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Oral phenobarbital freeze-dried powder preparation and preparation method thereof

A technology of phenobarbital and freeze-dried powder, which is applied in the field of phenobarbital oral freeze-dried powder and its preparation, can solve problems such as insufficient dosage, difficulty, and influence on drug treatment compliance, and achieve good drug compliance, Rapid onset, considerable economic and social benefits

Inactive Publication Date: 2015-12-16
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Neonates have difficulty swallowing tablets and capsules, which affects the compliance of drug therapy; ordinary preparations such as oral liquids are inaccurately measured, resulting in insufficient or excessive dosage for neonates, while oral lyophilized powder is dissolved in a small amount of water , put it into the newborn's mouth with the help of a children's medicine feeder, enter the digestive tract with the swallowing action, there is no mucosal absorption in the oral cavity, and the absorption and metabolism process in the body is the same as that of ordinary tablets, which can solve this problem

Method used

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  • Oral phenobarbital freeze-dried powder preparation and preparation method thereof
  • Oral phenobarbital freeze-dried powder preparation and preparation method thereof
  • Oral phenobarbital freeze-dried powder preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Each bottle contains phenobarbital 7.5mg, and the composition of 1000 bottles of phenobarbital orally disintegrating tablets is:

[0018]

[0019] (1) Add the prescribed amount of phenobarbital into the water for injection, heat to 60°C, then add the matrix agent to the above solution, stir to dissolve, adjust the pH of the solution to 6-7, and add sterilized water for injection to the full amount;

[0020] (2) Add gac in the prepared solution of step (1), the consumption of gac is 0.1g / mL of solution volume, filter;

[0021] (3) Place the filtrate obtained in step (2) in a freezer that has been cooled at -20°C, and freeze it for 3 hours, then lower it to -50°C, vacuumize, and heat up to -8 within 10 hours. ~-6°C, and maintain it for 6 hours, then raise the temperature to 22-30°C within 7-10 hours, and maintain it for 6 hours, to obtain phenobarbital oral freeze-dried powder.

Embodiment 2

[0023] Each bottle contains phenobarbital 10mg, and the composition of 1000 bottles of phenobarbital orally disintegrating tablets is:

[0024]

[0025] (1) Add the prescribed amount of phenobarbital into the water for injection, heat to 60°C, then add the matrix agent to the above solution, stir to dissolve, adjust the pH of the solution, and add sterilized water for injection to the full amount;

[0026] (2) Add gac in the prepared solution of step (1), the consumption of gac is 0.1g / mL of solution volume, filter;

[0027] (3) Place the filtrate obtained in step (2) in a freezer that has been cooled at -20°C, and freeze it for 3 hours, then lower it to -50°C, vacuumize, and heat up to -8 within 10 hours. ~-6°C, and maintain it for 6 hours, then raise the temperature to 22-30°C within 7-10 hours, and maintain it for 6 hours, to obtain phenobarbital oral freeze-dried powder.

Embodiment 3

[0029] Each bottle contains phenobarbital 7.5mg, and the composition of 1000 bottles of phenobarbital orally disintegrating tablets is:

[0030]

[0031] (1) Add the prescribed amount of phenobarbital into the water for injection, heat to 60°C, then add the matrix agent to the above solution, stir to dissolve, adjust the pH of the solution to 6-7, and add sterilized water for injection to the full amount;

[0032] (2) Add gac in the prepared solution of step (1), the consumption of gac is 0.1g / mL of solution volume, filter;

[0033] (3) Place the filtrate obtained in step (2) in a freezer that has been cooled at -20°C, and freeze it for 3 hours, then lower it to -50°C, vacuumize, and heat up to -8 within 10 hours. ~-6°C, and maintain it for 6 hours, then raise the temperature to 22-30°C within 7-10 hours, and maintain it for 6 hours, to obtain phenobarbital oral freeze-dried powder.

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Abstract

The invention relates to oral phenobarbital freeze-dried powder and a preparation method thereof. The oral phenobarbital freeze-dried powder comprises phenobarbital and a freeze-dried skeleton agent. The oral phenobarbital freeze-dried powder prepared by adopting a freeze drying technology is quick in the solution rate and accurate in the dosage, and can be used for treating diseases like neonatal jaundice.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and in particular relates to a phenobarbital oral freeze-dried powder and a preparation method thereof. Background technique [0002] In medicine, the jaundice of newborns under the full moon (within 28 days of birth) is called neonatal jaundice. It is a disease characterized by jaundice on the skin, mucous membranes and sclera. The disease can be divided into physiological and pathological. Physiological jaundice appears 2 to 3 days after birth, peaks at 4 to 6 days, subsides at 7 to 10 days, and lasts longer in premature infants. Except for a slight loss of appetite, there are no other clinical symptoms. If jaundice occurs 24 hours after birth, the daily serum bilirubin rises more than 5 mg / dl or >0.5 mg / dl per hour; the duration is long, full-term infants > 2 weeks, premature infants > 4 weeks and still persist, even If the jaundice continues to deepen or aggravates or reappears aft...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/515A61K31/7016A61K47/26A61P1/16
Inventor 何勇吴宗好高永好
Owner HEFEI HUAFANG PHARMA SCI & TECH
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