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Parecoxib sodium freeze-dried preparation and preparation method thereof

A technology of parecoxib sodium and freeze-dried preparations, which is applied in the field of parecoxib sodium freeze-dried preparations and its preparation, can solve problems such as incomplete solutions, and achieve the effects of quality assurance, shape delivery and quality control improvement

Active Publication Date: 2020-04-07
SHANDONG LUOXIN PHARMA GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] In summary, for the quality and excipient problems existing in the preparation process of parecoxib sodium freeze-dried preparation, the existing technology has not completely solved

Method used

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  • Parecoxib sodium freeze-dried preparation and preparation method thereof
  • Parecoxib sodium freeze-dried preparation and preparation method thereof
  • Parecoxib sodium freeze-dried preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The specification of 1000 pieces is 20mg / piece and the composition is as follows:

[0030]

[0031]

[0032] Preparation:

[0033] (1) Dissolve 1.42g of disodium hydrogen phosphate in 800mL of water for injection, add 1.10g of vitamin E, add 0.80g of tartaric acid, add 20g of parecoxib sodium, heat up to 40-50°C to dissolve, add 2g of medicinal charcoal, add 3, 0.15g of 4,5-trihydroxybenzoic acid, stirred for 30min, added 0.1M phosphoric acid to adjust the pH to 7.9, cooled to 5°C, filtered until clarified, added water for injection to 1000mL, filled in 2mL vials.

[0034] (2) Cool the above parecoxib sodium freeze-dried preparation solution to -40~-35°C and keep it warm for 2 hours; evacuate to 30-40Pa, heat up to 5-10°C, maintain a vacuum degree of 30-40Pa, keep 10 -15h until the ice line disappears; heat up to 20°C and keep warm for 6 hours.

[0035] (3) Capping the sample to obtain a freeze-dried preparation of parecoxib sodium.

Embodiment 2

[0037] 1000 sticks of 20mg parecoxib sodium freeze-dried preparations are composed as follows:

[0038]

[0039] Preparation:

[0040] (1) Dissolve 1.42g of disodium hydrogen phosphate in 800mL of water for injection, add 2.20g of vitamin E, add 1.60g of 2-hydroxypropionic acid, add 20g of parecoxib sodium, heat up to 40-50°C to dissolve, add 2g of medicinal charcoal , add 0.15g of 3,4,5-trihydroxybenzoic acid, stir for 30min, add 0.1M phosphoric acid to adjust the pH to 8.1, cool down to 5°C, filter until clear, add water for injection to 1000mL, and fill in a 2mL vial.

[0041] (2) Cool the above parecoxib sodium freeze-dried preparation solution to -40~-35°C and keep it warm for 2 hours; evacuate to 30-40Pa, heat up to 5-10°C, maintain a vacuum degree of 30-40Pa, keep 10 -15h until the ice line disappears; heat up to 20°C and keep warm for 6 hours.

[0042] (3) Capping the sample to obtain a freeze-dried preparation of parecoxib sodium.

Embodiment 3

[0044] 1000 tubes of 40 mg parecoxib sodium freeze-dried preparations are composed as follows:

[0045]

[0046] Preparation:

[0047] (1) Dissolve 2.84g of disodium hydrogen phosphate in 1600mL of water for injection, add 2.20g of vitamin E, add 1.60g of 2-hydroxypropionic acid, add 40g of parecoxib sodium, heat up to 40-50°C to dissolve, add 4g of medicinal charcoal , add 0.30g of 3,4,5-trihydroxybenzoic acid, stir for 30min, add 0.1M phosphoric acid to adjust the pH to 8.0, cool down to 5°C, filter until clarified, add water for injection to 1000mL, and fill in a 5mL vial.

[0048] (2) Cool the above parecoxib sodium freeze-dried preparation solution to -40~-35°C and keep it warm for 2 hours; evacuate to 30-40Pa, heat up to 5-10°C, maintain a vacuum degree of 30-40Pa, keep 10 -15h until the ice line disappears; heat up to 20°C and keep warm for 6 hours.

[0049](3) Capping the sample to obtain a freeze-dried preparation of parecoxib sodium.

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Abstract

The invention, which belongs to the technical field of medicines, particularly relates to a parecoxib sodium freeze-dried preparation and a preparation method thereof. The parecoxib sodium freeze-dried preparation provided by the invention comprises parecoxib sodium, disodium hydrogen phosphate, vitamin E, a stabilizer, 3, 4, 5-trihydroxybenzoic acid and a pH regulator. The Vitamin E and the stabilizer are mixed for use and the 3, 4, 5-trihydroxybenzoic acid is added in the preparation process, so that generation of main impurities, especially sulfonate impurities, in parecoxib sodium is effectively inhibited; the 3, 4, 5-trihydroxybenzoic acid is added when the parecoxib sodium is dissolved due to the fact that the 3, 4, 5-trihydroxybenzoic acid is dissolved in hot water and slightly dissolved in cold water, and then cooling and filtering are conducted, so that the product redissolution clarity is not affected while the quality is guaranteed.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a freeze-dried preparation of parecoxib sodium and a preparation method thereof. Background technique [0002] Parecoxib sodium, chemical name: N-[[4-(5-methyl-3-phenyl-4-isoxazolyl)phenyl]sulfonyl]propionamide sodium salt. For the short-term treatment of pain after surgery. Parecoxib sodium can be made into injection solution. Because of its poor stability in water, it is usually made into lyophilized agent, which is ready-to-use. The effective dose of parecoxib sodium injection is low. When the concentration of the drug is low, it will cause formability problems. It is usually necessary to add excipients, which will increase the difficulty and cost of the preparation. The freeze-dried powder disclosed in the prior art There are often problems such as collapse, shrinkage, yellowing, and more ice crystals appearing on the appearance; at the same time, the structure...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/22A61K47/02A61K47/12A61K31/4535A61P29/00
CPCA61K9/19A61K9/0019A61K47/22A61K47/02A61K47/12A61K31/4535A61P29/00
Inventor 陈雨孙运贝张奎强
Owner SHANDONG LUOXIN PHARMA GRP CO LTD