CN112315922B - Preparation method of cimetidine tablet - Google Patents
Preparation method of cimetidine tablet Download PDFInfo
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- CN112315922B CN112315922B CN202011082219.2A CN202011082219A CN112315922B CN 112315922 B CN112315922 B CN 112315922B CN 202011082219 A CN202011082219 A CN 202011082219A CN 112315922 B CN112315922 B CN 112315922B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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Abstract
The invention provides a preparation method of cimetidine tablets, and relates to a preparation method of cimetidine tablets. The preparation method of the cimetidine tablet mainly comprises the steps of sucrose treatment, starch pretreatment, starch slurry preparation, material mixing, granulating, drying, tabletting and the like. The invention overcomes the defects of the prior art, reduces the addition of auxiliary materials, ensures the dissolution rate of the medicine and improves the use feeling and the treatment efficiency of the medicine.
Description
Technical Field
The invention relates to the technical field of cimetidine tablet processing, in particular to a preparation method of cimetidine tablets.
Background
Cimetidine has remarkable gastric acid secretion inhibiting effect, can remarkably inhibit basic gastric acid secretion and nocturnal gastric acid secretion, can inhibit gastric acid secretion caused by stimulation of histamine, split gastrin, insulin, food, etc., reduces acidity, has effects of preventing and protecting corrosive gastritis caused by chemical stimulation, and has remarkable curative effects on stress gastric ulcer and upper gastrointestinal hemorrhage. However, because the product is widely distributed in the body and has complex pharmacological actions, the product has more side effects and adverse reactions.
In general, cimetidine Ding Daduo is prepared into tablets for swallowing, the medicaments are disintegrated in vivo after being swallowed, and then the active ingredients are absorbed by human bodies for treating diseases, so that most of cimetidine Ding Yaopian is prepared by using fillers, lubricants, disintegrants, binders, flavoring agents and the like, more and more researches indicate that auxiliary materials have toxic and side effects, incompatibility of the auxiliary materials and main medicaments, impurities in the auxiliary materials and the like can influence the safety of the medicaments, and the improvement of the dissolution rate of the medicaments is an important development direction of the preparation of the medicaments at the present stage while the addition of the auxiliary materials is reduced.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a preparation method of cimetidine tablets, which reduces the addition of auxiliary materials, ensures the dissolution rate of medicines and improves the use feeling and the treatment efficiency of medicines.
In order to achieve the above object, the technical scheme of the present invention is realized by the following technical scheme:
a method for preparing cimetidine tablets, comprising the steps of:
(1) Sucrose treatment: boiling purified water, adding sucrose, boiling with small fire until sugar solution is viscous and turns color, cooling, drying, and grinding to obtain sugar powder;
(2) Starch pretreatment: adding purified water into corn starch, stirring at normal temperature, steaming in a high-pressure reaction kettle at high temperature and high pressure for 15min to obtain cooked starch, taking out, freeze-drying in a low-temperature environment, and grinding and pulverizing to obtain pretreated starch for later use;
(3) Preparing starch slurry: adding the pretreated starch into the powdered sugar in the step (1), adding purified water, and placing in a water bath environment to be uniformly mixed and stirred to obtain gelatinized starch slurry for later use;
(4) Mixing materials: mixing pretreated starch and cimetidine, adding purified water and powdered sugar, maintaining the temperature in a water bath, stirring uniformly, rapidly cooling with liquid nitrogen, and grinding into powder to obtain mixed powder for later use;
(5) Granulating: adding the mixed powder into gelatinized starch slurry, placing in a water bath environment, mixing at constant temperature, stirring uniformly to obtain soft material, and sieving with 14 mesh sieve;
(6) And (3) drying: freeze-drying the soft material in a low-temperature vacuum environment, taking out, adding magnesium stearate and carboxymethyl starch sodium, mixing and grinding to obtain mixed powder for later use;
(7) Tabletting: and (3) putting the mixed powder into a tablet press for tabletting and shaping, and then putting the tablet into normal temperature for continuous drying and packaging to obtain cimetidine tablets.
Preferably, in the step (1), the mass ratio of the sucrose to the purified water is 3:2, and the boiling time is 15-20min.
Preferably, in the step (2), the mixing mass ratio of the corn starch and the purified water is 1:1, and the pressure of high-temperature high-pressure steaming is 12-14MPa, and the temperature is 80-100 ℃.
Preferably, the sugar powder and the pretreated starch are ground and then pass through a 200-mesh sieve.
The mass ratio of the pretreated starch to the sugar powder to the purified water in the step (3) is 8:1:100, the temperature of water bath mixing and stirring is 80-90 ℃, and the stirring time is 40-50min.
Preferably, in the step (4), the mass ratio of the pretreated starch, cimetidine, purified water and powdered sugar is 2.6:15:10:1, the temperature of water bath heat preservation and stirring is 60-80 ℃, the stirring time is 25-30min, and the mixed powder is sieved by a 100-mesh sieve.
Preferably, in the step (5), the mass ratio of the mixed powder to the gelatinized starch slurry is 1:1, the constant temperature stirring temperature in a water bath is 60-70 ℃, and the stirring time is 20-30min.
Preferably, the water content after freeze-drying in the step (6) is 8% -10%, and the mass ratio of the soft material to the magnesium stearate to the carboxymethyl starch sodium is 100:1:3.6.
Preferably, the water content after normal temperature drying in the step (7) is 2.5% -4%.
Preferably, the temperature of the low-temperature freeze-drying in the preparation process is 8 ℃ below zero to 10 ℃ below zero.
The invention provides a preparation method of cimetidine tablets, which has the following advantages compared with the prior art:
the invention reduces the addition of auxiliary materials, ensures the effect of the medicine under treatment, simultaneously ensures the dissolution rate of the medicine by carrying out high-temperature high-pressure treatment and mixed gelatinization treatment on the starch and combining with repeated freeze-drying, is convenient for the disintegration of the medicine in the body, is convenient for the absorption of the human body and improves the efficiency of medicine treatment.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions in the embodiments of the present invention will be clearly and completely described in the following in conjunction with the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Example 1:
a method for preparing cimetidine tablets, comprising the steps of:
(1) Sucrose treatment: boiling purified water until boiling, adding sucrose, boiling with slow fire for 15-20min until sugar solution is viscous and color-changing, cooling, drying, grinding, and sieving with 200 mesh sieve to obtain sugar powder;
(2) Starch pretreatment: adding purified water with equal mass into corn starch, stirring at normal temperature, placing in a high-pressure reaction kettle, steaming at 80-100deg.C under high pressure and 12-14MPa for 15min to obtain cooked starch, taking out, lyophilizing at 8-10deg.C, grinding, pulverizing, and sieving with 200 mesh sieve to obtain pretreated starch;
(3) Preparing starch slurry: adding the pretreated starch into the powdered sugar in the step (1), adding purified water, mixing the pretreated starch, the powdered sugar and the purified water according to the mass ratio of 8:1:100, and then placing the mixture in a water bath environment at 80-90 ℃ for mixing and stirring for 40-50min to obtain gelatinized starch slurry for later use;
(4) Mixing materials: mixing pretreated starch, cimetidine, purified water and powdered sugar according to the mass ratio of 2.6:15:10:1, performing heat preservation and stirring in a water bath at 60-80 ℃ for 25-30min, rapidly cooling by liquid nitrogen, grinding into powder, and sieving with a 100-mesh sieve to obtain mixed powder for later use;
(5) Granulating: adding the mixed powder into gelatinized starch slurry with equal mass, placing in a water bath environment with the temperature of 60-70 ℃ for constant temperature mixing and stirring for 20-30min to obtain a soft material, and sieving with a 14-mesh sieve for later use;
(6) And (3) drying: freeze-drying the soft material in a vacuum environment at a low temperature of 8-10 ℃ below zero until the water content is 8-10%, taking out, adding magnesium stearate and carboxymethyl starch sodium, mixing and grinding to obtain mixed powder for standby, wherein the mass ratio of the soft material to the magnesium stearate to the carboxymethyl starch sodium is 100:1:3.6;
(7) Tabletting: and (3) putting the mixed powder into a tablet press for tabletting and shaping, then putting the tablet into normal temperature for continuous drying until the water content is 2.5% -4%, and packaging to obtain cimetidine tablets.
Comparative example 1:
a method for preparing cimetidine tablets, comprising the steps of:
(1) Sucrose treatment: boiling purified water until boiling, adding sucrose, boiling with slow fire for 15-20min until sugar solution is viscous and color-changing, cooling, drying, grinding, and sieving with 200 mesh sieve to obtain sugar powder;
(2) Preparing starch slurry: adding starch into the powdered sugar in the step (1), adding purified water, mixing the starch, the powdered sugar and the purified water in a mass ratio of 8:1:100, and then placing the mixture in a water bath environment at 80-90 ℃ for mixing and stirring for 40-50min to obtain gelatinized starch slurry for later use;
(3) Mixing materials: mixing starch, cimetidine, purified water and powdered sugar according to the mass ratio of 2.6:15:10:1, performing heat preservation and stirring in a water bath at 60-80 ℃ for 25-30min, rapidly cooling by liquid nitrogen, grinding into powder, and sieving with a 100-mesh sieve to obtain mixed powder for later use;
(4) Granulating: adding the mixed powder into gelatinized starch slurry with equal mass, placing in a water bath environment with the temperature of 60-70 ℃ for constant temperature mixing and stirring for 20-30min to obtain a soft material, and sieving with a 14-mesh sieve for later use;
(5) And (3) drying: freeze-drying the soft material in a vacuum environment at a low temperature of 8-10 ℃ below zero until the water content is 8-10%, taking out, adding magnesium stearate and carboxymethyl starch sodium, mixing and grinding to obtain mixed powder for standby, wherein the mass ratio of the soft material to the magnesium stearate to the carboxymethyl starch sodium is 100:1:3.6;
(6) Tabletting: and (3) putting the mixed powder into a tablet press for tabletting and shaping, then putting the tablet into normal temperature for continuous drying until the water content is 2.5% -4%, and packaging to obtain cimetidine tablets.
Comparative example 2:
a method for preparing cimetidine tablets, comprising the steps of:
(1) Sucrose treatment: boiling purified water until boiling, adding sucrose, boiling with slow fire for 15-20min until sugar solution is viscous and color-changing, cooling, drying, grinding, and sieving with 200 mesh sieve to obtain sugar powder;
(2) Starch pretreatment: adding purified water with equal mass into corn starch, stirring at normal temperature, placing in a high-pressure reaction kettle, steaming at 80-100deg.C under high pressure and 12-14MPa for 15min to obtain cooked starch, taking out, lyophilizing at 8-10deg.C, grinding, pulverizing, and sieving with 200 mesh sieve to obtain pretreated starch;
(3) Preparing starch slurry: adding the pretreated starch into the powdered sugar in the step (1), adding purified water, mixing the pretreated starch, the powdered sugar and the purified water according to the mass ratio of 8:1:100, and then placing the mixture in a water bath environment at 80-90 ℃ for mixing and stirring for 40-50min to obtain gelatinized starch slurry for later use;
(4) Mixing materials: mixing pretreated starch, cimetidine, purified water and powdered sugar according to the mass ratio of 2.6:15:10:1, performing heat preservation and stirring in a water bath at 60-80 ℃ for 25-30min, drying, grinding into powder, and sieving with a 100-mesh sieve to obtain mixed powder for later use;
(5) Granulating: adding the mixed powder into gelatinized starch slurry with equal mass, placing in a water bath environment with the temperature of 60-70 ℃ for constant temperature mixing and stirring for 20-30min to obtain a soft material, and sieving with a 14-mesh sieve for later use;
(6) And (3) drying: freeze-drying the soft material in a vacuum environment at a low temperature of 8-10 ℃ below zero until the water content is 8-10%, taking out, adding magnesium stearate and carboxymethyl starch sodium, mixing and grinding to obtain mixed powder for standby, wherein the mass ratio of the soft material to the magnesium stearate to the carboxymethyl starch sodium is 100:1:3.6;
(7) Tabletting: and (3) putting the mixed powder into a tablet press for tabletting and shaping, then putting the tablet into normal temperature for continuous drying until the water content is 2.5% -4%, and packaging to obtain cimetidine tablets.
And (3) detection:
selecting a commercially available common cimetidine tablet as a control group, taking the cimetidine tablet obtained in the above example 1 as an experimental group 1, taking cimetidine tablets obtained in the above comparative examples 1-2 as an experimental group 2-3, respectively detecting friability according to a method of detecting X G of the second edition appendix of Chinese pharmacopoeia 2010, simultaneously taking 900ml of acetate buffer solution pH 6.0 as a dissolution medium according to a dissolution measuring method, sampling respectively at a rotating speed of 100r/min for 3min, 6min, 9min, 15min and 20min, taking a proper amount of dissolution liquid, filtering, taking a subsequent filtrate, and measuring absorbance at 254nm by adopting an ultraviolet spectrophotometry; in addition, about 10mg of cimetidine reference substance is precisely weighed, placed in a 25mL measuring flask, dissolved and diluted to a scale by adding a dissolution medium, shaken uniformly, precisely measured 2mL, placed in a 100mL measuring flask, diluted to the scale by adding the dissolution medium, shaken uniformly, measured by the same method, and the dissolution amount of each tablet is calculated, and the result is shown in the following table:
as shown in the table above, the cimetidine tablet prepared by the invention has good dissolution rate, and the dissolution rate of the medicine can be effectively improved by mixing the starch treated by high temperature and high pressure and the liquid nitrogen treated in the preparation process.
It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.
The above embodiments are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims (9)
1. A method for preparing cimetidine tablets, which is characterized by comprising the following steps:
(1) Sucrose treatment: boiling purified water, adding sucrose, boiling with small fire until sugar solution is viscous and turns color, cooling, drying, and grinding to obtain sugar powder;
(2) Starch pretreatment: mixing corn starch and purified water according to a mass ratio of 1:1, stirring uniformly at normal temperature, placing in a high-pressure reaction kettle, steaming at high temperature and high pressure of 80-100 ℃ for 15min under the pressure of 12-14MPa to obtain cooked starch, taking out, placing in a low-temperature environment for freeze-drying, and grinding and crushing to obtain pretreated starch for later use;
(3) Preparing starch slurry: adding the pretreated starch into the powdered sugar in the step (1), adding purified water, and placing in a water bath environment to be uniformly mixed and stirred to obtain gelatinized starch slurry for later use;
(4) Mixing materials: mixing pretreated starch and cimetidine, adding purified water and powdered sugar, maintaining the temperature in a water bath, stirring uniformly, rapidly cooling with liquid nitrogen, and grinding into powder to obtain mixed powder for later use;
(5) Granulating: adding the mixed powder into gelatinized starch slurry, placing in a water bath environment, mixing at constant temperature, stirring uniformly to obtain soft material, and sieving with 14 mesh sieve;
(6) And (3) drying: freeze-drying the soft material in a low-temperature vacuum environment, taking out, adding magnesium stearate and carboxymethyl starch sodium, mixing and grinding to obtain mixed powder for later use;
(7) Tabletting: and (3) putting the mixed powder into a tablet press for tabletting and shaping, and then putting the tablet into normal temperature for continuous drying and packaging to obtain cimetidine tablets.
2. A process for the preparation of cimetidine tablets according to claim 1, characterized in that: the mass ratio of the sucrose to the purified water in the step (1) is 3:2, and the boiling time is 15-20min.
3. A process for the preparation of cimetidine tablets according to claim 1, characterized in that: the sugar powder and the pretreated starch are ground and then are sieved by a 200-mesh sieve.
4. A process for the preparation of cimetidine tablets according to claim 1, characterized in that: the mass ratio of the pretreated starch to the sugar powder to the purified water in the step (3) is 8:1:100, the temperature of water bath mixing and stirring is 80-90 ℃, and the stirring time is 40-50min.
5. A process for the preparation of cimetidine tablets according to claim 1, characterized in that: the mass ratio of the pretreated starch, cimetidine, purified water and powdered sugar in the step (4) is 2.6:15:10:1, the temperature of water bath heat preservation stirring is 60-80 ℃, the stirring time is 25-30min, and the mixed powder is sieved by a 100-mesh sieve.
6. A process for the preparation of cimetidine tablets according to claim 1, characterized in that: the mass ratio of the mixed powder to the gelatinized starch slurry in the step (5) is 1:1, the constant temperature stirring temperature in a water bath is 60-70 ℃, and the stirring time is 20-30min.
7. A process for the preparation of cimetidine tablets according to claim 1, characterized in that: the water content after freeze-drying in the step (6) is 8% -10%, and the mass ratio of the soft material to the magnesium stearate to the carboxymethyl starch sodium is 100:1:3.6.
8. A process for the preparation of cimetidine tablets according to claim 1, characterized in that: the water content after normal temperature drying in the step (7) is 2.5% -4%.
9. A process for the preparation of cimetidine tablets according to claim 1, characterized in that: the temperature of low-temperature freeze-drying in the preparation process is 8 ℃ below zero to 10 ℃ below zero.
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|---|---|---|---|---|
| CA2234615A1 (en) * | 1995-10-19 | 1997-04-24 | Biogram Ab | Sustained release particles |
| CN102218040A (en) * | 2010-04-13 | 2011-10-19 | 齐鲁制药有限公司 | Oral disintegrating tablets of microcrystallites of aripiprazole composition and preparation method thereof |
| CN103191023A (en) * | 2013-03-22 | 2013-07-10 | 海南卫康制药(潜山)有限公司 | Low-temperature pressing method of rapidly disintegrating tablet |
| CN104546676A (en) * | 2014-12-25 | 2015-04-29 | 海南卫康制药(潜山)有限公司 | Cimetidine composition freeze-drying tablet and preparation method thereof |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2234615A1 (en) * | 1995-10-19 | 1997-04-24 | Biogram Ab | Sustained release particles |
| CN102218040A (en) * | 2010-04-13 | 2011-10-19 | 齐鲁制药有限公司 | Oral disintegrating tablets of microcrystallites of aripiprazole composition and preparation method thereof |
| CN103191023A (en) * | 2013-03-22 | 2013-07-10 | 海南卫康制药(潜山)有限公司 | Low-temperature pressing method of rapidly disintegrating tablet |
| CN104546676A (en) * | 2014-12-25 | 2015-04-29 | 海南卫康制药(潜山)有限公司 | Cimetidine composition freeze-drying tablet and preparation method thereof |
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