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Fluvastatin sodium liposome solid preparation

A technology for fluvastatin sodium and solid preparations, applied in the field of pharmaceutical preparations, can solve problems such as increasing drug retention time, and achieve the effects of improving medication compliance, reducing the number of administrations, and improving quality

Inactive Publication Date: 2013-01-23
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 fluvastatin sodium effectively overcomes the problem of poor stability of the main drug in common solid preparations, improves the dissolution rate of the drug, and increases the drug in the in vivo retention time

Method used

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  • Fluvastatin sodium liposome solid preparation
  • Fluvastatin sodium liposome solid preparation
  • Fluvastatin sodium liposome solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] The preparation of embodiment 1 fluvastatin sodium liposome capsule

[0058] The raw and auxiliary materials used are as follows:

[0059]

[0060] Adopt the following production process to prepare fluvastatin sodium liposome capsules:

[0061] (1) 30g soybean lecithin, 20g cholesterol, 4g soybean sterol, 10g sorbitan stearate are dissolved in 200ml volume ratio and are the mixed solvent of acetone and ethanol of 2: 3, mix uniformly, in rotary evaporator Remove the organic solvent under reduced pressure to obtain a phospholipid film;

[0062] (2) Add 200ml of phosphoric acid-sodium hydrogen phosphate buffer solution with a pH of 7.0, shake and stir to completely hydrate the phospholipid membrane, homogeneously emulsify at 3000rpm, and filter through a microporous membrane to obtain a blank liposome suspension;

[0063] (3) Dissolve 20 g of fluvastatin sodium in the blank liposome suspension, filter through a 0.45 μm microporous membrane, incubate at 49° C. for 50...

Embodiment 2

[0066] The preparation of embodiment 2 fluvastatin sodium liposome capsules

[0067] The raw and auxiliary materials used are as follows:

[0068]

[0069] Adopt the following production process to prepare fluvastatin sodium liposome capsules:

[0070] (1) 20g soybean lecithin, 18g cholesterol, 6g soybean sterol, 10g sorbitan stearate are dissolved in 20ml volume ratio and are the mixed solvent of acetone and ethanol of 2: 3, mix uniformly, in rotary evaporator Remove the organic solvent under reduced pressure to obtain a phospholipid film;

[0071] (2) Add 200ml of phosphoric acid-sodium hydrogen phosphate buffer solution with a pH of 7.0, shake and stir to completely hydrate the phospholipid membrane, homogeneously emulsify at 3000rpm, and filter through a microporous membrane to obtain a blank liposome suspension;

[0072] (3) 20 g of fluvastatin sodium was dissolved in blank liposome suspension, filtered through a 0.45 μm microporous membrane, incubated at 55° C. fo...

Embodiment 3

[0075] The preparation of embodiment 3 fluvastatin sodium liposome capsules

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

[0077]

[0078] Adopt the following production process to prepare fluvastatin sodium liposome capsules:

[0079] (1) 40g soybean lecithin, 36g cholesterol, 12g soybean sterol and 22g sorbitan stearate are dissolved in 40ml volume ratio and are the mixed solvent of acetone and ethanol of 2: 3, mix homogeneously, in rotary evaporator Remove the organic solvent under reduced pressure to obtain a phospholipid film;

[0080] (2) Add 400 ml of phosphoric acid-sodium hydrogen phosphate buffer solution with a pH of 7.0, shake and stir to completely hydrate the phospholipid membrane, homogeneously emulsify at 300 rpm, and filter through a microporous membrane to obtain a blank liposome suspension;

[0081] (3) 40 g of fluvastatin sodium was dissolved in blank liposome suspension, filtered through a 0.45 μm microporous membrane, kept at 40° C...

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Abstract

The invention discloses a fluvastatin sodium liposome solid preparation and a preparation method thereof. According to the invention, fluvastatin sodium, soya lecithin, cholesterin, soybean derived sterol and dehydrated sorbitol stearate are used according to a specific weight ratio to prepare fluvastatin sodium liposome with excellent quality, and the fluvastatin sodium liposome is prepared intoa solid preparation by using a common pharmaceutical method. Compared to conventional preparations, the preparation provided in the invention has greatly improved stability and bioavailability, stable drug release, remarkable curative effects, enhanced quality and reduced toxic and side effects.

Description

technical field [0001] The invention relates to a liposome solid preparation, in particular to a fluvastatin sodium liposome solid preparation, and belongs to the field of pharmaceutical preparations. 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 hypertension. Further, it can ef...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61K31/405A61K47/28A61K47/24A61K47/26A61P3/06
Inventor 廖爱国
Owner HAINAN MEIDA PHARMA
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