CN106924211A - A kind of enteric hollow capsule and preparation method thereof - Google Patents
A kind of enteric hollow capsule and preparation method thereof Download PDFInfo
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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Abstract
The invention discloses a kind of enteric hollow capsule and preparation method thereof; the outer surface of the capsule body of the Capsules is coated with enteric coat layer; capsule body is made up of Hydroxypropyl methylcellulose, gel and water; enteric coat layer is made up of low-acyl gellan gum, curing agent and water, and the percentage by weight composition of the Capsules is：Hydroxypropyl methylcellulose 70~80%, gel 2~5%, low-acyl gellan gum 10.5~14%, curing agent 0.05~2%, balance of water；There is the enteric hollow capsule stabilization in SGF environment to be kept for the 2h even longer times be not disintegrated, and the disintegration properties in 1h in simulated intestinal fluid environment meet《Chinese Pharmacopoeia》To the regulation of enteric hollow capsule；The preparation technology of the enteric hollow capsule dips in glue 1 calcification, 1 drying forming using 2 times, and preparation method is simple, easy to operate, does not use organic solvent in preparation process especially, without preservative, it is safe and reliable, it is environment-friendly, meet the development trend of present hollow capsule.
Description
Technical field
The invention belongs to pharmaceutic adjuvant technical field, and in particular to a kind of enteric hollow capsule and preparation method thereof.
Background technology
Capsules is broadly divided into gastric solubility capsule and enteric capsulation.Enteric capsulation can navigate to human body small intestine or
Large intestine simultaneously discharges medicine, and with protecting a drug from the destruction of enzyme or hydrochloric acid in gastric juice in stomach, to avoid medicine from producing stomach lining strong
The features such as stimulation.At present, the enteric hollow capsule of in the market mainly has gelatin hollow capsule and Hydroxypropyl methylcellulose Capsules
Two kinds.
Gelatin hollow capsule is often reacted with formaldehyde crosslinking or enteric-coating material coating in surface is made, hypromellose
Plain Capsules is also, in one layer of enteric coating of capsule shells outer wrapping, secondary coating to be carried out using enteric-coating material more than prevailing technology
Forming technique.Conventional enteric-coating material mainly has：Cellulose phthalate series, acroleic acid resin EuS100, EuL100 systems
Arrange, dissolved using ethanol or acetone as solvent more than these coating materials, being volatilized by solvent in forming process is molded, to operating
There is very big potential safety hazard in personnel and workshop.
Also have and be coated using the aqueous dispersion of enteric-coating material, it is to avoid the use of organic solvent, but
Because the aqueous dispersion can not drop down glue seriously in utricule surface solidification, coating surface is extremely uneven.
CN104288120A discloses a kind of enteric plant cellulose hard hollow capsule and preparation method thereof, the hollow and hard
Capsule body is mixed and processed by the raw material of following weight percents：Plant cellulose derivative 20-28%, pectin 10-16%,
Surfactant 0.2-0.25%, flocculation aid 0.1-5%, colouring agent 0-0.05%, titanium dioxide 0-5%, plasticizer 0.1-
0.5%, balance of water, the surfactant be selected from lauryl sodium sulfate or Tween-80, the plasticizer be selected from glycerine or
Polyethylene glycol, the flocculation aid be selected from sodium alginate, agar, carragheen, refrigeration glue in any one or a few, the coloring
Agent is any one in synthetic coloring matter, natural colorant and plant colouring agent.In the preparation of the Capsules, just utricule enters
Row is once coated, and concrete operations are as follows：Pectin is dissolved in purified water, pectin is 1 with the mass ratio of purified water:12-15, mixing
After being coated to first utricule as coating material in 3-5h, coating amount is the 10% of capsule quality；Or by hydroxypropyl first
Cellulose phthalate is dissolved in ethanol, and hypromellose phthalate is 1 with the mass ratio of ethanol:10-16,
8-12h is placed after mixing, then in being coated to first utricule as coating material in 3-5h, coating amount is capsule quality
10%.It can be seen that, enteric plant cellulose hard hollow capsule and preparation method thereof disclosed in CN104288120A, is exactly using organic
Etoh solvent is used as coating solvent, and it needs secondary drying to prepare enteric hollow capsule, and production technology is more complicated.
The content of the invention
The technical problems to be solved by the invention are to provide one kind, and there is the stabilization in SGF environment to keep 2h even
Longer time be not disintegrated, enteric hollow capsule of disintegration properties and preparation method thereof in 1h in simulated intestinal fluid environment.
The present invention solve the technical scheme that is used of above-mentioned technical problem for：A kind of enteric hollow capsule, including capsule sheet
Body, the outer surface of described capsule body is coated with enteric coat layer, and described capsule body is by Hydroxypropyl methylcellulose, gel
Constituted with water, described enteric coat layer is made up of low-acyl gellan gum, curing agent and water, the percentage by weight of the Capsules
Constitute and be：Hydroxypropyl methylcellulose 70~80%, gel 2~5%, low-acyl gellan gum 10.5~14%, curing agent 0.05~
2%, balance of water.
Enteric plant hollow capsule of the present invention, its capsule body is made up of soluble Hydroxypropyl methylcellulose, enteric coating
The material of main part of layer uses low-acyl gellan gum, and glucuronic acid residue is contained in the molecule, with good acid resistance and right
The stability of enzyme, and glucuronic acid can also be combined the hard acidproof gel of generation with bivalent cation.The enteric hollow glue
Organic solvent is not used in capsule preparation process, in the absence of dropping down glue caused by aqueous dispersion.The utricule of the enteric hollow capsule has
Stabilization keeps more than 2h not to be disintegrated in SGF environment, the characteristic being disintegrated in 1h in simulated intestinal fluid environment.Additionally, the sky
Heart-soothing capsule surface is smooth, flexible, uniform color, and without deformation, cyst membrane toughness is splendid, and product yield is high, while by long-term
Reserved sample observing finds that the Capsules is good to environmental resistance.
Preferably, described gel be kappa-carrageenan and low-acyl gellan gum in one or two.
Preferably, described curing agent is one or more in soluble calcium salt.
Preferably, the thickness of described enteric coat layer is 0.016~0.021mm.
Preferably, described curing agent is one or more of calcium chloride, calcium acetate and calcium lactate.
The preparation method of above-mentioned enteric hollow capsule, comprises the following steps：
(1) preparation of capsule body glue A：By 13.5~18.5 parts of Hydroxypropyl methylcellulose and 0.8~1.0 part of gel
It is well mixed, obtain mixed material；Disperse above-mentioned mixed material with 100 parts of deionized waters, in 80~100 DEG C of collosol temperature
0.5~1.5h of lower dissolving；Treat that colloidal sol terminates, 1~8h is incubated at a temperature of 50~55 DEG C, obtain uniform capsule body glue A；
(2) preparation of coating solution B：2.2~2.8 parts of coating material is taken, is added in 100 parts of deionized waters, heating for dissolving is obtained
It is stand-by by coating solution B in 50~65 DEG C of insulations to the glue of homogeneous transparent, as coating solution B；
(3) preparation of aqueous solution of curing agent C：Curing agent is dissolved in deionized water, stirring obtain containing curing agent 1.5~
5.0% aqueous solution C；
(4) glue embryo is dipped in：Under 17~20 DEG C of environment temperature, humidity 50~65%, the capsule die of suitable model is existed
Glue is dipped in described capsule body glue A and prepare blastaea, spin upside down and shape for several times；Again by the described coating solution B of blastaea insertion
Spin upside down and form coatings for several times；Then calcification 1 in the aqueous solution C containing curing agent 1.5~5.0% described in blastaea is dipped in
~3s；
(5) dry and pull out shell：Blastaea after calcification is placed in 25~40 DEG C of baking oven, after drying 2~2.5h, is put into
30min is balanced in 25 DEG C of temperature, the stable case of relative humidity 55%, then capsule shells is pulled up from capsule die, trimming, covered
Close, that is, obtain enteric hollow capsule.
Compared with prior art, the advantage of the invention is that：
1st, enteric hollow capsule disclosed by the invention, its capsule body is made up of soluble Hydroxypropyl methylcellulose, enteric
The material of main part of coatings uses low-acyl gellan gum, and the tolerance to acid is high, is not disintegrated under one's belt, and Capsules can be protected to exist
Stability in gastric juice；And coating solvent is deionized water, it is to avoid organic solvent is used, pollution-free, security is good, while not depositing
Glue is dropped down caused by aqueous dispersion coating solution.The utricule of the Capsules has the holding 2h in SGF environment even longer
Time is not disintegrated, the characteristic being disintegrated in 1h in simulated intestinal fluid environment, meets《Chinese Pharmacopoeia》To the regulation of enteric hollow capsule.
Additionally, the Capsules surface is smooth, and flexible, uniform color, without deformation, cyst membrane toughness is splendid, and product yield is high, while logical
Cross long-term reserved sample observing to find, the Capsules is good to environmental resistance.
2nd, the preparation technology of enteric hollow capsule disclosed by the invention dips in glue 1 calcification, 1 drying forming using 2 times, system
Preparation Method is simple, easy to operate, does not use organic solvent in preparation process especially, safe and reliable without preservative, environment friend
It is good, meet the development trend of present hollow capsule.
Brief description of the drawings
Fig. 1 is the relation of enteric coat layer thickness and enteric hollow capsule disintegration time in SGF environment；
Fig. 2 is the relation of enteric coat layer thickness and enteric hollow capsule disintegration time in simulated intestinal fluid environment；
Fig. 3 is the SEM figures on the surface of enteric hollow capsule prepared by embodiment 2；
Fig. 4 is the SEM figures on the surface of Capsules prepared by comparative example 1；
Fig. 5 is the SEM figures of the cross section of enteric hollow capsule prepared by embodiment 2；
Fig. 6 is the SEM figures of Capsules cross section prepared by comparative example 1.
Specific embodiment
The present invention is described in further detail below in conjunction with accompanying drawing embodiment.
The enteric hollow capsule of embodiment 1 includes capsule body, and the outer surface of capsule body is coated with enteric coat layer, glue
Capsule body is made up of Hydroxypropyl methylcellulose, gel and water, and enteric coat layer is made up of low-acyl gellan gum, curing agent and water,
Wherein, gel is kappa-carrageenan, and curing agent is calcium chloride.The percentage by weight of the Capsules of embodiment 1 is constituted：Hydroxypropyl
Methylcellulose 74%, kappa-carrageenan 5%, low-acyl gellan gum 12.5%, calcium chloride 0.08%, balance of water.The enteric hollow
The preparation method of capsule is as follows：
(1) preparation of capsule body glue A：Kappa-carrageenan by 14.5 parts of Hydroxypropyl methylcellulose with 0.9 part is well mixed,
Obtain mixed material；Disperse above-mentioned mixed material with 100 parts of deionized waters, 1.0h is dissolved under 95 DEG C of collosol temperature；Treat
Colloidal sol terminates, and 1h is incubated at a temperature of 50 DEG C, obtains uniform capsule body glue A；
(2) preparation of coating solution B：2.8 parts of low-acyl gellan gum is taken, is added in 100 parts of deionized waters, heating for dissolving is obtained
The glue of homogeneous transparent, as coating solution B, it is stand-by by coating solution B in 65 DEG C of insulations；
(3) preparation of calcium chloride water C：Calcium chloride is dissolved in deionized water, stirring obtains chloride containing calcium 2.5%
Aqueous solution C；
(4) glue embryo is dipped in：Under 20 DEG C of environment temperature, humidity 50~65%, by the capsule die of suitable model in capsule
Glue is dipped in body glue A and prepare blastaea, spin upside down and shape for several times；To be spun upside down in blastaea insertion coating solution B again and formed for several times
Coatings；Then blastaea is dipped in 1~3s of calcification in the aqueous solution C of chloride containing calcium 2.5%；
(5) dry and pull out shell：Blastaea after calcification is placed in 35 DEG C of baking oven, after drying 2h, be put into 25 DEG C of temperature,
30min is balanced in the stable case of relative humidity 55%, then capsule shells is pulled up from capsule die, trimming, fit obtains reality
Apply the enteric hollow capsule of example 1.
The enteric hollow capsule of embodiment 2 includes capsule body, and the outer surface of capsule body is coated with enteric coat layer, glue
Capsule body is made up of Hydroxypropyl methylcellulose, gel and water, and enteric coat layer is made up of low-acyl gellan gum, curing agent and water,
Wherein, gel is kappa-carrageenan, and curing agent is calcium lactate.The percentage by weight of the Capsules of embodiment 2 is constituted：Hydroxypropyl
Methylcellulose 75.2%, kappa-carrageenan 4.5%, low-acyl gellan gum 11.6%, calcium lactate 0.1%, balance of water.The enteric is empty
The preparation method of heart-soothing capsule is as follows：
(1) preparation of capsule body glue A：Kappa-carrageenan by 15.5 parts of Hydroxypropyl methylcellulose with 0.9 part is well mixed,
Obtain mixed material；Disperse above-mentioned mixed material with 100 parts of deionized waters, 1.0h is dissolved under 90 DEG C of collosol temperature；Treat
Colloidal sol terminates, and 1h is incubated at a temperature of 50 DEG C, obtains uniform capsule body glue A；
(2) preparation of coating solution B：2.6 parts of low-acyl gellan gum is taken, is added in 100 parts of deionized waters, heating for dissolving is obtained
The glue of homogeneous transparent, as coating solution B, it is stand-by by coating solution B in 60 DEG C of insulations；
(3) preparation of calcium lactate aqueous solution C：Calcium lactate is dissolved in deionized water, stirring is obtained containing calcium lactate 2.5%
Aqueous solution C；
(4) glue embryo is dipped in：Under 19 DEG C of environment temperature, humidity 50~65%, by the capsule die of suitable model in capsule
Glue is dipped in body glue A and prepare blastaea, spin upside down and shape for several times；To be spun upside down in blastaea insertion coating solution B again and formed for several times
Coatings；Then blastaea is dipped in 1~3s of calcification in the aqueous solution C containing calcium lactate 2.5%；
(5) dry and pull out shell：Blastaea after calcification is placed in 35 DEG C of baking oven, after drying 2h, be put into 25 DEG C of temperature,
30min is balanced in the stable case of relative humidity 55%, then capsule shells is pulled up from capsule die, trimming, fit obtains reality
Apply the enteric hollow capsule of example 2.
The enteric hollow capsule of embodiment 3 includes capsule body, and the outer surface of capsule body is coated with enteric coat layer, glue
Capsule body is made up of Hydroxypropyl methylcellulose, gel and water, and enteric coat layer is made up of low-acyl gellan gum, curing agent and water,
Wherein, gel by kappa-carrageenan and low-acyl gellan gum with 2:1 weight ratio is mixed, and curing agent is calcium acetate.Implement
The percentage by weight of the Capsules of example 3 is constituted：Hydroxypropyl methylcellulose 76%, kappa-carrageenan 3.25%, low-acyl gellan gum
12.2%, calcium acetate 0.1%, balance of water.The preparation method of the enteric hollow capsule is as follows：
(1) preparation of capsule body glue A：By 16.5 parts of Hydroxypropyl methylcellulose and 0.6 part of kappa-carrageenan and 0.3 part
Low-acyl gellan gum is well mixed, and obtains mixed material；Disperse above-mentioned mixed material with 100 parts of deionized waters, at 90 DEG C
1.0h is dissolved under collosol temperature；Treat that colloidal sol terminates, 1h is incubated at a temperature of 55 DEG C, obtain uniform capsule body glue A；
(2) preparation of coating solution B：2.4 parts of low-acyl gellan gum is taken, is added in 100 parts of deionized waters, heating for dissolving is obtained
The glue of homogeneous transparent, as coating solution B, it is stand-by by coating solution B in 55 DEG C of insulations；
(3) preparation of calcium acetate aqueous solution C：Calcium acetate is dissolved in deionized water, stirring is obtained containing calcium acetate 2.5%
Aqueous solution C；
(4) glue embryo is dipped in：Under 19 DEG C of environment temperature, humidity 50~65%, by the capsule die of suitable model in capsule
Glue is dipped in body glue A and prepare blastaea, spin upside down and shape for several times；To be spun upside down in blastaea insertion coating solution B again and formed for several times
Coatings；Then blastaea is dipped in 1~3s of calcification in the aqueous solution C containing calcium acetate 2.5%；
(5) dry and pull out shell：Blastaea after calcification is placed in 35 DEG C of baking oven, after drying 2h, be put into 25 DEG C of temperature,
30min is balanced in the stable case of relative humidity 55%, then capsule shells is pulled up from capsule die, trimming, fit obtains reality
Apply the enteric hollow capsule of example 3.
The enteric hollow capsule of embodiment 4 includes capsule body, and the outer surface of capsule body is coated with enteric coat layer, glue
Capsule body is made up of Hydroxypropyl methylcellulose, gel and water, and enteric coat layer is made up of low-acyl gellan gum, curing agent and water,
Wherein, gel is low-acyl gellan gum, and curing agent is calcium chloride.The percentage by weight of the Capsules of embodiment 4 is constituted：
Hydroxypropyl methylcellulose 78%, low-acyl gellan gum 13.8%, calcium chloride 0.1%, balance of water.The preparation of the enteric hollow capsule
Method is as follows：
(1) preparation of capsule body glue A：Low-acyl gellan gum by 17.5 parts of Hydroxypropyl methylcellulose with 0.9 part mixes
Uniformly, mixed material is obtained；Disperse above-mentioned mixed material with 100 parts of deionized waters, dissolved under 90 DEG C of collosol temperature
1.0h；Treat that colloidal sol terminates, 1h is incubated at a temperature of 55 DEG C, obtain uniform capsule body glue A；
(2) preparation of coating solution B：2.2 parts of low-acyl gellan gum is taken, is added in 100 parts of deionized waters, heating for dissolving is obtained
The glue of homogeneous transparent, as coating solution B, it is stand-by by coating solution B in 50 DEG C of insulations；
(3) preparation of calcium chloride water C：Calcium chloride is dissolved in deionized water, stirring obtains chloride containing calcium 2.5%
Aqueous solution C；
(4) glue embryo is dipped in：Under 18 DEG C of environment temperature, humidity 50~65%, by the capsule die of suitable model in capsule
Glue is dipped in body glue A and prepare blastaea, spin upside down and shape for several times；To be spun upside down in blastaea insertion coating solution B again and formed for several times
Coatings；Then blastaea is dipped in 1~3s of calcification in the aqueous solution C of chloride containing calcium 2.5%；
(5) dry and pull out shell：Blastaea after calcification is placed in 40 DEG C of baking oven, after drying 2h, be put into 25 DEG C of temperature,
30min is balanced in the stable case of relative humidity 55%, then capsule shells is pulled up from capsule die, trimming, fit obtains reality
Apply the enteric hollow capsule of example 4.
1~embodiment of above example 4 is prepared using the preparation technology of enteric hollow capsule of the present invention, and glue 1 is dipped in using 2 times
1 drying forming of secondary calcification, i.e., successively carry out the 1st time and dip in glue, dip in glue, 1 calcification, the preparation technology of 1 drying for the 2nd time.Make
It is contrast, selects the Capsules of comparative example 1 else, its preparing raw material and composition is identical with the Capsules of embodiment 2, but it is adopted
Prepared with secondary drying technique, i.e., successively carry out the 1st time and dip in glue, the 1st drying, dip in glue, 1 calcification, the 2nd drying for the 2nd time
Technique prepare.The preparation method of the Capsules of comparative example 1 is as follows：
(1) preparation of capsule body glue A：Kappa-carrageenan by 15.5 parts of Hydroxypropyl methylcellulose with 0.9 part is well mixed,
Obtain mixed material；Disperse above-mentioned mixed material with 100 parts of deionized waters, 1.0h is dissolved under 90 DEG C of collosol temperature；Treat
Colloidal sol terminates, and 1h is incubated at a temperature of 50 DEG C, obtains uniform capsule body glue A；
(2) preparation of coating solution B：2.6 parts of low-acyl gellan gum is taken, is added in 100 parts of deionized waters, heating for dissolving is obtained
The glue of homogeneous transparent, as coating solution B, it is stand-by by coating solution B in 60 DEG C of insulations；
(3) preparation of calcium lactate aqueous solution C：Calcium lactate is dissolved in deionized water, stirring is obtained containing calcium lactate 2.5%
Aqueous solution C；
(4) glue embryo is dipped in：Under 19 DEG C of environment temperature, humidity 50~65%, by the capsule die of suitable model in capsule
Glue is dipped in body glue A and prepare blastaea, spin upside down and shape for several times；
(5) shaping and drying：Blastaea is dried into 2h under conditions of 35 DEG C of temperature, humidity 45~55%, capsule blank is obtained；
(6) will be spun upside down in capsule blank insertion coating solution B and form coatings for several times；Then blastaea is dipped in containing lactic acid
1~3s of calcification in the aqueous solution C of calcium 2.5%；
(7) dry and pull out shell：Capsule blank after calcification is placed in 35 DEG C of baking oven, after drying 2h, temperature is put into
25 DEG C, balance 30min in the stable case of relative humidity 55%, then capsule shells are pulled up from capsule die, trimming, fit, i.e.,
Obtain the enteric hollow capsule of comparative example 1.
1~embodiment of embodiment 4 prepare enteric hollow capsule, utricule is smooth, flexible, uniform color, without deformation, nothing
Peculiar smell；And Capsules prepared by comparative example 1, utricule is coarse, color and luster is extremely uneven, elastic and poor toughness.In addition, the present invention one
The enteric hollow capsule of secondary drying forming, by taking embodiment 2 as an example, the SEM figures on its surface are shown in Fig. 3, the SEM figures of cross section are shown in Fig. 5,
The SEM figures on the Capsules surface of the comparative example 1 of secondary drying shaping are shown in Fig. 4, the SEM figures of cross section are shown in Fig. 6.The He of comparison diagram 3
Fig. 4 is visible, the Capsules of the embodiment 2 being molded compared to first drying, the Capsules of secondary drying shaping comparative example 1
Surface shows slightly coarse.Comparison diagram 5 and Fig. 6 are visible, the cross section network structure of the Capsules of the embodiment 2 of first drying shaping
Even compact, does not have sharp interface；And the cross-sectional structure of the Capsules of secondary drying shaping comparative example 1 is loose, formation
Network structure size is uneven.As fully visible, the enteric hollow capsule ectonexine stickiness of first drying shaping of the present invention is obvious
Better than the Capsules that secondary drying is molded.
For enteric hollow capsule of the present invention, reference《Chinese Pharmacopoeia》(2015 editions) are advised to the index of enteric hollow capsule
It is fixed, quality testing and stability test are carried out, concrete outcome is as follows：
1st, quality detection project and the results are shown in Table 1.
The quality measurements of enteric hollow capsule prepared by 1 1~embodiment of embodiment of table 4
Note：1=0.01mm
Known by table 1, the quality testing of the Capsules prepared to 1~embodiment of embodiment 4, indices meet《In
State's pharmacopeia》Requirement to enteric hollow capsule.
2nd, influence of the enteric coat layer thickness to enteric hollow capsule stability in SGF and intestinal juice environment
Enteric coat layer thickness is shown in Fig. 1, enteric with enteric hollow capsule relation of disintegration time in SGF environment
Coatings thickness is shown in Fig. 2 with enteric hollow capsule relation of disintegration time in simulated intestinal fluid environment.
Known by Fig. 1, increased with enteric coat layer thickness, capsule disintegration time extension in SGF environment.In enteric
When coatings thickness is 0.016~0.021mm, capsule is disintegrated needs 4~12 hours in gastric juice, considerably beyond《Middle traditional Chinese medicines
Allusion quotation》It is required that, this shows that enteric hollow capsule of the present invention is intact in 2 hours in SGF environment.
Known by Fig. 2, increased with enteric coat layer thickness, capsule disintegration time extension in simulated intestinal fluid environment.In enteric
When coatings thickness is 0.016~0.021mm, capsule is disintegrated in intestinal juice needs about 20~55 minutes, meets《Chinese Pharmacopoeia》
It is required that.
3rd, thimble test：Capsules prepared by 1~embodiment of embodiment 4 places 10 at a temperature of 40 DEG C
My god, sampled in the 5th day and the 10th day, determine its elasticity, friability, stabilization time in SGF and in simulated intestinal fluid
In disintegration time, the results are shown in Table 2.
The thimble test testing result of enteric hollow capsule prepared by 2 1~embodiment of embodiment of table 4
4th, high humidity stability test：Capsules prepared by 1~embodiment of embodiment 4 places 10 under 75%RH humidity
My god, in the 5th day and the 10th day sample, determine its elasticity, friability, the stabilization time in SGF, in simulated intestinal fluid
In disintegration time and loss on drying, the results are shown in Table 3.
The high humidity stability test testing result of enteric hollow capsule prepared by 3 1~embodiment of embodiment of table 4
5th, high light stability test：Enteric hollow capsule prepared by 1~embodiment of embodiment 4 25 DEG C, 4500Lx ±
Placed 10 days under 500Lx illuminance, in sampling in the 5th day and the 10th day, determine its elasticity, friability, in SGF
Stabilization time, disintegration time and loss on drying in simulated intestinal fluid, the results are shown in Table 4.
The high light stability test testing result of enteric hollow capsule prepared by 4 1~embodiment of embodiment of table 4
From above stability test testing result, the quality of enteric hollow capsule of the present invention is complied fully with《Middle traditional Chinese medicines
Allusion quotation》Enteric hollow capsule standard, it is ensured that it is not disintegrated not ruptured in gastric juice, the disintegratable release medicine in intestinal juice.Specifically
For, there is enteric hollow capsule of the present invention the holding 2h even longer times in SGF environment not to be disintegrated, in simulation intestines
Disintegration properties in 1h in pendular ring border.
Claims (6)
1. a kind of enteric hollow capsule, including capsule body, it is characterised in that the outer surface of described capsule body is coated with intestines
Molten coatings, described capsule body is made up of Hydroxypropyl methylcellulose, gel and water, and described enteric coat layer is by low acyl group
Gellan gum, curing agent and water composition, the percentage by weight of the Capsules constitute and are：Hydroxypropyl methylcellulose 70~80%, gel
2~5%, low-acyl gellan gum 10.5~14%, curing agent 0.05~2%, balance of water.
2. a kind of enteric hollow capsule according to claim 1, it is characterised in that described gel is κ carragheens and low
One or two in acyl gellan gum.
3. a kind of enteric hollow capsule according to claim 1, it is characterised in that described curing agent is soluble calcium salt
In one or more.
4. a kind of enteric hollow capsule according to claim 3, it is characterised in that described curing agent is calcium chloride, acetic acid
One or more of calcium and calcium lactate.
5. a kind of enteric hollow capsule according to claim 1, it is characterised in that the thickness of described enteric coat layer is
0.016~0.021mm.
6. the preparation method of a kind of enteric hollow capsule any one of Claims 1 to 5, it is characterised in that including following
Step：
（1）The preparation of capsule body glue A：Gel by 13.5~18.5 parts of Hydroxypropyl methylcellulose with 0.8~1.0 part mixes
Uniformly, mixed material is obtained；Disperse above-mentioned mixed material with 100 parts of deionized waters, it is molten under 80~100 DEG C of collosol temperature
0.5~1.5h of solution；Treat that colloidal sol terminates, 1~8h is incubated at a temperature of 50~55 DEG C, obtain uniform capsule body glue A；
（2）The preparation of coating solution B：2.2~2.8 parts of coating material is taken, is added in 100 parts of deionized waters, heating for dissolving is obtained
Even transparent glue, as coating solution B, it is stand-by by coating solution B in 50~65 DEG C of insulations；
（3）The preparation of aqueous solution of curing agent C：Curing agent is dissolved in deionized water, stirring is obtained containing curing agent 1.5~5.0%
Aqueous solution C；
（4）Dip in glue embryo：Under 17~20 DEG C of environment temperature, humidity 50~65%, by the capsule die of suitable model described
Glue is dipped in capsule body glue A and prepare blastaea, spin upside down and shape for several times；To up and down be turned in the described coating solution B of blastaea insertion again
Revolution time forms coatings；Then 1~3s of calcification in the aqueous solution C containing curing agent 1.5~5.0% described in blastaea is dipped in；
（5）Dry and pull out shell：Blastaea after calcification is placed in 25~40 DEG C of baking oven, after drying 2~2.5h, temperature is put into
25 DEG C, balance 30min in the stable case of relative humidity 55%, then capsule shells are pulled up from capsule die, trimming, fit is obtained final product
To enteric hollow capsule.
Priority Applications (1)
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| CN107296801A (en) * | 2017-08-09 | 2017-10-27 | 安徽黄山胶囊股份有限公司 | A kind of hydroxypropyl methyl cellulose plant hollow capsule |
| 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 |
| CN112546016A (en) * | 2020-12-15 | 2021-03-26 | 浙江万里学院 | Enteric hollow cellulose capsule and preparation method thereof |
| CN112655825A (en) * | 2020-12-23 | 2021-04-16 | 安徽希普生物科技有限公司 | Feather protein peptide particle composition and preparation method thereof |
| CN112773773A (en) * | 2020-09-25 | 2021-05-11 | 王有平 | Hollow capsule capable of achieving targeted release in intestinal tract |
| CN113244187A (en) * | 2021-05-13 | 2021-08-13 | 青岛益青生物科技股份有限公司 | Enteric hypromellose empty capsule with new formula and preparation method thereof |
| CN114748441A (en) * | 2022-05-06 | 2022-07-15 | 江苏力凡胶囊有限公司 | Enteric hydroxypropyl methylcellulose hollow capsule with low friability and preparation method thereof |
| CN114931560A (en) * | 2022-04-08 | 2022-08-23 | 南京健辉生物科技有限公司 | Preparation method of hydroxypropyl methyl cellulose hollow capsule |
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| CN107296801A (en) * | 2017-08-09 | 2017-10-27 | 安徽黄山胶囊股份有限公司 | A kind of hydroxypropyl methyl cellulose plant hollow capsule |
| CN107296801B (en) * | 2017-08-09 | 2020-03-17 | 安徽黄山胶囊股份有限公司 | Hydroxypropyl methyl cellulose plant empty capsule |
| 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 |
| CN112773773A (en) * | 2020-09-25 | 2021-05-11 | 王有平 | Hollow capsule capable of achieving targeted release in intestinal tract |
| CN112546016A (en) * | 2020-12-15 | 2021-03-26 | 浙江万里学院 | Enteric hollow cellulose capsule and preparation method thereof |
| CN112546016B (en) * | 2020-12-15 | 2022-04-22 | 浙江万里学院 | Enteric hollow cellulose capsule and preparation method thereof |
| CN112655825A (en) * | 2020-12-23 | 2021-04-16 | 安徽希普生物科技有限公司 | Feather protein peptide particle composition and preparation method thereof |
| CN113244187A (en) * | 2021-05-13 | 2021-08-13 | 青岛益青生物科技股份有限公司 | Enteric hypromellose empty capsule with new formula and preparation method thereof |
| CN114931560A (en) * | 2022-04-08 | 2022-08-23 | 南京健辉生物科技有限公司 | Preparation method of hydroxypropyl methyl cellulose hollow capsule |
| CN114748441A (en) * | 2022-05-06 | 2022-07-15 | 江苏力凡胶囊有限公司 | Enteric hydroxypropyl methylcellulose hollow capsule with low friability and preparation method thereof |
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