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Enalapril composition freeze-dried powder for injection

A technology of enalapril and freeze-dried powder injection, applied in the field of medicine and medicine manufacturing, can solve the problem of no chitosan-containing nanoparticles, etc., and achieve the effect of eliminating the active effect

Inactive Publication Date: 2014-01-29
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] 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 sustained release and targeting effects as a drug carrier. At present, there is no chitosan nanoparticle pharmaceutical dosage form

Method used

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  • Enalapril composition freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1. Preparation of enalapril composition freeze-dried powder for injection (specification: 10 mg, calculated as enalapril), in 1000 vials.

[0037] 1. Prescription:

[0038] Enalapril 10g

[0039] Chitosan Nanoparticles 7g

[0040] Water for injection 2000ml

[0041] 2. Preparation process:

[0042] 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.

[0043] 2) Continue to add 10g of enalapril and stir to dissolve until clear.

[0044] 3) Use sodium hydroxide to adjust the pH to 4.5, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then conduct decarburization circulation filtration through titanium rods for 30 minutes; then conduct sterilization circulation filtration through 0.45 μm and 0.22 μm , time 30 minutes; detection of intermediate content, according to enalapril 10mg per bottle to calculate the load...

Embodiment 2

[0046] Example 2. Preparation of enalapril composition freeze-dried powder for injection (specification: 10 mg, calculated as enalapril), calculated in 1000 vials.

[0047] 1. Prescription:

[0048] Enalapril 10g

[0049] Chitosan Nanoparticles 8g

[0050] Water for injection 2000ml

[0051] 2. Preparation process:

[0052] 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.

[0053] 2) Continue to add 10g of enalapril and stir to dissolve until clear.

[0054] 3) Use sodium hydroxide to adjust the pH to 4.5, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then conduct decarburization circulation filtration through titanium rods for 30 minutes; then conduct sterilization circulation filtration through 0.45 μm and 0.22 μm , time 30 minutes; detection of intermediate content, according to enalapril 10mg per bottle to calcula...

Embodiment 3

[0056] Example 3. Preparation of enalapril composition freeze-dried powder for injection (specification: 10 mg, calculated as enalapril), in 1000 vials.

[0057] 1. Prescription:

[0058] Enalapril 10g

[0059] Chitosan Nanoparticles 6g

[0060] Water for injection 2000ml

[0061] 2. Preparation process:

[0062] 1) Slowly add 6g of chitosan nanoparticles into the prescribed amount of water for injection (theoretical loading 2ml / bottle), and stir until dissolved while adding.

[0063] 2) Continue to add 10g of enalapril and stir to dissolve until clear.

[0064] 3) Use sodium hydroxide to adjust the pH to 4.5, add activated carbon with 0.1% volume of water for injection and stir for 30 minutes; then conduct decarburization circulation filtration through titanium rods for 30 minutes; then conduct sterilization circulation filtration through 0.45 μm and 0.22 μm , time 30 minutes; detection of intermediate content, according to enalapril 10mg per bottle to calculate the loadin...

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Abstract

The invention provides an enalapril composition freeze-dried powder for injection, and belongs to the field of medicine and medicine preparation technology. The enalapril composition freeze-dried powder comprises following raw material ingredients, by weight, 1 part of enalapril, 0.2 to 1.2 parts of chitosan nanoparticle, and 100 to 200 parts of injection water. Advantages of the enalapril composition freeze-dried powder are that: (1) a plurality of adverse responses, such as severe coughing, taste disorder and rash, may be caused by synthetic ACE-I; the enalapril composition freeze-dried powder is capable of increasing antihypertensive effect of enalapril significantly, reducing dosage of enalapril in clinic, and reducing adverse responses caused by enalapril; and it is confirmed by in vitro experiment that the ACE inhibition activity of 5mg of the enalapril composition freeze-dried powder containing the chitosan nanoparticle and the ACE inhibition activity of 10mg of enalapril containing no chitosan nanoparticle are the same; and (2) the chitosan nanoparticle can be used as a freeze-dried skeleton agent of the freeze-dried powder injection instead of mannitol so as to avoid active effects of mannitol on human bodies.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a freeze-dried powder injection of enalapril composition for injection. Background technique: [0002] Enalapril is an angiotensin-converting enzyme inhibitor (ACE-I), which is the second ACE-I listed in the world after captopril. The effect of treating hypertension is similar to captopril, but stronger than captopril, and the effect is slow and lasting. Like captopril, it can be combined with the diuretic dihydrochlorothiazide (trade name Vaseretic, launched in 1988), and the curative effect can generally be increased by 15%-30%. It is used for primary and renal hypertension, renovascular hypertension, malignant hypertension, etc. It is also suitable for congestive heart failure, especially for hypertensive patients with high renin and hypercalcemia who need long-term medication and digitalis and diuretic Patients with congestive heart failure who ar...

Claims

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Application Information

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IPC IPC(8): A61K38/05A61K9/19A61K47/36A61P9/12A61P9/04
Inventor 汪六一汪金灿程贤贵
Owner HAINAN WEI KANG PHARMA QIANSHAN