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Heparin sodium injection and preparation method thereof

A technology for the preparation of injections and heparin sodium, which is applied in the field of heparin sodium injections and its preparation, can solve the problems of increased toxicity and side effects, impact on stability, and reduction of drug efficacy, and achieve simple and scientific formulation of prescriptions without toxic and side effects Effect

Inactive Publication Date: 2016-07-20
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Heparin sodium is easily hydrolyzed under acidic conditions, and it is easy to oxidize with oxidants in the production process to inactivate and affect stability (see: Zuo Yong, Pan Xunhai. Research on factors affecting the stability of heparin sodium[J]. Journal of Sichuan Institute of Technology , 2009, 22 (6): 67-69), and then in the preparation process of heparin sodium injection, the requirements for environmental conditions and process parameters are very strict. Adverse effects, such as the degradation of heparin sodium, the reduction of drug efficacy, and the enhancement of toxic and side effects often occur

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Prescription: For the preparation of 1000ml (2ml: 1000 units) of heparin sodium injection, the dosage protection range of heparin sodium is: 250000-1000000 units; the dosage protection range of sodium chloride for injection is 2075g-11.0g; The benchmark scales up or down the allocation volume, and its raw materials and sodium chloride also change in the same proportion.

[0021] Preparation:

[0022] 1. Concentrated formulation: Add 50%-90% of the prescribed amount of water for injection into the batching tank, add the prescribed amount of heparin sodium and sodium chloride, stir to dissolve, add 0.1%-0.6% of activated carbon for needles, and heat to 50-90°C, keep warm for 15 minutes, circulate to make the liquid medicine uniform, and filter with 0.8um titanium rod while it is hot.

[0023] 2. Dilute formulation: Pour the liquid medicine into the dilute formulation tank, add water for injection to the full amount, adjust the pH to 6.0-9.0 with 2.5mol / L NaOH, pass the i...

Embodiment 2

[0025] Prescription: For the preparation of 1000ml (2ml: 5000 units) of heparin sodium injection, the dosage protection range of heparin sodium is: 1250000-5000000 units. The protection scope of the sodium chloride dosage for injection is 2.5g-10g. Taking the 1000ml preparation amount as a benchmark to enlarge or reduce the preparation amount in the same proportion, its raw materials and sodium chloride also change in the same proportion.

[0026] Preparation:

[0027] 1. Concentrated formulation: Add 50%-90% of the prescribed amount of water for injection into the batching tank, add the prescribed amount of heparin sodium and sodium chloride, stir to dissolve, add 0.1%-0.6% of activated carbon for needles, and heat to 50-90°C, keep warm for 15 minutes, circulate to make the liquid medicine uniform, and filter with 0.8um titanium rod while it is hot.

[0028] 2. Dilute formulation: Pour the liquid medicine into the dilute formulation tank, add water for injection to the full...

Embodiment 3

[0030] Prescription: For the preparation of 1000ml (2ml: 12,500 units) of heparin sodium injection, the dosage protection range of heparin sodium is: 3125000-12500000 units. The protection scope of the dosage of sodium chloride for injection is: 2.25g-9.0g. Taking the 1000ml preparation amount as a benchmark to enlarge or reduce the preparation amount in the same proportion, its raw materials and sodium chloride also change in the same proportion.

[0031] Preparation:

[0032] 1. Concentrated formulation: Add 50%-90% of the prescribed amount of water for injection into the batching tank, add the prescribed amount of heparin sodium and sodium chloride, stir to dissolve, add 0.1%-0.6% of activated carbon for needles, and heat to 50-90°C, keep warm for 15 minutes, circulate to make the liquid medicine uniform, and filter with 0.8um titanium rod while it is hot.

[0033] 2. Dilute formulation: Pour the liquid medicine into the dilute formulation tank, add water for injection to...

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Abstract

The invention discloses a heparin sodium injection and a preparation method thereof. The heparin sodium injection is characterized in that the dosage protection region of heparin sodium in the heparin sodium injection is 250000-1000000 units, and the dosage protection region of injection sodium chloride is 2.75-11.0g; an allocation quantity, which serves as a base, is increased or decreased according to a same proportion, and the dosages of raw materials and the sodium chloride are changed according to the same proportion as well. The heparin sodium injection disclosed by the invention is simple in preparation and stable in quality, and the preparation method is simple in requirement on production equipment, low in production cost and suitable for large-scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a heparin sodium injection and a preparation method thereof. Background technique [0002] Heparin sodium is the sodium salt of aminodextran sulfate extracted from the intestinal mucosa of pigs or cattle. It is a mucopolysaccharide substance and belongs to an anticoagulant drug. It can be taken up by vascular endothelial cells after entering the human body. It is commonly used clinically Prevention and treatment of thrombosis or embolism diseases (such as myocardial infarction, thrombophlebitis, pulmonary embolism, etc.); disseminated intravascular coagulation (DIC) caused by various reasons; also used in hemodialysis, extracorporeal circulation, catheterization, microvascular surgery Anticoagulant treatment of certain blood specimens or instruments during operations such as Heparin sodium is easily hydrolyzed under acidic conditions, and it is easy to oxid...

Claims

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Application Information

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IPC IPC(8): A61K33/14A61K31/727A61K9/08A61P7/02
Inventor 曾培安吴健民
Owner KAMP PHARMA