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A kind of stable fasudil hydrochloride injection and preparation method thereof

A technology of fasudil hydrochloride and injection, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, which can solve the problems of increasing the content of insoluble particles, reduce the dosage, reduce the Potential safety hazards and the effect of improving drug safety

Active Publication Date: 2017-10-27
中润药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The pharmaceutical composition of fasudil hydrochloride improves the stability of the preparation to light by adding a certain amount of cysteine ​​hydrochloride, but cysteine ​​hydrochloride is only stable under acidic conditions, and is stable under neutral and alkaline conditions. It is easy to form water-insoluble cystine precipitates, which increases the content of insoluble particles in the injection

Method used

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  • A kind of stable fasudil hydrochloride injection and preparation method thereof
  • A kind of stable fasudil hydrochloride injection and preparation method thereof
  • A kind of stable fasudil hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Every 1000 pieces of described fasudil hydrochloride injection, its formula consists of:

[0042]

[0043] The stabilizer is composed of N-carboxymethyl chitosan and reduced glutathione in a mass ratio of 1:0.25.

[0044] Preparation:

[0045](1) get the water for injection of recipe quantity and use the polyvinyl chloride exchange column that contains diethylaminoethyl dextran gel to carry out pyrogen removal treatment, then feed carbon dioxide to saturation, for subsequent use;

[0046] (2) get the recipe quantity of fasudil hydrochloride, N-carboxymethyl chitosan, reduced glutathione, anhydrous citric acid, sodium citrate dihydrate and sodium chloride and mix, add The water for injection of 90% of the recipe quantity treated in step (1) was stirred until dissolved, and the pH was adjusted to 5.0 with hydrochloric acid or sodium hydroxide, then 3 g of medicinal charcoal for freezing treatment in a -10°C refrigerator was added, and the stirring was carried out for ...

Embodiment 2

[0049] Every 1000 pieces of described fasudil hydrochloride injection, its formula consists of:

[0050]

[0051] The stabilizer is composed of N-carboxymethyl chitosan and reduced glutathione in a mass ratio of 1:0.25.

[0052] The preparation method is the same as in Example 1.

Embodiment 3

[0054] Every 1000 pieces of described fasudil hydrochloride injection, its formula consists of:

[0055]

[0056] The stabilizer is composed of N-carboxymethyl chitosan and reduced glutathione in a mass ratio of 1:0.25.

[0057] The preparation method is the same as in Example 1.

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Abstract

The invention belongs to the field of pharmaceutical preparation, and particularly relates to stable fasudil hydrochloride injection and a preparation method thereof. The fasudil hydrochloride injection comprises fasudil hydrochloride, stabilizers, anhydrous citric acid, sodium citrate dihydrate, sodium chloride and water for injection, wherein the stabilizers comprise N-carboxymethyl chitosan and reduced glutathione according to the mass ratio of 1:(0.05-0.35). The preparation method includes the steps: dissolving components in the formula by the water for injection after pyrogen removal; adjusting pH (potential of hydrogen); adding medicinal carbon for stirring adsorption to further remove pyrogen and perform discoloration; performing filtration and decarburization; performing filtration, sterilization, sub-package, potting and sterilization to obtain the fasudil hydrochloride injection. The fasudil hydrochloride injection has fine light stability and simple in formula, insoluble particles are effectively suppressed, the preparation process is easily operated, and industrialization is facilitated.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a stable fasudil hydrochloride injection and a preparation method thereof. Background technique [0002] Fasudil hydrochloride, chemical name is hexahydro-1-(5-sulfonylisoquinoline)-1(H)-1,4-diazepine hydrochloride, a RHO kinase inhibitor and novel intracellular Ca 2+ antagonist. The drug can dilate blood vessels by increasing the activity of myosin light chain phosphatase, reduce the tension of endothelial cells, improve the microcirculation of brain tissue, protect ischemic brain tissue, and at the same time can antagonize inflammatory factors, protect nerves against apoptosis, and promote nerve regeneration. Clinically, it is mainly used to prevent and improve vasospasm caused by various reasons, selectively expand spasmodic blood vessels, and improve cardiac and cerebral ischemia. Studies have shown that fasudil hydrochloride has certain side effects, such as h...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/551A61K47/36A61K47/12A61K47/18A61P9/08A61P9/10A61P25/00
CPCA61K9/0019A61K9/08A61K31/551A61K47/12A61K47/36A61K47/42
Inventor 魏林华魏林友崔旭升
Owner 中润药业有限公司
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