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Pridinol mesylate diclofenac sodium injection and preparation method thereof

A technology of nordiclofenac sodium and diclofenac sodium, which is applied in the field of pritinol mesylate preparation and its preparation, can solve the problems of decreased stability, failure to meet the concentration requirements of the preparation, low solubility, etc., and achieve low cost and meet the requirements of clinical treatment Need, Prescription Advanced Effects

Active Publication Date: 2015-01-21
SOUTHWEST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, since the solubility of pridinol mesylate and diclofenac sodium in water is small, the concentration requirements of the preparation cannot be reached, and the structure of diclofenac sodium contains easily oxidizable groups, and the stability in aqueous solution decreases. Therefore, it is necessary to find a suitable solvent System and improving formulation stability are the key issues in the preparation of Pridino Mesylate Diclofenac Sodium Injection

Method used

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  • Pridinol mesylate diclofenac sodium injection and preparation method thereof
  • Pridinol mesylate diclofenac sodium injection and preparation method thereof
  • Pridinol mesylate diclofenac sodium injection and preparation method thereof

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Embodiment 1

[0016] Embodiment 1, Prescription Research of Pridino Mesylate Diclofenac Sodium Injection

[0017] Because the dissolubility of pridinol mesylate and diclofenac sodium in water is all small, can not reach preparation concentration requirement; And, pridinol mesylate is a kind of weakly acidic salt, and diclofenac sodium is weak base in aqueous solution When the two are directly dissolved in water and then mixed, an acid-base reaction will occur to generate pridinol and diclofenac with less solubility and precipitate out of the solution. Therefore, finding a suitable solvent system is the technical key for preparing pridinol mesylate diclofenac sodium injection. After trial and error, the inventor finally determined to use water for injection and polyethylene glycol as the mixed solvent.

[0018] The structure of diclofenac sodium contains easily oxidizable groups and is unstable in aqueous solution. Therefore, improving the stability of the preparation is also the technical...

Embodiment 2

[0029] Embodiment 2, the preparation of pridinol mesylate diclofenac sodium injection

[0030] The optimal prescription screened out in Example 1 is used to prepare the pritinol mesylate diclofenac sodium injection, the preparation method is as follows: take 10mL of water for injection, add the pritinol mesylate of the prescribed amount, stir until completely dissolved, and obtain solution A Take 10 mL of water for injection, add mannitol and sodium metabisulfite in the prescribed amount, and stir until completely dissolved to obtain solution B; slowly add solution B to solution A under slow stirring conditions to obtain solution C; additionally take 10 mL of water for injection and Add the prescribed amount of PEG400, add the prescribed amount of diclofenac sodium, stir until completely dissolved, and obtain solution D; slowly add solution D to solution C under slow stirring conditions, then add the prescribed amount of benzyl alcohol, stir and mix, add Water for injection to...

Embodiment 3

[0032] Embodiment 3, the osmotic pressure determination of pridinol mesylate diclofenac sodium injection

[0033] Using the "Chinese Pharmacopoeia" 2010 edition two Appendix IX "Determination of Osmotic Pressure Molar Concentration", measure the osmotic pressure of Pridino Mesylate Diclofenac Sodium Injection. The result shows that the osmolality of the pridinol mesylate diclofenac sodium injection that embodiment 2 makes is 300.1mOsmol, and the normal human blood osmolality is 285~310mOsmol / kg, therefore, the mesylate prepared by the present invention Puridinol Acid Diclofenac Sodium Injection meets the osmotic pressure requirements.

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Abstract

The invention discloses a pridinol mesylate diclofenac sodium injection. The injection comprises the following components in every 100mL: 0.2g of pridinol mesylate, 2.5g of diclofenac sodium, 15-27mL of PEG400 (polyethylene glycol), 4-6mL of benzyl alcohol, 0.6g of mannitol, 0.3g of sodium pyrosulfite, a sodium hydroxide solution used for regulating the pH to 8.0-8.6, and the balance of injection water. The injection water and PEG400 are of a mixed solvent, and assisted by benzyl alcohol to solve the technical problem that pridinol mesylate and diclofenac sodium are easily separated out in the preparation process; sodium pyrosulfite and mannitol are combined for resisting oxidation, so that the problem that the diclofenac sodium is not stable in a water solution can be solved; the injection is advanced in prescription, simple in preparation process, low in cost, stable, safe and effective, is suitable for intramuscular, subcutaneous or intravenous injection delivery, and is advantageous to fulfill the requirement for clinical treatment.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a primidinol mesylate preparation and a preparation method thereof. Background technique [0002] Low back pain and neck, shoulder and wrist syndrome are the most common musculoskeletal pain syndromes in modern times, especially among the office workers, with a prevalence rate as high as 60% to 85%, which not only seriously affects the health and quality of life of patients, but also It will lead to a reduction or even loss of production and labor capacity. Parkinson's disease is a neurodegenerative disease that is common in middle-aged and elderly people, and its prevalence peaks in the age group of 70 to 79 years old. [0003] Ppridinol mesylate is a central anticholinergic drug with skeletal muscle relaxation, and has obvious relaxation effect on muscle spasm. It is clinically used for muscle spasm and Parkinson's syndrome and other movement disorders accomp...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4453A61K9/08A61P21/02A61P25/16A61P19/02A61P19/08A61P29/00A61K31/196
Inventor 罗永煌王翠园姜草罗雷谭明国王帅龙飞曾海春骆晓宏
Owner SOUTHWEST UNIV
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