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Niacin zantino injection composition, nicotin zantino freeze-dried powder injection and preparation method thereof

A technology of niacin, zantino, and freeze-dried powder injection, which is applied in freeze-dried delivery, drug combination, active ingredients of heterocyclic compounds, etc., can solve problems affecting drug safety, many uncontrollable factors, and high impurity content, etc. Achieve the effects of easy storage and market sales, good stability, and reduced production costs

Active Publication Date: 2018-01-30
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The nicotinic acid zantino is used in the form of sodium chloride injection, and the preparation method is relatively simple, but the impurity content is relatively large, and the stability is insufficient
[0004] Although the current preparation method of nicotinol and its freeze-dried powder preparation is relatively simple, and there are many marketed products and patents, there are too many uncontrollable factors, which often contain more impurities, which affect the safety of the drug

Method used

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  • Niacin zantino injection composition, nicotin zantino freeze-dried powder injection and preparation method thereof
  • Niacin zantino injection composition, nicotin zantino freeze-dried powder injection and preparation method thereof
  • Niacin zantino injection composition, nicotin zantino freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Prescription composition (specification: 0.6g) 1000 bottles:

[0029]

[0030] Preparation:

[0031] Weigh 80% of the total amount of water for injection and add it to the liquid preparation tank, add hydroxypropyl-β-cyclodextrin and mannitol to dissolve it, pass cooling water into the interlayer and cool it to 18°C, weigh niacin and add it to it, Stir to dissolve, add water for injection (cooled to 18°C ​​with another liquid mixing tank) to the full amount, adjust the pH value to 6.1-6.5 with 1mol / L sodium hydroxide solution; add activated carbon of 0.1% of the total amount of the prepared drug solution, Stirring for 30 minutes, coarse filtration and 0.22 μm microporous membrane sterilization filtration, the obtained semi-finished stock solution was divided into vials, half-covered with rubber stoppers, and freeze-dried.

[0032] The freeze-drying process is as follows: Put the divided semi-finished product stock solution into the freeze-drying box, keep the temper...

Embodiment 2

[0034] Prescription composition (specification: 0.6g) 1000 bottles:

[0035]

[0036] Preparation:

[0037] Weigh 80% of the total amount of water for injection and add it to the liquid preparation tank, add hydroxypropyl-β-cyclodextrin and mannitol to dissolve it, pass cooling water into the interlayer and cool it to 18°C, weigh niacin and add it to it, Stir to dissolve, add water for injection (cooled to 18°C ​​with another liquid mixing tank) to the full amount, adjust the pH value to 6.1-6.5 with 1mol / L sodium hydroxide solution; add activated carbon of 0.1% of the total amount of the prepared drug solution, Stirring for 30 minutes, coarse filtration and 0.22 μm microporous membrane sterilization filtration, the obtained semi-finished stock solution was divided into vials, half-covered with rubber stoppers, and freeze-dried.

[0038] Put the divided semi-finished product stock solution into the freeze-drying box, keep the temperature at -30°C for 3 hours; evacuate to l...

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PUM

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Abstract

The invention discloses a composition for injection of niacin, niacin, freeze-dried powder of niacin and a preparation method thereof. The niacin lyophilized powder is composed of niacin, hydroxypropyl Made of ‑β‑cyclodextrin, mannitol, and pH regulator, the mass ratio of niacin and hydroxypropyl‑β‑cyclodextrin is 1:1~2, and the pH regulator is 1mol / L NaOH aqueous solution . Through the addition of a stabilizer, the finished product of niacin zantino has stable quality, low cost and high yield, and is suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a composition for injection of niacin and guanidine, freeze-dried powder of niacin and a preparation method thereof. Background technique [0002] Niacin is suitable for the treatment of cerebrovascular disorders (such as cerebral thrombosis, cerebral embolism, sequelae of brain trauma, sequelae of brain surgery, sequelae of stroke, hypoxic encephalomalacia caused by carotid artery occlusion, senile brain dysfunction etc.), coronary heart disease, angina, post-myocardial infarction (prevention of recurrence), myocarditis, migraine, ear disease vertigo, extremity arterial spasm, intermittent claudication, diabetic gangrene, thrombophlebitis, varicose veins Ulcers, pulmonary embolism, bedsores, chilblains, and hyperlipidemia. [0003] The Chinese patent application with the publication number CN 102514755 A discloses a method for preparing Niacin Zantino Sodium Chloride ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/522A61K47/40A61K47/26A61P9/10
Inventor 刘景萍刘全国陈克领林文君李党
Owner HAINAN HULUWA PHARMA GRP CO LTD