CN110151711B - Domperidone orally disintegrating tablet and preparation method thereof - Google Patents
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/454—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
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Abstract
The invention provides a domperidone orally disintegrating tablet which comprises the following components in parts by weight: 6-12 parts of domperidone, 70-90 parts of filler, 5-12 parts of disintegrant, 1-6 parts of sweetener, 1-3 parts of glidant and 0.1-1 part of lubricant. According to the invention, through improving the formula and the preparation process, the flowability of the tabletting material is improved, and the monitoring data of the smoothness, the taste, the tablet weight difference and the dissolution rate of the tablet surface shows that the tabletting material conforms to the specification or better after the process is improved, so that the problems of sticking, unsmooth tablet surface, large tablet weight difference, unsmooth taste and the like in the tabletting process are solved, the product meets the quality standard requirement, and the quality is ensured.
Description
Technical Field
The invention relates to a domperidone orally disintegrating tablet and a preparation method thereof.
Background
Domperidone is a peripheral dopamine receptor antagonist with strong action, directly acts on gastrointestinal walls, can increase the tension of lower esophageal sphincter to a medium extent and prevent gastro-esophageal reflux; enhancing tail peristalsis, promoting gastric emptying, improving the movement coordination of stomach and duodenum, preventing bile reflux, and regulating and recovering the movement of the upper part of gastrointestinal tract; inhibiting nausea and emesis. The traditional Chinese medicine composition is clinically used for treating dyspepsia accompanied with slow gastric emptying and esophageal reflux, such as abdominal distention, flatulence, nausea and vomiting after meals. It can also be used for treating nausea and emesis caused by radiotherapy, postoperative emesis, and emesis symptoms caused by brain function (such as pylorospasm and periodic emesis), organic substance, toxic infection, food or acetoemia, etc.
The domperidone orally disintegrating tablet is convenient to use, melts in the mouth immediately, can be swallowed without water, can be mostly dissolved after encountering saliva in the oral cavity, and is fast to absorb after being taken.
Disclosure of Invention
The invention provides a domperidone orally disintegrating tablet and a preparation method thereof on the basis of overcoming the defects of the prior art, and solves the problems of sticking, unsmooth tablet surface, large tablet weight difference, unsmooth mouthfeel and the like in the tabletting process by improving the formula and the preparation method of the domperidone orally disintegrating tablet and adding a specific lubricant and increasing the mesh number of a screen to reduce the granularity of raw and auxiliary materials in the preparation process.
In order to realize the purpose, the technical scheme is as follows: a domperidone orally disintegrating tablet comprises the following components in parts by weight: 6-12 parts of domperidone, 70-90 parts of filler, 5-12 parts of disintegrant, 1-6 parts of sweetener, 1-3 parts of glidant and 0.1-1 part of lubricant.
Preferably, the domperidone orally disintegrating tablet comprises the following components in parts by weight: 10 parts of domperidone, 80 parts of filler, 10 parts of disintegrant, 5 parts of sweetener, 2.1 parts of glidant and 0.54 part of lubricant.
Preferably, the lubricant is a mixture of magnesium stearate, glyceryl behenate, sodium stearyl fumarate.
Preferably, the weight ratio of the magnesium stearate to the glyceryl behenate to the sodium stearyl fumarate is 3:1: 2.
Preferably, the filler is microcrystalline cellulose, the disintegrant is croscarmellose sodium, the sweetener is aspartame, and the glidant is silicon dioxide.
Preferably, the domperidone, the filling agent, the disintegrating agent, the sweetening agent and the glidant are all sieved by a 100-mesh sieve.
The invention provides a preparation method of the domperidone orally disintegrating tablet, which comprises the following steps:
(1) respectively crushing domperidone, a filling agent, a disintegrating agent, a sweetening agent and a flow aid, and respectively sieving the powder with a 100-mesh sieve;
(2) uniformly mixing the domperidone obtained in the step (1) and a part of filler;
(3) adding part of the filler, the disintegrant, the sweetener, the glidant and part of the lubricant obtained in the step (1) and uniformly mixing;
(4) and (2) adding the residual filler and the lubricant obtained in the step (1), uniformly mixing, and tabletting to obtain the domperidone orally disintegrating tablet.
Preferably, the weight ratio of the filler in the step (2), the filler in the step (3) and the filler in the step (4) is 1:2: 5.
Preferably, the weight ratio of the lubricant in the step (3) to the lubricant in the step (4) is 1: 1.
Preferably, the mixing time of step (2) is 10 minutes; the mixing time in the step (3) is 10 minutes; the mixing time in the step (4) is 30 minutes.
Has the advantages that:
according to the invention, through improving the formula and the preparation process, the flowability of the tabletting material is improved, and the monitoring data of the smoothness, the taste, the tablet weight difference and the dissolution rate of the tablet surface shows that the tabletting material conforms to the specification or better after the process is improved, so that the problems of sticking, unsmooth tablet surface, large tablet weight difference, unsmooth taste and the like in the tabletting process are solved, the product meets the quality standard requirement, and the quality is ensured.
Detailed Description
To better illustrate the objects, aspects and advantages of the present invention, the present invention will be further described with reference to specific examples.
Example 1
One embodiment of the domperidone orally disintegrating tablet comprises the following components in parts by weight: 10 parts of domperidone, 80 parts of filler, 10 parts of disintegrant, 5 parts of sweetener, 2.1 parts of glidant and 0.54 part of lubricant. The bulking agent is microcrystalline cellulose, the disintegrant is croscarmellose sodium, the sweetener is aspartame, and the glidant is silicon dioxide. The lubricant is a mixture of magnesium stearate, glyceryl behenate and sodium stearyl fumarate, and the weight ratio of the magnesium stearate to the glyceryl behenate to the sodium stearyl fumarate is 3:1: 2.
The preparation method of the domperidone orally disintegrating tablet comprises the following steps:
(1) respectively crushing domperidone, a filling agent, a disintegrating agent, a sweetening agent and a flow aid, and respectively sieving the powder with a 100-mesh sieve;
(2) mixing 10 parts by weight of domperidone obtained in the step (1) and 10 parts by weight of filler for 10 minutes;
(3) adding 20 parts by weight of the filler obtained in the step (1), 10 parts by weight of the disintegrant, 5 parts by weight of the sweetener, 2.1 parts by weight of the glidant and 0.27 part by weight of the lubricant, and mixing for 10 minutes;
(4) adding 50 parts by weight of the filler obtained in the step (1) and 0.27 part by weight of the lubricant, uniformly mixing for 30 minutes, and tabletting to obtain the domperidone orally disintegrating tablet.
Example 2
One embodiment of the domperidone orally disintegrating tablet comprises the following components in parts by weight: 10 parts of domperidone, 80 parts of filler, 10 parts of disintegrant, 5 parts of sweetener, 2.1 parts of glidant and 0.54 part of lubricant. The bulking agent is microcrystalline cellulose, the disintegrant is croscarmellose sodium, the sweetener is aspartame, and the glidant is silicon dioxide. The lubricant is a mixture of magnesium stearate, glyceryl behenate and sodium stearyl fumarate, and the weight ratio of the magnesium stearate to the glyceryl behenate to the sodium stearyl fumarate is 1:1: 4.
The preparation method of the domperidone orally disintegrating tablet comprises the following steps:
(1) respectively crushing domperidone, a filling agent, a disintegrating agent, a sweetening agent and a flow aid, and respectively sieving the powder with a 100-mesh sieve;
(2) mixing 10 parts by weight of domperidone obtained in the step (1) and 10 parts by weight of filler for 10 minutes;
(3) adding 20 parts by weight of the filler obtained in the step (1), 10 parts by weight of the disintegrant, 5 parts by weight of the sweetener, 2.1 parts by weight of the glidant and 0.27 part by weight of the lubricant, and mixing for 10 minutes;
(4) adding 50 parts by weight of the filler obtained in the step (1) and 0.27 part by weight of the lubricant, uniformly mixing for 30 minutes, and tabletting to obtain the domperidone orally disintegrating tablet.
Example 3
One embodiment of the domperidone orally disintegrating tablet comprises the following components in parts by weight: 10 parts of domperidone, 80 parts of filler, 10 parts of disintegrant, 5 parts of sweetener, 2.1 parts of glidant and 0.54 part of lubricant. The bulking agent is microcrystalline cellulose, the disintegrant is croscarmellose sodium, the sweetener is aspartame, and the glidant is silicon dioxide. The lubricant is a mixture of magnesium stearate, glyceryl behenate and sodium stearyl fumarate, and the weight ratio of the magnesium stearate to the glyceryl behenate to the sodium stearyl fumarate is 1:5: 2.
The preparation method of the domperidone orally disintegrating tablet comprises the following steps:
(1) respectively crushing domperidone, a filling agent, a disintegrating agent, a sweetening agent and a flow aid, and respectively sieving the powder with a 100-mesh sieve;
(2) mixing 10 parts by weight of domperidone obtained in the step (1) and 10 parts by weight of filler for 10 minutes;
(3) adding 20 parts by weight of the filler obtained in the step (1), 10 parts by weight of the disintegrant, 5 parts by weight of the sweetener, 2.1 parts by weight of the glidant and 0.27 part by weight of the lubricant, and mixing for 10 minutes;
(4) adding 50 parts by weight of the filler obtained in the step (1) and 0.27 part by weight of the lubricant, uniformly mixing for 30 minutes, and tabletting to obtain the domperidone orally disintegrating tablet.
Comparative example 1
One embodiment of the domperidone orally disintegrating tablet comprises the following components in parts by weight: 10 parts of domperidone, 80 parts of filler, 10 parts of disintegrant, 5 parts of sweetener, 2.1 parts of glidant and 0.54 part of lubricant. The bulking agent is microcrystalline cellulose, the disintegrant is croscarmellose sodium, the sweetener is aspartame, and the glidant is silicon dioxide. The lubricant is a mixture of magnesium stearate and glyceryl behenate, and the weight ratio of the magnesium stearate to the glyceryl behenate is 3: 1.
The preparation method of the domperidone orally disintegrating tablet comprises the following steps:
(1) respectively crushing domperidone, a filling agent, a disintegrating agent, a sweetening agent and a flow aid, and respectively sieving the powder with a 100-mesh sieve;
(2) mixing 10 parts by weight of domperidone obtained in the step (1) and 10 parts by weight of filler for 10 minutes;
(3) adding 20 parts by weight of the filler obtained in the step (1), 10 parts by weight of the disintegrant, 5 parts by weight of the sweetener, 2.1 parts by weight of the glidant and 0.27 part by weight of the lubricant, and mixing for 10 minutes;
(4) adding 50 parts by weight of the filler obtained in the step (1) and 0.27 part by weight of the lubricant, uniformly mixing for 30 minutes, and tabletting to obtain the domperidone orally disintegrating tablet.
Comparative example 2
One embodiment of the domperidone orally disintegrating tablet comprises the following components in parts by weight: 10 parts of domperidone, 80 parts of filler, 10 parts of disintegrant, 5 parts of sweetener, 2.1 parts of glidant and 0.54 part of lubricant. The bulking agent is microcrystalline cellulose, the disintegrant is croscarmellose sodium, the sweetener is aspartame, and the glidant is silicon dioxide. The lubricant is a mixture of glyceryl behenate and sodium stearyl fumarate, and the weight ratio of the glyceryl behenate to the sodium stearyl fumarate is 1: 2.
The preparation method of the domperidone orally disintegrating tablet comprises the following steps:
(1) respectively crushing domperidone, a filling agent, a disintegrating agent, a sweetening agent and a flow aid, and respectively sieving the powder with a 100-mesh sieve;
(2) mixing 10 parts by weight of domperidone obtained in the step (1) and 10 parts by weight of filler for 10 minutes;
(3) adding 20 parts by weight of the filler obtained in the step (1), 10 parts by weight of the disintegrant, 5 parts by weight of the sweetener, 2.1 parts by weight of the glidant and 0.27 part by weight of the lubricant, and mixing for 10 minutes;
(4) adding 50 parts by weight of the filler obtained in the step (1) and 0.27 part by weight of the lubricant, uniformly mixing for 30 minutes, and tabletting to obtain the domperidone orally disintegrating tablet.
Comparative example 3
One embodiment of the domperidone orally disintegrating tablet comprises the following components in parts by weight: 10 parts of domperidone, 80 parts of filler, 10 parts of disintegrant, 5 parts of sweetener, 2.1 parts of glidant and 0.54 part of lubricant. The bulking agent is microcrystalline cellulose, the disintegrant is croscarmellose sodium, the sweetener is aspartame, and the glidant is silicon dioxide. The lubricant is a mixture of magnesium stearate and sodium stearyl fumarate, and the weight ratio of the magnesium stearate to the sodium stearyl fumarate is 3: 2.
The preparation method of the domperidone orally disintegrating tablet comprises the following steps:
(1) respectively crushing domperidone, a filling agent, a disintegrating agent, a sweetening agent and a flow aid, and respectively sieving the powder with a 100-mesh sieve;
(2) mixing 10 parts by weight of domperidone obtained in the step (1) and 10 parts by weight of filler for 10 minutes;
(3) adding 20 parts by weight of the filler obtained in the step (1), 10 parts by weight of the disintegrant, 5 parts by weight of the sweetener, 2.1 parts by weight of the glidant and 0.27 part by weight of the lubricant, and mixing for 10 minutes;
(4) adding 50 parts by weight of the filler obtained in the step (1) and 0.27 part by weight of the lubricant, uniformly mixing for 30 minutes, and tabletting to obtain the domperidone orally disintegrating tablet.
Comparative example 4
One embodiment of the domperidone orally disintegrating tablet comprises the following components in parts by weight: 10 parts of domperidone, 80 parts of filler, 10 parts of disintegrant, 5 parts of sweetener, 2.1 parts of glidant and 0.54 part of lubricant. The bulking agent is microcrystalline cellulose, the disintegrant is croscarmellose sodium, the sweetener is aspartame, and the glidant is silicon dioxide. The lubricant is a mixture of magnesium stearate, glyceryl behenate and sodium stearyl fumarate, and the weight ratio of the magnesium stearate to the glyceryl behenate to the sodium stearyl fumarate is 3:1: 2.
The preparation method of the domperidone orally disintegrating tablet comprises the following steps:
(1) respectively crushing domperidone, a filling agent, a disintegrating agent, a sweetening agent and a flow aid, and respectively sieving the powder with a 80-mesh sieve;
(2) mixing 10 parts by weight of domperidone obtained in the step (1) and 10 parts by weight of filler for 10 minutes;
(3) adding 20 parts by weight of the filler obtained in the step (1), 10 parts by weight of the disintegrant, 5 parts by weight of the sweetener, 2.1 parts by weight of the glidant and 0.27 part by weight of the lubricant, and mixing for 10 minutes;
(4) adding 50 parts by weight of the filler obtained in the step (1) and 0.27 part by weight of the lubricant, uniformly mixing for 30 minutes, and tabletting to obtain the domperidone orally disintegrating tablet.
Example 4
1. Improved tablet weight difference and dissolution rate monitoring
Samples were taken from the disintegrated tablets before and after the modification, and each tablet was weighed by an electronic balance (JJ200B) to monitor the difference in tablet weight, and the results are shown in Table 1.
TABLE 1 comparison of tablet weight difference before and after improvement
From the results in table 1, it can be seen that the combination of the three lubricants, i.e., magnesium stearate, glyceryl behenate and sodium stearyl fumarate, has a smaller difference in tablet weight, and is significantly better than the combination of the two lubricants.
2. Dissolution monitoring before and after improvement
Sampling from the disintegrating tablets before and after improvement, testing according to a second method of 'dissolution testing operation rules', taking 500ml of hydrochloric acid solution of sodium chloride (2.0 g of sodium chloride is taken, 7ml of hydrochloric acid is added, and water is added to 1000ml) as a dissolution medium, operating at the rotating speed of 100 revolutions per minute according to a method, filtering the solution after 15 minutes, testing according to 'ultraviolet spectrophotometry testing operation rules', and measuring the absorbance at the wavelength of 284 nm; another 10mg of domperidone reference substance dried at 105 ℃ to constant weight was precisely weighed, placed in a 100ml measuring flask, dissolved and diluted to the scale with the dissolution medium, shaken up, precisely weighed 5ml, placed in a 25ml measuring flask, diluted to the scale with the dissolution medium, shaken up, measured for absorbance in the same way, and the dissolution amount of each tablet was calculated, with the results shown in table 2.
Calculating formula and result:
Asample (A)，ATo pairAbsorbance of the measured sample solution and the control sample solution, respectively
mTo pair-accurately weighing the amount of domperidone reference, mg
a-content of control
TABLE 2 comparison of dissolution before and after improvement
| Example 1 | Example 2 | Example 3 | Comparative example 1 | Comparative example 2 | Comparative example 3 |
| 99.0％ | 95.1％ | 93.6％ | 90.8％ | 90.6％ | 88.6％ |
| 99.8％ | 96.2％ | 95.4％ | 90.9％ | 89.4％ | 89.7％ |
| 98.4％ | 95.5％ | 94.6％ | 91.1％ | 90.9％ | 90.2％ |
| 98.2％ | 93.8％ | 96.1％ | 89.8％ | 90.1％ | 90.1％ |
| 99.0％ | 95.8％ | 95.2％ | 90.2％ | 89.6％ | 89.9％ |
| 98.5％ | 94.7％ | 94.16％ | 89.6％ | 90.0％ | 90.4％ |
From the results in table 2, it can be seen that the combined use of the three lubricants, i.e., magnesium stearate, glyceryl behenate and sodium stearyl fumarate, has higher dissolution rate, which is obviously superior to the combined use of two lubricants, wherein the dissolution rate of example 1 is the best.
3. Improved front and back sticking contrast
Sampling of the disintegrated tablets before and after the modification revealed that the disintegrated tablet of example 1 had no sticking and that the sticking occurred in all of comparative examples 1 to 3.
4. Improved front and back mouthfeel contrast
Sampling was performed on the disintegrated tablets before and after the improvement, and it was found that the disintegrated tablet of example 1 had a smooth mouth feel and no feeling of gritty texture; the disintegrating tablet of comparative example 4 had a non-smooth mouthfeel and a sandy granular feeling.
The invention solves the technical problems of sticking, insufficient surface smoothness of finished products, large piece weight difference, easy occurrence of overrun and the like in the preparation process by adopting the specific lubricant. When part of the raw and auxiliary materials are not sieved by a 100-mesh sieve and are only sieved by a 80-mesh sieve, the finished product has poor taste and has a gritty feeling in the oral cavity. The finished product prepared by adopting the specific lubricant and sieving the 100-mesh sieve has smooth surface, small tablet weight difference, better dissolution rate, good taste and meets the requirement of quality standard.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.
Claims (7)
1. The domperidone orally disintegrating tablet is characterized by comprising the following components in parts by weight: 6-12 parts of domperidone, 70-90 parts of filler, 5-12 parts of disintegrant, 1-6 parts of sweetener, 1-3 parts of glidant and 0.1-1 part of lubricant;
wherein the lubricant is a mixture of magnesium stearate, glyceryl behenate and sodium stearyl fumarate; the domperidone, the filling agent, the disintegrating agent, the sweetening agent and the glidant are all sieved by a 100-mesh sieve.
2. The domperidone orally disintegrating tablet of claim 1, which comprises the following components in parts by weight: 10 parts of domperidone, 80 parts of filler, 10 parts of disintegrant, 5 parts of sweetener, 2.1 parts of glidant and 0.54 part of lubricant.
3. The domperidone orally disintegrating tablet of claim 1, wherein the weight ratio of magnesium stearate, glyceryl behenate and sodium stearyl fumarate is 3:1: 2.
4. The domperidone orally disintegrating tablet of claim 1, wherein the filler is microcrystalline cellulose, the disintegrant is croscarmellose sodium, the sweetener is aspartame, and the glidant is silicon dioxide.
5. The process for preparing an orally disintegrating tablet of domperidone according to any one of claims 1-4, which comprises the following steps:
(1) respectively crushing domperidone, a filling agent, a disintegrating agent, a sweetening agent and a flow aid, and respectively sieving the powder with a 100-mesh sieve;
(2) uniformly mixing the domperidone obtained in the step (1) and a part of filler for 10 minutes;
(3) adding part of the filler, the disintegrant, the sweetener, the glidant and part of the lubricant obtained in the step (1), and uniformly mixing for 10 minutes;
(4) and (2) adding the residual filler and the lubricant obtained in the step (1), uniformly mixing for 30 minutes, and tabletting to obtain the domperidone orally disintegrating tablet.
6. The method according to claim 5, wherein the weight ratio of the filler in the step (2), the filler in the step (3) and the filler in the step (4) is 1:2: 5.
7. The method according to claim 5, wherein the weight ratio of the lubricant in the step (3) to the lubricant in the step (4) is 1: 1.
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| CN101152156A (en) * | 2006-09-29 | 2008-04-02 | 上海爱的发制药有限公司 | Domperidone orally disintegrating tablets and method for preparing the same |
| FR2909877B1 (en) * | 2006-12-13 | 2009-07-10 | Galenix Dev Soc Par Actions Si | PHARMACEUTICAL COMPOSITION CONTENT OF 5-CHLORO-1- [1- [3- (2-OXO-2,3-DIHYDRO-1H-BENZIMIDAZOL-1-YL) PROPYL] PIPERIDIN-4-YL] -1,3-DIHYDRO -2H-BENZIMIDAZOL-2-ONE AND PROCESS FOR PREPARING THE SAME |
| CN101804036B (en) * | 2009-02-13 | 2013-05-08 | 北京以岭生物工程技术有限公司 | Domperidone orally disintegrating tablet and preparation method thereof |
| CN104027318A (en) * | 2014-06-13 | 2014-09-10 | 青岛市市立医院 | Domperidone tablet and preparation method thereof |
| CN105560199B (en) * | 2016-03-01 | 2018-07-06 | 山东司邦得制药有限公司 | A kind of children's domperidone oral disintegrating tablet and preparation method thereof |
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|---|---|
| CN110151711A (en) | 2019-08-23 |
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