阅读说明：本技术 一种柳酚咖敏片及其制备方法 (Salicorol, caffeine and chlorphenamine maleate tablet and preparation method thereof ) 是由 胡峻 徐春夏 张兆伟 于 2019-12-16 设计创作，主要内容包括：本发明公开了一种柳酚咖敏片,如下方法制备：将所述的盐酸去氧肾上腺素、马来酸溴苯那敏、填充剂、崩解剂混合,然后加入润湿粘合剂制得软材,用挤出滚圆机制得微丸,干燥,包防潮薄膜衣,即得所述微丸,取对乙酰氨基酚、水杨酰胺、无水咖啡因及填充剂、崩解剂、润滑剂混合均匀制粒,加入所述微丸中,压制成片,包防潮薄膜衣,即得。本复方制剂通过制备成微丸,工艺简单可行,可明显提高复方制剂的稳定性,保证产品质量,降低毒副作用,提高了患者的顺应性,并且能延长药物的保质期,适合临床用药发展的需要。(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.)

1. The saligenin and chlorphenamine maleate tablet is characterized by comprising a drug-containing pellet and a drug-containing outer layer, wherein the pellet comprises phenylephrine hydrochloride, brompheniramine maleate and pharmaceutically acceptable auxiliary materials, and the drug-containing outer layer comprises acetaminophen, salicylamide, anhydrous caffeine and pharmaceutically acceptable auxiliary materials.

2. The paracetamol and caffeine tablet according to claim 1, wherein the pharmaceutically acceptable excipients in the pellets comprise: 50 to 80 percent of filling agent, 1 to 5 percent of adhesive and 0.5 to 4 percent of disintegrating agent.

3. The paracetamol and caffeine tablet according to claim 2, wherein the bulking agent is: one or more of microcrystalline cellulose, pregelatinized starch, and starch.

4. The paracetamol and caffeine tablet according to claim 2, wherein the binder is water.

5. The paracetamol and caffeine tablet according to claim 2, wherein the disintegrating agent is: one or more of crospovidone, croscarmellose sodium, carboxymethylcellulose calcium, sodium carboxymethyl starch, and low-substituted hydroxypropyl cellulose.

6. The paracetamol and caffeine tablet according to claim 1, wherein the pharmaceutically acceptable excipients in the outer drug-containing layer comprise 10% to 30% of a filler, 0.5% to 2% of a disintegrant, and 0.5% to 2% of a lubricant.

7. The paracetamol and caffeine tablet according to claim 6, wherein the pharmaceutical excipients are the following fillers: one or more of microcrystalline cellulose, pregelatinized starch, sucrose, and starch.

8. The paracetamol and caffeine tablet according to claim 6, wherein the pharmaceutical excipients are disintegrating agents: one or more of crospovidone, croscarmellose sodium, carboxymethylcellulose calcium, and sodium carboxymethyl starch.

9. The paracetamol and caffeine tablet according to claim 6, wherein the pharmaceutical excipients are selected from one of magnesium stearate, calcium stearate and talc.

10. The paracetamol and caffeine tablet according to claims 1 to 9, characterized by 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.

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.