CN110420192B - Isosorbide mononitrate sustained-release tablet and preparation method thereof - Google Patents
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Abstract
The invention belongs to the technical field of western medicine preparations, and particularly provides an isosorbide mononitrate sustained-release tablet and a preparation method thereof, wherein the sustained-release tablet comprises the following components in parts by weight: isosorbide mononitrate, lactose, a sustained release material, microcrystalline cellulose, a glidant and a lubricant. The isosorbide mononitrate mixed powder prepared by the special preparation process in the formula has good fluidity, is suitable for direct powder tabletting, and the prepared sustained-release tablet has good stability and better sustained-release effect.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an isosorbide mononitrate sustained-release tablet and a preparation method thereof.
Background
Isosorbide mononitrate is a new generation of nitrate anti-angina drug, is firstly developed by Boehringer Mannheim Gmb.h company of Germany, is a main active metabolite in vivo of isosorbide mononitrate, and has the advantages of quick oral absorption, high absolute bioavailability and small individual difference. The biological half-life period is 4-5 hours, the common preparation needs to be taken 2-3 times a day, and the drug resistance is easy to generate after the common preparation is taken orally for several weeks. The sustained release preparation can effectively overcome the drug resistance, and the isosorbide mononitrate sustained release tablet is widely used in clinic.
Researches find that the crystal form of isosorbide mononitrate is white needle-shaped crystal or crystalline powder and has low hardness, hard and large agglomerates are easily formed after the crystal form is crushed and placed for a period of time, the flowability is low in the production process of the preparation, and the preparation processes of direct powder tabletting, generally wet granulation and tabletting are adopted; in order to achieve the purpose of sustained and controlled release, a sustained-release material is generally adopted as a framework and then coated to prepare sustained-release tablets, sustained-release pellets, osmotic pump type controlled-release preparations and the like.
Patent CN200410030824 discloses an isosorbide mononitrate sustained-release tablet, which is prepared by wet granulation, granule drying, granule finishing, adding a proper amount of lubricant and tabletting; firstly, isosorbide mononitrate is easy to explode when being heated or impacted, the temperature is strictly controlled after granulation and drying is not suitable to be too high, otherwise, the explosion risk exists; secondly, the process is complex, the powder mixing direct compression process cannot be adopted, the time is long, the granulation is needed for the next day, and the tabletting efficiency is not high.
The patent CN104644589 discloses an isosorbide mononitrate sustained-release tablet and a preparation method thereof, the method firstly prepares a mesoporous carbon-isosorbide mononitrate compound, then uses ethyl cellulose as a sustained-release coating material, uses hydroxyethyl cellulose as a pore-forming agent, adopts a fluidized bed to perform bottom spray coating, prepares a sustained-release coated pellet, and then mixes the pellet with other pharmaceutically acceptable auxiliary materials to press the pellet into the tablet. The method has a complex preparation process, and is not beneficial to large-scale and batch industrial production in a workshop.
The patent CN20121016996 discloses an isosorbide mononitrate sustained-release tablet and a preparation method thereof, in the method, hydroxypropyl methyl cellulose K4M is used as a sustained-release framework material, powder direct-pressure coating is used for preparing the sustained-release tablet, and hydroxypropyl methyl cellulose K4M is used as the sustained-release framework material, so that the sustained-release material has low viscosity, the drug dissolution rate is high, and the sustained-release effect is not ideal.
At present, the isosorbide mononitrate sustained-release tablets sold on the market have more small specifications (such as 30mg, 50mg, 60mg and the like), and along with the increase of the disease condition of a patient, the need of increasing the administration dosage, the research and development of the 120 mg-specification isosorbide mononitrate sustained-release tablets are particularly important. At present, a plurality of bottlenecks exist in the research and development of the isosorbide mononitrate sustained-release tablet of 120mg, so that a preparation method of the isosorbide mononitrate sustained-release tablet of 120mg is necessary.
Disclosure of Invention
Based on the defects of the prior art and the research and development difficulty of the product, the invention mainly provides the isosorbide mononitrate sustained-release tablet which is simple and easy to operate, slow to dissolve and more stable in product quality and the preparation method thereof.
The hydroxypropyl methyl cellulose has poor fluidity, and in order to ensure the slow release effect of the product and the fluidity of the mixed powder, the hydroxypropyl methyl cellulose type number with high viscosity is selected firstly, the using amount of the hydroxypropyl methyl cellulose type number is optimized, the cost is reduced, and the slow release effect is ensured. Researches find that the hydroxypropyl methyl cellulose and the hydrogenated castor oil are used as slow-release materials at the same time according to a certain proportion, so that the slow-release effect is better, and the fluidity can be improved.
The colloidal silicon dioxide is fluffy, the colloidal silicon dioxide is firstly mixed with isosorbide mononitrate and then sieved by a 20-mesh sieve, so that the colloidal silicon dioxide is adsorbed on the surface of isosorbide mononitrate as far as possible, then the colloidal silicon dioxide is mixed with a slow-release material and then sieved by the 20-mesh sieve, the isosorbide mononitrate and the slow-release material are uniformly mixed, lactose and microcrystalline cellulose are added and then uniformly mixed again and sieved by the 20-mesh sieve, finally, talcum powder is added and uniformly mixed again, the obtained mixed powder is directly tabletted, after the preparation process is carried out, the mixed powder has good fluidity and is directly tabletted, the tablet weight difference is small, the slow-release or dissolution effect is superior to that of the original preparation, and the colloidal silicon dioxide is suitable for industrial mass production.
The technical scheme of the invention is as follows:
an isosorbide mononitrate sustained-release tablet, which consists of the following components: isosorbide mononitrate, lactose, microcrystalline cellulose, a slow release material, a glidant and a lubricant; wherein the slow release material is composed of hydroxypropyl methylcellulose and hydrogenated castor oil.
The mass ratio of the slow-release material hypromellose to the hydrogenated castor oil is 1: 0.55-0.82; the preferable mass ratio is 1: 0.68.
the hydroxypropyl methylcellulose is one selected from hydroxypropyl methylcellulose K4M, hydroxypropyl methylcellulose K15M, hydroxypropyl methylcellulose K40M, hydroxypropyl methylcellulose K100M and hydroxypropyl methylcellulose K200M.
The hydroxypropyl methylcellulose is hydroxypropyl methylcellulose K200M, and the dosage of the hydroxypropyl methylcellulose is 90-130 parts.
The isosorbide mononitrate sustained-release tablet comprises the following components: 120 parts of isosorbide mononitrate, 50-90 parts of lactose, a slow-release material, 60-120 parts of microcrystalline cellulose, 20-35 parts of a glidant and 5-15 parts of a lubricant; wherein the slow release material is composed of hydroxypropyl methylcellulose and hydrogenated castor oil; the mass ratio of the slow-release material hypromellose to the hydrogenated castor oil is 1: 0.55-0.82; the hydroxypropyl methylcellulose is hydroxypropyl methylcellulose K200M, and the dosage of the hydroxypropyl methylcellulose is 90-130 parts.
The isosorbide mononitrate sustained-release tablet comprises the following components: 120 parts of isosorbide mononitrate, 70 parts of lactose, a slow release material, 90 parts of microcrystalline cellulose, 25 parts of a glidant and 10 parts of a lubricant; wherein the slow release material is composed of hydroxypropyl methylcellulose and hydrogenated castor oil; the mass ratio of the slow-release material hypromellose to the hydrogenated castor oil is 1: 0.68; the hydroxypropyl methylcellulose is hydroxypropyl methylcellulose K200M, and the dosage of the hydroxypropyl methylcellulose is 90-130 parts.
The glidant is colloidal silicon dioxide.
The lubricant is talcum powder.
The isosorbide mononitrate sustained release tablet is prepared by directly tabletting powder; the method specifically comprises the following steps:
a. first, isosorbide mononitrate and glidant are mixed evenly and sieved by a 20-mesh sieve;
b. adding the mixed powder obtained in the step (a) into a slow-release material, uniformly mixing, and sieving by a 20-mesh sieve;
c. adding lactose and microcrystalline cellulose into the mixed powder obtained in the step (b), uniformly mixing, and then sieving by a 20-mesh sieve;
d. adding the mixed powder obtained in the step (c) into a lubricant, uniformly mixing the mixed powder again, and directly tabletting the powder.
Prescription and process screening:
screening the dosage of hydroxypropyl methylcellulose: isosorbide mononitrate belongs to BCS I medicines, hydroxypropyl methylcellulose is hydrophilic gel, the flowability of the sustained-release material is poor, the dosage of the hydroxypropyl methylcellulose has a crucial influence on the drug release behavior of isosorbide mononitrate sustained-release tablets, the dosage of hydroxypropyl methylcellulose K200M is selected to be 70 parts, 90 parts, 110 parts, 130 parts and 150 parts respectively, and the influence of the dosage of hydroxypropyl methylcellulose K200M on the drug release is examined. The recipe composition is shown in table 1.
TABLE 1 dosage screening prescription of hypromellose K200M
Weighing isosorbide mononitrate and colloidal silicon dioxide according to the prescription amount, uniformly mixing, sieving by a 20-mesh sieve, adding hydroxypropyl methylcellulose K200M according to the prescription amount, uniformly mixing, sieving by a 20-mesh sieve, adding lactose and microcrystalline cellulose according to the prescription amount, uniformly mixing, sieving by a 20-mesh sieve, adding talcum powder according to the prescription amount, uniformly mixing and tabletting. The results are shown in Table 2.
TABLE 2 hypromellose K200M dosage screening results
As can be seen from the results in table 2, the release rate gradually becomes slower with the increase of the dosage of hypromellose K200M, but the powder mixing angle of repose of the formula is greater than 40 °, and the powder mixing fluidity gradually becomes worse with the increase of the dosage of hypromellose K200M; when the dosage of the hypromellose K200M is too small, the fluidity of the mixed powder meets the requirement, but the release rate is too fast, thus not meeting the administration requirement of the sustained release tablet.
The inventor has surprisingly found that adding a certain proportion of hydrogenated castor oil into the sustained-release material can improve the fluidity and play a better sustained-release effect through a great deal of creative research, and when the mass ratio of the hypromellose to the hydrogenated castor oil is 1: 0.55-0.82, the flowability can meet the requirement of tabletting in production, the release rate can meet the requirement of medication, and when the mass ratio of the hypromellose to the hydrogenated castor oil is 1: at 0.68, the fluidity of the mixed powder is the best. Further, when the weight part of the hydroxypropyl methylcellulose is 90-130 parts, the isosorbide mononitrate sustained-release tablet has a good release effect.
Detailed Description
The invention is further illustrated by the following examples. It should be properly understood that: the examples of the present invention are given solely for the purpose of illustration and not as limitations of the present invention, and therefore, simple modifications of the present invention in the context of the methods of the present invention are intended to fall within the scope of the claims.
Example 1
1) Prescription
2) The preparation process comprises the following steps:
(1) accurately weighing and mixing isosorbide mononitrate and colloidal silicon dioxide according to the prescription amount for 10min, and sieving with a 20-mesh sieve; (2) adding hydroxypropyl methylcellulose K200M and hydrogenated castor oil into the mixed powder according to the formula amount, mixing for 15min, and sieving with a 20-mesh sieve; (3) adding lactose and microcrystalline cellulose according to the prescription amount, mixing for 15min, and sieving with a 20-mesh sieve; (4) adding the prescribed amount of talcum powder again, mixing for 5min, and tabletting.
Example 2
1) Prescription
2) The preparation process comprises the following steps: the preparation process is the same as in example 1.
Example 3
1) Prescription
2) The preparation process comprises the following steps: the preparation process is the same as in example 1.
Example 4
1) Prescription
2) The preparation process comprises the following steps: the preparation process is the same as in example 1.
Example 5
1) Prescription
2) The preparation process comprises the following steps: the preparation process is the same as in example 1.
Example 6
1) Prescription
2) The preparation process is the same as in example 1.
Example 7
1) Prescription
2) The preparation process is the same as in example 1.
Example 8
1) Prescription
2) The preparation process is the same as in example 1.
Example 9
1) Prescription
2) The preparation process is the same as in example 1.
Comparative example 1
1) Prescription
2) The preparation process comprises the following steps:
(1) accurately weighing isosorbide mononitrate, hydroxypropyl methyl fiber K200M and hydrogenated castor oil according to the prescription amount, mixing for 10min, and sieving with a 20-mesh sieve; (2) adding microcrystalline cellulose, lactose and silicon dioxide into the mixed powder according to the prescription amount, mixing for 15min, and then sieving by a 20-mesh sieve; (3) adding pulvis Talci, mixing for 5min, and tabletting.
Comparative example 2
1) Prescription
2) The preparation process comprises the following steps:
(1) accurately weighing isosorbide mononitrate, microcrystalline cellulose and lactose according to the prescription amount, mixing for 10min, and sieving by a 20-mesh sieve; (2) adding hydroxypropyl methyl fiber K200M, hydrogenated castor oil and silicon dioxide into the mixed powder according to the prescription amount, mixing for 15min, and then sieving by a 20-mesh sieve; (3) adding pulvis Talci, mixing for 5min, and tabletting.
Comparative example 3
1) Prescription
2) The preparation process comprises the following steps:
(1) accurately weighing isosorbide mononitrate, hydroxypropyl methyl fiber K200M, microcrystalline cellulose, lactose, hydrogenated castor oil and colloidal silicon dioxide according to the prescription amount, mixing for 10min, and sieving with a 20-mesh sieve; (2) mixing the mixed powder for 15min again, and sieving with 20 mesh sieve; (3) adding pulvis Talci, mixing for 5min, and tabletting.
Comparative example 4
1) Prescription
2) The preparation process comprises the following steps:
(1) accurately weighing hydroxypropyl methyl fiber K200M, microcrystalline cellulose, lactose, hydrogenated castor oil and colloidal silicon dioxide according to the prescription amount, and mixing for 10 min; (2) adding isosorbide mononitrate in a prescribed amount while sieving with a 20-mesh sieve, and mixing the mixed powder for 15 min; (3) adding pulvis Talci, mixing for 5min, and tabletting.
Comparative example 5
1) Prescription
2) The preparation process comprises the following steps:
(1) accurately weighing hydroxypropyl methyl fiber K200M, microcrystalline cellulose, lactose, hydrogenated castor oil and colloidal silicon dioxide according to the prescription amount, and mixing for 10 min; (2) adding the isosorbide mononitrate of the prescription amount, mixing the mixed powder for 15min, and sieving the mixed powder with a 20-mesh sieve; (3) adding pulvis Talci, mixing for 5min, and tabletting.
Comparative example 6
1) Prescription
2) The preparation process comprises the following steps:
(1) accurately weighing hydroxypropyl methyl fiber K200M, microcrystalline cellulose, lactose, hydrogenated castor oil and colloidal silicon dioxide according to the prescription amount, mixing for 10min, and sieving with a 20-mesh sieve; (2) adding the isosorbide mononitrate of the prescription amount, mixing the mixed powder for 15min, and sieving the mixed powder with a 20-mesh sieve; (3) adding pulvis Talci, mixing for 5min, and tabletting.
Comparative example 7
1) Prescription
2) The preparation process comprises the following steps:
(1) accurately weighing isosorbide mononitrate, hydroxypropyl methyl fiber K200M, microcrystalline cellulose, lactose, hydrogenated castor oil and colloidal silicon dioxide according to the prescription amount, mixing for 15min, and sieving with a 20-mesh sieve; (2) using 75% ethanol as adhesive, granulating by wet method, drying at 40-80 deg.C, and drying to obtain dry granules; (3) adding pulvis Talci into the dry granule, mixing for 5min, and tabletting.
Comparative example 8
1) Prescription
2) The preparation process is the same as in example 1.
Comparative example 9
1) Prescription
2) The preparation process is the same as in example 1.
Comparative example 10
1) Prescription
2) The preparation process is the same as in example 1.
Comparative example 11
1) Prescription
2) The preparation process is the same as in example 1.
Verification of the examples:
repose angle detection method
The powder fluidity detector is adopted for determination, the principle is that the repose angle is calculated by measuring the height of a powder cone and the diameter of the bottom of the powder, and the formula is calculated as follows: tan (a) ═ H/0.5R, a is the angle of repose, H is the height of the powder cone, and R is the diameter of the powder base.
Dissolution release degree detection method
A method for detecting the release rate of isosorbide mononitrate sustained-release tablets under USP items is adopted, namely: the pulp method takes water as a standard release medium, the volume is 900mL, the rotating speed is 50 r/min, the water temperature is 37 ℃, and samples are taken at different times to measure the release rate.
The repose angle is an important index for evaluating the fluidity of mixed powder, and the condition that the repose angle is less than or equal to 40 degrees and tabletting is easier when the repose angle is smaller and the weight difference of the prepared tablets is smaller must be met for realizing the direct tabletting of the mixed powder, so that the tablet is more suitable for large-scale production. Specific test results are shown in Table 3. data results of examples
TABLE 3 data results of the examples
As can be seen from the angle of repose and release results in table 3: 1) the angle of repose of examples 1-9 is less than 40 degrees, the fluidity is better, the release degree is controlled in the corresponding parameter range, and the medication requirement is met; the preparation methods of comparative examples 1 to 7 are different, and the results show that comparative examples 1 to 6 have too large angle of repose and are not suitable for direct tabletting of mixed powder, and comparative example 7 has unsatisfactory release degree; comparative examples 8, 9, 10 all achieved direct compression of the powder, but comparative examples 8, 9 released too quickly and comparative example 10 released too slowly; comparative example 11 has an angle of repose >40 deg., is less fluid and is not suitable for direct compression of a blend powder.
Claims (9)
1. An isosorbide mononitrate sustained-release tablet is characterized by comprising the following components: 120 parts of isosorbide mononitrate, 50-90 parts of lactose, 60-120 parts of microcrystalline cellulose, a slow-release material, 20-35 parts of a glidant and 5-15 parts of a lubricant; the sustained-release material is composed of hydroxypropyl methylcellulose and hydrogenated castor oil, and the mass ratio of the hydroxypropyl methylcellulose to the hydrogenated castor oil is 1: 0.55-0.82; the dosage of the hydroxypropyl methylcellulose is 90-130 parts.
2. The isosorbide mononitrate sustained-release tablet of claim 1, wherein the mass ratio of the sustained-release materials hypromellose and hydrogenated castor oil is 1: 0.68.
3. the isosorbide mononitrate sustained-release tablet of claim 1, wherein the hypromellose is selected from one of hydroxypropyl methylcellulose K4M, hydroxypropyl methylcellulose K15M, hydroxypropyl methylcellulose K40M, hydroxypropyl methylcellulose K100M, and hydroxypropyl methylcellulose K200M.
4. The isosorbide mononitrate sustained-release tablet of claim 3, wherein the hypromellose is hydroxypropyl methylcellulose K200M in an amount of 90-130 parts.
5. The isosorbide mononitrate sustained-release tablet of claim 1, which is composed of the following components: 120 parts of isosorbide mononitrate, 50-90 parts of lactose, a slow-release material, 60-120 parts of microcrystalline cellulose, 20-35 parts of a glidant and 5-15 parts of a lubricant; wherein the slow release material is composed of hydroxypropyl methylcellulose and hydrogenated castor oil; the mass ratio of the slow-release material hypromellose to the hydrogenated castor oil is 1: 0.55-0.82; the hydroxypropyl methylcellulose is hydroxypropyl methylcellulose K200M, and the dosage of the hydroxypropyl methylcellulose is 90-130 parts.
6. The isosorbide mononitrate sustained-release tablet of claim 5, which is composed of the following components: 120 parts of isosorbide mononitrate, 70 parts of lactose, a slow release material, 90 parts of microcrystalline cellulose, 25 parts of a glidant and 10 parts of a lubricant; wherein the slow release material is composed of hydroxypropyl methylcellulose and hydrogenated castor oil; the mass ratio of the slow-release material hypromellose to the hydrogenated castor oil is 1: 0.68; the hydroxypropyl methylcellulose is hydroxypropyl methylcellulose K200M, and the dosage of the hydroxypropyl methylcellulose is 90-130 parts.
7. The isosorbide mononitrate sustained-release tablet of claim 1, wherein the glidant is colloidal silicon dioxide.
8. The isosorbide mononitrate sustained-release tablet of claim 1, wherein the lubricant is talc.
9. The isosorbide mononitrate sustained release tablet of any one of claims 1-8, wherein the preparation process is direct powder compression; the method specifically comprises the following steps:
a. first, isosorbide mononitrate and glidant are mixed evenly and sieved by a 20-mesh sieve;
b. adding the mixed powder obtained in the step (a) into a slow-release material, uniformly mixing, and sieving by a 20-mesh sieve;
c. adding lactose and microcrystalline cellulose into the mixed powder obtained in the step (b), uniformly mixing, and then sieving by a 20-mesh sieve;
d. adding the mixed powder obtained in the step (c) into a lubricant, uniformly mixing the mixed powder again, and directly tabletting the powder.
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| CN112294770A (en) * | 2020-11-16 | 2021-02-02 | 仁和堂药业有限公司 | Isosorbide mononitrate compound preparation and application and preparation method thereof |
| CN114652691A (en) * | 2020-12-23 | 2022-06-24 | 鲁南贝特制药有限公司 | Isosorbide mononitrate sustained-release tablet and preparation method thereof |
| CN114469886B (en) * | 2021-03-06 | 2023-01-24 | 鲁南贝特制药有限公司 | Isosorbide mononitrate sustained-release tablet and preparation method thereof |
| CN113476416B (en) * | 2021-08-03 | 2022-02-18 | 北京阳光诺和药物研究股份有限公司 | Pharmaceutical composition for treating vasodilatation |
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| CN110420192A (en) | 2019-11-08 |
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