CN108113974A - A kind of preparation method of porous hollow capsule and the capsule thus prepared - Google Patents
A kind of preparation method of porous hollow capsule and the capsule thus prepared Download PDFInfo
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- CN108113974A CN108113974A CN201810109713.XA CN201810109713A CN108113974A CN 108113974 A CN108113974 A CN 108113974A CN 201810109713 A CN201810109713 A CN 201810109713A CN 108113974 A CN108113974 A CN 108113974A
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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
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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
- A61K9/4825—Proteins, e.g. gelatin
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Abstract
The present invention provides a kind of preparation methods of porous hollow capsule, are foamed by the capsule embryo material containing bicarbonate at a temperature of higher than 100 DEG C, then are cooled fast to less than 100 DEG C sizings and are prepared.The porous hollow capsule density smaller that preparation method according to the invention is prepared, grain weight is lighter, and faster, faster, the friability of capsule is relatively low for degradation in vivo speed, meets the requirement of Chinese Pharmacopoeia for disintegration time.Meanwhile the porous capsule that is prepared of preparation method of the invention is white and whiteness is suitable with commercially available white capsule, but any white pigment is not contained, eliminate the risk that pigment generates human body harm.The present invention also provides a kind of porous hollow capsules, and it includes the one or more and carbonate and water having in cellulose, gelatin, Propiram or starch.
Description
Technical field
The present invention relates to Capsules fields, and in particular to a kind of preparation method of porous hollow capsule and thus makes
Standby capsule.
Background technology
Capsules refers to the bladder made of extraordinary filmogen (such as gelatin, cellulose, polysaccharide etc.) in medicine,
Content (such as powdery, liquid various kinds of drug) is packed into wherein, convenient for swallowing.The drug filled with capsule, typically to food
Road and gastric mucosa powder excitatory or particle or mouthfeel are bad, be easy to volatilization, easily decomposed in the oral cavity by saliva and
The easily medicine of sucking tracheae.These medicines are packed into capsule, both medicine property of medicine are protected not to be destroyed, and also protect digestive organs and breathing
Road.Remove capsule shells and be likely to result in drug wastage, drug waste, drug effect reduction.
Packaging material of the Capsules as special article, although having the function of above-mentioned protection capsule 's content etc.,
Itself is there is no special drug effect, and capsule prepares raw material must reach food-grade and pharmaceutical grade.But the raw material of capsule
And its impurity may be contained in production process or be contaminated, therefore can have the risk being detrimental to health；The quality of capsule
It is too big, the transportation cost and cost of material of capsule can be improved, and the degradation rate of capsule shells in vivo is slack-off, and degradation time increases
Add, the responding time of drug in capsule can be influenced, influence the therapeutic effect of drug.
Meanwhile the capsule for not containing pigment is water white transparency, some drugs can shadow due to its special shape or color
The mood of patient is rung, therefore patient is not intended to see；Or see that light can decompose and lose drug effect, it is necessary to carry out shading treatment；Separately
Outside, sometimes it is also required to increase the identification of capsule.In order to achieve the above object, people would generally add in various face in capsule
The pigment of color makes capsule carry color.In the capsule of a variety of colors, white capsule is most common, and white pigment has very much
Kind, it can specifically enumerate such as titanium dioxide, zinc oxide, barium sulfate, magnesium carbonate, magnesia, calcium carbonate, barium carbonate.These pigment
Under conditions of certain additive amount, itself will not do harm to huamn body, but since pigment is inevitably containing some are miscellaneous
Matter, and these impurity have the potential risk of do harm to huamn body.
For this reason, it may be necessary to one kind in the case where ensureing Capsules using effect, reduces Capsules quality, so as to reduce
The risk that capsule is brought；Also the transportation cost and energy consumption of capsule can be reduced, improves the therapeutic effect of capsule；Meanwhile
It is also required to that certain color can be presented on the premise of any pigment is not added, eliminates the risk that pigment brings human body.
The content of the invention
For this purpose, the present invention provides a kind of preparation methods of porous hollow capsule, comprise the steps of：
Step a：By the basis material of capsule, i.e., one or more and carbonic acid in cellulose, gelatin, Propiram or starch
Hydrogen salt is soluble in water, and the aqueous solution of capsule blank is made；
Step b：After capsule die is impregnated into the aqueous solution of capsule blank, take out, in die of capsule under drying temperature
Capsule blank is formed on tool；
Step c：Capsule blank is heated to by drying temperature in 10s to 110 DEG C or more of maximum heating temperature, and isothermal
1~10s；
Step d：In 10s less than 100 DEG C, and 1~10s of isothermal are cooled to from maximum heating temperature.
Further, the bicarbonate described in step a is in sodium acid carbonate, calcium bicarbonate, saleratus, ammonium hydrogen carbonate
One or more, and in the capsule blank, the mass percentage of bicarbonate is 1%~10%.Bicarbonate
Output carbon dioxide and water can be decomposed at high temperature, made there are a large amount of bubbles in capsule embryo material, after temperature decrease, capsule is fixed
Type, capsule wall internal holes form and prepare porous hollow capsule.When the mass percentage of bicarbonate in capsule embryo material
Less than 1%, the gas production that bicarbonate decomposes is low, and hole number is few in capsule wall, it is difficult to obtain the capsule of porous structure prosperity；When
The mass percentage of bicarbonate is more than 10% in capsule embryo material, and the gas production of bicarbonate is too big, the porosity of capsule is big,
Hole count is more, and the intensity (such as friability) of capsule is low, influences the practicability of capsule.Preferably, in the capsule blank, carbonic acid
The mass percentage of hydrogen salt is 4%~7%.
Wherein, capsule blank refer to by capsule it is raw materials used according to made of capsules preparation technique be free of porose hollow glue
Capsule.
Further, the nucleating agent in the capsule blank containing mass percentage below 10%.It is of the present invention
Nucleating agent contribute to the substance of bubble formation, be specifically talcum powder, calcium carbonate, silica, titanium dioxide, calcium oxide,
One or more in magnesia, carbon black or mica.Nucleating agent of the mass percentage below 5% is preferably comprised, it is further excellent
Select the nucleating agent containing mass percentage 0.5~3%.
Further, the molecular weight more than 600 in the capsule blank containing mass percentage below 10% is poly-
One or more in ethylene glycol or derivatives thereof.Molecular weight of the present invention refers to weight average molecular weight.Molecular weight more than 600
Polyethylene glycol or derivatives thereof can improve in capsule manufacturing process, the generation rate in hole, and the diameter of adjustment hole, number,
The porous structures such as pore-size distribution, surface hole number.When the polyethylene glycol of Capsules middle-molecular-weihydroxyethyl more than 600 or derivatives thereof
Content is more than 10%, and the hole strength of capsule can be had an impact, and friability improves, and practicability reduces, it is preferred that Capsules
The mass percentage of the polyethylene glycol of middle-molecular-weihydroxyethyl more than 600 or derivatives thereof is 4%~8%.
Author has found generation rate and porous structure of the molecular weight to adjustment hole of suitable polyethylene glycol or derivatives thereof
There is certain help, but the too high generation for inhibiting hole instead of molecular weight.Preferably, the molecular weight of polyethylene glycol or derivatives thereof is
2000~4000.It is further preferred that the porous hollow capsule contains molecular weight of the mass percentage below 4~8% is
One or more in 2000~4000 polyethyleneglycol derivative.
Further, described polyethylene glycol of molecular weight more than 600 or derivatives thereof is that polyethylene glycol, hydroxycarboxyl group gather
Ethylene glycol, hydroxyl amino polyethylene glycol, hydracrylic acid polyethylene glycol, polyethylene-poly(ethylene glycol) block copolymer, (2- amino
Ethyl) one or more in polyethylene glycol, methoxy poly (ethylene glycol), carboxy polyethylene glycol or amino-polyethyleneglycols.Preferably
Molecular weight is 2000~4000 hydroxycarboxyl group polyethylene glycol, hydroxyl amino polyethylene glycol, hydracrylic acid polyethylene glycol, poly- second
One or more in alkene-poly(ethylene glycol) block copolymer, (2- amino-ethyls) polyethylene glycol or methoxy poly (ethylene glycol).
Further, the drying temperature described in step b<80℃.Drying temperature is too high, the bicarbonate during drying
Salt may decompose in advance, the porous structure of foaming process and product after influence.Drying temperature is too low, and drying time increases,
Capsule performance is also poor.Preferably, the drying temperature described in step b is 50~70 DEG C.
Further, the heating time of step a is in 5s, the cooling time of step b is in 5s.
Further, the maximum heating temperature in the step c is 120~140 DEG C, and isothermal time is 3~7s.Herein
It foams in step.Temperature is too low, and gas production is inadequate in capsule idiosome, and capsule wall voidage is too low, and quality is too big；Temperature is too
Height, gas production rate is too fast, and capsule idiosome insufficient strength, porous structure is difficult to control, and gas may escape capsule wall, make glue
Capsule surface forms hole, influences beautiful and capsule intensity.
Further, the cooling temperature in the step d is 80~95 DEG C, and isothermal time is 3~7s.It is more in this step
Pore structure is shaped.
Further, the step c and d is carried out in the mold of closing, is conducive to control porous structure.
In above-mentioned preparation process, the heating time is that capsule embryo material is heated to maximum heating temperature from drying temperature
Time.Refer to that capsule idiosome is cooled to the time of cooling temperature from maximum heating temperature cooling time.
Further, it is by the system of above-mentioned porous hollow capsule the present invention provides a kind of porous hollow capsule
What Preparation Method was prepared.
The present invention also provides a kind of porous hollow capsules, and it includes have in cellulose, gelatin, Propiram or starch
One or more and carbonate and water.It can be prepared by method of the present invention.
Further, there is a diameter of 10~1000nm, aperture point in the capsule wall of porous hollow capsule of the invention
Cloth<2 hole, porosity be 30~80%, and on the outer surface of capsule and inner surface the surface holes of 100~800nm of diameter number
Mesh is distinguished<10/mm2；Preferably, there is a diameter of 10~1000nm, hole in porous hollow Capsule wall of the invention
Footpath is distributed<1.5 hole, porosity be 40~70%, and on the outer surface of capsule and inner surface 100~800nm of diameter surface
The number difference in hole<5/mm2。
Further, pigment, gelling agent, coagulant, increasing can also be contained in porous hollow capsule of the present invention
Mould the additives such as agent, adhesive, PH conditioning agents.
The pigment refers to be the substance of capsule colouring, for known any one, concrete example such as turmeric, core yellow
Element, quinoline yellow, chlorophyll, titanium dioxide, indigo, tomato red, capsanthin, lutein, anthocyanidin, beet red, arnotto, tannic acid
Or the one or more in iron oxide.
The gelling agent refers in capsule manufacturing process, and capsule aqueous solution of raw material can be made gradually to be transformed into uniform half
Rigid solid gel simultaneously keeps former shaped additive.Can be acetylation gellan gum, deacetylation gellan gum, κ type OK a karaoke clubs
Glue, β types carragheen, ι types carragheen, agar, pectin, sodium alginate, xanthans, tragacanth, Karaya Gum, locust bean gum,
One or more in furcellaran, tamarind gum, tara gum, the poly- glue in sclerotium Portugal, microbial alginate or carbomer.
The coagulant refers in capsule manufacturing process, can improve capsule aqueous solution of raw material and gradually be transformed into uniformly
Semi-rigid solid gel and the additive for keeping original shape rate.Can be potassium chloride, calcium chloride, potassium phosphate or citric acid
One or more in potassium.
The plasticizer is the additive that can improve capsule Raw material processing performance, can be glycerine, D-sorbite, second
Glycol, ethyl acetate, 1,3 butylene glycol, 1,4 butanediols, xylitol, glycerine diethylester, triacetin, glycerine list acetic acid
One or more in ester, mannitol, inositol, maltitol, glucose or polypropylene glycol etc..
The adhesive can be starch, dextrin, polyethylene pyrrole network alkanone, carboxymethyl chitin, polyvinyl alcohol, sesbania
Glue, Arabic gum, meat silica gel, Propiram, elsinan, Indian gum, glucose or ethylene pyrrole network alkanone and vinyl acetate copolymerized
One or more in object.
The PH conditioning agents are used to adjust the pH value of the aqueous solution of raw material in Capsules preparation process, can be carbonic acid
Sodium, potassium carbonate, sodium hydroxide, potassium hydroxide, calcium hydroxide, ammonium carbonate, sodium dihydrogen phosphate, potassium dihydrogen phosphate or dipotassium hydrogen phosphate
In one or more.
The preparation method of a kind of porous hollow capsule provided by the invention, using bicarbonate and water as porous hollow
The foaming agent of capsule prepares porous hollow capsule by fast foaming and fast cooling shaping, foaming agent materials safety without
Harm, expansion rate and porous structure are easy to control；Further, porous hollow capsule of the invention also contains nucleating agent, into
Core agent can promote the generation of bubble, improve the quantity of capsule mesoporous, reduce grain weight in the example of capsule；Preparation method is simply easy
It goes, rapidly and efficiently, without adding new equipment and process, is suitble to mass production and automation control.
The present invention also provides the porous hollow capsules that the above method is used to prepare, and are ensureing capsule with sufficient intensity
While (such as friability), capsule raw materials used less, density smaller, quality is lighter, disintegration time limited is shorter, with the present invention
Capsules capsule takes effect faster.In addition, white is presented in the porous hollow capsule appearance of the present invention, it is white compared to commercially available
Coloring agent capsule need not add pigment, eliminate the risk that white pigment generates human body harm.
It should be appreciated that such as " having ", "comprising" and " comprising " term used herein are not precluded from one or more
A other materials, ingredient, performance, state, element or the presence or addition of its combination；" being more than ", " being less than " all do not include numerical value
Itself, " more than ", " following " all include 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 scope.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 achieved, thus it is 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, grain weight：It is measured with assay balance, measures ten times, be averaged.
2nd, moisture content：By version in 2015《Chinese Pharmacopoeia》Middle dry weightless mensuration is measured.
3rd, friability：By version in 2015《Chinese Pharmacopoeia》The test method of four gelatin hollow capsule friabilities is surveyed
Examination.
4th, disintegration time limited：By version in 2015《Chinese Pharmacopoeia》The test method of four gelatin hollow capsule disintegration time limiteds carries out
Test.
5th, whiteness (W)：Capsule is cut to the long and wide rectangular film for being all higher than 4mm, uses a Konica Minolta
CM-3600A spectral photometric colour measuring meters, the GanzWhiteness of test sample.
The calculation formula of GanzWhiteness is W=Y+800 (0.3138-x)+1700 (0.3309-y).Wherein Y exists for sample
Brightness under 10 ° of visual field D65 standard sources, x and y are chromaticity coordinates of the sample under 10 ° of visual field D65 standard sources.
The embodiment of the present invention is raw materials used：
<Basis material>
D1：Gelatin, the production of Henan An Rui bio tech ltd.
D2：Hydroxymethyl starch, the production of Henan An Rui bio tech ltd.
D3：Hypromellose, Heda Co., Ltd, Shandong's production.
D4：Pulullan polysaccharide, Jiangxi hundred be full of bio tech ltd production.
<Bicarbonate>
A1：Sodium acid carbonate, Shanghai one are ground bio tech ltd and are sold；
A2：Saleratus, Shanghai one are ground bio tech ltd and are sold.
<Nucleating agent>
B1：Talcum powder, poly- thousand Chemical Co., Ltd. in Shanghai sells；
B2：Silica, Suzhou Fu Lu bio tech ltd is sold.
<Polyethylene glycol or derivatives thereof>
C1:Hydracrylic acid polyethylene glycol, molecular weight 619, the production of Beijing Jian Kai Science and Technology Co., Ltd.；
C2:Hydroxycarboxyl group polyethylene glycol, molecular weight 1000, the production of Beijing Jian Kai Science and Technology Co., Ltd.；
C3:Hydroxyl amino polyethylene glycol, molecular weight 3500, the production of Beijing Jian Kai Science and Technology Co., Ltd.；
C4:Methoxy poly (ethylene glycol), molecular weight 2000, the production of Beijing Jian Kai Science and Technology Co., Ltd.；
C5:Hydroxyl amino polyethylene glycol, molecular weight 546, the production of Beijing Jian Kai Science and Technology Co., Ltd.；
Examples 1 to 20
Using the raw material shown in table 1 and the preparation parameter shown in table 2, the 0# for being prepared by the following method out the present invention is more
Permeability Capsules.
Step a：The basis material of capsule and bicarbonate is soluble in water, the aqueous solution of capsule blank is made；
Step b：After capsule die is impregnated into the aqueous solution of capsule blank, take out, in capsule under drying temperature T1
The capsule blank of water content Φ shown in table 1 is formed on mold；
Step c：Capsule blank is heated to maximum heating temperature T2 by heating time t1, and isothermal t2 for a period of time；
Step d：Cooling temperature T3 is cooled to by t3 cooling time again, and isothermal t4 for a period of time, it is cooled back to room temperature
Obtain the 0# porous hollow capsules of the present invention.
Table 1："/" expression does not contain the substance.
Table 2
Comparative example 1
Commercially available 0# gelatin white hollow capsule does not contain hole in capsule wall.
Comparative example 2
Commercially available 0# Propirams white hollow capsule does not contain hole in capsule wall.
Comparative example 3
Commercially available 0# hypromellose white hollow capsule does not contain hole in capsule wall.
0# porous hollows capsule and the commercially available 0# Capsuleses of comparative example prepared by embodiment is according to of the present invention
Detection method carry out performance measurement, measurement result is as shown in table 3.
Table 3
From table 3 it can be seen that compared with comparative example, the porous hollow capsule grain weight smaller of embodiment, disintegration time limited is more
Short, with taking effect faster for Capsules capsule of the present invention, but the friability of capsule is not much different with comparative example, meets capsule
The requirement of practicability.Meanwhile white is presented in porous hollow capsule appearance of the invention, whiteness is suitable with commercially available white capsule,
But white pigment is used compared to commercially available white capsule, Capsules of the invention need not add pigment, eliminate white face
Expect to generate the risk endangered to human body.
Claims (10)
1. a kind of preparation method of porous hollow capsule, which is characterized in that comprise the steps of：
Step a：By the basis material of capsule, i.e., one or more and bicarbonate in cellulose, gelatin, Propiram or starch
It is soluble in water, the aqueous solution of capsule blank is made；
Step b：After capsule die is impregnated into the aqueous solution of capsule blank, take out, on capsule die under drying temperature
Form capsule blank；
Step c：Capsule blank is heated to by drying temperature in 10s to 110 DEG C or more of maximum heating temperature, and isothermal 1~
10s；
Step d：Less than 100 DEG C of cooling temperature, and 1~10s of isothermal are cooled to from maximum heating temperature in 10s.
2. the preparation method of porous hollow capsule according to claim 1, which is characterized in that the bicarbonate is
One or more in sodium acid carbonate, calcium bicarbonate, saleratus, ammonium hydrogen carbonate, and in the capsule blank, bicarbonate
The mass percentage of salt is 1%~10%.
3. the preparation method of porous hollow capsule according to claim 1, which is characterized in that in the capsule blank
Nucleating agent containing mass percentage below 10%, the nucleating agent are talcum powder, calcium carbonate, silica, titanium dioxide
One or more in titanium, calcium oxide, magnesia, carbon black or mica.
4. the preparation method of porous hollow capsule according to claim 1, which is characterized in that in the capsule blank
One or more in polyethylene glycol of molecular weight more than 600 containing mass percentage below 10% or derivatives thereof.
5. the preparation method of porous hollow capsule according to claim 4, which is characterized in that the molecular weight 600
Above polyethylene glycol or derivatives thereof is polyethylene glycol, hydroxycarboxyl group polyethylene glycol, hydroxyl amino polyethylene glycol, hydracrylic acid
Polyethylene glycol, polyethylene-poly(ethylene glycol) block copolymer, (2- amino-ethyls) polyethylene glycol, methoxy poly (ethylene glycol), carboxyl
One or more in polyethylene glycol or amino-polyethyleneglycols.
6. the preparation method of porous hollow capsule according to claim 1, which is characterized in that the drying temperature<
80℃。
7. the preparation method of porous hollow capsule according to claim 1, which is characterized in that the highest heating temperature
Degree is 120~140 DEG C, and isothermal time is 3~7s.
8. the preparation method of porous hollow capsule according to claim 1, which is characterized in that the cooling temperature is
80~95 DEG C, isothermal time is 3~7s.
9. a kind of porous hollow capsule, according to the preparation method of claim 1~8 any one of them porous hollow capsule
It is prepared.
10. a kind of porous hollow capsule, which is characterized in that contain one kind in cellulose, gelatin, Propiram or starch or more
Kind and carbonate and water.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201810109713.XA CN108113974A (en) | 2018-02-05 | 2018-02-05 | A kind of preparation method of porous hollow capsule and the capsule thus prepared |
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| CN201810109713.XA CN108113974A (en) | 2018-02-05 | 2018-02-05 | A kind of preparation method of porous hollow capsule and the capsule thus prepared |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109137482A (en) * | 2018-08-02 | 2019-01-04 | 苏州市天翱特种织绣有限公司 | A kind of preparation method of air-permeable cool type finishing agent |
| CN114010617A (en) * | 2021-12-21 | 2022-02-08 | 新昌辽远科技有限公司 | Hydroxypropyl starch empty capsule and preparation method thereof |
| CN114010616A (en) * | 2021-12-06 | 2022-02-08 | 江苏力凡胶囊有限公司 | Rapidly disintegrating hollow capsule and preparation method thereof |
| CN114306273A (en) * | 2022-01-11 | 2022-04-12 | 新昌辽远科技有限公司 | Multilayer hollow capsule and preparation method thereof |
| CN114732793A (en) * | 2022-04-21 | 2022-07-12 | 湖北人福药用辅料股份有限公司 | Hollow capsule and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109137482A (en) * | 2018-08-02 | 2019-01-04 | 苏州市天翱特种织绣有限公司 | A kind of preparation method of air-permeable cool type finishing agent |
| CN114010616A (en) * | 2021-12-06 | 2022-02-08 | 江苏力凡胶囊有限公司 | Rapidly disintegrating hollow capsule and preparation method thereof |
| CN114010617A (en) * | 2021-12-21 | 2022-02-08 | 新昌辽远科技有限公司 | Hydroxypropyl starch empty capsule and preparation method thereof |
| CN114306273A (en) * | 2022-01-11 | 2022-04-12 | 新昌辽远科技有限公司 | Multilayer hollow capsule and preparation method thereof |
| CN114732793A (en) * | 2022-04-21 | 2022-07-12 | 湖北人福药用辅料股份有限公司 | Hollow capsule and preparation method thereof |
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Application publication date: 20180605 |