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Diclofenac sodium lidocaine hydrochloride compound drug injection liquid and preparation method thereof

A technology of lidocaine hydrochloride and diclofenac sodium, applied in drug combination, drug delivery, antipyretics, etc., can solve the problems of high risk of adverse reactions and allergic reactions

Inactive Publication Date: 2015-01-14
CHENGDU LIST PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although Tween-80 is not involved in this patented technology, due to the addition of more auxiliary materials, the risk of adverse reactions and allergic reactions is still relatively large. Therefore, a diclofenac sodium hydrochloride with stable quality and good safety is needed. Lidocaine compound drug injection preparation

Method used

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  • Diclofenac sodium lidocaine hydrochloride compound drug injection liquid and preparation method thereof
  • Diclofenac sodium lidocaine hydrochloride compound drug injection liquid and preparation method thereof
  • Diclofenac sodium lidocaine hydrochloride compound drug injection liquid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0107] Example 1 Prescription 1

[0108] Diclofenac Sodium 60g

[0109] Lidocaine Hydrochloride 10g

[0110] Mannitol 80g

[0111] HS15 80g

[0112] Add water for injection to 2000ml

[0113] Makes 1000 bottles

[0114] (1) Take the prescribed amount of polyethylene glycol hydroxystearic acid (HS15), add it to half of the prescribed amount of water for injection at 35-45°C, stir and dissolve it as a spare solution A;

[0115] (2) Add diclofenac sodium to the reserve solution A, stir well to dissolve it, and make it as the reserve solution B;

[0116] (3) Add the prescribed amount of mannitol and lidocaine hydrochloride in sequence to the reserve solution B, stir well to dissolve, add water for injection to the prescribed amount,

[0117] (4) Then use multi-stage filtration, filter with a 0.22 μm sterilizing filter at the end, wash and dry the linkage production line to wash and dry bottles, dry and seal, sterilize (F0>8), and pack.

Embodiment 2

[0118] Example 2 Prescription 2

[0119] Diclofenac Sodium 80g

[0120]Lidocaine Hydrochloride 20g

[0121] Mannitol 100g

[0122] HS15 100g

[0123] Add water for injection to 2000ml

[0124] Makes 1000 bottles

[0125] (1) Take the prescribed amount of polyethylene glycol hydroxystearic acid (HS15), add it to half of the prescribed amount of water for injection at 35-45°C, stir and dissolve it as a spare solution A;

[0126] (2) Add diclofenac sodium to the reserve solution A, stir well to dissolve it, and make it as the reserve solution B;

[0127] (3) Add the prescribed amount of mannitol and lidocaine hydrochloride in sequence to the reserve solution B, stir well to dissolve, add water for injection to the prescribed amount,

[0128] (4) Then use multi-stage filtration, filter with a 0.22 μm sterilizing filter at the end, wash and dry the linkage production line to wash and dry bottles, dry and seal, sterilize (F0>8), and pack.

Embodiment 3

[0129] Example 3 Prescription 3

[0130] Diclofenac Sodium 100g

[0131] Lidocaine Hydrochloride 30g

[0132] Mannitol 120g

[0133] HS15 120g

[0134] Add water for injection to 2000ml

[0135] Makes 1000 bottles

[0136] (1) Take the prescribed amount of polyethylene glycol hydroxystearic acid (HS15), add it to half of the prescribed amount of water for injection at 35-45°C, stir and dissolve it as a spare solution A;

[0137] (2) Add diclofenac sodium to the reserve solution A, stir well to dissolve it, and make it as the reserve solution B;

[0138] (3) Add the prescribed amount of mannitol and lidocaine hydrochloride in sequence to the reserve solution B, stir well to dissolve, add water for injection to the prescribed amount,

[0139] (4) Then use multi-stage filtration, filter with a 0.22 μm sterilizing filter at the end, wash and dry the linkage production line to wash and dry bottles, dry and seal, sterilize (F0>8), and pack.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a diclofenac sodium lidocaine hydrochloride compound drug injection liquid and a preparation method thereof. The injection liquid is an injection preparation prepared by adding sterilization injection water into the following raw materials: 30-50mg / ml of diclofenac sodium, 5-15mg / ml of lidocaine hydrochloride, 40-60mg / ml of mannitol, and 40-60mg / ml of polyethylene glycol-12 hydroxy stearate. The compound drug injection liquid not only can reduce the patient aching feeling caused by injection, and the drug preparation is stable, non-hemolytic and low-anaphylactic.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a diclofenac sodium lidocaine hydrochloride compound drug injection preparation and a preparation method thereof. Background technique [0002] Diclofenac sodium, chemical name 2-[(2,6-dichlorophenyl) amino] phenylacetic acid monosodium salt, belongs to non-steroidal anti-inflammatory drugs, has anti-inflammatory, analgesic and antipyretic effects. For rheumatoid arthritis, adhesive spondylitis, non-inflammatory joint pain, arthritis, non-articular rheumatism, pain caused by non-articular inflammation, various neuralgia, cancer pain, post-traumatic pain and various inflammations resulting in fever etc. When diclofenac sodium is used for injection, the patient has a strong sense of pain. [0003] Lidocaine hydrochloride, chemical name N-(2,6-xylyl)-2-(diethylamino)acetamide hydrochloride, is an amide compound of aromatic amine, and lidocaine has g...

Claims

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Application Information

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IPC IPC(8): A61K31/196A61K9/08A61K47/34A61P23/02A61P29/00A61K31/167
CPCA61K9/08A61K31/167A61K31/196A61K2300/00
Inventor 张浩金红娣梁慧蓉
Owner CHENGDU LIST PHARMA
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