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Preparation method of oxytocin injection

A technology of oxytocin and injection, which is applied in the field of preparation of oxytocin injection, can solve problems such as hidden dangers of medication for patients, poor correspondence of prescription labeling quantities, and influence on the uniform antibacterial effect of active ingredient oxytocin, which is not easy to achieve The effect of oxidative degradation

Inactive Publication Date: 2019-10-18
CHENGDU HAITONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chlorobutanol is often used as antiseptic and bacteriostatic agent and plasticizer, etc. Existing studies have shown that its role in oxytocin injection is not only antiseptic and bacteriostatic agent, but also has a good dispersion effect, but trichlorobutanol Tert-butanol itself also has a certain toxic effect, so the concentration of chlorobutanol must be properly controlled. If the content of chlorobutanol in the injection is low, it will affect the uniformity of the active ingredient oxytocin and the pH of the solution. Bacterial effect, but when the content of chlorobutanol in the injection is high, the probability of side effects will increase significantly
At present, the content of chlorobutanol in commercially available preparations varies greatly between enterprises and between batches within enterprises, and the correspondence with the labeling amount of prescriptions is poor, which has caused great hidden dangers to patients' medication.

Method used

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  • Preparation method of oxytocin injection
  • Preparation method of oxytocin injection
  • Preparation method of oxytocin injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1 The preparation of oxytocin injection of the present invention

[0023] Formula: 110kg of water, 550g of chlorobutanol, 2g of oxytocin

[0024] Preparation:

[0025] 1) Add water for injection with a total volume of 90% in the dilute preparation tank, control the temperature at 25°C, pass nitrogen gas into the liquid for 30 minutes, and then adjust the pH value to 3.5-4.0 with 2mol / L glacial acetic acid solution.

[0026] 2) Take chlorobutanol and add it to step 1) dilute preparation tank, seal the tank body, feed nitrogen gas until the pressure inside the tank reaches 0.12 MPa or more, stop feeding nitrogen gas, and continue stirring until the solution is clear.

[0027] 3) Take oxytocin and add it to step 2) into the dilute tank, stir until it is evenly mixed, take a sample for detection, and adjust the pH value to 3.5-3.7 with 2mol / L glacial acetic acid solution, continue to fill with nitrogen, and add water for injection to the full amount , stop feed...

Embodiment 2

[0028] Embodiment 2 The preparation of oxytocin injection of the present invention

[0029] Formula: 110kg of water, 550g of chlorobutanol, 2g of oxytocin

[0030] Preparation:

[0031] 1) Add water for injection with a total volume of 70% in the dilute preparation tank, control the temperature at 27°C, pass nitrogen into the liquid for 25 minutes, and then adjust the pH value to 3.5-4.0 with 2mol / L glacial acetic acid solution.

[0032] 2) Take chlorobutanol and add it to step 1) dilute preparation tank, seal the tank body, feed nitrogen gas until the pressure inside the tank reaches 0.12 MPa or more, stop feeding nitrogen gas, and continue stirring until the solution is clear.

[0033] 3) Take oxytocin and add it to step 2) into the dilute tank, stir until it is evenly mixed, take a sample for detection, and adjust the pH value to 3.5-3.7 with 2mol / L glacial acetic acid solution, continue to fill with nitrogen, and add water for injection to the full amount , stop feeding ...

Embodiment 3

[0034] Embodiment 3 The preparation of oxytocin injection of the present invention

[0035] Formula: 110kg of water, 550g of chlorobutanol, 2g of oxytocin

[0036] Preparation:

[0037] 1) Add water for injection with a total volume of 85% in the dilute preparation tank, control the temperature at 26°C, pass nitrogen into the liquid for 30 minutes, and then adjust the pH value to 3.5-4.0 with 2mol / L glacial acetic acid solution.

[0038] 2) Take chlorobutanol and add it to step 1) dilute preparation tank, seal the tank body, feed nitrogen gas until the pressure inside the tank reaches 0.12 MPa or more, stop feeding nitrogen gas, and continue stirring until the solution is clear.

[0039] 3) Take oxytocin and add it to step 2) into the dilute tank, stir until it is evenly mixed, take a sample for detection, and adjust the pH value to 3.5-3.7 with 2mol / L glacial acetic acid solution, continue to fill with nitrogen, and add water for injection to the full amount , stop feeding ...

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Abstract

The invention provides a preparation method of an oxytocin injection. According to the preparation method of the oxytocin injection, through control over the temperature in the preparation process anda nitrogen introduction mode and accurate adjustment for the pH value, chlorbutol in the injection is more stable and cannot be easily subjected to oxydative degradation and volatilized, and the oxytocin injection well corresponding to the labelled amount on a prescription is obtained and has practical application and popularization value.

Description

technical field [0001] The invention relates to a preparation method of oxytocin injection. Background technique [0002] Oxytocin injection is a colorless clear or almost clear liquid, which is used for induction of labor, oxytocin, postpartum and post-abortion uterine bleeding caused by uterine weakness or poor contraction, and to understand the placental reserve function (oxytocin-stimulated test), its main components are oxytocin, chlorobutanol, glacial acetic acid, and water for injection. [0003] Clinical application has found that oxytocin injection often has adverse reactions, so controlling the quality of injections has very important clinical significance. Chlorobutanol is often used as antiseptic and bacteriostatic agent and plasticizer, etc. Existing studies have shown that its role in oxytocin injection is not only antiseptic and bacteriostatic agent, but also has a good dispersion effect, but trichlorobutanol Tert-butanol itself also has a certain toxic effe...

Claims

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Application Information

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IPC IPC(8): A61K38/095A61K9/08A61K47/10A61P7/04A61P15/04
CPCA61K9/0019A61K9/08A61K38/095A61K47/10A61P7/04A61P15/04
Inventor 史凌洋张安玲宋永红
Owner CHENGDU HAITONG PHARMA
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