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Pitavastatin calcium lipid solid preparation

A technology of pitavastatin calcium and solid preparation, applied in the field of medicine, can solve problems such as increasing drug retention time, and achieve the effects of improving medication compliance, improving quality and improving curative effect

Inactive Publication Date: 2012-01-04
HAINAN MEIDA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Through a large number of experiments, it was found that the liposome solid preparation made of specific excipients and pitavastatin calcium effectively overcomes the problem of poor stability of the main drug, improves the dissolution rate of the drug, and increases the retention of the drug in the body time

Method used

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  • Pitavastatin calcium lipid solid preparation
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  • Pitavastatin calcium lipid solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Example 1 Preparation of Pitavastatin Calcium Liposome Tablets

[0066] The raw and auxiliary materials used are as follows:

[0067]

[0068]

[0069] Adopt the following production process to prepare pitavastatin calcium liposome tablet:

[0070] (a) Dissolve 150g DPPC, 50g stearylamide, 200g octadecylamine and 50g Tween 80 in a mixed solvent of ethanol and chloroform with a volume ratio of 5:1 in 1000ml, mix well, and depressurize at 45°C on a rotary evaporator Remove ethanol and chloroform to obtain a phospholipid film;

[0071] (b) Add 1000ml of pH 6.8 phosphate buffer solution, oscillate and stir to completely hydrate the phospholipid membrane, homogeneously emulsify at 500rpm, and filter through a 0.45 μm microporous membrane to obtain a blank liposome suspension;

[0072] (c) 1 g of pitavastatin calcium was dissolved in blank liposome suspension, filtered through a 0.45 μm microporous membrane, kept at 50° C. for 30 minutes, and spray-dried to obtain l...

Embodiment 2

[0075] The preparation of embodiment 2 pitavastatin calcium liposome sheet

[0076] The raw and auxiliary materials used are as follows:

[0077]

[0078] Adopt the following production process to prepare pitavastatin calcium liposome tablet:

[0079] (a) Dissolve 150g DPPC, 100g stearylamide, 50g octadecylamine and 150g Tween 80 in 1200ml of a mixed solvent of ethanol and chloroform with a volume ratio of 5:1, mix well, and depressurize at 45°C on a rotary evaporator Remove ethanol and chloroform to obtain a phospholipid film;

[0080] (b) Add 1200ml of phosphate buffer solution with a pH of 6.8, oscillate and stir to completely hydrate the phospholipid membrane, homogeneously emulsify at 5000rpm, and filter through a 0.45 μm microporous membrane to obtain a blank liposome suspension;

[0081] (c) 1 g of pitavastatin calcium was dissolved in blank liposome suspension, filtered through a 0.45 μm microporous membrane, kept at 50° C. for 50 minutes, and spray-dried to obtai...

Embodiment 3

[0084] The preparation of embodiment 3 pitavastatin calcium liposome sheet

[0085] The raw and auxiliary materials used are as follows:

[0086]

[0087] Adopt the following production process to prepare pitavastatin calcium liposome tablet:

[0088](a) 180g DPPC, 80g stearylamide, 130g octadecylamine and 140g Tween 80 are dissolved in 1500ml of a mixed solvent of ethanol and chloroform with a volume ratio of 5:1, mix well, and reduce the temperature at 45°C on a rotary evaporator. Ethanol and chloroform were removed by pressure to obtain a phospholipid film;

[0089] (b) Add 1500ml of pH 6.8 phosphate buffer solution, oscillate and stir to hydrate the phospholipid membrane completely, homogeneously emulsify at 5000rpm, and filter through a 0.45 μm microporous membrane to obtain a blank liposome suspension;

[0090] (c) 2 g of pitavastatin calcium was dissolved in blank liposome suspension, filtered through a 0.45 μm microporous membrane, kept at 50° C. for 40 minutes, a...

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Abstract

The invention discloses a pitavastatin calcium lipid solid preparation and a preparation method thereof. The preparation method comprises the following steps: preparing pitavastatin calcium lipid with excellent quality from pitavastatin calcium, DPPC (dipalmitoyl phosphatidylcholine), stearamide, octadecylamine and Tween 80 in a specific weight proportion; and preparing the pitavastatin calcium lipid into a solid preparation by a conventional preparation method. Compared with the existing preparation, the preparation disclosed by the invention has the advantages of greatly improved stability and bioavailability, enhanced quality, reduced toxic and side effects, smooth and stable drug release, and remarkable curative effect.

Description

technical field [0001] The invention relates to a liposome solid preparation, in particular to a liposome solid preparation of pitavastatin calcium and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Cardiovascular disease is one of the most common and serious diseases that endanger human health. It has the characteristics of "high incidence, high disability rate, high mortality rate, high recurrence rate and many complications". At present, there are more than 270 million patients with cardiovascular and cerebrovascular diseases in my country. In recent years, domestic and foreign guidelines for the prevention and treatment of hypertension have indicated that the blood pressure of hypertensive patients should be actively and persistently lowered to below 140 / 90 mmHg (the best should be lowered to below 130 / 80 mmHg). ), can effectively reduce the damage of target organs such as heart, brain and kidney caused by hypert...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K9/20A61K31/47A61K47/34A61P3/06
Inventor 廖爱国
Owner HAINAN MEIDA PHARMA
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