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Lercanidipine hydrochloride tablets and preparation method thereof

A technology of lercanidipine hydrochloride and lercanidipine hydrochloride, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problem that the yield and dissolution rate of lercanidipine hydrochloride need to be improved , the problem of high cost of raw materials, to achieve the effect of high dissolution rate, high yield and feasible preparation process

Active Publication Date: 2015-12-23
JIANGSU FUBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The raw material cost of the existing lercanidipine hydrochloride tablet preparation process is relatively high, and the yield and dissolution rate of lercanidipine hydrochloride in the tablet need to be improved

Method used

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  • Lercanidipine hydrochloride tablets and preparation method thereof
  • Lercanidipine hydrochloride tablets and preparation method thereof
  • Lercanidipine hydrochloride tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Prescription 1

[0021]

[0022]

[0023] The preparation process is as follows:

[0024] (1) Pulverize the raw material of lercanidipine hydrochloride, pass through a 100 mesh sieve, pass lactose, microcrystalline cellulose, and sodium carboxymethyl starch respectively through an 80 mesh sieve, dissolve povidone K30 in purified water, and make a mass fraction of 5% povidone K30 solution;

[0025] (2) 10g of lercanidipine hydrochloride and 70g of lactose were mixed uniformly by the method of equal increments, then 29g of microcrystalline cellulose and 8g of sodium carboxymethyl starch were added, placed in a mixer and mixed uniformly;

[0026] (3) Transfer the mixed powder into a swinging granulator, use 0.8g, 5% povidone K30 to make a soft material, pass through a 30-mesh sieve for granulation, and dry at 50°C;

[0027] (4) passing the dry granules through a 30-mesh sieve for granulation, adding 0.7g of magnesium stearate, and mixing uniformly to obtain an inte...

Embodiment 2

[0032] Prescription 2

[0033]

[0034] The preparation process is as follows:

[0035] (1) Pulverize the raw material of lercanidipine hydrochloride, pass through a 100 mesh sieve, pass lactose, microcrystalline cellulose, and sodium carboxymethyl starch respectively through an 80 mesh sieve, dissolve povidone K30 in purified water, and make a mass fraction of 5% povidone K30 solution;

[0036] (2) 10g of lercanidipine hydrochloride and 72g of lactose were mixed uniformly by the method of equal increments, then 31g of microcrystalline cellulose and 9g of sodium carboxymethyl starch were added, placed in a mixer and mixed uniformly;

[0037] (3) Transfer the mixed powder into a swinging granulator, use 1g, 5% povidone K30 to make a soft material, pass through a 30-mesh sieve to granulate, and dry at 50°C;

[0038] (4) passing the dry granules through a 40-mesh sieve for granulation, adding 0.8g of magnesium stearate, and mixing uniformly to obtain an intermediate;

[003...

Embodiment 3

[0043] Prescription 3

[0044]

[0045] The preparation process is as follows:

[0046] (1) Pulverize the raw material of lercanidipine hydrochloride, pass through a 100 mesh sieve, pass lactose, microcrystalline cellulose, and sodium carboxymethyl starch respectively through an 80 mesh sieve, dissolve povidone K30 in purified water, and make a mass fraction of 5% povidone K30 solution;

[0047] (2) 10g of lercanidipine hydrochloride and 73.5g of lactose were mixed uniformly by the method of equal increments, then 31.5g of microcrystalline cellulose and 10g of sodium carboxymethyl starch were added, placed in a mixer and mixed uniformly;

[0048] (3) Transfer the mixed powder into a swinging granulator, use 1.1g, 5% povidone K30 to make a soft material, pass through a 30-mesh sieve to granulate, and dry at 50°C;

[0049] (4) Pass the dry granules through a 50-mesh sieve for granulation, add 1g of magnesium stearate, and mix uniformly to obtain an intermediate;

[0050] (...

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Abstract

The invention discloses lercanidipine hydrochloride tablets. The lercanidipine hydrochloride tablets comprise lercanidipine hydrochloride, lactose, microcrystalline cellulose, carboxymethyl starch sodium, 5% povidone K30 solution and magnesium stearate, wherein the weight ratio of the lercanidipine hydrochloride, lactose, microcrystalline cellulose, carboxymethyl starch sodium, 5% povidone K30 solution and magnesium stearate is 10:70-75:29-33:8-12:0.8-1.2:0.7-3. The invention further provides a preparation method of the lercanidipine hydrochloride tablets. The method includes: the lercanidipine hydrochloride is mixed with the lactose and the like in an equal-quantity increasing manner and then evenly mixed with other auxiliary materials. The lercanidipine hydrochloride tablets have the advantages that the raw materials and auxiliary materials are evenly mixed, the tablets are even in lercanidipine hydrochloride content and high in dissolution rate, in vivo absorption is benefited, and the bioavailability of the tablets is increased.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a lercanidipine hydrochloride tablet and a preparation method thereof. Background technique [0002] Hypertension is a disease caused by many factors. Long-term hypertension can cause various complications, such as stroke, congestive heart failure, ischemic heart disease, and kidney failure. Experiments have proved that persistent high blood pressure can cause coronary artery sclerosis and cardiac hypertrophy, which will later produce myocardial ischemia, angina pectoris, myocardial infarction and re-infarction. The high morbidity, high disability and high death rate of hypertension in China make the control of hypertension a great challenge. Combined with the high proportion of isolated systolic hypertension and high-salt eating habits in Chinese hypertensive patients, there is no shortage of calcium ion antagonists in the treatment of such hypertensive patients. ...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/4422A61K47/26A61P9/12
Inventor 姜和平黄金友何林受车红俊
Owner JIANGSU FUBANG PHARMA
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