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Medicine composition without any excipients and preparation process thereof

A preparation process and composition technology, which can be used in drug combination, drug delivery, and devices for making drugs into special physical or taking forms, etc., and can solve problems such as injection pain, poor drug reconstitution, and slow solvent dissolution.

Active Publication Date: 2009-09-09
SHENYANG XINMA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the current marketed products have the following defects and deficiencies: 1. Drug freeze-drying molding is not good, and the appearance is loose and uneven
2. The resolubility of the drug is not good, that is, the solvent for injection is dissolved slowly and incompletely before injection.
Such shortcomings will bring the following risks to clinical medication: undissolved particles embolize blood vessels; undissolved particles stimulate blood vessels and cause phlebitis; injection pain, etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0007] The pharmaceutical composition of the present invention is prepared according to the following steps:

[0008] 1. Pharmaceutical composition processing

[0009] Take 40L of water for injection, add 4kg of sodium valproate, and make it completely dissolved, add 0.1% (g / ml) activated carbon, keep stirring at 70°C for 30 minutes; decarburize by titanium rod filtration, coarse filter with 0.45μm microporous filter element; test the drug content, use a 0.22μm microporous filter element to filter and sterilize; after testing the clarity, it is divided into vials according to the prescription amount.

[0010] 2. Freeze-drying process

[0011] a. Pre-freezing: Put all the bottles into the box, turn on the freeze dryer, cool down the temperature of the plate, so that the temperature of the product drops to -20°C, adjust the temperature of the plate, keep the product at this temperature for 120 minutes, and continue to reduce the temperature of the plate, so that The temperatur...

Embodiment 2

[0015] The pharmaceutical composition of the present invention is prepared according to the following steps:

[0016] 1. Pharmaceutical composition processing

[0017] Take 40L of water for injection, add 4kg of sodium valproate, and make it completely dissolved, add 0.1% (g / ml) activated carbon, keep stirring at 100°C for 30 minutes; decarburize by titanium rod filtration, coarse filter with 0.45μm microporous filter element; detect the drug content, use a 0.2μm microporous filter element to filter and sterilize; after testing the clarity, it is divided into vials according to the prescription amount.

[0018] 2. Freeze-drying process

[0019] a. Pre-freezing: Put all the bottles into the box, turn on the freeze dryer, cool down the temperature of the plate, so that the temperature of the product drops to -30°C, adjust the temperature of the plate, keep the product at this temperature for 30 minutes, and continue to reduce the temperature of the plate, so that The temperatu...

Embodiment 3

[0023] The pharmaceutical composition of the present invention is prepared according to the following steps:

[0024] 1. Pharmaceutical composition processing

[0025] Take 40L of water for injection, add 4kg of sodium valproate, and make it completely dissolved, add 0.1% (g / ml) activated carbon, keep stirring at 70°C for 30 minutes; decarburize by titanium rod filtration, coarse filter with 0.45μm microporous filter element; test the drug content, use a 0.22μm microporous filter element to filter and sterilize; after testing the clarity, it is divided into vials according to the prescription amount.

[0026] 2. Freeze-drying process

[0027] a. Pre-freezing: Put all the bottles into the box, turn on the freeze dryer, cool down the temperature of the plate, so that the temperature of the product drops to -25°C, adjust the temperature of the plate, keep the product at this temperature for 60 minutes, and continue to reduce the temperature of the plate, so that The temperature...

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Abstract

The invention relates to a medicine composition without any excipients and a preparation process thereof; the invention carries out deep and careful research to the composition of sodium vedproate for injection and the preparation process, finally, the medical prescription, only containing effective ingredients: sodium vedproate and water, is determined. By adopting a plurality of critical processes in the adjusting and freeze-dry process, namely, in the pre-freezing step, the medicine composition is kept for a long time at the eutectic point of -2 degrees, so as to ensure a crystal nucleus to be big enough; vacuum pressure is adjusted in the steps of a first drying and a second drying, the action is repeated in a large-range vacuum degree with mass transferring and heat transmission principles. Under the condition that any excipients are not used, the appearance of the freeze-dry products and the compound dissolubility are remarkably improved, the freeze-dry time is obviously shortened, and the energy source is saved.

Description

Technical field: [0001] The invention relates to a pharmaceutical composition containing sodium valproate and a preparation process thereof. Background technique: [0002] Sodium valproate (Sodium Valproate) is a saturated fatty acid sodium salt, and its chemical name is sodium 2-valproate. It was first confirmed by Meurier of France to have anti-epileptic effect in 1963, and it was successfully trial-produced in my country in 1977. It has been confirmed that sodium valproate has curative effect on various types of epilepsy, especially on absence seizures, tonic-clonic seizures and some refractory epilepsy. At present, sodium valproate is widely used in our country. In addition to epilepsy, it is also used in the treatment of manic depression in psychiatry. [0003] Sodium valproate is currently a commonly used antiepileptic drug, and its mechanism of action is related to the inhibition of voltage-sensitive Na+ channels; it inhibits γ-aminobutyric acid (GABA) metabolic enzy...

Claims

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Application Information

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IPC IPC(8): A61K31/20A61P25/08A61P25/00A61K9/00A61J3/00
Inventor 闫志刚杨秀伟马向霞黄牧童
Owner SHENYANG XINMA PHARMA
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