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Freeze-dried powder of pravastatin sodium composition for injection

A technology of pravastatin sodium and freeze-dried powder injection, which is applied in the field of medicine and medicine manufacturing, can solve the problem of no chitosan-containing nanoparticles, etc., and achieve the effects of reducing adverse reactions, eliminating active effects and enhancing lipid-lowering effects.

Inactive Publication Date: 2014-02-26
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Chitosan nanoparticles are particles with a particle size of less than 100nm, which can not only overcome the water-insoluble properties of chitosan itself, but also have slow-release and targeting effects as a drug carrier. Pharmaceutical dosage forms of sugar nanoparticles

Method used

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  • Freeze-dried powder of pravastatin sodium composition for injection
  • Freeze-dried powder of pravastatin sodium composition for injection
  • Freeze-dried powder of pravastatin sodium composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1. Preparation of pravastatin sodium composition freeze-dried powder for injection (specification: 10 mg, calculated as pravastatin sodium), in 1000 vials.

[0040] 1. Prescription:

[0041] Pravastatin Sodium 10g

[0042] Chitosan Nanoparticles 8g

[0043] Water for injection 2000ml

[0044] 2. Preparation process:

[0045] 1) Slowly add 8g of chitosan nanoparticles into the prescribed amount of water for injection (theoretical loading 2ml / bottle), and stir until dissolved while adding.

[0046] 2) Continue to add 10g of pravastatin sodium and stir to dissolve until clear.

[0047] 3) Use sodium hydroxide to adjust the pH to 5.5-6.0, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then decarburize and circulate and filter through titanium rods for 30 minutes; then sterilize through 0.45 μm and 0.22 μm Circulate filtration for 30 minutes; detect the content of intermediates, and calculate the filling amount based on 10 ...

Embodiment 2

[0049] Embodiment 2, preparation of pravastatin sodium composition freeze-dried powder for injection (specification: 10 mg, calculated as pravastatin sodium), calculated in 1000 pieces.

[0050] 1. Prescription:

[0051] Pravastatin Sodium 10g

[0052] Chitosan Nanoparticles 9g

[0053] Water for injection 2000ml

[0054] 2. Preparation process:

[0055] 1) Slowly add 9g of chitosan nanoparticles into the prescribed amount of water for injection (theoretical loading 2ml / bottle), and stir until dissolved while adding.

[0056] 2) Continue to add 10g of pravastatin sodium and stir to dissolve until clear.

[0057] 3) Use sodium hydroxide to adjust the pH to 5.5-6.0, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then decarburize and circulate and filter through titanium rods for 30 minutes; then sterilize through 0.45 μm and 0.22 μm Circulate filtration for 30 minutes; detect the content of intermediates, and calculate the filling amount...

Embodiment 3

[0059] Example 3. Preparation of pravastatin sodium composition freeze-dried powder for injection (specification: 10 mg, calculated as pravastatin sodium), in 1000 vials.

[0060] 1. Prescription:

[0061] Pravastatin Sodium 10g

[0062] Chitosan Nanoparticles 7g

[0063] Water for injection 2000ml

[0064] 2. Preparation process:

[0065] 1) Slowly add 7g of chitosan nanoparticles into the prescribed amount of water for injection (theoretical loading 2ml / bottle), and stir until dissolved while adding.

[0066] 2) Continue to add 10g of pravastatin sodium and stir to dissolve until clear.

[0067] 3) Use sodium hydroxide to adjust the pH to 5.5-6.0, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then decarburize and circulate and filter through titanium rods for 30 minutes; then sterilize through 0.45 μm and 0.22 μm Circulate filtration for 30 minutes; detect the content of intermediates, and calculate the filling amount based on 10 ...

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Abstract

The invention provides a freeze-dried powder of a pravastatin sodium composition for injection, and relates to the technical field of medicines and medicine production. The freeze-dried powder comprises the following raw materials by weight: 1 part of pravastatin sodium, 0.2-1.4 parts of chitosan nanoparticles and 100-200 parts of water for injection. The freeze-dried powder has the advantages that (1) chitosan, as a cosolvent, can increase solubility of pravastatin sodium in water and shorten dissolution time, and is helpful for clinical application; (2) the composition can significantly enhance a lipid-decreasing of pravastatin sodium, reduce usage amount of pravastatin sodium clinically and alleviate adverse effects of pravastatin sodium; in-vitro experiments demonstrate that the lipid-decreasing capacity of 10 mg of the freeze-dried powder of pravastatin sodium composition comprising the chitosan nanoparticles is equivalent to that of 20 mg of pravastatin sodium with no chitosan nanoparticles; and (3) chitosan nanoparticles can replace mannitol to be used as a freeze-drying skeleton agent, so that active effects of mannitol to a human body can be eliminated.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a pravastatin sodium composition freeze-dried powder for injection. Background technique: [0002] Pravastatin sodium is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA reductase), which is the rate-limiting enzyme in the early stage of cholesterol biosynthesis. The product reversibly inhibits HMG-CoA reductase, thereby inhibiting the biosynthesis of cholesterol, and its chemical structure is as follows. [0003] [0004] [0005] Pravastatin sodium is currently the most extensively researched and clinically applied lipid-lowering drug in the world. In a series of clinical trials, it can reduce the risk of cardiovascular events and slow down the progression of atherosclerosis in patients with coronary heart disease with hypercholesterolemia. The West of Scotland Coronary Heart Disease Prevention Study (WOS Tri...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/22A61K47/36A61P3/06A61P9/10
Inventor 汪六一汪金灿肖雪
Owner HAINAN WEI KANG PHARMA QIANSHAN
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