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Naloxone hydrchloride freeze-dried powder preparation for injection

A technology of naloxone hydrochloride and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, medical preparations containing active ingredients, anti-toxins, etc., and can solve the problems of difficult industrial production of products, difficult implementation of preparation processes, and poor patient tolerance and other problems, to achieve the effect of loose and porous products, simple and easy preparation process, and good stability

Inactive Publication Date: 2005-05-18
YANGGUANG RUNHE SCI & TECHNOLGY BEIJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The raw material drug used in the preparation is naloxone, and naloxone is insoluble or almost insoluble in water, and the preparation process is difficult to implement; and the pH value of the preparation is 3.0-4.5, which is relatively acidic, and it is used for intramuscular injection or intravenous injection in clinical application. When injected, it is highly irritating to the blood vessels, skin, mucous membranes and muscles of the patient, and the patient's tolerance is poor, so it is difficult to realize the industrial production of the product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] prescription:

[0023] Naloxone Hydrochloride 0.2g

[0024] Mannitol 10g

[0025] Process: ① Take 1000ml of water for injection and put it in the liquid mixing tank, add the full amount of mannitol prescribed, and stir until dissolved; ② Add the prescribed amount of naloxone hydrochloride, stir until dissolved; then use a 0.22 μm microporous membrane filter to Clarity; ③ potting in vials (filling 1ml liquid in 2ml volume vials); ④ freeze-drying (pre-freeze, make the temperature drop to -40°C, and after two hours, heat up at a rate of 0.15°C per minute. Raise the temperature to -5°C, sublimate and dry at this temperature for 10 hours, then raise the temperature to 40°C at a rate of 0.4°C per minute, and dry at this temperature for 7 to 10 hours); ⑤ Press cap, label, and pack , after passing the inspection, the finished product is obtained. PH value: Take 10 sticks of this product, add 1ml of water to dissolve each stick, combine them, and measure according to the law ...

Embodiment 2

[0027] prescription:

[0028] Naloxone Hydrochloride 0.4g

[0029] Mannitol 20g

[0030] Process: ① Take 1000ml of water for injection and put it in the liquid mixing tank, add the full amount of mannitol prescribed, and stir until dissolved; ② Add the prescribed amount of naloxone hydrochloride, stir until dissolved; then use a 0.22 μm microporous membrane filter to Clarity; 3. potting in vials (same as Example 1); 4. freeze-drying (pre-freezing, making the temperature drop to -40°C, and raising the temperature to -5°C at a heating rate of 0.15°C per minute after two hours, Sublimation and drying at this temperature for 10 hours, then raising the temperature to 40°C at a heating rate of 0.4°C per minute, and drying at this temperature for 7 to 10 hours); .

[0031] PH value: measuring method is the same as embodiment 1, and pH value is 6.06. .

Embodiment 3

[0033] prescription:

[0034] Naloxone Hydrochloride 1g

[0035] Mannitol 30g

[0036] Process: ① Take 1000ml of water for injection and put it in the liquid mixing tank, add the full amount of mannitol prescribed, and stir until dissolved; ② Add the prescribed amount of naloxone hydrochloride, stir until dissolved; then use a 0.22 μm microporous membrane filter to Clarity; 3. potting in vials (same as Example 1); 4. freeze-drying (pre-freezing, making the temperature drop to -40°C, and raising the temperature to -5°C at a heating rate of 0.15°C per minute after two hours, Sublimation and drying at this temperature for 10 hours, then raising the temperature to 40°C at a heating rate of 0.4°C per minute, and drying at this temperature for 7 to 10 hours); .

[0037] PH value: measuring method is the same as embodiment 1, and pH value is 5.85.

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PUM

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Abstract

The freeze dried naloxone hydrochloride powder for injection consists of naloxone hydrochloride in effective medicine amount and proper amount of medicinal carrier. The naloxone hydrochloride content is 0.08-70.59 wt% or 0.1-12 mg; and the medicinal carrier may be one or several of mannitol, glucol, sodium chloride, beta-cyclodextrin, dextran, fructose, sorbic alcohol, etc., is preferably mannitol and glucol and has the ratio in the preparation of 29.41-99.92 wt%.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation, in particular to a naloxone hydrochloride freeze-dried powder preparation for injection, which contains a therapeutically effective amount of naloxone hydrochloride and an appropriate amount of drug carrier. Background technique: [0002] Naloxone hydrochloride (chemical name 17-allyl-4,5a-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate (please make sure if naloxone hydrochloride is only its Dihydrate can be used for pharmacy, if its non-hydrate or the hydrate of other water content also can be used as medicine, please explain in detail here, namely explain that naloxone hydrochloride can have multiple forms, naloxone hydrochloride of the present invention includes These all forms of naloxone hydrochloride, but most preferably the above-mentioned dihydrate), are opioid receptor antagonists, used for respiratory depression caused by opioid combined anesthesia after surgery, and awakenin...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/485A61P25/32A61P39/02
Inventor 王颖袁明旭
Owner YANGGUANG RUNHE SCI & TECHNOLGY BEIJING
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