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A kind of ibuprofen pharmaceutical composition for congenital heart disease of premature infants

A composition and drug technology, applied in the field of pharmaceutical preparations, can solve the problems of less than 1 mg solubility and poor solubility, and achieve the effect of reducing the content and solving the problem of exceeding the standard of insoluble particles

Inactive Publication Date: 2018-08-10
BEIJING LANDAN PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

One of the main disadvantages of ibuprofen is its poor solubility in water, less than 1mg / ml in water
[0005] When we were studying the combination of tromethamine and ibuprofen for the treatment of patent ductus arteriosus in premature infants, we unexpectedly found that for the preferred ibuprofen concentration of 4 mg / ml in the patent CN102892410, the corresponding concentration of tromethamine It is 3.8mg / ml. At this time, the problem of exceeding the standard of particles is not easy to occur when the transportation encounters low temperature

Method used

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  • A kind of ibuprofen pharmaceutical composition for congenital heart disease of premature infants
  • A kind of ibuprofen pharmaceutical composition for congenital heart disease of premature infants
  • A kind of ibuprofen pharmaceutical composition for congenital heart disease of premature infants

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] prescription:

[0067]

[0068] Preparation:

[0069] (1) Add tromethamine, sodium hydroxide and sodium chloride to 80% water for injection, stir until dissolved, then add ibuprofen;

[0070] (2) Heat the mixed material to 40°C for 15 minutes, maintain it at 40°C for 20 minutes, and then cool it down to 20°C for 15 minutes to complete the first heating and cooling cycle; the first heating and cooling cycle will be completed The material was heated to 40°C in 15 minutes, maintained at 40°C for 20 minutes, and then cooled to 20°C in 15 minutes to complete the second heating and cooling cycle.

[0071] (3) adjust the pH value to 8.0 with hydrochloric acid;

[0072] (4) Add liquid volume 0.1% (w / v) activated carbon, stir;

[0073] (5) filter, add water for injection to a sufficient amount;

[0074] (6) Filling and sealing of glass ampoules;

[0075] (7) Sterilize (121°C, F0>12), ready to use.

Embodiment 2

[0077] prescription:

[0078]

[0079] Preparation:

[0080] (1) Add tromethamine, sodium hydroxide and sodium chloride to 80% water for injection, stir until dissolved, then add ibuprofen;

[0081] (2) Heat the mixed material to 50°C for 15 minutes, maintain it at 50°C for 15 minutes, and then cool it down to 20°C for 15 minutes to complete the first heating and cooling cycle; the first heating and cooling cycle will be completed The material was heated to 50°C in 15 minutes, maintained at 50°C for 15 minutes, and then cooled to 20°C in 15 minutes to complete the second heating and cooling cycle.

[0082] (3) adjust the pH value to 7.5 with hydrochloric acid;

[0083] (4) Add liquid volume 0.1% (w / v) activated carbon, stir;

[0084] (5) filter, add water for injection to a sufficient amount;

[0085] (6) Filling and sealing of glass ampoules;

[0086] (7) Sterilize (121°C, F0>12), ready to use.

Embodiment 3

[0088] prescription:

[0089]

[0090] Preparation:

[0091] (1) Add tromethamine, sodium hydroxide and sodium chloride to 80% water for injection, stir until dissolved, then add ibuprofen;

[0092] (2) Heat the mixed material to 55°C for 15 minutes, maintain it at 55°C for 10 minutes, and then cool it down to 20°C for 15 minutes to complete the first heating and cooling cycle; the first heating and cooling cycle will be completed The material was heated to 55° C. over 15 minutes, maintained at 55° C. for 10 minutes, and then cooled to 20° C. over 15 minutes to complete the second heating and cooling cycle.

[0093] (3) adjust the pH value to 8.0 with hydrochloric acid;

[0094] (4) Add liquid volume 0.1% (w / v) activated carbon, stir;

[0095] (5) filter, add water for injection to a sufficient amount;

[0096] (6) Filling and sealing of glass ampoules;

[0097] (7) Sterilize (121°C, F0>12), ready to use.

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Abstract

The invention provides an ibuprofen pharmaceutical composition, wherein ibuprofen concentration is 4.5-5.5mg / ml and tromethamine concentration is 3.6-4.0mg / ml. The invention also provides a preparation method of the ibuprofen pharmaceutical composition, wherein the preparation method comprises the following steps: (1) adding tromethamine, sodium hydroxide and sodium chloride to injection water, stirring until the materials are dissolved and adding ibuprofen; (2) heating and cooling the mixed materials in a circulating mode at least twice, wherein the heating-cooling circulation means to heat the materials from 10-30 DEG C to 40-60 DEG C and then to cool the materials from 40-60 DEG C to 10-30 DEG C; and (3) filtering, filling and sterilizing so as to obtain the ibuprofen pharmaceutical composition. Through the technical scheme, the stability of the ibuprofen pharmaceutical composition is significantly improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ibuprofen pharmaceutical composition for treating patent ductus arteriosus (PDA) in premature infants. Background technique [0002] The ductus arteriosus was originally the normal blood flow channel between the pulmonary artery and the aorta during the fetal period. Due to pulmonary respiratory dysfunction at this time, the pulmonary artery blood from the right ventricle enters the descending aorta through the duct, while the blood from the left ventricle enters the ascending aorta. The ductus arteriosus is necessary for a specific pattern of circulation during the embryonic period. After birth, the lung expands and undertakes the function of gas exchange, the pulmonary circulation and the systemic circulation perform their respective duties, and soon the catheter is self-selected and closed due to disuse. A patent ductus arteriosus is formed if it continues to rem...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/205A61K9/08A61P9/00
Inventor 不公告发明人
Owner BEIJING LANDAN PHARMA TECH
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