Lacidipine sustained-release preparation and preparation process thereof

A technology of lacidipine and preparations, which is applied in the field of salt sustained-release pharmaceutical preparations and its preparation, and can solve problems such as difficulties

Active Publication Date: 2010-02-24
北京科信聚润医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After conventional preparations are taken, the drug concentration rises rapidly to the maximum value, and then decreases rapidly due to metabolism, e...

Method used

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  • Lacidipine sustained-release preparation and preparation process thereof
  • Lacidipine sustained-release preparation and preparation process thereof
  • Lacidipine sustained-release preparation and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Plain Tablet Prescription:

[0039] Lacidipine 4g

[0040] Copovidone 20g

[0041] Microcrystalline Cellulose 40g

[0042] Lactose 84g

[0043] Hydroxypropyl Methyl Cellulose 60g

[0044] Magnesium Stearate 2g

[0045] Proper amount of ethanol

[0046] Coating Solution Prescription:

[0047] Opadry 30g

[0048] Appropriate amount of water

[0049]Makes 1000 pieces

[0050] Preparation process

[0051] 1 Preparation process of plain tablets

[0052] 1.1 Preparation of dispersion Take the lacidipine and copovidone of the prescription amount and dissolve them in ethanol to make a 5% (w / w) copovidone ethanol dispersion for subsequent use;

[0053] 1.2 Granulation After sieving the lactose with 80 meshes, put it into the mixing granulator together with hypromellose and microcrystalline cellulose, mix, and add copovidone ethanol dispersion for wet granulation after uniformity, and take out the granules for 20 mesh sieve for wet sizing. After drying, pass through ...

Embodiment 2

[0061] Plain Tablet Prescription:

[0062] Lacidipine 4g

[0063] Ethyl cellulose 60g

[0064] Microcrystalline Cellulose 30g

[0065] Mannitol 100g

[0066] Povidone 40g

[0067] Stearic acid 4g

[0068] Proper amount of ethanol

[0069] Coating Solution Prescription:

[0070] Opadry 30g

[0071] Appropriate amount of water

[0072] Makes 1000 pieces

[0073] Preparation process

[0074] 1 Preparation process of plain tablets

[0075] 1.1 Preparation of adhesive: Dissolve the povidone of the prescribed amount in ethanol to make a 10% (w / w) adhesive for subsequent use;

[0076] 1.2 Granulation Put lacidipine and mannitol through 80-mesh sieve respectively, put them into a mixing granulator together with hypromellose and microcrystalline cellulose, mix them, and then add binders to carry out wet granulation. Take out the granules and carry out wet sizing with a 20 mesh sieve. After drying, pass through a 20-mesh sieve for granulation and set aside.

[0077] 1.3 Ta...

Embodiment 3

[0082] Plain Tablet Prescription:

[0083] Lacidipine 4g

[0084] Carnauba Wax 50g

[0085] Microcrystalline Cellulose 30g

[0086] Lactose 70g

[0087] Povidone 30g

[0088] Magnesium Stearate 5g

[0089] Proper amount of ethanol

[0090] Makes 1000 pieces

[0091] Coating solution prescription: (1000 tablets dosage)

[0092] Cellulose diacetate 40g

[0093] Polyethylene glycol 5g

[0094] Dibutyl sebacate 4g

[0095] Proper amount of acetone

[0096] Preparation process

[0097] 1 Preparation process of plain tablets

[0098] 1.1 Preparation of adhesive: Dissolve the povidone of the prescribed amount in ethanol to make a 5% (w / w) adhesive for subsequent use;

[0099] 1.2 Granulation After sieving lactose and microcrystalline cellulose with 80 meshes respectively, put them into a mixing granulator together with lacidipine and carnauba wax, mix them, and add binders after they are uniform for wet granulation, and take out the granules for 20 mesh sieve for wet si...

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PUM

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Abstract

The invention discloses a lacidipine sustained-release preparation and a preparation process thereof. The lacidipine sustained-release preparation comprises an effective dose of lacidipine or a physiologically acceptable salt of the lacidipine and a pharmaceutically acceptable medicinal auxiliary material. The lacidipine sustained-release pharmaceutical preparation prepared by the preparation process can make medicaments released smoothly in vivo to ensure the smooth of the blood concentration in vivo, thereby ensuring that the effective blood concentration in vivo of a patient during medication is smooth, and fundamentally improving the safety and the effectiveness of the medicaments.

Description

technical field [0001] The invention relates to a slow-release pharmaceutical preparation, in particular to an antihypertensive drug lacidipine or a physiologically acceptable salt sustained-release pharmaceutical preparation and a preparation method thereof. technical background [0002] Calcium ion antagonists (or calcium ion channel blockers) have been widely used in the treatment of hypertension. Its antihypertensive effects are similar to beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and thiazide diuretics. Existing studies have shown that dihydropyridine (DHP) calcium antagonists can reduce the incidence of stroke in elderly patients with systolic hypertension, and this type of drug has become a recommended drug for this group of patients. Moreover, this class of drugs can also be used as an alternative to angiotensin-converting enzyme inhibitors for the treatment of hypertension and systolic heart failure. The combination of DHP calcium antagonists,...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/30A61K31/4422A61P9/12
Inventor 林鹏郑顺利李育巧
Owner 北京科信聚润医药科技有限公司
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