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A kind of freeze-dried powder preparation of naproxen sodium for injection and preparation method thereof

A technology of naproxen sodium and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of poor resolubility, poor turbidity stability, and high insoluble particles, and achieve good product resolubility, good appearance, and quality indicators Improved effect

Active Publication Date: 2017-10-03
HAINAN HUALON PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after the freeze-drying of naproxen sodium for injection, the finished product has high insoluble particles and poor turbidity stability. Therefore, to make good naproxen sodium for injection, it is necessary to solve the problems of high insoluble particles and poor turbidity stability. defect
In addition, the existing products also have the problems of poor appearance (easy to form grooves) and poor resolubility

Method used

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  • A kind of freeze-dried powder preparation of naproxen sodium for injection and preparation method thereof
  • A kind of freeze-dried powder preparation of naproxen sodium for injection and preparation method thereof
  • A kind of freeze-dried powder preparation of naproxen sodium for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Prepare one thousand bottles of the naproxen sodium freeze-dried powder preparation for injection whose solution total amount is 3000g before freeze-drying:

[0035] (1) Accurately weigh 275g of naproxen sodium and 100g of mannitol respectively, and set aside.

[0036] (2) Put the weighed naproxen sodium in the liquid preparation container, add 2000g of water for injection, stir until completely dissolved; then add the weighed mannitol and stir until completely dissolved, add water for injection to 2700g, stir to uniform.

[0037] (3) After the solution is completely dissolved and stirred evenly, measure the pH value, and slowly add an appropriate amount of 1mol / L sodium hydroxide solution to adjust the pH to 9.5.

[0038] (4) Weigh 1.35 g of activated carbon for needles, add it to the solution, and absorb for 30 minutes;

[0039] (5) After absorbing for 30 minutes, use a filter device with a pore size of 0.45 microns to filter and decarbonize, and the filtered medici...

Embodiment 2

[0047] The process is basically the same as in Example 1, except that in steps (3) and (5), the corresponding values ​​of each pH value are 9.65.

Embodiment 3

[0049] The process is basically the same as in Example 1, except that in steps (3) and (5), the corresponding values ​​of each pH value are 9.8.

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Abstract

The invention provides a freeze-dried powder preparation of naproxen sodium for injection with controllable quality, good solubility and stability and a preparation method thereof. Every 1000 bottles of the described naproxen sodium freeze-dried powder preparation for injection are formed by freeze-drying the solution of 3000g; the pH value of the solution is 9.5~9.8, contains 275g naproxen sodium, 100g excipient, and the solvent is Water for Injection. Compared with the prior art, the present invention has the following advantages: (1) The concentration of naproxen sodium in the dosing solution is reduced, and the eutectic point of naproxen sodium and water decreases during freeze-drying, which helps to improve the properties of the product. The temperature recovery and freeze-drying process is adopted to promote the change of the crystal form and freeze-dried skeleton of naproxen sodium, which is beneficial to the sublimation of water and the reconstitution of the freeze-dried product. The resolubility of the product is good, which is beneficial to clinical use. (2) Adjust the pH to 9.5-9.8 when preparing the solution. If the pH value of the solution is high, the production of naproxen will be reduced, and the quality indicators such as insoluble particles and turbidity of the finished product will be improved.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a freeze-dried preparation, in particular to a freeze-dried powder preparation of naproxen sodium for injection and a preparation method thereof. Background technique [0002] Naproxen Sodium for Injection is used for the symptomatic treatment of fever and pain caused by various reasons. In the acute stage of the above-mentioned diseases, it can also be used for pain relief after primary dysmenorrhea and medium and minor operations. [0003] Naproxen sodium is currently available in dosage forms such as tablets, capsules, and injections. Compared with water injection, the powder injection adopts the freeze-drying production process. The medicine is in a closed container, and the low-temperature drying under vacuum makes the medicine not easy to oxidize and avoid decomposition due to high heat; the freeze-dried powder preparation made by freeze-drying, the finished product contains...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/192A61K47/10A61J3/02A61P19/02A61P29/00A61P19/08A61P19/04A61P25/00A61P19/06A61P15/00
Inventor 陈益智黄国豪
Owner HAINAN HUALON PHARM