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Bone-targeted parecoxib sodium nanocapsule freeze-dried injection and preparation method thereof

A technology of parecoxib sodium and freeze-dried injection, which is applied in the field of parecoxib sodium nanocapsule freeze-dried injection and its preparation, can solve the problems of affecting drug efficacy, high density, difficulty, etc., to reduce the occurrence of adverse reactions, The effect of promoting reaching the target site and reducing the content of degradation products

Active Publication Date: 2017-09-08
上海华源药业(宁夏)沙赛制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, bone tissue has biological specialties, such as low blood flow, high density, and poor permeability, which bring great difficulties to clinical drug use.
According to the traditional way of administration, common dosage forms of parecoxib sodium injection enter the blood circulation through intravenous infusion, so as to play a therapeutic role. However, according to the particularity of bone tissue, it is difficult for ordinary medicines to reach the lesion in an ideal state, which affects the treatment effect of the medicine. curative effect

Method used

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  • Bone-targeted parecoxib sodium nanocapsule freeze-dried injection and preparation method thereof
  • Bone-targeted parecoxib sodium nanocapsule freeze-dried injection and preparation method thereof
  • Bone-targeted parecoxib sodium nanocapsule freeze-dried injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] 1. Preparation of parecoxib sodium bone-targeted nanocapsule preparation (1000ml amount)

[0040] Prescription: 20g of parecoxib sodium, 20g of poloxamer, 40g of n-butyl cyanoacrylate, 20g of nano-hydroxyapatite, 20g of mannitol, and appropriate amount of water for injection.

[0041] Preparation:

[0042]Measure 1600ml of water for injection, add the prescribed amount of poloxamer, and stir until dissolved; add the prescribed amount of parecoxib sodium into the above liquid medicine, and stir until dissolved; adjust the pH to 4 with phosphate buffer; Add 20g poly-n-butyl cyanoacrylate, stir and react for 2h; add prescription amount of nano-hydroxyapatite to the above solution, stir and then add 20g poly-n-butyl cyanoacrylate, stir and react for 2h; Distill under reduced pressure at 60°C to 1000ml, add the prescribed amount of mannitol to dissolve, first filter with a G3 vertical glass funnel, and then filter with a 0.45μm microporous membrane, divide the solution into...

Embodiment 2

[0071] 1. Preparation of parecoxib sodium bone-targeted nanocapsule preparation (1000ml amount)

[0072] Prescription: Parecoxib sodium 30g, poloxamer 30g, polycyanoacrylate n-butyl 30g, nano-hydroxyapatite 30g, mannitol 30g, appropriate amount of water for injection.

[0073] Preparation:

[0074] Measure 1600ml of water for injection, add the prescribed amount of poloxamer, and stir until dissolved; add the prescribed amount of parecoxib sodium into the above liquid medicine, and stir until dissolved; adjust the pH to 5 with phosphate buffer; Add 30g poly-n-butyl cyanoacrylate, stir and react for 2h; add prescription amount of nano-hydroxyapatite to the above solution, stir and then add 30g poly-n-butyl cyanoacrylate, stir and react for 2h; Distill under reduced pressure at 60°C to 1000ml, add the prescribed amount of mannitol to dissolve, first filter with a G3 vertical glass funnel, and then filter with a 0.45μm microporous membrane, divide the solution into vials, half-s...

Embodiment 3

[0088] 1. Preparation of parecoxib sodium bone-targeted nanocapsule preparation (1000ml amount)

[0089] Prescription: 40g of parecoxib sodium, 40g of poloxamer, 80g of n-butyl cyanoacrylate, 40g of nano-hydroxyapatite, 40g of mannitol, and appropriate amount of water for injection.

[0090] Preparation:

[0091]Measure 1600ml of water for injection, add the prescribed amount of poloxamer, and stir until dissolved; add the prescribed amount of parecoxib sodium into the above liquid medicine, and stir until dissolved; adjust the pH to 6 with phosphate buffer; Add 40g poly-n-butyl cyanoacrylate, stir and react for 2h; add prescription amount of nano-hydroxyapatite to the above solution, stir and then add 40g poly-n-butyl cyanoacrylate, stir and react for 2h; Distill under reduced pressure at 60°C to 1000ml, add the prescribed amount of mannitol to dissolve, first filter with a G3 vertical glass funnel, and then filter with a 0.45μm microporous membrane, divide the solution into...

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Abstract

The invention discloses a bone-targeted nanocapsule freeze-dried injection containing parecoxib sodium and a preparation method of the injection. By virtue of a preparation, namely the injection, the concentration of parecoxib sodium in a bone tissue can be increased, so that the effects of parecoxib sodium in orthopedic surgeries and bone cancer analgesia are improved. By utilizing a capsule material and a carrier material which have good biodegradability and biocompatibility, a drug can be tightly combined with soft and hard tissues in a human body in a short time after entering the human body so as to rapidly play a role of treatment. By utilizing a nanocapsule packaging manner, the content of degradation products of the preparation is extremely low.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a bone-targeted parecoxib sodium nanocapsule freeze-dried injection and a preparation method thereof. Background technique [0002] Parecoxib sodium is the first specific cyclooxygenase-2 (COX-2) inhibitor that can be administered intravenously and intramuscularly, which can solve the difficulty of oral administration or insufficient analgesic effect in postoperative patients with oral dosage forms Quick downsides. Parecoxib sodium has been shown to reduce the need for opioid anesthetics in surgical patients. [0003] The inflammatory response after noxious stimuli such as surgery and trauma can lead to the release of inflammatory mediators and pain-causing substances. In addition to directly causing pain, they can also cause blood vessels to dilate, tissue edema, increase the sensitivity of effector receptors, and reduce the pain threshold. Causes peripheral hyperalgesia. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/42A61K47/02A61K9/51A61K47/32A61P35/00A61P25/00A61P29/00
CPCA61K9/0019A61K9/19A61K9/5138A61K31/42A61K47/02
Inventor 芦莉娜刘伟强
Owner 上海华源药业(宁夏)沙赛制药有限公司