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A kind of nimodipine oral long-acting suspension and preparation method thereof

A nimodipine and nimodipine nanotechnology, applied in the field of medicine, can solve the problems of unclear effectiveness and safety, low bioavailability, slow dissolution rate, etc., and achieve high drug encapsulation efficiency and high drug utilization , quick effect

Active Publication Date: 2019-11-05
XUZHOU MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For patients, especially children, the oral compliance of ordinary tablets is poor, the drug is difficult to dissolve in water, and the dissolution rate is slow, so the onset of action is slow, and the action time is short, and the toxicity is strong after taking multiple times. Low; and the commercially available nimodipine injection has no definite research data for children, and its effectiveness and safety are not clear

Method used

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  • A kind of nimodipine oral long-acting suspension and preparation method thereof
  • A kind of nimodipine oral long-acting suspension and preparation method thereof
  • A kind of nimodipine oral long-acting suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Table 1 Prescription of nimodipine oral solution

[0043]

[0044]

[0045] Preparation Process:

[0046] (1) Get 0.75g nimodipine, 0.5g benzoic acid and disperse in 100ml ethanol;

[0047] (2) Add 150ml polyethylene glycol and 125ml glycerin to the above solution, and mechanically stir for 10min until dissolved;

[0048] (3) Take 60ml of purified water and add the prescription amount of sodium dihydrogen phosphate and disodium hydrogen phosphate and mechanically stir for 10 minutes until dissolved;

[0049] (4) Add the prescription amount of maltitol to the solution prepared in (3) and mechanically stir for 10 minutes until dissolved;

[0050](5) Add the solution prepared in (4) above to the solution prepared in (2), and stir mechanically for 10 minutes;

[0051] (6) Dilute the purified water to the prescribed amount, and filter with a 0.45 micron filter element.

Embodiment 2

[0053] Table 2 Prescription of nimodipine oral solution

[0054]

[0055]

[0056] Preparation Process:

[0057] (1) Disperse 0.75g of nimodipine in 100ml of ethanol.

[0058] (2) Add 125ml of polyethylene glycol, 150ml of glycerin, and 5ml of benzyl alcohol to the above solution, and stir mechanically for 10 minutes until dissolved.

[0059] (3) Take 60ml of purified water, add the prescribed amount of citric acid and sodium citrate, and mechanically stir for 10 minutes until dissolved.

[0060] (4) Add the prescribed amount of sucralose to the solution prepared in (3) and mechanically stir for 10 minutes until dissolved.

[0061] (5) Add the solution prepared in (4) above to the solution prepared in (2), and stir mechanically for 10 minutes.

[0062] (6) Dilute the purified water to the prescribed amount, filter with a 0.45 micron filter element, perform quality inspection, and pack in a brown glass bottle.

Embodiment 3

[0064] Example 3

[0065] After the sample was kept away from light and sealed for 3 months under accelerated stability (40°C, RH75%), the content of nimodipine was detected by liquid phase.

[0066]

[0067] We can find out by experiment, the stability of this invention prescription process nimodipine is high.

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Abstract

The invention discloses a nimodipine oral long-acting suspension and a preparation method thereof. -2 parts, 1-5 parts of pH buffer, 0.1-2 parts of preservative, 90-100 parts of solvent; the carrier material of nimodipine nanoparticles is the composition of polylactic acid-glycolic acid copolymer and pluronic F68, The mass percentage of Pluronic F68 in the carrier material is 5-40%. The nimodipine oral long-acting suspension of the present invention is convenient to take and has a good mouthfeel; the existence of some medicines in a free state can accelerate the absorption rate and have a quick effect; In granules, the first-pass effect can be reduced, the utilization rate of drugs is high, the drug loading capacity of nanoparticles is large, the encapsulation rate is high, the release is slow, and the action time is long, which reduces the frequency of administration and makes up for the shortcomings of existing commercially available dosage forms; preparation The method has good reproducibility and repeatability, and is easy to implement and popularize vigorously in the industry.

Description

technical field [0001] The invention relates to a nimodipine oral long-acting suspension and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Subarachnoid hemorrhage (SAH) is a very serious common disease, mainly caused by rupture of blood vessels at the base of the brain or on the surface of the brain, and blood flowing into the subarachnoid space. The main complications are cerebral vasospasm, cerebral hemorrhage Water, rebleeding, etc. The World Health Organization survey shows that the incidence rate in China is about 2.0 / 100,000 person-years, and it is also reported that it is 6-20 / 100,000 person-years per year. Migraine (migraine) is the most common type of primary headache clinically, clinically characterized by paroxysmal moderate to severe, throbbing headache as the main manifestation, most of the onsets are in children and adolescence, and the incidence peaks in young and middle-aged adults. [0003] Nimodi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K9/51A61K47/34A61K47/10A61K31/4422A61P9/10A61P25/06A61P27/16A61P9/12
CPCA61K9/0053A61K9/10A61K9/5146A61K9/5153A61K31/4422A61P9/10A61P9/12A61P25/06A61P27/16
Inventor 张彦卓王静王方李晓楠
Owner XUZHOU MEDICAL UNIV
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