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Stable naloxone hydrochloride lyophilized preparation and preparation method thereof

A technology of naloxone hydrochloride and freeze-dried preparations, which can be used in freeze-dried delivery, nervous system diseases, powder delivery, etc. It can solve the problems of affecting patient safety, many excipients, unknown side effects, etc., and achieves good resolubility, few side effects, Recipe Simple Effects

Inactive Publication Date: 2012-10-17
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, too many excipients are added to the above-mentioned freeze-dried preparations, which may cause unknown side effects and affect patient safety.

Method used

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  • Stable naloxone hydrochloride lyophilized preparation and preparation method thereof
  • Stable naloxone hydrochloride lyophilized preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Naloxone hydrochloride 0.4g, mannitol 80g, mix naloxone hydrochloride and mannitol, add water for injection and stir until completely dissolved, adjust pH to 3.5 with hydrochloric acid and sodium hydroxide, add water for injection to 1000ml, add a total of 0.05 % of needles with activated carbon, stirred for 15 minutes, filtered and decarbonized, and the medicinal solution was finely filtered with a 0.22 μm sterile microporous filter membrane, and the pH value, content, and half stopper were measured, and then the medicinal product was put into a freeze-drying box for pre-freezing. -40°C for 2 hours. After the drug is frozen, start the vacuum machine to evacuate to 10Pa, turn off the freezer, and heat up the drug to keep the temperature of the frozen product at -40°C~-10°C; the time is 25h. Gradually raise the temperature to 25°C, keep warm and vacuum dry for 3 hours. A freeze-dried formulation was obtained.

Embodiment 2

[0052] Naloxone hydrochloride 2g, mannitol 60g, mix naloxone hydrochloride and mannitol, add water for injection and stir until completely dissolved, adjust pH to 4 with hydrochloric acid and sodium hydroxide, add water for injection to 1000ml, add a total of 0.05 % of needles with activated carbon, stirred for 15 minutes, filtered and decarbonized, and the medicinal solution was finely filtered with a 0.22 μm sterile microporous filter membrane, and the pH value, content, and half stopper were measured, and then the medicinal product was put into a freeze-drying box for pre-freezing. -40°C for 2 hours. After the drug is frozen, start the vacuum machine to evacuate to 10Pa, turn off the freezer, and heat up the drug to keep the temperature of the frozen product at -40°C~-10°C; the time is 25h. Gradually raise the temperature to 25°C, keep warm and vacuum dry for 3 hours. A freeze-dried formulation was obtained.

Embodiment 3

[0054] Naloxone hydrochloride 0.4g, mannitol 70g, mix naloxone hydrochloride and mannitol, add water for injection and stir until completely dissolved, adjust pH to 3 with hydrochloric acid and sodium hydroxide, add water for injection to 1000ml, add the total amount 0.05% activated carbon for needles, stirred for 15 minutes, filtered and decarbonized, finely filtered the drug solution with a 0.22 μm sterile microporous filter membrane, measured pH value, content, and half stoppered, and then put the drug into a freeze-drying box for pre-freezing. The temperature is -40°C, and the time is 2 hours. After the medicine is frozen, start the vacuum machine to evacuate to 10 Pa, turn off the freezer, and heat up the medicine to keep the temperature of the frozen product at -40°C ~ -10°C; the time is 25h. The medicine is gradually heated to 25°C, and vacuum-dried for 3 hours. A freeze-dried formulation was obtained.

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Abstract

A stable naloxone hydrochloride lyophilized preparation comprises naloxone hydrochloride and mannitol in a weight ratio of 1 : 30 - 200. The lyophilized preparation has a simple formula and fewer side effects, and employs an advanced freeze-drying process. The prepared products have full appearance, good solubility, and excellent quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, relates to a pharmaceutical composition, in particular to a stable freeze-dried preparation of naloxone hydrochloride and a preparation method thereof. Background technique [0002] CN03107128.7 discloses a naloxone freeze-dried powder preparation and its preparation process, which contains naloxone, a pH regulator and other pharmaceutical carriers. The preparation process disclosed in this invention: weigh the prescription amount of nalox The ketone is dissolved in water for injection to make a naloxone solution, and an appropriate amount of pharmaceutical carrier is added to adjust the pH value, aseptically filled, freeze-dried, vacuum-pressed and then taken out, and the aluminum-pressed cap is labeled to obtain the finished product. The naloxone freeze-dried powder preparation prepared according to the preparation process of the invention has better stability, long validity period, l...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/485A61P25/36
Inventor 王国华刘萍梅勇
Owner YAOPHARMA CO LTD
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