CN108143724A - A kind of high oxygen-impermeable plant hollow capsule and preparation method thereof - Google Patents
A kind of high oxygen-impermeable plant hollow capsule and preparation method thereof Download PDFInfo
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- CN108143724A CN108143724A CN201810177772.0A CN201810177772A CN108143724A CN 108143724 A CN108143724 A CN 108143724A CN 201810177772 A CN201810177772 A CN 201810177772A CN 108143724 A CN108143724 A CN 108143724A
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- capsule
- plant hollow
- hollow capsule
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- coating
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Classifications
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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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
-
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
Abstract
The invention discloses a kind of plant hollow capsule, the inner surface of capsule wall contains at least one layer of coating on inner surface, and the coating on inner surface contains one or more in vegetable oil, animal oil, silicone oil or mineral oil.The plant hollow capsule of the present invention has very high oxygen barrier rate, reduces the rate that oxygen enters in capsule, improves the holding time of capsule.In addition, the roughness of the plant hollow capsule inner surface of the present invention is very low, adhesion rate of the capsule 's content in capsule inner surface, and the good toughness of capsule are reduced, breakage rate is pierced through, can be used for loading inhalable dry powder formulations, for treating respiratory disease.Meanwhile the present invention also carries out plasma treatment by the plant hollow capsule to preparation, further improves the above-mentioned performance of capsule, utilization is more extensive.
Description
Technical field
The present invention relates to plant hollow capsule fields, and in particular to a kind of high oxygen-impermeable plant hollow capsule and its preparation side
Method.
Background technology
With the development of pharmaceuticals industry, capsule is since it may be used with nearly any drug, free from extraneous odour, easily swallows, easily disappears
Change the features such as absorbing, is without side-effects to body, development is very fast, is widely used in food, drug and field of health care products.
Capsule is made of Capsules shell and its content, and Capsules shell can be divided into gelatin hollow capsule and plant
Capsules.Traditional Capsules shell is made of gelatin, and gelatin is by the connective tissues such as animal skin, bone, sarolemma, flesh evil spirit
Collagenous portion degrade, gelatin main component is protein, easy microbial contamination, easy friability when water content is low, and
It can be crosslinked with some drugs and react and make drug failure.Plant hollow capsule is the hollow glue using plant origin object as raw material
Capsule, specifically comprising starch hollow capsule, hypromellose Capsules and Propiram Capsules etc..Hydroxypropyl methylcellulose
Element is that cellulosic sections methylate and gather hydroxypropyl etherified product, is a kind of non-ionic compound ether, is to prepare hydroxypropyl
The primary raw material of cellulose hollow capsule.Capsules prepared therefrom, compared with gelatine capsule, water content is low, chemical stabilization
Property it is good, do not react with content, toughness it is high, moreover it can be used to vegetarian, utilization are more extensive.
But compared with gelatine capsule, the oxygen barrier rate of hypromellose Capsules is poor, and oxygen can enter in capsule
Portion and aoxidize capsule 's content, be not suitable for load reducing substances, limit hypromellose Capsules extensively make
With, therefore it is badly in need of a kind of hypromellose Capsules with higher oxygen barrier rate.
In addition, the treatment of respiratory disease particularly pulmonary disease is often by the way of inhalation by pharmaceutical activity
Ingredient is applied directly to respiratory system by way of sucking, obtains better therapeutic effect.During in order to ensure drug sucking not
It brings capsule fragments into and harm is generated to respiratory system, need to ensure that capsule has enough toughness, will not be generated when piercing through broken
Piece.Although relative to gelatine capsule, hypromellose capsule is less broken when pierced, but still has broken generation
The situation of capsule fragments so needing to further improve the toughness of hypromellose capsule, reduces and pierces through breakage rate.And
Capsules demould for convenience, and the roughness of inner surface is higher, and capsule 's content is easily adhered in inside capsule wall, influences capsule
Agent is particularly useful for the treatment of the therapeutic effect of the dry powder inhaler formulations of respiratory disease.
For this reason, it may be necessary to a kind of plant capsule, can solve the above problems, there is high oxygen barrier rate, low puncture breakage rate and low interior
The advantages that surface roughness.
Invention content
For this purpose, the present invention provides a kind of plant hollow capsules, which is characterized in that the inner surface of capsule wall contains at least one
Layer coating on inner surface, the coating on inner surface contains one or more in vegetable oil, animal oil, silicone oil or mineral oil.It is interior
Face coat can improve the oxygen barrier rate of plant hollow capsule, reduce the rate that capsule 's content is oxidized by oxygen, and extend capsule
Holding time；Meanwhile coating on inner surface can reduce the roughness of capsule inner surface, reduce capsule 's content in capsule surface
Adhesion rate；Coating on inner surface can also improve the toughness of plant capsule, reduce the puncture breakage rate of plant capsule.
Wherein, the inner surface of the capsule wall refers to contact a side surface of drug during Capsules powder charge.Coating is
Refer to continuous film coated in body surface, playing specific function.Oxygen barrier rate refers to barrier property of the capsule wall to oxygen, and the present invention makes
It is characterized with OTR oxygen transmission rate, OTR oxygen transmission rate is lower, and oxygen barrier rate is higher.
Vegetable oil refers to be occurred by unrighted acid and glycerine the substance of esterification.Specifically including but not limited to peanut
It is one or more in oil, soya-bean oil, linseed oil, castor oil, rapeseed oil, sunflower oil etc..
Animal oil refers to be occurred by saturated fatty acid and glycerine the substance of esterification.Specifically including but not limited to lard,
It is one or more in butter, sheep oil, fish oil, whale oil etc..
Silicone oil refers to that polymer molecule backbone is made of silicon oxygen bond, the substance being connected on side chain with organic illness.Specific packet
Contain but be not limited to dimethicone, diethyl silicone oil, phenyl silicone oil, polymethylphenyl siloxane fluid, ethyl containing hydrogen silicone oil, methyl hydrogen silicon
Oil, MethylethoxylsiliconFluid Fluid, hydroxyl dimethicone, hydroxyl hydrogen silicone oil, vinyl silicone oil, methyl vinyl silicon oil, amino
It is one or more in silicone oil, silicone oil of carboxyl and epoxy silicon oil etc..
Mineral oil is refining liquid hydrocarbons, the predominantly objects such as the cycloalkane of saturation, alkane, alkene obtained by oil
Matter, specifically including but not limited to one or more in hexane, heptane, octane, hexamethylene, hexene, heptene etc..
The coating on inner surface of the present invention also includes the derivative of above-mentioned substance, i.e., the hydrogen atom in above-mentioned substance molecule or its
The substance that his group is replaced by one or more different groups, the group specifically including but not limited to alkyl, hydroxyl,
Amino, carboxyl, epoxy group, phenyl ring, halogen, nitro or sulfydryl etc.；Also include the polymer and mixture of these substances.It is preferred that
, coating on inner surface of the invention includes one or more in vegetable oil, silicone oil or their derivatives.
Further, the coating on inner surface includes peanut oil, soya-bean oil, linseed oil, castor oil, rapeseed oil, sunflower seeds
One in oil, hydroxyl dimethicone, MethylethoxylsiliconFluid Fluid, amido silicon oil, silicone oil of carboxyl, vinyl silicone oil or epoxy silicon oil
Kind is a variety of.
Further, the coating on inner surface contains the mixture of sunflower oil and castor oil.Castor oil and methyl second
Oxygroup silicone oil has synergistic effect, when the mixture containing castor oil and MethylethoxylsiliconFluid Fluid in coating on inner surface, capsule
The OTR oxygen transmission rate of wall is lower, and toughness is more preferable.
Further, in the coating on inner surface of the plant hollow capsule, using the MethylethoxylsiliconFluid Fluid as 100
Parts by weight meter, castor oil are 100~400 parts by weight.When above two material quality ratio is within the above range in coating on inner surface
When, the OTR oxygen transmission rate of capsule wall is lower, and toughness is more preferable.Preferably, using the MethylethoxylsiliconFluid Fluid as 100 parts by weight
Meter, castor oil are 200~300 parts by weight.
Further, the thickness of coating on inner surface is 1~15 μm in the plant hollow capsule.When coating on inner surface
When thickness is less than 1 μm, the OTR oxygen transmission rate of capsule is higher；When the thickness of coating on inner surface is more than 15 μm, capsule inner surface can
Can be tacky, adhesion rate of the capsule 's content in capsule surface can be improved instead.Preferably, interior table in the plant hollow capsule
The thickness of finishing coat is 5~10 μm.
Further, hypromellose, starch, Propiram are contained in the capsule wall raw material of the plant hollow capsule
It is or one or more in the derivative of these substances.Preferably hypromellose.
Further, the present invention provides a kind of capsule, contains above-mentioned plant hollow capsule.
Capsule preparation method thereof known in the art may be used in the preparation method of plant hollow capsule of the present invention.Concrete example
It is as follows：
1st, capsule die is immersed in the mixed dispersion liquid containing coating on inner surface, drying is taken out, on capsule die surface
Form one layer of coating on inner surface；
2nd, capsule wall raw material is dissolved in water and aqueous solution is made, it is former that the capsule die containing coating on inner surface is immersed capsule wall
Glue is dipped in material aqueous solution, take out and dries the plant hollow capsule for demoulding and suiting and can obtain the present invention.
Further, the preparation method of plant hollow capsule of the invention also include to plant hollow capsule after molding into
The process of row plasma treatment.After plasma treatment being carried out to plant hollow capsule after molding, the coating on inner surface meeting of capsule
Reaction is crosslinked, the OTR oxygen transmission rate and inside surface roughness of plant hollow capsule can be reduced, improves toughness.
The plasma treatment refers to make inertia the methods of involving high-energy radiation with electric discharge, high-frequency electromagnetic oscillation, impact
Gas or oxygen-containing gas generate plasma, the method handled material surface.
Further, the plasma treatment is voltage bias type plasma treatment.
Further, in the plasma treatment, using capsule die as cathode, and voltage be -100~-800V, power
It is 1~10min for 10~50W, processing time.Preferably, the voltage is -300~-600V, and power is 20~40W, place
The reason time is 4~7min.
Further, the atmosphere residing for the plasma treatment can be one kind in oxygen, nitrogen, helium or argon gas
It is or a variety of.Preferably, the plasma treatment carries out in oxygen atmosphere.
The plant hollow capsule of the present invention contains coating on inner surface, can substantially reduce the OTR oxygen transmission rate of plant capsule,
Oxygen barrier rate is improved, reduces the rate that oxygen enters in capsule, can be used for loading reducing substances and extend capsule
Holding time.In addition, the roughness of the plant hollow capsule inner surface of the present invention is very low, capsule 's content table in capsule is reduced
The adhesion rate in face, and the good toughness of capsule, puncture breakage rate is low, can be used for loading inhalable dry powder formulations, for treating
Respiratory disease.
Meanwhile plant hollow capsule of the invention is crosslinked capsule coating on inner surface, further also comprising plasma treatment
The above-mentioned performance of capsule is improved, applicability is more preferable, and utilization is more extensive.
It should be appreciated that the terms such as " having " used herein, "comprising" and " comprising " be not precluded one or
A number of other substances, ingredient, performance, state, the presence or addition of element or combination；" being more than ", " being less than " all do not include number
Value in itself, " more than ", " following " all comprising numerical value in itself.
Specific embodiment
It is further illustrated the present invention below by the mode of embodiment, does not therefore limit the present invention to the embodiment
Among range.The techniques implemented on the basis of the foregoing are all within the scope of the present invention.For being familiar with this field
For personnel, other modification is easily implemented, therefore general general being limited without departing substantially from claim and equivalency range
Under thought, the present invention is not limited to specific details.
Test event of the present invention and its assay method are as follows, unless otherwise instructed, each test all at 25 DEG C into
Row.
1st, roughness (Sa)：Use the rough surface of non-planar contact surfaces shape tester (Vertscan) test sample
Spend Sa.
2nd, breakage rate is pierced through：Using a Symbion Bexicap (Beximco Pharma corporations) to Capsules
The both ends of sample are carried out at the same time puncture experiment.There is the fragment of 1 or 1 or more in sample, is considered as unqualified；Otherwise it is considered as conjunction
Lattice.200 experiments are carried out to each sample, disqualification rate is to pierce through breakage rate.Test condition is 25 DEG C, 50%RH.
3rd, oxygen permeability：According to being formulated of Capsules sample, each layer thickness ratio and and manufacture craft, it is flat using one piece
Plate prepares the glued membrane that thickness is 110 μm, then the oxygen permeability by standard ASTM D3985 test glued membranes as mold, with
This oxygen permeability as Capsules sample, unit cm3/m2d。
4th, medicinal powder-capsule wall adhesion rate：The talcum that 100mg number average bead diameters are 50 microns is added in into 3# Capsules samples
Powder, the body and cap of sealed capsule simultaneously ensure not leak powder, and hand holds capsule shells both ends, after overturning 10 times back and forth, capsule is opened, by cunning
Mountain flour is poured out, and is measured the quality m (unit mg) of the talcum powder of outflow, is accurate to 1mg.Adhesion rate S=(100-m)/100 ×
100%, replication 10 times is averaged.
5th, thickness：It is measured using calibrator.
The embodiment of the present invention is raw materials used as follows
<Capsule wall raw material>
A1：Hypromellose, the production of Shanghai Lu An bio tech ltd；
A2：Starch, the production of Shanghai Lu An bio tech ltd；
A3：Pulullan polysaccharide, the production of Shanghai Lu An bio tech ltd.
<Coating on inner surface raw material>
B1：Capmul MCM C8, the production of Jiangsu Cai Wei bio tech ltd；
B2：Epoxy silicon oil, the production of Hangzhou Hai Ding Chemical Co., Ltd.s；
B3：Castor oil, Shanghai is expanded produces along bio tech ltd；
B4：MethylethoxylsiliconFluid Fluid, the production of Ji Peng fluosilicics Materials Co., Ltd of Shenzhen.
Examples 1 to 22
According to the raw material of the capsule wall shown in table 1 and the raw material of coating on inner surface and formula, prepare in accordance with the following steps
Obtain the 3# plant hollow capsules of the present invention.
Step 1：Coating on inner surface raw material shown in table 1 is evenly spread to by shown proportioning in ethyl alcohol, obtains inner surface
Coating mixed liquor, then 3# capsule dies are immersed in the mixed liquor containing coating on inner surface, take out drying removal ethyl alcohol and are cooled down
To room temperature, one layer of coating on inner surface is formed on capsule die surface；
Step 2：Capsule wall raw material shown in table 1 is soluble in water, uniform aqueous solution is made, then step 1 is obtained
Surface also has the above-mentioned aqueous solution of capsule die immersion of one layer of coating on inner surface to dip in glue, and taking-up drying demoulding, which suits, can obtain 3#
Plant hollow capsule.
Step 3, plasma treatment is carried out to the 3# plant hollow capsules that step 2 obtains according to the condition shown in table 1, obtained
The plant hollow capsule of the present invention.Wherein, using capsule die as cathode.
By controlling in above-mentioned steps 1,2 the dense of corresponding raw material in coating on inner surface mixed liquor and capsule wall aqueous solution of raw material
The thickness to control coating on inner surface and capsule wall raw material is spent, specific thickness is as shown in table 1.Capsule wall total thickness is 110 μm.Deng from
Subprocessing carries out all in oxygen atmosphere.
Table 1
Embodiment 23
Same thickness is prepared using the raw material and proportioning of the identical capsule wall raw material of embodiment 20 and external surface coating
Plant hollow capsule, but without the plasma treatment of step 3 in embodiment.
Embodiment 24
Same thickness is prepared using the hypromellose of embodiment 4 and the raw material of external surface coating and proportioning
Hypromellose Capsules, but plasma treatment carries out in nitrogen atmosphere.
Embodiment 25
Same thickness is prepared using the hypromellose of embodiment 20 and the raw material of external surface coating and proportioning
Hypromellose Capsules, but plasma treatment carries out in nitrogen atmosphere.
Comparative example 1
Commercially available 3# hypromellose Capsules, do not contain coating on inner surface.
By the plant hollow capsule that embodiment and comparative example of the present invention obtains according to measure side of the present invention
Method carries out the measure of performance, and measurement result is as shown in table 2.
Table 2
From table 2 it can be seen that with comparative example 1 commercially available hypromellose plant capsule and compared with, plant of the invention
The performance of object Capsules is all more excellent, overcomes the shortcomings that hypromellose plant capsule oxygen barrier rate itself is low, can
For loading reducing substances, and the holding time of capsule is longer；Meanwhile plant hollow capsule of the invention is because interior
The presence of face coat, the roughness of capsule inner surface substantially reduce, and medicinal powder is low in the adhesion rate of inner wall, and the plant of the present invention
Object Capsules toughness is more preferable, and puncture breakage rate is low, can be used for loading dry powder inhaler formulations, treats respiratory system correlation disease
Disease.In addition, compared with not passing through the embodiment 23 of plasma treatment process, the embodiment 20 by plasma treatment, in table
Each property of its capsule all improves a lot, and the applicability of capsule is more preferable, has and uses prospect very well.
Claims (10)
1. a kind of plant hollow capsule, which is characterized in that the inner surface of capsule wall contains at least one layer of coating on inner surface, described
Coating on inner surface contains one or more in vegetable oil, animal oil, silicone oil or mineral oil.
2. plant hollow capsule according to claim 1, which is characterized in that the coating on inner surface contain castor oil and
The mixture of MethylethoxylsiliconFluid Fluid.
3. plant hollow capsule according to claim 2, which is characterized in that using the MethylethoxylsiliconFluid Fluid as 100
Parts by weight meter, castor oil are 100~400 parts by weight.
4. plant hollow capsule according to claim 1, which is characterized in that the thickness of the coating on inner surface for 1~
15μm。
5. plant hollow capsule according to claim 1, which is characterized in that contain hydroxypropyl first in the capsule wall raw material
Base cellulose, starch, Propiram or these substances derivative in it is one or more.
6. a kind of capsule, which is characterized in that contain Claims 1 to 5 any one of them plant hollow capsule.
7. the preparation method of Claims 1 to 5 any one of them plant hollow capsule, which is characterized in that at plasma
Science and engineering sequence.
8. the preparation method of plant hollow capsule according to claim 7, which is characterized in that the plasma treatment is
Voltage bias type plasma treatment.
9. the preparation method of plant hollow capsule according to claim 7, which is characterized in that using capsule die as cathode,
Voltage is -100~-800V, power is 10~50W, processing time is 1~10min.
10. the preparation method of plant hollow capsule according to claim 7, which is characterized in that the plasma treatment
It is carried out in oxygen atmosphere.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201810177772.0A CN108143724A (en) | 2018-03-05 | 2018-03-05 | A kind of high oxygen-impermeable plant hollow capsule and preparation method thereof |
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| CN201810177772.0A CN108143724A (en) | 2018-03-05 | 2018-03-05 | A kind of high oxygen-impermeable plant hollow capsule and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108451922A (en) * | 2018-05-03 | 2018-08-28 | 汤臣倍健股份有限公司 | A kind of soft capsule prevents adhesion technique |
| CN109528689A (en) * | 2018-12-24 | 2019-03-29 | 江苏辰星药业股份有限公司 | A kind of enteric slow release plant capsule and preparation method thereof |
| CN110133194A (en) * | 2019-05-27 | 2019-08-16 | 江苏力凡胶囊有限公司 | A method of measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate |
| CN112641121A (en) * | 2020-10-10 | 2021-04-13 | 广州启键生物科技有限公司 | Preparation method of filling hollow capsules of hydroxypropyl methylcellulose and algal polysaccharide |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108451922A (en) * | 2018-05-03 | 2018-08-28 | 汤臣倍健股份有限公司 | A kind of soft capsule prevents adhesion technique |
| CN109528689A (en) * | 2018-12-24 | 2019-03-29 | 江苏辰星药业股份有限公司 | A kind of enteric slow release plant capsule and preparation method thereof |
| CN109528689B (en) * | 2018-12-24 | 2021-09-21 | 江苏辰星药业股份有限公司 | Enteric slow-release plant capsule and preparation method thereof |
| CN110133194A (en) * | 2019-05-27 | 2019-08-16 | 江苏力凡胶囊有限公司 | A method of measurement Foradil Aerolizer formoterol fumarate Capsules Emptying Rate |
| CN112641121A (en) * | 2020-10-10 | 2021-04-13 | 广州启键生物科技有限公司 | Preparation method of filling hollow capsules of hydroxypropyl methylcellulose and algal polysaccharide |
| CN112641121B (en) * | 2020-10-10 | 2022-04-19 | 广州玖洲胶囊生物科技有限公司 | Preparation method of filled hollow capsules of hydroxypropyl methylcellulose and carrageenan |
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