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High-safety ropivacaine hydrochloride injection and preparation method thereof

A high-safety technology of ropivacaine hydrochloride, applied in the field of medicine, can solve the problems of adding a large amount of desiccation protective agent, freeze-dried powder injection, unqualified impurities in clarity, poor stability, etc., to ensure physical stability and biological stability Sex, reduce the chance of bacterial contamination, good adsorption effect

Active Publication Date: 2012-07-11
GUANGDONG JIABO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But, present ropivacaine hydrochloride injection has the shortcoming of poor stability
In order to solve the problem of poor stability of ropivacaine injection, the patent applications with application numbers 200310117329, 200410077510, and 200710013027 freeze-dried the salt form of ropivacaine to make ropivacaine salt freeze-dried powder injection, with a view to Improving the storage stability of ropivacaine
[0004] It is worth noting that although the above-mentioned patent application removes the water that will affect the stability of ropivacaine through freeze-drying technology, it also introduces new problems, such as the clarity of the freeze-dried powder injection is not up to standard when reconstituted or There may be new impurities, and a large amount of dry protection agent needs to be added, and the freeze-drying process is complicated and costly, and it is inconvenient to apply due to the need for additional reconstitution steps, etc.

Method used

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  • High-safety ropivacaine hydrochloride injection and preparation method thereof
  • High-safety ropivacaine hydrochloride injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0032] prescription:

[0033] Ropivacaine hydrochloride 50g,

[0034] Sodium chloride 80g,

[0035] Sodium hydroxide or hydrochloric acid qs, and

[0036] Add water for injection to 10000ml;

[0037] The formula is made into 1000 injections, and the pH of the injection is 5.0;

[0038] The preparation method is as follows: stirring and dissolving ropivacaine hydrochloride and sodium chloride in 1 / 3 volume of water for injection of the whole amount, adding an appropriate amount of sodium hydroxide or hydrochloric acid, and adjusting the pH value to 5.0; The liquid medicine is circulated and filtered and adsorbed in a plate and frame filter containing 0.01% activated carbon for 10 minutes to perform coarse filtration, and the content and pH value of the intermediate product are measured. After passing the test, filter with a 0.22 μm microporous membrane; To the full amount, stirred for 10 minutes and left to stand for 0.5 hours, then canned in a high-temperature-resistant pl...

Embodiment 2

[0040] prescription:

[0041] Ropivacaine Hydrochloride 75g,

[0042] Sodium chloride 75g,

[0043] Sodium hydroxide or hydrochloric acid qs, and

[0044] Add water for injection to 10000ml;

[0045] The formula is made into 1000 injections, and the pH of the injection is 5.0;

[0046] The preparation method is as follows: stirring and dissolving ropivacaine hydrochloride and sodium chloride in 4 / 5 volume of water for injection of the whole amount, adding appropriate amount of sodium hydroxide or hydrochloric acid, and adjusting the pH value to 5.0; The liquid medicine is circulated, filtered and adsorbed for 60 minutes in a plate-and-frame filter containing 0.5% activated carbon to carry out coarse filtration, and the content and pH value of the intermediate product are measured. After passing the test, filter it with a 0.22 μm microporous membrane; To the full amount, stir for 10 minutes and let it stand for 2 hours, then can it in a high-temperature-resistant plastic co...

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Abstract

The invention relates to a high-safety ropivacaine hydrochloride injection and a preparation method of the high-safety ropivacaine hydrochloride injection. The formula of the high-safety ropivacaine hydrochloride injection comprises 20-200g of ropivacaine hydrochloride, 70-100g of sodium chloride, appropriate amount of sodium hydroxide or hydrochloric acid and 10000ml of water for injection. The formula is prepared into 1000 injections, and the pH value of the injection is 4.0-6.0. The injection has good stability, high drug content and safe and reliable effect.

Description

technical field [0001] The invention relates to the technical field of medicine. In particular, it relates to a high-safety ropivacaine hydrochloride injection and a preparation method thereof. Background technique [0002] Ropivacaine is a new long-acting amide local anesthetic, suitable for surgical anesthesia, epidural anesthesia, postoperative or labor pain. Ropivacaine was approved by the FDA as a local anesthetic in 2000 because of its low toxicity to the heart and less impact on uteroplacental blood flow, and it is used for 72 hours of local anesthesia during surgery, postoperative pain, and childbirth. Clinical application shows that ropivacaine has mild motor nerve block in parturients, a high rate of natural delivery, and newborns have good tolerance to ropivacaine. Therefore, ropivacaine is a safe and effective local anesthetic in current clinical application, and has high application value. [0003] When ropivacaine is used as a local anesthetic, it is usually...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/445A61P23/02
Inventor 岳峰梁成标曾少群童伟国蔡文坚
Owner GUANGDONG JIABO PHARM CO LTD
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