CN112826807B - Soft capsule shell, soft capsule prepared from soft capsule shell and preparation method of soft capsule - Google Patents
Soft capsule shell, soft capsule prepared from soft capsule shell and preparation method of soft capsule Download PDFInfo
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- CN112826807B CN112826807B CN202110129656.3A CN202110129656A CN112826807B CN 112826807 B CN112826807 B CN 112826807B CN 202110129656 A CN202110129656 A CN 202110129656A CN 112826807 B CN112826807 B CN 112826807B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
- A61K47/02—Inorganic compounds
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
Abstract
The invention relates to the field of soft capsule shell preparation, in particular to a soft capsule shell, a soft capsule prepared from the soft capsule shell and a preparation method of the soft capsule shell. The soft capsule shell provided by the invention comprises the following raw materials: the water quality control method comprises the following steps of (1) purifying water, glycerol, an additive and gelatin, wherein the mass ratio of the purifying water to the glycerol to the additive to the gelatin is 1: (0.4-0.6): (0.0001-0.021): 1; wherein the additive is inorganic salt and/or chitosan. The soft capsule shell provided by the invention can effectively enhance the mechanical strength of the capsule shell, reduce the oxygen transmission rate of the capsule shell and slow down the oxidation of the capsule contents.
Description
Technical Field
The invention relates to the field of soft capsule shell preparation, in particular to a soft capsule shell, a soft capsule prepared from the soft capsule shell and a preparation method of the soft capsule shell.
Background
With the development of pharmaceutical industry, soft capsules have been developed very rapidly due to the characteristics of almost any medicine, no peculiar smell, easy swallowing, easy digestion and absorption, no side effect on the body, and the like, and are widely used in the fields of foods, medicines and health care products. The soft capsule consists of a capsule shell and a capsule shell content, has the characteristics of high bioavailability, sealing safety, accurate dosage, attractive appearance and the like, and is widely applied to the research of traditional Chinese medicines.
The capsule shell of the existing soft capsule mainly comprises gelatin, glycerol and water in a certain proportion, and the conventional formula is gelatin: glycerol: the water is 1: (0.4-0.6): 1. however, the existing soft capsule taking gelatin as the main component of the capsule shell has poor oxygen isolation rate of the capsule shell, oxygen easily enters the capsule to oxidize the content of the capsule, thereby limiting the wide use of the soft capsule taking gelatin as the main component of the capsule shell, and meanwhile, the capsule shell taking gelatin as the main component has poor mechanical property; therefore, the development of a soft capsule shell with good oxygen insulation rate and mechanical property is urgently needed.
Disclosure of Invention
The invention aims to overcome the defects of poor oxygen insulation effect and poor mechanical property of a capsule shell taking gelatin as a main component in the prior art, and further provides a soft capsule shell, a soft capsule prepared from the soft capsule shell and a preparation method of the soft capsule shell.
In order to achieve the purpose, the invention adopts the following technical scheme:
a soft capsule shell comprises the following raw materials: the water quality control method comprises the following steps of (1) purifying water, glycerol, an additive and gelatin, wherein the mass ratio of the purifying water to the glycerol to the additive to the gelatin is 1: (0.4-0.6): (0.0001-0.021): 1; wherein the additive is inorganic salt and/or chitosan.
Preferably, the soft capsule shell comprises the following raw materials: the water quality control method comprises the following steps of (1) purifying water, glycerol, inorganic salt and gelatin, wherein the mass ratio of the purified water to the glycerol to the inorganic salt to the gelatin is 1: (0.4-0.6): (0.0001-0.0002): 1.
preferably, the soft capsule shell comprises the following raw materials: the water quality control agent comprises purified water, glycerol, chitosan and gelatin, wherein the mass ratio of the purified water to the glycerol to the chitosan to the gelatin is 1: (0.4-0.6): (0.01-0.02): 1.
preferably, the soft capsule shell comprises the following raw materials: the water quality control method comprises the following steps of (1) purifying water, glycerol, inorganic salt, chitosan and gelatin, wherein the mass ratio of the purified water to the glycerol to the inorganic salt to the chitosan to the gelatin is 1: (0.4-0.6): (0.0001-0.0002): (0.01-0.02): 1.
preferably, the inorganic salt is calcium chloride and/or sodium lauryl sulfate.
The invention also provides a preparation method of the soft capsule shell, which comprises the following steps:
1) Mixing purified water, glycerol, additive and gelatin, and heating the mixture to obtain glue solution;
2) Pressing the glue solution into a film, and performing injection molding on the film to obtain the soft capsule shell.
Preferably, the heating temperature is 70-80 ℃, and the heat preservation time is 20-40min at 70-80 ℃.
Preferably, the step 1) further comprises the steps of degassing and sieving the obtained glue solution, and storing the sieved glue solution at 55-65 ℃ for later use.
Preferably, the obtained glue solution is vacuumized for three times under the vacuum degree of-0.08 MPa-0 MPa, each time for 10-15min for degassing, and the degassed glue solution is sieved by a 110-130 mesh sieve.
The invention also provides a soft capsule which is composed of the capsule shell or the capsule shell prepared by the method and capsule contents.
The invention also provides a preparation method of the soft capsule, which comprises the following steps:
1) Mixing purified water, glycerol, additive and gelatin, and heating the mixture to obtain glue solution;
2) Pressing the glue solution into a glue piece, injection-molding the glue piece, adding the capsule content, and sealing the opening to obtain a capsule;
3) And (4) shaping and drying the soft capsules, washing and drying again to obtain the soft capsules.
The present invention is not particularly limited in kind of capsule contents, and any capsule contents that can be conventionally used as soft capsules can be used as the capsule contents of the present invention.
Preferably, the setting and drying temperature in the step 3) is 18-20 ℃, and the setting and drying time is 1-2h;
the solvent used in the washing step is edible alcohol;
the secondary drying temperature is 20-30 ℃, the relative humidity is 10-50%, and the drying time is 40-50 h.
The invention has the beneficial effects that:
1. the soft capsule shell comprises the following raw materials: the water quality control agent comprises purified water, glycerol, an additive and gelatin, wherein the mass ratio of the purified water to the glycerol to the additive to the gelatin is 1: (0.4-0.6): (0.0001-0.021): 1; wherein the additive is inorganic salt and/or chitosan.
The inorganic salt and/or chitosan in a specific proportion are added into the ingredients which take the gelatin as the main component, the inorganic salt can adjust the ion concentration and the storage modulus of the gelatin solution, increase the intermolecular electrostatic force, establish a salt bridge, strengthen the structural stability, enhance the plasticity of the gelatin solution, crosslink amino acid residues in the gelatin and reduce the self-crosslinking degree of the gelatin.
2. The soft capsule shell provided by the invention comprises the following raw materials: the water quality control method comprises the following steps of (1) purifying water, glycerol, inorganic salt, chitosan and gelatin, wherein the mass ratio of the purified water to the glycerol to the inorganic salt to the chitosan to the gelatin is 1: (0.4-0.6): (0.0001-0.0002): (0.01-0.02): 1; the inorganic salt and the chitosan with the specific proportion are matched with other components, so that the tensile strength of the capsule shell can be further enhanced, and the oxygen transmission rate of the capsule shell can be reduced.
3. Further, the inorganic salt is calcium chloride and/or sodium dodecyl sulfate. The specific inorganic salt is matched with other components, so that the tensile strength of the capsule shell can be further enhanced, and the oxygen transmission rate of the capsule shell can be further reduced.
Detailed Description
The following examples are provided to better understand the present invention, not to limit the best mode, and not to limit the content and protection scope of the present invention, and any product that is the same or similar to the present invention and is obtained by combining the present invention with other features of the prior art and the present invention falls within the protection scope of the present invention.
The examples do not indicate specific experimental procedures or conditions, and can be performed according to the procedures or conditions of the conventional experimental procedures described in the literature in the field. The reagents or instruments used are conventional reagent products which are commercially available, and manufacturers are not indicated.
Example 1
The embodiment provides a soft capsule, which comprises a capsule shell, wherein the capsule shell comprises the following raw materials: 100g of purified water, 40g of glycerol, 2g of chitosan and 100g of gelatin;
the preparation method of the soft capsule comprises the following steps:
1) Sequentially putting purified water, glycerol, chitosan and gelatin into a gelatin melting tank, stirring, mixing, heating the mixture to 70 ℃, and preserving heat at 70 ℃ for 30min to completely melt the gelatin to obtain a gelatin solution;
2) Vacuumizing the obtained glue solution for three times under the vacuum degree of-0.08 MPa, degassing for 10min each time, removing bubbles in the glue solution, sieving the degassed glue solution with a 120-mesh sieve, and storing the sieved glue solution at 60 ℃ for later use;
3) Pressing the glue solution obtained in the step 2) into a glue film with the thickness of 0.8mm by a glue spreading wheel, performing injection molding on the glue film to obtain a soft capsule shell, sealing the lower end of the soft capsule shell, rapidly adding propolis solution (capsule content), and rapidly sealing the opening of the soft capsule shell to form a closed soft capsule;
4) Shaping the capsule by a rolling cage type drying machine matched with a soft capsule machine, wherein the shaping and drying temperature is 20 ℃, the shaping and drying time is 1h, and the shaped and dried capsule is uniformly placed in a drying disc and temporarily stored in a pre-drying room;
5) Washing the shaped and dried soft capsules with 95% edible alcohol by mass fraction, and drying the soft capsules after the washing is finished, wherein the drying temperature is 30 ℃, the relative humidity is 30%, and the drying time is 40h, so as to obtain the soft capsules.
Example 2
The embodiment provides a soft capsule, which comprises a capsule shell, wherein the capsule shell comprises the following raw materials: 100g of purified water, 40g of glycerol, 0.02g of calcium chloride and 100g of gelatin;
the preparation method of the soft capsule comprises the following steps:
1) Sequentially adding purified water, glycerol, calcium chloride and gelatin into a gelatin melting tank, stirring, mixing, heating the mixture to 70 ℃, and keeping the temperature at 70 ℃ for 30min to completely melt the gelatin to obtain a gelatin solution;
2) Vacuumizing the obtained glue solution for three times under the vacuum degree of-0.08 MPa, degassing for 10min each time, removing bubbles in the glue solution, sieving the degassed glue solution with a 120-mesh sieve, and storing the sieved glue solution at 60 ℃ for later use;
3) Pressing the glue solution obtained in the step 2) into a glue sheet with the thickness of 0.8mm through a glue spreading wheel, performing injection molding on the glue sheet to obtain a soft capsule shell, sealing the lower end of the soft capsule shell, quickly adding the propolis solution (capsule content), and quickly sealing the opening of the soft capsule shell to form a sealed soft capsule pill;
4) Shaping the soft capsules by a roller cage type dryer matched with the soft capsule machine, wherein the shaping and drying temperature is 20 ℃, the shaping and drying time is 1h, and the shaped and dried soft capsules are uniformly placed in a drying disc and temporarily stored in a pre-drying room;
5) Washing the shaped and dried soft capsules with edible alcohol with the mass fraction of 95%, and drying the soft capsules after the washing is finished, wherein the drying temperature is 30 ℃, the relative humidity is 30%, and the drying time is 40h, so as to obtain the soft capsules.
Example 3
The embodiment provides a soft capsule, which comprises a capsule shell, wherein the capsule shell comprises the following raw materials: 100g of purified water, 40g of glycerol, 0.02g of calcium chloride, 1.98g of chitosan and 100g of gelatin;
the preparation method of the soft capsule comprises the following steps:
1) Sequentially adding purified water, glycerol, calcium chloride, chitosan and gelatin into a gelatin melting tank, stirring, mixing, heating the mixture to 70 ℃, and preserving heat at 70 ℃ for 30min to completely melt the gelatin to obtain a gelatin solution;
2) Vacuumizing the obtained glue solution for three times at a vacuum degree of-0.08 MPa, degassing for 10min each time, removing bubbles in the glue solution, sieving the degassed glue solution by a 120-mesh sieve, and storing the sieved glue solution at 60 ℃ for later use;
3) Pressing the glue solution obtained in the step 2) into a glue film with the thickness of 0.8mm by a glue spreading wheel, performing injection molding on the glue film to obtain a soft capsule shell, sealing the lower end of the soft capsule shell, rapidly adding propolis solution (capsule content), and rapidly sealing the opening of the soft capsule shell to form a closed soft capsule;
4) Shaping the capsule by a rolling cage type drying machine matched with a soft capsule machine, wherein the shaping and drying temperature is 20 ℃, the shaping and drying time is 1h, and the shaped and dried capsule is uniformly placed in a drying disc and temporarily stored in a pre-drying room;
5) Washing the shaped and dried soft capsules with 95% edible alcohol by mass fraction, and drying the soft capsules after the washing is finished, wherein the drying temperature is 30 ℃, the relative humidity is 30%, and the drying time is 40h, so as to obtain the soft capsules.
Example 4
The embodiment provides a soft capsule, which comprises a capsule shell, wherein the capsule shell comprises the following raw materials: 100g of purified water, 40g of glycerol, 2g of calcium chloride and 100g of gelatin;
the preparation method of the soft capsule comprises the following steps:
1) Sequentially adding purified water, glycerol, calcium chloride and gelatin into a gelatin melting tank, stirring, mixing, heating the mixture to 70 deg.C, and maintaining at 70 deg.C for 30min to completely melt gelatin to obtain gelatin solution;
2) Vacuumizing the obtained glue solution for three times under the vacuum degree of-0.08 MPa, degassing for 10min each time, removing bubbles in the glue solution, sieving the degassed glue solution with a 120-mesh sieve, and storing the sieved glue solution at 60 ℃ for later use;
3) Pressing the glue solution obtained in the step 2) into a glue film with the thickness of 0.8mm by a glue spreading wheel, performing injection molding on the glue film to obtain a soft capsule shell, sealing the lower end of the soft capsule shell, rapidly adding propolis solution (capsule content), and rapidly sealing the opening of the soft capsule shell to form a closed soft capsule;
4) Shaping the soft capsules by a roller cage type dryer matched with the soft capsule machine, wherein the shaping and drying temperature is 20 ℃, the shaping and drying time is 1h, and the shaped and dried soft capsules are uniformly placed in a drying disc and temporarily stored in a pre-drying room;
5) Washing the shaped and dried soft capsules with 95% edible alcohol by mass fraction, and drying the soft capsules after the washing is finished, wherein the drying temperature is 30 ℃, the relative humidity is 30%, and the drying time is 40h, so as to obtain the soft capsules.
Example 5
The embodiment provides a soft capsule, which comprises a capsule shell, wherein the capsule shell comprises the following raw materials: 100g of purified water, 50g of glycerol, 0.01g of sodium dodecyl sulfate, 1g of chitosan and 100g of gelatin;
the preparation method of the soft capsule comprises the following steps:
1) Sequentially adding purified water, glycerol, sodium dodecyl sulfate, chitosan and gelatin into a gelatin melting tank, stirring, mixing, heating the mixture to 80 ℃, and preserving heat at 80 ℃ for 20min to completely melt the gelatin to obtain a gelatin solution;
2) Vacuumizing the obtained glue solution for three times under the vacuum degree of-0.08 MPa, degassing for 15min each time, removing bubbles in the glue solution, sieving the degassed glue solution with a 120-mesh sieve, and storing the sieved glue solution at 55 ℃ for later use;
3) Pressing the glue solution obtained in the step 2) into a glue film with the thickness of 0.8mm by a glue spreading wheel, performing injection molding on the glue film to obtain a soft capsule shell, sealing the lower end of the soft capsule shell, rapidly adding propolis solution (capsule content), and rapidly sealing the opening of the soft capsule shell to form a closed soft capsule;
4) Shaping the soft capsules by a rolling cage type drying machine matched with a soft capsule machine, wherein the shaping and drying temperature is 18 ℃, the shaping and drying time is 2 hours, and the shaped and dried soft capsules are uniformly placed in a drying disc and temporarily stored in a pre-drying room;
5) Washing the shaped and dried soft capsules with 95% edible alcohol by mass fraction, and drying the soft capsules after the washing is finished, wherein the drying temperature is 20 ℃, the relative humidity is 20%, and the drying time is 50h, so as to obtain the soft capsules.
Example 6
The embodiment provides a soft capsule, which comprises a capsule shell, wherein the capsule shell comprises the following raw materials: 100g of purified water, 40g of glycerol, 0.02g of sodium dodecyl sulfate, 2g of chitosan and 100g of gelatin;
the preparation method of the soft capsule comprises the following steps:
1) Sequentially adding purified water, glycerol, sodium dodecyl sulfate, chitosan and gelatin into a gelatin melting tank, stirring, mixing, heating the mixture to 80 ℃, and preserving heat at 80 ℃ for 20min to completely melt the gelatin to obtain a gelatin solution;
2) Vacuumizing the obtained glue solution for three times under the vacuum degree of-0.08 MPa, degassing for 10min each time, removing bubbles in the glue solution, sieving the degassed glue solution with a 120-mesh sieve, and storing the sieved glue solution at 65 ℃ for later use;
3) Pressing the glue solution obtained in the step 2) into a glue sheet with the thickness of 0.8mm through a glue spreading wheel, performing injection molding on the glue sheet to obtain a soft capsule shell, sealing the lower end of the soft capsule shell, quickly adding the propolis solution (capsule content), and quickly sealing the opening of the soft capsule shell to form a sealed soft capsule pill;
4) Shaping the soft capsules by a roller cage type dryer matched with the soft capsule machine, wherein the shaping and drying temperature is 18 ℃, the shaping and drying time is 2 hours, and the shaped and dried soft capsules are uniformly placed in a drying disc and temporarily stored in a pre-drying room;
5) Washing the shaped and dried soft capsules with 95% edible alcohol by mass fraction, and drying the soft capsules after the washing is finished, wherein the drying temperature is 30 ℃, the relative humidity is 25%, and the drying time is 50h, so as to obtain the soft capsules.
Comparative example 1
The present comparative example provides a soft capsule comprising a capsule shell comprising the following raw materials: 100g of purified water, 40g of glycerol and 100g of gelatin;
the preparation method of the soft capsule comprises the following steps:
1) Sequentially putting purified water, glycerol and gelatin into a gelatin melting tank, stirring, mixing, heating the mixture to 70 ℃, and preserving heat at 70 ℃ for 30min to completely melt the gelatin to obtain a gelatin solution;
2) Vacuumizing the obtained glue solution for three times under the vacuum degree of-0.08 MPa, degassing for 10min each time, removing bubbles in the glue solution, sieving the degassed glue solution with a 120-mesh sieve, and storing the sieved glue solution at 60 ℃ for later use;
3) Pressing the glue solution obtained in the step 2) into a glue film with the thickness of 0.8mm by a glue spreading wheel, performing injection molding on the glue film to obtain a soft capsule shell, sealing the lower end of the soft capsule shell, rapidly adding propolis solution (capsule content), and rapidly sealing the opening of the soft capsule shell to form a closed soft capsule;
4) Shaping the soft capsules by a roller cage type dryer matched with the soft capsule machine, wherein the shaping and drying temperature is 20 ℃, the shaping and drying time is 1h, and the shaped and dried soft capsules are uniformly placed in a drying disc and temporarily stored in a pre-drying room;
5) Washing the shaped and dried soft capsules with edible alcohol with the mass fraction of 95%, and drying the soft capsules after the washing is finished, wherein the drying temperature is 30 ℃, the relative humidity is 30%, and the drying time is 40h, so as to obtain the soft capsules.
Test example 1
In order to verify the mechanical properties and oxygen transmission rate of the capsule shell structure of the soft capsule of the present invention, the 0.8mm thick films obtained in the above examples 1-6 and step 3) of the comparative example were tested after drying, wherein the oxygen transmission rate was tested according to the GB/T19789-2005 standard; mechanical properties were tested according to GB/T1040.3-2006. The test results are shown in table 1.
TABLE 1 results of mechanical Properties and oxygen Transmission Rate test of Capsule shells films
It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. This need not be, nor should it be exhaustive of all embodiments. And obvious variations or modifications derived therefrom are intended to be within the scope of the invention.
Claims (8)
1. The soft capsule shell is characterized by comprising the following raw materials: the water quality control method comprises the following steps of (1) purifying water, glycerol, inorganic salt, chitosan and gelatin, wherein the mass ratio of the purified water to the glycerol to the inorganic salt to the chitosan to the gelatin is 1: (0.4-0.6): (0.0001-0.0002): (0.01-0.02): 1;
the inorganic salt is calcium chloride and/or sodium dodecyl sulfate.
2. A process for the preparation of the soft capsule shell of claim 1, comprising the steps of:
1) Mixing purified water, glycerol, inorganic salt, chitosan and gelatin, and heating the mixture to obtain a glue solution;
2) Pressing the glue solution into a glue piece, and performing injection molding on the glue piece to obtain the soft capsule shell.
3. The process for preparing a soft capsule shell according to claim 2, wherein the heating temperature is 70-80 ℃ and the holding time at 70-80 ℃ is 20-40min.
4. The method for preparing a soft capsule shell according to claim 3, wherein the step 1) further comprises degassing and sieving the obtained gelatin solution.
5. The method for preparing the soft capsule shell according to claim 4, wherein the step 1) further comprises the step of storing the sieved gelatin solution at 55-65 ℃ for later use.
6. A soft capsule, characterized in that it consists of a capsule shell according to claim 1 or a capsule shell prepared by a process according to any one of claims 2 to 5 and the capsule contents.
7. A process for the preparation of the soft capsules according to claim 6, comprising the steps of:
1) Mixing purified water, glycerol, inorganic salt, chitosan and gelatin, and heating the mixture to obtain a glue solution;
2) Pressing the glue solution into a glue piece, injection-molding the glue piece, adding the capsule content, and sealing the opening to obtain a capsule;
3) And (4) shaping and drying the soft capsules, washing and drying again to obtain the soft capsules.
8. The method for preparing the soft capsule according to claim 7, wherein the setting and drying temperature in the step 3) is 18 ℃ to 20 ℃, and the setting and drying time is 1 to 2 hours;
the solvent used in the washing step is edible alcohol;
the secondary drying temperature is 20-30 ℃, the relative humidity is 10-50%, and the drying time is 40-50 h.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001178376A (en) * | 1999-12-24 | 2001-07-03 | Sankyo:Kk | Soft capsule and method of producing the same |
| CN102895926A (en) * | 2012-11-08 | 2013-01-30 | 云南烟草科学研究院 | Moistureproof treatment method for soft capsules |
| WO2021016305A1 (en) * | 2019-07-23 | 2021-01-28 | R.P. Scherer Technologies, Llc | Softshell capsule formulations, and methods of preparation and use thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101185760A (en) * | 2006-11-15 | 2008-05-28 | 郭燕峰 | Capsule material formula of soft capsule |
| ITUB20156821A1 (en) * | 2015-12-09 | 2017-06-09 | Altergon Sa | JELLY CAPSULES SPRINGS RELEASE INDEPENDENT pH |
| CN105434397B (en) * | 2015-12-31 | 2018-06-29 | 厦门金达威生物科技有限公司 | A kind of autonomic soft capsules rubber composition and preparation method thereof |
| CN111759821B (en) * | 2020-08-24 | 2021-10-08 | 四川奥邦投资有限公司 | Dutasteride soft capsule pharmaceutical composition |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2001178376A (en) * | 1999-12-24 | 2001-07-03 | Sankyo:Kk | Soft capsule and method of producing the same |
| CN102895926A (en) * | 2012-11-08 | 2013-01-30 | 云南烟草科学研究院 | Moistureproof treatment method for soft capsules |
| WO2021016305A1 (en) * | 2019-07-23 | 2021-01-28 | R.P. Scherer Technologies, Llc | Softshell capsule formulations, and methods of preparation and use thereof |
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