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Lercanidipine hydrochloride and losartan potassium compound preparation and preparation method thereof

A technology for lercanidipine hydrochloride and dipine losartan, applied in the field of medicine, can solve problems such as unreported hypertension, achieve good clinical application prospects, reduce adverse reactions, and improve the effects of efficiency

Active Publication Date: 2012-07-25
ZHAOKE PHARMA HEFEI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Currently on the market, both are single preparations, and there is no report about the combination of the two for the treatment of hypertension.

Method used

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  • Lercanidipine hydrochloride and losartan potassium compound preparation and preparation method thereof
  • Lercanidipine hydrochloride and losartan potassium compound preparation and preparation method thereof
  • Lercanidipine hydrochloride and losartan potassium compound preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1: the preparation of lercanidipine-losartan compound preparation of the present invention

[0025] Weighing lercanidipine hydrochloride bulk drug and losartan bulk drug and sieving for standby; lercanidipine hydrochloride is 0.5-40%, and losartan potassium is 6.25-50%.

[0026] Weigh lactose-hydrate, microcrystalline cellulose, hydroxyethyl starch sodium (type A), povidone K30, magnesium stearate, pregelatinized starch, colloidal silicon dioxide and stir to mix evenly; 20-40%, microcrystalline cellulose 10-40%, hydroxyethyl starch sodium (type A) 10-20%, povidone K302-8%, magnesium stearate 0.5-2.5%, pregelatinized starch 5-15%, colloidal silicon dioxide 1-10%

[0027] Vacuum compression, milling, sieving and granulation; tableting to control tablet core hardness.

[0028] Preparation of isolation coat solution: Take Opadry, add it to ethanol under stirring condition, stir until dispersed, then add purified water and stir to make isolation coat solution. ...

Embodiment 2

[0032] Embodiment 2: Preparation of lercanidipine-losartan compound preparation of the present invention

[0033] Weighing lercanidipine hydrochloride bulk drug and losartan bulk drug and sieving for standby; lercanidipine hydrochloride is 0.5-40%, and losartan potassium is 6.25-50%.

[0034] Weigh lactose-hydrate, microcrystalline cellulose, hydroxyethyl starch sodium (type A), povidone K30, magnesium stearate, pregelatinized starch, colloidal silicon dioxide and stir to mix evenly; 20-40%, microcrystalline cellulose 10-40%, hydroxyethyl starch sodium (type A) 10-20%, povidone K302-8%, magnesium stearate 0.5-2.5%, pregelatinized starch 5-15%, colloidal silicon dioxide 1-10%

[0035] Vacuum compression, milling, sieving and granulation; tableting to control tablet core hardness.

[0036] Preparation of isolation coat solution: Take Opadry, add it to ethanol under stirring condition, stir until dispersed, then add purified water and stir to make isolation coat solution.

[0...

Embodiment 3

[0040] Embodiment 3: Carry out quality research to lercanidipine losartan compound preparation Wherein the content determination of lercanidipine hydrochloride,

[0041] The HPLC method was used to determine the content of lercanidipine hydrochloride in the lercanidipine-losartan compound preparation prepared in Example 1. The liquid phase detection conditions are shown in Table 1.

[0042] The HPLC assay condition of lercanidipine hydrochloride in the compound preparation of table 1

[0043]

[0044]Preparation method of buffer A: dissolve 1.36g of potassium dihydrogen phosphate in 1L of water, add 1g of octane sulphonic acid sodium salt (octane sulphonic acid sodium salt) after dissolving, and use 10% phosphoric acid (v / v) for ultrasonic treatment Adjust the pH to 2.5 ± 0.05.

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Abstract

The invention relates to the field of medicines, and in particular discloses a lercanidipine hydrochloride and losartan potassium compound preparation. Particularly, the invention also provides a compound preparation which takes lercanidipine hydrochloride and losartan potassium as basic remedy, takes lactose monohydrate, microcrystalline cellulose, A-type sodium starch glycollate, povidone K30, magnesium stearate, pregelatinized starch and colloidal silicon dioxide as excipients, and takes white Opadry as a coating to prepare a tablet. Clinical tests prove that compared with the single-component preparation, the lercanidipine hydrochloride and losartan potassium compound preparation provided by the invention is remarkably increased in effective rate in light and moderate blood pressures, is remarkably reduced in occurrence rate of adverse effects, and has better clinical application prospect because patients have good tolerance.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a compound preparation of lercanidipine hydrochloride and losartan potassium and a preparation method thereof. Background technique [0002] Hypertension is the most important risk factor for cardiovascular disease. Long-term development can cause serious damage to heart, brain, kidney and other target organs. Its complications such as coronary heart disease, stroke, and renal failure have high disability and death rates. Rate. In my country, high blood pressure has now become the first leading cause of death. Statistics show that by 2006, the number of hypertensive patients in my country has reached 200 million, while about 1 billion people in the world suffer from high blood pressure. Therefore, the prevention, treatment and medication of hypertension are the most important tasks of pharmaceutical research and development. [0003] Lercanidipine hydrochloride is a third-generation di...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4422A61K9/36A61P9/12A61K31/4178
CPCA61K31/4178A61K2300/00A61K31/4422A61K9/00A61K9/2018A61K9/2027A61K9/2054A61K9/2059A61K9/2866A61K9/284A61K9/2009A61K9/2013A61K9/2893A61P3/14A61P43/00A61P9/10A61P9/12A61K9/28A61K31/4418
Inventor 李小羿张国辉戴向荣凌娟吴艳
Owner ZHAOKE PHARMA HEFEI
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