A kind of freeze-dried preparation of neostigmine methylsulfate for injection and preparation method thereof

A technology of neostigmine methylsulfate and freeze-dried preparation, applied in the field of medicine, can solve problems such as unfavorable product storage or long-distance transportation

Active Publication Date: 2022-05-06
JIANGSU JIUXU PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is not good for product storage or long-distance transportation

Method used

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  • A kind of freeze-dried preparation of neostigmine methylsulfate for injection and preparation method thereof
  • A kind of freeze-dried preparation of neostigmine methylsulfate for injection and preparation method thereof
  • A kind of freeze-dried preparation of neostigmine methylsulfate for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] a. Weigh 1g neostigmine methylsulfate, 20g mannitol, dissolve and dilute to 1000ml with water for injection;

[0053] b. Filter with a 0.22um filter element, and fill 1ml of the filtrate into a 3ml vial;

[0054] c. Put the control bottle of sub-package liquid into the freeze dryer;

[0055] d. Reduce the shelf temperature of the freeze dryer to below -35°C at a rate of 30°C per hour;

[0056] e. When the temperature of the product drops below -40°C, keep it warm for 2 hours;

[0057] f. Raise the shelf temperature to -20°C and keep it warm for 1 hour;

[0058] g. Lower the shelf temperature to -40°C and keep it warm for 2 hours;

[0059] h. Raise the shelf temperature to -25°C and keep it warm for 1 hour;

[0060] i. Lower the shelf temperature to -45°C and keep it warm for 4 hours;

[0061] j. Start vacuuming, when the vacuum degree is below 10-20Pa, start to heat up;

[0062] k. Raise the shelf temperature to -15°C and keep it for 15 hours;

[0063] l. Raise the...

Embodiment 2

[0067] a. Weigh 1g neostigmine methylsulfate, 50g mannitol, dissolve and dilute to 1500ml with water for injection;

[0068] b. Filter with a 0.22um filter element, and fill 1.5ml of the filtrate into a 3ml vial;

[0069] c. Put the control bottle of sub-package liquid into the freeze dryer;

[0070] d. Reduce the shelf temperature of the freeze dryer to below -35°C at a rate of 30°C per hour;

[0071] e. When the temperature of the product drops below -40°C, keep it warm for 2 hours;

[0072] f. Raise the shelf temperature to -20°C and keep it warm for 2 hours;

[0073] g. Lower the shelf temperature to -40°C and keep it warm for 2 hours;

[0074] h. Raise the shelf temperature to -25°C and keep it warm for 2 hours;

[0075] i. Then lower the shelf temperature to -45°C and keep it warm for 5 hours;

[0076] j. Start vacuuming, when the vacuum degree is below 10-20Pa, start to heat up;

[0077] k. Raise the shelf temperature to -15°C and keep it for 17 hours;

[0078] l...

Embodiment 3

[0082] a. Weigh 1g neostigmine methosulfate, 100g mannitol, dissolve and dilute to 2000ml with water for injection;

[0083] b. Filter with a 0.22um filter element, and fill 2ml of the filtrate into a 5ml vial;

[0084] c. Put the control bottle of sub-package liquid into the freeze dryer;

[0085] d. Reduce the shelf temperature of the freeze dryer to below -35°C at a rate of 30°C per hour;

[0086] e. When the temperature of the product drops below -45°C, keep it warm for 3 hours;

[0087] f. Raise the shelf temperature to -20°C and keep it warm for 2 hours;

[0088] g. Lower the shelf temperature to -40°C and keep it warm for 3 hours;

[0089] h. Raise the shelf temperature to -25°C and keep it warm for 2 hours;

[0090] i. Then lower the shelf temperature to -50°C and keep it warm for 5 hours;

[0091] j. Start vacuuming, when the vacuum degree is below 10-20Pa, start to heat up;

[0092] k. Raise the shelf temperature to -15°C and keep it for 20 hours;

[0093] l. ...

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Abstract

The invention relates to a freeze-dried preparation of neostigmine methylsulfate for injection and a preparation method thereof. Neostigmine methosulfate injection is unstable when exposed to light and heat, and the main degradation impurity, 3-hydroxytrimethylaniline methosulfate, has a genotoxicity warning structure. In order to improve its stability, the inventor improved its dosage form to make a freeze-dried preparation, and obtained a freeze-dried preparation product through prescription screening and process improvement. The obtained product has good appearance, good resolubility and good clarity, the main degradation impurity 3-hydroxytrimethylaniline methosulfate is greatly reduced, and the product safety and stability are improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a freeze-dried preparation of neostigmine methylsulfate for injection and a preparation method thereof. [0002] technical background [0003] Neostigmine methosulfate is a category A variety in the national basic medical insurance catalogue, and it is widely used clinically to antagonize the residual effect of non-polarizing muscle relaxants, diagnose myasthenia gravis, prevent and treat functional paralytic ileus and contractile urinary tract obstruction. retention. [0004] At present, the main dosage forms of neostigmine methosulfate are tablets or injections. For example, CN201610105070.2 discloses a neostigmine methosulfate injection, which dissolves neostigmine methosulfate in water, filters, controls pH, encapsulates and sterilizes, and obtains an injection. [0005] However, neostigmine methosulfate injection is likely to cause some troubles to production and storage due...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/27A61K47/26A61P1/00A61P13/10A61P21/04F26B5/06
CPCA61K31/27A61K9/19A61K9/0019A61K47/26A61P21/04A61P1/00A61P13/10F26B5/06
Inventor 李宏毛黎静理广洲
Owner JIANGSU JIUXU PHARMA
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