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Preparation of pH-stable pentoxifylline injection

A technology of theobromine injection and pentoxifylline, which is applied in the field of pH-stable pentoxifylline injection and its preparation, and can solve the problems of increased substance content, large changes in pH value, and poor pH stability, etc.

Inactive Publication Date: 2021-05-28
南京泽恒医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The prescription consists of pentoxifylline, sodium chloride and water for injection, which has the disadvantage of poor pH stability. During long-term storage, it is prone to large changes in pH value and increased content of related substances, resulting in poor product stability. Adverse reactions occur, which restricts the wide application of this product in clinical practice

Method used

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  • Preparation of pH-stable pentoxifylline injection
  • Preparation of pH-stable pentoxifylline injection
  • Preparation of pH-stable pentoxifylline injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Per 1000mL Pentoxifylline Injection:

[0031] Pentoxifylline 20g Sodium chloride 6.88g L-Lysine 3g Add water for injection to 1000mL

[0032] Add the prescribed amount of sodium chloride, L-lysine, and pentoxifylline to nitrogen-saturated water for injection to dissolve in turn, add water to the full amount, and then pass the liquid medicine through a 0.45 μm coarse filter and a 0.22 μm polyether The sulfone filter core fine filter is filtered into the temporary storage tank, and then the temporary storage tank is filled with a terminal filter, and terminally sterilized at 121°C for 15 minutes to obtain the product.

Embodiment 2

[0034] Per 1000mL Pentoxifylline Injection:

[0035] Pentoxifylline 20g Sodium chloride 6.88g L-Lysine 4g Add water for injection to 1000mL

[0036] Add the prescribed amount of sodium chloride, L-lysine, and pentoxifylline to nitrogen-saturated water for injection to dissolve in turn, add water to the full amount, and then pass the liquid medicine through a 0.45 μm coarse filter and a 0.22 μm polyether The sulfone filter core fine filter is filtered into the temporary storage tank, and then the temporary storage tank is filled with a terminal filter, and terminally sterilized at 121°C for 15 minutes to obtain the product.

Embodiment 3

[0038] Per 1000mL Pentoxifylline Injection:

[0039] Pentoxifylline 20g Sodium chloride 6.88g L-Lysine 5g Add water for injection to 1000mL

[0040] Add the prescribed amount of sodium chloride, L-lysine, and pentoxifylline to nitrogen-saturated water for injection to dissolve in turn, add water to the full amount, and then pass the liquid medicine through a 0.45 μm coarse filter and a 0.22 μm polyether The sulfone filter element fine filter is filtered into the temporary storage tank, and then the temporary storage tank is filled with a terminal filter, and terminally sterilized at 121°C for 15 minutes to obtain the product.

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Abstract

The invention discloses a prescription and a preparation method of a pH-stable pentoxifylline injection. The prescription is composed of pentoxifylline, sodium chloride, L-lysine and water for injection, and the dosage of the L-lysine is 3-7 mg / ml. After the L-lysine (pH 5.5-6.0) is added, the pH value of the pentoxifylline injection is more stable, and the L-lysine serving as a brain protective agent for systemic brain trauma, chronic tissue ischemia and ischemic diseases has a synergistic effect with the pentoxifylline, so that the effect of pentoxifylline for improving the blood flow volume of the brain and improving nutritional microcirculation of the body and oxygen supply of an ischemic area are improved. The pentoxifylline injection disclosed by the invention is simple and efficient in prescription process and good in safety.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a pH-stable pentoxifylline injection and a preparation method thereof. Background technique [0002] Pentoxifylline is a methylxanthine derivative. It is an alkaloid obtained from theobromine extracted from cocoa beans and then introduced into a pentanone group. It is a white powder or granule; it is easily soluble in water, ethanol, Slightly soluble in ether. Odorless, bitter taste. Molecular formula is C 13 h 18 N 4 o 3 , the molecular weight is 278.31, the chemical name is 3,7-dihydro-3,7-dimethyl-1-(5-oxohexyl)-1H-purine-2,6-dione, the structural formula is as attached figure 1 shown. [0003] Pentoxifylline is clinically used as a vasodilator for the treatment of peripheral vascular diseases. It can improve the deformability of damaged red blood cells, increase fibrinolysis, thereby reducing blood viscosity and inhibiting platelet aggregation. Pentoxifylline can also increase t...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/522A61K47/02A61K47/18A61P9/08
CPCA61K31/522A61K9/0019A61K47/02A61K9/08A61K47/183A61P9/08
Inventor 徐成郭倩倩胡雄林熊冬冬
Owner 南京泽恒医药技术开发有限公司
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