Edaravone injection solution and preparation method thereof

A technology of edaravone and injection, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as unsatisfactory anti-oxidation effects and threats to the lives of patients. Achieve good antioxidant properties, good therapeutic effect, and high stability

Active Publication Date: 2013-10-16
北京普瑞博思生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] It can be seen from the above table that antioxidants are added to the prescriptions to prevent the oxidation of Edaravone, but the market response shows that the antioxidant effects of these preparations are not ideal , and after listing, it is found that it is difficult to solve the problem of easy oxidation and instability of this product only with sodium bisulfite, and the validity period of the prepared sample is only 1.5 years
Particles will be generated during the transportation and storage of its preparations, threatening the life safety of patients

Method used

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  • Edaravone injection solution and preparation method thereof
  • Edaravone injection solution and preparation method thereof
  • Edaravone injection solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] An edaravone injection, containing vitamin C and glutathione in the edaravone injection. In the edaravone injection, the concentration of edaravone is 0.1%-0.2% (W / V), the concentration of vitamin C is 0.1%-0.5% (W / V), and the concentration of glutathione The concentration is 1.0%-10.0% (W / V).

[0042] The preparation method of this Edaravone injection comprises the steps:

[0043] a. Take the prescribed amount of Edaravone, add 1 / 2 to 1 / 3 of the prescribed amount of water for injection at a temperature of 90 to 100°C, and stir to completely dissolve the Edaravone to obtain an Edaravone solution;

[0044] b. Add the vitamin C and glutathione to the edaravone solution, stir evenly, add water for injection to 80% of the prescription amount, and then cool to 70-80°C to obtain a mixed solution;

[0045] c. Add medical activated carbon to the mixed solution, the amount of the medical activated carbon added is 0.3% (W / V), stir for 15 minutes, filter while hot to decarbonize...

Embodiment 2

[0060] This embodiment is a preferred scheme based on embodiment 1, and the quality of the raw materials used is the same as that of embodiment 1.

[0061] In the described Edaravone injection, the concentration of Edaravone is 0.15% (W / V), the concentration of vitamin C is 0.25% (W / V), and the concentration of glutathione is 5.0% (W / V). / V).

[0062] The specific consumption of each raw material is:

[0063] Edaravone: 750g, vitamin C: 1.25kg, glutathione: 25kg, dilute hydrochloric acid: appropriate amount, sodium hydroxide: appropriate amount, add water for injection to 500L.

[0064] Refer to Example 1 for the preparation method of this example.

[0065] The optimum concentration of vitamin C dosage of the present embodiment is determined as shown in table 1:

[0066]

[0067] As can be seen from Table 1, the greater the concentration of vitamin C, the better the results of the influencing factors of Edaravone injection. Almost, it shows that the optimal dosage of vi...

Embodiment 3

[0084] This embodiment is a preferred scheme based on embodiment 1, and the quality of the raw materials used is the same as that of embodiment 1.

[0085] In the described Edaravone injection, the concentration of Edaravone is 0.1% (W / V), the concentration of vitamin C is 0.1% (W / V), and the concentration of glutathione is 1.0% (W / V). / V).

[0086] The specific consumption of each raw material is:

[0087] Edaravone: 2g, vitamin C: 2g, glutathione: 20g, dilute hydrochloric acid: appropriate amount, sodium hydroxide: appropriate amount, add water for injection to 2L.

[0088] Refer to Example 1 for the preparation method of this example.

[0089] The sample of this embodiment is subjected to a high temperature 60 degree centigrade influence factor test. The detection method is referred to in Example 2. The detection data are as follows, see Table 5:

[0090]

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Abstract

The invention relates to an edaravone injection solution and a preparation method thereof. The edaravone injection solution contains vitamin C and glutathione, wherein the concentration of edaravone is 0.1%-0.2% (W / V), the concentration of the vitamin C is 0.1%-0.5% (W / V), and the concentration of glutathione is 1.0%-10.0% (W / V). Compared with the prior art, the edaravone injection solution has the beneficial effects that the edaravone, the vitamin C and the glutathione are reasonably matched to enable the three ingredients to exert a synergistic effect, so that the excellent oxidation property is given full play, the cerebral injury and the complications are well treated, and the stability is high.

Description

technical field [0001] The invention belongs to the field of medicament preparation, and in particular relates to an edaravone injection and a preparation method thereof. Background technique [0002] Stroke is an acute local brain dysfunction caused by cerebral blood circulation disorder, clinically manifested as symptoms and signs such as aphasia, limb paralysis and sensory disturbance. Acute ischemic stroke is the most common type of stroke, accounting for 60% to 80% of all strokes. In some literatures, stroke specifically refers to cerebral infarction, and the time division of the acute phase is not uniform, generally within two weeks after the onset. The management of acute ischemic stroke should emphasize early diagnosis, early treatment, early rehabilitation and early prevention of recurrence. [0003] The incidence of stroke in China ranks second in the world after Siberia, Russia. Epidemiological studies have shown that there are 1.5 to 2 million new cases of str...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/06A61K31/4152A61K9/08A61K47/22A61P25/28A61P39/06A61K31/375
Inventor 何龙其缪也夫
Owner 北京普瑞博思生物科技有限公司
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