Method for preparing isradipine capsule

A technology for isradipine and capsules, which is applied in the field of preparation of isradipine capsules, can solve the problems of low capsule dissolution, high cost, and long production cycle, and achieve the goals of increasing in vitro dissolution, reducing production costs, and good clinical efficacy Effect

Inactive Publication Date: 2015-11-11
SICHUAN BAILI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Capsules prepared by existing preparation methods have low dissolution rate, long production cycle and high cost

Method used

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  • Method for preparing isradipine capsule

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Experimental program
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Effect test

Embodiment 1

[0031] Embodiment 1: a kind of isradipine capsule, prescription is as follows:

[0032] Isradipine 5.0g

[0033] Pregelatinized starch 50.0g

[0034] Microcrystalline cellulose 20.0g

[0035] Povidone K30 10.0g

[0036] Magnesium stearate 1.0g

[0037] Ethanol 65g

[0038] Made: 1000 capsules;

[0039] The preparation method is as follows:

[0040] A, get the prescription quantity isradipine raw material and be dissolved in the prescription quantity ethanol, then add Povidone K30 and stir to dissolve;

[0041] B. Take the prescribed amount of pregelatinized starch and microcrystalline cellulose and put them in the fluidized bed, start the fan, adjust the air volume until the fluidization is good, set the inlet air temperature at 35-40°C, and when the temperature of the material rises to 25°C, The solution prepared by spraying into step A is granulated;

[0042] C. Pass the prepared granules through a 30-mesh sieve for granulation, add magnesium stearate, mix evenly, an...

Embodiment 2

[0043] Embodiment 2: a kind of isradipine capsule, prescription is as follows:

[0044] Isradipine 2.5g

[0045] Pregelatinized starch 50.0g

[0046] Microcrystalline cellulose 20.0g

[0047] Povidone K30 5.0g

[0048] Magnesium stearate 1.0g

[0049] Ethanol 32.5g

[0050] Made: 1000 capsules;

[0051] The preparation method is as follows:

[0052] A, get the prescription quantity isradipine raw material and be dissolved in the prescription quantity ethanol, then add Povidone K30 and stir to dissolve;

[0053] B. Take the prescribed amount of pregelatinized starch and microcrystalline cellulose and put them in the fluidized bed, start the fan, adjust the air volume until the fluidization is good, set the inlet air temperature at 35-40°C, and when the temperature of the material rises to 25°C, Spray the solution prepared in step A to granulate, control the atomization pressure and the speed of the peristaltic pump, and continue drying until the moisture content is ≤2% a...

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Abstract

The invention discloses a method for preparing an isradipine capsule. The method comprises the following steps: dissolving an isradipine raw material according to the amount of a prescription in prescribed ethanol, and adding povidone K3 to stir and dissolve; putting prescribed pregelatinized starch and microcrystalline cellulose in a fluidized bed, starting a fan, regulating the air volume to excellent fluidizing, setting the air inlet temperature to be 35-40 DEG C, spraying the solution prepared in the step A when the material temperature rises to 25 DEG C to granulate; and finishing the prepared particles through a 30-mesh screen, adding magnesium stearate, uniformly mixing, and filling capsules with the particles. According to the method, the raw materials and the auxiliaries are used for preparing solid dispersion by adopting a spray drying mode, are prepared to form fine particles by one step, and are used for filling capsules, so that the dissolution in vitro of the capsule can be effectively increased, the production cost can be reduced, the bioavailability of the capsule can be improved, and a better clinical curative effect can be achieved.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmacy and relates to a preparation method of isradipine capsules. Background technique [0002] Isradipine is a dihydropyridine calcium channel blocker. By blocking transmembrane calcium ion influx, it can effectively and selectively inhibit the contraction caused by depolarization, and play a role in cardiac muscle and vascular smooth muscle. This product has a strong vasodilator effect, but no heart inhibitory effect, and almost does not cause reflex tachycardia. Clinical and animal experiments have proved that the drug has obvious antihypertensive and anti-atherosclerotic effects. By maintaining or restoring the blood flow under the left ventricular endothelium, it can prevent local ischemic damage and improve the health of patients with angina pectoris and congestive heart failure. The amount of exercise, while treating high blood pressure, has a protective effect on the heart. Isradipin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4439A61P9/12A61P9/10
Inventor 朱义王一茜杜书良
Owner SICHUAN BAILI PHARM CO LTD
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