CN111214443A - Bismuth potassium citrate granules and preparation method thereof - Google Patents
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
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- 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 belongs to the field of medicaments, and particularly relates to bismuth potassium citrate granules and a preparation method thereof, wherein the preparation method of the bismuth potassium citrate granules comprises the following steps: respectively sieving bismuth potassium citrate, filler, disintegrant and adhesive through a screen; weighing the bismuth potassium citrate meeting the particle size requirement, the filler, the disintegrant and the adhesive according to the prescription amount, and uniformly mixing in a three-dimensional mixer; adding the mixed material into a dry-method granulator to obtain crushed dry granules; sieving the crushed dry particles, and grading to obtain dry particles; weighing a lubricant, and then uniformly mixing the dry particles and the lubricant in a three-dimensional mixer to prepare first particles; and subpackaging the first granules to obtain bismuth potassium citrate granules. The invention is composed of a new prescription, adopts a dry granulation process to obtain granules with better fluidity, is added with a lubricant, and can ensure the stability of the product and the possibility of continuous production.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to bismuth potassium citrate granules and a preparation method thereof.
Background
Digestive tract diseases are common diseases and frequently encountered diseases, the incidence rate of the diseases of the stomach and the duodenum is the highest among the diseases of the digestive tract, and the number of the diseases accounts for more than 10 percent of the world population. Gastrointestinal ulcer is one of the main diseases affecting human health at present, so that finding an anti-ulcer medicament with good curative effect and low price is a hot point in the research and development field of Chinese medicaments.
Bismuth potassium citrate is a bismuth-containing compound of indefinite composition, in the form of a white powder. Bismuth potassium citrate has the characteristics of salty taste, easy water solubility and very slight ethanol solubility. The bismuth potassium citrate is dissolved in hot water and taken orally, and after being hydrolyzed by gastric juice, the bismuth potassium citrate can generate the deposit with the effective component of colloidal bismuth subcitrate to form a diffuse protective layer which covers the ulcer surface and can promote the regeneration of ulcer mucosa and the healing of ulcer.
At present, the auxiliary materials used in the bismuth potassium citrate granules in China generally comprise starch, sodium carboxymethyl cellulose, magnesium stearate and the like. The wet granulation is generally adopted for split charging, the product stability difference of the wet granulation process is large, uniform colloid precipitation is difficult to form rapidly in the stomach, and the difference is very large compared with the colloid precipitation condition of a reference preparation in artificial gastric juice. The clinical treatment is not favorable for colloid sedimentation on ulcer surfaces, ulcer mucosa regeneration and ulcer healing, and the clinical treatment effect difference is large.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provides bismuth potassium citrate granules and a preparation method thereof. The prepared bismuth potassium citrate particles quickly form colloid precipitate in gastric juice, and are more favorable for protecting ulcer surfaces in clinical application.
In order to achieve the purpose, the invention adopts the following technical scheme:
on one hand, the invention provides bismuth potassium citrate particles, wherein the bismuth potassium citrate particles comprise the following components in percentage by mass, based on the total mass of the bismuth potassium citrate particles as 100 percent:
in one embodiment, the bismuth potassium citrate particles comprise the following components in percentage by mass, based on 100% of the total mass of the bismuth potassium citrate particles:
in one embodiment, the filler includes at least one of pregelatinized starch, microcrystalline cellulose, mannitol, and lactose.
In one embodiment, the disintegrant comprises at least one of sodium carboxymethyl starch, carboxymethyl cellulose, crospovidone, and low-substituted hydroxypropyl cellulose.
In one embodiment, the binder comprises at least one of pregelatinized starch, hydroxypropyl cellulose, hypromellose, and povidone.
In one embodiment, the lubricant comprises at least one of stearic acid, magnesium stearate, calcium stearate, and aerosil.
On the other hand, the invention also provides a preparation method of the bismuth potassium citrate granules, which comprises the following steps:
screening the raw material bismuth potassium citrate by a screen with a first mesh number to obtain bismuth potassium citrate meeting the requirement of particle size;
respectively sieving the filler, the disintegrant and the adhesive with a second mesh screen to obtain the filler, the disintegrant and the adhesive which meet the requirement of the particle size;
weighing the bismuth potassium citrate meeting the particle size requirement, the filler, the disintegrant and the adhesive according to the prescription amount, and uniformly mixing in a three-dimensional mixer to obtain a mixed material;
adding the mixed material into a dry-method granulator to obtain crushed dry granules;
straightening the crushed dry particles through a screen with a third mesh number to obtain dry particles;
weighing a lubricant according to the prescription amount, and then uniformly mixing the dry particles and the lubricant in a three-dimensional mixer to prepare first particles;
and subpackaging the first granules to obtain bismuth potassium citrate granules.
In one embodiment, the first mesh number is 60-100;
and/or the second mesh number is 60-100;
and/or the third mesh number is 16-30.
In one embodiment, in the step of adding the mixed material into a dry granulator to obtain crushed dry granules, the feeding frequency is set to be 5-10Hz, the tabletting speed is set to be 5-10Hz, the tabletting pressure is set to be 30-50PSI, and the whole granulation frequency is set to be 10-20 Hz.
In one embodiment, the lubricant is weighed according to batch feeding amount, and then the dry particles and the lubricant are uniformly mixed in a three-dimensional mixer, wherein in the step of preparing the particles, the mixing time is 10-30 min.
The invention mainly overcomes the defects of poor product stability and uneven colloid settlement caused by the traditional wet granulation process. The granules with better fluidity are obtained by a new prescription composition and a dry granulation process, and the stability and the possibility of continuous production of the product can be ensured by adding a lubricant. The prepared bismuth potassium citrate particles can quickly form colloid precipitate in gastric juice and are more favorable for protecting ulcer surfaces in clinical application.
Detailed Description
In order to make the technical problems, technical solutions and advantageous effects to be solved by the present invention more clearly apparent, the present invention is further described in detail below with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
In one aspect, an embodiment of the present invention provides a bismuth potassium citrate granule, where the total mass of the bismuth potassium citrate granule is 100%, and the bismuth potassium citrate granule includes the following components by mass:
further, the most preferred prescription composition is as follows, based on the total mass of the bismuth potassium citrate particles being 100 percent:
the filler comprises at least one of pregelatinized starch, microcrystalline cellulose, mannitol and lactose, wherein corn starch or microcrystalline cellulose is preferred, and microcrystalline cellulose is most preferred. Among other things, fillers may be used to fill the weight or volume of the tablet, thereby facilitating tableting.
The disintegrant comprises at least one of sodium carboxymethyl starch, carboxymethyl cellulose, crospovidone and low-substituted hydroxypropyl cellulose, wherein the sodium carboxymethyl starch or carboxymethyl cellulose is preferred, and the sodium carboxymethyl starch is most preferred.
The binder comprises at least one of pregelatinized starch, hydroxypropyl cellulose, hypromellose and povidone, preferably povidone or pregelatinized starch, and most preferably povidone.
The lubricant comprises at least one of stearic acid, magnesium stearate, calcium stearate and aerosil, wherein the magnesium stearate and calcium stearate are preferred, and the magnesium stearate is most preferred.
On the other hand, the invention also provides a preparation method of the bismuth potassium citrate granules, which comprises the following steps:
step S10, the raw material bismuth potassium citrate is screened by a first mesh screen to obtain bismuth potassium citrate meeting the requirement of particle size;
step S20, the filling agent, the disintegrating agent and the adhesive are respectively screened by a screen with a second mesh number to obtain the filling agent, the disintegrating agent and the adhesive which meet the requirement of the grain diameter;
step S30, weighing the bismuth potassium citrate meeting the particle size requirement, the filler, the disintegrant and the adhesive according to the prescription amount, and uniformly mixing in a three-dimensional mixer to obtain a mixed material;
step S40, adding the mixed material into a dry-method granulator to obtain crushed dry particles;
step S50, straightening the crushed dry particles with a third mesh sieve to obtain dry particles;
step S60, weighing a lubricant according to the prescription amount, and then uniformly mixing the dry particles and the lubricant in a three-dimensional mixer to prepare first particles;
and step S70, subpackaging the first granules to obtain bismuth potassium citrate granules.
Further, in step S10, the mesh number of the first mesh screen is 60 to 100, and may be selected according to the particle size of the desired particles, and may be, for example, 60, 61, 62, 63, 64, 65, 70, 80, 90, 100, etc., preferably 60.
Further, in step S20, the mesh number of the second mesh screen is 60 to 100, and may be selected according to the particle size of the desired particles, and may be, for example, 60, 61, 62, 63, 64, 65, 70, 80, 90, 100, etc., preferably 60.
Further, in step S40, the feeding frequency is 5 to 10Hz, and may be, for example, 5Hz, 6Hz, 7Hz, 8Hz, 9Hz, 10Hz, or the like. The tabletting rate is 5-10Hz, and may be, for example, 5Hz, 6Hz, 7Hz, 8Hz, 9Hz, 10Hz, etc. The compression pressure is 30-50PSI, such as 30PSI, 31PSI, 32PSI, 33PSI, 34PSI, 35PSI, 40PSI, 45PSI, 50PSI, etc. The whole grain frequency is 10-20Hz, and may be, for example, 10Hz, 11Hz, 12Hz, 13Hz, 14Hz, 15Hz, or 20 Hz.
Further, in step S50, the mesh number of the third mesh sieve is 16 to 30, which can be selected according to the particle size of the desired particles, and for example, 16, 17, 18, 19, 20, 25, 30, etc., preferably 20.
Further, in step S60, the mixing time is 10 to 30min, for example, 10min, 11min, 12min, 13min, 14min, 15min, 20min, 25min, 30min, and the like.
The invention mainly overcomes the defects of poor product stability and uneven colloid settlement caused by the traditional wet granulation process. The granules with better fluidity are obtained by a new prescription composition and a dry granulation process, and the stability and the possibility of continuous production of the product can be ensured by adding a lubricant. The prepared bismuth potassium citrate particles can quickly form colloid precipitate in gastric juice and are more favorable for protecting ulcer surfaces in clinical application.
The invention is described in further detail with reference to a part of the test results, which are described in detail below with reference to specific examples.
Example 1
The bismuth potassium citrate granules comprise the following components in percentage by mass, calculated by preparing each granule as 110 mg:
| name (R) | Weight ratio (%) | Function of |
| Bismuth Potassium citrate | 35％ | Active ingredient |
| Pregelatinized starch | 55％ | Filler |
| Cross-linked polyvidone | 5％ | Disintegrating agent |
| Povidone | 4％ | Adhesive agent |
| Magnesium stearate | 1％ | Lubricant agent |
The preparation process is a dry granulation process and comprises the following steps:
s1, the raw material bismuth potassium citrate is firstly screened by a 60-mesh screen to obtain bismuth potassium citrate with the grain diameter meeting the requirement;
s2, respectively sieving the pregelatinized starch, the crospovidone and the povidone by a 60-mesh sieve to obtain the pregelatinized starch, the crospovidone and the povidone meeting the requirement of the particle size;
s3, weighing the bismuth potassium citrate, the pregelatinized starch, the crospovidone and the povidone meeting the particle size requirement obtained in the steps S1 and S2 according to the prescription amount, and uniformly mixing in a three-dimensional mixer to obtain a mixed material;
s4, adding the mixed material obtained in the step S3 into a dry-method granulator, setting the feeding frequency to be 5-10Hz, the tabletting speed to be 5-10Hz, the tabletting pressure to be 30-50PSI and the whole granule frequency to be 10-20Hz, and obtaining crushed dry granules;
s5, sieving the crushed dry particles obtained in the step S4 by a 20-mesh sieve for size stabilization to obtain dry particles;
s6, weighing magnesium stearate according to the formula amount, and then uniformly mixing the dry granules obtained in the step S5 and the magnesium stearate in a three-dimensional mixer for 10-30 min to prepare granules;
s7, subpackaging the granules obtained in the step S6 to obtain bismuth potassium citrate granules.
Weighing the bismuth potassium citrate particles obtained in the step S7 in 50ml of artificial gastric juice, stirring for 5min to uniformly disperse the bismuth in the artificial gastric juice with the concentration of 110mg/50ml, standing by using a measuring cylinder, and observing the change trend of the liquid level height along with the time; referring to the investigation of colloid stability in the standard of the Chinese pharmacopoeia 2015 edition of standards of colloidal bismuth pectin, we have carried out the investigation of sedimentation speed and time on bismuth potassium citrate particles. The results of the measurement of 50ml artificial gastric juice in one of examples 1 to 3 and the reference formulation are shown in the table.
Preparing artificial gastric juice: weighing 16.4ml of dilute hydrochloric acid, 800ml of water and 10g of pepsin, uniformly mixing in a beaker, then adding 200ml of water, and uniformly stirring to obtain the artificial gastric juice.
Example 2
The bismuth potassium citrate granules comprise the following components in percentage by mass, calculated by preparing each granule as 110 mg:
| name (R) | Weight ratio (%) | Function of |
| Bismuth Potassium citrate | 30％ | Active ingredient |
| Pregelatinized starch | 55％ | Filler |
| Cross-linked polyvidone | 10％ | Disintegrating agent |
| Povidone | 4％ | Adhesive agent |
| Magnesium stearate | 1％ | Lubricant agent |
The preparation process is a dry granulation process and comprises the following steps:
s1, the raw material bismuth potassium citrate is firstly screened by a 60-mesh screen to obtain bismuth potassium citrate with the grain diameter meeting the requirement;
s2, respectively sieving the pregelatinized starch, the crospovidone and the povidone by a 60-mesh sieve to obtain the pregelatinized starch, the crospovidone and the povidone meeting the requirement of the particle size;
s3, weighing the bismuth potassium citrate, the pregelatinized starch, the crospovidone and the povidone meeting the particle size requirement obtained in the steps S1 and S2 according to the prescription amount, and uniformly mixing in a three-dimensional mixer to obtain a mixed material;
s4, adding the mixed material obtained in the step S3 into a dry-method granulator, setting the feeding frequency to be 5-10Hz, the tabletting speed to be 5-10Hz, the tabletting pressure to be 30-50PSI and the whole granule frequency to be 10-20Hz, and obtaining crushed dry granules;
s5, sieving the crushed dry particles obtained in the step S4 by a 20-mesh sieve for size stabilization to obtain dry particles;
s6, weighing magnesium stearate according to the formula amount, and then uniformly mixing the dry granules obtained in the step S5 and the magnesium stearate in a three-dimensional mixer for 10-30 min to prepare granules;
s7, subpackaging the granules obtained in the step S6 to obtain bismuth potassium citrate granules.
Weighing the bismuth potassium citrate particles obtained in the step S7 in 50ml of artificial gastric juice, stirring for 5min to uniformly disperse the bismuth in the artificial gastric juice with the concentration of 110mg/50ml, standing by using a measuring cylinder, and observing the change trend of the liquid level height along with the time; referring to the investigation of colloid stability in the standard of the Chinese pharmacopoeia 2015 edition of standards of colloidal bismuth pectin, we have carried out the investigation of sedimentation speed and time on bismuth potassium citrate particles. The results of the measurement of 50ml artificial gastric juice in one of examples 1 to 3 and the reference formulation are shown in the table.
Preparing artificial gastric juice: weighing 16.4ml of dilute hydrochloric acid, 800ml of water and 10g of pepsin, uniformly mixing in a beaker, then adding 200ml of water, and uniformly stirring to obtain the artificial gastric juice.
Example 3
The bismuth potassium citrate granules comprise the following components in percentage by mass, calculated by preparing each granule as 110 mg:
| name (R) | Weight ratio (%) | Function of |
| Bismuth Potassium citrate | 25％ | Active ingredient |
| Pregelatinized starch | 65％ | Filler |
| Cross-linked polyvidone | 5％ | Disintegrating agent |
| Povidone | 4％ | Adhesive agent |
| Magnesium stearate | 1％ | Lubricant agent |
The preparation process is a dry granulation process and comprises the following steps:
s1, the raw material bismuth potassium citrate is firstly screened by a 60-mesh screen to obtain bismuth potassium citrate with the grain diameter meeting the requirement;
s2, respectively sieving the pregelatinized starch, the crospovidone and the povidone by a 60-mesh sieve to obtain the pregelatinized starch, the crospovidone and the povidone meeting the requirement of the particle size;
s3, weighing the bismuth potassium citrate, the pregelatinized starch, the crospovidone and the povidone meeting the particle size requirement obtained in the steps S1 and S2 according to the prescription amount, and uniformly mixing in a three-dimensional mixer to obtain a mixed material;
s4, adding the mixed material obtained in the step S3 into a dry-method granulator, setting the feeding frequency to be 5-10Hz, the tabletting speed to be 5-10Hz, the tabletting pressure to be 30-50PSI and the whole granule frequency to be 10-20Hz, and obtaining crushed dry granules;
s5, sieving the crushed dry particles obtained in the step S4 by a 20-mesh sieve for size stabilization to obtain dry particles;
s6, weighing magnesium stearate according to the formula amount, and then uniformly mixing the dry granules obtained in the step S5 and the magnesium stearate in a three-dimensional mixer for 10-30 min to prepare granules;
s7, subpackaging the granules obtained in the step S6 to obtain bismuth potassium citrate granules.
Weighing the bismuth potassium citrate particles obtained in the step S7 in 50ml of artificial gastric juice, stirring for 5min to uniformly disperse the bismuth in the artificial gastric juice with the concentration of 110mg/50ml, standing by using a measuring cylinder, and observing the change trend of the liquid level height along with the time; referring to the investigation of colloid stability in the standard of the Chinese pharmacopoeia 2015 edition of standards of colloidal bismuth pectin, we have carried out the investigation of sedimentation speed and time on bismuth potassium citrate particles. The results of the measurement of 50ml artificial gastric juice in one of examples 1 to 3 and the reference formulation are shown in the table.
Preparing artificial gastric juice: weighing 16.4ml of dilute hydrochloric acid, 800ml of water and 10g of pepsin, uniformly mixing in a beaker, then adding 200ml of water, and uniformly stirring to obtain the artificial gastric juice.
TABLE 50ml simulated gastric fluid assay results for examples 1-3 and reference formulations
And (4) conclusion: the comparison of the sedimentation rates of the samples shows that the colloidal stability of the bismuth potassium citrate granules of examples 1-3 is consistent with that of the reference formulation.
Reference formulation
Bismuth potassium citrate tablets;
the manufacturer: spain is marketed by Tora Laboratories s.l.
Weighing the bismuth potassium citrate tablets in 50ml of artificial gastric juice, stirring for 5min to uniformly disperse the bismuth at the concentration of 110mg/50ml, standing by using a measuring cylinder, and observing the change trend of the liquid level height along with the time; referring to the investigation of colloid stability in the standard of the Chinese pharmacopoeia 2015 edition of standards of colloidal bismuth pectin, we have carried out the investigation of sedimentation speed and time on bismuth potassium citrate particles. The results of the measurement of 50ml artificial gastric juice in one of examples 1 to 3 and the reference formulation are shown in the table.
Preparing artificial gastric juice: weighing 16.4ml of dilute hydrochloric acid, 800ml of water and 10g of pepsin, uniformly mixing in a beaker, then adding 200ml of water, and uniformly stirring to obtain the artificial gastric juice.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.
Claims (10)
1. The bismuth potassium citrate particles are characterized by comprising the following components in percentage by mass based on 100% of the total mass of the bismuth potassium citrate particles:
2. the bismuth potassium citrate granules of claim 1, wherein said bismuth potassium citrate granules comprise the following ingredients in mass percent, based on 100% of the total mass of said bismuth potassium citrate granules:
3. the potassium bismuth citrate granules of claim 1, wherein the filler comprises at least one of pregelatinized starch, microcrystalline cellulose, mannitol, and lactose.
4. The bismuth potassium citrate granule of claim 1, wherein the disintegrant comprises at least one of sodium carboxymethyl starch, carboxymethyl cellulose, crospovidone, and low substituted hydroxypropyl cellulose.
5. The bismuth potassium citrate granule of claim 1, wherein the binder comprises at least one of pregelatinized starch, hydroxypropyl cellulose, hypromellose, and povidone.
6. The bismuth potassium citrate granules of claim 1, wherein said lubricant comprises at least one of stearic acid, magnesium stearate, calcium stearate, and aerosil.
7. A process for the preparation of bismuth potassium citrate granules according to any one of claims 1 to 6, comprising the steps of:
screening the raw material bismuth potassium citrate by a screen with a first mesh number to obtain bismuth potassium citrate meeting the requirement of particle size;
respectively sieving the filler, the disintegrant and the adhesive with a second mesh screen to obtain the filler, the disintegrant and the adhesive which meet the requirement of the particle size;
weighing the bismuth potassium citrate meeting the particle size requirement, the filler, the disintegrant and the adhesive according to the prescription amount, and uniformly mixing in a three-dimensional mixer to obtain a mixed material;
adding the mixed material into a dry-method granulator to obtain crushed dry granules;
straightening the crushed dry particles through a screen with a third mesh number to obtain dry particles;
weighing a lubricant according to the prescription amount, and then uniformly mixing the dry particles and the lubricant in a three-dimensional mixer to prepare first particles;
and subpackaging the first granules to obtain bismuth potassium citrate granules.
8. The method of claim 7, wherein said first mesh number is 60-100;
and/or the second mesh number is 60-100;
and/or the third mesh number is 16-30.
9. The method of claim 7, wherein the step of feeding the mixture into a dry granulator to obtain dry granules which are crushed sets a feeding frequency of 5 to 10Hz, a tabletting speed of 5 to 10Hz, a tabletting pressure of 30 to 50PSI, and a granulation frequency of 10 to 20 Hz.
10. The method of claim 7, wherein the step of preparing the granules comprises weighing the lubricant according to a prescribed amount, and mixing the dry granules and the lubricant uniformly in a three-dimensional mixer for 10-30 min.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112263553A (en) * | 2020-10-21 | 2021-01-26 | 北京鑫开元医药科技有限公司 | Bismuth potassium citrate tablet, preparation method and application thereof |
| CN112294841A (en) * | 2020-10-21 | 2021-02-02 | 北京鑫开元医药科技有限公司 | Famotidine bismuth potassium citrate compound composition, preparation method and application thereof |
| CN114129532A (en) * | 2021-12-10 | 2022-03-04 | 丽珠集团丽珠制药厂 | Bismuth potassium citrate preparation |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112263553A (en) * | 2020-10-21 | 2021-01-26 | 北京鑫开元医药科技有限公司 | Bismuth potassium citrate tablet, preparation method and application thereof |
| CN112294841A (en) * | 2020-10-21 | 2021-02-02 | 北京鑫开元医药科技有限公司 | Famotidine bismuth potassium citrate compound composition, preparation method and application thereof |
| CN114129532A (en) * | 2021-12-10 | 2022-03-04 | 丽珠集团丽珠制药厂 | Bismuth potassium citrate preparation |
| CN114129532B (en) * | 2021-12-10 | 2023-09-19 | 丽珠集团丽珠制药厂 | Bismuth potassium citrate preparation |
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