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Lidocaine hydrochloride compound medicine injection and preparation method thereof

The technology of lidocaine hydrochloride and injection is applied in the field of lidocaine hydrochloride compound drug injection preparation and preparation thereof, and can solve the problems of elevation, easy rancidity, risk of clinical medication and the like

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

[0006] The prior art shows that Tween-80 is generally used as a solubilizer in the preparation of lidocaine hydrochloride compound preparations at present, but Tween-80 is prone to rancidity in the later storage process after being sterilized by high temperature in the process of drug preparation. This will lead to an increase in the content of impurities, which is one of them; second, Tween-80 itself has strong hemolytic and allergenic properties, leading to an increase in the probability of adverse reactions in injections, and clinical use is risky

Method used

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  • Lidocaine hydrochloride compound medicine injection and preparation method thereof
  • Lidocaine hydrochloride compound medicine injection and preparation method thereof
  • Lidocaine hydrochloride compound medicine injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] Example 1 Prescription 1

[0098] Lidocaine Hydrochloride 8.0g

[0099] Menthol 1.3g

[0100] Sodium chloride 2.0g

[0101] Glycerin 50.0ml

[0102] Ethanol 133.0ml

[0103] HS15 5.0ml

[0104] Add water for injection to 1000ml

[0105] Makes 200 bottles

[0106] Take the prescribed amount of menthol, add ethanol to dissolve, wait until the menthol is completely dissolved, then add lidocaine hydrochloride and stir, after completely dissolving, add glycerin, HS15, sodium chloride in sequence, then add water for injection at 35-45°C to mix and adjust To the prescription amount, then adopt multi-stage filtration, filter with a 0.22 μm sterilizing filter at the end, wash and dry the linkage production line to wash the bottle, dry the bottle and fill it, sterilize (F0>8), and pack it.

Embodiment 2

[0107] Example 2 Prescription 2

[0108] Lidocaine Hydrochloride 8.0g

[0109] Menthol 1.3g

[0110] Sodium chloride 2.0g

[0111] Glycerin 50.0ml

[0112] Ethanol 133.0ml

[0113] HS15 1.0ml

[0114] Add water for injection to 1000ml

[0115] Makes 200 bottles

[0116] Take the prescribed amount of menthol, add ethanol to dissolve, wait until the menthol is completely dissolved, then add lidocaine hydrochloride and stir, after completely dissolving, add glycerin, HS15, sodium chloride in sequence, then add water for injection at 35-45°C to mix and adjust To the prescription amount, then adopt multi-stage filtration, filter with a 0.22 μm sterilizing filter at the end, wash and dry the linkage production line to wash the bottle, dry the bottle and fill it, sterilize (F0>8), and pack it.

Embodiment 3

[0117] Example 3 Prescription 3

[0118] Lidocaine Hydrochloride 8.0g

[0119] Menthol 1.3g

[0120] Sodium chloride 2.0g

[0121] Glycerin 50.0ml

[0122] Ethanol 133.0ml

[0123] HS15 10.0ml

[0124] Add water for injection to 1000ml

[0125] Makes 200 bottles

[0126]Take the prescribed amount of menthol, add ethanol to dissolve, wait until the menthol is completely dissolved, then add lidocaine hydrochloride and stir, after completely dissolving, add glycerin, HS15, sodium chloride in sequence, then add water for injection at 35-45°C to mix and adjust To the prescription amount, then adopt multi-stage filtration, filter with a 0.22 μm sterilizing filter at the end, wash and dry the linkage production line to wash the bottle, dry the bottle and fill it, sterilize (F0>8), and pack it.

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Abstract

The invention belongs to the technical field of medicinal preparations, and concretely relates to a lidocaine hydrochloride compound medicine injection and a preparation method thereof. The injection comprises 8mg / ml of lidocaine hydrochloride, 1.3mg / ml of menthol, 2.0mg / ml of sodium chloride, 0.05ml / ml of glycerin, 1.33ml / ml of ethanol and 0.001-0.01mg / ml of polyethylene glycol-12-hydroxystearate. The compound injection has the advantages of excellent long-acting anaesthesia effect, stable medicinal preparation, no hemolysis and low allergy.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a lidocaine hydrochloride compound drug injection preparation and a preparation method thereof. Background technique [0002] Lidocaine hydrochloride, chemical name N-(2,6-xylyl)-2-(diethylamino)acetamide hydrochloride, is an amide compound of aromatic amine, and lidocaine has good local anesthetic penetration, Strong diffusion, commonly used in topical anesthesia, infiltration anesthesia, conduction anesthesia and epidural anesthesia. [0003] Menthol, chemical name: [1R-(1α, 2β, 5α)]-5-methyl-2-(1-methylethyl) cyclohexanol; mint ice; terpene alcohol-[3]; p-alkane- 3-alcohol; [1R-(1A, 2B, 5A)]-5-methyl-2-(1-methylethyl); 2-isopropyl-5-methylcyclohexanol, antipruritic, Analgesic, antiseptic, stimulating, anesthetic, cooling and anti-inflammatory effects, can cure headache, neuralgia, itching and respiratory inflammation, atrophic rhinitis, hoarse...

Claims

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Application Information

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IPC IPC(8): A61K31/167A61K9/08A61K47/34A61P23/02A61P29/00A61K31/045
CPCA61K9/0019A61K9/08A61K31/045A61K31/167A61K47/14A61K2300/00
Inventor 张浩金红娣梁慧蓉
Owner CHENGDU LIST PHARMA
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