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Amlodipine besylate dropping pills and preparation method thereof

A kind of technology of amlodipine besylate and amlodipine besylate, applied in the field of biomedicine, can solve problems such as unfavorable absorption, and achieve the effects of being beneficial to absorption and improving product qualification rate

Active Publication Date: 2021-03-30
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

Embodiment 1

[0024] [Example 1] Amlodipine Besylate Dropping Pills

[0025] 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.

[0026] 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.

[0027] The coating powder is also included, and the ratio of coating powder:amlodipine besylate is 0.13:5.

Embodiment 2

[0028] [embodiment two] the preparation method of amlodipine besylate dropping pills

[0029] 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.

[0030] 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.

[0031] The coating powder is also included, and the ratio of coating powder:amlodipine besylate is 0.33:5.

Embodiment 3

[0032] [Example three] The preparation method of amlodipine besylate dropping pills

[0033] 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.

[0034] Specifically, in each drop pill, amlodipine besylate is 10 mg, pocridine potassium is 4 mg, polyethylene glycol 4000 is 17.5 mg, and polyethylene glycol 6000 is 6 mg.

[0035] The coating powder is also included, and the coating powder:amlodipine besylate is 0.53:5 by weight ratio.

[0036] The dripping pills made in embodiment one, embodiment two and embodiment three are used as experimental samples to carry out dissolution test. When selecting the experimental samples, all the samples that were tumbled but coated were selected for experimentation and observation. Select three groups of experiments A, B and C, respectively corresponding to E...

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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 dripping pills. 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% and no heart failure, this prod...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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