Compound antihypertensive tablet and preparation method thereof

A compound formula and tablet technology, which is applied in the field of medicine, can solve the problems such as the difficulty of stably controlling the blood pressure of elderly patients with hypertension, and achieve the effects of good in vitro dissolution, optimization of process parameters and reduction of losses.

Pending Publication Date: 2022-01-04
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

[0003] Family genetic history, disease history, eating habits, etc. At present, it is difficult to achieve the effect of stable control of blood pressure in the treatment of elderly hypertension with single drug therapy. Studies have shown that the effect of combined therapy is more ideal

Method used

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  • Compound antihypertensive tablet and preparation method thereof
  • Compound antihypertensive tablet and preparation method thereof
  • Compound antihypertensive tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] In this embodiment, 10,000 tablets of valsartan and amlodipine are prepared (each tablet contains 160 mg of valsartan, 5 mg of amlodipine, and the conversion factor of amlodipine and amlodipine besylate is 0.721), and its prescription is as follows in Table 1 Shown:

[0055] Table 1 Prescription of 10,000 valsartan and amlodipine tablets

[0056]

[0057]

[0058] The preparation method comprises the following steps:

[0059] The raw materials amlodipine besylate and colloidal silicon dioxide are respectively passed through a 40-mesh sieve, and the raw and auxiliary materials are weighed according to the prescription quantity. According to the order of addition: first add a part of microcrystalline cellulose (40% of the total mass), and then cross-link Povidone, amlodipine besylate, silicon dioxide, magnesium stearate (internal addition), valsartan, add in the multifunctional wet mixing granulator, stirring speed is 120rpm, and the cutting knife speed is 120rpm, ...

Embodiment 2

[0061] In this embodiment, 10,000 tablets of valsartan and amlodipine are prepared (each tablet contains 160 mg of valsartan, 5 mg of amlodipine, and the conversion factor of amlodipine and amlodipine besylate is 0.721), and its prescription is as follows in Table 2 Shown:

[0062] Table 2 Prescription of 10,000 Valsartan and Amlodipine Tablets

[0063]

[0064]

[0065] The preparation method comprises the following steps:

[0066] The preparation method is the same as that in Example 1 of the present invention, the difference is that the oil pressure is added, and the specific dry granulation parameters are as follows, the feeding speed is 40rpm, the roller is 12rpm, the oil pressure is 70bar, the granulation is 100rpm, and the roller gap is 0.6-0.7 mm for granulation, the specific particle size distribution is shown in Table 5.

Embodiment 3

[0068] In this embodiment, 100,000 valsartan and amlodipine tablets (each containing 160 mg of valsartan, 5 mg of amlodipine, and a conversion factor of 0.721 for amlodipine and amlodipine besylate) are prepared, and the prescription is as follows in Table 3 Shown:

[0069] Table 3 Prescription of 100,000 Valsartan and Amlodipine Tablets

[0070] components Dosagekg Valsartan 16.0 Amlodipine 0.694 microcrystalline cellulose 10.906 Crospovidone 4 colloidal silica 0.3 Magnesium stearate (added) 0.6 Magnesium Stearate (additional) 0.3

[0071] The preparation method comprises the following steps:

[0072] The preparation method is the same as that in Example 1 of the present invention, the difference is that the gap between the rollers has been increased in the investigation, and the specific dry granulation parameters are as follows, the setting is to increase the feeding speed to 50 rpm, the roller to 12 rpm, the oil pre...

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Abstract

The invention discloses a compound antihypertensive tablet and a preparation method thereof. The method comprises the following steps: 1) performing pretreatment: respectively sieving raw materials of amlodipine besylate and colloidal silicon dioxide with a 40-mesh sieve, and respectively weighing the raw materials; 2) performing premixing: mixing a part of microcrystalline cellulose with valsartan for a certain time, then cleaning a valsartan bag with the remaining microcrystalline cellulose, and performing wet premixing to obtain premixed powder; 3) performing dry granulation: performing granulation on the premixed powder in a dry granulator to obtain dry granules, and performing particle size distribution; 4) performing total mixing: mixing the dry particles with additional magnesium stearate in a hopper mixer; (5) performing tabletting; and 6) performing coating to obtain the compound antihypertensive tablet. The dry granulation solves the problem of unstable quality caused by hygroscopicity of valsartan, and besides, the particles of the valsartan are controlled through dry granulation parameters and particle size distribution, so that the prepared valsartan amlodipine tablet has better dissolution rate, the bioavailability is improved, and the quality of the tablet is safe and stable.

Description

technical field [0001] The invention relates to a compound antihypertensive drug tablet and a preparation method thereof, in particular to a valsartan amlodipine tablet (II) and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Hypertension is a clinically common multiple disease, especially concentrated in the middle-aged and elderly groups, and its incidence is increasing year by year with the aging population. Among them, essential hypertension accounts for more than 90% of diseases, and the mechanism of disease treatment has not yet been clearly determined. According to the literature survey, essential hypertension may be associated with the patient's family [0003] It is related to family genetic history, disease history, eating and rest habits, etc. At present, it is difficult to achieve the effect of stable blood pressure control in the treatment of elderly hypertension with a single drug. Studies have shown th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K47/12A61K31/4422A61K31/41A61P9/12
CPCA61K9/2095A61K9/2054A61K9/2013A61K9/2077A61K9/2806A61K31/4422A61K31/41A61P9/12A61K2300/00
Inventor 韩琳琳马昂佟德全胡永丰
Owner 北京阳光诺和药物研究股份有限公司
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