CN113244187A - Enteric hypromellose empty capsule with new formula and preparation method thereof - Google Patents
Enteric hypromellose empty capsule with new formula and preparation method thereof Download PDFInfo
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- CN113244187A CN113244187A CN202110524548.6A CN202110524548A CN113244187A CN 113244187 A CN113244187 A CN 113244187A CN 202110524548 A CN202110524548 A CN 202110524548A CN 113244187 A CN113244187 A CN 113244187A
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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
- 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
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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
- A61K47/14—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
- 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
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
Abstract
The invention provides a novel enteric hydroxypropyl methylcellulose hollow capsule with a new formula, which is a novel enteric hydroxypropyl methylcellulose hollow capsule which takes zinc oxide, magnesium oxide, calcium salt and barium salt as opacifiers to replace titanium dioxide 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: inner layer: 5.0-25.0% of hydroxypropyl methylcellulose, 0.1-5.0% of gellan gum, 800.1-1.0% of tween, 0-1.0% of pigment, 0.05-9.0% of opacifier and a 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 sunscreen agent used in the capsule can achieve light-shielding effect and ensure the stability of the light-sensitive medicine. Multiple tests prove that the uniformity of the capsules produced by the method is improved, and the market demand is met.
Description
Technical Field
The invention belongs to the technical field of pharmaceutic adjuvants, and particularly relates to an enteric hydroxypropyl methylcellulose 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 that titanium dioxide is not used as the opacifier is provided for avoiding related medicine reaction and for safety consideration of some foreign customers, so that a new formula of enteric hypromellose hollow capsules which can be used for medicines and health products instead of titanium dioxide as the opacifier is urgently needed to meet the market requirement.
Disclosure of Invention
The invention provides an enteric hypromellose hollow capsule with a new formula and a preparation method thereof, which can solve the problem that the enteric hypromellose hollow capsule with the new formula which can replace titanium dioxide as an opacifier and can be used for medicines and health care products is lacked in the prior art. The enteric hydroxypropyl methylcellulose hollow capsule which takes zinc oxide, magnesium oxide, calcium salt and barium salt as opacifiers is prepared to meet the market demand.
In order to solve the technical problems, the invention adopts the technical scheme that the enteric hypromellose 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 hypromellose hollow capsules in Chinese pharmacopoeia.
The enteric hypromellose empty capsule with the new formula comprises the following components in percentage by weight: inner layer: 5.0-25.0% of hydroxypropyl methylcellulose, 0.1-5.0% of gellan gum, 800.1-1.0% of tween, 0-1.0% of pigment, 0.05-9.0% of opacifier and a 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 hypromellose empty 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 an inner layer: weighing 5.0-25.0 wt% of hydroxypropyl methylcellulose and 0.1-5.0 wt% of gellan gum, stirring uniformly, adding deionized water with the temperature of more than 85 ℃, stirring until the system is completely dissolved, stabilizing in a water bath at 80-90 ℃ for 1-2h, adding 0.1-1.0 wt% of tween 80, weighing corresponding opacifier solution according to the formula requirement, adding into a glue preparation barrel, starting stirring, adding pigment according to the formula requirement, adjusting to the required color, fully and uniformly stirring the glue solution at the stirring speed of 20-50r/min for 20-30min, and continuously stabilizing the glue solution at 60-65 ℃ for 0.5-1 h; carrying out mould dipping molding on the stable glue solution, and drying in a drying kiln for 40-80 minutes at the temperature of 28-35 ℃ to obtain a capsule cap body 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 solution is stable, the mould with the hydroxypropyl methylcellulose layer is coated and dipped for 2 times for forming, and the novel enteric hydroxypropyl methylcellulose 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 hypromellose empty capsule without titanium dioxide meet the standard requirements of the enteric hypromellose empty capsule in the 2020 edition of Chinese pharmacopoeia.
Compared with the prior art, the invention has the advantages and positive effects that: the invention provides an enteric hydroxypropyl methylcellulose 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 hypromellose empty capsule with the new formula is prepared by the following steps:
(1) preparing an inner 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 hydroxypropyl methylcellulose glue solution, starting stirring, adding 200 parts of prepared opacifier solution, adding 6 parts of carmine and 2 parts of lemon yellow while stirring, fully and uniformly stirring the glue solution at the stirring speed of 45r/min for 20min, and continuously stabilizing the glue solution at 60 ℃ for 1h to produce by using a capsule production machine to obtain a capsule cap body glue 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 solution is stable, coating and glue dipping forming are carried out on the mould with the hydroxypropyl methylcellulose layer for 2 times, and demoulding, cutting and sleeving are carried out by utilizing a demoulding device to produce the novel enteric hydroxypropyl methylcellulose hollow capsule which does not contain titanium dioxide and meets the standard requirement;
example 2
The enteric hypromellose empty capsule with the new formula is prepared by the following steps:
(1) preparing an inner 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 hydroxypropyl methylcellulose glue solution, starting stirring, adding 150 parts of prepared opacifier solution, adding 4 parts of brilliant blue, 1 part of carmine, 2 parts of amaranth and 6 parts of yellow ferric oxide while stirring, fully and uniformly stirring the glue solution at the stirring speed of 40r/min for 25min, and continuously stabilizing the glue solution at 60 ℃ for 0.5h to produce by using a capsule production machine to obtain a capsule cap body glue 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 solution is stable, coating and glue dipping forming are carried out on the mould with the hydroxypropyl methylcellulose layer for 2 times, and demoulding, cutting and sleeving are carried out by utilizing a demoulding device to produce the novel enteric hydroxypropyl methylcellulose hollow capsule which does not contain titanium dioxide and meets the standard requirement;
example 3
The enteric hypromellose empty capsule with the new formula is prepared by the following steps:
(1) preparing an inner 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 hydroxypropyl methylcellulose glue solution, starting stirring, adding 150 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 glue solution at the stirring speed of 40r/min for 25min, and continuously stabilizing the glue solution at 60 ℃ for 0.5h to produce by using a capsule production machine to obtain a capsule cap body glue 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 solution is stable, coating and glue dipping forming are carried out on the mould with the hydroxypropyl methylcellulose layer for 2 times, and demoulding, cutting and sleeving are carried out by utilizing a demoulding device to produce the novel enteric hydroxypropyl methylcellulose hollow capsule which does not contain titanium dioxide and meets the standard requirement;
example 4
The enteric hypromellose empty capsule with the new formula is prepared by the following steps:
(1) preparing an inner 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 hydroxypropyl methylcellulose glue solution, starting stirring, adding 150 parts of prepared opacifier solution, adding 7 parts of brilliant blue, 6 parts of carmine and 1 part of erythrosine while stirring, fully and uniformly stirring the glue solution at the stirring speed of 35r/min for 30min, and continuously stabilizing the glue solution at 60 ℃ for 0.5h to produce by using a capsule production machine to obtain a capsule cap body glue 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 solution is stable, coating and glue dipping forming are carried out on the mould with the hydroxypropyl methylcellulose layer for 2 times, and demoulding, cutting and sleeving are carried out by utilizing a demoulding device to produce the novel enteric hydroxypropyl methylcellulose hollow capsule which does not contain titanium dioxide and meets the standard requirement;
example 5
The enteric hypromellose empty capsule with the new formula is prepared by the following steps:
(1) preparing an inner 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 hydroxypropyl methylcellulose glue solution, starting stirring, adding 150 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 glue solution at the stirring speed of 35r/min for 30min, and continuously stabilizing the glue solution at 60 ℃ for 0.5h to produce by using a capsule production machine to obtain a capsule cap body glue 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 solution is stable, coating and glue dipping forming are carried out on the mould with the hydroxypropyl methylcellulose layer for 2 times, and demoulding, cutting and sleeving are carried out by utilizing a demoulding device to produce the novel enteric hydroxypropyl methylcellulose hollow capsule which does not contain titanium dioxide and meets the standard requirement;
the enteric hypromellose hollow capsules prepared in examples 1 to 5 were subjected to performance testing according to the determination method for the 2020 version of the chinese pharmacopoeia enteric gelatin hollow capsules and the hypromellose hollow capsules, and the obtained data (shown in the following table) meet the use requirements specified in the chinese pharmacopoeia.
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) | ≤0.030 | ≤0.027 | ≤0.025 | ≤0.023 | ≤0.024 | ≤0.026 |
The invention provides a novel enteric hypromellose empty 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 empty capsule developed by the invention is improved in uniformity through comparative research. The improvement of uniformity can improve the filling efficiency of the empty capsules in the pharmaceutical industry (data as above).
The Tween 80 used in the patent can promote better intermiscibility of material molecules in a formula, and is beneficial to arrangement of molecular chains during capsule dipping and forming so as to avoid aggregation of the molecular chains; 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 hypromellose empty capsule with the new formula is characterized in that: the hollow capsule comprises the following components in percentage by weight:
inner layer: 5.0 to 25.0 percent of hydroxypropyl methylcellulose,
0.1 to 5.0 percent of gellan gum,
800.1 to 1.0 percent of tween,
0 to 1.0 percent of pigment,
0.05 to 9.0 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 hypromellose empty capsule of new formulation according to claim 1, characterized in that: the opacifier is one or more of zinc oxide, magnesium oxide, calcium salt and barium salt.
3. The enteric hypromellose empty capsule of new formulation according to claim 2, characterized in that: 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 hypromellose empty capsule of new formulation according to claim 2, characterized in that: the barium salt is one or more of barium carbonate, barium sulfate, barium hydrogen phosphate and barium phosphate.
5. The enteric hypromellose empty capsule of new formulation according to claim 2, characterized in that: particle size range of the opacifier: 0.1-30 μm.
6. The enteric hypromellose empty capsule of new formulation according to claim 2, characterized in that: the pigment includes synthetic pigment, natural pigment, and ferric oxide pigment.
7. A preparation method of the enteric hypromellose empty capsule with the new formula as claimed in claim 1 is characterized by comprising the following 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 an inner layer: weighing 5.0-25.0 wt% of hydroxypropyl methylcellulose and 0.1-5.0 wt% of gellan gum, stirring uniformly, adding deionized water with the temperature of more than 85 ℃, stirring until the system is completely dissolved, stabilizing in a water bath at 80-90 ℃ for 1-2h, adding 0.1-1.0 wt% of tween 80, weighing corresponding opacifier solution according to the formula requirement, adding into a glue preparation barrel, starting stirring, adding pigment according to the formula requirement, adjusting to the required color, fully and uniformly stirring the glue solution at the stirring speed of 20-50r/min for 20-30min, and continuously stabilizing the glue solution at 60-65 ℃ for 0.5-1 h; carrying out mould dipping molding on the stable glue solution, and drying in a drying kiln for 40-80 minutes at the temperature of 28-35 ℃ to obtain a capsule cap body 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 solution is stable, the mould with the hydroxypropyl methylcellulose layer is coated and dipped for 2 times for forming, and the novel enteric hydroxypropyl methylcellulose 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.
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Cited By (1)
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| CN114159402A (en) * | 2021-12-21 | 2022-03-11 | 湖州展望天明药业有限公司 | Opaque plant capsule and preparation method thereof |
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