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Histamine dihydrochloride injection and preparation method thereof

A technology of histamine dihydrochloride and injection, which is applied in the field of orthopedics, can solve the problems of affecting drug efficacy, safety issues, and easy shape changes, and achieves the effects of stable and feasible process, reduced safety concerns, and low cost

Inactive Publication Date: 2019-08-02
HEFEI YIFAN MEDICINE MARKETING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there is no histamine dihydrochloride injection approved for marketing in China. According to the provisions of Annex II of the "Measures for the Administration of Drug Registration", this product belongs to category 3.1 of chemical drugs and is a non-origin product.
[0004] Histamine dihydrochloride is easily soluble in water, but the stability of its aqueous solution is not good, and its shape is easy to change when left for a long time, which affects the efficacy. At present, some studies have added propylene glycol, sodium thiosulfate and other auxiliary materials to its solution to maintain its properties. Stable, the addition of auxiliary materials not only increases the production cost, but also these auxiliary materials have great safety problems, so it is necessary to improve the preparation process of histamine dihydrochloride injection

Method used

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  • Histamine dihydrochloride injection and preparation method thereof
  • Histamine dihydrochloride injection and preparation method thereof
  • Histamine dihydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A histamine dihydrochloride injection is composed of histamine dihydrochloride, a pH regulator and water for injection.

[0026] like figure 1 Shown a kind of preparation method of histamine dihydrochloride injection, comprises the steps:

[0027] S1, drug dissolution concentrated preparation: accurately weigh 0.505g of histamine dihydrochloride, add 50ml of water for injection, fully stir to dissolve it, and obtain a concentrated solution of histamine dihydrochloride with a concentration of about 10mg / ml;

[0028] S2, activated carbon adsorbs pyrogen: heat the concentrated solution of histamine dihydrochloride prepared in step S1 to 60°C in a water bath, then add 0.1% (W / V) activated carbon for needles, adsorb at a constant temperature of 60°C for 25 minutes, filter through a 0.22 μm filter Membrane decarburization;

[0029] S3, dilution of medicinal solution and determination of pH: adding water for injection to the solution after decarburization in step S2 and dilu...

Embodiment 2

[0034] A histamine dihydrochloride injection is composed of histamine dihydrochloride, a pH regulator and water for injection.

[0035] like figure 1 Shown a kind of preparation method of histamine dihydrochloride injection, comprises the steps:

[0036] S1, drug dissolution and concentrated preparation: accurately weigh 0.501g of histamine dihydrochloride, add 50ml of water for injection, fully stir to dissolve it, and obtain a concentrated solution of histamine dihydrochloride with a concentration of about 10mg / ml;

[0037] S2, activated carbon adsorbs pyrogen: heat the concentrated solution of histamine dihydrochloride prepared in step S1 to 60°C in a water bath, then add 0.1% (W / V) activated carbon for needles, adsorb at a constant temperature of 60°C for 28 minutes, filter through a 0.22 μm filter Membrane decarburization;

[0038] S3, dilution of medicinal solution and determination of pH: adding water for injection to the solution after decarburization in step S2 and ...

Embodiment 3

[0043] A histamine dihydrochloride injection is composed of histamine dihydrochloride, a pH regulator and water for injection.

[0044] like figure 1 Shown a kind of preparation method of histamine dihydrochloride injection, comprises the steps:

[0045] S1, drug dissolving concentrated preparation: accurately weigh 0.504g of histamine dihydrochloride, add 50ml of water for injection, fully stir to dissolve it, and obtain a concentrated solution of histamine dihydrochloride with a concentration of about 10mg / ml;

[0046] S2, activated carbon adsorbs pyrogen: heat the concentrated solution of histamine dihydrochloride prepared in step S1 to 60°C in a water bath, then add 0.1% (W / V) activated carbon for needles, adsorb at a constant temperature of 60°C for 30min, filter through a 0.22 μm filter Membrane decarburization;

[0047] S3, dilution of medicinal solution and determination of pH: adding water for injection to the solution after decarburization in step S2 and diluting t...

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Abstract

The invention discloses a histamine dihydrochloride injection. The histamine dihydrochloride injection is prepared from histamine dihydrochloride, a PH regulator and injection water. A preparation method of the histamine dihydrochloride injection includes: dissolving and densely mixing chemicals, adsorbing a heat source with activated carbon, diluting a chemical solution and determining PH, packaging with a filter membrane, and performing disinfection, lamp detection and packaging. Shape and properties, pH value, solution clarity, color, relevant substances, content and the like of a product obtained in the invention are in accordance with stipulations of quality specifications. Addition of supplementary materials is small, concerns for safety is greatly reduced, the cost is low and the technique is stable and feasible.

Description

technical field [0001] The invention belongs to the field of orthopedics, in particular to a histamine dihydrochloride injection and a preparation method thereof. Background technique [0002] Histamine dihydrochloride injection was approved for marketing in Europe on October 7, 2008 under the trade name of Ceplene, which is used in combination with IL-2 for the maintenance treatment of adult acute myeloid leukemia (AML). The European Medicines Agency (EMEA) approved strength is 0.5ml: 0.5mg, and the approved route of administration is subcutaneous injection. [0003] At present, no histamine dihydrochloride injection has been approved for marketing in China. According to the provisions of Annex II of the "Administrative Measures for Drug Registration", this product belongs to category 3.1 of chemical drugs, which is a non-original research variety. [0004] Histamine dihydrochloride is easily soluble in water, but its aqueous solution has poor stability, and its shape is e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/417A61P35/02
CPCA61K9/0019A61K9/08A61K31/417A61P35/02
Inventor 周文艳刘存吴建雄
Owner HEFEI YIFAN MEDICINE MARKETING
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