Lacidipine self-microemulsifying soft capsules and preparation method thereof

A technology of lacidipine and self-microemulsification, which is applied in the field of medicine, can solve the problems of short maintenance time and achieve the effects of improving dissolution rate, improving bioavailability and avoiding damage

Inactive Publication Date: 2011-04-13
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, in order to overcome the problem of short supersaturated maintenance time, high molecular polymers are added to the prescription to prolong the maintenance time of the supersaturated solution of the drug

Method used

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  • Lacidipine self-microemulsifying soft capsules and preparation method thereof
  • Lacidipine self-microemulsifying soft capsules and preparation method thereof
  • Lacidipine self-microemulsifying soft capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The composition of the prescription is as follows: (g)

[0025] Lacidipine 4

[0026] Miglyol81281

[0027] Solutol HS15 162

[0028] Transcutol 27

[0029] Vitamin E 5

[0030] Made 1000 softgels in total

[0031] Preparation process: lacidipine self-microemulsifying soft capsule: Weigh an appropriate amount of lacidipine, add the prescribed amount of Miglyol 812, SolutolHS15, Transcutol, at 37°C, 30 r.min -1 Stir in a constant temperature water bath for 60 minutes, and operate in the dark, so that the drug is fully dissolved and dispersed evenly. Then add the antioxidant and stir evenly. After the medicinal liquid drops to room temperature, press it into capsules.

Embodiment 2

[0033] The composition of the prescription is as follows: (g)

[0034] Lacidipine 4

[0035] Miglyol81263

[0036] Tween80 175

[0037] Transcutol 27

[0038] Vitamin E 5

[0039] Made 1000 softgels in total

[0040] The preparation process is the same as Example 1.

Embodiment 3

[0042] The composition of the prescription is as follows: (g)

[0043] Lacidipine 4

[0044] Miglyol812 60

[0045] Cremophor RH40 178

[0046] Transcutol 27

[0047] Vitamin E 5

[0048] Made 1000 softgels in total

[0049] The preparation process is the same as Example 1.

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Abstract

The invention belongs to the technical field of medicines and relates to lacidipine self-microemulsifying soft capsules and a preparation method thereof. The lacidipine self-microemulsifying soft capsules is uniform transparent solution prepared from an oil phase, an emulsifier and an auxiliary emulsifier, wherein under the conditions of an ambient temperature and mild stirring, the lacidipine self-microemulsifying soft capsules spontaneously emulsify to form emulsion droplet smaller than 500 nanometers; the ratio of the lacidipine to the auxiliary emulsifier to the emulsifier to the oil phase is 1:1-30:1-60:0.5-10 or 1: 1-30:1-30:0.5-10; a water soluble macromoleclar polymer can be added for prolonging the maintenance time of the saturated state of the solution of the medicament; and an antioxygen can be added for improving the chemical stability of the preparation. In the invention, the biological utilization rate of oral lacidipine is improved; and the cost is low, and the process is simple.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a lacidipine self-microemulsified soft capsule and a preparation method thereof. Background technique [0002] Lacidipine (Lacidipine) is a dihydropyridine calcium antagonist, its chemical name is (E)-4-[2-[3-(carboxy tert-butyl)-3-oxo-1-propenyl]-1 ,4-Dihydro-2,6-dimethyl-3,5-pyridine-dicarboxylate, molecular formula: C 26 h 33 N0 6 , Molecular weight: 455.59, it is a selective dihydropyridine calcium ion channel blocker developed by GlaxoSmithKline Company of the United Kingdom. Calcium ion channels in vascular smooth muscle, expand peripheral arteries, reduce peripheral vascular resistance and lower blood pressure. It is relatively safe for the elderly or patients with coronary heart disease, heart failure, renal insufficiency, asthma, peripheral vascular disease, gout or diabetes, and has been used in the treatment of hypertension in many countries. [0003] After oral ad...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K9/48A61P9/12
Inventor 孙进何仲贵任鑫霞孙英华周雪芹罗聪
Owner SHENYANG PHARMA UNIVERSITY
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