CN119112822A - A kind of uncoated enteric soft capsule composition - Google Patents
A kind of uncoated enteric soft capsule composition Download PDFInfo
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- CN119112822A CN119112822A CN202411242806.1A CN202411242806A CN119112822A CN 119112822 A CN119112822 A CN 119112822A CN 202411242806 A CN202411242806 A CN 202411242806A CN 119112822 A CN119112822 A CN 119112822A
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- enteric
- gelatin
- soft capsule
- gum
- capsule
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- 239000007901 soft capsule Substances 0.000 title claims abstract description 128
- 239000000203 mixture Substances 0.000 title claims abstract description 37
- 108010010803 Gelatin Proteins 0.000 claims abstract description 129
- 239000008273 gelatin Substances 0.000 claims abstract description 129
- 229920000159 gelatin Polymers 0.000 claims abstract description 129
- 235000019322 gelatine Nutrition 0.000 claims abstract description 129
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 129
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 118
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 54
- 235000011187 glycerol Nutrition 0.000 claims abstract description 43
- 239000008213 purified water Substances 0.000 claims abstract description 42
- 238000000576 coating method Methods 0.000 claims abstract description 35
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- 229920001525 carrageenan Polymers 0.000 claims abstract description 26
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- 235000010419 agar Nutrition 0.000 claims abstract description 25
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- 229920000161 Locust bean gum Polymers 0.000 claims abstract description 24
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- 239000000711 locust bean gum Substances 0.000 claims abstract description 24
- 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 24
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- 238000003825 pressing Methods 0.000 claims description 37
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- 229920000591 gum Polymers 0.000 claims description 10
- 235000021323 fish oil Nutrition 0.000 claims description 8
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- 239000010647 garlic oil Substances 0.000 claims description 2
- 239000012676 herbal extract Substances 0.000 claims description 2
- 239000006041 probiotic Substances 0.000 claims description 2
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- 238000010025 steaming Methods 0.000 description 32
- 239000010410 layer Substances 0.000 description 24
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 22
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- 238000001514 detection method Methods 0.000 description 16
- 239000003814 drug Substances 0.000 description 14
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- 210000000813 small intestine Anatomy 0.000 description 2
- OMDQUFIYNPYJFM-XKDAHURESA-N (2r,3r,4s,5r,6s)-2-(hydroxymethyl)-6-[[(2r,3s,4r,5s,6r)-4,5,6-trihydroxy-3-[(2s,3s,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-2-yl]methoxy]oxane-3,4,5-triol Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O[C@H]2[C@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)O)[C@H](O)[C@H](O)[C@H](O)O1 OMDQUFIYNPYJFM-XKDAHURESA-N 0.000 description 1
- 240000008886 Ceratonia siliqua Species 0.000 description 1
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- SHZGCJCMOBCMKK-UHFFFAOYSA-N D-mannomethylose Natural products CC1OC(O)C(O)C(O)C1O SHZGCJCMOBCMKK-UHFFFAOYSA-N 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 229920000926 Galactomannan Polymers 0.000 description 1
- IAJILQKETJEXLJ-UHFFFAOYSA-N Galacturonsaeure Natural products O=CC(O)C(O)C(O)C(O)C(O)=O IAJILQKETJEXLJ-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- SHZGCJCMOBCMKK-JFNONXLTSA-N L-rhamnopyranose Chemical compound C[C@@H]1OC(O)[C@H](O)[C@H](O)[C@H]1O SHZGCJCMOBCMKK-JFNONXLTSA-N 0.000 description 1
- PNNNRSAQSRJVSB-UHFFFAOYSA-N L-rhamnose Natural products CC(O)C(O)C(O)C(O)C=O PNNNRSAQSRJVSB-UHFFFAOYSA-N 0.000 description 1
- 241000206572 Rhodophyta Species 0.000 description 1
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- IAJILQKETJEXLJ-QTBDOELSSA-N aldehydo-D-glucuronic acid Chemical compound O=C[C@H](O)[C@@H](O)[C@H](O)[C@H](O)C(O)=O IAJILQKETJEXLJ-QTBDOELSSA-N 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 229920001586 anionic polysaccharide Polymers 0.000 description 1
- 150000004836 anionic polysaccharides Chemical class 0.000 description 1
- 239000002585 base Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 210000002421 cell wall Anatomy 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000001055 chewing effect Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
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- 239000003995 emulsifying agent Substances 0.000 description 1
- 238000000855 fermentation Methods 0.000 description 1
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- 238000011049 filling Methods 0.000 description 1
- 210000004211 gastric acid Anatomy 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000003349 gelling agent Substances 0.000 description 1
- 230000009477 glass transition Effects 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 229940097043 glucuronic acid Drugs 0.000 description 1
- -1 good stability Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
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- 210000000056 organ Anatomy 0.000 description 1
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- 210000002784 stomach Anatomy 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 239000002562 thickening agent Substances 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
- A61K9/4816—Wall or shell material
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/30—Encapsulation of particles, e.g. foodstuff additives
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/30—Encapsulation of particles, e.g. foodstuff additives
- A23P10/35—Encapsulation of particles, e.g. foodstuff additives with oils, lipids, monoglycerides or diglycerides
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K9/4825—Proteins, e.g. gelatin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
Abstract
本申请提出了一种无包衣的肠溶软胶囊组合物，涉及保健品制剂技术领域。该肠溶软胶囊组合物由肠溶胶皮层和包裹于胶皮层内的功能性内容物组成。肠溶胶皮层的组成可以由明胶、甘油、纯化水、果胶、刺槐豆胶和琼脂等制成；也可以由明胶、甘油、纯化水、结冷胶、卡拉胶和黄原胶等制成。本申请肠溶软胶囊由肠溶胶皮层和功能性内容物组成，其中特定组成成分和比例制备的肠溶胶皮层可以保护胶囊在胃液中不被崩解，起到肠溶效果；通过软胶皮层代替传统的包衣层，可以避免传统肠溶胶囊包衣额外造成的负面影响。
The present application proposes a non-coated enteric soft capsule composition, which relates to the technical field of health care product preparations. The enteric soft capsule composition consists of an enteric gel cortex and functional contents wrapped in the gel cortex. The enteric gel cortex can be made of gelatin, glycerin, purified water, pectin, locust bean gum, agar, etc.; it can also be made of gelatin, glycerin, purified water, gellan gum, carrageenan, xanthan gum, etc. The enteric soft capsule of the present application consists of an enteric gel cortex and functional contents, wherein the enteric gel cortex prepared with specific components and proportions can protect the capsule from being disintegrated in gastric juice and play an enteric effect; by replacing the traditional coating layer with a soft gel cortex, the negative effects caused by the additional coating of traditional enteric capsules can be avoided.
Description
Technical Field
The application relates to the technical field of health-care product preparations, in particular to an enteric soft capsule composition without a coating.
Background
Enteric capsule refers to a hard capsule prepared by filling particles or pellets coated with an enteric material into a capsule, or a hard capsule or a soft capsule prepared by using a proper enteric material. An enteric preparation is a preparation which does not release or hardly releases a drug in the stomach for a prescribed period of time and enters the intestine, and can release a majority or all of the drug in a certain part of the intestine, and an enteric capsule belongs to one of enteric preparations.
The enteric capsule has the advantages over other capsules in that 1, the gastric mucosa is protected from irritation, certain medicaments can cause irritation and damage to the gastric mucosa, and the enteric capsule can prevent the irritation from occurring in the gastric acid environment. 2. The enteric capsule can prolong the residence time of the medicine in the small intestine, increase the contact area of the medicine and the intestinal wall, thereby increasing the absorption of the medicine to the intestinal tract, and 3, reduce the dosage of the medicine, namely, the dosage of the medicine can be reduced due to the protective effect of the enteric capsule, and the burden of the medicine to other organs of a human body is lightened. 4. The utilization rate of the capsule is improved, the medicine absorbed by the small intestine is mainly transferred to the part with the highest concentration as possible, and the bioavailability is improved.
However, the conventional enteric capsule achieves the enteric effect by coating (coating the enteric material) and coating the enteric hard capsule shell, but the common coating has the problems of 1, adhesion, namely, the particles can be adhered together due to collision of other particles if mist drops are not completely dried in the coating process. This can lead to tearing of the coating film from the tablet core, resulting in uncoated areas or localized excessive thickness, affecting the uniformity and integrity of the coating, and 2, affecting the mechanical properties of the tablet core, i.e. the hardness and friability of the tablet core, which have a decisive influence on the quality of the film coating. If the mechanical properties of the tablet core are poor, it is difficult to ensure the quality of the coating film even though the film coating is performed, 3, the production cost is increased, namely, although the coating can improve the stability of the drug and the drug administration experience of patients, the coating process can increase the production cost, including the material cost, the equipment cost and the production time cost, 4, the dissolution and the absorption of the drug can be affected, and if the quality of the coating layer is poor, such as uneven or too thick, the dissolution rate and the absorption degree of the drug can be affected, thereby affecting the drug efficacy.
Disclosure of Invention
The present application aims to provide an enteric soft capsule composition without coating, which has the effect of maintaining excellent enteric disintegration properties without coating.
In order to solve the technical problems, the application adopts the technical scheme that:
the application provides an enteric soft capsule composition without coating, which consists of an enteric skin layer and functional contents wrapped in the gel skin layer.
The enteric cortex can be composed of gelatin, glycerol, purified water, pectin, locust bean gum and agar, or gelatin, glycerol, purified water, gellan gum, carrageenan and xanthan gum.
Compared with the prior art, the embodiment of the application has at least the following advantages or beneficial effects:
The enteric soft capsule consists of an enteric skin layer and functional contents, wherein the enteric skin layer prepared by specific components and proportion can protect the capsule from being disintegrated in gastric juice to play the enteric effect, the soft gel layer replaces the traditional coating layer to avoid the additional negative influence caused by the traditional enteric capsule coating, and the preparation process of the enteric soft capsule is simplified after the coating is omitted, thereby 8
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, it being understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and other related drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 shows a glue melting apparatus used in embodiment 1 of the present application;
FIG. 2 shows a pelleting apparatus used in example 1 of the present application;
FIG. 3 shows an enteric soft capsule product prepared in example 1 of the present application.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions of the embodiments of the present application will be clearly and completely described below. The specific conditions are not noted in the examples and are carried out according to conventional conditions or conditions recommended by the manufacturer. The reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
It should be noted that, without conflict, the embodiments of the present application and features of the embodiments may be combined with each other. The present application will be described in detail with reference to specific examples.
An enteric soft capsule composition without coating, which consists of an enteric skin layer and a functional content wrapped in the gel skin layer.
In some embodiments of the application, the functional content comprises one or more of fish oil, krill oil, garlic oil, probiotic composition, and herbal extract.
In some embodiments of the application, the components of the enteric gum layer described above include gelatin, glycerin, purified water, pectin, locust bean gum, and agar.
In some embodiments of the present application, the enteric gum layer comprises, by mass, 37-42% gelatin, 17-18% glycerol, 35-40% purified water, 0.5-8% pectin, 0.1-2.0% locust bean gum, and 0.1-2.0% agar.
Gelatin is a polypeptide molecular mixture with wide molecular weight distribution, is a hydrolysis product of collagen protein, has good water retention, gelation and thermal reversibility, and is widely applied in the food industry. But the melting temperature is lower and the adhesion is easy at high temperature.
The glycerol has smaller molecular size, lower glass transition temperature (-52 ℃) and higher ratio of hydroxyl groups contained in single molecule to molecular mass, thus having good permeability. The application takes the polymer as a plasticizer, and reduces intermolecular attraction between adjacent polymer chains by being inserted into the middle of the polymer molecular chains, improves the mobility of the polymer chains, and reduces the crystallinity of the polymer molecular chains, thereby improving the elasticity and operability of the rubber and increasing the extensibility.
Pectin is an acidic heteropolysaccharide with a complex structure, widely exists in primary cell walls of various higher terrestrial plants in nature, and is often used as a gelling agent, a thickener, an emulsifier and the like in the food industry. The low-ester pectin and gelatin are compounded to have good synergy, because the gelatin with positive charges and the anionic polysaccharide are combined together through static electricity to generate strong attractive force to form a compound, and the charged pectin can promote gelatin molecules to gather.
Agar is a seaweed polysaccharide with very wide application, has extremely strong gel capability, and the formed gel has thermal reversibility, but has the defects of large brittleness, easy liquid removal, shrinkage and the like, so that the agar needs to be compounded with other colloids for use.
Locust bean gum is a linear galactomannan obtained from the endosperm of the seed of the locust tree. Locust bean gum has no gelation and has high viscosity at low concentration. In the process of aggregating agar molecules to form a three-dimensional network, the locust bean gum molecules participate in the process, and the hydrogen bond action between the locust bean gum molecules and the agar molecules promotes the gelation process of a mixed glue solution system, so that the apparent viscosity of the composite solution is rapidly increased. The skeleton structure mesh of the composite gel becomes finer and denser, the gel hardness, the resistance to chewing and the elasticity show a decreasing trend, but the cohesiveness shows an increasing trend.
In some embodiments of the application, the enteric soft capsule composition is prepared by heating and stirring purified water, glycerol, pectin, locust bean gum and agar, adding gelatin, stirring until the gelatin is dissolved, vacuumizing to obtain a gelatin solution, and pressing the gelatin solution and the functional content into soft capsules.
In some embodiments of the application, the components of the enteric gum layer described above include gelatin, glycerin, purified water, gellan gum, carrageenan, and xanthan gum.
In some embodiments of the present application, the enteric gum layer comprises, by mass, 38.5-41% gelatin, 16.2-19.2% glycerin, 36.3-39.75% purified water, 0.05-6.0% gellan gum, 0.2-2.5% carrageenan, and 0.35-2.0% xanthan gum.
Gellan gum is an extracellular polysaccharide produced by Sphingomonas paucimobilis under aerobic fermentation conditions, and is a linear tetraose repeating unit polymer formed by connecting glucose, glucuronic acid and rhamnose according to the ratio of 2:1:1. The gellan gum can form gel at the dosage of 0.05%, can keep higher gel strength and viscosity at 90 ℃ and can keep stable within the pH range of 2-10, namely has the characteristics of less dosage of the gellan gum, good stability, acid resistance and high temperature resistance.
Carrageenan, also known as carrageenan, carageenan, is a water-soluble colloid extracted from red algae, and is one of three industrial products of seaweeds (agar, carrageenan, algin) in the world. Gelatin also has short plates as a base material for the gel sheet, for example, the sheet is greatly affected by temperature. The carrageenan has stronger moisture resistance and thermal stability, and the application adopts the gelatin-carrageenan to compound and use, so that the heat resistance and the moisture resistance of a single gelatin rubber can be improved, and the thermal stability of the single gelatin rubber can be improved.
Xanthan gum is a polysaccharide extracted from Xanthomonas after fermentation, and is also known as xanthan gum. The xanthan gum can be dissolved in water, and can form high-viscosity colloid at low concentration (1%), multiple high-grade structures exist in the xanthan gum, wherein side chains in molecules are reversely wound around a main chain skeleton to form a spiral structure, rod-shaped double-spiral structures are formed among molecules through secondary acting forces, and then a double-spiral net-shaped three-dimensional structure is formed by weak acting forces, so that the xanthan gum has very strong capability of resisting acid, alkali, salt and temperature. Good viscosity is maintained in the appropriate pH range (4-10) and changes only at the more extreme pH (1-3 or 11-12) and at a concentration of 0.3%. After being compounded with other hydrophilic colloids, the xanthan gum can show obvious synergistic effect, the effect promotes the viscosity of the compounded solution to be obviously increased, and the acid resistance of a single gelatin rubber can be improved.
In some embodiments of the application, the enteric soft capsule composition is prepared by heating and stirring purified water, glycerol, gellan gum, carrageenan and xanthan gum, adding gelatin, stirring until the gelatin is dissolved, vacuumizing to obtain a gelatin solution, and pressing the gelatin solution and the functional content into soft capsules.
In some embodiments of the application, the heating temperature is 80-85 ℃.
The features and capabilities of the present application are described in further detail below in connection with the examples.
Example 1
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
Wherein the components of the enteric cortex comprise gelatin 150.00%, glycerol 18.00%, purified water 39.30%, pectin 0.50%, locust bean gum 0.10% and agar 0.10%, and the functional content is fish oil;
The preparation method comprises adding purified water, glycerol, pectin, locust bean gum and agar into the gel melting equipment shown in figure 1, heating and stirring, adding gelatin when the temperature rises to 80deg.C, vacuumizing, and steaming. Steaming under negative pressure for 50min, and vacuum degree is required to reach-0.05 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 10min until vacuum degree reaches above-0.06 MPa, and collecting gelatin solution for use, filtering the content by 100 mesh during pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with gelatin thickness of 0.60-0.85mm. The glue solution temperature is 60.0 ℃, the gelatin box temperature is 65 ℃, the spray temperature is 40.0 ℃ and the glue drum temperature is 20 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsule prepared in the embodiment is subjected to disintegration time limit detection according to a disintegration time limit detection method of Chinese pharmacopoeia 0921, and the detection method of enteric capsules in the capsule has the advantages that a baffle is not added to the hydrochloric acid solution (9-1000) for detection for 2 hours, the capsule shells of each capsule do not have cracks or disintegration phenomenon, the baffle is added to the artificial intestinal juice for detection, and the disintegration time limit detection meets the disintegration time limit standard of the enteric soft capsule.
Example 2
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
Wherein the components of the enteric cortex comprise gelatin 150.00%, glycerol 18.00%, purified water 37.50%, pectin 2.00%, locust bean gum 0.50% and agar 1.00%, and the functional content is fish oil;
The preparation method comprises adding purified water, glycerol, pectin, locust bean gum and agar into a gel container, heating and stirring, adding gelatin when the temperature rises to 85deg.C, vacuumizing, and steaming. Steaming under negative pressure for 60min, and vacuum degree is required to reach-0.04 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 12min until vacuum degree reaches above-0.06 MPa, and keeping the gelatin solution for later use, filtering the content by 120 meshes in the process of pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with thickness of gelatin skin of 0.60-0.85mm. The glue solution temperature is 65.0 ℃, the gelatin box temperature is 65 ℃, the spray temperature is 38.0 ℃ and the glue drum temperature is 23 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsules prepared in the embodiment are subjected to disintegration time limit detection, and the result is that the soft capsules are inspected for 2 hours in hydrochloric acid solution (9-1000) without adding a baffle, the capsule shells of each capsule do not have cracks or disintegration phenomenon, and the soft capsules are inspected in artificial intestinal juice by adding the baffle and disintegrated for 12 minutes. Meets the disintegration standard of enteric soft capsules.
Example 3
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
wherein the components of the enteric cortex comprise gelatin 150.00%, glycerol 18.00%, purified water 35.90%, pectin 4.00%, locust bean gum 0.10% and agar 2.00%, and the functional content is fish oil;
The preparation method comprises adding purified water, glycerol, pectin, locust bean gum and agar into a gel container, heating and stirring, adding gelatin when the temperature rises to 85deg.C, vacuumizing, and steaming. Steaming under negative pressure for 55min, and vacuum degree is required to reach-0.08 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 5min until vacuum degree reaches above-0.06 MPa, and keeping the gelatin solution for later use, filtering the content by 150 meshes in the process of pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with thickness of gelatin skin of 0.60-0.85mm. The glue solution temperature is 60 ℃, the gelatin box temperature is 60 ℃, the spray temperature is 40.0 ℃, and the glue drum temperature is 20 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsules prepared in the embodiment are subjected to disintegration time limit detection, and the result is that the soft capsules are inspected for 2 hours in hydrochloric acid solution (9-1000) without adding a baffle, the capsule shells of each capsule do not have cracks or disintegration phenomenon, and the soft capsules are inspected in artificial intestinal juice by adding the baffle and disintegrated for 14 minutes. Meets the disintegration standard of enteric soft capsules.
Example 4
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
wherein the components of the enteric cortex comprise gelatin 180.00%, glycerol 18.00%, purified water 36.50%, pectin 6.00%, locust bean gum 2.00% and agar 0.50%, and the functional content is krill oil;
The preparation method comprises adding purified water, glycerol, pectin, locust bean gum and agar into a gel container, heating and stirring, adding gelatin when the temperature rises to 82 deg.C, vacuumizing, and steaming. Steaming under negative pressure for 55min, and vacuum degree is required to reach-0.06 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 10min until vacuum degree reaches above-0.06 MPa, and keeping the gelatin solution for later use, filtering the content by 100 meshes in the process of pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with thickness of gelatin skin of 0.60-0.85mm. The glue solution temperature is 60.0 ℃, the gelatin box temperature is 70 ℃, the spray temperature is 42.0 ℃ and the glue drum temperature is 18 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsules prepared in the embodiment are subjected to disintegration time limit detection, and the result is that the soft capsules are inspected for 2 hours in hydrochloric acid solution (9-1000) without adding a baffle, the capsule shells of each capsule do not have cracks or disintegration phenomenon, and the soft capsules are inspected in artificial intestinal juice by adding the baffle and disintegrated for 14 minutes. Meets the disintegration standard of enteric soft capsules.
Example 5
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
Wherein the components of the enteric cortex comprise gelatin 180.00%, glycerol 17.00%, purified water 35.00%, pectin 8.00%, locust bean gum 1.00% and agar 1.00%, and the functional content is oleum Bulbus Allii;
The preparation method comprises adding purified water, glycerol, pectin, locust bean gum and agar into a gel container, heating and stirring, adding gelatin when the temperature rises to 80deg.C, vacuumizing, and steaming. Steaming under negative pressure for 60min, and vacuum degree is required to reach-0.08 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 12min until vacuum degree reaches above-0.06 MPa, and keeping the gelatin solution for later use, filtering the content by 100 meshes in the process of pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with thickness of gelatin skin of 0.60-0.85mm. The glue solution temperature is 60.0 ℃, the gelatin box temperature is 70 ℃, the spray temperature is 38.0 ℃ and the glue drum temperature is 23 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsules prepared in the embodiment are subjected to disintegration time limit detection, and the result is that the soft capsules are inspected for 2 hours in hydrochloric acid solution (9-1000) without adding a baffle, the capsule shells of each capsule do not have cracks or disintegration phenomenon, and the soft capsules are inspected in artificial intestinal juice by adding the baffle and disintegrated for 16 minutes. Meets the disintegration standard of enteric soft capsules.
Comparative example 1
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
wherein the components of the enteric cortex comprise gelatin 150.00%, glycerol 16.00%, purified water 33.00%, pectin 10.00%, locust bean gum 2.50% and agar 2.50%, and the functional content is krill oil;
The preparation method comprises adding purified water, glycerol, pectin, locust bean gum and agar into a gel container, heating and stirring, adding gelatin when the temperature rises to 80deg.C, vacuumizing, and steaming. Steaming under negative pressure for 50min, and vacuum degree is required to reach-0.06 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 10min until vacuum degree reaches above-0.06 MPa, and keeping the gelatin solution for later use.
Comparative example 2
An enteric soft capsule composition without coating comprises enteric cortex and functional content wrapped in the gelatin layer, wherein the gelatin is 150.00%, the glycerin is 18.00% and the purified water is 40.00%, and the functional content is krill oil;
The preparation method comprises heating and stirring purified water and glycerol, adding gelatin when the temperature rises to 80deg.C, vacuumizing, and beginning to cook. Steaming under negative pressure for 60min, and vacuum degree is required to reach-0.06 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 10 min until vacuum degree reaches above-0.06 MPa, and keeping the gelatin solution for later use, filtering the content by 100 meshes in the process of pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with thickness of gelatin skin of 0.60-0.85mm. The glue solution temperature is 60.0 ℃, the gelatin box temperature is 65 ℃, the spray temperature is 40.0 ℃ and the glue drum temperature is 20 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsule prepared in the embodiment is subjected to disintegration time limit detection, and the result is that the soft capsule is disintegrated in hydrochloric acid solution (9-1000) for 10min and does not meet the disintegration standard of enteric soft capsules.
Example 6
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
wherein the components of the enteric coating are gelatin 150.00%, glycerol 17.20%, purified water 39.75%, gellan gum 0.05%, carrageenan 1.00% and xanthan gum 1.00%, and the functional content is fish oil;
The preparation method comprises adding purified water, glycerol, gellan gum, carrageenan, and xanthan gum into a gelatin container, heating and stirring, adding gelatin when the temperature rises to 82 deg.C, vacuumizing, and beginning to cook. Steaming under negative pressure for 50min, and vacuum degree is required to reach-0.05 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 10min until vacuum degree reaches above-0.06 MPa, and collecting gelatin solution for use, filtering the content by 100 mesh during pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with gelatin thickness of 0.60-0.85mm. The glue solution temperature is 60.0 ℃, the gelatin box temperature is 65 ℃, the spray temperature is 40.0 ℃ and the glue drum temperature is 20 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsules prepared in the embodiment are subjected to disintegration time limit detection, and the result is that the soft capsules are inspected for 2 hours in hydrochloric acid solution (9-1000) without adding a baffle, the capsule shells of each capsule do not have cracks or disintegration phenomenon, and the soft capsules are inspected in artificial intestinal juice by adding the baffle and disintegrated for 16 minutes. Meets the disintegration standard of enteric soft capsules.
Example 7
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
wherein the components of the enteric coating are gelatin 150.00%, glycerol 17.20%, purified water 38.30%, gellan gum 0.50%, carrageenan 2.00% and xanthan gum 2.00%, and the functional content is fish oil;
The preparation method comprises the steps of putting purified water, glycerol, gellan gum, carrageenan and xanthan gum into a gelatin container, heating and stirring, putting gelatin into the container when the temperature rises to 80-85 ℃, vacuumizing, and beginning to cook. Steaming under negative pressure for 50min, and vacuum degree is required to reach-0.05 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 10min until vacuum degree reaches above-0.06 MPa, and collecting gelatin solution for use, filtering the content by 100 mesh during pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with gelatin thickness of 0.60-0.85mm. The glue solution temperature is 60.0 ℃, the gelatin box temperature is 65 ℃, the spray temperature is 40.0 ℃ and the glue drum temperature is 20 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsules prepared in the embodiment are subjected to disintegration time limit detection, and the result is that the soft capsules are inspected for 2 hours in hydrochloric acid solution (9-1000) without adding a baffle, the capsule shells of each capsule do not have cracks or disintegration phenomenon, and the soft capsules are inspected in artificial intestinal juice by adding the baffle and disintegrated for 13 minutes. Meets the disintegration standard of enteric soft capsules.
Example 8
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
Wherein the components of the enteric coating are gelatin 150.00%, glycerol 19.20%, purified water 38.30%, gellan gum 2.00%, carrageenan 0.20% and xanthan gum 0.30%, and the functional content is fish oil;
The preparation method comprises the steps of putting purified water, glycerol, gellan gum, carrageenan and xanthan gum into a gelatin container, heating and stirring, putting gelatin into the container when the temperature rises to 80-85 ℃, vacuumizing, and beginning to cook. Steaming under negative pressure for 50min, and vacuum degree is required to reach-0.05 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 10min until vacuum degree reaches above-0.06 MPa, and collecting gelatin solution for use, filtering the content by 100 mesh during pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with gelatin thickness of 0.60-0.85mm. The glue solution temperature is 60.0 ℃, the gelatin box temperature is 65 ℃, the spray temperature is 40.0 ℃ and the glue drum temperature is 20 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsules prepared in the embodiment are subjected to disintegration time limit detection, and the result is that the soft capsules are inspected for 2 hours in hydrochloric acid solution (9-1000) without adding a baffle, the capsule shells of each capsule do not have cracks or disintegrate phenomenon, and the soft capsules are inspected in artificial intestinal juice by adding the baffle and disintegrate for 18 minutes. Meets the disintegration standard of enteric soft capsules.
Example 9
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
Wherein the components of the enteric cortex comprise gelatin 150.00%, glycerol 16.20%, purified water 36.30%, gellan gum 4.00%, carrageenan 2.50% and xanthan gum 2.00%, and the functional content is krill oil;
The preparation method comprises adding purified water, glycerol, gellan gum, carrageenan, and xanthan gum into a gelatin container, heating and stirring, adding gelatin when the temperature rises to 82 deg.C, vacuumizing, and beginning to cook. Steaming under negative pressure for 50min, and vacuum degree is required to reach-0.07 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 10min until vacuum degree reaches above-0.06 MPa, and collecting gelatin solution for use, filtering the content by 100 mesh during pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with gelatin thickness of 0.60-0.85mm. The glue solution temperature is 60.0 ℃, the gelatin box temperature is 65 ℃, the spray temperature is 40.0 ℃ and the glue drum temperature is 20 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsules prepared in the embodiment are subjected to disintegration time limit detection, and the result is that the soft capsules are inspected for 2 hours in hydrochloric acid solution (9-1000) without adding a baffle, the capsule shells of each capsule do not have cracks or disintegration phenomenon, and the soft capsules are inspected in artificial intestinal juice by adding the baffle and disintegrated for 16 minutes. Meets the disintegration standard of enteric soft capsules.
Example 10
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
Wherein the components of the enteric cortex comprise gelatin 150.50%, glycerol 16.20%, purified water 36.30%, gellan gum 6.00%, carrageenan 1.50% and xanthan gum 1.50%, and the functional content is oleum Bulbus Allii;
The preparation method comprises the steps of putting purified water, glycerol, gellan gum, carrageenan and xanthan gum into a gelatin container, heating and stirring, putting gelatin into the container when the temperature rises to 80-85 ℃, vacuumizing, and beginning to cook. Steaming under negative pressure for 50min, and vacuum degree is required to reach-0.05 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 10min until vacuum degree reaches above-0.06 MPa, and collecting gelatin solution for use, filtering the content by 100 mesh during pelleting, and pressing with 10# olive type die at rotation speed of 3.0rpm with gelatin thickness of 0.60-0.85mm. The glue solution temperature is 60.0 ℃, the gelatin box temperature is 65 ℃, the spray temperature is 40.0 ℃ and the glue drum temperature is 20 ℃. And (5) pressing the glue solution and the content into soft capsules by adopting a soft capsule pill pressing machine. And drying to obtain soft capsule meeting the requirements. The water content of the soft capsule rubber is controlled to be 8-15%. The surface of the qualified capsule is smooth, the capsule has no oil leakage, no deformation, no abnormal pill, and the joint is smooth and the joint is perfect.
The soft capsules prepared in the embodiment are subjected to disintegration time limit detection, and the result is that the soft capsules are inspected for 2 hours in hydrochloric acid solution (9-1000) without adding a baffle, the capsule shells of each capsule do not have cracks or disintegrate phenomenon, and the soft capsules are inspected in artificial intestinal juice by adding the baffle and disintegrate for 13 minutes. Meets the disintegration standard of enteric soft capsules.
Comparative example 3
An enteric soft capsule composition without coating comprises an enteric cortex and a functional content wrapped in the gelatin layer;
wherein the components of the enteric cortex comprise gelatin 150.50%, glycerol 16.20%, purified water 33.30%, gellan gum 8.00%, carrageenan 3.00% and xanthan gum 3.00%, and the functional content is krill oil;
The preparation method comprises the steps of putting purified water, glycerol, gellan gum, carrageenan and xanthan gum into a gelatin container, heating and stirring, putting gelatin into the container when the temperature rises to 80-85 ℃, vacuumizing, and beginning to cook. Steaming under negative pressure for 60min, and vacuum degree is required to reach-0.06 MPa. Stirring and heating until gelatin is completely dissolved, steaming, vacuumizing for 12 min until vacuum degree reaches above-0.06 MPa, and keeping the gelatin solution for later use.
The embodiments described above are some, but not all embodiments of the application. The detailed description of the embodiments of the application is not intended to limit the scope of the application, as claimed, but is merely representative of selected embodiments of the application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
Claims (9)
1. An enteric soft capsule composition without coating is characterized by comprising an enteric gum layer and functional contents wrapped in the gum layer.
2. The uncoated enteric soft capsule composition of claim 1, wherein the functional content comprises one or more of fish oil, krill oil, garlic oil, probiotic composition, and herbal extract.
3. The uncoated enteric soft capsule composition of claim 2, wherein the components of the enteric gum layer include gelatin, glycerin, purified water, pectin, locust bean gum, and agar.
4. A non-coated enteric soft capsule composition according to claim 3, wherein the components of the enteric gum layer are, by mass, 37-42% gelatin, 17-18% glycerin, 35-40% purified water, 0.5-8% pectin, 0.1-2.0% locust bean gum and 0.1-2.0% agar.
5. The enteric soft capsule composition without coating according to claim 4, wherein the enteric soft capsule composition is prepared by heating and stirring purified water, glycerin, pectin, locust bean gum and agar, adding gelatin, stirring until the gelatin is dissolved, vacuumizing to obtain a gelatin solution, and pressing the gelatin solution and the functional content into soft capsules.
6. The uncoated enteric soft capsule composition of claim 2, wherein the components of the enteric gum layer include gelatin, glycerin, purified water, gellan gum, carrageenan, and xanthan gum.
7. The enteric soft capsule composition of claim 6, wherein the enteric gum layer comprises, by mass, 38.5-41% gelatin, 16.2-19.2% glycerin, 36.3-39.75% purified water, 0.05-6.0% gellan gum, 0.2-2.5% carrageenan, and 0.35-2.0% xanthan gum.
8. The enteric soft capsule composition without coating according to claim 7, wherein the enteric soft capsule composition is prepared by heating and stirring purified water, glycerol, gellan gum, carrageenan and xanthan gum, adding gelatin, stirring until the gelatin is dissolved, vacuumizing to obtain a gelatin solution, and pressing the gelatin solution and the functional content into soft capsules.
9. A non-coated enteric soft capsule composition according to claim 5 or 8, wherein the heating temperature is 80-85 ℃.
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