CN115227722A - Preparation method of Paracetamol, caffein and chlorphenamine maleate capsules - Google Patents
Preparation method of Paracetamol, caffein and chlorphenamine maleate capsules Download PDFInfo
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Abstract
The invention relates to a preparation method of an Paracetamol, caffeine and chlorphenamine maleate capsule granule, which comprises the following steps: s1, sieving both corn starch and dextrin by a 80-mesh sieve; s2, uniformly dividing acetaminophen, anhydrous caffeine, chlorphenamine maleate and dextrin into five parts respectively, dividing corn starch into two parts, wherein one part of corn starch is used for pulping, and the rest part is uniformly divided into five parts; s3, preparing 15% starch slurry from the corn starch for pulping, and uniformly dividing the starch slurry into five parts for later use; s4, respectively using the granules A, B and C for preparing the Paracetamol, caffeine and chlorphenamine maleate granules; s5, respectively boiling and drying the particles A, the particles B and the particles C; s6, sieving the boiling-dried granules A, the boiling-dried granules B and the boiling-dried granules C respectively through a vibrating sieve. The Paracetamol, radix aconiti kusnezoffii and chlorphenamine maleate capsules prepared by the method are bright in color, uniform in particle, free of powder, convenient to fill the particles into the capsules, stable in filling amount and capable of effectively guaranteeing quality safety of the capsules.
Description
Technical Field
The invention belongs to the technical field of medicinal preparations, and particularly relates to a preparation method of an Paracetamol, caffeine and chlorphenamine maleate capsule granule.
Background
Paracetamol, caffeine, chlorphenamine maleate and artificial bezoar are effective components of the Ankahuangmin, which is a common cold drug. Acetaminophen has analgesic and antipyretic effects, and can inhibit synthesis of prostaglandin in central nervous system and block impulse of pain nerve terminal to produce analgesic effect, and relieve fever by regulating central blood vessel dilation, sweating and heat dissipation via hypothalamus temperature. The caffeine (small dose) acts on nerve center of cerebral cortex to excite mental, relieve fatigue, and promote cerebral vasoconstriction and relieve permeability caused by cerebral vasodilation. Chlorpheniramine maleate is an antihistamine, has the function of competitively blocking histamine receptors, can relieve allergic symptoms, and can also relieve symptoms caused by cold, such as nasal obstruction, watery nasal discharge, sneeze and the like. The artificial bezoar has effects of relieving fever and pain, relieving cough and eliminating phlegm, resisting bacteria, virus and allergy, activating acetaminophen, and enhancing pain relieving and fever relieving effects.
At present, the preparation method of the content of the Paracetamol and chlorphenamine maleate capsules mainly comprises the steps of mixing raw material medicines of acetaminophen, caffeine, chlorphenamine maleate and artificial bezoar, adding auxiliary materials, granulating, drying and finishing granules. However, the content prepared by the existing preparation method is granules and powder, the powder is grey in color and luster, and the granules are different in size, so that the capsules are inconvenient to fill, and the filling amount difference is large, thereby influencing the quality safety of the Paracetamol and chlorphenamine maleate capsules.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides the preparation method of the Ankahuangmin capsule particles, the prepared Ankahuangmin capsule particles are bright in color, uniform in particle, free of powder, convenient to fill the particles into the capsule, stable in filling amount and capable of effectively ensuring the quality safety of the capsule.
In order to achieve the purpose, the technical scheme of the invention is as follows:
the preparation method of the Ankahuangmin capsule particles comprises the following steps of taking acetaminophen, anhydrous caffeine, chlorphenamine maleate, artificial bezoar, corn starch, dextrin and carmine pigment according to pharmacopoeia:
s1, screening corn starch and dextrin through a 80-mesh sieve by adopting a vortex type vibrating sieve;
s2, taking a proper amount of acetaminophen, anhydrous caffeine, chlorphenamine maleate, artificial bezoar, corn starch, dextrin and carmine pigment, uniformly dividing acetaminophen, anhydrous caffeine, chlorphenamine maleate and dextrin into five parts respectively, dividing the corn starch into two parts firstly, wherein one part of the corn starch is used for pulping, and the other part is uniformly divided into five parts;
s3, placing the corn starch for pulping into a pulping pot, adding a proper amount of purified water, uniformly stirring, heating to prepare 15% starch slurry, cooling, and uniformly dividing into five parts for later use;
s4, preparing three particles of the Paracetamol, caffeine and chlorphenamine maleate capsules, namely particles A, particles B and particles C respectively;
preparing granules A, respectively taking a part of acetaminophen, anhydrous caffeine, chlorphenamine maleate, corn starch and dextrin, dry-mixing the acetaminophen, the anhydrous caffeine, the chlorphenamine maleate, the corn starch and the dextrin, adding a part of 15% starch slurry, stirring and cutting, finally preparing the granules A by using a granulator with a 22-mesh nylon screen, and simultaneously or respectively preparing three-machine granules A; combining the two, performing shot blasting by using a shot blasting machine, adding a proper amount of purified water during shot blasting, and performing standby after the shot blasting is completed;
preparing granules B, respectively putting a part of acetaminophen, anhydrous caffeine, chlorphenamine maleate, corn starch and dextrin and artificial bezoar into a wet mixing granulator for dry mixing, then adding a part of 15% starch slurry for stirring and cutting, finally preparing the granules B by a granulator with a 22-mesh nylon screen mesh, and preparing a machine of granules B; performing shot blasting on the prepared particles B by using a shot blasting machine, adding a proper amount of purified water during shot blasting, and performing standby after the shot blasting is completed;
preparing particles C, respectively putting the last part of acetaminophen, anhydrous caffeine, chlorphenamine maleate, corn starch and dextrin into a wet mixing granulator for dry mixing, adding 15% starch slurry mixed with carmine pigment into the granulator, stirring and cutting, and preparing the particles C by using a granulator with a 22-mesh nylon screen mesh to prepare one machine of particles C; performing shot blasting on the prepared particles C by using a shot blasting machine, adding a proper amount of purified water during shot blasting, and reserving for later use after the shot blasting is completed;
s5, respectively putting the shot-blasted particles A, B and C into a boiling dryer for boiling drying;
s6, sieving the boiling-dried granules A, B and C respectively through vibrating sieves with an upper 14-mesh sieve and a lower 40-mesh sieve, and respectively containing the sieved granules by using low-density polyethylene bags.
Preferably, in the S2, the acetaminophen is 375Kg, the anhydrous caffeine is 20.6Kg, the chlorpheniramine maleate is 1.5Kg, the artificial bezoar is 15Kg, the corn starch is 51.15Kg, the dextrin is 36Kg, and the carmine pigment is 105g.
Preferably, in the S2, the amount of each part of acetaminophen is 75Kg, the amount of anhydrous caffeine is 4.12Kg, the amount of chlorpheniramine maleate is 0.3Kg, and the amount of dextrin is 7.2Kg;
two portions of corn starch, wherein the portion of the corn starch used for pulping is 26.25Kg, the portion of the other portion of the corn starch is 24.9Kg, and after the five portions are divided, the portion of each portion is 4.98Kg.
Preferably, in the S3, the part amount of the purified water is 149Kg; heating the beaten corn starch at 80-90 ℃ for 40min; the 15% starch slurry was divided into five portions each of which was 35Kg in weight.
Preferably, in the S4, the weight of the particles A added into each shot blasting machine is 20-25Kg.
Preferably, in the step S4, the dry mixing time for preparing the particles a, the particles B and the particles C is 10min; the stirring and chopping time is 6min; the frequency of the rotating speed of the shot blasting machine is set to be 10HZ-15HZ, the shot blasting time is 10-15min, and the purified water added in each shot blasting machine is 50ML.
Preferably, in the S4, the carmine pigment is added to 15% starch slurry after being boiled with 100g of hot water.
Preferably, in the S5, the boiling drying process includes setting the air inlet temperature of the boiling dryer to 100 ℃, the air outlet temperature to 40 ℃, starting the steam switch, starting the air door for drying, boiling, heating, drying and starting the material, drying for 15-30min, measuring moisture, controlling the moisture of the particles to be below 3.0%, stopping heating, inducing air to boil, reducing the temperature to be below 30 ℃, closing the switch, discharging, and naturally cooling.
The invention has the technical effects and advantages that:
according to the preparation method of the Ankahuangmin capsule particles, provided by the invention, after wet mixing and granulation, the shot blasting machine is used for carrying out shot blasting, and after boiling and drying, the vibrating screen is used for sieving, so that the prepared Ankahuangmin capsule particles are bright in color, uniform in particle and free of powder, the capsule shell is not adhered with powder during filling, the particles are conveniently filled into the capsule, the filling amount is stable, and the quality safety of the capsule is effectively guaranteed.
Drawings
FIG. 1 is a diagram showing the effect of the Ankahuangmin capsule granules prepared by the invention;
FIG. 2 is a graph showing the effect of the Paracetamol, kahuangmin and chlorphenamine maleate granules prepared by the prior art;
FIG. 3 is a diagram showing the effect of filling capsules of the Paracetamol, cabernet Sambucus seed and Paracetamol capsules prepared by the present invention;
FIG. 4 is a diagram showing the effect of filling capsules of Paracetamol, cabernet Sambucus and Paracetamol capsules prepared by the prior art.
Detailed Description
The present invention will be described in further detail with reference to the following examples, which are given in conjunction with the accompanying drawings.
Examples
A preparation method of an Paracetamol and chlorphenamine maleate capsule particle comprises raw material components of acetaminophen, anhydrous caffeine, chlorphenamine maleate, artificial bezoar, corn starch, dextrin and carmine pigment.
The preparation method comprises the following steps:
s1, screening the corn starch and the dextrin through a 80-mesh sieve by adopting a vortex type vibration sieve.
S2, taking 375Kg of acetaminophen, 20.6Kg of anhydrous caffeine, 1.5Kg of chlorphenamine maleate, 15Kg of artificial bezoar, 51.15Kg of corn starch, 36Kg of dextrin and 105g of carmine pigment according to production instructions, uniformly dividing acetaminophen, anhydrous caffeine, chlorphenamine maleate and dextrin into five parts respectively, dividing corn starch into two parts, pulping one part of corn starch, and uniformly dividing the other part into five parts.
The specific implementation method comprises the following steps of 75Kg of acetaminophen, 4.12Kg of anhydrous caffeine, 0.3Kg of chlorpheniramine maleate and 7.2Kg of dextrin.
Two portions of corn starch, wherein the portion of the pulped corn starch is 26.25Kg, the portion of the other portion of corn starch is 24.9Kg, and after the corn starch is divided into five portions, the portion of each portion is 4.98Kg.
S3, placing the pulped corn starch into a pulping pot, adding 149Kg of purified water, stirring uniformly, heating the mixture to prepare 15% starch slurry, cooling and uniformly dividing the starch slurry into five parts for later use.
In specific implementation, the heating temperature of the pulping corn starch is 80-90 ℃, and the heating time is 40min; the 15% starch slurry is prepared with 175Kg of starch slurry, and after being divided into five parts, each part is 35Kg of starch slurry.
S4, respectively preparing three particles of the Paracetamol, cabernet Sagittifolium and Paracetamol, wherein the three particles are particle A, particle B and particle C.
Wherein, preparing the granule A, respectively taking 75Kg of acetaminophen, 4.12Kg of anhydrous caffeine, 0.3Kg of chlorphenamine maleate, 4.98Kg of corn starch and 7.2Kg of dextrin, dry-mixing for 10min in a wet mixing granulator, then adding 35Kg of 15% starch slurry, stirring and cutting for 6min, and finally preparing the granule A by a granulator with a 22-mesh nylon screen; and performing shot blasting on the prepared particles A for 10-15min by using a shot blasting machine, adding 50ML of purified water during shot blasting, and taking the condition that spherical particles are uniform and have no agglomeration visually as the criterion, wherein the particles are ready for use after the shot blasting is finished.
In specific implementation, the method and the parts are used for preparing three machines of particles A, the weight of the particles A added into each machine of shot blasting machine is 20-25Kg, and the frequency of the rotating speed of the shot blasting machine is set to be 10HZ-15HZ.
Preparing granules B, namely respectively putting 75Kg of acetaminophen, 4.12Kg of anhydrous caffeine, 0.3Kg of chlorphenamine maleate, 4.98Kg of corn starch and 7.2Kg of dextrin and 15Kg of calculus bovis factitious into a wet mixing granulator for dry mixing for 10min, adding 35Kg of 15% starch slurry, stirring and cutting for 6min, and finally preparing the granules B by using a granulator with a 22-mesh nylon screen; and performing shot blasting on the prepared particles B for 10-15min by using a shot blasting machine, adding 50ML of purified water during shot blasting, and taking the condition that spherical particles are uniform and have no agglomeration by visual inspection as the criterion, wherein the particles B are reserved after the shot blasting is finished.
In specific implementation, one machine of particles B is prepared, the weight of the particles B added into the shot blasting machine is 20-25Kg, and the frequency of the rotating speed of the shot blasting machine is set to be 10HZ-15HZ.
Preparing particles C, namely respectively putting 75Kg of acetaminophen, 4.12Kg of anhydrous caffeine, 0.3Kg of chlorphenamine maleate, 4.98Kg of corn starch and 7.2Kg of dextrin into a wet mixing granulator for dry mixing for 10min, adding 35Kg of 15% starch slurry mixed with 105g of carmine pigment into the granulator, stirring and cutting the mixture for 6min, and finally preparing the particles C by using a granulator with a 22-mesh nylon screen, wherein the particles C are prepared by one machine; and performing shot blasting on the prepared particles C for 10-15min by using a shot blasting machine, adding 50ML of purified water during shot blasting to ensure that spherical particles are uniform and have no agglomeration by visual inspection, and performing the shot blasting for later use.
In specific implementation, one machine of particles C is prepared, the weight of the particles C added into the shot blasting machine is 20-25Kg, and the frequency of the rotating speed of the shot blasting machine is set to be 10HZ-15HZ.
In specific implementation, the carmine pigment is added into 15% starch slurry after 100g of hot water is boiled.
And S5, respectively putting the shot-blasted particles A, B and C into a boiling dryer for boiling drying.
Specifically, the boiling drying process comprises setting the air inlet temperature of the boiling dryer to be 100 ℃, the air outlet temperature to be 40 ℃, starting a steam switch, starting an air door, starting an air adjusting door for drying, boiling, heating, drying and starting the material, drying for 15-30min, measuring moisture, controlling the moisture of particles to be below 3.0%, stopping heating, inducing air to boil, reducing the temperature to be below 30 ℃, closing a switch, discharging, and naturally cooling.
S6, sieving the boiling-dried granules A, B and C respectively through vibrating sieves with an upper 14-mesh sieve and a lower 40-mesh sieve, and respectively containing the sieved granules by using low-density polyethylene bags.
According to the invention, after wet mixing granulation, shot blasting is carried out by using a shot blasting machine, and after boiling drying, the granules are sieved by using a vibrating sieve, so that the prepared Paracetamol, cabernet Sambucus williamsii Hance capsule granules are bright in color, uniform in granule and free of powder, and the comparison between the figure 1 and the figure 2 shows that. Thereby rendering the capsule shell powder-free upon filling, as can be seen by comparing fig. 3 and 4. The Paracetamol, radix aconiti kusnezoffii and chlorphenamine maleate capsules prepared by the invention can be conveniently filled into capsules, are stable in filling amount, and effectively ensure the quality safety of the capsules.
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, it is possible to make various changes and modifications without departing from the inventive concept, and these changes and modifications are all within the scope of the present invention.
Claims (8)
1. A preparation method of an Paracetamol, caffein and chlorphenamine maleate capsule particle is characterized by comprising the following steps: the Paracetamol, anhydrous caffeine, chlorphenamine maleate, artificial bezoar, corn starch, dextrin and carmine pigment are taken according to pharmacopeia, and the preparation method comprises the following steps:
s1, screening corn starch and dextrin through a 80-mesh sieve by adopting a vortex type vibration sieve;
s2, taking a proper amount of acetaminophen, anhydrous caffeine, chlorphenamine maleate, artificial bezoar, corn starch, dextrin and carmine pigment, uniformly dividing acetaminophen, anhydrous caffeine, chlorphenamine maleate and dextrin into five parts respectively, dividing the corn starch into two parts firstly, wherein one part of the corn starch is used for pulping, and the other part is uniformly divided into five parts;
s3, placing the corn starch for pulping into a pulping pot, adding a proper amount of purified water, uniformly stirring, heating to prepare starch slurry with the mass ratio of 15%, cooling, and uniformly dividing into five parts for later use;
s4, respectively preparing three particles of the Paracetamol, cabernet Sagittiflora and Paracetamol, wherein the three particles are respectively particle A, particle B and particle C;
preparing granules A, respectively taking a part of acetaminophen, anhydrous caffeine, chlorphenamine maleate, corn starch and dextrin, dry-mixing the acetaminophen, the anhydrous caffeine, the chlorphenamine maleate, the corn starch and the dextrin, adding a part of 15% starch slurry, stirring and cutting, finally preparing the granules A by using a granulator with a 22-mesh nylon screen, and simultaneously or respectively preparing three-machine granules A; combining the two, performing shot blasting by using a shot blasting machine, adding a proper amount of purified water during shot blasting, and performing standby after the shot blasting is finished;
preparing granules B, respectively taking a part of acetaminophen, anhydrous caffeine, chlorphenamine maleate, corn starch and dextrin, putting the mixture and artificial bezoar into a wet mixing granulator for dry mixing, then adding a part of 15% starch slurry for stirring and cutting, finally preparing the granules B by using a granulator with a nylon screen mesh of 22 meshes, and preparing one machine of granules B; performing shot blasting on the prepared particles B by using a shot blasting machine, adding a proper amount of purified water during shot blasting, and reserving for later use after the shot blasting is completed;
preparing granules C, namely respectively putting the last part of acetaminophen, anhydrous caffeine, chlorphenamine maleate, corn starch and dextrin into a wet mixing granulator for dry mixing, adding 15% starch slurry mixed with carmine pigment into the granulator for stirring and cutting, preparing the granules C by using a granulator with a nylon screen mesh of 22 meshes, and preparing the granules C by using a machine; performing shot blasting on the prepared particles C by using a shot blasting machine, adding a proper amount of purified water during shot blasting, and performing standby after the shot blasting is completed;
s5, respectively putting the shot-blasted particles A, B and C into a boiling dryer for boiling drying;
s6, sieving the boiling-dried particles A, B and C respectively through vibrating sieves with an upper 14-mesh sieve and a lower 40-mesh sieve, and respectively containing the sieved particles by using low-density polyethylene bags.
2. The preparation method of the Ankahuangmin capsule granules according to claim 1, wherein the preparation method comprises the following steps: in the S2, 375Kg of acetaminophen, 20.6Kg of anhydrous caffeine, 1.5Kg of chlorpheniramine maleate, 15Kg of calculus bovis factitious, 51.15Kg of corn starch, 36Kg of dextrin and 105g of carmine are taken.
3. The preparation method of the Ankahuangmin capsule granules according to claim 2, wherein the preparation method comprises the following steps: in the S2, the weight of each part of acetaminophen is 75Kg, the weight of anhydrous caffeine is 4.12Kg, the weight of chlorpheniramine maleate is 0.3Kg, and the weight of dextrin is 7.2Kg;
two portions of corn starch, wherein the portion of the corn starch for beating is 26.25Kg, the portion of the other portion of the corn starch is 24.9Kg, and after the corn starch is divided into five portions, the portion of each portion is 4.98Kg.
4. The preparation method of the Ankahuangmin capsule granules according to claim 1, wherein the preparation method comprises the following steps: in the S3, the part of the purified water is 149Kg; the heating temperature of the corn starch for pulping is 80-90 ℃, and the heating time is 40min; the 15% starch slurry is prepared with 175Kg of starch slurry, and after being divided into five parts, each part is 35Kg of starch slurry.
5. The method for preparing the Paracetamol, cabernet Sambucus capsules according to claim 1, wherein the method comprises the following steps: in S4, the weight of the particles A added into each shot blasting machine is 20-25Kg.
6. The method for preparing the Paracetamol, cabernet Sagittiflora and Hemsleya amabilis capsule particles according to claim 5, wherein the Paracetamol, cabernet Sauvignon and Hemsleya amabilis capsule particles are prepared by the following steps: in the S4, the dry mixing time for preparing the particles A, the particles B and the particles C is 10min; the stirring and chopping time is 6min; the rotating speed frequency of the shot blasting machine is set to be 10HZ-15HZ, the shot blasting time is 10-15min, and the purified water added in each shot blasting machine is 50ML.
7. The method for preparing the Paracetamol, cabernet Sagittiflora and Hemsleya amabilis capsule particles according to claim 5, wherein the Paracetamol, cabernet Sauvignon and Hemsleya amabilis capsule particles are prepared by the following steps: in the S4, the carmine pigment is added into 15% starch slurry after 100g of hot water is dissolved.
8. The method for preparing the Paracetamol, cabernet Sambucus capsules according to claim 1, wherein the method comprises the following steps: and in the S5, in the boiling drying process, setting the air inlet temperature of the boiling dryer to be 100 ℃, the air outlet temperature to be 40 ℃, starting a steam switch, starting an air door, starting an air adjusting door for drying, boiling, heating, drying and starting the material, drying for 15-30min, measuring moisture, controlling the moisture of the particles to be below 3.0%, stopping heating, inducing air to boil, reducing the temperature to be below 30 ℃, closing a switch, discharging, and naturally cooling.
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CN105748522A (en) * | 2014-12-17 | 2016-07-13 | 康普药业股份有限公司 | Compound paracetamol and amantadine hydrochloride capsule and preparation method thereof |
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