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Dexamethasone sodium phosphate lipidosome injection

A technology of dexamethasone sodium phosphate and dexamethasone sodium phosphate, which is applied in the field of injection, can solve the problems of the influence of epidermal sebum structure, the large fluctuation of blood drug concentration, the short action clearance time, etc. Faster, less dosage effect

Inactive Publication Date: 2010-12-29
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

, due to the characteristics of propylene glycol as a fat-soluble solvent, long-term use of high-concentration propylene glycol will have an impact on the epidermal sebum structure; in addition, as an auxiliary material and solvent, propylene glycol has potential dangers, which can cause hyperosmotic pressure, lactic acidosis, Adverse reactions such as central nervous system depression, hemolysis, local phlebitis, and respiratory and cardiac toxicity
In addition, dexamethasone sodium phosphate is a water-soluble glucocorticoid. Although it has the advantage of faster onset of action when injected, it also has the problem of shorter clearance time (shorter duration of action), especially for some For systemic diseases, due to its short duration of action, a large amount of drug has to be injected during treatment, resulting in large fluctuations in blood drug concentration, which objectively increases the probability and risk of adverse reactions

Method used

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  • Dexamethasone sodium phosphate lipidosome injection
  • Dexamethasone sodium phosphate lipidosome injection
  • Dexamethasone sodium phosphate lipidosome injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The formula of liposome solution:

[0034] Dexamethasone Sodium Phosphate 1g Soy Lecithin 20g Cholesterol 2g α-Tocopherol 1g

[0035] Water for injection to 1000ml (adjusted to pH=7.0, 0.2mol / L phosphate buffer)

[0036] Sodium chloride 40g is added in the above-mentioned water for injection and mixed to obtain water for injection (1)

[0037] Preparation:

[0038]Phospholipids, cholesterol, α-tocopherol that take prescription quantity are dissolved in dichloromethane / methanol (V: V=1: 1), will add and melt into the water for injection (1) 200ml of prescription quantity dexamethasone sodium phosphate, use Ultrasonic emulsification for 30 minutes, the resulting emulsion was evaporated at 37°C under reduced pressure to remove the solvent, and when the emulsion formed a viscous gel-like liquid, add the remaining water for injection (1), continue to evaporate the solvent under reduced pressure at 37°C, and ultrasonically Emulsify, make up the evaporated water for injecti...

Embodiment 2

[0040] The liposome solution formula is:

[0041] Dexamethasone Sodium Phosphate 0.5g Hydrogenated Soy Lecithin 10g Cholesterol 1.5g α-Tocopherol 0.5g

[0042] Water for injection to 1000ml (adjusted to pH=7.2, 0.2mol / L phosphate buffer)

[0043] Sodium chloride 70g is added in the above-mentioned water for injection and mixed to obtain water for injection (1)

[0044] Prepare 0.05% dexamethasone sodium phosphate liposome injection as in Example 1.

Embodiment 3

[0046] Liposome Solution Formula:

[0047] Dexamethasone Sodium Phosphate 0.25g Egg Yolk Lecithin 1.25g Cholesterol 0.2g

[0048] Water for injection to 1000ml (adjusted to pH=7.2, 0.2mol / L phosphate buffer)

[0049] Add 1g of EDTA and 10ml of propylene glycol to the above water for injection and mix well to obtain water for injection (1)

[0050] Prepare 0.05% dexamethasone sodium phosphate liposome injection as in Example 1.

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Abstract

The invention relates to a lipidosome injection with dexamethasone sodium phosphate as an active component, which comprises dexamethasone sodium phosphate lipidosomes and one or more medical auxiliary materials for injection, wherein the liposome encapsulation rate of the active component is 40-70 percent, and the lipidosome injection comprises 0.025-0.5 percent of the dexamethasone sodium phosphate as the active component, 0.125-5 percent of phospholipid, 0.002-1 percent of lipophilic additive, a pH buffering agent with the pH value kept at 7-7.5 and the balance of water for injection.

Description

field of invention [0001] The invention relates to a liposome preparation, in particular to an injection containing dexamethasone sodium phosphate liposome. Background technique [0002] Dexamethasone sodium phosphate (DEXAMETHASONE SODIUM PHOSPHATE, referred to as "de sodium", CAS: 2392-39-4), is an adrenocortical hormone drug. It has anti-inflammatory, anti-allergic, anti-rheumatic and immunosuppressive effects, and is widely used in the treatment of allergic and autoimmune inflammatory diseases. Such as connective tissue disease, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc. It is also used for some serious infections, poisoning, and malignant lymphoma. treat. The common dosage form is sodium desalination injection. Its molecular formula is as follows: [0003] [0004] The formula of sodium dina injection in the prior art, taking 5 mg / ml specification as an example...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K9/107A61K31/573A61P37/08A61P37/06A61P29/00
Inventor 孙亮陈松赵琳
Owner TIANJIN JINYAO GRP
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