CN113244186A - Enteric gelatin hollow capsule with new formula and preparation method thereof - Google Patents
Enteric gelatin hollow capsule with new formula and preparation method thereof Download PDFInfo
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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
- A61K9/4825—Proteins, e.g. gelatin
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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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- 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
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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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
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Abstract
The invention provides a novel enteric gelatin hollow capsule with a new formula, which is a novel enteric gelatin hollow capsule which takes zinc oxide, magnesium oxide, calcium salt and barium salt as opacifiers to replace titanium dioxide used as opacifiers in the prior art and can be applied to medicines and health care products. The hollow capsule comprises the following components in percentage by weight: gelatin layer: 75.5 to 82.5 percent of gelatin for capsules, 0.1 to 1.0 percent of polyethylene glycol, 0 to 1.0 percent of pigment and 0.04 to 4.0 percent of opacifier; coating layer: polyacrylic resin 0.1-8.0 wt%, polyethylene o-phthalic diacetate 0.1-8.0 wt%, and glyceryl triacetate 0.1-4.0 wt%; the balance of water. The opacifier used by the capsule can achieve the light-shielding effect and ensure the stability of the light-sensitive medicine, and multiple tests prove that the uniformity of the capsule produced by adopting the invention is improved.
Description
Technical Field
The invention belongs to the technical field of pharmaceutic adjuvants, and particularly relates to an enteric gelatin hollow capsule taking zinc oxide, magnesium oxide, calcium salt and barium salt as opacifiers and a preparation method thereof.
Background
The hollow capsule is a common preparation formulation in medicines and health care products, and can achieve the effect of keeping out of the sun and ensure the stability of the photosensitive medicine by adding the opacifier. At present, titanium dioxide is adopted as an opacifier for capsules, and in some medicines and health products, the requirement of not using titanium dioxide as the opacifier is provided for avoiding related medicine reaction and for safety reasons of some foreign customers, so that a new formula of enteric gelatin hollow capsules which can be used for medicines and health products as the opacifier instead of titanium dioxide is urgently needed to meet the market demand.
Disclosure of Invention
The invention provides an enteric gelatin hollow capsule with a new formula and a preparation method thereof, which can solve the problem that the enteric gelatin hollow capsule with the new formula which replaces titanium dioxide as an opacifier and can be used for medicines and health care products is lacked in the prior art. The invention prepares the enteric gelatin hollow capsule which takes zinc oxide, magnesium oxide, calcium salt and barium salt as opacifier to meet the market demand.
In order to solve the technical problems, the invention adopts the technical scheme that the enteric gelatin hollow capsule taking zinc oxide, magnesium oxide, calcium salt and barium salt as opacifiers is provided, the hollow capsule is low in cost, good in uniformity and small in capsule weight difference, and can meet the use requirements of enteric gelatin hollow capsules in Chinese pharmacopoeia.
The enteric gelatin hollow capsule with the new formula comprises the following components in percentage by weight: gelatin layer: 75.5 to 82.5 percent of gelatin for capsules, 0 to 1.0 percent of polyethylene glycol, 0 to 1.0 percent of pigment and 0.04 to 4.0 percent of opacifier; coating layer: polyacrylic resin 0.1-8.0 wt%, polyethylene o-phthalic diacetate 0.1-8.0 wt%, and glyceryl triacetate 0.1-4.0 wt%; the balance of water.
Wherein the opacifier is one or more of zinc oxide, magnesium oxide, calcium salt and barium salt.
Wherein the calcium salt is one or more of calcium carbonate, calcium sulfate, calcium gluconate, calcium chloride, calcium hydrogen phosphate and calcium lactate.
Wherein the barium salt is one or more of barium carbonate, barium sulfate, barium hydrogen phosphate and barium phosphate.
Wherein the particle size range of the opacifier is: 0.1-30 μm.
Wherein the pigment comprises synthetic pigment, natural pigment, and ferric oxide pigment.
The preparation method of the enteric gelatin hollow capsule with the new formula comprises the following specific preparation steps:
preparing an opacifier solution: adding hot purified water with the temperature of more than 85 ℃ into a dispersion tank in advance, adding an opacifier while stirring, stirring until the opacifier is completely dissolved, preparing an opacifier solution with the weight percentage of 5.0-25.0%, starting a homogenizer at the speed of 2000 plus 6000 r/min, and continuously stirring for 1-3 hours after the opacifier is completely added to obtain the opacifier solution;
preparing a gelatin layer: pumping purified water into a sol tank in advance, heating to over 85 ℃, adding gelatin and polyethylene glycol into the sol tank according to the formula requirements for gelatin dissolution, and preparing a main gelatin solution for later use; putting the prepared glue solution into a glue barrel, weighing corresponding opacifier solution according to the formula requirements, adding the opacifier solution into the glue barrel, starting stirring, adding pigments according to the corresponding formula requirements, adjusting to the required color, adjusting to the required glue dipping viscosity by using hot purified water, and stabilizing for 2-4 hours at 50-55 ℃. Carrying out mould dipping molding on the stable glue solution to obtain a capsule cap body glue blank;
preparing a coating layer: adding absolute ethyl alcohol into a sol bucket, starting stirring, pouring equivalent polyacrylic resin and polyethylene o-phthalate into the sol bucket to prepare a sol solution with the weight percentage of the polyacrylic resin being 10-20%, uniformly stirring for 15-30 minutes, adding the formula required amount of glyceryl triacetate, and continuously stirring for 30-50 minutes. The stabilization is carried out at room temperature for 4-6 hours. After the coating liquid is stable, the mould with the gelatin layer is coated and dipped for 2 times for molding, and the novel enteric gelatin hollow capsule which does not contain titanium dioxide and meets the standard requirement can be produced by demoulding, cutting and sleeving by using a demoulding device.
All indexes of the produced novel enteric gelatin hollow capsule without titanium dioxide meet the standard requirements of enteric gelatin hollow capsule in 'Chinese pharmacopoeia' 2020 edition.
Compared with the prior art, the invention has the advantages and positive effects that: the invention provides an enteric gelatin hollow capsule which is lacked in the prior art and adopts zinc oxide, magnesium oxide, calcium salt and barium salt as opacifiers. Multiple tests prove that the uniformity of the capsule produced by the method is improved.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the embodiments described herein are merely illustrative of the present invention and are not intended to limit the present invention.
Example 1
The enteric gelatin hollow capsule with the new formula is prepared by the following steps:
(1) preparing a gelatin layer: weighing 100 parts of zinc oxide, adding into 900 parts of hot purified water, stirring while adding, stirring until the zinc oxide is completely dissolved, starting a homogenizer at the speed of 3500 rpm, and continuously stirring for 2 hours after the opacifier is completely added. Taking 1000 parts of dissolved gelatin solution, starting stirring, adding 100 parts of prepared opacifier solution, adding 5 parts of brilliant blue, 2 parts of lemon yellow and 2 parts of allura red while stirring, fully and uniformly stirring the gelatin solution, adjusting the gelatin solution to proper gelatin dipping viscosity by using hot purified water, stirring at the speed of 35r/min for 20min, continuously stabilizing the gelatin solution at 50 ℃ for 2 hours, and producing the stabilized gelatin solution by using a capsule production machine to obtain a capsule cap body blank;
(2) preparing a coating layer: adding 600 parts of absolute ethyl alcohol into a sol bucket, starting stirring, pouring 90 parts of polyacrylic resin and 90 parts of polyethylene o-phthalate into the sol bucket, uniformly stirring for 20 minutes, adding 20 parts of glyceryl triacetate, and continuously stirring for 30 minutes. Stabilization was performed at room temperature for 6 hours. After the coating liquid is stable, coating and glue dipping forming are carried out on the mould with the gelatin layer for 2 times, and demoulding, cutting and sleeving are carried out by utilizing a demoulding device to produce the novel enteric gelatin hollow capsule which does not contain titanium dioxide and meets the standard requirement;
example 2
The enteric gelatin hollow capsule with the new formula is prepared by the following steps:
(1) preparing a gelatin layer: weighing 80 parts of zinc oxide, 30 parts of calcium carbonate and 10 parts of barium sulfate, adding into 1000 parts of hot purified water, stirring while adding until the mixture is completely dissolved, starting a homogenizer at the speed of 3500 rpm, and continuously stirring for 2 hours after the opacifier is completely added. Taking 1000 parts of dissolved gelatin liquid, starting stirring, adding 90 parts of prepared opacifier solution, adding 4 parts of brilliant blue, 1 part of carmine and 2 parts of amaranth while stirring, fully and uniformly stirring the gelatin liquid, adjusting the gelatin liquid to proper gelatin dipping viscosity by using hot purified water, stirring at the speed of 35r/min for 25min, continuously stabilizing the gelatin liquid at 53 ℃ for 3 hours, and producing the stabilized gelatin liquid by using a capsule production machine to obtain a capsule cap body blank;
(2) preparing a coating layer: adding 600 parts of absolute ethyl alcohol into a sol bucket, starting stirring, pouring 90 parts of polyacrylic resin and 90 parts of polyethylene o-phthalate into the sol bucket, uniformly stirring for 20 minutes, adding 20 parts of glyceryl triacetate, and continuously stirring for 30 minutes. Stabilization was carried out at room temperature for 5 hours. After the coating liquid is stable, coating and glue dipping forming are carried out on the mould with the gelatin layer for 2 times, and demoulding, cutting and sleeving are carried out by utilizing a demoulding device to produce the novel enteric gelatin hollow capsule which does not contain titanium dioxide and meets the standard requirement;
example 3
The enteric gelatin hollow capsule with the new formula is prepared by the following steps:
(1) preparing a gelatin layer: weighing 100 parts of magnesium oxide, 30 parts of calcium carbonate and 30 parts of zinc oxide, adding into 1000 parts of hot purified water, stirring while adding until the magnesium oxide, the calcium carbonate and the zinc oxide are completely dissolved, starting a homogenizer at a speed of 3500 rpm, and continuously stirring for 2 hours after the opacifier is completely added. Taking 1000 parts of dissolved gelatin liquid, starting stirring, adding 100 parts of prepared opacifier solution, adding 6 parts of carmine, 2 parts of lemon yellow and 4 parts of erythrosine while stirring, fully and uniformly stirring the gelatin liquid, adjusting the gelatin liquid to proper gelatin dipping viscosity by using hot purified water, stirring at the speed of 35r/min for 30min, continuously stabilizing the gelatin liquid at 53 ℃ for 3 hours, and producing the stabilized gelatin liquid by using a capsule production machine to obtain a capsule cap body blank;
(2) preparing a coating layer: adding 600 parts of absolute ethyl alcohol into a sol bucket, starting stirring, pouring 90 parts of polyacrylic resin and 90 parts of polyethylene o-phthalate into the sol bucket, uniformly stirring for 20 minutes, adding 20 parts of glyceryl triacetate, and continuously stirring for 30 minutes. Stabilization was carried out at room temperature for 5 hours. After the coating liquid is stable, coating and glue dipping forming are carried out on the mould with the gelatin layer for 2 times, and demoulding, cutting and sleeving are carried out by utilizing a demoulding device to produce the novel enteric gelatin hollow capsule which does not contain titanium dioxide and meets the standard requirement;
example 4
The enteric gelatin hollow capsule with the new formula is prepared by the following steps:
(1) preparing a gelatin layer: weighing 100 parts of magnesium oxide, 20 parts of calcium gluconate and 20 parts of barium phosphate, adding into 1000 parts of hot purified water, stirring while adding until the magnesium oxide, the calcium gluconate and the barium phosphate are completely dissolved, starting a homogenizer at a speed of 3500 rpm, and continuously stirring for 2 hours after the opacifier is completely added. Taking 1000 parts of dissolved gelatin liquid, starting stirring, adding 100 parts of prepared opacifier solution, adding 7 parts of brilliant blue, 6 parts of carmine, 1 part of erythrosine and 10 parts of yellow ferric oxide while stirring, fully and uniformly stirring the gelatin liquid, adjusting the gelatin liquid to proper gelatin dipping viscosity by using hot purified water, stirring at the speed of 35r/min for 30min, continuously stabilizing the gelatin liquid at 55 ℃ for 4 hours, and producing the stabilized gelatin liquid by using a capsule production machine to obtain a capsule cap body blank;
(2) preparing a coating layer: adding 600 parts of absolute ethyl alcohol into a sol bucket, starting stirring, pouring 90 parts of polyacrylic resin and 90 parts of polyethylene o-phthalate into the sol bucket, uniformly stirring for 20 minutes, adding 20 parts of glyceryl triacetate, and continuously stirring for 30 minutes. Stabilization was carried out at room temperature for 5 hours. After the coating liquid is stable, coating and glue dipping forming are carried out on the mould with the gelatin layer for 2 times, and demoulding, cutting and sleeving are carried out by utilizing a demoulding device to produce the novel enteric gelatin hollow capsule which does not contain titanium dioxide and meets the standard requirement;
example 5
The enteric gelatin hollow capsule with the new formula is prepared by the following steps:
(1) preparing a gelatin layer: weighing 90 parts of magnesium oxide, 80 parts of zinc oxide and 10 parts of calcium sulfate, adding into 1000 parts of hot purified water, stirring while adding until the magnesium oxide, the zinc oxide and the calcium sulfate are completely dissolved, starting a homogenizer at a speed of 3500 rpm, and continuously stirring for 2 hours after the opacifier is completely added. Taking 1000 parts of dissolved gelatin liquid, starting stirring, adding 100 parts of prepared opacifier solution, adding 5 parts of lemon yellow, 1 part of brilliant blue, 1 part of erythrosine and 3 parts of carmine while stirring, fully and uniformly stirring the gelatin liquid, adjusting the gelatin liquid to proper gelatin dipping viscosity by using hot purified water, stirring at the speed of 35r/min for 30min, continuously stabilizing the gelatin liquid at 55 ℃ for 2 hours, and producing the stabilized gelatin liquid by using a capsule production machine to obtain a capsule cap body blank;
(2) preparing a coating layer: adding 600 parts of absolute ethyl alcohol into a sol bucket, starting stirring, pouring 90 parts of polyacrylic resin and 90 parts of polyethylene o-phthalate into the sol bucket, uniformly stirring for 20 minutes, adding 20 parts of glyceryl triacetate, and continuously stirring for 30 minutes. Stabilization was carried out at room temperature for 5 hours. After the coating liquid is stable, coating and glue dipping forming are carried out on the mould with the gelatin layer for 2 times, and demoulding, cutting and sleeving are carried out by utilizing a demoulding device to produce the novel enteric gelatin hollow capsule which does not contain titanium dioxide and meets the standard requirement;
the enteric gelatin hollow capsules prepared in the examples 1 to 5 are subjected to performance test according to 2020 version Chinese pharmacopoeia, the obtained data (shown in the following table) meet the use requirements specified by the Chinese pharmacopoeia, compared with the prior art, the enteric gelatin hollow capsule with the new formula and without titanium dioxide as an opacifier is developed, and the capsule uniformity is proved to be good through tests.
Capsule uniformity and capsule on-machine rate comparison:
| detecting items | Contrast capsule | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 |
| Upper probability (%) | 98.9％ | 99.1％ | 99.0％ | 99.6％ | 99.9％ | 99.2％ |
| Capsule uniformity (mm) | ≤0.025 | ≤0.021 | ≤0.020 | ≤0.019 | ≤0.018 | ≤0.022 |
The invention provides a novel enteric gelatin hollow capsule capable of replacing titanium dioxide as an opacifier, the core content of the technology is to solve the problem that only titanium dioxide can be relied on as the opacifier in the prior art, and meanwhile, the hollow capsule developed by the invention is improved uniformly through comparative research. The improvement of uniformity can improve the filling efficiency of the empty capsules in the pharmaceutical industry (data as above).
The polyethylene glycol used in the patent can improve the hardness of the capsule; polyacrylic resin and polyethylene phthalate are main film forming materials of the coating film; the glyceryl triacetate is a plasticizer which can reduce the friability of the capsule; the used pigment can meet the color requirements of different customers on the capsule shells.
Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: it is to be understood that modifications may be made to the above-described embodiments, or some features may be replaced by equivalents, and any such modifications or alterations may be made without departing from the spirit and scope of the present invention.
Claims (7)
1. The enteric gelatin hollow capsule with the new formula is characterized in that: the hollow capsule comprises the following components in percentage by weight:
gelatin layer: 75.5 to 82.5 percent of gelatin for capsules,
0 to 1.0 percent of polyethylene glycol,
0 to 1.0 percent of pigment,
0.04 to 4.0 percent of opacifier;
coating layer: 0.1 to 8.0 percent of polyacrylic resin,
0.1 to 8.0 percent of polyethylene o-phthalic acetate,
0.1-4.0% of glyceryl triacetate;
the balance of water.
2. The enteric gelatin empty capsule with new formula as claimed in claim 1, wherein: the opacifier is one or more of zinc oxide, magnesium oxide, calcium salt and barium salt.
3. The enteric gelatin empty capsule with new formula as claimed in claim 2, wherein: the calcium salt is one or more of calcium carbonate, calcium sulfate, calcium gluconate, calcium chloride, calcium hydrogen phosphate and calcium lactate.
4. The enteric gelatin empty capsule with new formula as claimed in claim 2, wherein: the barium salt is one or more of barium carbonate, barium sulfate, barium hydrogen phosphate and barium phosphate.
5. The enteric gelatin empty capsule with new formula as claimed in claim 2, wherein: wherein the particle size range of the opacifier is: 0.1-30 μm.
6. The enteric gelatin empty capsule with new formula as claimed in claim 1, wherein: wherein the pigment comprises synthetic pigment, natural pigment, and ferric oxide pigment.
7. The preparation method of the enteric gelatin hollow capsule with the new formula as claimed in claim 1 is characterized by comprising the following specific preparation steps:
(1) preparing an opacifier solution: adding hot purified water with the temperature of more than 85 ℃ into a dispersion tank in advance, adding an opacifier while stirring, stirring until the opacifier is completely dissolved, preparing an opacifier solution with the weight percentage of 5.0-25.0%, starting a homogenizer at the speed of 2000 plus 6000 r/min, and continuously stirring for 1-3 hours after the opacifier is completely added to obtain the opacifier solution;
(2) preparing a gelatin layer: pumping purified water into a sol tank in advance, heating to over 85 ℃, adding gelatin and polyethylene glycol into the sol tank according to the formula requirements for gelatin dissolution, and preparing a main gelatin solution for later use; putting the prepared glue solution into a glue barrel, weighing corresponding opacifier solution according to the formula requirements, adding the opacifier solution into the glue barrel, starting stirring, adding pigments according to the corresponding formula requirements, adjusting to the required color, adjusting to the required glue dipping viscosity by using hot purified water, and stabilizing for 2-4 hours at 50-55 ℃; carrying out mould dipping molding on the stable glue solution to obtain a capsule cap body glue blank;
(3) preparing a coating layer: adding absolute ethyl alcohol into a sol bucket, starting stirring, pouring equivalent polyacrylic resin and polyethylene o-phthalate into the sol bucket to prepare a sol solution with the weight percentage of the polyacrylic resin being 10-20%, uniformly stirring for 15-30 minutes, adding triacetin according to the formula requirement, continuously stirring for 30-50 minutes, and stabilizing for 4-6 hours at room temperature; after the coating liquid is stable, the mould with the gelatin layer is coated and dipped for 2 times for molding, and the novel enteric gelatin hollow capsule which does not contain titanium dioxide and meets the standard requirement can be produced by demoulding, cutting and sleeving by using a demoulding device.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN202110524533.XA CN113244186A (en) | 2021-05-13 | 2021-05-13 | Enteric gelatin hollow capsule with new formula and preparation method thereof |
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| CN202110524533.XA CN113244186A (en) | 2021-05-13 | 2021-05-13 | Enteric gelatin hollow capsule with new formula and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4309649A1 (en) * | 2022-07-19 | 2024-01-24 | Qualicaps Europe, S.A. | A titanium dioxide free hard capsule shell |
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2021
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4309649A1 (en) * | 2022-07-19 | 2024-01-24 | Qualicaps Europe, S.A. | A titanium dioxide free hard capsule shell |
| WO2024017886A1 (en) * | 2022-07-19 | 2024-01-25 | Qualicaps Europe, S.A. | A titanium dioxide free hard capsule shell |
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Application publication date: 20210813 |