CN109528689A - A kind of enteric slow release plant capsule and preparation method thereof - Google Patents
A kind of enteric slow release plant capsule and preparation method thereof Download PDFInfo
- Publication number
- CN109528689A CN109528689A CN201811580026.2A CN201811580026A CN109528689A CN 109528689 A CN109528689 A CN 109528689A CN 201811580026 A CN201811580026 A CN 201811580026A CN 109528689 A CN109528689 A CN 109528689A
- Authority
- CN
- China
- Prior art keywords
- capsule
- enteric
- parts
- slow release
- release plant
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000002775 capsule Substances 0.000 title claims abstract description 131
- 238000002360 preparation method Methods 0.000 title claims abstract description 22
- 241000196324 Embryophyta Species 0.000 claims abstract description 44
- 238000010030 laminating Methods 0.000 claims abstract description 32
- 241000206575 Chondrus crispus Species 0.000 claims abstract description 27
- 239000004372 Polyvinyl alcohol Substances 0.000 claims abstract description 24
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims abstract description 24
- 229920002451 polyvinyl alcohol Polymers 0.000 claims abstract description 24
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 claims abstract description 21
- 239000001103 potassium chloride Substances 0.000 claims abstract description 12
- 235000011164 potassium chloride Nutrition 0.000 claims abstract description 12
- 239000002994 raw material Substances 0.000 claims abstract description 12
- 239000000845 maltitol Substances 0.000 claims abstract description 8
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims abstract description 8
- 229940035436 maltitol Drugs 0.000 claims abstract description 8
- 235000010449 maltitol Nutrition 0.000 claims abstract description 8
- 239000000843 powder Substances 0.000 claims abstract description 8
- 239000004094 surface-active agent Substances 0.000 claims abstract description 7
- 238000003756 stirring Methods 0.000 claims description 16
- 241000219782 Sesbania Species 0.000 claims description 15
- 239000006185 dispersion Substances 0.000 claims description 10
- 239000007788 liquid Substances 0.000 claims description 10
- 210000001161 mammalian embryo Anatomy 0.000 claims description 10
- 238000001035 drying Methods 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 8
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims description 6
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 6
- 239000008367 deionised water Substances 0.000 claims description 6
- 229910021641 deionized water Inorganic materials 0.000 claims description 6
- 235000010445 lecithin Nutrition 0.000 claims description 6
- 239000000787 lecithin Substances 0.000 claims description 6
- 229940067606 lecithin Drugs 0.000 claims description 6
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 6
- 229920000053 polysorbate 80 Polymers 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 239000003643 water by type Substances 0.000 claims description 5
- 239000003292 glue Substances 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 230000003213 activating effect Effects 0.000 claims 1
- 210000004211 gastric acid Anatomy 0.000 abstract description 4
- 238000004090 dissolution Methods 0.000 abstract description 2
- 244000275012 Sesbania cannabina Species 0.000 abstract 1
- 229940068984 polyvinyl alcohol Drugs 0.000 description 18
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 18
- 230000000968 intestinal effect Effects 0.000 description 8
- 108010010803 Gelatin Proteins 0.000 description 7
- 239000012530 fluid Substances 0.000 description 7
- 239000008273 gelatin Substances 0.000 description 7
- 229920000159 gelatin Polymers 0.000 description 7
- 235000019322 gelatine Nutrition 0.000 description 7
- 235000011852 gelatine desserts Nutrition 0.000 description 7
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 5
- -1 Enol acetate phthalate ester Chemical class 0.000 description 4
- 239000002253 acid Substances 0.000 description 4
- 230000002496 gastric effect Effects 0.000 description 4
- 210000002784 stomach Anatomy 0.000 description 4
- GXCLVBGFBYZDAG-UHFFFAOYSA-N N-[2-(1H-indol-3-yl)ethyl]-N-methylprop-2-en-1-amine Chemical compound CN(CCC1=CNC2=C1C=CC=C2)CC=C GXCLVBGFBYZDAG-UHFFFAOYSA-N 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 230000002459 sustained effect Effects 0.000 description 3
- 229940079593 drug Drugs 0.000 description 2
- 210000004051 gastric juice Anatomy 0.000 description 2
- 210000000813 small intestine Anatomy 0.000 description 2
- 239000007901 soft capsule Substances 0.000 description 2
- 230000000638 stimulation Effects 0.000 description 2
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 description 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 235000006694 eating habits Nutrition 0.000 description 1
- 238000005485 electric heating Methods 0.000 description 1
- 239000002702 enteric coating Substances 0.000 description 1
- 238000009505 enteric coating Methods 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000030136 gastric emptying Effects 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 229910001385 heavy metal Inorganic materials 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000005022 packaging material Substances 0.000 description 1
- 235000003563 vegetarian diet Nutrition 0.000 description 1
Classifications
-
- 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
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a kind of enteric slow release plant capsules and preparation method thereof, the plant capsule includes capsule housing and the enteric laminating layer for fitting in the capsule housing inner wall, the capsule housing includes the raw material of following parts by weight: 60 ~ 80 parts of carragheens, 7 ~ 10 parts of sesbania gums, 0.1 ~ 0.5 part of maltitol powder, 0.2 ~ 0.7 part of potassium chloride, 10 ~ 20 parts of polyvinyl alcohol phthalate；The enteric laminating layer includes the raw material of following parts by weight: 50 ~ 70 parts of polyvinyl alcohol phthalate, 0.01 ~ 0.05 part of surfactant.Enteric slow release plant capsule made from preparation method of the present invention significantly more efficient can prevent dissolution of the content under gastric acid environment, substantially increase the quality of capsule product.
Description
Technical field
The present invention relates to capsule preparation technical fields more particularly to a kind of enteric slow release plant capsule and preparation method thereof.
Background technique
Capsulae enterosolubilis is that one kind can be disintegrated in small enteral and discharge the capsule of drug, is typically used as the medicine haveing damage to stomach
Object packaging material.Existing capsulae enterosolubilis, is mostly made with gelatin and enteric-coating material, can make capsule in the acidic environment of stomach not
Disintegration, and small intestine can be entered with gastric emptying, it is disintegrated in the alkaline environment of small intestine, discharges drug.
Gelatin is mainly derived from the collagenous portion in the connective tissues such as animal skin, bone, sarolemma, common in food industry
Gelatin is more with the source of pig and ox.In recent years, the edible safety event relevant report for seeing capsule repeatly, due to industrial gelatin
Containing more heavy metal ion, harmfulness is very big, and cheap price usually becomes the approach that illegal retailer makes profit；And gelatin
Itself is easy that soft capsule is made to become unstable, influences the storage and transport of soft gel products there is being crosslinked；Meanwhile
It is animal derived due to gelatin, the eating habit of Islamic or vegetarianism is not met with gelatin soft capsule as main component yet
With require, therefore, for plant capsule research very it is necessary to.
Summary of the invention
In view of the above-mentioned problems, the object of the present invention is to provide a kind of enteric slow release plant capsule and preparation method thereof, it should
Enteric slow release plant capsule made from preparation method significantly more efficient can prevent dissolution of the content under gastric acid environment, significantly
Improve the quality of capsule product.
In order to solve the above-mentioned technical problem, the first aspect of the present invention provides a kind of enteric slow release plant capsule, described
Plant capsule includes capsule housing and the enteric laminating layer for fitting in the capsule housing inner wall, the capsule housing include with
The raw material of lower parts by weight: 60 ~ 80 parts of carragheens, 7 ~ 10 parts of sesbania gums, 0.1 ~ 0.5 part of maltitol powder, 0.2 ~ 0.7 part of potassium chloride,
10 ~ 20 parts of polyvinyl alcohol phthalate；The enteric laminating layer includes the raw material of following parts by weight: 50 ~ 70 parts of poly- second
Enol acetate phthalate ester, 0.01 ~ 0.05 part of surfactant.
Further, the carragheen includes Kappa-Carraginan and l- carragheen, the Kappa-Carraginan and the l- carragheen
Weight ratio be (2 ~ 5): 1.
Further, the surfactant is one of Tween 80, dodecyl sodium sulfate or Fabaceous Lecithin or a variety of.
The second aspect of the present invention provides a kind of preparation method of enteric slow release plant capsule, which comprises
By 50 ~ 70 parts of polyvinyl alcohol phthalate, 0.01 ~ 0.05 part of surfactant is dissolved in 100 parts of deionized waters,
It is cooled to 25 ~ 30 DEG C until completely dissolved, obtains enteric laminating layer solution；
By 60 ~ 80 parts of carragheens, 7 ~ 10 parts of sesbania gums, 0.1 ~ 0.5 part of maltitol powder, 0.2 ~ 0.7 part of potassium chloride is dissolved in 100 parts
In deionized water at normal temperature, capsule shells dispersion liquid is stirred to get；Using capsule shells dispersion liquid described in microwave heating to 800 ~ 100 DEG C
Afterwards, 30 ~ 90min is stirred and kept the temperature, is then cooled to 50 ~ 60 DEG C, 10 ~ 20 parts of polyvinyl alcohol phthalate are added, stir
30 ~ 50min is mixed and kept the temperature, is cooled to 22 ~ 25 DEG C, stirs and keep the temperature 60 ~ 120min, obtains capsule shells colloidal solution；
The enteric laminating layer solution is dipped using capsule die, the enteric patch is formed with the outer surface in the capsule die
Close layer；The capsule die that outer surface covers the enteric laminating layer is put into the capsule shells colloidal solution again and dips the glue
Softgel shell colloidal solution obtains capsule embryo；
After the capsule embryo is carried out drying and processing, is demoulded, is cut into the enteric slow release plant capsule.
Further, the frequency of the microwave is 150 ~ 300MHz.
Further, it is 30 ~ 40 DEG C that the condition of the drying and processing, which includes: temperature, and drying time is 2 ~ 4 hours.
Further, the surfactant is one of Tween 80, dodecyl sodium sulfate or Fabaceous Lecithin or a variety of.
A kind of enteric slow release plant capsule of the invention and preparation method thereof, has the following beneficial effects:
Enteric slow release plant capsule of the invention is due to capsule housing and the enteric laminating layer for fitting in the capsule housing inner wall
Acid resistance is all had, to still be able to ensure in gastric acid ring in the case where capsule housing occurs damaged due to external impact
Under border, content will not be dissolved out, thus the significantly more efficient stimulation for avoiding content to stomach.
In addition, the present invention is prepared when preparing capsule shells colloidal solution using microwave heating, and 50 ~ 60 are down in temperature
DEG C when polyvinyl alcohol phthalate is added, the stability and acidproof degree of colloidal solution are substantially increased, to have
Conducive to the stability and acid resistance for improving the capsule housing formed by the colloidal solution.
In addition, including sesbania gum in capsule shells of the invention, the addition of the sesbania gum can shorten capsule shells in intestinal juice
Disintegration time, accelerate the release of content.
The disintegration time limited of enteric slow release plant capsule of the invention is to be greater than 2 hours in gastric juice, 7 ~ 10 points in intestinal juice
Disintegration, meets the regulation of pharmacopeia in clock.
Specific embodiment
The following is a clear and complete description of the technical scheme in the embodiments of the invention, it is clear that described embodiment
Only a part of the embodiment of the present invention, instead of all the embodiments.Based on the embodiments of the present invention, the common skill in this field
Art personnel every other embodiment obtained without making creative work belongs to the model that the present invention protects
It encloses.
Embodiment 1
The embodiment of the present invention provides a kind of enteric slow release plant capsule, and the plant capsule includes capsule housing and fits in institute
State the enteric laminating layer of capsule housing inner wall.
The capsule housing includes the raw material of following parts by weight: 60 parts of carragheens, 7 parts of sesbania gums, 0.1 part of maltitol powder,
0.2 part of potassium chloride, 10 parts of polyvinyl alcohol phthalate；Wherein, carragheen include weight ratio be 2:1 Kappa-Carraginan and
L- carragheen.
The enteric laminating layer includes the raw material of following parts by weight: 50 parts of polyvinyl alcohol phthalate, and 0.01 part
Tween 80.
Above-mentioned enteric slow release plant capsule the preparation method is as follows:
(1) by 50 parts of polyvinyl alcohol phthalate, 0.01 part of Tween 80 is dissolved in 100 parts of deionized waters, to completely molten
It is cooled to 25 DEG C after solution, obtains enteric laminating layer solution.
(2) by 60 parts of carragheens (weight ratio of Kappa-Carraginan and l- carragheen is 2:1), 7 parts of sesbania gums, 0.1 part of malt
Icing Sugar, 0.2 part of potassium chloride are dissolved in 100 parts of deionized water at normal temperature, stir to get capsule shells dispersion liquid；Use frequency for 150MHz
Microwave heating described in capsule shells dispersion liquid to after 80 DEG C, stir and keep the temperature 30min, be then cooled to 50 DEG C, be added 10 parts it is poly-
Vinyl alcohol acetate phthalate ester, stirs and keeps the temperature 30min, is cooled to 22 ~ 25 DEG C, stirs and keeps the temperature 60min, obtain capsule shells
Colloidal solution.
(3) the enteric laminating layer solution is dipped using capsule die, to form institute in the outer surface of the capsule die
State enteric laminating layer；The capsule die that outer surface covers the enteric laminating layer is put into the capsule shells colloidal solution again and is dipped in
The capsule shells colloidal solution is taken, capsule embryo is obtained.
(4) the capsule embryo after drying and processing 4 hours, is demoulded at a temperature of 30 DEG C, is cut into the enteric
It is sustained plant capsule.
After tested, it is limited to 4.2 hours when disintegration of the enteric slow release plant capsule of above-mentioned preparation in simulated gastric fluid is,
It is 10 minutes that disintegration in simulated intestinal fluid, which is prescribed a time limit,.
Embodiment 2
The embodiment of the present invention provides a kind of enteric slow release plant capsule, and the plant capsule includes capsule housing and fits in institute
State the enteric laminating layer of capsule housing inner wall.
The capsule housing includes the raw material of following parts by weight: 70 parts of carragheens, 9 parts of sesbania gums, 0.3 part of maltitol powder,
0.5 part of potassium chloride, 15 parts of polyvinyl alcohol phthalate；Wherein, carragheen include weight ratio be 4:1 Kappa-Carraginan and
L- carragheen.
The enteric laminating layer includes the raw material of following parts by weight: 60 parts of polyvinyl alcohol phthalate, and 0.03 part
Dodecyl sodium sulfate.
Above-mentioned enteric slow release plant capsule the preparation method is as follows:
(1) by 60 parts of polyvinyl alcohol phthalate, 0.03 part of dodecyl sodium sulfate is dissolved in 100 parts of deionized waters,
It is cooled to 30 DEG C until completely dissolved, obtains enteric laminating layer solution.
(2) by 70 parts of carragheens (weight ratio of Kappa-Carraginan and l- carragheen is 4:1), 9 parts of sesbania gums, 0.3 part of malt
Icing Sugar, 0.5 part of potassium chloride are dissolved in 100 parts of deionized water at normal temperature, stir to get capsule shells dispersion liquid；Use frequency for 200MHz
Microwave heating described in capsule shells dispersion liquid to after 90 DEG C, stir and keep the temperature 60min, be then cooled to 55 DEG C, be added 15 parts it is poly-
Vinyl alcohol acetate phthalate ester, stirs and keeps the temperature 40min, is cooled to 22 ~ 25 DEG C, stirs and keeps the temperature 90min, obtain capsule shells
Colloidal solution.
(3) the enteric laminating layer solution is dipped using capsule die, to form institute in the outer surface of the capsule die
State enteric laminating layer；The capsule die that outer surface covers the enteric laminating layer is put into the capsule shells colloidal solution again and is dipped in
The capsule shells colloidal solution is taken, capsule embryo is obtained.
(4) the capsule embryo after drying and processing 2 hours, is demoulded at a temperature of 40 DEG C, is cut into the enteric
It is sustained plant capsule.
After tested, it is limited to 4.6 hours when disintegration of the enteric slow release plant capsule of above-mentioned preparation in simulated gastric fluid is,
It is 9 minutes that disintegration in simulated intestinal fluid, which is prescribed a time limit,.
Embodiment 3
The embodiment of the present invention provides a kind of enteric slow release plant capsule, and the plant capsule includes capsule housing and fits in institute
State the enteric laminating layer of capsule housing inner wall.
The capsule housing includes the raw material of following parts by weight: 80 parts of carragheens, 10 parts of sesbania gums, 0.5 part of maltitol powder,
0.7 part of potassium chloride, 20 parts of polyvinyl alcohol phthalate；Wherein, carragheen include weight ratio be 5:1 Kappa-Carraginan and
L- carragheen.
The enteric laminating layer includes the raw material of following parts by weight: 70 parts of polyvinyl alcohol phthalate, and 0.05 part
Fabaceous Lecithin.
Above-mentioned enteric slow release plant capsule the preparation method is as follows:
(1) by 70 parts of polyvinyl alcohol phthalate, 0.05 part of Fabaceous Lecithin is dissolved in 100 parts of deionized waters, to completely molten
It is cooled to 30 DEG C after solution, obtains enteric laminating layer solution.
(2) by 80 parts of carragheens (weight ratio of Kappa-Carraginan and l- carragheen is 5:1), 10 parts of sesbania gums, 0.5 part of malt
Icing Sugar, 0.7 part of potassium chloride are dissolved in 100 parts of deionized water at normal temperature, stir to get capsule shells dispersion liquid；Use frequency for 300MHz
Microwave heating described in capsule shells dispersion liquid to after 100 DEG C, stir and keep the temperature 90min, be then cooled to 60 DEG C, be added 20 parts it is poly-
Vinyl alcohol acetate phthalate ester, stirs and keeps the temperature 50min, is cooled to 22 ~ 25 DEG C, stirs and keeps the temperature 120min, obtain capsule
Shell colloidal solution.
(3) the enteric laminating layer solution is dipped using capsule die, to form institute in the outer surface of the capsule die
State enteric laminating layer；The capsule die that outer surface covers the enteric laminating layer is put into the capsule shells colloidal solution again and is dipped in
The capsule shells colloidal solution is taken, capsule embryo is obtained.
(4) the capsule embryo after drying and processing 3 hours, is demoulded at a temperature of 35 DEG C, is cut into the enteric
It is sustained plant capsule.
After tested, it is limited to 5.3 hours when disintegration of the enteric slow release plant capsule of above-mentioned preparation in simulated gastric fluid is,
It is 7 minutes that disintegration in simulated intestinal fluid, which is prescribed a time limit,.
Comparative example
The structure and embodiment 3 of enteric slow release plant capsule are consistent, the difference is that, are free of sesbania gum on composition.
The enteric slow release plant capsule is prepared using the preparation method of embodiment 3, the difference is that, it is prepared by (1)
Microwave heating is not used in journey, directlys adopt electric heating；(2) polyvinyl alcohol phthalate and carragheen, maltose and
Potassium chloride is added together into the deionized water of room temperature.
After tested, it is limited to 2.3 hours when disintegration of the enteric slow release plant capsule of preparation in simulated gastric fluid is, artificial
It is 47 minutes that disintegration in intestinal juice, which is prescribed a time limit,.
To sum up, enteric slow release plant capsule of the invention is due to capsule housing and the intestines for fitting in the capsule housing inner wall
Molten laminating layer all has acid resistance, to still be able to ensure in the case where capsule housing occurs damaged due to external impact
Under gastric acid environment, content will not be dissolved out, thus the significantly more efficient stimulation for avoiding content to stomach.
In addition, the present invention is prepared when preparing capsule shells colloidal solution using microwave heating, and 50 ~ 60 are down in temperature
DEG C when polyvinyl alcohol phthalate is added, the stability and acidproof degree of colloidal solution are substantially increased, to have
Conducive to the stability and acid resistance for improving the capsule housing formed by the colloidal solution.
In addition, including sesbania gum in capsule shells of the invention, the addition of the sesbania gum can shorten capsule shells in intestinal juice
Disintegration time, accelerate the release of content.
The disintegration time limited of enteric slow release plant capsule of the invention is to be greater than 2 hours in gastric juice, 7 ~ 10 points in intestinal juice
Disintegration, meets the regulation of pharmacopeia in clock.
Above description sufficiently discloses a specific embodiment of the invention.It should be pointed out that being familiar with the field
Range of any change that technical staff does a specific embodiment of the invention all without departing from claims of the present invention.
Correspondingly, the scope of the claims of the invention is also not limited only to previous embodiment.
Claims (7)
1. a kind of enteric slow release plant capsule, which is characterized in that the plant capsule includes capsule housing and fits in described
The enteric laminating layer of capsule housing inner wall, the capsule housing include the raw material of following parts by weight: 60 ~ 80 parts of carragheens, and 7 ~ 10
Part sesbania gum, 0.1 ~ 0.5 part of maltitol powder, 0.2 ~ 0.7 part of potassium chloride, 10 ~ 20 parts of polyvinyl alcohol phthalate；It is described
Enteric laminating layer includes the raw material of following parts by weight: 50 ~ 70 parts of polyvinyl alcohol phthalate, 0.01 ~ 0.05 part of surface
Activating agent.
2. a kind of enteric slow release plant capsule according to claim 1, which is characterized in that the carragheen includes k- OK a karaoke club
The weight ratio of glue and l- carragheen, the Kappa-Carraginan and the l- carragheen is (2 ~ 5): 1.
3. a kind of enteric slow release plant capsule according to claim 1, which is characterized in that the surfactant is tween
80, one of dodecyl sodium sulfate or Fabaceous Lecithin or a variety of.
4. a kind of preparation method of enteric slow release plant capsule, which is characterized in that the described method includes:
By 50 ~ 70 parts of polyvinyl alcohol phthalate, 0.01 ~ 0.05 part of surfactant is dissolved in 100 parts of deionized waters,
It is cooled to 25 ~ 30 DEG C until completely dissolved, obtains enteric laminating layer solution；
By 60 ~ 80 parts of carragheens, 7 ~ 10 parts of sesbania gums, 0.1 ~ 0.5 part of maltitol powder, 0.2 ~ 0.7 part of potassium chloride is dissolved in 100 parts
In deionized water at normal temperature, capsule shells dispersion liquid is stirred to get；Using capsule shells dispersion liquid described in microwave heating to 800 ~ 100 DEG C
Afterwards, 30 ~ 90min is stirred and kept the temperature, is then cooled to 50 ~ 60 DEG C, 10 ~ 20 parts of polyvinyl alcohol phthalate are added, stir
30 ~ 50min is mixed and kept the temperature, is cooled to 22 ~ 25 DEG C, stirs and keep the temperature 60 ~ 120min, obtains capsule shells colloidal solution；
The enteric laminating layer solution is dipped using capsule die, the enteric patch is formed with the outer surface in the capsule die
Close layer；The capsule die that outer surface covers the enteric laminating layer is put into the capsule shells colloidal solution again and dips the glue
Softgel shell colloidal solution obtains capsule embryo；
After the capsule embryo is carried out drying and processing, is demoulded, is cut into the enteric slow release plant capsule.
5. a kind of preparation method of enteric slow release plant capsule according to claim 4, which is characterized in that
The frequency of the microwave is 150 ~ 300MHz.
6. a kind of preparation method of enteric slow release plant capsule according to claim 4, which is characterized in that at the drying
The condition of reason includes: that temperature is 30 ~ 40 DEG C, and drying time is 2 ~ 4 hours.
7. a kind of preparation method of enteric slow release plant capsule according to claim 4, which is characterized in that the surface is living
Property agent be one of Tween 80, dodecyl sodium sulfate or Fabaceous Lecithin or a variety of.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811580026.2A CN109528689B (en) | 2018-12-24 | 2018-12-24 | Enteric slow-release plant capsule and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811580026.2A CN109528689B (en) | 2018-12-24 | 2018-12-24 | Enteric slow-release plant capsule and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109528689A true CN109528689A (en) | 2019-03-29 |
| CN109528689B CN109528689B (en) | 2021-09-21 |
Family
ID=65856594
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811580026.2A Active CN109528689B (en) | 2018-12-24 | 2018-12-24 | Enteric slow-release plant capsule and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109528689B (en) |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000018377A1 (en) * | 1998-09-28 | 2000-04-06 | Warner-Lambert Company | Enteric and colonic delivery using hpmc capsules |
| CN101485643A (en) * | 2009-02-25 | 2009-07-22 | 刘松林 | Plant hollow capsule |
| CN101637610A (en) * | 2008-08-01 | 2010-02-03 | 江苏辰星海洋生物科技有限公司 | Carrageenan soft capsule wall material and preparation method thereof |
| KR20120044637A (en) * | 2010-10-28 | 2012-05-08 | 근화제약주식회사 | Pharmaceutical preparation |
| CN103260741A (en) * | 2010-10-26 | 2013-08-21 | 比利时胶囊公司 | Bulk enteric capsule shells |
| CN103520134A (en) * | 2013-10-29 | 2014-01-22 | 刘松林 | Duodenum targeted hollow capsules |
| CN106361722A (en) * | 2016-08-30 | 2017-02-01 | 浙江宏辉胶丸有限公司 | Hydroxypropyl methylcellulose hollow capsule and production technology thereof |
| CN106924211A (en) * | 2017-01-18 | 2017-07-07 | 浙江万里学院 | A kind of enteric hollow capsule and preparation method thereof |
| CN108143724A (en) * | 2018-03-05 | 2018-06-12 | 上海祺宇生物科技有限公司 | A kind of high oxygen-impermeable plant hollow capsule and preparation method thereof |
-
2018
- 2018-12-24 CN CN201811580026.2A patent/CN109528689B/en active Active
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000018377A1 (en) * | 1998-09-28 | 2000-04-06 | Warner-Lambert Company | Enteric and colonic delivery using hpmc capsules |
| CN101637610A (en) * | 2008-08-01 | 2010-02-03 | 江苏辰星海洋生物科技有限公司 | Carrageenan soft capsule wall material and preparation method thereof |
| CN101485643A (en) * | 2009-02-25 | 2009-07-22 | 刘松林 | Plant hollow capsule |
| CN103260741A (en) * | 2010-10-26 | 2013-08-21 | 比利时胶囊公司 | Bulk enteric capsule shells |
| KR20120044637A (en) * | 2010-10-28 | 2012-05-08 | 근화제약주식회사 | Pharmaceutical preparation |
| CN103520134A (en) * | 2013-10-29 | 2014-01-22 | 刘松林 | Duodenum targeted hollow capsules |
| CN106361722A (en) * | 2016-08-30 | 2017-02-01 | 浙江宏辉胶丸有限公司 | Hydroxypropyl methylcellulose hollow capsule and production technology thereof |
| CN106924211A (en) * | 2017-01-18 | 2017-07-07 | 浙江万里学院 | A kind of enteric hollow capsule and preparation method thereof |
| CN108143724A (en) * | 2018-03-05 | 2018-06-12 | 上海祺宇生物科技有限公司 | A kind of high oxygen-impermeable plant hollow capsule and preparation method thereof |
Non-Patent Citations (3)
| Title |
|---|
| 张奇: "《国防特色教材 军用药物制剂工程学》", 30 April 2012, 北京理工大学出版社 * |
| 李维凤等: "《药学专业知识 2 第7版》", 28 February 2013, 中国医药科技出版社 * |
| 钟静芬: "《表面活性剂在药学中的应用》", 29 February 1996, 人民卫生出版社 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN109528689B (en) | 2021-09-21 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN106924211B (en) | A kind of enteric hollow capsule and preparation method thereof | |
| WO1999033924A1 (en) | Gelatine compositions | |
| CN104436204A (en) | Pullulan polysaccharide capsule and preparation process thereof | |
| CN101708171B (en) | Enteric plant hollow capsule | |
| KR102519593B1 (en) | enteric capsules | |
| JP2010047548A (en) | Method for producing enteric soft capsule, and enteric soft capsule | |
| EP2244588A1 (en) | Soft gel capsules | |
| CN106723031A (en) | Matrimony vine zeaxanthin, lutein, the preparation method of vitamin E soft capsule | |
| CN105878208B (en) | A kind of starch base plant medicinal hard capsule forming agent and its application | |
| CN109157528A (en) | A kind of enteric algal polysaccharides Capsules and preparation method thereof | |
| US3826666A (en) | Enteric capsules | |
| CN109602718A (en) | A kind of enteric plant soft capsule and preparation method thereof | |
| WO2020073592A1 (en) | Pullulan empty hard capsule and preparation method therefor | |
| CN105534945B (en) | Plant type enteric soft capsule | |
| CN101606919A (en) | Produce the method for medical capsule shells with carrageenan | |
| CN109528689A (en) | A kind of enteric slow release plant capsule and preparation method thereof | |
| CN103690510B (en) | A kind of nanometer level cellulose hollow hard capsule and preparation method thereof | |
| JPH10310519A (en) | Capsule | |
| BRPI0822140A2 (en) | coated pharmaceutical or nutraceutical preparation having pulsed active subsatance release | |
| JP2009234975A (en) | Composition for oral material coating, covering material for oral material, edible container and oral material using the same | |
| CN110585162A (en) | Enteric film coating premix for soft capsules and preparation method thereof | |
| CN103520134B (en) | Duodenum targeted hollow capsules | |
| CN110507629A (en) | A kind of plant cellulose soft capsule rubber and preparation method thereof | |
| CN104922087B (en) | A kind of preparation method of vegetalitas capsulae enterosolubilis | |
| EP3556358A1 (en) | Acid resistant capsule shell composition |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Enteric coated sustained-release plant capsule and its preparation method Effective date of registration: 20221109 Granted publication date: 20210921 Pledgee: Jiangsu Nantong Rural Commercial Bank Co.,Ltd. high tech Zone sub branch Pledgor: JIANGSU ZODIAC PHARMACEUTICAL CO.,LTD. Registration number: Y2022980021371 |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right | ||
| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Date of cancellation: 20231103 Granted publication date: 20210921 Pledgee: Jiangsu Nantong Rural Commercial Bank Co.,Ltd. high tech Zone sub branch Pledgor: JIANGSU ZODIAC PHARMACEUTICAL CO.,LTD. Registration number: Y2022980021371 |
|
| PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A enteric coated sustained-release plant capsule and its preparation method Effective date of registration: 20231108 Granted publication date: 20210921 Pledgee: Jiangsu Nantong Rural Commercial Bank Co.,Ltd. high tech Zone sub branch Pledgor: JIANGSU ZODIAC PHARMACEUTICAL CO.,LTD. Registration number: Y2023980064331 |
|
| PE01 | Entry into force of the registration of the contract for pledge of patent right |