CN114732793B - Hollow capsule and preparation method thereof - Google Patents
Hollow capsule and preparation method thereof Download PDFInfo
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- CN114732793B CN114732793B CN202210425091.8A CN202210425091A CN114732793B CN 114732793 B CN114732793 B CN 114732793B CN 202210425091 A CN202210425091 A CN 202210425091A CN 114732793 B CN114732793 B CN 114732793B
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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
- A61K47/30—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
- A61K47/40—Cyclodextrins; Derivatives thereof
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02W—CLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO WASTEWATER TREATMENT OR WASTE MANAGEMENT
- Y02W90/00—Enabling technologies or technologies with a potential or indirect contribution to greenhouse gas [GHG] emissions mitigation
- Y02W90/10—Bio-packaging, e.g. packing containers made from renewable resources or bio-plastics
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- Food Science & Technology (AREA)
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Abstract
The invention provides a hollow capsule, which comprises the following components in parts by weight: 18-30 parts of film forming agent, 0.1-5 parts of curing agent, 0.1-6 parts of potassium salt, 1-3 parts of sodium dodecyl sulfate, 1-5 parts of pigment, 1-10 parts of nano zinc oxide and 60-70 parts of purified water, wherein the nano zinc oxide is modified by metal oxide and cyclodextrin. The invention takes zinc oxide as the opacifier, can completely replace the titanium dioxide opacifier adopted in the prior art, and can achieve the light-shading effect to ensure the stability of the photosensitive medicine.
Description
Technical Field
The invention relates to the technical field of empty capsules, in particular to an empty capsule and a preparation method thereof.
Background
The hollow capsule is a common dosage form in medicines and health products, and the light shielding effect can be achieved by adding the light shielding agent, so that the stability of the light sensitive medicine is ensured. Titanium dioxide is a commonly used opacifier in the prior art to enhance the whiteness or opacity of the capsules by virtue of the light scattering properties. However, titanium dioxide has been recently listed as a carcinogen by the international cancer research institute and the european chemical administration. Therefore, a hollow capsule which can replace titanium dioxide and is used for medicines and health care products needs to be studied to meet the market demand.
Disclosure of Invention
In view of the above, the present invention provides a hollow capsule using zinc oxide as a light-shielding agent and a preparation method thereof.
The technical scheme of the invention is realized as follows: the invention provides a hollow capsule which comprises the following components in parts by weight: 18-30 parts of film forming agent, 0.1-5 parts of curing agent, 0.1-6 parts of potassium salt, 1-3 parts of sodium dodecyl sulfate, 1-5 parts of pigment, 1-10 parts of nano zinc oxide and 60-70 parts of purified water, wherein the nano zinc oxide is modified by metal oxide and cyclodextrin.
On the basis of the technical scheme, preferably, the film forming agent is one of gelatin, hydroxypropyl methylcellulose, pullulan and hydroxypropyl starch.
On the basis of the technical scheme, preferably, the curing agent is one or a combination of more of carrageenan, xanthan gum and gellan gum.
On the basis of the technical scheme, preferably, the potassium salt is potassium acetate or potassium citrate.
On the basis of the technical scheme, the particle size of the nano zinc oxide is preferably 50-100nm.
On the basis of the technical scheme, preferably, the invention also provides a preparation method of the hollow capsule, which comprises the following steps:
s1, preprocessing nano zinc oxide: firstly, coating nano zinc oxide by adopting one or two of silicon dioxide and aluminum oxide, and then embedding the coated nano zinc oxide by adopting cyclodextrin;
s2, sol: adding purified water into a sol tank, heating to 70-90 ℃, then adding a film forming agent, a curing agent, potassium salt and sodium dodecyl sulfate, stirring to be transparent, and then preserving heat for 0.5-1h at 70-90 ℃ to dissolve;
s3, glue raising: placing the glue solution prepared in the step S2 at the temperature of 45-65 ℃ and preserving heat for 4-6h;
s4, glue dipping and blank making: adding pigment and nano zinc oxide treated in the step S1 into the glue solution prepared in the step S3, stirring uniformly, dipping the glue at the temperature of 45-65 ℃ and setting at the temperature of 20-30 ℃;
s5, drying: drying the green body prepared in the step S4 at the temperature of 20-40 ℃;
s6, demolding, cutting and sleeving: and demolding the dried blank, and cutting and sleeving to obtain the hollow capsule after quality inspection is qualified.
On the basis of the technical scheme, the coating treatment method of the nano zinc oxide is preferably as follows: dissolving nano zinc oxide particles in ethanol solution or isopropanol solution, adding one or two of tetraethoxysilane and aluminum isopropoxide, and stirring and reacting for 2-5h under the condition of pH8-10 to form gel; after the reaction is finished, the nano zinc oxide coated with one or two of silicon dioxide and aluminum oxide is obtained through centrifugation, filtration and washing.
On the basis of the technical scheme, preferably, the nano zinc oxide: the mass ratio of the tetraethoxysilane is 1 (2-6); nano zinc oxide: the mass ratio of the aluminum isopropoxide is 1 (2-7), the mass fraction of the ethanol solution or the isopropanol solution is 10-50%, and the solvent is water.
On the basis of the technical scheme, preferably, the nano zinc oxide embedding treatment method comprises the following steps: adding the coated nano zinc oxide into saturated beta-CD water solution, stirring and reacting for 8-12h, cooling, crystallizing, filtering and drying after the reaction is finished to obtain the cyclodextrin-embedded nano zinc oxide.
On the basis of the technical scheme, preferably, the coated nano zinc oxide: the mass ratio of the saturated beta-CD aqueous solution is 1 (8-10).
Compared with the prior art, the hollow capsule and the preparation method thereof have the following beneficial effects:
(1) The invention takes zinc oxide as the opacifier, can completely replace the titanium dioxide opacifier adopted in the prior art, and can achieve the light-shading effect to ensure the stability of the photosensitive medicine.
(2) The hollow capsule prepared by the invention has low friability and good toughness, is not easy to break in the transportation process, has short disintegration time, and meets the requirements of pharmacopoeia and use in terms of upper probability and smoothness.
(3) According to the invention, the nano zinc oxide is coated and embedded, so that on one hand, the dispersion and wettability of the nano zinc oxide are increased, the dissolution rate of the hollow capsule is increased, and the absorption of the medicine is promoted; on the other hand, the color change of the hollow capsule in the illumination environment can be inhibited.
Detailed Description
The following description of the embodiments of the present invention will clearly and fully describe the technical aspects of the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the present invention without making any inventive effort, are intended to fall within the scope of the present invention.
Example 1
The hollow capsule of the embodiment comprises the following components in parts by weight: 30 parts of gelatin, 0.1 part of carrageenan, 0.1 part of potassium acetate, 1 part of sodium dodecyl sulfate, 1 part of pigment, 1 part of nano zinc oxide with the particle size of 50nm and 60 parts of purified water. The pigment is medicinal pigment lemon yellow.
The preparation method of the empty capsule of the embodiment comprises the following steps:
s1, sol: adding purified water into a sol tank, heating to 70 ℃, adding gelatin, carrageenan, potassium acetate and sodium dodecyl sulfate, stirring to be transparent, and then preserving heat for 0.5h at 70 ℃ to dissolve.
S2, glue raising: and (3) placing the glue solution prepared in the step (S2) at the temperature of 45 ℃ and preserving heat for 4 hours.
S3, glue dipping and blank making: and (3) adding pigment and nano zinc oxide into the glue solution prepared in the step (S3), stirring uniformly, dipping the glue at the temperature of 45 ℃, and setting at the temperature of 20 ℃.
S4, drying: the green body prepared in step S4 was dried at a temperature of 20 ℃.
S5, demolding, cutting and sleeving: and demolding the dried blank, and cutting and sleeving to obtain the hollow capsule after quality inspection is qualified.
Example two
The hollow capsule of the embodiment comprises the following components in parts by weight: 30 parts of gelatin, 0.1 part of carrageenan, 0.1 part of potassium acetate, 1 part of sodium dodecyl sulfate, 1 part of pigment, 1 part of nano zinc oxide with the particle size of 50nm and 60 parts of purified water. The pigment is medicinal pigment lemon yellow.
The preparation method of the empty capsule of the embodiment comprises the following steps:
s1, preprocessing nano zinc oxide: dissolving 1 part of nano zinc oxide particles in an ethanol water solution with the mass fraction of 10%, adding 2 parts of tetraethoxysilane, and stirring and reacting for 2 hours under the condition of pH8 to form gel; after the reaction is finished, the nano zinc oxide coated with silicon dioxide is obtained through centrifugation, filtration and washing.
Adding 1 part of coated nano zinc oxide into 8 parts of saturated beta-CD water solution, stirring and reacting for 8 hours, and cooling, crystallizing, filtering and drying after the reaction is finished to obtain the cyclodextrin-embedded nano zinc oxide.
S2, sol: adding purified water into a sol tank, heating to 70 ℃, adding gelatin, carrageenan, potassium acetate and sodium dodecyl sulfate, stirring to be transparent, and then preserving heat for 0.5h at 70 ℃ to dissolve.
S3, glue raising: and (3) placing the glue solution prepared in the step (S2) at the temperature of 45 ℃ and preserving heat for 4 hours.
S4, glue dipping and blank making: adding pigment and nano zinc oxide treated in the step S1 into the glue solution prepared in the step S3, stirring uniformly, dipping the glue at the temperature of 45 ℃, and setting at the temperature of 20 ℃.
S5, drying: the green body prepared in step S4 was dried at a temperature of 20 ℃.
S6, demolding, cutting and sleeving: and demolding the dried blank, and cutting and sleeving to obtain the hollow capsule after quality inspection is qualified.
Example III
The hollow capsule of the embodiment comprises the following components in parts by weight: 18 parts of hydroxypropyl methyl cellulose, 2 parts of carrageenan, 3 parts of gellan gum, 4 parts of potassium citrate, 3 parts of sodium dodecyl sulfate, 3 parts of pigment, 10 parts of nano zinc oxide with the particle size of 100nm and 70 parts of purified water. The pigment is medicinal pigment lemon yellow.
The preparation method of the empty capsule in the embodiment comprises the following steps:
s1, preprocessing nano zinc oxide: 1 part of nano zinc oxide particles are dissolved in 50% isopropyl alcohol aqueous solution by mass fraction, 7 parts of aluminum isopropoxide is added, and stirring reaction is carried out for 5 hours under the condition of pH10, so that gel is formed; after the reaction is finished, the nano zinc oxide coated with the aluminum oxide is obtained through centrifugation, filtration and washing.
Adding 1 part of coated nano zinc oxide into 10 parts of saturated beta-CD water solution, stirring and reacting for 12 hours, and cooling, crystallizing, filtering and drying after the reaction is finished to obtain the cyclodextrin-embedded nano zinc oxide.
S2, sol: adding purified water into a sol tank, heating to 90 ℃, then adding hydroxypropyl methylcellulose, xanthan gum, potassium citrate and sodium dodecyl sulfate, stirring to be transparent, and then preserving heat at 90 ℃ for 1h to dissolve.
S3, glue raising: and (3) placing the glue solution prepared in the step (S2) at the temperature of 65 ℃ and preserving heat for 6 hours.
S4, glue dipping and blank making: adding pigment and nano zinc oxide treated in the step S1 into the glue solution prepared in the step S3, stirring uniformly, dipping the glue at the temperature of 65 ℃ and setting at the temperature of 30 ℃.
S5, drying: the green body prepared in step S4 was dried at a temperature of 40 ℃.
S6, demolding, cutting and sleeving: and demolding the dried blank, and cutting and sleeving to obtain the hollow capsule after quality inspection is qualified.
Example IV
The hollow capsule of the embodiment comprises the following components in parts by weight: 22 parts of pullulan, 1 part of carrageenan, 3 parts of gellan gum, 5 parts of potassium citrate, 2 parts of sodium dodecyl sulfate, 2 parts of pigment, 3 parts of nano zinc oxide with the particle size of 80nm and 65 parts of purified water. Wherein the pigment is medicinal pigment lemon yellow.
The preparation method of the empty capsule in the embodiment comprises the following steps:
s1, preprocessing nano zinc oxide: dissolving 1 part of nano zinc oxide particles in 30% ethanol water solution by mass fraction, adding 3 parts of tetraethoxysilane and 4 parts of aluminum isopropoxide, and stirring and reacting for 4 hours under the condition of pH9 to form gel; after the reaction is finished, the nano zinc oxide coated with silicon dioxide and aluminum oxide is obtained through centrifugation, filtration and washing.
Adding 1 part of coated nano zinc oxide into 9 parts of saturated beta-CD water solution, stirring and reacting for 10 hours, and cooling, crystallizing, filtering and drying after the reaction is finished to obtain the cyclodextrin-embedded nano zinc oxide.
S2, sol: adding purified water into a sol tank, heating to 75 ℃, adding a film forming agent, a curing agent, potassium salt and sodium dodecyl sulfate, stirring to be transparent, and then preserving heat at 75 ℃ for 1h to dissolve.
S3, glue raising: and (3) placing the glue solution prepared in the step (S2) at the temperature of 50 ℃ and preserving heat for 5 hours.
S4, glue dipping and blank making: adding pigment and nano zinc oxide treated in the step S1 into the glue solution prepared in the step S3, stirring uniformly, dipping the glue at the temperature of 55 ℃, and setting at the temperature of 25 ℃.
S5, drying: the green body prepared in step S4 is dried at a temperature of 30 ℃.
S6, demolding, cutting and sleeving: and demolding the dried blank, and cutting and sleeving to obtain the hollow capsule after quality inspection is qualified.
Example five
The hollow capsule of the embodiment comprises the following components in parts by weight: 25 parts of hydroxypropyl starch, 2 parts of carrageenan, 3 parts of gellan gum, 6 parts of potassium citrate, 1 part of sodium dodecyl sulfate, 5 parts of pigment, 6 parts of nano zinc oxide with the particle size of 90nm and 70 parts of purified water. Wherein the pigment is medicinal pigment lemon yellow.
The preparation method of the empty capsule in the embodiment comprises the following steps:
s1, preprocessing nano zinc oxide: dissolving 1 part of nano zinc oxide particles in 40% ethanol water solution by mass fraction, adding 4 parts of tetraethoxysilane and 2 parts of aluminum isopropoxide, and stirring and reacting for 4 hours under the condition of pH8 to form gel; after the reaction is finished, the nano zinc oxide coated with silicon dioxide and aluminum oxide is obtained through centrifugation, filtration and washing.
Adding 1 part of coated nano zinc oxide into 9 parts of saturated beta-CD water solution, stirring and reacting for 11 hours, and cooling, crystallizing, filtering and drying after the reaction is finished to obtain the cyclodextrin-embedded nano zinc oxide.
S2, sol: adding purified water into a sol tank, heating to 85 ℃, adding a film forming agent, a curing agent, potassium salt and sodium dodecyl sulfate, stirring to be transparent, and then preserving heat for 0.5h at 85 ℃ to dissolve.
S3, glue raising: and (3) placing the glue solution prepared in the step (S2) at the temperature of 60 ℃ and preserving heat for 5 hours.
S4, glue dipping and blank making: adding pigment and nano zinc oxide treated in the step S1 into the glue solution prepared in the step S3, stirring uniformly, dipping the glue at the temperature of 60 ℃, and setting at the temperature of 30 ℃.
S5, drying: the green body prepared in step S4 is dried at a temperature of 30 ℃.
S6, demolding, cutting and sleeving: and demolding the dried blank, and cutting and sleeving to obtain the hollow capsule after quality inspection is qualified.
Comparative example one
Comparative example one example was followed except that the opacifying agent was titanium dioxide.
Comparative example two
Comparative example two is the same as example two except that the nano zinc oxide pretreatment does not include cyclodextrin entrapment.
Comparative example three
Comparative example III is the same as example III except that the nano zinc oxide is not pretreated.
And performing performance test on the prepared hollow capsule according to the 2020 edition of Chinese pharmacopoeia, wherein the obtained data accords with the use requirements specified by the Chinese pharmacopoeia.
Table 1 friability and disintegration time performance test of empty capsules
| Friability (granule) | Disintegration time (min) | |
| Example 1 | 0 | 6.8 |
| Example two | 0 | 7.0 |
| Example III | 0 | 6 |
| Example IV | 0 | 6.5 |
| Example five | 0 | 6.1 |
| Comparative example one | 3 | 7.6 |
| Comparative example two | 2 | 7.5 |
| Comparative example three | 0 | 10.1 |
As can be seen from Table 1, the friability and disintegration time limit of the hollow capsule prepared by using nano zinc oxide to replace titanium dioxide all meet the standards of Chinese pharmacopoeia. And the disintegration time limit of the hydroxypropyl methylcellulose hollow capsule is reduced from 10min to 6min, which is close to that of a gelatin hollow capsule.
The color difference detection method comprises the following steps: in an ultraviolet aging oven, 2 ultraviolet lamps with the wavelength of 320-400nm and the distance of 15w are irradiated for 30 days at a distance of 30 cm. The L, a, b values of the samples without uv irradiation and after 30 days of uv irradiation were measured by a color difference meter, and Δe was calculated using the following formula: Δe= [ (Δl) 2 +(△a) 2 +(△b) 2 ]1/2。
Dissolution rate of capsules: the method adopts a spin basket method, the content is amoxicillin, water is taken as a dissolution medium, sampling is carried out after 45min, and the quantity of the dissolved medicine is measured by adopting an ultraviolet spectrophotometry.
Table 2 color difference, dissolution and upper probability test of empty capsules
As can be seen from Table 2, the color difference of the capsules is reduced, the dissolution rate and the smoothness are improved, and the upper probability is more than 99%. The modified nano zinc oxide can inhibit color change, improve the dissolution rate of the hollow capsule and achieve the effect of promoting drug absorption.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, alternatives, and improvements that fall within the spirit and scope of the invention.
Claims (8)
1. A hollow capsule, characterized in that: the composition comprises the following components in parts by weight: 18-30 parts of film forming agent, 0.1-5 parts of curing agent, 0.1-6 parts of potassium salt, 1-3 parts of sodium dodecyl sulfate, 1-5 parts of pigment, 1-10 parts of nano zinc oxide and 60-70 parts of purified water, wherein the nano zinc oxide is modified by metal oxide and cyclodextrin;
the film forming agent is one of gelatin, hydroxypropyl methylcellulose, pullulan and hydroxypropyl starch, and the curing agent is one or a combination of more of carrageenan, xanthan gum and gellan gum;
the modification treatment method of the nano zinc oxide comprises the following steps: firstly, coating nano zinc oxide by adopting silicon dioxide, and then embedding the coated nano zinc oxide by adopting cyclodextrin;
the coating treatment method of the nano zinc oxide comprises the following steps: dissolving nano zinc oxide particles in ethanol solution, adding tetraethoxysilane, and stirring and reacting for 2-5h under the condition of pH8-10 to form gel; after the reaction is finished, the nano zinc oxide coated with silicon dioxide is obtained through centrifugation, filtration and washing.
2. A hollow capsule according to claim 1, wherein: the potassium salt is potassium acetate or potassium citrate.
3. A hollow capsule according to claim 1, wherein: the particle size of the nano zinc oxide is 50-100nm.
4. A method of preparing a hollow capsule according to any one of claims 1 to 3, wherein: the method comprises the following steps:
s1, preprocessing nano zinc oxide: firstly, coating nano zinc oxide by adopting silicon dioxide, and then embedding the coated nano zinc oxide by adopting cyclodextrin;
s2, sol: adding purified water into a sol tank, heating to 70-90 ℃, then adding a film forming agent, a curing agent, potassium salt and sodium dodecyl sulfate, stirring to be transparent, and then preserving heat for 0.5-1h at 70-90 ℃ to dissolve;
s3, glue raising: placing the glue solution prepared in the step S2 at the temperature of 45-65 ℃ and preserving heat for 4-6h;
s4, glue dipping and blank making: adding pigment and nano zinc oxide treated in the step S1 into the glue solution prepared in the step S3, stirring uniformly, dipping the glue at the temperature of 45-65 ℃ and setting at the temperature of 20-30 ℃;
s5, drying: drying the green body prepared in the step S4 at the temperature of 20-40 ℃;
s6, demolding, cutting and sleeving: and demolding the dried blank, and cutting and sleeving to obtain the hollow capsule after quality inspection is qualified.
5. A method of preparing a hollow capsule according to claim 4, wherein: the coating treatment method of the nano zinc oxide comprises the following steps: dissolving nano zinc oxide particles in ethanol solution, adding tetraethoxysilane, and stirring and reacting for 2-5h under the condition of pH8-10 to form gel; after the reaction is finished, the nano zinc oxide coated with silicon dioxide is obtained through centrifugation, filtration and washing.
6. A method of preparing a hollow capsule according to claim 5, wherein: the nano zinc oxide: the mass ratio of the tetraethoxysilane is 1 (2-6); the mass fraction of the ethanol solution is 10-50%, and the solvent is water.
7. A method of preparing a hollow capsule according to claim 4, wherein: the nano zinc oxide embedding treatment method comprises the following steps: adding the coated nano zinc oxide into saturated beta-CD water solution, stirring and reacting for 8-12h, cooling, crystallizing, filtering and drying after the reaction is finished to obtain the cyclodextrin-embedded nano zinc oxide.
8. A method of preparing a hollow capsule according to claim 7, wherein: the nanometer zinc oxide after the coating treatment: the mass ratio of the saturated beta-CD aqueous solution is 1 (8-10).
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| CN105434396B (en) * | 2015-12-31 | 2018-10-30 | 广东国方医药科技有限公司 | A kind of Capsules and preparation method thereof containing nano-ZnO |
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| CN113209041A (en) * | 2021-05-13 | 2021-08-06 | 青岛益青生物科技股份有限公司 | New formula hydroxypropyl methylcellulose hollow capsule and preparation method thereof |
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