Olmesartan medoxomil amlodipine compound tablet and preparation method thereof

A technology for olmesartan medoxomil and compound tablets, which is applied in the field of medicine, can solve problems such as complex preparation process, inconsistent release curve, poor material fluidity, etc., and achieve the effect of simple preparation method, qualified dissolution curve and improved product quality

Pending Publication Date: 2022-04-15
北京阳光诺和药物研究股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This preparation process does not consider that the raw material of olmesartan medoxomil is an insoluble drug, and the particle size is not controlled. At the same time, the powder is mixed and directly compressed, and the fluidity of the material is too poor, which is not suitable for large-scale industrial production.
[0008] Chinese patent CN103006651B discloses a compound preparation of amlodipine dispersible tablets and olmesartan medoxomil, which solves the problem of inconsistent release curves of the two drugs in the body and reduces the side effects of the drug, but the preparation process requires separate preparation Dispersion, the preparation process is complicated, the production cost is too high, and it is not suitable for industrialized large-scale production
[0009] Chinese patent CN103565807B discloses a dry granulation process, using microcrystalline cellulose and croscarmellose sodium as auxiliary materials. The preparation method is simple, and the dry granulation process also improves the fluidity of the material. However, this preparation process does not consider that the raw material of olmesartan me

Method used

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  • Olmesartan medoxomil amlodipine compound tablet and preparation method thereof
  • Olmesartan medoxomil amlodipine compound tablet and preparation method thereof
  • Olmesartan medoxomil amlodipine compound tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044]Embodiment 1, prepare the compound tablet of olmesartan medoxomil and amlodipine besylate

[0045] Formulate a prescription composition of 1000 tablets

[0046]

[0047]

[0048] making process:

[0049] 1) Processing of raw materials: pulverizing olmesartan medoxomil to control particle size D 90 ≤40μm; crush amlodipine besylate to control particle size D 90 ≤70μm.

[0050] The particle size detection results of raw materials are shown in Table 1

[0051] Table 1

[0052]

[0053] It can be seen from Table 1 that the raw material particle sizes of olmesartan medoxomil and amlodipine besylate all meet the requirements.

[0054] 2) Premixing of raw and auxiliary materials: olmesartan medoxomil, amlodipine besylate, pregelatinized starch, silicified microcrystalline cellulose, and croscarmellose sodium were mixed in a mixer, and then sieved through a 1.5mm sieve, continue mixing;

[0055] 3) Dry granulation: the pre-mixed material is prepared into granules ...

Embodiment 2

[0066] Embodiment 2, angle of repose measurement result

[0067] The angle of repose of the blended materials of Example 1, Comparative Example 1, and Comparative Example 2 was measured, and the results are shown in Table 3. After Example 1 and Comparative Example 2 were granulated by dry method, the fluidity of the blend was good; in Comparative Example 1, the powder was directly mixed, and the fluidity of the blend was poor.

[0068] table 3

[0069]

Embodiment 3

[0070] Embodiment 3, mixing uniformity measuring result

[0071] The mixing uniformity of the total blending in Example 1 all met the requirements, and the mixing uniformity of the total blending in Comparative Example 2 did not meet the requirements, which was related to the different particle sizes of the raw materials.

[0072] Mixing uniformity inspection, the results are shown in Table 4.

[0073] Table 4

[0074]

[0075]

[0076] For the mixing uniformity of the two active ingredients, Example 1 satisfies RSD%≤3.0%, indicating that the mixing is uniform; Comparative Example 2 does not meet RSD%≤3.0%, and the mixing is uneven.

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Abstract

The invention discloses a compound tablet of olmesartan medoxomil and amlodipine besylate and a preparation method of the compound tablet. The compound tablet is prepared from the following raw materials in parts by mass: 20 to 40 parts of olmesartan medoxomil, 5 to 10 parts of amlodipine besylate, 15 to 25 parts of pregelatinized starch, 50 to 60 parts of silicified microcrystalline cellulose, 5 to 10 parts of croscarmellose sodium, 1 to 2 parts of magnesium stearate and 2 to 5 parts of film coating premix. The preparation method comprises the following steps: 1) controlling the particle size D90 of olmesartan medoxomil to be less than or equal to 40 microns, and controlling the particle size D90 of amlodipine besylate to be less than or equal to 70 microns; (2) mixing olmesartan medoxomil, amlodipine besylate, pregelatinized starch, silicified microcrystalline cellulose and croscarmellose sodium in a mixing machine, then sieving with a 1.5 mm sieve, and continuously mixing; (3) preparing particles from the premixed materials by adopting a dry granulation method; 4) adding magnesium stearate and mixing; (5) tabletting; and (6) coating.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a compound tablet of olmesartan medoxomil and amlodipine and a preparation method thereof. Background technique [0002] According to statistics, 1 / 4 of the world's population suffers from high blood pressure, but the control rate of blood pressure is not ideal, and patients often cannot reach the target recommended by the guidelines. WHO multi-country monitoring of cardiovascular disease incidence trends and determinants (MONICA study) confirmed that only 13% to 38% of males and 17% to 54% of female patients with hypertension between the ages of 35 and 64 received antihypertensive treatment However, many patients who received treatment did not reach the target, and the treatment target ratios of male and female patients were only 13%-67% and 12%-63%, respectively. Many patients require multiple antihypertensive drug regimens to achieve goals. [0003] The 2007 "Eu...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K31/4178A61K9/20A61K9/28A61P9/12
Inventor 罗桓白靳飞边华欣姚正阳童元峰谌宗永
Owner 北京阳光诺和药物研究股份有限公司
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