starch 25~75%;Carragheen
10~30%;Plasticizer 10~25%;Water 40~50%;Thickener 2~12%;The color of soft capsule capsule and pill as needed
Added pigment.
Chinese patent CN 201480036675.X discloses a kind of soft capsule shelling composition, and the soft capsule is used for
It accommodates comprising being the 20% or higher core containing phosphatide oil with phospholipid concentration by mass, the composition includes: (A) forms sediment
Powder and/or dextrin;(B) gelling agent;(C) glycerol and (D) D-sorbite;Wherein (C) glycerol: the mass ratio of (D) D-sorbite is
(100:30)-(100:120).Wherein gelling agent is in carragheen, locust bean gum, natural gellan gum and deacylated gellan gum
One or two or more.
Chinese patent CN 201480082150.X discloses a kind of buffer without using Chemical metal salt, using modification
The method that starch and ι-carragheen composition composition prepare soft capsule, modified starch and ι-carragheen weight ratio are 4.1:1
To 6.5:1.
Chinese patent CN 201580053770.5 then discloses a kind of composition of soft capsule envelope, including ι-carragheen
In the presence of salt through waxy corn starch made of humid heat treatment.
However, phyteral polysaccharide gelling agent is although expensive, in many field of food as gelling agent, especially increase
Thick dose often most suitable, but since its majority does not have the obdurability and elasticity of gelatin gel, especially their gel-
Collosol temperature is often higher than Sol-gel transition temperatures, so that production efficiency is low in the production process for preparing soft capsule, capsule and pill is close
Envelope bonding is insecure, and quality is unstable.Simultaneously because starch and starch derivatives often do not have the property for generating reversible gel
Can, it is added in the gelling agent of phyteral polysaccharide formation with it, often as just filler, it is more can not only increases plant
The mechanical strength of sugared gel, instead often in the mechanical strength for destroying plant polyose gel to a certain degree.Therefore, although phase
Pass patent is numerous, but the shadow of soft capsule is still seldom seen in market, and a small amount of product is also to be released with the U.S. or South Korea
It is prepared with carragheen etc. for the seaweed glue rubber powder of primary raw material, expensive, production efficiency is lower.
Summary of the invention
In order to improve the deficiencies in the prior art, the present invention provides a kind of combination for being used to prepare soft capsule
Object, the composition include hydroxypropul starch acetate, gelling agent, plasticizer.
According to an embodiment of the invention, in the hydroxypropul starch acetate acetyl group content can for >=
0.02wt%, preferably >=0.3wt%, more preferably >=0.5wt%, the example can be 0.5 wt%, 0.8wt%,
1wt%, 1.2wt, 1.5wt%, 2wt%, 2.5wt% are particularly preferred to be 0.5~2.5wt%.
The content of hydroxy propyloxy group can be >=0.1wt% in the hydroxypropul starch acetate, preferably >=
0.2wt%, more preferably >=0.5wt%, the example can be 3.5wt%, 4.2wt%, 4.5 wt%, 6.5wt%, especially
Preferably 0.5~6.5wt%.
According to an embodiment of the invention, the hydroxypropul starch acetate can be further through sodium trimetaphosphate or three
Chlorethoxyfos are lightly crosslinked.
According to an embodiment of the invention, the gelling agent can be carragheen (such as kappa-carrageenan, ι-carragheen, λ-
Carragheen etc.), pectin, xanthan gum, locust bean gum, gellan gum, agar, sesbania gum, one of konjac glucomannan or a variety of, preferably
It is a variety of for one of carragheen, gellan gum, agar, xanthan gum.
According to an embodiment of the invention, the plasticizer can be in glycerol, sorbierite, xylitol or mannitol
It is one or more, preferably one of glycerol, sorbierite or a variety of.
According to an embodiment of the invention, can optionally add Artemisia Glue in the composition, the Artemisia Glue can be with
It is 0~3 part, the example can be 0.1 part, 0.2 part.
According to an embodiment of the invention, in parts by weight, hydroxypropul starch acetate can be 20 in the composition
~60 parts, such as 30~50 parts, the example can be 40 parts;
The gelling agent can be 0.1~20 part, such as 0.2~15 part, such as 0.5~8 part, and the example can be 2 parts;
The plasticizer can be 5~80 parts, such as 10~70 parts, such as 12~60 parts, and the example can be 16 parts;
According to an embodiment of the invention, surplus is water in the composition.The water can be 5~100 parts, such as
10~90 parts, such as 20~80 parts, the example can be 40 parts.
According to an embodiment of the invention, including following component in parts by weight: hydroxypropul starch in the composition
40 parts of acetate, 0.5~8 part of gelling agent, 12~60 parts of plasticizer, 20~80 parts of water.
Other auxiliary materials are added according to an embodiment of the invention, can according to need in the composition, described other are auxiliary
Material can be selected from such as one of smoke agent for shielding, pigment, flocculation aid or a variety of.
According to an embodiment of the invention, the smoke agent for shielding can be one of titanium dioxide, calcium carbonate or a variety of.
According to an embodiment of the invention, the flocculation aid can for sodium chloride, potassium chloride, potassium carbonate, potassium citrate,
One of potassium acetate, calcium chloride or calcium acetate are a variety of, preferably one of potassium chloride, sodium chloride or a variety of.
According to an embodiment of the invention, when also including one of smoke agent for shielding, pigment, flocculation aid in the composition
Or when a variety of, in parts by weight, the smoke agent for shielding can be 0.01~0.5 part, such as 0.05~0.2 part, and the example can be
0.1 part;
The flocculation aid can be 0.0001~0.005 part, such as 0.0005~0.002 part, and the example can be 0.001
Part.
The present invention also provides the application of the composition, can be used for preparing soft capsule.
The present invention also provides the method that the composition is used to prepare soft capsule, include the following steps: described group
Object is closed after pyrosol, de-bubbled, produces soft capsule through conventional equipment.
According to an embodiment of the invention, the high temperature can be 70 DEG C~120 DEG C, such as 80 DEG C~100 DEG C, in fact
Example can be 85 DEG C, 90 DEG C, 92 DEG C;
The time of the pyrosol can be 0.5~6h, such as 0.5~4h, the example can be 2h.
The conventional equipment can be the equipment that this field routinely prepares soft capsule, such as conventional revolving die production equipment.
The present invention also provides a kind of Capsules or soft capsule, the Capsules or software capsule are by above-mentioned composition
It is prepared.
Beneficial effects of the present invention:
The present invention is mixed with the gelling agent, plasticizer and water in a small amount of natural plant gum source by using hydroxypropul starch acetate
Conjunction obtains composition, because of the introducing of acetyl group in hydroxypropul starch acetate, so that hydroxypropul starch acetate and phyteral are more
Sugared gelling agent has good compatibility, or even can generate synergistic effect, so that composition is obtained through sol-gel process tough
Property higher gel rubber to reduce the cost of raw material ensure that the efficiency and product quality of soft capsule production,
So that being provided with economic benefit and promotional value with this composition production soft capsule.
Specific embodiment
Further detailed description is done to the present invention below in conjunction with specific embodiment.It should be appreciated that the following example
It is merely illustrative the ground description and interpretation present invention, and is not necessarily to be construed as limiting the scope of the invention.It is all to be based on this hair
In the range of the technology that bright above content is realized is encompassed by the present invention is directed to protect.
Experimental method used in following embodiments is conventional method unless otherwise specified;Institute in following embodiments
Reagent, material etc., are commercially available unless otherwise specified.
Embodiment 1
Be made into composition by following weight: 40 parts of hydroxypropul starch acetate (acetyl group containing 0.02wt% and
The hydroxy propyloxy group of 6.5wt%), 0.5 part of gellan gum, 12 parts of glycerol, 20 parts of water.
The above-mentioned composition for being used to prepare soft capsule is heated to 100 DEG C in glue pot, heating time is 30 points
Clock after degassing, prepares Soft Capsule Machinery using routine and prepares capsule.
Rubber crack-free phenomenon in production process, production being capable of continuous-stable progress.
Embodiment 2
Be made into composition by following weight: 40 parts of hydroxypropul starch acetate (acetyl group containing 2.5wt% and
The hydroxy propyloxy group of 0.5wt%), 0.1 part of Artemisia Glue, 8 parts of carragheen, 60 parts of glycerol, 80 parts of water.
By the above-mentioned composition for being used to prepare soft capsule further add 0.001 part of potassium chloride in glue pot plus
For heat to 80 DEG C, heating time is 4 hours, after degassing, prepares Soft Capsule Machinery using routine and prepares capsule.
Rubber crack-free phenomenon in production process, production being capable of continuous-stable progress.
Embodiment 3
Be made into composition by following weight: 40 parts of hydroxypropul starch acetate (acetyl group containing 0.8wt% and
The hydroxy propyloxy group of 4.5wt%), 2 parts of agar, 60 parts of sorbierite, 40 parts of water.
The above-mentioned composition for being used to prepare soft capsule is further added 0.1 part of titanium dioxide to heat in glue pot
To 90 DEG C, heating time is 2 hours, after degassing, prepares Soft Capsule Machinery using routine and prepares capsule.
Rubber crack-free phenomenon in production process, production being capable of continuous-stable progress.
Embodiment 4
Be made into composition by following weight: 40 parts of hydroxypropul starch acetate (acetyl group containing 1.2wt% and
The hydroxy propyloxy group of 3.5wt%), 3 parts of Artemisia Glue, 2 parts of carragheen, 60 parts of mannitol, 40 parts of water.
The above-mentioned composition for being used to prepare soft capsule is heated to 90 DEG C in glue pot, heating time is 2 small
When, after degassing, Soft Capsule Machinery is prepared using routine and prepares capsule.
Rubber crack-free phenomenon in production process, production being capable of continuous-stable progress.
Embodiment 5
Be made into composition by following weight: 40 parts of hydroxypropul starch acetate (acetyl group containing 0.5wt% and
The hydroxy propyloxy group of 4.2wt%), 0.2 part of Artemisia Glue, 2 parts of carragheen, 16 parts of glycerol, 40 parts of water.
The above-mentioned composition for being used to prepare soft capsule is heated to 85 DEG C in glue pot, heating time is 2 small
When, after degassing, Soft Capsule Machinery is prepared using routine and prepares capsule.
Rubber crack-free phenomenon in production process, production being capable of continuous-stable progress.
Embodiment 6
Weighing the hydroxypropul starch acetates of six kinds of different acetyl contents respectively, (hydroxypropoxy content is 4.2
Wt%) each 40 parts, 1 part of kappa-carrageenan, 42 parts of water and 12 parts of glycerol is added in every kind of hydroxypropul starch acetate, are made into six
Kind of composition, through 92 DEG C after pyrosol 2 hours, de-bubbled produces soft capsule through revolving die Soft Capsule Machinery, tests glue
The tensile strength of skin, tensile strength and fracture extension rate data are as shown in table 1.
Tensile strength test: using 1122 type test macro of Instron, and sample to be tested is placed in climatic chamber (temperature
Degree be 23 DEG C, relative humidity 50%) in balance 5 hours after, according to GB/T13735-1992 regulation tested.
The tensile strength test for the composition that the hydroxypropul starch acetate of the different acetyl contents of table 1 is made into
Acetyl content/wt% in hydroxypropul starch acetate | 0 | 0.02 | 0.5 | 1 | 2 | 2.5 |
Rubber tensile strength/MPa | 1.0 | 1.1 | 1.6 | 1.8 | 2.2 | 2.6 |
Elongation at break/% of rubber | 92 | 92 | 110 | 143 | 172 | 186 |
As can be seen that in the composition with the increase of acetyl content in hydroxypropul starch acetate, the anti-tensile of rubber
Intensity increases, and elongation at break increases.
More than, embodiments of the present invention are illustrated.But the present invention is not limited to above embodiment.It is all
Within the spirit and principles in the present invention, any modification, equivalent substitution, improvement and etc. done should be included in guarantor of the invention
Within the scope of shield.
Claims (10)
1. a kind of composition for being used to prepare soft capsule, which is characterized in that the composition includes hydroxypropul starch acetic acid
Ester, gelling agent, plasticizer.
2. composition according to claim 1, which is characterized in that the content of acetyl group in the hydroxypropul starch acetate
It can be >=0.02wt%, the content of hydroxy propyloxy group can be >=0.1wt%, and the hydroxypropul starch acetate can be into one
It walks lightly crosslinked through sodium trimetaphosphate or phosphorus oxychloride;
The gelling agent can be carragheen (such as kappa-carrageenan, ι-carragheen, lambda-carrageenan etc.), pectin, xanthan gum, locust tree
One of bean gum, gellan gum, agar, sesbania gum, konjac glucomannan are a variety of;
The plasticizer can be one of glycerol, sorbierite, xylitol or mannitol or a variety of.
3. composition according to claim 1 or 2, which is characterized in that can optionally add sand sagebrush (Artemisia filifolia) in the composition
Glue, the Artemisia Glue can be 0~3 part.
4. composition according to any one of claims 1 to 3, which is characterized in that in parts by weight, hydroxyl in the composition
Propyl starch acetate can be 20~60 parts, and the gelling agent can be 0.1~20 part, and the plasticizer can be 5~80
Part.
5. composition according to any one of claims 1 to 4, which is characterized in that surplus is water in the composition, described
Water can be 5~100 parts.
6. composition according to any one of claims 1 to 5, which is characterized in that include with parts by weight in the composition
The following component of meter: 40 parts of hydroxypropul starch acetate, 0.5~8 part of gelling agent, 12~60 parts of plasticizer, 20~80 parts of water.
7. composition according to any one of claims 1 to 6, which is characterized in that can according to need in the composition
Other auxiliary materials are added, other described auxiliary materials can be selected from such as one of smoke agent for shielding, pigment, flocculation aid or a variety of;
The smoke agent for shielding can be one of titanium dioxide, calcium carbonate or a variety of;
The flocculation aid can be one in sodium chloride, potassium chloride, potassium carbonate, potassium citrate, potassium acetate, calcium chloride or calcium acetate
Kind is a variety of;
When also including one of smoke agent for shielding, pigment, flocculation aid in the composition or being a variety of, in parts by weight, the screening
Covering agent can be 0.01~0.5 part, and the flocculation aid can be 0.0001~0.005 part.
8. the application of any one of claim 1 to 7 composition, can be used for preparing soft capsule.
9. the method that any one of claim 1 to 7 composition is used to prepare soft capsule, includes the following steps: institute
Composition is stated after pyrosol, de-bubbled, produces soft capsule through conventional equipment;
The high temperature can be 70 DEG C~120 DEG C, and the time of the pyrosol can be 0.5~6h, and the conventional equipment can
Think the equipment that this field routinely prepares soft capsule.
10. a kind of Capsules or soft capsule, the Capsules or software capsule are by the combination of any one of claim 1 to 7
Object is prepared.
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Cited By (4)
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CN111454490A (en) * | 2020-04-14 | 2020-07-28 | 中国科学院化学研究所 | Composition for preparing edible plant plasma membrane and application thereof |
CN112294775A (en) * | 2020-12-10 | 2021-02-02 | 浙江艾兰得生物科技有限公司 | Plant-based soft capsule rubber with anti-adhesion function |
CN112586587A (en) * | 2020-12-10 | 2021-04-02 | 浙江艾兰得生物科技有限公司 | Anti-sticking chewable plant gel candy gel rubber |
CN115584133A (en) * | 2021-07-06 | 2023-01-10 | 宋悠洋 | Thermoplastic composition based on degradable biopolymer and preparation method and application thereof |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN112294775A (en) * | 2020-12-10 | 2021-02-02 | 浙江艾兰得生物科技有限公司 | Plant-based soft capsule rubber with anti-adhesion function |
CN112586587A (en) * | 2020-12-10 | 2021-04-02 | 浙江艾兰得生物科技有限公司 | Anti-sticking chewable plant gel candy gel rubber |
CN115584133A (en) * | 2021-07-06 | 2023-01-10 | 宋悠洋 | Thermoplastic composition based on degradable biopolymer and preparation method and application thereof |
CN115584133B (en) * | 2021-07-06 | 2023-12-15 | 深圳市朴飞生物科技有限公司 | Thermoplastic composition based on degradable biopolymer, preparation method and application thereof |
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