CN113384549A - Acetaminophen vitamin C effervescent tablet and preparation method thereof - Google Patents
Acetaminophen vitamin C effervescent tablet and preparation method thereof Download PDFInfo
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Abstract
The invention relates to an acetaminophen vitamin C effervescent tablet and a preparation method thereof. The paracetamol vitamin C effervescent tablet is prepared from an acidic component, an alkaline component, an auxiliary material and an adhesive solution; wherein the acidic component comprises vitamin C, anhydrous citric acid, DL-tartaric acid; the alkaline component comprises acetaminophen and sodium bicarbonate; the auxiliary materials comprise sucrose, polyethylene glycol 6000 and sodium benzoate; the adhesive solution comprises polyvinylpyrrolidone K29/32, 95% medicinal ethanol and purified water. The acetaminophen vitamin C effervescent tablet has good disintegration and solubility and no sticking phenomenon through optimization of formula components and optimization of formula structure; in addition, the preparation method carries out wet granulation on the acid component and the alkaline component in the formula respectively by reasonably arranging the production process so as to avoid the problem that the acid component and the alkaline component are subjected to acid-base reaction in the presence of moisture to cause failure of the acid component and the alkaline component due to direct wet granulation.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to an acetaminophen vitamin C effervescent tablet and a preparation method thereof.
Background
Acetaminophen (paraetamol), otherwise known as Tylenol (Tylenol), beneton (Panadol), buperanin (bufferine), Paracetamol, an in vivo metabolite of phenacetin, reduces the synthesis and release of prostaglandin PGE1, bradykinin and histamine, etc., by inhibiting hypothalamic thermoregulatory central prostaglandin synthase. PGE1 acts mainly on nerve center, and its decrease will result in the decrease of central body temperature set point, and the body temperature receptor feels relatively hot, and thus the peripheral blood vessel is dilated and sweaty through nerve regulation to achieve antipyretic effect.
Vitamin C is a water-soluble vitamin belonging to the group of polyhydroxy compounds and having the chemical formula C6H8O6Often found in vegetables and fruits, and may also be artificially synthesized. Vitamin C is necessary for antibody and collagen formation, tissue repair (including certain redox actions), metabolism of phenylalanine, tyrosine and folic acid, utilization of iron and carbohydrate, synthesis of fat and protein, maintenance of immune function, hydroxylation of 5-hydroxytryptamine, maintenance of vascular integrity, promotion of non-heme iron absorption and the like; vitamin C is mainly used for preventing and treating scurvy, can enhance body resistance, is used for preventing and treating various acute and chronic infectious diseases and other diseases, and can be used for the adjuvant treatment of convalescent period after illness, wound healing period and allergic diseases. Meanwhile, the vitamin C also has the effects of resisting oxidation, resisting free radicals and inhibiting the formation of tyrosinase, thereby achieving the effects of whitening and fading spots.
The effervescent tablet is a novel medicament dosage form, is different from a common tablet, takes organic acid and alkali type carbonate (hydrogen) as an effervescent disintegrant, is put into water, generates an effervescent reaction immediately, generates and releases a large amount of carbon dioxide gas, accelerates the disintegration and melting of the effervescent tablet, is favorable for improving the bioavailability of the medicament, is a cup of sour, sweet and delicious drink after the effervescent tablet with better quality effervesces, and is very suitable for children, old people and patients who can not swallow.
Because the raw materials of the effervescent tablet comprise acidic auxiliary materials and alkaline auxiliary materials, if moisture exists in the production process, acid-base reaction is easily caused, the production of the effervescent tablet in the prior art mostly adopts a method of non-aqueous granulation tabletting, namely, tabletting after dry granulation, or directly compressing raw material powder to form tablets, but the properties and the crystallization shapes of various raw material materials are different, which brings difficulty to dry granulation, and special equipment is needed for the dry granulation; the mode of directly pressing raw material powder to form a sheet body has the defects of poor powder flowability, large sheet weight difference, easy cracking of powder tabletting and the like, so that the application of the process is limited to a certain extent.
Disclosure of Invention
Based on the above, the present invention provides an acetaminophen vitamin C effervescent tablet and a preparation method thereof, which have the advantages of rapid disintegration, effective dissolution of the drug, simple production process, and high applicability.
The embodiment of the invention achieves the technical purpose through the following technical scheme:
an acetaminophen vitamin C effervescent tablet is prepared from an acidic component, an alkaline component, an auxiliary material and an adhesive solution; the acid component comprises the following raw materials in parts by weight: 180-220 parts of vitamin C, 350-450 parts of anhydrous citric acid and 350-450 parts of DL-tartaric acid; the alkaline component comprises the following raw materials in parts by weight: 300-350 parts of acetaminophen and 1100-1150 parts of sodium bicarbonate; the auxiliary materials comprise the following raw materials in parts by weight: 300-500 parts of cane sugar, 600080-90 parts of polyethylene glycol and 40-60 parts of sodium benzoate; the adhesive solution comprises the following raw materials in parts by weight: polyvinyl pyrrolidone K29/322-3 parts, 95% medicinal ethanol 70-85 parts, and purified water 40-50 parts.
Further, the acid component comprises the following raw materials in parts by weight: 200 parts of vitamin C, 400 parts of anhydrous citric acid and 400 parts of DL-tartaric acid; the alkaline component comprises the following raw materials in parts by weight: 330 parts of acetaminophen and 1120 parts of sodium bicarbonate; the auxiliary materials comprise the following raw materials in parts by weight: 400 parts of cane sugar, 600087 parts of polyethylene glycol and 50 parts of sodium benzoate; the adhesive comprises the following raw materials in parts by weight: polyvinyl pyrrolidone K29/322.5 parts, 95% medicinal ethanol 79 parts and purified water 46 parts.
In addition, the preparation method of the acetaminophen-vitamin C effervescent tablet provided by the embodiment of the invention comprises the following specific operation steps:
s1, preprocessing: respectively crushing the acidic component and the alkaline component, and sieving the sucrose;
s2, adhesive preparation: the formula amount of polyvinylpyrrolidone K29/32 was adjusted in a ratio of 1.1: 1.4, distributing the mixture into two preparation devices according to the weight part ratio, and mixing the 95% medicinal ethanol with the formula amount according to the ratio of 8: 7, respectively adding the mixture into two preparation devices, and then adding the formula amount of purified water according to a ratio of 2: 7, respectively adding the components into two preparation devices in parts by weight, and respectively obtaining an acid adhesive solution and an alkaline adhesive solution after uniformly mixing;
s3, granulating acidic auxiliary materials: weighing the anhydrous citric acid, DL-tartaric acid, vitamin C and half of the sucrose in formula amount after crushing, and adding into wet granulation equipment, wherein the stirring speed is 80-100 rpm, the cutter speed is 800-1200 rpm, and the operation time is 8-12 min; then starting the stirring speed to be 80-100 rpm, rotating the cutter at 1000-1400 rpm, and atomizing and adding the acid binder solution for 1-2 min; finally, starting stirring at a rotating speed of 80-100 rpm, operating at a rotating speed of 1000-1400 rpm for 3-5 min, finishing granulation, and selecting a 24-mesh screen for granulation to obtain acid particles;
s4, granulating basic auxiliary materials: weighing sodium bicarbonate, acetaminophen and cane sugar which are crushed according to the formula amount and the rest formula amount, adding the sodium bicarbonate, the acetaminophen and the cane sugar into wet granulation equipment, wherein the stirring speed is 80-100 rpm, the cutter speed is 800-1200 rpm, and the operation time is 8-12 min; then starting the stirring speed to be 80-100 rpm, rotating the cutter at 1000-1400 rpm, and atomizing and adding the alkali binder solution for 2-3 min; finally, starting stirring at a rotating speed of 80-100 rpm, operating at a rotating speed of 1000-1400 rpm for 2-4 min, finishing granulation, and finishing granules by using a 24-mesh screen to obtain alkaline granules;
s5, drying: uniformly spreading the acidic particles and the alkaline particles obtained in the steps S3 and S4 on a plate, drying until the moisture of the particles is less than 2%, and finishing the dried particles;
s6, total mixing: putting the acid particles and the alkaline particles dried in the step S5, and polyethylene glycol 6000 and sodium benzoate in a formula amount into a mixing device for total mixing to obtain mixed particles;
s7, tabletting: tabletting the mixed granules by using a die and a punch, wherein the difference of tablet weight is controlled within +/-5.0%, and the hardness is controlled to be 100-140N;
s8, packaging: and (5) packaging the tablet preparation obtained in the step (S7) to obtain the acetaminophen vitamin C effervescent tablet.
Further, in step S1, a 30B universal pulverizer is used for pulverization, wherein the acidic component is pulverized with 60 mesh, the alkaline component is pulverized with 80 mesh, and the sucrose is sieved with a 60 mesh stainless steel sieve.
Further, in the step S5, drying is performed in a hot air circulation oven, the drying temperature is 55 ℃, wherein the particles need to be turned over once every 10 minutes of drying, sampling is performed after drying for 2.5 hours to detect moisture, and the particles are taken out of the oven after the moisture of the particles is measured to be less than 2%; and finishing the dried particles by using a 24-mesh stainless steel screen.
Further, before the total mixing in step S6, the method further comprises 80-mesh crushing of sodium benzoate using a 30B universal crusher.
Further, in the step S7, the environmental temperature is controlled to be below 25 ℃ and the humidity is controlled to be within 30% RH during the tabletting operation, and the tabletting is performed
Circle ofAnd (3) performing flat and oblique punching, and lubricating a punch by using 3-5 parts by weight of magnesium stearate before tabletting.
The acetaminophen vitamin C effervescent tablet provided by the embodiment of the invention utilizes the effervescent reaction of the effervescent tablet when the effervescent tablet is put into water, so that a large amount of carbon dioxide gas is generated and released, the disintegration and melting of the preparation are promoted, the bioavailability of acetaminophen and vitamin C is improved, and the optimization of formula components and formula structure is matched, so that the effervescent tablet has good disintegration and solubility and no sticking phenomenon; in addition, in the preparation process of the paracetamol and vitamin C effervescent tablet provided by the embodiment of the invention, the production process is reasonably arranged, the acid component and the alkaline component in the formula are respectively subjected to wet granulation to avoid the problem that the acid component and the alkaline component are subjected to acid-base reaction in the presence of moisture to cause failure of the acid component and the alkaline component due to direct wet granulation, meanwhile, compared with the non-aqueous granulation tabletting adopted by the effervescent tablet in the prior art or the method for directly pressing the raw material powder into the tablet body, the preparation method of the embodiment of the invention has small influence on the properties and the crystal shapes of various materials, and special granulation equipment is not needed, the pressing flowability is good, the tablet weight difference and the tablet form are easy to control, and the applicability of the effervescent tablet production process is effectively improved.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention more comprehensible, embodiments of the present invention are described in detail below.
In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, but the present invention may be practiced in other ways than those specifically described herein, and it will be apparent to those of ordinary skill in the art that the present invention may be practiced without departing from the spirit and scope of the present invention, and therefore the present invention is not limited by the examples disclosed below.
Example 1
The embodiment 1 of the invention provides an acetaminophen vitamin C effervescent tablet, which comprises an acidic component, an alkaline component, an auxiliary material and an adhesive solution; the acid component comprises the following raw materials in parts by weight: 180 parts of vitamin C, 350 parts of anhydrous citric acid and 350 parts of DL-tartaric acid; the alkaline component comprises the following raw materials in parts by weight: 300 parts of acetaminophen and 1100 parts of sodium bicarbonate; the auxiliary materials comprise the following raw materials in parts by weight: 300 parts of cane sugar, 600080 parts of polyethylene glycol and 40 parts of sodium benzoate; the adhesive comprises the following raw materials in parts by weight: polyvinyl pyrrolidone K29/322 parts, 95% medicinal ethanol 70 parts and purified water 40 parts.
Example 2
Embodiment 2 of the invention provides an acetaminophen vitamin C effervescent tablet, which comprises an acidic component, an alkaline component, an auxiliary material and an adhesive solution; the acid component comprises the following raw materials in parts by weight: 220 parts of vitamin C, 450 parts of anhydrous citric acid and 450 parts of DL-tartaric acid; the alkaline component comprises the following raw materials in parts by weight: 350 parts of acetaminophen and 1150 parts of sodium bicarbonate; the auxiliary materials comprise the following raw materials in parts by weight: 500 parts of cane sugar, 600090 parts of polyethylene glycol and 60 parts of sodium benzoate; the adhesive comprises the following raw materials in parts by weight: polyvinyl pyrrolidone K29/323 parts, 95% medicinal ethanol 85 parts and purified water 50 parts.
Example 3
Embodiment 3 of the present invention provides an acetaminophen vitamin C effervescent tablet, which includes an acidic component, an alkaline component, an adjuvant, and a binder solution; the acid component comprises the following raw materials in parts by weight: 200 parts of vitamin C, 400 parts of anhydrous citric acid and 400 parts of DL-tartaric acid; the alkaline component comprises the following raw materials in parts by weight: 330 parts of acetaminophen and 1120 parts of sodium bicarbonate; the auxiliary materials comprise the following raw materials in parts by weight: 400 parts of cane sugar, 600087 parts of polyethylene glycol and 50 parts of sodium benzoate; the adhesive comprises the following raw materials in parts by weight: polyvinyl pyrrolidone K29/322.5 parts, 95% medicinal ethanol 79 parts and purified water 46 parts.
Example 4
Embodiment 4 of the present invention provides a method for preparing an acetaminophen vitamin C effervescent tablet, which is prepared according to the formula ratio of the acetaminophen vitamin C effervescent tablet described in embodiment 1, and comprises the following specific operation steps:
s1, preprocessing: respectively crushing the acidic component and the alkaline component, and sieving the sucrose;
the embodiment of the invention adopts a 30B universal pulverizer for pulverization, wherein the acidic component is pulverized by 60 meshes, the alkaline component is pulverized by 80 meshes, and sucrose is sieved by a 60-mesh stainless steel sieve;
preparing an adhesive: the formula amount of polyvinylpyrrolidone K29/32 was adjusted in a ratio of 1.1: 1.4, distributing the mixture into two preparation devices according to the weight part ratio, and mixing the 95% medicinal ethanol with the formula amount according to the ratio of 8: 7, respectively adding the mixture into two preparation devices, and then adding the formula amount of purified water according to a ratio of 2: 7, respectively adding the components into two preparation devices in parts by weight, and respectively obtaining an acid adhesive solution and an alkaline adhesive solution after uniformly mixing;
s3, granulating acidic auxiliary materials: weighing the anhydrous citric acid, DL-tartaric acid, vitamin C and half of the sucrose in formula amount after crushing, and adding into an LHS400B high-efficiency wet mixing granulator, wherein the stirring speed is 80rpm, the cutter speed is 800rpm, and the running time is 12 min; then starting the stirring speed to be 80rpm, starting the cutter to rotate at the speed of 1000rpm, and atomizing and adding the acid binder solution for 2 min; finally, starting a stirring rotating speed of 80rpm, starting a cutter rotating speed of 1000rpm, running for 3min, finishing granulation and selecting a 24-mesh screen for granulation to obtain acid particles;
s4, granulating basic auxiliary materials: weighing sodium bicarbonate, acetaminophen and cane sugar which are crushed according to the formula amount and the rest formula amount, and adding the sodium bicarbonate, the acetaminophen and the cane sugar into an LHS400B high-efficiency wet mixing granulator, wherein the stirring speed is 80rpm, the cutter speed is 800rpm, and the running time is 8-12 min; then starting the stirring speed to be 80rpm, starting the cutter to rotate at the speed of 1000rpm, and atomizing and adding the alkali binder solution for 2 min; finally, starting a stirring rotating speed of 80rpm, starting a cutter rotating speed of 1000rpm, running for 4min, finishing granulation and selecting a 24-mesh screen for finishing granules to obtain alkaline granules;
s5, drying: respectively and uniformly spreading the acidic particles and the alkaline particles obtained in the steps S3 and S4 on a plate, conveying the acidic particles and the alkaline particles into a hot air circulation oven for drying, wherein the drying temperature is 55 ℃, the particles need to be turned over once every 10 minutes of drying, sampling and detecting the moisture after drying for 2.5 hours, and taking the particles out of the oven after the moisture of the particles is measured to be less than 2%; finishing the dried particles by using a 24-mesh stainless steel screen;
s6, total mixing: putting the acid particles and the alkaline particles dried in the step S5, and polyethylene glycol 6000 and sodium benzoate in a formula amount into a mixing device for total mixing to obtain mixed particles; wherein the sodium benzoate needs to be crushed into 80 meshes by a 30B universal crusher before being put into the total mixing;
s7, tabletting: tabletting the mixed granules by using a die and a punch, controlling the difference of tablet weight within +/-5.0%, controlling the hardness within 100-140N, controlling the environmental temperature below 25 ℃ and the humidity within 30% RH during tabletting operation, and tabletting
Before tabletting, lubricating the punch by using magnesium stearate with the total weight of 3 parts;
s8, packaging: and (5) packaging the tablet preparation obtained in the step (S7) to obtain the acetaminophen vitamin C effervescent tablet.
Example 5
Embodiment 5 of the present invention provides a method for preparing an acetaminophen vitamin C effervescent tablet, which is prepared according to the formula ratio of the acetaminophen vitamin C effervescent tablet described in embodiment 2, and comprises the following specific operation steps:
s1, preprocessing: respectively crushing the acidic component and the alkaline component, and sieving the sucrose;
the embodiment of the invention adopts a 30B universal pulverizer for pulverization, wherein the acidic component is pulverized by 60 meshes, the alkaline component is pulverized by 80 meshes, and sucrose is sieved by a 60-mesh stainless steel sieve;
preparing an adhesive: the formula amount of polyvinylpyrrolidone K29/32 was adjusted in a ratio of 1.1: 1.4, distributing the mixture into two preparation devices according to the weight part ratio, and mixing the 95% medicinal ethanol with the formula amount according to the ratio of 8: 7, respectively adding the mixture into two preparation devices, and then adding the formula amount of purified water according to a ratio of 2: 7, respectively adding the components into two preparation devices in parts by weight, and respectively obtaining an acid adhesive solution and an alkaline adhesive solution after uniformly mixing;
s3, granulating acidic auxiliary materials: weighing the anhydrous citric acid, DL-tartaric acid, vitamin C and half of the sucrose in formula amount after crushing, and adding into an LHS400B high-efficiency wet mixing granulator, wherein the stirring speed is 100rpm, the cutter speed is 1200rpm, and the running time is 8 min; then starting the stirring speed to be 100rpm, rotating the cutter to be 1400rpm, atomizing and adding the acid binder solution, wherein the adding time is 1 min; finally, starting stirring at a rotating speed of 100rpm, rotating a cutter at a rotating speed of 1400rpm, running for 3min, finishing granulation and selecting a 24-mesh screen for granulation to obtain acid particles;
s4, granulating basic auxiliary materials: weighing sodium bicarbonate, acetaminophen and cane sugar which are crushed according to the formula amount and the rest formula amount, and adding the sodium bicarbonate, the acetaminophen and the cane sugar into an LHS400B high-efficiency wet mixing granulator, wherein the stirring speed is 100rpm, the cutter speed is 1200rpm, and the running time is 8 min; then starting the stirring speed to be 100rpm, rotating the cutter to be 1400rpm, atomizing and adding the alkali binder solution for 2 min; finally, starting stirring at a rotating speed of 100rpm, rotating a cutter at a rotating speed of 1400rpm, running for 2min, finishing granulation and selecting a 24-mesh screen for finishing granules to obtain alkaline granules;
s5, drying: respectively and uniformly spreading the acidic particles and the alkaline particles obtained in the steps S3 and S4 on a plate, conveying the acidic particles and the alkaline particles into a hot air circulation oven for drying, wherein the drying temperature is 55 ℃, the particles need to be turned over once every 10 minutes of drying, sampling and detecting the moisture after drying for 2.5 hours, and taking the particles out of the oven after the moisture of the particles is measured to be less than 2%; finishing the dried particles by using a 24-mesh stainless steel screen;
s6, total mixing: putting the acid particles and the alkaline particles dried in the step S5, and polyethylene glycol 6000 and sodium benzoate in a formula amount into a mixing device for total mixing to obtain mixed particles; wherein the sodium benzoate needs to be crushed into 80 meshes by a 30B universal crusher before being put into the total mixing;
s7, tabletting: tabletting the mixed granules by using a die and a punch, controlling the difference of tablet weight within +/-5.0%, controlling the hardness within 100-140N, controlling the environmental temperature below 25 ℃ and the humidity within 30% RH during tabletting operation, and tabletting
The circular flat-oblique punching, before tabletting, lubricating the punch by using magnesium stearate with the total weight of 5 parts;
s8, packaging: and (5) packaging the tablet preparation obtained in the step (S7) to obtain the acetaminophen vitamin C effervescent tablet.
Example 6
Embodiment 6 of the present invention provides a method for preparing an acetaminophen vitamin C effervescent tablet, which is prepared according to the formula ratio of the acetaminophen vitamin C effervescent tablet described in embodiment 3, and comprises the following specific operation steps:
s1, preprocessing: respectively crushing the acidic component and the alkaline component, and sieving the sucrose;
the embodiment of the invention adopts a 30B universal pulverizer for pulverization, wherein the acidic component is pulverized by 60 meshes, the alkaline component is pulverized by 80 meshes, and sucrose is sieved by a 60-mesh stainless steel sieve;
preparing an adhesive: the formula amount of polyvinylpyrrolidone K29/32 was adjusted in a ratio of 1.1: 1.4, distributing the mixture into two preparation devices according to the weight part ratio, and mixing the 95% medicinal ethanol with the formula amount according to the ratio of 8: 7, respectively adding the mixture into two preparation devices, and then adding the formula amount of purified water according to a ratio of 2: 7, respectively adding the components into two preparation devices in parts by weight, and respectively obtaining an acid adhesive solution and an alkaline adhesive solution after uniformly mixing;
s3, granulating acidic auxiliary materials: weighing the anhydrous citric acid, DL-tartaric acid, vitamin C and half of the sucrose in formula amount after crushing, and adding into an LHS400B high-efficiency wet mixing granulator, wherein the stirring speed is 90rpm, the cutter speed is 1000rpm, and the running time is 10 min; then starting the stirring speed at 90rpm and the cutter rotation speed at 1200rpm, and atomizing and adding the acid binder solution for 1 min; finally, starting a stirring rotating speed of 90rpm and a cutter rotating speed of 1200rpm, running for 3-5 min, finishing granulation and selecting a 24-mesh screen for granulation to obtain acid particles;
s4, granulating basic auxiliary materials: weighing sodium bicarbonate, acetaminophen and cane sugar which are crushed according to the formula amount and the rest formula amount, and adding the sodium bicarbonate, the acetaminophen and the cane sugar into an LHS400B high-efficiency wet mixing granulator, wherein the stirring speed is 90rpm, the cutter speed is 1000rpm, and the running time is 9 min; then starting the stirring speed at 90rpm and the cutter rotation speed at 1200rpm, and atomizing and adding the alkali binder solution for 2 min; finally, starting stirring at a rotating speed of 90rpm, rotating a cutter at a rotating speed of 1200rpm, running for 2min, finishing granulation and selecting a 24-mesh screen for finishing granules to obtain alkaline granules;
s5, drying: respectively and uniformly spreading the acidic particles and the alkaline particles obtained in the steps S3 and S4 on a plate, conveying the acidic particles and the alkaline particles into a hot air circulation oven for drying, wherein the drying temperature is 55 ℃, the particles need to be turned over once every 10 minutes of drying, sampling and detecting the moisture after drying for 2.5 hours, and taking the particles out of the oven after the moisture of the particles is measured to be less than 2%; finishing the dried particles by using a 24-mesh stainless steel screen;
s6, total mixing: putting the acid particles and the alkaline particles dried in the step S5, and polyethylene glycol 6000 and sodium benzoate in a formula amount into a mixing device for total mixing to obtain mixed particles; wherein the sodium benzoate needs to be crushed into 80 meshes by a 30B universal crusher before being put into the total mixing;
s7, tabletting: tabletting the mixed granules by using a die and a punch, controlling the difference of tablet weight within +/-5.0%, controlling the hardness within 100-140N, controlling the environmental temperature below 25 ℃ and the humidity within 30% RH during tabletting operation, and tabletting
The round flat-oblique punching method also comprises the step of lubricating a punch by using 4 parts by weight of magnesium stearate before tabletting;
s8, packaging: and (5) packaging the tablet preparation obtained in the step (S7) to obtain the acetaminophen vitamin C effervescent tablet.
The acetaminophen vitamin C effervescent tablet provided by the embodiment of the invention utilizes the effervescent reaction of the effervescent tablet when the effervescent tablet is put into water, so that a large amount of carbon dioxide gas is generated and released, the disintegration and melting of the preparation are promoted, the bioavailability of acetaminophen and vitamin C is improved, and the optimization of formula components and formula structure is matched, so that the effervescent tablet has good disintegration and solubility and no sticking phenomenon; in addition, in the preparation process of the paracetamol and vitamin C effervescent tablet provided by the embodiment of the invention, the production process is reasonably arranged, the acid component and the alkaline component in the formula are respectively subjected to wet granulation to avoid the problem that the acid component and the alkaline component are subjected to acid-base reaction in the presence of moisture to cause failure of the acid component and the alkaline component due to direct wet granulation, meanwhile, compared with the non-aqueous granulation tabletting adopted by the effervescent tablet in the prior art or the method for directly pressing the raw material powder into the tablet body, the preparation method of the embodiment of the invention has small influence on the properties and the crystal shapes of various materials, and special granulation equipment is not needed, the pressing flowability is good, the tablet weight difference and the tablet form are easy to control, and the applicability of the effervescent tablet production process is effectively improved.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention.
Claims (7)
1. An acetaminophen vitamin C effervescent tablet is characterized by being prepared from an acidic component, an alkaline component, an auxiliary material and an adhesive solution; the acid component comprises the following raw materials in parts by weight: 180-220 parts of vitamin C, 350-450 parts of anhydrous citric acid and 350-450 parts of DL-tartaric acid; the alkaline component comprises the following raw materials in parts by weight: 300-350 parts of acetaminophen and 1100-1150 parts of sodium bicarbonate; the auxiliary materials comprise the following raw materials in parts by weight: 300-500 parts of cane sugar, 600080-90 parts of polyethylene glycol and 40-60 parts of sodium benzoate; the adhesive solution comprises the following raw materials in parts by weight: polyvinyl pyrrolidone K29/322-3 parts, 95% medicinal ethanol 70-85 parts, and purified water 40-50 parts.
2. An effervescent paracetamol vitamin C tablet according to claim 1 wherein: the acid component comprises the following raw materials in parts by weight: 200 parts of vitamin C, 400 parts of anhydrous citric acid and 400 parts of DL-tartaric acid; the alkaline component comprises the following raw materials in parts by weight: 330 parts of acetaminophen and 1120 parts of sodium bicarbonate; the auxiliary materials comprise the following raw materials in parts by weight: 400 parts of cane sugar, 600087 parts of polyethylene glycol and 50 parts of sodium benzoate; the adhesive comprises the following raw materials in parts by weight: polyvinyl pyrrolidone K29/322.5 parts, 95% medicinal ethanol 79 parts and purified water 46 parts.
3. A process for preparing paracetamol vitamin C effervescent tablet according to claim 1 or 2, which comprises the following specific operating steps:
s1, preprocessing: respectively crushing the acidic component and the alkaline component, and sieving the sucrose;
s2, adhesive preparation: the formula amount of polyvinylpyrrolidone K29/32 was adjusted in a ratio of 1.1: 1.4, distributing the mixture into two preparation devices according to the weight part ratio, and mixing the 95% medicinal ethanol with the formula amount according to the ratio of 8: 7, respectively adding the mixture into two preparation devices, and then adding the formula amount of purified water according to a ratio of 2: 7, respectively adding the components into two preparation devices in parts by weight, and respectively obtaining an acid adhesive solution and an alkaline adhesive solution after uniformly mixing;
s3, granulating acidic auxiliary materials: weighing the anhydrous citric acid, DL-tartaric acid, vitamin C and half of the sucrose in formula amount after crushing, and adding into wet granulation equipment, wherein the stirring speed is 80-100 rpm, the cutter speed is 800-1200 rpm, and the operation time is 8-12 min; then starting the stirring speed to be 80-100 rpm, rotating the cutter at 1000-1400 rpm, and atomizing and adding the acid binder solution for 1-2 min; finally, starting stirring at a rotating speed of 80-100 rpm, operating at a rotating speed of 1000-1400 rpm for 3-5 min, finishing granulation, and selecting a 24-mesh screen for granulation to obtain acid particles;
s4, granulating basic auxiliary materials: weighing sodium bicarbonate, acetaminophen and cane sugar which are crushed according to the formula amount and the rest formula amount, adding the sodium bicarbonate, the acetaminophen and the cane sugar into wet granulation equipment, wherein the stirring speed is 80-100 rpm, the cutter speed is 800-1200 rpm, and the operation time is 8-12 min; then starting the stirring speed to be 80-100 rpm, rotating the cutter at 1000-1400 rpm, and atomizing and adding the alkali binder solution for 2-3 min; finally, starting stirring at a rotating speed of 80-100 rpm, operating at a rotating speed of 1000-1400 rpm for 2-4 min, finishing granulation, and finishing granules by using a 24-mesh screen to obtain alkaline granules;
s5, drying: uniformly spreading the acidic particles and the alkaline particles obtained in the steps S3 and S4 on a plate, drying until the moisture of the particles is less than 2%, and finishing the dried particles;
s6, total mixing: putting the acid particles and the alkaline particles dried in the step S5, and polyethylene glycol 6000 and sodium benzoate in a formula amount into a mixing device for total mixing to obtain mixed particles;
s7, tabletting: tabletting the mixed granules by using a die and a punch, wherein the difference of tablet weight is controlled within +/-5.0%, and the hardness is controlled to be 100-140N;
s8, packaging: and (5) packaging the tablet preparation obtained in the step (S7) to obtain the acetaminophen vitamin C effervescent tablet.
4. A process for preparing an effervescent tablet of acetaminophen and vitamin C according to claim 3, wherein: in step S1, a 30B universal pulverizer is used for pulverization, wherein the acidic component is pulverized with 60 meshes, the alkaline component is pulverized with 80 meshes, and the sucrose is sieved with a 60-mesh stainless steel sieve.
5. A process for preparing an effervescent tablet of acetaminophen and vitamin C according to claim 3, wherein: drying in a hot air circulation oven at 55 ℃ in step S5, wherein the particles need to be turned over once every 10 minutes of drying, sampling and detecting moisture after drying for 2.5 hours, and taking out the particles after the moisture of the particles is measured to be less than 2%; and finishing the dried particles by using a 24-mesh stainless steel screen.
6. A process for preparing an effervescent tablet of acetaminophen and vitamin C according to claim 3, wherein: and step S6, before the total mixing, 80-mesh crushing of sodium benzoate is carried out by using a 30B universal crusher.
7. A process for preparing an effervescent tablet of acetaminophen and vitamin C according to claim 3, wherein: and step S7, during tabletting operation, the environment temperature is controlled below 25 ℃ and the humidity is controlled within 30% RH, the round flat and oblique punch with the diameter of 23.0mm is used for tabletting, and the punch is lubricated by using 3-5 parts by weight of magnesium stearate before tabletting.
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