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Artesunate and L-arginine composition for injection and preparation method thereof

A technology of artesunate and composition, which is applied in the field of drug preparation, can solve the problems of unstable sodium bicarbonate solution, low solubility of artesunate in water, safety risks, etc., and achieve easy and convenient preparation, increase the scope of use, The effect of stability improvement

Inactive Publication Date: 2015-03-18
CHONGQING HUIZHI PHARMA RES INST +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] (3), the inventors also found that the sodium bicarbonate solution of artesunate is extremely unstable, which may lead to safety risks
This combination can overcome the shortcomings such as the low water solubility of the existing artesunate for injection, and more importantly, the stability of the composition has an unexpected improvement. For this reason, the present invention is proposed

Method used

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  • Artesunate and L-arginine composition for injection and preparation method thereof
  • Artesunate and L-arginine composition for injection and preparation method thereof
  • Artesunate and L-arginine composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Prescription: Artesunate 1000 parts, L-arginine 450 parts;

[0028] The preparation steps are as follows:

[0029] (1) After the raw material sterile artesunate and the auxiliary material L-arginine are removed from the outer packaging, they are dust-cleaned, wiped and sterilized, and put into a sterile room for standby;

[0030] (2) In the 100-level clean area, artesunate and L-arginine were crushed separately and passed through an 80-mesh sieve;

[0031] (3) Weigh the artesunate and L-arginine obtained in step (2) in a 100-level clean area, mix them evenly according to the prescription ratio, and pack them into control bottles after the measured content is qualified, cork and cap , Light inspection, inspection qualified, labeling, packaging.

Embodiment 2

[0033] Prescription: Artesunate 1000 parts, L-arginine 900 parts;

[0034] Preparation steps:

[0035] (1) After the raw material sterile artesunate and auxiliary material L-arginine are removed from the outer packaging, dust is removed, cleaned, wiped and sterilized, and put into a sterile room for standby;

[0036] (2) In the 100-level clean area, artesunate and L-arginine were crushed separately and passed through an 80-mesh sieve;

[0037] (3) Weigh the artesunate and L-arginine obtained in step (2) in a 100-level clean area, mix them evenly according to the prescription ratio, and pack them into control bottles after the measured content is qualified, cork and cap , Light inspection, inspection qualified, labeling, packaging.

Embodiment 3

[0039] Prescription: Artesunate 1000 parts, L-arginine 675 parts;

[0040] The preparation steps are as follows:

[0041] (1) Weigh artesunate and L-arginine according to the prescription ratio and add them to the water for injection, then add an appropriate amount of mannitol, stir to dissolve, and sterile filter into the sterile room for standby;

[0042] (2) After the semi-finished product passes the inspection, it is divided into control bottles and waits for freeze-drying;

[0043] (3) Freeze drying process:

[0044] 1) Pre-freezing: first pre-lower the temperature of the condenser to below -50°C, and then quickly drop the temperature of the plate layer to below -35°C after the product enters the box, and keep it in a low temperature state for 2 hours;

[0045] 2) Primary drying: Turn on the vacuum pump, keep the vacuum at 10-15Pa, slowly raise the temperature to 4-6°C, keep it warm for 5-8 hours, and perform primary drying;

[0046] 3) Secondary drying: raise the temp...

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Abstract

The invention discloses an artesunate and L-arginine composition for injection. The artesunate and L-arginine composition comprises the following components in parts by weight: 1,000 parts of artesunate as a raw material and 450-900 parts of L-arginine as an auxiliary material. According to the composition, the artesunate which is poor in solubility can be dissolved; the pH value can be adjusted to be neutral to slightly alkaline for injection; the solution is clear, transparent and colorless; the composition has good solubility and mobility, and can be sub-packaged into a practical powder preparation for injection; and more importantly, the stability of the composition is improved beyond thought. The invention also provides a preparation process of the artesunate and L-arginine composition for injection. The preparation method comprises the following steps: directly mixing the raw materials, namely artesunate and L-arginine; sub-packaging, or dissolving and degerming firstly and then preparing powder for injection by adopting a freeze-drying technology. The artesunate and L-arginine composition for injection disclosed by the invention is simple in preparation process and stable and reliable in quality.

Description

technical field [0001] The invention relates to a composition composed of artesunate and L-arginine, which belongs to the technical field of medicine preparation. Background technique [0002] Artemisinin is currently the most effective drug for treating cerebral malaria and chloroquine-resistant falciparum malaria in the world. It is called "the best hope for the treatment of malaria" by the World Health Organization. It has the characteristics of rapidity, high efficiency, no drug resistance, and low side effects . Scientists modified the structure of artemisinin and successfully developed artemether, artether, dihydroartemisinin and artesunate. Artesunate was approved for marketing in 1987 for anti-malarial treatment. [0003] Artesunate (Artesunate) is dihydroartemisinin-10-α-succinate with a free carboxylic acid; molecular formula: C 19 h 28 o 8 , molecular weight: 384.42. The chemical structural formula of artesunate is as follows. [0004] [0005] In the str...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/19A61K31/357A61K47/18A61P33/06
Inventor 李能刚刘军贾春荣
Owner CHONGQING HUIZHI PHARMA RES INST
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