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Diclofenac sodium and lidocaine hydrochloride injection and preparation method thereof

A technology of lidocaine hydrochloride and diclofenac sodium, which is applied in the field of medicine, can solve problems such as product color turning yellow, unstable product quality, and excessive product content drop, and achieve the effect of improving product quality

Active Publication Date: 2009-07-22
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The solubility of diclofenac sodium in water is small, and during the preparation of diclofenac sodium lidocaine hydrochloride injection by conventional technology, the problem of crystallization of diclofenac sodium in aqueous solution is prone to occur
[0004] In CN1711996A, it was once mentioned to utilize β-cyclodextrin to improve the solubility of diclofenac sodium in aqueous solution, but, even utilizing the above-mentioned technology, when the concentration of diclofenac sodium in aqueous solution reached 30mg / ml and above, then lidocaine hydrochloride was added to In the diclofenac sodium aqueous solution, the crystallization of diclofenac sodium also tends to occur
[0005] Simultaneously, when the Diclofenac Sodium Lidocaine Hydrochloride Injection prepared by the prior art is sterilized by conventional techniques, the product color often turns yellow, the product content drops too much, and the product quality is not stable.

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] ① Take 3g of sodium sulfite and 1.25g of disodium edetate in parts by weight, add them to 250ml of 40°C water for injection, stir to dissolve, and obtain solution A;

[0049] ②Take 150ml of propylene glycol and 210ml of polyethylene glycol, add to the above solution A, stir and mix to obtain solution B;

[0050] ③ Take 2 / 3 of the volume of the above solution B, add 37.5 g of diclofenac sodium, stir to dissolve, and obtain solution C;

[0051] ④ Take 1 / 3 of the volume of the above-mentioned solution B, add 11.5 g of lidocaine hydrochloride, stir to dissolve, and obtain solution D;

[0052]⑤Take the above solution C and solution D, mix them, add water for injection to 1000ml, and use Na with a concentration of 100mg / ml 2 CO 3 The pH value of the solution was adjusted to 8.2 to obtain solution E;

[0053] 6. Get solution E, filter by conventional method, fill, sterilize, pack, obtain diclofenac sodium lidocaine hydrochloride injection of the present invention.

Embodiment 2

[0055] ① Take 3g of sodium sulfite and 1g of disodium edetate in parts by weight, add them to 250ml of water for injection at 35°C, stir to dissolve, and obtain solution A;

[0056] ②Take 100ml of propylene glycol and 150ml of polyethylene glycol, add them to the above solution A, stir and mix to obtain solution B;

[0057] ③ Take 2 / 3 of the volume of the above-mentioned solution B, add 30 g of diclofenac sodium, stir to dissolve, and obtain solution C;

[0058] ④ Take 1 / 3 of the volume of the above-mentioned solution B, add 10 g of lidocaine hydrochloride, stir to dissolve, and obtain solution D;

[0059] Other steps are the same as in Example 1 to obtain the diclofenac sodium lidocaine hydrochloride injection of the present invention.

Embodiment 3

[0061] ① Take 3g of sodium sulfite and 3g of disodium edetate in parts by weight, add them to 250ml of water for injection at 45°C, stir to dissolve, and obtain solution A;

[0062] ②Take 200ml of propylene glycol and 300ml of polyethylene glycol, add to the above solution A, stir and mix to obtain solution B;

[0063] ③ Take 2 / 3 of the volume of the above-mentioned solution B, add 50 g of diclofenac sodium, stir to dissolve, and obtain solution C;

[0064] ④ Take 1 / 3 of the volume of the above-mentioned solution B, add 15 g of lidocaine hydrochloride, stir to dissolve, and obtain solution D;

[0065] ⑤Take the above solution C and solution D, mix them, add water for injection to 1000ml, and use Na with a concentration of 100mg / ml 2 CO 3 The pH value of the solution was adjusted to 8.5 to obtain solution E;

[0066] Other steps are the same as in Example 1 to obtain the diclofenac sodium lidocaine hydrochloride injection of the present invention.

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Abstract

The invention relates to the technical field of medicines, in particular to a diclofenac sodium lidocaine hydrochloride injection and a method for preparing the same. The invention aims to overcome defects in the prior art and provides the diclofenac sodium lidocaine hydrochloride injection with stable quality. Moreover, the invention also provides a method for preparing the diclofenac sodium lidocaine hydrochloride injection, which can avoid the technical difficult problem that the active ingredient, namely diclofenac sodium is separated out during the preparation of the injection.

Description

technical field [0001] The invention belongs to the technical field of medicine, specifically, the invention mainly relates to a diclofenac sodium lidocaine hydrochloride injection, and the invention also provides a preparation method thereof. Background technique [0002] Diclofenac sodium, the chemical name is 2-[(2,6-dichlorophenyl) amino] phenylacetic acid monosodium salt, this product is used in various rheumatism, rheumatoid arthritis, neuritis, lupus erythematosus, ankylosing spondylosis Inflammation, pain caused by cancer surgery and fever caused by various reasons, etc., as a strong inhibitor of cyclooxygenase, it can reduce the synthesis of prostaglandin, prostacyclin and thromboxane products, so as to achieve the purpose of analgesia and anti-inflammation . When diclofenac sodium injection is used for injection, the patient feels a strong sense of pain. Lidocaine hydrochloride is an anesthetic preparation, and after being prepared into diclofenac sodium lidocain...

Claims

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Application Information

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IPC IPC(8): A61K31/196A61K31/167A61K9/08A61J3/00A61P29/00A61P19/02A61P25/00A61P19/04A61P19/00A61P23/02
Inventor 卢秀莲邢晋华王绍同薛长明李大涛
Owner CISEN PHARMA
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