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Freeze-dried powder containing ritodrine hydrochloride as well as application and preparation method thereof

A technology of ritodrine hydrochloride and freeze-dried powder, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, and freeze-dried transportation, so as to achieve the advantages of expanding production, facilitating transportation and storage, and reducing transportation costs. Effect

Active Publication Date: 2022-06-07
THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no ritodrine hydrochloride freeze-dried powder on the market

Method used

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  • Freeze-dried powder containing ritodrine hydrochloride as well as application and preparation method thereof
  • Freeze-dried powder containing ritodrine hydrochloride as well as application and preparation method thereof
  • Freeze-dried powder containing ritodrine hydrochloride as well as application and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1: a kind of ritodrine hydrochloride freeze-dried powder, described component content and preparation technology are as follows:

[0034]

[0035] Preparation Process:

[0036] (1) take by weighing sorbitol, add an appropriate amount of water for injection, stir and dissolve, add tert-butanol and ritodrine hydrochloride successively, stir to dissolve the main drug completely;

[0037] (2) Add activated carbon, stir for more than 10 minutes, decarbonize, and add water for injection to the full amount;

[0038] (3) using citric acid to adjust the pH value to 4.5, and filling with nitrogen for protection;

[0039] (4) filling the medicinal liquid in the ampoule bottle and freeze-drying; the freeze-drying curve is:

[0040] S1 pre-freezing treatment: cool down to -40±5℃, keep for 2-3 hours;

[0041] S2 heating stage: raise the temperature to -20±5°C, and keep the temperature for 2 to 4 hours;

[0042] S3 cooling stage: cool down to -35±5℃, keep warm for 2-...

Embodiment 2

[0046] Embodiment 2: a kind of ritodrine hydrochloride freeze-dried powder, described component content and preparation technology are as follows:

[0047]

[0048] The preparation process is the same as:

[0049] (1) take by weighing sorbitol, add an appropriate amount of water for injection, stir and dissolve, add tert-butanol and ritodrine hydrochloride successively, stir to dissolve the main drug completely;

[0050] (2) Add activated carbon, stir for more than 10 minutes, decarbonize, and add water for injection to the full amount;

[0051] (3) use citric acid to adjust pH value to be 6.0, and fill with nitrogen protection;

[0052] (4) filling the medicinal liquid in the ampoule bottle and freeze-drying; the freeze-drying curve is:

[0053] S1 pre-freezing treatment: cool down to -40±5℃, keep for 2-3 hours;

[0054] S2 heating stage: raise the temperature to -20±5°C, and keep the temperature for 2 to 4 hours;

[0055] S3 cooling stage: cool down to -35±5℃, keep wa...

Embodiment 3

[0059] Embodiment 3: a kind of ritodrine hydrochloride freeze-dried powder, described component content and preparation technology are as follows:

[0060]

[0061]

[0062] Preparation Process:

[0063] (1) take by weighing sorbitol, add an appropriate amount of water for injection, stir and dissolve, add tert-butanol and ritodrine hydrochloride successively, stir to dissolve the main drug completely;

[0064] (2) Add activated carbon, stir for more than 10 minutes, decarbonize, and add water for injection to the full amount;

[0065] (3) use glycine to adjust the pH value to 5.0, and fill with nitrogen for protection;

[0066] (4) filling the medicinal liquid in the ampoule bottle and freeze-drying; the freeze-drying curve is:

[0067] S1 pre-freezing treatment: cool down to -40±5℃, keep for 2-3 hours;

[0068] S2 heating stage: raise the temperature to -20±5°C, and keep the temperature for 2 to 4 hours;

[0069] S3 cooling stage: cool down to -35±5℃, keep warm for 2...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and discloses ritodrine hydrochloride-containing freeze-dried powder as well as application and a preparation method thereof, and the ritodrine hydrochloride freeze-dried powder is prepared from ritodrine hydrochloride, sorbitol, tert-butyl alcohol and a pH regulator; the preparation process is simple and comprises the following steps: dissolving sorbitol in water for injection, adding tert-butyl alcohol and ritodrine hydrochloride, replenishing water for injection to full dose, adjusting the pH value, filling into an ampoule, freeze-drying, and pulling and sealing. Detection on the obtained product shows that the ritodrine hydrochloride freeze-dried powder is relatively high in stability, low in content of related substances, low in moisture content, good in appearance and beneficial to long-time transportation and shelf life.

Description

technical field [0001] The invention belongs to the field of biopharmaceuticals, in particular to a freeze-dried powder of ritodrine hydrochloride and a preparation method thereof. Background technique [0002] Ritodrine hydrochloride is a direct-acting sympathomimetic drug with mainly beta-adrenergic activity and selective action on beta2 receptors (beta2 agonists). Reduces uterine contractility and is used to prevent premature labor. Ritodrine hydrochloride is usually administered by intravenous infusion. Where possible, 5% dextrose should be used as a diluent with the aid of a syringe pump when the concentration should be 3 mg / mL. The recommended initial infusion rate is 50 to 100 pg / min, increasing at 10 to 20-min intervals in 50 pg / min increments until there is evidence of patient response. Maintenance therapy should be maintained at the lowest effective dose, usually about 50 to 100 pg / min. If no syringe pump is available, infusion can be performed using a controll...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/137A61K47/26A61K47/10A61P15/06
CPCA61K9/19A61K31/137A61K47/26A61K47/10A61P15/06Y02A50/30
Inventor 李灵燕陈志敏李秀芳
Owner THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIV
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