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Naloxone hydrochloride nano granule powder injection formulation and preparation thereof

A technology of naloxone hydrochloride and nanoparticles, applied in the field of medicine, can solve the problems of quality decline and unstable pH value, and achieve the effects of stable pH value, rapid reconstitution and strong operability

Inactive Publication Date: 2008-12-17
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Water injections are more likely to be oxidized, and the pH value is unstable, resulting in a decline in the quality of this product after long-term storage

Method used

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  • Naloxone hydrochloride nano granule powder injection formulation and preparation thereof
  • Naloxone hydrochloride nano granule powder injection formulation and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1: Prescription

[0031] Naloxone Hydrochloride 0.4g

[0032] Dextran 0.15g

[0033] Sodium bisulfite 0.5g

[0034] Sodium sulfate 0.2g

[0035] Methyl cyanoacrylate 0.6g

[0036] Mannitol 10g

[0037] Water for injection 1000ml

[0038] Preparation Process:

[0039] 1. Weigh 0.4g of naloxone hydrochloride, 0.15g of dextran and 0.5g of sodium bisulfite, add 200ml of water for injection to dissolve, adjust the pH value to 2.2 with 1mol / L hydrochloric acid solution, and stir evenly;

[0040] 2. Slowly add 0.6 g of methyl cyanoacrylate under electromagnetic stirring, continue stirring at room temperature for 3 hours, add 0.2 g of sodium sulfate, continue stirring for 3 hours, and adjust the pH value to 3.7 with 0.5 mol / L sodium hydroxide solution, Add water for injection to 800ml, stir well;

[0041] 3. Add 10g of mannitol, stir to dissolve, set the volume to 1000ml, add 0.5g of charcoal for needles, stir at room temperature for 10 minutes, filter for decar...

Embodiment 2

[0048] Example 2: Prescription

[0049] Naloxone Hydrochloride 4g

[0050] Dextran 2g

[0051] Sodium bisulfite 8g

[0052] Sodium sulfate 4g

[0053] Ethyl cyanoacrylate 10g

[0054] Glucose 1200g

[0055] Water for injection 4000ml

[0056] Preparation Process:

[0057] 1. Weigh 4g of naloxone hydrochloride, 2g of dextran and 8g of sodium bisulfite, add 2000ml of water for injection to dissolve, adjust the pH value to 2.4 with 1mol / L hydrochloric acid solution, and stir evenly;

[0058] 2. Slowly add 10g of ethyl cyanoacrylate under electromagnetic stirring, continue to stir at room temperature for 3 hours, add 4g of sodium sulfate, and continue to stir for 3 hours, adjust the pH value to 3.6 with 0.5mol / L sodium hydroxide solution, add Water for injection to 3600ml, stir well;

[0059] 3. Add 1200g of glucose, stir to dissolve, set the volume to 4000ml, then add 20g of charcoal for needles, stir at room temperature for 30 minutes, filter for decarburization, and the...

Embodiment 3

[0062] Example 3: Prescription

[0063] Naloxone Hydrochloride 2g

[0064] Dextran 1.2g

[0065] Sodium bisulfite 4.3g

[0066] Sodium sulfate 2.5g

[0067] Propyl cyanoacrylate 5.6g

[0068] Sucrose 400g

[0069] Water for injection 2000ml

[0070] Preparation Process:

[0071] 1. Weigh 2g of naloxone hydrochloride, 1.2g of dextran and 4.3g of sodium bisulfite, add 1000ml of water for injection to dissolve, adjust the pH value to 2.5 with 1mol / L hydrochloric acid solution, and stir evenly;

[0072] 2. Slowly add 5.6g of propyl cyanoacrylate under electromagnetic stirring, continue stirring at room temperature for 3 hours, add 2.5g of sodium sulfate, continue stirring for 3 hours, adjust the pH value to 3.5 with 0.5mol / L sodium hydroxide solution, Add water for injection to 1600ml, stir well;

[0073] 3. Add 400g of sucrose, stir to dissolve, set the volume to 2000ml, then add 5g of charcoal for needles, stir at room temperature for 20 minutes, filter for decarburizati...

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Abstract

The invention discloses a naloxone hydrochloride nano-particle powder injection, containing the raw materials with the following parts by weight: 0.4-4 parts of naloxone hydrochloride, 0.15-2 parts of dextran, 0.5-8 parts of sodium bisulfite, 0.2-4 parts of sodium sulfate, 0.6-10 parts of polyalkylcyano-acrylate, 10-1,200 parts of freeze-drying support agent. The invention further discloses a preparation method of the preparation. The preparation has fine stability and compatibility.

Description

technical field [0001] The invention relates to the technical field of medicine, and provides a new dosage form of naloxone hydrochloride-a nanoparticle preparation and a preparation method thereof. Background technique [0002] Naloxone hydrochloride is a pure opioid receptor antagonist with no intrinsic activity itself. For morphine compound anesthesia, relieve respiratory depression, wake up and acute alcoholism. Naloxone takes effect quickly and has a strong antagonistic effect. Naloxone also reverses all effects of opioid agonists, including analgesia. In addition, it also has resuscitating effects that are not related to antagonizing opioid receptors. It can quickly reverse the respiratory depression caused by opioid analgesics, can cause high excitement, and make cardiovascular hyperfunction. This product still has anti-shock effect. Morphine-like dependence, withdrawal symptoms and respiratory depression are not produced. Most of the listed preparations of nalo...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/485A61K47/16A61K47/36A61P25/32A61P25/36A61P43/00
Inventor 朱正兵
Owner HAINAN LINGKANG PHARMA CO LTD
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