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Irbesartan-hydrochlorothiazide drug combination liposome solid preparation

A technology of hydrochlorothiazide and solid preparations, applied in the field of medicine, which can solve the problems of high drug risk, harsh storage conditions, and unsatisfactory stability, and achieve the effects of improving solubility, improving therapeutic index, and ensuring stability

Inactive Publication Date: 2011-09-14
HAINAN MEILAN SMITH KLINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The existing marketed products all have unsatisfactory stability and harsh storage conditions; in clinical use, the release rate is not easy to control, and the risk of drug use is high.

Method used

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  • Irbesartan-hydrochlorothiazide drug combination liposome solid preparation
  • Irbesartan-hydrochlorothiazide drug combination liposome solid preparation
  • Irbesartan-hydrochlorothiazide drug combination liposome solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] The preparation prescription of embodiment 1 irbesartan hydrochlorothiazide liposome sheet (1000)

[0072] Irbesartan 75g

[0073] Hydrochlorothiazide 12.5g

[0074] Distearoylphosphatidylcholine 120g

[0075] Sodium taurocholate 50g

[0076] Microcrystalline Cellulose 180g

[0077] Sorbitol 60g

[0078] Carboxymethyl Starch Sodium 30g

[0079] Povidone K30 10g

[0080] Talc powder 15g

[0081] Magnesium Stearate 5g

[0082] making process:

[0083] (1) Distearoylphosphatidylcholine 120g and sodium taurocholate 50g are dissolved in 800ml volume ratio and are the mixed solvent of ethanol and acetone of 3: 2, mix homogeneously, remove mixed solvent under reduced pressure on the rotary film evaporator, Prepare phospholipid film;

[0084] (2) Add 500ml of sodium dihydrogen phosphate-disodium hydrogen phosphate buffer solution with a pH value of 6.2, shake and stir to completely hydrate the phospholipid membrane, emulsify at a high speed, and filter through a 0.45 ...

Embodiment 2

[0089] The preparation prescription (1000) of embodiment 2 irbesartan hydrochlorothiazide liposome sheet

[0090] Irbesartan 150g

[0091] Hydrochlorothiazide 12.5g

[0092] Distearoylphosphatidylcholine 500g

[0093] Sodium taurocholate 110g

[0094] Lactose 130g

[0095] Starch 180g

[0096] Crospovidone 42g

[0097] Povidone K30 15g

[0098] Talc powder 25g

[0099] Magnesium stearate 8g

[0100] making process:

[0101] (1) Distearoylphosphatidylcholine 500g and sodium taurocholate 110g are dissolved in 2000ml volume ratio and are the mixed solvent of ethanol and acetone of 3: 2, mix homogeneously, remove mixed solvent under reduced pressure on the rotary film evaporator, Prepare phospholipid film;

[0102] (2) Add 1000ml of sodium dihydrogen phosphate-disodium hydrogen phosphate buffer solution with a pH value of 6.2, shake and stir to completely hydrate the phospholipid membrane, emulsify at a high speed, and filter through a 0.45 μm microporous membrane to obtai...

Embodiment 3

[0108] The preparation prescription (1000) of embodiment 3 irbesartan hydrochlorothiazide liposome capsules

[0109] Irbesartan 150g

[0110] Hydrochlorothiazide 12.5g

[0111] Distearoylphosphatidylcholine 300g

[0112] Sodium Taurocholate 80g

[0113] Microcrystalline Cellulose 280g

[0114] Low-substituted hydroxypropyl cellulose 50g

[0115] Hypromellose 4g

[0116] Talc powder 27g

[0117] making process:

[0118] (1) 300 g of distearoylphosphatidylcholine and 80 g of sodium taurocholate are dissolved in 1000 ml of a mixed solvent of dichloromethane and n-butanol at a volume ratio of 1:2, mixed evenly, and removed under reduced pressure on a rotary film evaporator Mixing solvents to prepare a phospholipid film;

[0119] (2) Add 800ml of citric acid-sodium citrate buffer solution with a pH value of 6.2, shake and stir to completely hydrate the phospholipid membrane, emulsify at a high speed, and filter through a 0.45 μm microporous membrane to obtain a blank lipid ...

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Abstract

The invention relates to an irbesartan-hydrochlorothiazide drug combination liposome solid preparation, which is prepared with irbesartan-hydrochlorothiazide drug combination liposome and other solid preparation auxiliary materials, and the irbesartan-hydrochlorothiazide drug combination liposome is prepared with irbesartan, hydrochlorothiazide, distearoyl phosphatidylcholine and sodium taurocholate. Compared with the conventional preparation, the stability and bioavailability of the preparation are greatly enhanced, release is stable, the side effect is minor, and the treatment effect is more remarkable.

Description

technical field [0001] The invention relates to a liposome solid preparation of a pharmaceutical composition, in particular to a liposome solid preparation of an irbesartan hydrochlorothiazide pharmaceutical composition and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Hypertension is the most common disease with the highest incidence rate in the world today. The prevalence of hypertension in my country is about 12%, and there are more than 100 million hypertensive patients, and the number is increasing at a rate of 3 million per year. However, high blood pressure itself is not terrible, and diagnosis and treatment are easy. What is terrible is the various complications of high blood pressure: due to the continuous increase of arterial pressure in patients with high blood pressure, it will cause systemic arteriosclerosis, which will affect the blood supply of tissues and organs. , causing various serious consequenc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/549A61K31/4184A61K9/127A61P9/12
Inventor 陶灵刚
Owner HAINAN MEILAN SMITH KLINE PHARMA
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