Dextro-oxiracetam powder injection for injecting and preparation method thereof

A kind of technology of dextrooxypyramid powder and dextrooxypyramid, which is applied in the field of dextrooxypyramid preparations, and can solve the problems of high related substances, unstable quality, unfavorable clinical application and the like

A kind of technology of dextrooxypyramid powder and dextrooxypyramid, which is applied in the field of dextrooxypyramid preparations, and can solve the problems of high related substances, unstable quality, unfavorable clinical application and the like

CN110384659AInactive Publication Date: 2019-10-29CHONGQING RUNZE PHARM CO LTD
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Use n-propanol to dissolve the commercially available raw material of dextrooxypyridamide at a concentration of 25 mg / mL, cover and seal, stir at a temperature of 35 °C at a speed of 250 r / min for 15 h, filter, and let the filtrate stand for volatilization and crystallization, collect The crystals were dried for 5 hours at a temperature of 70°C and a relative humidity of 25% to obtain the dextrooxypyridamide crystalline compound.

[0018] Powder Diffraction Determination (XRPD): Test instrument conditions: use Bruker D2 PHASER powder diffractometer for room temperature test, test conditions: Cu Ka (1.5418 Å) as light source, voltage 30 kV, current 10 mA, test step size 0.014 o , scanning speed 0.1 s / step, scanning range 5-40 o (2θ). After testing, the X-ray powder diffraction spectrum of the dextrooxypyridamide crystalline compound prepared in Example 1 of the present invention represented by a diffraction angle of 2θ±0.2° is within 2 θ is 12.6±0.2°, 16.66±0.2°, 17.5...

Embodiment 2

[0020] Use n-propanol to dissolve the commercially available dextrooxypyridamide raw material at a concentration of 18 mg / mL, cover and seal, stir at a temperature of 20 °C at a speed of 300 r / min for 10 h, filter, and let the filtrate stand for volatilization and crystallization, collect The crystals were dried for 4 hours at a temperature of 60° C. and a relative humidity of 35% to obtain the dextrooxypyridamide crystalline compound. The determination method of Example 1 was used to detect that the dextrooxypyridine crystalline compound prepared in Example 2 was the same crystal form of dextrooxypyramide as in Example 1.

Embodiment 3

[0022] Use n-propanol to dissolve the commercially available raw material of dextrooxypyridamide at a concentration of 45 mg / mL, cover and seal, stir at a temperature of 45 °C at a speed of 100 r / min for 5 h, filter, and let the filtrate stand for volatilization and crystallization, collect The crystals were dried for 6 hours at a temperature of 75° C. and a relative humidity of 15% to obtain the dextrooxypyridamide crystalline compound. The detection method of Example 1 was used to detect that the dextrooxypyridine crystalline compound prepared in Example 3 was the same crystal form of dextrooxypyridine in Example 1.

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Abstract

The invention provides a dextro-oxiracetam powder injection for injecting. The powder injection is sterile powder and is prepared from dextro-oxiracetam in a crystal form and lysine in a specific proportion. An inventor conducts a large number of experiments and unexpectedly finds that after the dextro-oxiracetam powder injection used for injecting and prepared from the lysine and the dextro-oxiracetam in the crystal form in the a specific proportion in a combined mode is dissolved by water for injecting, the dextro-oxiracetam powder injection is stable in quality, has few insoluble particlesand thus is very suitable for injecting; and a preparation method is simple, short in operation time, high in production efficiency and suitable for industrial production.

Description

technical field [0001] The invention relates to a dextrooxypyridine preparation, in particular to a dextrooxypyridine powder for injection and a preparation method thereof. Background technique [0002] Epilepsy, also known as cerebral epilepsy or sheep epilepsy, is a syndrome of chronic recurrent transient brain dysfunction. According to statistics, the incidence of epilepsy in my country is about 23 / 100,000 per year, and the prevalence rate is 3.5-4.8‰. Seizures can cause a series of symptoms, and convulsions are one of the typical symptoms of epilepsy, including repetitive movements of limbs, abnormal behavior, and general convulsions with loss of consciousness, etc., and even cause body damage or death. The treatment of epilepsy includes various methods such as drug therapy, surgical therapy, physical therapy and psychotherapy, among which drug therapy is the most commonly used and most important means at present. Currently clinically used drugs for the treatment of ep...

Claims

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Application Information

Patent Timeline
29 Oct 2019
Publication
CN110384659A
IPC
A61K9/14; A61K47/18; A61K31/4015; A61P25/08; C07D207/273
CPC
A61K9/0019; A61K9/145; A61K31/4015; A61P25/08; C07B2200/07; C07B2200/13; C07D207/273
Inventors
叶雷