CN113041230B - Capsule shell of soft capsule and soft capsule prepared from capsule shell - Google Patents
Capsule shell of soft capsule and soft capsule prepared from capsule shell Download PDFInfo
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- D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
- D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
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- D01F8/00—Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof
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Abstract
The invention discloses a capsule shell of a soft capsule and the soft capsule prepared by the capsule shell, and relates to the technical field of soft capsules. The capsule shell of the soft capsule and the soft capsule prepared by the capsule shell comprise the following raw materials: the capsule comprises gelatin, glycerol, proteoglycan, composite collagen fibers, brown iron oxide and purified water, and specifically, the capsule shell comprises the following raw materials in parts by weight: 50-60 parts of gelatin, 15-25 parts of glycerol, 10-15 parts of proteoglycan, 10-15 parts of composite collagen fiber, 0.1-0.5 part of brown ferric oxide and 45-55 parts of purified water. The invention discloses a capsule shell of a soft capsule, which introduces proteoglycan and composite collagen fiber into raw materials for the first time, reduces the influence of gelatin aging on the disintegration rate, and has good mechanical strength and toughness.
Description
Technical Field
The invention relates to the technical field of soft capsules, in particular to a capsule shell of a soft capsule and the soft capsule prepared by the capsule shell.
Background
The soft capsule is prepared by processing liquid medicine or liquid solid medicine and sealing in soft capsule material. In the prior art, the capsule shell of the soft capsule is usually prepared by using gelatin, glycerin or other appropriate pharmaceutical excipients singly or in a mixing way, and the gelatin has biodegradability, good biocompatibility and film forming property, so that the ratio of the gelatin in the field of soft capsule manufacturing reaches 90%.
Although gelatin has many advantages, soft capsule products in the market at present generally have the problems of disintegration and dissolution delay stability in the long-term storage process, and the soft capsule is disintegrated and dissolution delay can cause the problems of release and absorption delay of the medicine, so that the bioavailability and the efficacy of the medicine are influenced.
Disclosure of Invention
Aiming at the problems, the invention aims to disclose a capsule shell of a soft capsule, which introduces proteoglycan and composite collagen fiber into raw materials for the first time, reduces the influence of gelatin aging on the disintegration rate, and has good mechanical strength and toughness.
Specifically, the capsule shell of the soft capsule comprises the following raw materials: gelatin, glycerol, proteoglycan, composite collagen fiber, brown iron oxide and purified water.
Further, the capsule shell comprises the following raw materials in parts by weight: 50-60 parts of gelatin, 15-25 parts of glycerol, 10-15 parts of proteoglycan, 10-15 parts of composite collagen fiber, 0.1-0.5 part of brown ferric oxide and 45-55 parts of purified water.
Further, the capsule shell comprises the following raw materials in parts by weight: 56 parts of gelatin, 23 parts of glycerol, 12 parts of proteoglycan, 12 parts of composite collagen fiber, 0.3 part of brown iron oxide and 50 parts of purified water.
Further, the composite collagen fiber is a nano short fiber obtained by wet spinning by using collagen, diterpene orthoester compounds and chitosan as raw materials.
According to the soft capsule shell, the proteoglycan and the composite collagen fiber are added into the raw materials for the first time, and can replace part of gelatin, so that the using amount of the gelatin is reduced, the influence of self-crosslinking of the gelatin on capsule disintegration is reduced, the proteoglycan and the composite collagen fiber can form a network structure through hydrogen bond connection, the composite collagen fiber can also form a network structure by self, and the prepared capsule shell has high mechanical strength and toughness due to the multi-level structure of intermolecular interaction, so that the requirements of the strength and the toughness of the capsule shell are still met even if the using amount of the gelatin is reduced; secondly, diterpene orthoester compounds are added into the composite collagen fiber, namely, orthoester groups are introduced into the composite collagen fiber, so that on one hand, the composite collagen fiber has acid sensitivity, and in the process of taking, the orthoester in the composite collagen fiber is rapidly decomposed under the acid environment of gastric juice, so that the disintegration of a capsule shell is accelerated, the content can be rapidly dissolved out, and on the other hand, the composite collagen fiber can react with aldehyde groups and imino groups in gelatin, so that the aging of the gelatin is inhibited to a certain degree.
Further, the preparation method of the composite collagen fiber comprises the following steps: respectively dissolving collagen and chitosan in 3wt% of glacial acetic acid, stirring until the collagen and the chitosan are completely dissolved to obtain a collagen solution with the mass fraction of 2-3% and a chitosan solution with the mass fraction of 1-2%, centrifugally defoaming, uniformly stirring and mixing the collagen solution and the chitosan solution, adding diterpene orthoester compounds, keeping the temperature at 1-3 ℃, stirring until the collagen solution and the chitosan solution are completely dissolved, centrifugally defoaming to obtain a spinning solution, spinning the spinning solution by a wet spinning process, coagulating in a coagulating bath, taking out, washing with deionized water, and naturally drying to obtain the composite collagen fiber.
Further, the diameter of the composite collagen fiber is 500-700 nm.
In addition, the invention also discloses a soft capsule which comprises a capsule shell and contents sealed in the capsule shell, wherein the capsule shell is the capsule shell, and a preparation method of the soft capsule comprises the following steps:
a1: heating purified water to 45-50 ℃, adding glycerol and brown ferric oxide, stirring and mixing uniformly, adding composite collagen fibers and gelatin, stirring and mixing uniformly, soaking until the materials are fully expanded, heating to 70-80 ℃, preserving heat for 1-2 hours, adding proteoglycan, stirring and mixing uniformly, continuously preserving heat for 1-2 hours, preserving heat and vacuumizing, keeping for 30min to remove bubbles, preserving heat at 60 ℃, standing to remove bubbles in a glue solution, and obtaining a capsule shell glue solution;
a2: preparing the content to be packaged to obtain content material liquid, and placing the content material liquid and capsule shell glue liquid on a pill press to press into pills;
a3: feeding the pressed pellets into a rolling cage, performing primary drying and shaping along with the rotation of the cage, and treating for 2-3h under the conditions that the rotation speed is 8-12r/min and the relative humidity is less than 35% to obtain a crude capsule product;
a4: cleaning the crude capsule with 95% ethanol, drying in a drying chamber for 24-30 hr until the soft capsule has no sticky damp feeling, selecting, removing unqualified pill, and bottling.
Further, in the step a2, the preparation method of the content material liquid comprises the following steps: mixing soybean oil, Ganoderma spore essential oil and cortex Cinnamomi essential oil, heating to 80 deg.C, adding Cera flava, stirring for 20min until Cera flava is completely melted, cooling to 50 deg.C, adding soybean concentrated phospholipid, stirring for 20min, adding the fine powder of extract, mixing, stirring, grinding for 3 times by colloid mill, and vacuum degassing to obtain content liquid.
Further, the raw materials of the extract fine powder comprise one or more of rhodiola rosea extract, ginseng extract, astragalus extract and acanthopanax extract.
Further, in the step A2, the capsule temperature of the pelleting machine is 55-60 ℃, the spray body temperature is 35-45 ℃, the indoor temperature is 20-24 ℃, the relative humidity is less than 35%, and the content mass of each soft capsule is 0.55 g.
The invention has the beneficial effects that:
the invention discloses a capsule shell of a soft capsule, which introduces proteoglycan and composite collagen fiber into raw materials for the first time, reduces the influence of gelatin aging on the disintegration rate, and has good mechanical strength and toughness.
Detailed Description
The present invention will be described in detail below with reference to specific examples:
the capsule shell of the soft capsule comprises the following raw materials: the invention discloses a soft capsule which is prepared from gelatin, glycerol, proteoglycan, composite collagen fibers, brown iron oxide and purified water, wherein the proteoglycan and the composite collagen fibers are added into raw materials for the first time, so that the stability of the capsule shell can be ensured to a certain extent, and the influence of gelatin aging on the disintegration time of the capsule shell is reduced.
Example one
Preparation of composite collagen fiber: respectively dissolving collagen and chitosan in 3wt% of glacial acetic acid, keeping the temperature at 1-3 ℃, stirring until completely dissolving, obtaining a collagen solution with the mass fraction of 3% and a chitosan solution with the mass fraction of 2% after centrifugal deaeration, stirring and mixing the collagen solution and the chitosan solution uniformly according to the volume ratio of 7:3, adding diterpene orthoester compounds with the same chitosan mass, keeping the temperature at 1-3 ℃, stirring until completely dissolving, obtaining spinning solution through centrifugal deaeration, stirring and mixing acetone and deionized water uniformly according to the volume ratio of 4:6, adding ammonia water to adjust the pH value to 8 to obtain a coagulating bath, spinning the spinning solution by a wet spinning technology, coagulating in a coagulating bath, taking out, washing with deionized water, and naturally drying to obtain the composite collagen fiber with the diameter of 500-700 nm.
Preparation of soft capsules
A1: shearing the prepared composite collagen fiber into a length of 0.01-0.02mm, drying for later use, heating 50 parts by weight of purified water to 50 ℃, adding 23 parts by weight of glycerol and 0.3 part by weight of iron oxide brown, stirring and mixing uniformly, adding 12 parts by weight of composite collagen fiber and 56 parts by weight of gelatin, stirring and mixing uniformly, soaking until the mixture is fully expanded, heating to 80 ℃, keeping the temperature for 2 hours, adding 12 parts by weight of proteoglycan, selecting grifolan according to the embodiment, stirring and mixing uniformly, keeping the temperature for 2 hours continuously, keeping the temperature and vacuumizing to-0.06 MPa, keeping the temperature for 30 minutes to remove bubbles, keeping the temperature at 60 ℃, standing to remove bubbles in a glue solution, and obtaining a capsule shell glue solution;
a2: uniformly mixing soybean oil, ganoderma lucidum spore essential oil and cinnamon essential oil with equal mass, heating to 80 ℃, adding beeswax which is 1/4 times of the mass of soybean oil, stirring for 20min until the beeswax is completely melted, cooling to 50 ℃, adding soybean concentrated phospholipid with equal mass of the beeswax, stirring for 20min, uniformly mixing, adding extract fine powder which is 1/2 times of the mass of the soybean oil, uniformly mixing and stirring, grinding for 3 times by a colloid mill until the mixture is uniformly ground, and degassing in vacuum under the condition of-0.08 Mpa to obtain content liquid, wherein the extract fine powder is prepared by mixing rhodiola rosea extract, a ginseng extract, an astragalus extract and an acanthopanax root extract according to the mass ratio of 1:1:1, placing the content liquid and capsule shell glue solution on a pelleting machine, pelleting under the conditions that the capsule box temperature is 60 ℃, the spray body temperature is 35 ℃, the indoor temperature is 24 ℃, and the relative humidity is less than 35%, the content mass of each soft capsule is 0.55 g;
a3: feeding the pressed pellets into a rolling cage, performing primary drying and shaping along with the rotation of the cage, and treating for 2h under the conditions that the rotating speed is 10r/min, the indoor temperature is 24 ℃ and the relative humidity is less than 35% to cool the capsules and volatilize surface moisture, so that the capsules are shaped and primarily dried to obtain a crude capsule product;
a4: cleaning the crude capsule with 95% ethanol, removing oil stain on the surface of the capsule, drying in a drying chamber for 24-30 hr until the surface of the soft capsule has no damp feeling, selecting in a pill selecting chamber with indoor temperature of 20 deg.C and relative humidity less than 40%, removing large pills, removing unqualified pills such as abnormal-shaped pills, obvious screen-printed pills, leaked pills, shriveled pills, thin-walled pills, and bubble pills, and bottling.
Example two
The preparation of the composite collagen fiber was the same as in example one.
Preparation of soft capsules
A1: shearing the prepared composite collagen fiber into a length of 0.01-0.02mm, taking 55 parts by weight of purified water, heating to 45 ℃, adding 25 parts by weight of glycerol and 0.1 part by weight of brown iron oxide, stirring and mixing uniformly, adding 10 parts by weight of composite collagen fiber and 60 parts by weight of gelatin, stirring and mixing uniformly, soaking until the mixture is fully expanded, heating to 75 ℃, keeping the temperature for 1 hour, adding 10 parts by weight of proteoglycan, selecting heparin sulfate proteoglycan for the proteoglycan of the embodiment, stirring and mixing uniformly, keeping the temperature for 2 hours continuously, keeping the temperature and vacuumizing to-0.07 Mpa, keeping the temperature for 30min to remove bubbles, keeping the temperature at 60 ℃, and standing to remove bubbles in the glue solution to obtain a capsule shell glue solution;
a2: uniformly mixing soybean oil, ganoderma lucidum spore essential oil and cinnamon essential oil with equal mass, heating to 80 ℃, adding beeswax which is 1/3 times of soybean oil in mass, stirring for 20min until the beeswax is completely melted, cooling to 50 ℃, adding soybean concentrated phospholipid with equal mass of beeswax, stirring for 20min, uniformly mixing, adding extract fine powder which is 1/2 times of soybean oil in mass, uniformly mixing and stirring, grinding for 3 times by using a colloid mill until the beeswax is uniformly ground, and degassing in vacuum under the condition of-0.07 Mpa to obtain content liquid, wherein the extract fine powder is prepared from rhodiola extract, the content liquid and capsule shell glue solution are placed on a pill press, and the content of each soft capsule is 0.55g by pressing at the capsule temperature of 55 ℃, the spray body temperature of 45 ℃, the indoor temperature of 20 ℃ and the relative humidity of less than 35%;
a3: feeding the pressed pellets into a rolling cage, performing primary drying and shaping along with the rotation of the cage, and treating for 3h under the conditions that the rotating speed is 8r/min, the indoor temperature is 20 ℃ and the relative humidity is less than 35% to cool the capsules and volatilize surface moisture, so that the capsules are shaped and primarily dried to obtain a crude capsule product;
a4: cleaning the crude capsule with 95% ethanol, removing oil stain on the surface of the capsule, drying in a drying chamber for 24-30h until the surface of the soft capsule has no damp feeling, selecting in a pill selection chamber with indoor temperature of 22 deg.C and relative humidity less than 40%, removing large pills, removing unqualified pills such as abnormal pills, obvious screen printed pills, leaked pills, shriveled pills, thin-walled pills, and bubble pills, and bottling.
EXAMPLE III
The preparation of the composite collagen fiber is the same as in example one.
Preparation of soft capsules
A1: shearing the prepared composite collagen fiber into a length of 0.01-0.02mm, taking 45 parts by weight of purified water, heating to 50 ℃, adding 15 parts by weight of glycerol and 0.5 part by weight of ferric oxide, stirring and mixing uniformly, adding 15 parts by weight of composite collagen fiber and 50 parts by weight of gelatin, stirring and mixing uniformly, soaking until the mixture is fully expanded, heating to 70 ℃, keeping the temperature for 2 hours, adding 15 parts by weight of proteoglycan, selecting the proteoglycan of the embodiment, stirring and mixing uniformly, keeping the temperature for 1 hour continuously, keeping the temperature and vacuumizing to-0.08 MPa, keeping the temperature for 30 minutes to remove air bubbles, keeping the temperature at 60 ℃, and standing to remove the air bubbles in the glue solution to obtain a capsule shell glue solution;
a2: uniformly mixing soybean oil, ganoderma lucidum spore essential oil and cinnamon essential oil with equal mass, heating to 80 ℃, adding beeswax which is 1/3 times of the mass of soybean oil, stirring for 20min until the beeswax is completely melted, cooling to 50 ℃, adding soybean concentrated phospholipid with equal mass of the beeswax, stirring for 20min, uniformly mixing, adding extract fine powder which is 1/2 times of the mass of the soybean oil, uniformly mixing and stirring, grinding for 3 times by a colloid mill until the mixture is uniformly ground, degassing in vacuum under the condition of-0.06 MPa to obtain content material liquid, wherein the extract fine powder is prepared by mixing rhodiola rosea extract, ginseng extract and astragalus extract according to the mass ratio of 1:2:1, placing the content material liquid and capsule skin on a pill press, pressing and preparing pills under the conditions that the temperature of a capsule box is 55 ℃, the spray temperature is 40 ℃, the indoor temperature is 22 ℃, and the relative humidity is less than 35%, the content mass of each soft capsule is 0.55 g;
a3: feeding the pressed pellets into a rolling cage, performing primary drying and shaping along with the rotation of the cage, and treating for 3h under the conditions that the rotating speed is 12r/min, the indoor temperature is 24 ℃ and the relative humidity is less than 35% to cool the capsules and volatilize surface moisture, so that the capsules are shaped and primarily dried to obtain a crude capsule product;
a4: cleaning the crude capsule with 95% ethanol, removing oil stain on the surface of the capsule, drying in a drying chamber for 24-30h until the surface of the soft capsule has no damp feeling, selecting in a pill selection chamber with indoor temperature of 24 deg.C and relative humidity less than 40%, removing large pills, removing unqualified pills such as abnormal pills, obvious screen printed pills, leaked pills, shriveled pills, thin-walled pills, and bubble pills, and bottling.
Comparative example 1
The difference between the comparative example and the first example is that proteoglycan is not added to the raw material of the capsule shell in this example.
Comparative example No. two
The difference between the comparative example and the first example is that no composite collagen fiber is added to the raw material of the capsule shell in the present example.
Comparative example No. three
Compared with the first embodiment, the difference between the present comparative example and the first embodiment is that the present embodiment adopts the existing capsule shell formula to prepare the capsule shell glue solution, specifically:
respectively weighing gelatin, glycerol, purified water and brown iron oxide according to the mass ratio of 10:5:9:0.1, heating the purified water to 50 ℃, adding the glycerol and the brown iron oxide, uniformly mixing, adding the materials into the materials, soaking the materials until the materials are fully swelled, heating the materials to 80 ℃, keeping the temperature for 2 hours, completely melting the gelatin solution, keeping the temperature and vacuumizing the temperature to-0.06 MPa, keeping the temperature for 30 minutes to remove bubbles, keeping the temperature at 60 ℃, and standing the materials to remove the bubbles in the gelatin solution to obtain the gelatin solution of the capsule shell.
The soft capsules prepared in the first to third embodiments and the first to third comparative examples are subjected to disintegration time detection according to a method in the appendix of Chinese pharmacopoeia, wherein the initial disintegration time of the soft capsule is detected in an artificial gastric juice environment, the soft capsule is placed in an intelligent disintegration tester and subjected to accelerated aging under the conditions of 40 ℃ and 75% relative humidity, a part of samples are taken out at 30d, 60d, 90d and 120d respectively for disintegration time detection and stability detection, and finally, the measured results are shown in tables 1 and 2:
TABLE 1 disintegration time test results
| Initial disintegration time | Disintegration time of 30d | 60d disintegration time | 90d disintegration time | 120d disintegration time | |
| Example one | 7min | 7.5min | 9min | 10.2min | 14min |
| Example two | 7min | 7.7min | 9.3min | 10min | 13.8min |
| EXAMPLE III | 7min | 7.5min | 9.1min | 10min | 14.2min |
| Comparative example 1 | 9min | 13min | 18min | 29min | 38min |
| Comparative example No. two | 6min | 7min | 9min | 6min | 4min |
| Comparative example No. three | 10min | 15min | 21min | 36min | 44min |
TABLE 2 stability test results
It can be seen from tables 1 and 2 that the capsule shell prepared by the formulation of the present invention can significantly improve the problem of prolonged disintegration time caused by aging of the capsule shell, and the prepared soft capsule has good stability, while the data of the first example and the second comparative examples show that the interaction between proteoglycan and composite collagen fiber added in the present invention can lead to insufficient stability of the capsule shell if the composite collagen fiber is absent, the capsule shell is easily damaged along with the increase of storage time, and the improvement effect on the problem of prolonged disintegration time is greatly reduced if the proteoglycan is absent.
Although the present invention has been described in detail with reference to the preferred embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the present invention, which is defined by the claims appended hereto. The techniques, shapes, and configurations not described in detail in the present invention are all known techniques.
Claims (8)
1. The capsule shell of the soft capsule is characterized by comprising the following raw materials: the composite collagen fiber is a nano short fiber obtained by wet spinning by using collagen, diterpene orthoester compounds and chitosan as raw materials.
2. The capsule shell of the soft capsule according to claim 1, wherein the capsule shell comprises the following raw materials in parts by weight: 50-60 parts of gelatin, 15-25 parts of glycerol, 10-15 parts of proteoglycan, 10-15 parts of composite collagen fiber, 0.1-0.5 part of brown ferric oxide and 45-55 parts of purified water.
3. The capsule shell of the soft capsule according to claim 1, wherein the capsule shell comprises the following raw materials in parts by weight: 56 parts of gelatin, 23 parts of glycerol, 12 parts of proteoglycan, 12 parts of composite collagen fiber, 0.3 part of brown iron oxide and 50 parts of purified water.
4. The capsule shell of the soft capsule according to claim 1, wherein the composite collagen fiber is prepared by the following steps: respectively dissolving collagen and chitosan in 3wt% of glacial acetic acid, stirring until completely dissolving, performing centrifugal deaeration to obtain a collagen solution with the mass fraction of 3% and a chitosan solution with the mass fraction of 2%, uniformly stirring and mixing the collagen solution and the chitosan solution, adding diterpene ortho-ester compounds, keeping the temperature at 1-3 ℃, stirring until completely dissolving, performing centrifugal deaeration to obtain a spinning solution, spinning the spinning solution by a wet spinning process, condensing in a coagulation bath, taking out, washing with deionized water, and naturally drying to obtain the composite collagen fiber.
5. The capsule shell of a soft capsule according to claim 4, wherein the diameter of the composite collagen fiber is 500-700 nm.
6. A soft capsule comprising a capsule shell according to any one of claims 1 to 5 and a content enclosed in the capsule shell.
7. The process for the preparation of the soft capsules according to claim 6, characterized in that it comprises the following steps:
a1: heating purified water to 45-50 ℃, adding glycerol and iron oxide brown, stirring and mixing uniformly, adding composite collagen fiber and gelatin, stirring and mixing uniformly, soaking until the materials are fully expanded, heating to 70-80 ℃, preserving heat for 1-2h, adding proteoglycan, stirring and mixing uniformly, continuously preserving heat for 1-2h, preserving heat and vacuumizing, keeping for 30min to remove bubbles, preserving heat at 60 ℃, standing to remove bubbles in a glue solution, and obtaining a capsule shell glue solution;
a2: preparing the content to be packaged to obtain content material liquid, and placing the content material liquid and capsule shell glue liquid on a pill press to press into pills;
a3: feeding the pressed pellets into a rolling cage, performing primary drying and shaping along with the rotation of the cage, and treating for 2-3h under the conditions that the rotation speed is 8-12r/min and the relative humidity is less than 35% to obtain a crude capsule product;
a4: cleaning the crude capsule with 95% ethanol, drying in a drying chamber for 24-30 hr until the soft capsule has no sticky damp feeling, selecting, removing unqualified pill, and bottling.
8. The method for preparing soft capsules according to claim 7, wherein in the step A2, the method for preparing the content material liquid is as follows: mixing soybean oil, Ganoderma spore essential oil and cortex Cinnamomi essential oil, heating to 80 deg.C, adding Cera flava, stirring for 20min until Cera flava is completely melted, cooling to 50 deg.C, adding soybean concentrated phospholipid, stirring for 20min, adding extract fine powder, mixing, stirring, grinding for 3 times by colloid mill, vacuum degassing to obtain content liquid, wherein the extract fine powder is prepared from one or more of radix Rhodiolae extract, Ginseng radix extract, radix astragali extract and radix Acanthopanacis Senticosi extract.
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