CN110833540B - Salicorol, caffeine and chlorphenamine maleate tablet and preparation method thereof - Google Patents
Salicorol, caffeine and chlorphenamine maleate tablet and preparation method thereof Download PDFInfo
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- CN110833540B CN110833540B CN201911294031.1A CN201911294031A CN110833540B CN 110833540 B CN110833540 B CN 110833540B CN 201911294031 A CN201911294031 A CN 201911294031A CN 110833540 B CN110833540 B CN 110833540B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/609—Amides, e.g. salicylamide
-
- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
Abstract
The invention discloses a saligenin caffeine tablet which is prepared by the following method: mixing the phenylephrine hydrochloride, the brompheniramine maleate, the filler and the disintegrant, then adding a wetting adhesive to prepare a soft material, preparing a pellet by using an extrusion spheronizer, drying, coating a moisture-proof film coat to obtain the pellet, uniformly mixing paracetamol, salicylamide, anhydrous caffeine, the filler, the disintegrant and a lubricant, granulating, adding the mixture into the pellet, pressing into a tablet, and coating the moisture-proof film coat to obtain the finished product. The compound preparation is prepared into the pellets, the process is simple and feasible, the stability of the compound preparation can be obviously improved, the product quality is ensured, the toxic and side effects are reduced, the compliance of patients is improved, the quality guarantee period of the medicine can be prolonged, and the compound preparation is suitable for the development requirement of clinical medication.
Description
Technical Field
The invention belongs to the technical field of medicines, relates to a medicine and a preparation method of an active ingredient thereof, and particularly relates to a saligenin, caffeine and chlorphenamine maleate tablet and a preparation method thereof.
Background
The cold is a disease which cannot be ignored and is one of the most common diseases in the world, and is one of the main public health problems facing human beings. According to statistics, the annual incidence rate of cold is 10-30%, and thousands of people are infected every year around the world. Almost people have the experience of being in person, almost no people have the cold in the whole life, and the symptoms are as follows: nasal obstruction, nasal discharge, sneezing, cough, fever, general soreness, etc. The course of disease is usually 1-2 weeks, and diseases such as pharyngitis, otitis media, bronchitis, pneumonia, acute nephritis, rheumatism, myocarditis and the like can be induced if the treatment is not timely performed. The disease has high incidence and strong infectivity, and causes great harm to human health and human labor production. In recent years, people can generate immunity through infection or inoculation, but the immunity has no protective effect on new variant virus strains. Outbreaks and pandemics of the cold can be catastrophic, since the cold virus mutates very rapidly and the new lines created by people's variations of the cold virus often lack immunity.
The saligenin and chlorphenamine maleate tablet is a compound preparation consisting of acetaminophen, salicylamide, phenylephrine hydrochloride, brompheniramine maleate and anhydrous caffeine, is a cold non-prescription medicine, and is clinically suitable for relieving symptoms such as fever, headache, soreness of limbs, sneeze, rhinorrhea, nasal obstruction, pharyngalgia and the like caused by common cold and influenza. At present, the dosage form on the market of the paracetamol and caffeine tablet is mainly a double-layer tablet, and the dosage of the paracetamol and caffeine tablet for an adult is usually 1-2 tablets once and 2 times a day. After administration, the drug is rapidly dissolved, resulting in rapid rise of blood drug concentration after administration, rapid metabolism of the active ingredient, and consequent decrease of blood drug concentration. Therefore, it is necessary to increase the number of administrations to maintain an effective blood concentration. And the double-layer tablet has complex process, and the preparation process easily causes the problems of layer separation, insufficient hardness, inaccurate tablet weight control and the like.
In view of the reasons, the phenylephrine hydrochloride, the brompheniramine maleate and the pharmaceutically acceptable auxiliary materials are prepared into the pellets, and the acetaminophen, the salicylamide, the anhydrous caffeine and the pharmaceutically acceptable auxiliary materials are added to be pressed into the tablets.
Disclosure of Invention
The invention aims to provide the saligenin caffeine and chlorphenamine maleate tablet sustained-release preparation which effectively reduces the frequency of taking medicines, reduces the toxic and side effects after taking medicines, can better control the blood concentration, improves the compliance of patients and is suitable for the requirement of clinical medicine application development.
In order to achieve the purpose, the slow release preparation of the chlorphenamine maleate tablet comprises the following specific embodiments:
the saligenin and chlorphenamine maleate tablet is characterized by comprising a drug-containing pellet and an outer layer, wherein the pellet contains phenylephrine hydrochloride, brompheniramine maleate and pharmaceutically acceptable auxiliary materials, and the outer layer contains acetaminophen, salicylamide, anhydrous caffeine and pharmaceutically acceptable auxiliary materials.
The saligenin caffeine tablet, the pharmaceutically acceptable auxiliary materials in the pellet comprise: 20 to 60 percent of filling agent, 1 to 5 percent of adhesive and 0.5 to 4 percent of disintegrating agent.
The saligenin caffeine tablet is characterized in that the filler is: one or more of microcrystalline cellulose, pregelatinized starch, and starch.
The saligenin caffeine tablet is characterized in that the adhesive is water.
The saligenin caffeine tablet is characterized in that the disintegrating agent is: one or more of crospovidone, croscarmellose sodium, carboxymethylcellulose calcium, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose.
The saligenin chlorphenamine maleate tablet is characterized in that pharmaceutically acceptable auxiliary materials in the outer layer comprise 10% -30% of filling agent, 0.5% -2% of disintegrating agent and 0.5% -2% of lubricating agent.
The saligenin chlorphenamine maleate tablet is characterized in that the filler is prepared from the following medicinal auxiliary materials: lactose or microcrystalline cellulose, pregelatinized starch, sucrose, and starch.
The salix-paracetamol and caffeine tablet is characterized in that the disintegrating agent is prepared from the following pharmaceutical excipients: one or more of crospovidone, croscarmellose sodium, carboxymethylcellulose calcium, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose.
The saligenin chlorphenamine maleate tablet is characterized in that the pharmaceutical auxiliary material is lubricant selected from one of magnesium stearate, calcium stearate and talcum powder.
The saligenin caffeine tablet is characterized by comprising the following steps:
mixing phenylephrine hydrochloride, brompheniramine maleate, a filling agent and a disintegrating agent according to a prescription amount, then adding a wetting adhesive to prepare a soft material, preparing a pellet by using an extrusion spheronizer, drying, coating a moisture-proof film coat to obtain the pellet, uniformly mixing paracetamol, salicylamide, anhydrous caffeine and pharmaceutical excipients, granulating, adding the mixture into the pellet, pressing into a tablet, and coating the moisture-proof film coat to obtain the finished product.
According to the invention, phenylephrine hydrochloride, brompheniramine maleate and pharmaceutically acceptable auxiliary materials are prepared into pellets, and acetaminophen, salicylamide, anhydrous caffeine and pharmaceutically acceptable auxiliary materials are added to be pressed into tablets, so that the stability of a compound preparation can be obviously improved, the product quality is ensured, the toxic and side effects are reduced, the compliance of patients is improved, the quality guarantee period of the medicine can be prolonged, and the compound preparation is suitable for the requirement of clinical medication development.
Detailed Description
The following examples are intended to further illustrate the invention and are not to be construed as limiting the invention in any way.
Example 1
The embodiment provides an elargol and chlorphenamine maleate tablet, and the compound preparation of the elargol and chlorphenamine maleate tablet is prepared by the following preparation steps:
the preparation method comprises the following steps: mixing phenylephrine hydrochloride, brompheniramine maleate, microcrystalline cellulose and crospovidone, adding water to prepare a soft material, preparing pellets by using an extrusion spheronizer, drying, coating a moisture-proof film coat to obtain the pellets, uniformly mixing paracetamol, salicylamide, anhydrous caffeine, microcrystalline cellulose, croscarmellose sodium and magnesium stearate, granulating, adding the mixture into the pellets, pressing into tablets, and coating the moisture-proof film coat to obtain the finished product.
Example 2
The embodiment provides an elargol and chlorphenamine maleate tablet, and the compound preparation of the elargol and chlorphenamine maleate tablet is prepared by the following preparation steps:
the preparation method comprises the following steps: mixing phenylephrine hydrochloride, brompheniramine maleate, microcrystalline cellulose and crospovidone, adding water to prepare a soft material, preparing pellets by using an extrusion spheronizer, drying, coating a moisture-proof film coat to obtain the pellets, uniformly mixing paracetamol, salicylamide, anhydrous caffeine, pregelatinized starch, sodium carboxymethyl starch and magnesium stearate, granulating, adding the mixture into the pellets, pressing into tablets, and coating the moisture-proof film coat to obtain the finished product.
Example 3
The embodiment provides an elargol and chlorphenamine maleate tablet, and the compound preparation of the elargol and chlorphenamine maleate tablet is prepared by the following preparation steps:
the preparation method comprises the following steps: mixing phenylephrine hydrochloride, brompheniramine maleate, pregelatinized starch and carboxymethylcellulose calcium, adding water to obtain soft material, extruding and spheronizing to obtain pellet, drying, coating with moisture-proof film coat to obtain pellet, mixing acetaminophen, salicylamide, anhydrous caffeine, starch and croscarmellose sodium magnesium stearate, granulating, adding into the pellet, tabletting, and coating with moisture-proof film coat.
Comparative example 1
| Name (R) | Weight g |
| Acetaminophen | 150 |
| Salicylamides | 150 |
| Phenylephrine hydrochloride | 5 |
| Bromphenine maleate | 2.5 |
| Anhydrous caffeine | 20 |
| Starch | 100 |
| Sodium octyl sulfosuccinate | 20 |
| Magnesium stearate | 5 |
| Lactose | 100 |
| Povidone derivatives | 15 |
| Talcum powder | 3 |
The preparation method comprises the following steps: mixing acetaminophen, salicylamide, anhydrous caffeine, starch, sodium sulfosuccinate and magnesium stearate, and granulating. Mixing phenylephrine hydrochloride, brompheniramine maleate, lactose, povidone and talcum powder uniformly, and granulating for later use. And respectively filling the two kinds of granules into 2 feeding hoppers of a multifunctional rotary tablet press, and pressing the double-layer tablet.
Verification examples
In vitro dissolution test
The tablets obtained using examples 1 to 3 according to the invention were compared in quality with comparative example 1, the results being as follows:
in vitro dissolution test results Table-1
In vitro dissolution test results table-2
Stability test
Substance results table
The results show that the acetaminophen, the salicylamide and the anhydrous caffeine in the examples 1 to 3 of the invention can be completely released within 0.5 hour after being dissolved out in vitro, the effect is obviously better than that of the comparative example 1, the related substances are obviously better than that of the comparative example 1, and the stability of the invention is better.
The data show that the salidroside tablet prepared by the invention has simple and feasible process, can obviously improve the stability of the compound preparation, ensure the product quality, reduce the toxic and side effects, improve the compliance of patients, prolong the quality guarantee period of the medicine, and is suitable for the requirement of clinical medication development.
Claims (3)
1. The preparation method of the saligenin and chlorphenamine maleate tablet is characterized in that the saligenin and chlorphenamine maleate tablet comprises a drug-containing pellet and a drug-containing outer layer, wherein the pellet contains phenylephrine hydrochloride, brompheniramine maleate and pharmaceutically acceptable auxiliary materials, and the drug-containing outer layer contains acetaminophen, salicylamide, anhydrous caffeine and pharmaceutically acceptable auxiliary materials;
the pharmaceutically acceptable auxiliary materials in the pellet comprise: 50-80% of filler, 1-5% of adhesive and 0.5-4% of disintegrant, wherein the filler is microcrystalline cellulose or pregelatinized starch, the adhesive is water, and the disintegrant is crospovidone, carboxymethylcellulose calcium or sodium carboxymethyl starch;
the pharmaceutically acceptable auxiliary materials in the outer layer containing the medicine comprise 10 to 30 percent of filling agent, 0.5 to 2 percent of disintegrating agent and 0.5 to 2 percent of lubricant; wherein the filler is one or more of microcrystalline cellulose, pregelatinized starch, sucrose and starch;
the preparation method of the saligenin caffeine tablet comprises the following steps:
mixing phenylephrine hydrochloride, brompheniramine maleate, a filler and a disintegrating agent according to a prescription amount, then adding a wetting adhesive to prepare a soft material, preparing a pellet by using an extrusion spheronizer, drying, and coating a moisture-proof film coat to obtain the pellet; mixing acetaminophen, salicylamide, anhydrous caffeine and medicinal adjuvants, granulating, adding into the pellet, tabletting, and coating with moisture-proof film.
2. The method for preparing the paracetamol and caffeine tablet according to claim 1, wherein the disintegrating agent in the drug-containing outer layer is: one or more of crospovidone, croscarmellose sodium, carboxymethylcellulose calcium, and sodium carboxymethyl starch.
3. The method for preparing the paracetamol and caffeine tablet according to claim 1, wherein the lubricant in the drug-containing outer layer is one selected from magnesium stearate, calcium stearate and talcum powder.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911294031.1A CN110833540B (en) | 2019-12-16 | 2019-12-16 | Salicorol, caffeine and chlorphenamine maleate tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911294031.1A CN110833540B (en) | 2019-12-16 | 2019-12-16 | Salicorol, caffeine and chlorphenamine maleate tablet and preparation method thereof |
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| Publication Number | Publication Date |
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| CN110833540A CN110833540A (en) | 2020-02-25 |
| CN110833540B true CN110833540B (en) | 2022-02-08 |
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| CN113181128A (en) * | 2021-04-27 | 2021-07-30 | 南京恒远科技开发有限公司 | Salicophenol caffeine and chlorphenamine maleate three-layer tablet and preparation method thereof |
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