Amlodipine besylate drop pill and preparation method thereof

A technology of amlodipine besylate and amlodipine besylate, which is applied in the field of biomedicine, can solve problems such as unfavorable absorption, and achieve the effect of facilitating absorption and improving product qualification rate

Active Publication Date: 2019-03-08
CHENGDU HENGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the current market is in the form of flakes. Under the same weight, the surface area of ​​the flakes is lower than that of the dripping pills, which is not conducive to absorption.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0019] The preparation method of amlodipine besylate dropping pills, the steps are:

[0020] S1. Stir and mix polyethylene glycol 4000 and polyethylene glycol 6000, then slowly heat to a molten state at 55°C;

[0021] S2. Add the molten material in step S1 to the drip irrigation equipment. The temperature in the drip irrigation equipment is kept at 75°C. After the polyethylene glycol 4000 and polyethylene glycol 6000 are liquefied, add amlodipine besylate and pocridine potassium , fully mixed for 1h;

[0022] S3, dripping, adjust the speed of dripping by controlling the pressure in the drip irrigation equipment, after the medicinal liquid dripped from the drip irrigation equipment is initially cooled by the cooling gas, then fall into the simethicone cooling liquid for secondary cooling, and then After draining off the simethicone, wash with petroleum ether, and evaporate to dry to form preliminary drop pills;

[0023] S4, coating, coating the preliminary dropping pills in s...

Embodiment 1

[0025] [Example 1] Amlodipine Besylate Dropping Pills

[0026] Including active agent, disintegrating agent, pill base, wherein said active agent is amlodipine besylate, disintegrating agent is polycridine potassium, and the pill base includes polyethylene glycol 4000 and polyethylene glycol 6000. Amlodipine besylate, pocridine potassium, macrogol 4000, macrogol 6000, calculated as 5:2:15:4 by weight.

[0027] Specifically, in each drop pill, amlodipine besylate is 2.5 mg, pocridine potassium is 1 mg, polyethylene glycol 4000 is 10 mg, and polyethylene glycol 6000 is 2 mg.

[0028] The coating powder is also included, and the ratio of coating powder:amlodipine besylate is 0.13:5.

Embodiment 2

[0029] [embodiment two] the preparation method of amlodipine besylate dropping pills

[0030] Including active agent, disintegrating agent, pill base, wherein said active agent is amlodipine besylate, disintegrating agent is polycridine potassium, and the pill base includes polyethylene glycol 4000 and polyethylene glycol 6000. Amlodipine besylate, pocridine potassium, macrogol 4000, macrogol 6000, calculated as 5:2:15:4 by weight.

[0031] Specifically, in each drop pill, the content of amlodipine besylate is 6.25 mg, that of pocridine potassium is 2.5 mg, that of polyethylene glycol 4000 is 13.75 mg, and that of polyethylene glycol 6000 is 4 mg.

[0032] The coating powder is also included, and the ratio of coating powder:amlodipine besylate is 0.33:5.

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Abstract

The invention relates to a preparation method for an amlodipine besylate drop pill. The preparation method comprises the following steps: S1) mixing and stirring polyethylene glycol 4000 and polyethylene glycol 6000 and then slowly heating to a molten state at 55 DEG C; S2) adding a molten material obtained in step S1 into drip irrigation equipment, keeping temperature in the drip irrigation equipment at 75 DEG C, adding amlodipine besylate after liquifying polyethylene glycol 4000 and polyethylene glycol 6000, and fully mixing for 1 h; S3) dropwise adding, adjusting the speed of dropwise adding by controlling the pressure in the drip irrigation equipment, primarily cooling liquor dropped from the drip irrigation equipment by cooling gas, and then falling into a dimeticone liquid coolant for secondary cooling, draining off dimeticone and then cleaning with petroleum ether, and drying by volatilizing to form a primary drop pill; and S4) coating: coating the primary drop pill obtained instep S3 to form an end product of the drop pill. The composition of the amlodipine besylate drop pill is also disclosed in the scheme. The invention can achieve the beneficial effects of long storageperiod and easiness in disintegration.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to amlodipine besylate dropping pills and a preparation method thereof. Background technique [0002] Amlodipine Besylate Tablets, the indication is hypertension This product is suitable for the treatment of hypertension. It can be used alone or in combination with other antihypertensive drugs. It can also be used for chronic stable angina pectoris of coronary heart disease (CAD). This product is suitable for symptomatic treatment of chronic stable angina pectoris. It can be used alone or in combination with other antianginal drugs. Vasospastic angina (Prinzmetal's or variant angina) This product is suitable for the treatment of confirmed or suspected vasospastic angina. It can be used alone or in combination with other antianginal drugs. Coronary heart disease confirmed by angiography In patients with coronary heart disease confirmed by angiography, but with an ejection fraction ≥ 40...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4422A61K47/10A61P9/10A61P9/12
CPCA61K9/2031A61K9/28A61K31/4422A61P9/10A61P9/12
Inventor 朱德其刘辉肖仕远肖波邱银
Owner CHENGDU HENGRUI PHARMA
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