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The preparation method of lidocaine carbonate injection

A technology of lidocaine carbonate and lidocaine hydrochloride, which is applied in the directions of pharmaceutical formulations, drug delivery, inorganic non-active ingredients, etc.

Active Publication Date: 2012-02-22
SHANGHAI FOSUN PHARMA (GROUP) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is because part of CO2 escapes from the solution during sterilization, resulting in crystallization, which affects the pass rate of visible foreign matter inspection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1-10( example 10

[0039] Instance 1-10 (example 10 is former process contrast):

[0040] Recipe:

[0041] Raw material name dosage

[0042] Lidocaine Hydrochloride 106.6g

[0043] Sodium bicarbonate for injection 35g

[0044] Add water for injection to 5L

[0045] 1000 pieces

[0046] Operation process: (instance 1-9)

[0047] 1) Dosing: dissolve sodium bicarbonate for injection and lidocaine hydrochloride in water for injection respectively;

[0048] 2) Slowly pour the sodium bicarbonate aqueous solution into the lidocaine hydrochloride aqueous solution, stir and mix evenly, add cold water for injection to the full amount, add activated carbon for needles to the above solution, stir and absorb, and adjust the pH value of the solution to 6.0~ with carbon dioxide gas within 7.5;

[0049] 3) The solution is circulated and filtered with a titanium filter for 15 minutes, and the solution is circulated and filtered with a titanium filter, a 0.45 μm microporous membrane cartr...

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PUM

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Abstract

The invention provides a preparation method of lidocaine carbonate injection. The present invention adds an oscillating step on the basis of the original process: it overcomes the deficiencies of the existing process, the visible foreign matter is obviously improved, the product quality is improved, and it is more conducive to the safety and effectiveness of the medicine. Suitable for large-scale industrial production.

Description

Technical field: [0001] The present invention relates to pharmaceutical preparations. Specifically relates to a preparation method of lidocaine hydrochloride injection. Background technique: [0002] Lidocaine hydrochloride injection is an amide-type local anesthetic commonly used in clinical practice. In recent years, domestic and foreign studies have been carried out on the clinical application of its alkaline solution. When alkaline solution is used as local anesthetic, its anesthesia incubation period is significantly shorter than that of non-alkalized solution, and the analgesic effect is significantly prolonged. [0003] Local anesthetics enter the nerve axoplasm through the nerve sheath and the outer membrane of the axon, and attach to the sodium channel of the nerve fiber membrane to produce local blockade. Since the nerve sheath and the outer membrane of the nerve axon are lipid structures, the drug must pass through the membrane in a non-ionic form with high fat ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/167A61K9/08A61K47/02A61P23/02
Inventor 周建伟熊洁钱伟钢付林
Owner SHANGHAI FOSUN PHARMA (GROUP) CO LTD