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Naloxone Hydrochloride Injection and its preparation method

A technology of naloxone hydrochloride and naloxone acid, applied in the field of opioid receptor pure antagonists, to achieve the effects of reducing impurities, easy packaging and transportation, and improving product quality

Inactive Publication Date: 2005-01-19
张哲峰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The present invention just aims at the defect that the existing naloxone hydrochloride injection only has a small water injection (specification: 1ml: 0.4mg) dosage form, which is difficult to meet the clinical needs, and provides a kind of naloxone hydrochloride injection which is convenient to use, good in safety, stable in quality and remarkable in curative effect. Naloxone Hydrochloride Injection Form

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] Present embodiment prescription is as follows:

[0118] Consumption per 1 stick Consumption per 1000 sticks

[0119] Naloxone hydrochloride (press C 19 h 21 NO 4 · HCl) 1.2mg 1.2g

[0120] Sodium chloride 900mg 900g

[0121] Add water for injection to 100ml 100L

[0122] Preparation method: 1. Prepare concentrated solution of isotonic agent: take 900 grams of sodium chloride, add 2700 grams of water for injection, stir to dissolve, add 0.3% activated carbon for needles and boil for 30 minutes, filter and decarbonize through a sand filter rod to obtain final product; 2. Prepare concentrated solution of naloxone hydrochloride: take 1.2 grams of naloxone hydrochloride, add 24 grams of water for injection, stir to dissolve, and obtain. 3. Combine the above two solutions, add water for injection to 100 liters, ultrafilter with a hollow fiber ultrafiltration membrane (pore size not greater than 100,000), measure the intermediate content a...

Embodiment 2

[0124] Present embodiment prescription is as follows:

[0125] Consumption per 1 stick Consumption per 1000 sticks

[0126] Naloxone hydrochloride (press C 19 h 21 NO 4 HCl) 0.4mg 0.4g

[0127] Glucose 5g 5000g

[0128] Sodium thiosulfate 0.1g 100g

[0129] Calcium Sodium EDTA 0.01g 10g

[0130] Add water for injection to 100ml 100L

[0131] Preparation method: 1. Prepare the concentrated dosing solution of isotonic agent: get 5000 grams of glucose, 100 grams of sodium thiosulfate and 10 grams of calcium sodium EDTA, add 15000 grams of water for injection, stir and dissolve, add 0.3% activated carbon for needles and boil for 30 minutes, 2. Preparation of concentrated naloxone hydrochloride solution: take 0.4 g of naloxone hydrochloride, add 8 g of water for injection, stir to dissolve, and obtain the product. 3. Combine the above two solutions, add water for injection to 100 liters, ultrafilter with a hollow fiber ultrafiltration membrane...

Embodiment 3

[0133] Present embodiment prescription is as follows:

[0134] Consumption per 1 stick Consumption per 1000 sticks

[0135] Naloxone hydrochloride (press C 19 h 21 NO 4 HCl) 0.8mg 0.8g

[0136] Sodium chloride 900mg 900g

[0137] Add water for injection to 50ml 50L

[0138] Preparation method: 1. Prepare concentrated solution of isotonic agent: take 900 grams of sodium chloride, add 2700 grams of water for injection, stir to dissolve, add 0.3% activated carbon for needles and boil for 30 minutes, filter and decarbonize through a sand filter rod to obtain final product; 2. Prepare concentrated solution of naloxone hydrochloride: take 0.8 g of naloxone hydrochloride, add 16 g of water for injection, stir to dissolve, and obtain. 3. Combine the above two solutions, add water for injection to 50 liters, ultrafilter with a hollow fiber ultrafiltration membrane (pore size not greater than 100,000), measure the intermediate content and pH value, ...

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PUM

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Abstract

The invention discloses a Naloxone hydrochloride injection and powder injection, and the process for preparation, wherein middle aperture fiber film hyperfiltration technology is employed to remove the impurities, thus diminishing the damage of main medicaments and improving the quality of products.

Description

technical field [0001] The invention relates to an opioid receptor pure antagonist, a drug having completely opposite pharmacological effects to morphine-naloxone hydrochloride injection dosage form and a preparation method thereof. Background technique [0002] Naloxone hydrochloride (Naloxone hydrochloride) is a specific opioid receptor antagonist, which does not stimulate the receptor itself, but has a greater affinity with the receptor than morphine and enkephalin, and can competitively block or replace opioids and endogenous substances. The combination of the derived opioid peptide and the receptor relieves the poisoning of morphine drugs, antagonizes the inhibition of the respiratory center, and has a wake-up effect. The Ministry of Health of my country approved its small water injection (specification: 1ml: 0.4mg) to go on the market in 1990. It is used for intramuscular injection or intravenous injection to relieve respiratory depression, awakeni...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K31/485A61P39/02
Inventor 张哲峰
Owner 张哲峰
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