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Nicardipine hydrochloride sodium chloride injection and preparation method thereof

A technology of nicardipine hydrochloride and dipine sodium chloride, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve the problems of easy generation of decomposition products, poor thermal stability, etc., and achieve stable properties and easy Storage, Quality and Reliable Effects

Active Publication Date: 2015-11-04
HUIYINBI GRP JIANGXI EAST ASIA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, nicardipine has poor stability to strong light and high heat, and it is easy to produce decomposition products during production and storage.

Method used

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  • Nicardipine hydrochloride sodium chloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 Preparation of Nicardipine Hydrochloride Sodium Chloride Injection

[0033] Weigh 10.76g nicardipine hydrochloride, 900g sodium chloride, 1000g mannitol, dissolve in 90000ml water for injection.

[0034] Add glacial acetic acid to adjust the pH to 4.0.

[0035] Add water for injection to a total volume of 100000ml.

[0036] Add needles to decolorize with activated charcoal for 30 min.

[0037] Filter and decarbonize, take samples to measure the pH value and content, and the pH and the content of each component are in line with the standard;

[0038] Fine filter with 0.2μm microporous membrane;

[0039] Fill to 100ml glass infusion bottle, 100ml per bottle, crimp the cap;

[0040] Sterilize at 121°C for 8 minutes, and cool down to room temperature within 30 minutes after sterilization.

Embodiment 2

[0041] Example 2 Preparation of Nicardipine Hydrochloride Sodium Chloride Injection

[0042] Weigh 21.52g nicardipine hydrochloride, 900g sodium chloride, 1000g mannitol, dissolve in 90000ml water for injection.

[0043] Add glacial acetic acid to adjust the pH to 4.0.

[0044] Add water for injection to a total volume of 100000ml.

[0045] Add needles to decolorize with activated charcoal for 30 min.

[0046] Filter and decarbonize, take samples to measure the pH value and content, and the pH and the content of each component are in line with the standard;

[0047] Fine filter with 0.2μm microporous membrane;

[0048] Fill to 100ml glass infusion bottle, 100ml per bottle, crimp the cap;

[0049] Sterilize at 121°C for 8 minutes, and cool down to room temperature within 30 minutes after sterilization.

Embodiment 3

[0050] Example 3 pH Stability

[0051] Nicardipine hydrochloride injection is sensitive to light and heat, and the color of the injection will become darker if it is exposed to light or heated for a long time. And nicardipine hydrochloride injection increases with pH value, and stability reduces. The pH stability of Nicardipine Hydrochloride Sodium Chloride Injection of the present invention is tested, method: prepare the Nicardipine Hydrochloride Sodium Chloride Injection of different pH values ​​respectively according to the prescription of Example 2, place in 80 ℃ oven 10 days, the results are shown in Table 1.

[0052] Table 1 pH stability of nicardipine hydrochloride sodium chloride injection

[0053] pH value Decomposition products + related substances (%) 3.0 >3.0 3.5 <3.0

[0054] It can be seen from the results in Table 1 that nicardipine hydrochloride is the most stable around pH 4.0, and the stability is reduced if the pH is too high or too lo...

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Abstract

The invention provides a nicardipine hydrochloride sodium chloride injection and a preparation method thereof. The nicardipine hydrochloride sodium chloride injection contains 0.01-0.02% of nicardipine and 0.9% of sodium chloride. The nicardipine hydrochloride sodium chloride injection provided by the invention is stable in quality and easy to store, can be preserved for more than 24 months at light-shielded and cool places (no greater than 20 DEG C), is applicable to brief treatment on hypertension patients who are not applicable to or unavailable for oral treatment, and is particularly applicable to emergency treatment on dyslipidemic hypertension or hypertensive emergency in operation.

Description

Technical field [0001] The present invention relates to an injection and a preparation method thereof, specifically to a nicardipine hydrochloride sodium chloride injection and a preparation method thereof. Background technique [0002] Nicardipine hydrochloride, also known as nolatitan hydrochloride, has a chemical name of 2,6-dimethyl-4-(3'-nitrophenyl)-1,4-dihydropyridine-3, 5-dicarboxylic acid-3-[β-(N-benzyl-N-methylamino)]-ethyl ester-5-methyl ester hydrochloride, the molecular formula is C 26 H 29 N 3 O 6 ·HCl, molecular weight is 515.99, structural formula is as follows: [0003] [0004] Nicardipine hydrochloride is a calcium ion antagonist and vasodilator. It is mainly used in patients with ischemic cerebrovascular disease and essential hypertension. It can inhibit the transmembrane calcium ion influx of myocardium and vascular smooth muscle without changing blood calcium. concentration, has a high degree of vascular selectivity, and has a stronger calcium i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4422A61K47/02A61P9/12
Inventor 王大冲翟绪武王建何榕王雪梅吴对荣
Owner HUIYINBI GRP JIANGXI EAST ASIA PHARMA CO LTD
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