Ropivacaine hydrochloride sodium chloride injection and preparation method thereof

Abstract

The invention provides a ropivacaine hydrochloride sodium chloride injection and a preparation method thereof. The method comprises the process steps of: burdening, carbon adsorption, rough filtering, fine filtering, filling, sterilizing, lamp detecting, packing and the like. The prepared ropivacaine hydrochloride sodium chloride injection has a definite medicinal effect and high safety; the testresult of each index in a stability test is accordant with specifications, and the defects of the requirement of repeated injection, inconvenience in using, easiness in increasing secondary pollutionby freeze-dried powder and the like existing in a ropivacaine water injection are overcome; the ropivacaine hydrochloride sodium chloride injection is particularly suitable for a patient using an analgesia pump; during use in a large volume, an instant stable concentration is kept for a medicinal liquid, so that a remarkable postoperative analgesic effect is achieved, and the requirement of an opioid medicament is remarkably lowered; and moreover, the effect can be enhanced rapidly by administrating in a self-pressing way.

Description

technical field

[0001] The invention belongs to the field of medicine and relates to an injection and a preparation method thereof, in particular to a ropivacaine hydrochloride sodium chloride injection and a preparation method thereof. Background technique

[0002] Ropivacaine is the first new long-acting amide local anesthetic synthesized in pure isomers. Its pharmacological properties are low cardiotoxicity, more obvious separation of sensory block and motor block, and vasoconstriction. Ropivacaine has dual effects of anesthesia and analgesia, high concentration can produce surgical anesthesia, low concentration can effectively block sensory nerve transmission and produce analgesic effect, and it has little effect on motor nerves.

[0003] In the prior art, ropivacaine mesylate injection requires multiple water injections to provide 24 hours, 48 ​​hours or even 72 hours of postoperative pain relief, and the suffering of patients is self-evident; for patients using analges...

Examples

Embodiment 1

[0034] A ropivacaine hydrochloride sodium chloride injection, containing 1.0 g of ropivacaine hydrochloride and 6.0 g of sodium chloride per liter of the injection.

[0035] The specific steps of the preparation method include:

[0036] (1) Pre-treatment: process the infusion bottle or bag according to the injection requirements;

[0037] (2) Ingredients: Weigh the prescribed amount of ropivacaine hydrochloride and sodium chloride, add them to water for injection accounting for 20% of the total amount of water for injection, and then stir to dissolve completely;

[0038] (3) Activated carbon adsorption: add 0.05% (g / ml) activated carbon for needles to the above solution, keep warm at 80°C for 30 minutes, filter to remove carbon, add water for injection to the full amount, adjust the pH to 4.0-4.5, and stir to mix. uniform;

[0039] (4) Testing: 95.0-105.0% of the labeled amount of ropivacaine hydrochloride, 95.0-105.0% of the labeled amount of sodium chloride, and a pH of 4....

Embodiment 2

[0044] A ropivacaine hydrochloride sodium chloride injection, containing 2.116 g of ropivacaine hydrochloride and 8.6 g of sodium chloride per liter of the injection.

[0045] The specific steps of the preparation method include:

[0046] (1) Pre-treatment: process the infusion bottle or bag according to the injection requirements;

[0047] (2) Ingredients: Weigh the prescribed amount of ropivacaine hydrochloride and sodium chloride, add them to water for injection accounting for 35% of the total amount of water for injection, and then stir to dissolve completely;

[0048] (3) Activated carbon adsorption: Add 0.05% (g / ml) activated carbon for needles to the above solution, keep warm at 80°C for 30 minutes, filter to remove carbon, add water for injection to the full amount, adjust the pH to 4.5-5.5, and stir to mix. uniform;

[0049] (4) Testing: 95.0-105.0% of the labeled amount of ropivacaine hydrochloride, 95.0-105.0% of the labeled amount of sodium chloride, and a pH of ...

Embodiment 3

[0054] A ropivacaine hydrochloride sodium chloride injection, containing 4.0 g of ropivacaine hydrochloride and 10.0 g of sodium chloride per liter of the injection.

[0055] The specific steps of the preparation method include:

[0056] (1) Pre-treatment: process the infusion bottle or bag according to the injection requirements;

[0057] (2) Ingredients: Weigh the prescribed amount of ropivacaine hydrochloride and sodium chloride, add them to water for injection accounting for 50% of the total amount of water for injection, and then stir to dissolve completely;

[0058] (3) Activated carbon adsorption: Add 0.05% (g / ml) activated carbon for needles to the above solution, keep warm at 80°C for 30 minutes, filter to remove carbon, add water for injection to the full amount, adjust the pH to 5.5-6.0, and stir to mix. uniform;

[0059] (4) Testing: 95.0-105.0% of the labeled amount of ropivacaine hydrochloride, 95.0-105.0% of the labeled amount of sodium chloride, and a pH of 5...

technical field

[0001] The invention belongs to the field of medicine and relates to an injection and a preparation method thereof, in particular to a ropivacaine hydrochloride sodium chloride injection and a preparation method thereof. Background technique

[0002] Ropivacaine is the first new long-acting amide local anesthetic synthesized in pure isomers. Its pharmacological properties are low cardiotoxicity, more obvious separation of sensory block and motor block, and vasoconstriction. Ropivacaine has dual effects of anesthesia and analgesia, high concentration can produce surgical anesthesia, low concentration can effectively block sensory nerve transmission and produce analgesic effect, and it has little effect on motor nerves.

[0003] In the prior art, ropivacaine mesylate injection requires multiple water injections to provide 24 hours, 48 ​​hours or even 72 hours of postoperative pain relief, and the suffering of patients is self-evident; for patients using analges...

Examples

Embodiment 1

[0034] A ropivacaine hydrochloride sodium chloride injection, containing 1.0 g of ropivacaine hydrochloride and 6.0 g of sodium chloride per liter of the injection.

[0035] The specific steps of the preparation method include:

[0036] (1) Pre-treatment: process the infusion bottle or bag according to the injection requirements;

[0037] (2) Ingredients: Weigh the prescribed amount of ropivacaine hydrochloride and sodium chloride, add them to water for injection accounting for 20% of the total amount of water for injection, and then stir to dissolve completely;

[0038] (3) Activated carbon adsorption: add 0.05% (g / ml) activated carbon for needles to the above solution, keep warm at 80°C for 30 minutes, filter to remove carbon, add water for injection to the full amount, adjust the pH to 4.0-4.5, and stir to mix. uniform;

[0039] (4) Testing: 95.0-105.0% of the labeled amount of ropivacaine hydrochloride, 95.0-105.0% of the labeled amount of sodium chloride, and a pH of 4....

Embodiment 2

[0044] A ropivacaine hydrochloride sodium chloride injection, containing 2.116 g of ropivacaine hydrochloride and 8.6 g of sodium chloride per liter of the injection.

[0045] The specific steps of the preparation method include:

[0046] (1) Pre-treatment: process the infusion bottle or bag according to the injection requirements;

[0047] (2) Ingredients: Weigh the prescribed amount of ropivacaine hydrochloride and sodium chloride, add them to water for injection accounting for 35% of the total amount of water for injection, and then stir to dissolve completely;

[0048] (3) Activated carbon adsorption: Add 0.05% (g / ml) activated carbon for needles to the above solution, keep warm at 80°C for 30 minutes, filter to remove carbon, add water for injection to the full amount, adjust the pH to 4.5-5.5, and stir to mix. uniform;

[0049] (4) Testing: 95.0-105.0% of the labeled amount of ropivacaine hydrochloride, 95.0-105.0% of the labeled amount of sodium chloride, and a pH of ...

Embodiment 3

[0054] A ropivacaine hydrochloride sodium chloride injection, containing 4.0 g of ropivacaine hydrochloride and 10.0 g of sodium chloride per liter of the injection.

[0055] The specific steps of the preparation method include:

[0056] (1) Pre-treatment: process the infusion bottle or bag according to the injection requirements;

[0057] (2) Ingredients: Weigh the prescribed amount of ropivacaine hydrochloride and sodium chloride, add them to water for injection accounting for 50% of the total amount of water for injection, and then stir to dissolve completely;

[0058] (3) Activated carbon adsorption: Add 0.05% (g / ml) activated carbon for needles to the above solution, keep warm at 80°C for 30 minutes, filter to remove carbon, add water for injection to the full amount, adjust the pH to 5.5-6.0, and stir to mix. uniform;

[0059] (4) Testing: 95.0-105.0% of the labeled amount of ropivacaine hydrochloride, 95.0-105.0% of the labeled amount of sodium chloride, and a pH of 5...

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