CN109528689B - Enteric slow-release plant capsule and preparation method thereof - Google Patents
Enteric slow-release plant capsule and preparation method thereof Download PDFInfo
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- CN109528689B CN109528689B CN201811580026.2A CN201811580026A CN109528689B CN 109528689 B CN109528689 B CN 109528689B CN 201811580026 A CN201811580026 A CN 201811580026A CN 109528689 B CN109528689 B CN 109528689B
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- 239000002775 capsule Substances 0.000 title claims abstract description 127
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 239000000679 carrageenan Substances 0.000 claims abstract description 37
- 229940113118 carrageenan Drugs 0.000 claims abstract description 37
- 229920001525 carrageenan Polymers 0.000 claims abstract description 37
- 241000196324 Embryophyta Species 0.000 claims abstract description 36
- 239000004372 Polyvinyl alcohol Substances 0.000 claims abstract description 26
- GAMPNQJDUFQVQO-UHFFFAOYSA-N acetic acid;phthalic acid Chemical compound CC(O)=O.OC(=O)C1=CC=CC=C1C(O)=O GAMPNQJDUFQVQO-UHFFFAOYSA-N 0.000 claims abstract description 26
- 229920002451 polyvinyl alcohol Polymers 0.000 claims abstract description 26
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims abstract description 24
- 238000010030 laminating Methods 0.000 claims abstract description 19
- 235000010418 carrageenan Nutrition 0.000 claims abstract description 17
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims abstract description 17
- 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 claims abstract description 12
- 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 claims abstract description 12
- 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
- 239000000843 powder Substances 0.000 claims abstract description 11
- 239000004094 surface-active agent Substances 0.000 claims abstract description 8
- 244000275012 Sesbania cannabina Species 0.000 claims abstract 3
- 239000010410 layer Substances 0.000 claims description 32
- 238000003756 stirring Methods 0.000 claims description 20
- 238000001816 cooling Methods 0.000 claims description 12
- 239000008367 deionised water Substances 0.000 claims description 11
- 229910021641 deionized water Inorganic materials 0.000 claims description 11
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 11
- 239000006185 dispersion Substances 0.000 claims description 10
- 239000007788 liquid Substances 0.000 claims description 10
- 238000001035 drying Methods 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 8
- JLPULHDHAOZNQI-ZTIMHPMXSA-N 1-hexadecanoyl-2-(9Z,12Z-octadecadienoyl)-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C/C\C=C/CCCCC JLPULHDHAOZNQI-ZTIMHPMXSA-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 5
- 238000005520 cutting process Methods 0.000 claims description 5
- 238000007598 dipping method Methods 0.000 claims description 5
- 238000004090 dissolution Methods 0.000 claims description 5
- 210000001161 mammalian embryo Anatomy 0.000 claims description 5
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 5
- 229920000053 polysorbate 80 Polymers 0.000 claims description 5
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 5
- 229940083466 soybean lecithin Drugs 0.000 claims description 3
- 239000002702 enteric coating Substances 0.000 claims description 2
- 238000009505 enteric coating Methods 0.000 claims description 2
- 238000013270 controlled release Methods 0.000 claims 1
- 210000004211 gastric acid Anatomy 0.000 abstract description 4
- 241000219782 Sesbania Species 0.000 description 13
- 238000013268 sustained release Methods 0.000 description 12
- 239000012730 sustained-release form Substances 0.000 description 12
- 108010010803 Gelatin Proteins 0.000 description 8
- 235000011389 fruit/vegetable juice Nutrition 0.000 description 8
- 229920000159 gelatin Polymers 0.000 description 8
- 239000008273 gelatin Substances 0.000 description 8
- 235000019322 gelatine Nutrition 0.000 description 8
- 235000011852 gelatine desserts Nutrition 0.000 description 8
- 230000000968 intestinal effect Effects 0.000 description 8
- 239000002253 acid Substances 0.000 description 6
- 239000000084 colloidal system Substances 0.000 description 6
- 210000004051 gastric juice Anatomy 0.000 description 6
- 210000002784 stomach Anatomy 0.000 description 5
- 239000003814 drug Substances 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- 210000000813 small intestine Anatomy 0.000 description 3
- 239000007901 soft capsule Substances 0.000 description 3
- 239000008347 soybean phospholipid Substances 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 2
- 230000000638 stimulation Effects 0.000 description 2
- 241000283690 Bos taurus Species 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 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
- 229920001436 collagen Polymers 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 235000020930 dietary requirements Nutrition 0.000 description 1
- 235000006694 eating habits Nutrition 0.000 description 1
- 238000005485 electric heating Methods 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 229910001385 heavy metal Inorganic materials 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 239000002075 main ingredient Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000000518 sarcolemma Anatomy 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 238000003860 storage Methods 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
Abstract
The invention relates to an enteric slow-release plant capsule and a preparation method thereof, the plant capsule comprises a capsule shell and an enteric attaching layer attached to the inner wall of the capsule shell, and the capsule shell comprises the following raw materials in parts by weight: 60-80 parts of carrageenan, 7-10 parts of sesbania gum, 0.1-0.5 part of maltose powder, 0.2-0.7 part of potassium chloride and 10-20 parts of polyvinyl alcohol acetate phthalate; the enteric-coated laminating layer comprises the following raw materials in parts by weight: 50-70 parts of polyvinyl alcohol acetate phthalate and 0.01-0.05 part of surfactant. The enteric slow-release plant capsule prepared by the preparation method can more effectively prevent the content from dissolving out in a gastric acid environment, and greatly improves the quality of the capsule product.
Description
Technical Field
The invention relates to the technical field of capsule preparation, in particular to an enteric slow-release plant capsule and a preparation method thereof.
Background
Enteric capsules are capsules that disintegrate and release the drug in the small intestine and are generally used as a drug package that is damaged to the stomach. The existing enteric-coated capsules are mostly made of gelatin and enteric-coated materials, so that the capsules can not disintegrate in the acidic environment of the stomach, can enter the small intestine along with the emptying of the stomach, and can disintegrate and release medicines in the alkaline environment of the small intestine.
Gelatin is mainly derived from collagen in connective tissues such as animal skin, bone, and sarcolemma, and gelatin commonly used in the food industry is derived from pig and cattle. In recent years, the edible safety events of the capsule are frequently reported, and as industrial gelatin contains more heavy metal ions, the hazard is extremely high, and the low price of the industrial gelatin is often a way for the illegal trader to profit; the gelatin has the problem of cross-linking, so that the soft capsule is easy to become unstable, and the storage and transportation of the soft capsule product are influenced; meanwhile, due to the animal origin of gelatin, the soft capsule using gelatin as the main ingredient also does not meet the dietary habits and requirements of halal or vegetarian diet, so the research on the plant capsule is very necessary.
Disclosure of Invention
In view of the above problems, the present invention aims to provide an enteric sustained-release plant capsule and a preparation method thereof, and the enteric sustained-release plant capsule prepared by the preparation method can more effectively prevent the dissolution of the content in the gastric acid environment, thereby greatly improving the quality of the capsule product.
In order to solve the technical problem, a first aspect of the present invention provides an enteric sustained-release plant capsule, where the plant capsule includes a capsule shell and an enteric attaching layer attached to an inner wall of the capsule shell, and the capsule shell includes the following raw materials in parts by weight: 60-80 parts of carrageenan, 7-10 parts of sesbania gum, 0.1-0.5 part of maltose powder, 0.2-0.7 part of potassium chloride and 10-20 parts of polyvinyl alcohol acetate phthalate; the enteric-coated laminating layer comprises the following raw materials in parts by weight: 50-70 parts of polyvinyl alcohol acetate phthalate and 0.01-0.05 part of surfactant.
Further, the carrageenan comprises k-carrageenan and l-carrageenan, and the weight ratio of the k-carrageenan to the l-carrageenan is (2-5): 1.
Further, the surfactant is one or more of tween 80, sodium dodecyl sulfate or soybean lecithin.
The second aspect of the present invention provides a preparation method of an enteric sustained-release plant capsule, comprising:
dissolving 50-70 parts of polyvinyl alcohol acetate phthalate and 0.01-0.05 part of surfactant in 100 parts of deionized water, and cooling to 25-30 ℃ after complete dissolution to obtain an enteric coating layer solution;
dissolving 60-80 parts of carrageenan, 7-10 parts of sesbania gum, 0.1-0.5 part of maltose powder and 0.2-0.7 part of potassium chloride in 100 parts of normal-temperature deionized water, and stirring to obtain a capsule shell dispersion liquid; heating the capsule shell dispersion liquid to 800-100 ℃ by using microwaves, stirring and preserving heat for 30-90 min, then cooling to 50-60 ℃, adding 10-20 parts of polyvinyl alcohol acetate phthalate, stirring and preserving heat for 30-50 min, cooling to 22-25 ℃, stirring and preserving heat for 60-120 min to obtain a capsule shell colloidal solution;
dipping the enteric-coated laminating layer solution by adopting a capsule mould so as to form the enteric-coated laminating layer on the outer surface of the capsule mould; then putting the capsule mold with the outer surface covered with the enteric-coated attaching layer into the capsule shell colloidal solution to dip the capsule shell colloidal solution to obtain a capsule blank;
and drying the capsule embryo, demolding, and cutting to obtain the enteric slow-release plant capsule.
Furthermore, the frequency of the microwave is 150-300 MHz.
Further, the conditions of the drying process include: the temperature is 30-40 ℃, and the drying time is 2-4 hours.
Further, the surfactant is one or more of tween 80, sodium dodecyl sulfate or soybean lecithin.
The enteric slow-release plant capsule and the preparation method thereof have the following beneficial effects:
according to the enteric slow-release plant capsule, the capsule shell and the enteric attaching layer attached to the inner wall of the capsule shell have acid resistance, so that under the condition that the capsule shell is damaged due to external collision, the content can still be ensured not to be dissolved out in a gastric acid environment, and the stimulation of the content to the stomach is effectively avoided.
In addition, the capsule shell colloid solution is prepared by microwave heating, and the polyvinyl alcohol acetate phthalate is added when the temperature is reduced to 50-60 ℃, so that the stability and the acid resistance of the colloid solution are greatly improved, and the stability and the acid resistance of the capsule shell formed by the colloid solution are favorably improved.
In addition, the capsule shell of the invention contains sesbania gum, and the sesbania gum can shorten the disintegration time of the capsule shell in intestinal juice and accelerate the release of contents.
The enteric sustained-release plant capsule has the disintegration time limit of more than 2 hours in gastric juice and the disintegration time limit of 7-10 minutes in intestinal juice, and meets the regulation of pharmacopoeia.
Detailed Description
The technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.
Example 1
The embodiment of the invention provides an enteric slow-release plant capsule, which comprises a capsule shell and an enteric attaching layer attached to the inner wall of the capsule shell.
The capsule shell comprises the following raw materials in parts by weight: 60 parts of carrageenan, 7 parts of sesbania gum, 0.1 part of maltose powder, 0.2 part of potassium chloride and 10 parts of polyvinyl alcohol acetate phthalate; wherein the carrageenan comprises k-carrageenan and l-carrageenan in a weight ratio of 2: 1.
The enteric-coated laminating layer comprises the following raw materials in parts by weight: 50 parts of polyvinyl alcohol acetate phthalate and 0.01 part of Tween 80.
The preparation method of the enteric slow-release plant capsule comprises the following steps:
(1) 50 parts of polyvinyl alcohol acetate phthalate and 0.01 part of Tween 80 are dissolved in 100 parts of deionized water, and after complete dissolution, the temperature is reduced to 25 ℃ to obtain the enteric-coated laminating layer solution.
(2) Dissolving 60 parts of carrageenan (the weight ratio of k-carrageenan to l-carrageenan is 2: 1), 7 parts of sesbania gum, 0.1 part of maltose powder and 0.2 part of potassium chloride in 100 parts of normal-temperature deionized water, and stirring to obtain a capsule shell dispersion liquid; heating the capsule shell dispersion liquid to 80 ℃ by adopting microwave with the frequency of 150MHz, stirring and preserving heat for 30min, then cooling to 50 ℃, adding 10 parts of polyvinyl alcohol acetate phthalate, stirring and preserving heat for 30min, cooling to 22-25 ℃, stirring and preserving heat for 60min to obtain a capsule shell colloidal solution.
(3) Dipping the enteric-coated laminating layer solution by adopting a capsule mould so as to form the enteric-coated laminating layer on the outer surface of the capsule mould; and then putting the capsule mold with the outer surface covered with the enteric-coated attaching layer into the capsule shell colloidal solution to dip the capsule shell colloidal solution to obtain a capsule blank.
(4) And drying the capsule embryo at the temperature of 30 ℃ for 4 hours, demolding, and cutting to prepare the enteric slow-release plant capsule.
Tests show that the enteric sustained-release plant capsule prepared in the way is disintegrated in artificial gastric juice within 4.2 hours and in artificial intestinal juice within 10 minutes.
Example 2
The embodiment of the invention provides an enteric slow-release plant capsule, which comprises a capsule shell and an enteric attaching layer attached to the inner wall of the capsule shell.
The capsule shell comprises the following raw materials in parts by weight: 70 parts of carrageenan, 9 parts of sesbania gum, 0.3 part of maltose powder, 0.5 part of potassium chloride and 15 parts of polyvinyl alcohol acetate phthalate; wherein the carrageenan comprises k-carrageenan and l-carrageenan in a weight ratio of 4: 1.
The enteric-coated laminating layer comprises the following raw materials in parts by weight: 60 parts of polyvinyl alcohol acetate phthalate and 0.03 part of sodium dodecyl sulfate.
The preparation method of the enteric slow-release plant capsule comprises the following steps:
(1) 60 parts of polyvinyl alcohol acetate phthalate and 0.03 part of sodium dodecyl sulfate are dissolved in 100 parts of deionized water, and after complete dissolution, the temperature is reduced to 30 ℃ to obtain the enteric-coated laminating layer solution.
(2) Dissolving 70 parts of carrageenan (the weight ratio of k-carrageenan to l-carrageenan is 4: 1), 9 parts of sesbania gum, 0.3 part of maltose powder and 0.5 part of potassium chloride in 100 parts of normal-temperature deionized water, and stirring to obtain a capsule shell dispersion liquid; heating the capsule shell dispersion liquid to 90 ℃ by using microwaves with the frequency of 200MHz, stirring and preserving heat for 60min, then cooling to 55 ℃, adding 15 parts of polyvinyl alcohol acetate phthalate, stirring and preserving heat for 40min, cooling to 22-25 ℃, stirring and preserving heat for 90min to obtain a capsule shell colloidal solution.
(3) Dipping the enteric-coated laminating layer solution by adopting a capsule mould so as to form the enteric-coated laminating layer on the outer surface of the capsule mould; and then putting the capsule mold with the outer surface covered with the enteric-coated attaching layer into the capsule shell colloidal solution to dip the capsule shell colloidal solution to obtain a capsule blank.
(4) And drying the capsule embryo at the temperature of 40 ℃ for 2 hours, demolding, and cutting to prepare the enteric slow-release plant capsule.
Tests show that the disintegration time limit of the enteric sustained-release plant capsule in the artificial gastric juice is 4.6 hours, and the disintegration time limit in the artificial intestinal juice is 9 minutes.
Example 3
The embodiment of the invention provides an enteric slow-release plant capsule, which comprises a capsule shell and an enteric attaching layer attached to the inner wall of the capsule shell.
The capsule shell comprises the following raw materials in parts by weight: 80 parts of carrageenan, 10 parts of sesbania gum, 0.5 part of maltose powder, 0.7 part of potassium chloride and 20 parts of polyvinyl alcohol acetate phthalate; wherein the carrageenan comprises k-carrageenan and l-carrageenan in a weight ratio of 5: 1.
The enteric-coated laminating layer comprises the following raw materials in parts by weight: 70 parts of polyvinyl alcohol acetate phthalate and 0.05 part of soybean phospholipid.
The preparation method of the enteric slow-release plant capsule comprises the following steps:
(1) 70 parts of polyvinyl alcohol acetate phthalate and 0.05 part of soybean phospholipid are dissolved in 100 parts of deionized water, and after the polyvinyl alcohol acetate phthalate and the soybean phospholipid are completely dissolved, the temperature is reduced to 30 ℃ to obtain the enteric-coated laminating layer solution.
(2) Dissolving 80 parts of carrageenan (the weight ratio of k-carrageenan to l-carrageenan is 5: 1), 10 parts of sesbania gum, 0.5 part of maltose powder and 0.7 part of potassium chloride in 100 parts of normal-temperature deionized water, and stirring to obtain a capsule shell dispersion liquid; and heating the capsule shell dispersion liquid to 100 ℃ by using microwave with the frequency of 300MHz, stirring and preserving heat for 90min, then cooling to 60 ℃, adding 20 parts of polyvinyl alcohol acetate phthalate, stirring and preserving heat for 50min, cooling to 22-25 ℃, stirring and preserving heat for 120min to obtain a capsule shell colloidal solution.
(3) Dipping the enteric-coated laminating layer solution by adopting a capsule mould so as to form the enteric-coated laminating layer on the outer surface of the capsule mould; and then putting the capsule mold with the outer surface covered with the enteric-coated attaching layer into the capsule shell colloidal solution to dip the capsule shell colloidal solution to obtain a capsule blank.
(4) And drying the capsule embryo at 35 ℃ for 3 hours, demolding, and cutting to prepare the enteric slow-release plant capsule.
Tests show that the enteric sustained-release plant capsule prepared in the way is disintegrated in artificial gastric juice within 5.3 hours and in artificial intestinal juice within 7 minutes.
Comparative example
The structure of the enteric sustained-release plant capsule is the same as that of example 3, and the difference in composition is that no sesbania gum is contained.
The enteric slow-release plant capsule is prepared by the preparation method of the embodiment 3, and the difference is that (1) microwave heating is not adopted in the preparation process, and electric heating is directly adopted; (2) polyvinyl alcohol acetate phthalate, carrageenan, maltose and potassium chloride are added into deionized water at normal temperature.
Tests show that the prepared enteric sustained-release plant capsule has the disintegration time limit of 2.3 hours in artificial gastric juice and the disintegration time limit of 47 minutes in artificial intestinal juice.
In conclusion, the enteric sustained-release plant capsule has the advantages that the capsule shell and the enteric attaching layer attached to the inner wall of the capsule shell have acid resistance, so that the content can still be ensured not to be dissolved out in a gastric acid environment under the condition that the capsule shell is damaged due to external collision, and the stimulation of the content to the stomach is effectively avoided.
In addition, the capsule shell colloid solution is prepared by microwave heating, and the polyvinyl alcohol acetate phthalate is added when the temperature is reduced to 50-60 ℃, so that the stability and the acid resistance of the colloid solution are greatly improved, and the stability and the acid resistance of the capsule shell formed by the colloid solution are favorably improved.
In addition, the capsule shell of the invention contains sesbania gum, and the sesbania gum can shorten the disintegration time of the capsule shell in intestinal juice and accelerate the release of contents.
The enteric sustained-release plant capsule has the disintegration time limit of more than 2 hours in gastric juice and the disintegration time limit of 7-10 minutes in intestinal juice, and meets the regulation of pharmacopoeia.
The foregoing description has disclosed fully preferred embodiments of the present invention. It should be noted that those skilled in the art can make modifications to the embodiments of the present invention without departing from the scope of the appended claims. Accordingly, the scope of the appended claims is not to be limited to the specific embodiments described above.
Claims (2)
1. The enteric slow-release plant capsule is characterized by comprising a capsule shell and an enteric attaching layer attached to the inner wall of the capsule shell, wherein the capsule shell comprises the following raw materials in parts by weight: 60-80 parts of carrageenan, 7-10 parts of sesbania gum, 0.1-0.5 part of maltose powder, 0.2-0.7 part of potassium chloride and 10-20 parts of polyvinyl alcohol acetate phthalate; the enteric-coated laminating layer comprises the following raw materials in parts by weight: 50-70 parts of polyvinyl alcohol acetate phthalate and 0.01-0.05 part of surfactant; the carrageenan comprises k-carrageenan and l-carrageenan, and the weight ratio of the k-carrageenan to the l-carrageenan is (2-5) to 1; the surfactant is one or more of tween 80, sodium dodecyl sulfate or soybean lecithin;
the preparation method of the enteric slow-release plant capsule comprises the following steps: dissolving 50-70 parts of polyvinyl alcohol acetate phthalate and 0.01-0.05 part of surfactant in 100 parts of deionized water, and cooling to 25-30 ℃ after complete dissolution to obtain an enteric coating layer solution; dissolving 60-80 parts of carrageenan, 7-10 parts of sesbania gum, 0.1-0.5 part of maltose powder and 0.2-0.7 part of potassium chloride in 100 parts of normal-temperature deionized water, and stirring to obtain a capsule shell dispersion liquid; heating the capsule shell dispersion liquid to 800-100 ℃ by using microwaves, stirring and preserving heat for 30-90 min, then cooling to 50-60 ℃, adding 10-20 parts of polyvinyl alcohol acetate phthalate, stirring and preserving heat for 30-50 min, cooling to 22-25 ℃, stirring and preserving heat for 60-120 min to obtain a capsule shell colloidal solution; dipping the enteric-coated laminating layer solution by adopting a capsule mould so as to form the enteric-coated laminating layer on the outer surface of the capsule mould; then putting the capsule mold with the outer surface covered with the enteric-coated attaching layer into the capsule shell colloidal solution to dip the capsule shell colloidal solution to obtain a capsule blank; drying the capsule embryo, demolding, and cutting to obtain the enteric slow-release plant capsule; the frequency of the microwave is 150-300 MHz.
2. The enteric controlled-release plant capsule according to claim 1, wherein the drying conditions comprise: the temperature is 30-40 ℃, and the drying time is 2-4 hours.
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 |
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| 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 |
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| Publication Number | Publication Date |
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| CN109528689A CN109528689A (en) | 2019-03-29 |
| CN109528689B true CN109528689B (en) | 2021-09-21 |
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Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
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| 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 |
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| 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 |
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| CN109528689A (en) | 2019-03-29 |
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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 |