Diclofenac sodium and lidocaine hydrochloride injection and preparation method thereof

A technology of lidocaine hydrochloride and diclofenac sodium, applied in the field of diclofenac sodium lidocaine hydrochloride injection and preparation thereof, can solve the problem of high cost of cysteine, and achieve the effects of reducing production cost and improving economic benefits

Inactive Publication Date: 2020-08-11
马鞍山思哲知识产权服务有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the process of preparing diclofenac sodium lidocaine hydrochloride injection, it is necessary to add a stabilizer to stabilize the pH value of the injection. At present, the commonly used stabilizer is cysteine, but the cost of cysteine ​​is higher

Method used

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  • Diclofenac sodium and lidocaine hydrochloride injection and preparation method thereof
  • Diclofenac sodium and lidocaine hydrochloride injection and preparation method thereof
  • Diclofenac sodium and lidocaine hydrochloride injection and preparation method thereof

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preparation example Construction

[0025] Under preferred conditions, the preparation method of described diclofenac sodium lidocaine hydrochloride injection comprises the steps:

[0026] (1) Preparation of medicinal solution A: Dissolve anhydrous sodium sulfite in 30-40vol% water for injection, then add propylene glycol and mix well, then add polyethylene glycol 400 and mix well, then slowly add diclofenac sodium, stir to make it Dissolve to obtain liquid A;

[0027] (2) Medicinal solution B: dissolving lidocaine hydrochloride and edetate disodium in 15-20 vol% water for injection to obtain medicinal solution B;

[0028] (3) Under the condition of stirring, slowly add medicinal solution B to medicinal solution A, and keep stirring, adjust the pH of the system to 7.5-8.5 with sodium carbonate solution after mixing, add the remaining amount of water for injection after cooling to room temperature, Stir, let stand for 15 minutes, and control the pH of the system to 7.5-8.5;

[0029] (4) Coarse filtration: use a...

Embodiment 1

[0038] A diclofenac sodium lidocaine hydrochloride injection is made from the following raw materials in parts by weight:

[0039]

[0040] The preparation method of described diclofenac sodium lidocaine hydrochloride injection comprises the steps:

[0041] (1) Preparation of medicinal solution A: Dissolve anhydrous sodium sulfite in 33.3vol% water for injection, then add propylene glycol and mix well, then add polyethylene glycol 400 and mix well, then slowly add diclofenac sodium, stir to dissolve , to obtain liquid A;

[0042] (2) Medicinal solution B: dissolve lidocaine hydrochloride and edetate disodium in 16.6vol% water for injection to obtain medicinal solution B;

[0043] (3) Under the condition of stirring, slowly add the medicinal solution B to the medicinal solution A, and keep stirring, after mixing, adjust the pH of the system to 7.75-8.25 with a sodium carbonate solution with a mass fraction of 15wt%, cool to room temperature and then add 50.2vol% water for ...

Embodiment 2

[0047] A diclofenac sodium lidocaine hydrochloride injection is made from the following raw materials in parts by weight:

[0048]

[0049] The preparation method of described diclofenac sodium lidocaine hydrochloride injection comprises the steps:

[0050] (1) Preparation of medicinal solution A: Dissolve anhydrous sodium sulfite in 30vol% water for injection, then add propylene glycol and mix well, then add polyethylene glycol 400 and mix well, then slowly add diclofenac sodium, stir to dissolve, Get liquid A;

[0051] (2) Medicinal solution B: dissolve lidocaine hydrochloride and edetate disodium in 15vol% water for injection to obtain medicinal solution B;

[0052] (3) Under the condition of stirring, slowly add the medicinal solution B to the medicinal solution A, and keep stirring, after mixing, adjust the pH of the system to 7.5-8 with a sodium carbonate solution with a mass fraction of 12wt%, and add it after cooling to room temperature 55vol% water for injection,...

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Abstract

The invention relates to the technical field of red diclofenac sodium and lidocaine hydrochloride injections and preparation thereof, in particular to a diclofenac sodium and lidocaine hydrochloride injection and a preparation method thereof. The diclofenac sodium and lidocaine hydrochloride injection is prepared from the following raw materials in parts by weight: 300 to 420 parts of diclofenac sodium, 80 to 150 parts of lidocaine hydrochloride, 1200 to 2500 parts of polyethylene glycol 400, 1000 to 2000 parts of propylene glycol, 1-10 parts of anhydrous sodium carbonate, 0.5 to 1.5 parts ofedetate disodium, and 5-12 parts of anhydrous sodium sulfite. The anhydrous sodium carbonate is used as a pH stabilizer instead of the existing cysteine, thereby lowering the production cost and enhancing the economic benefit under the condition of not influencing the drug effect.

Description

technical field [0001] The invention relates to the technical field of diclofenac sodium lidocaine hydrochloride injection and its preparation, in particular to diclofenac sodium lidocaine hydrochloride injection and a preparation method thereof. Background technique [0002] Diclofenac Sodium Lidocaine Hydrochloride Injection is indicated for inflammation of muscles, joints, joint capsules, mucous bursa, tendons, tendon sheaths and spine, and degenerative joint and extra-articular diseases. Such as ankylosing spondylitis, soft tissue rheumatism, bursitis, tenosynovitis, tendonitis, low back pain, sciatica, cervical nerve root syndrome and various types of neuritis and neuralgia. Acute attack of gout. Pain caused by non-rheumatic inflammation. [0003] In the process of preparing diclofenac sodium lidocaine hydrochloride injection, it is necessary to add a stabilizer to stabilize the pH value of the injection. At present, the commonly used stabilizer is cysteine, but the c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/02A61K31/196A61K31/167A61P21/00A61P19/02A61P19/04A61P9/08A61P29/00A61P25/02A61P25/00A61P19/06
CPCA61K9/0019A61K9/08A61K31/167A61K31/196A61K47/02A61P9/08A61P19/02A61P19/04A61P19/06A61P21/00A61P25/00A61P25/02A61P29/00A61K2300/00
Inventor 刘龙云
Owner 马鞍山思哲知识产权服务有限公司
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