CN114831944A - Medicinal granule with taste masking effect and application thereof - Google Patents

Medicinal granule with taste masking effect and application thereof Download PDF

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Publication number
CN114831944A
CN114831944A CN202210369873.4A CN202210369873A CN114831944A CN 114831944 A CN114831944 A CN 114831944A CN 202210369873 A CN202210369873 A CN 202210369873A CN 114831944 A CN114831944 A CN 114831944A
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China
Prior art keywords
medicine
tablet
granules
material composition
auxiliary material
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CN202210369873.4A
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Chinese (zh)
Inventor
孙梦娟
胡锦忻
侯小燕
孙春萌
涂家生
吴方
展文珍
涂慧丹
敬祎玫
刘小菡
张士扬
魏晨茜
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China Pharmaceutical University
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China Pharmaceutical University
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Priority to CN202210369873.4A priority Critical patent/CN114831944A/en
Publication of CN114831944A publication Critical patent/CN114831944A/en
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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates

Abstract

The invention discloses a drug particle with a taste masking effect and application thereof, belonging to the technical field of pharmaceutical preparations. The drug granules with the taste masking effect are prepared from a drug, carbon dioxide and an auxiliary material composition. The invention utilizes auxiliary materials and carbon dioxide to prepare medicine particles, and certain jumping feeling can occur when the medicine particles are placed in the mouth. The granules are applied to oral solid pharmaceutical preparations, so that the interestingness of medication can be increased, and the compliance of children medication is particularly improved.

Description

Medicinal granule with taste masking effect and application thereof
Technical Field
The invention belongs to the technical field of medicinal preparations, and particularly relates to a medicinal granule with a taste masking effect and application thereof.
Background
Aiming at the problems of low proportion of children preparations, few selectable varieties, low enthusiasm of enterprises for researching and developing the children preparations and the like in Chinese medical products, a series of policy documents encourage the research and development of the children preparations in recent years in China. Children's medication has certain specificities compared to adults, including: children are not able to take their medication in a simple weight conversion as opposed to adults; most of the medicines have poor taste and smell, so that children naturally resist taking the medicines, and the compliance is poor. Wherein, the dosage of the children medicine is generally determined by clinical trial data, real world data and the like; the compliance problem can be improved by means of pharmaceutical means. At present, most of the marketed children preparations reduce or eliminate the bad taste and smell of the medicines only by adding a sweetening agent or a taste masking agent, and the method is single. Therefore, the development of a children preparation which can correct the taste and has interestingness simultaneously has important clinical significance.
Disclosure of Invention
The invention aims to provide a drug particle with a taste masking effect and application thereof.
In order to achieve the purpose, the invention adopts the following technical scheme:
a drug particle with a taste masking effect is prepared from a drug, carbon dioxide and an auxiliary material composition, and comprises the following components in percentage by mass: 1-50% of medicine components and 50-99% of auxiliary material composition, wherein the sum of the mass percentages of the components is 100%.
Furthermore, the medicine is a medicine active component for oral administration or medicine-containing powder or granules prepared from the medicine active component and other pharmaceutically acceptable auxiliary materials.
Furthermore, the medicine-containing powder or granules prepared from the medicine active ingredients and other pharmaceutically acceptable auxiliary materials for oral administration are medicines subjected to taste masking treatment, and the taste masking technology comprises but is not limited to adding a flavoring agent, coating, clathrating, preparing microcapsules or microspheres, adjusting the solubility of the medicines, preparing a solid dispersion, adding a bitter taste retardant, forming a compound, adopting ion exchange resin technology and other pharmaceutically acceptable taste masking technologies.
Further, the pharmaceutical active ingredient comprises ibuprofen, acetaminophen, aspirin, analgin, nimesulide, loratadine, cetirizine, ambroxol, chlorpheniramine maleate, erythromycin, azithromycin, clarithromycin, cefaclor, cefixime, amoxicillin, ampicillin, loperamide, sodium carposulfonate, gemfibrozil, clonidine, carbinoxamine, hydrocodone, pseudoephedrine, methylphenidate, dextro-methylphenidate, diphenhydramine, carbamazepine, oxymorphone, ibuprofen, morphine, codeine, tramadol, phenylephrine, venlafaxine, metformin, dexchlorpheniramine, fexofenadine, phenylpropanolamine, chlorpheniramine, amphetamine, naproxen, diclofenac, paroxetine, ribavirin, oseltamivir, acyclovir, amantadine, rimantadine and the like in clinical application and pharmaceutically acceptable salts thereof.
Further, the auxiliary material composition at least comprises a sweetening agent, and can be selected from one or a combination of more of a coloring agent, a disintegrating agent, an essence and a spice or an organic acid.
Further, the sweetener is one of pharmaceutically acceptable sweeteners such as sucrose, lactose, isomalt, fructose, glucose, acacia, sucralose, maltose, xylitol, trehalose, stevioside, sorbitol, maltitol, corn syrup, maltose syrup, fruit syrup, etc., and a combination of any of the above.
Further, the colorant may be selected from amaranth, carmine, erythrosine, new red, lemon yellow, sunset yellow, indigo blue, brilliant blue, tea yellow, tea green pigment, lithopone, orange yellow, black bean red, black currant red, safflower yellow, red rice red, red yeast rice red, peanut skin red, turmeric, curcumin, caramel pigment, chrysanthemum seed brown, yellow extract, cocoa shell color, capsicum orange, capsanthin, blueberry red, radish red, black nightshade red, roselle red, pale yellow, grape skin red, mulberry red, seabuckthorn yellow, zizyphi spinosa color, natural amaranth, acorn hull brown, cochineal, annatto, lutein, chlorophyll copper sodium salt, chlorophyll copper potassium salt, corn yellow, yuantangerine, algae blue, yellow, gardenia yellow, plant carbon black, gardenia red, and shellac red, or a combination thereof.
Furthermore, the disintegrating agent can be one or more of croscarmellose sodium, sodium carboxymethyl starch, crospovidone, low-substituted hydroxypropyl cellulose, dry starch, effervescent disintegrating agent, alginic acid and sodium alginate.
Further, the essence and flavor is one or a combination of several of natural flavors such as lemon, fennel, peppermint oil and the like, apple flavor, orange flavor, osmanthus essence, banana flavor, honey peach flavor, strawberry flavor, pineapple flavor, litchi flavor, mango flavor, lemon flavor, chocolate flavor, cream flavor and the like.
Further, the organic acid can be one or more of citric acid, malic acid, tartaric acid, fumaric acid, stearic acid, oxalic acid, benzoic acid, and ascorbic acid.
The preparation of the medicine particles comprises the following steps:
(1) mixing: weighing the medicine and auxiliary material composition according to the prescription, putting the medicine and auxiliary material composition into a pressure container, adding water according to 10-60% of the mass sum of the medicine and the sweetening agent, and stirring to fully mix;
(2) melting: heating under the condition of mechanical stirring to raise the temperature of the materials to 140-180 ℃, and preserving the heat;
(3) and (3) inflating: evacuating the pressure vessel and subsequently charging CO into the pressure vessel 2 Continuously stirring for 5-15min until the pressure in the container is 4-7 MPa;
(4) termination and post-treatment: stopping heating, cooling the pressure container to room temperature, releasing pressure to normal pressure to obtain blocks, and pulverizing to obtain medicinal granules.
The purpose of adding water in the preparation process of the medicine particles comprises the following steps: make sweetener and batching part dissolve or dissolve completely, improve material fluidity, be favorable to the stirring to make the material misce bene, further guarantee to be heated evenly, avoid local overheat to lead to the sweetener coking. Heating at a set temperature to further mix the sweetener with water; the moisture in the material is continuously evaporated along with the rise of the temperature, because the moisture evaporation needs to absorb heat, a plateau period (namely, the material slowly rises or is kept at a certain temperature in a certain temperature interval) occurs in the temperature rise process within the range of 100-130 ℃ for a certain time, the plateau period is the moisture evaporation process, the duration time of the plateau period is positively correlated with the water adding amount, and after the moisture is completely evaporated, the material can be continuously heated to the target temperature (namely, 140-180 ℃). Therefore, the boiling time is not required to be limited in the sugar boiling process, and the end point can be judged by judging whether the material temperature reaches the set temperature.
In addition, the amount of water added in the formulation of the present invention is not strictly limited in theory. However, when the amount of water added is too small, it is difficult to effectively improve the fluidity of the material; when the water is added excessively, more energy is consumed to completely evaporate the water, which is not beneficial to energy conservation and environmental protection. Meanwhile, the mass ratio of the medicament and the sweetener in the medicament particles is relatively large, so that the water adding amount is limited to 10-60% of the sum of the mass of the medicament and the sweetener.
An oral solid medicine comprises the medicine particles and other pharmaceutically acceptable auxiliary materials.
Further, the dosage form of the medicament comprises pills, granules, tablets or capsules.
Further, the dosage form of the tablet includes a single-layer tablet, a multi-layer tablet, a chewable tablet, a dispersible tablet, a sustained release tablet, a controlled release tablet, a sublingual tablet, a buccal tablet, an oral patch or an oral fast disintegrating tablet.
Advantageous effects
1. Improving compliance
The carbon dioxide is used for preparing the medicine particles, a certain jumping motion effect can be generated when the medicine particles are placed in the mouth, the interestingness in medicine taking is further increased on the basis that the sweetening agent plays a role in correcting the taste, and the compliance of children in medicine taking can be effectively improved.
2. Convenient to use
The medicine granule can be taken orally with water or directly, and has the advantages of increased optional mode and convenience for selection as required.
3. Mode of disintegration
The medicine granules prepared by the invention contain carbon dioxide, and the carbon dioxide is dissolved when meeting water auxiliary materials, and releases a certain pressure, and if the medicine granules are used in tablets, the carbon dioxide release can promote the disintegration of the tablets.
4. Square type for expanding application
The medicine particles prepared by the invention can be independently or mixed with other pharmaceutically acceptable auxiliary materials to be further processed into other oral solid medicines, and the oral solid medicines comprise: pills, granules, capsules, single-layer tablets, multilayer tablets, chewable tablets, dispersible tablets, sustained-release tablets, controlled-release tablets, sublingual tablets, buccal tablets, oral patches, oral fast-disintegrating tablets and other tablets, and has wide expanded application forms.
Detailed Description
The present invention is described in further detail below with reference to specific examples, but the present invention should not be construed as being limited thereto. Modifications or substitutions to methods, procedures, or conditions of the invention may be made without departing from the spirit and scope of the invention. The experimental methods and reagents of the formulations not specified in the examples are in accordance with the conventional conditions in the art.
Example 1
Preparation of ibuprofen granules with taste masking effect
The prescription is as follows:
Figure BDA0003587812240000041
adding the medicines and the auxiliary materials into a pressure container according to the prescription, mechanically stirring and premixing, and heating to 170 ℃; sealing the container after vacuumizing; charging CO 2 Keeping the pressure at 6Mpa, and stirring for 10 min; stopping heating and stirring, cooling the pressure container to room temperature to obtain block containing ibuprofen, and pulverizing to obtain ibuprofen granule.
And (3) effect observation:
the ibuprofen granules were placed in water and found to bounce in water until completely dissolved, indicating that the CO entrapped in the ibuprofen granules 2 Released during dissolution of the particles.
Example 2
Preparation of nimesulide granules with taste masking effect
The prescription is as follows:
Figure BDA0003587812240000042
adding the medicines and the auxiliary materials into a pressure container according to the prescription, mechanically stirring and premixing, and heating to 160 ℃; sealing the container after vacuumizing; charging CO 2 Keeping the pressure at 7Mpa, and stirring for 8 min; stopping heating and stirring, cooling the pressure container to room temperature to obtain blocks containing nimesulide, and pulverizing to obtain nimesulide granules.
And (3) effect observation:
the nimesulide particles are placed in water, and the nimesulide particles are found to jump in the water until the nimesulide particles are completely dissolved, which indicates that CO is wrapped in the nimesulide particles 2 Released during dissolution of the particles.
Example 3
Preparation of loratadine granules with taste masking effect
The prescription is as follows:
(Mono) loratadine-cyclodextrin inclusion compounds
Figure BDA0003587812240000051
(Di) loratadine particle prescription
Figure BDA0003587812240000052
The preparation process of the granules comprises the following steps:
step 1, preparation of loratadine-cyclodextrin inclusion compound: accurately weighing 5g of loratadine, and dissolving in 50ml of ethanol to obtain a loratadine ethanol solution; accurately weighing 40g of 2, 6-dimethyl-beta-cyclodextrin, adding into 500g of purified water, stirring, heating to 60 ℃ for complete dissolution, and keeping the temperature to obtain a cyclodextrin water solution; slowly dripping the loratadine ethanol solution into the cyclodextrin water solution, keeping the temperature, continuously stirring until the loratadine ethanol solution is dripped, stopping heating, continuously stirring, cooling to room temperature, placing in an ice bath, completely precipitating, performing suction filtration, and drying a filter cake at 50 ℃ to obtain the loratadine-cyclodextrin inclusion compound.
Step 2, adding the loratadine-cyclodextrin inclusion compound, the auxiliary material and the purified water into a pressure container according to the formula, mechanically stirring and premixing, and heating to 165 ℃; sealing the container after vacuumizing; charging CO 2 Keeping the pressure at 7Mpa for 10 min; stopping heating and stirring, cooling the pressure container to room temperature to obtain blocks containing loratadine, and pulverizing to obtain loratadine particles.
And (3) effect observation:
when the loratadine particles are placed in water, the loratadine particles are found to jump in the water until the loratadine particles are completely dissolved, which indicates that CO coated in the loratadine particles 2 Released during dissolution of the particles.
Example 4
Preparation of chlorphenamine tablet with taste masking effect
The prescription is as follows:
prescription of chlorpheniramine hydrochloride granules
Figure BDA0003587812240000061
The prescription of the (di) chlorpheniramine tablet comprises the following components:
Figure BDA0003587812240000062
the preparation process of the tablet comprises the following steps:
step 1, preparation of chlorpheniramine particles: adding the medicines, the auxiliary materials and the purified water into a pressure container according to the prescription, mechanically stirring and premixing, and heating to 170 ℃; sealing the container after vacuumizing; charging CO 2 Keeping the pressure at 7Mpa for 15 min; stopping heating and stirring, cooling the pressure container to room temperature to obtain block containing chlorpheniramine, and pulverizing to obtain chlorpheniramine granules.
Step 2, preparing chlorphenamine tablets: mixing chlorphenamine granules, lactose-microcrystalline cellulose blank granules, magnesium stearate and croscarmellose sodium according to the above formula, and tabletting.
And (3) effect observation: the specification of the chlorpheniramine tablet is 4mg, the tablet weight is 200mg, the hardness is 40-60N, and a certain amount of bubbles can be observed to be generated when the chlorpheniramine tablet is put into water, which shows that CO is 2 The tablet is released in the dissolution process, can promote the dissolution of the tablet together with a disintegrant, and can be completely disintegrated within 5 min.

Claims (7)

1. A drug particle having taste masking properties, characterized in that: the medicament is prepared from a medicament, carbon dioxide and an auxiliary material composition, and comprises the following components in percentage by mass: 1-50% of medicine and 50-99% of auxiliary material composition, wherein the sum of the mass percentages of the medicine and the auxiliary material composition is 100%;
the auxiliary material composition at least comprises a sweetening agent, and can selectively comprise one or a combination of more of a coloring agent, a disintegrating agent, an essence and a perfume or an organic acid.
2. The drug particle of claim 1, wherein: the sweetener is one or more of sucrose, lactose, isomalt, fructose, glucose, sucralose, maltose, xylitol, trehalose, stevioside, sorbitol, maltitol, corn syrup, maltose syrup or fruit syrup.
3. The drug particle of claim 1, wherein: the medicine is a medicine active component which can be used for oral administration or medicine-containing powder or granules which are prepared from the medicine active component and other pharmaceutically acceptable auxiliary materials.
4. A process for the preparation of pharmaceutical granules according to any one of claims 1 to 3, characterized in that: the method comprises the following steps:
(1) Mixing: placing the medicine and auxiliary material composition in a pressure container, adding water according to 10-60% of the mass sum of the medicine and the sweetening agent, and stirring to fully mix;
(2) melting: heating under the condition of mechanical stirring to raise the temperature of the materials to 140-180 ℃ and preserving the heat;
(3) and (3) inflating: vacuumizing the pressure container, sealing, and filling CO into the pressure container 2 Continuously stirring for 5-15min until the pressure in the container is 4-7 MPa;
(4) termination and post-treatment: stopping heating, cooling the pressure container to room temperature, releasing pressure to normal pressure to obtain block adjuvant, and pulverizing to obtain medicinal granule.
5. An oral solid medicament, characterized in that: comprising the pharmaceutical granules according to any one of claims 1 to 3 and pharmaceutically acceptable further excipients.
6. The oral solid pharmaceutical of claim 5, wherein: the dosage form of the oral solid medicine is pills, granules, dry suspension, tablets or capsules.
7. The oral solid pharmaceutical of claim 6, wherein: the tablet is a single-layer tablet, a multi-layer tablet, a chewable tablet, a dispersible tablet, a sustained release tablet, a controlled release tablet, a sublingual tablet, a buccal tablet, an oral patch or an oral fast disintegrating tablet.
CN202210369873.4A 2022-04-08 2022-04-08 Medicinal granule with taste masking effect and application thereof Pending CN114831944A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108078943A (en) * 2018-01-29 2018-05-29 中国药科大学 A kind of preparation for processing auxiliary material altogether and its application in long-acting stomach floating preparation
CN111184694A (en) * 2020-01-19 2020-05-22 广东青云山药业有限公司 Preparation method of oral instant granules
CN113057950A (en) * 2020-01-02 2021-07-02 上海信谊万象药业股份有限公司 Oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granule preparation and preparation process thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108078943A (en) * 2018-01-29 2018-05-29 中国药科大学 A kind of preparation for processing auxiliary material altogether and its application in long-acting stomach floating preparation
CN113057950A (en) * 2020-01-02 2021-07-02 上海信谊万象药业股份有限公司 Oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granule preparation and preparation process thereof
CN111184694A (en) * 2020-01-19 2020-05-22 广东青云山药业有限公司 Preparation method of oral instant granules

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