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New pyritinol hydrochloride injection

A technology of pyrithione hydrochloride and injection, which is used in medical preparations containing active ingredients, organic active ingredients, nervous system diseases, etc., can solve problems such as reducing acidity, and achieve reduced irritation, good solubility and solubility. Good results

Inactive Publication Date: 2011-01-05
BEIJING KAWIN TECH SHARE HLDG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, in order to solve the clinical problems of pyrithione hydrochloride preparations, there have been some related reports, patent number: 02138236.0, Suzhou Changzheng-Xinkai Pharmaceutical Co., Ltd., invention name: Diluted drug containing pyrithione hydrochloride for improving brain metabolism Concentrated and clear solution for intravenous injection, using a mixed solvent composed of propylene glycol and ethanol to dissolve pyrithione hydrochloride crude drug to make pyrithione hydrochloride injection; patent number 03114968.3, Shanghai Botai Pharmaceutical Technology Co., Ltd., invention name: a Pyritinol hydrochloride additive for injection uses divalent metal ions, such as calcium ions and magnesium ions as masking agents to reduce its acidity; application number: 200410022280.2, Guizhou Shengjitang Pharmaceutical Co., Ltd., invention name: pyrithione hydrochloride injection Liquid and preparation method thereof, adopt methods such as cyclodextrin inclusion, but do not see the relevant report that adopts amino acid buffer solution, polyethylene glycol, the mixed solvent that Tween 80 forms as yet

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Pyritinol Hydrochloride 100g

[0016] Macrogol 200 75ml

[0017] PH 4 Glycine-HCl Buffer 425ml

[0018] Tween 80 0.05g

[0019] Total 500ml

[0020] Preparation:

[0021] (1) Measure 75ml of polyethylene glycol 200 and add it to 425ml of PH4 glycine-hydrochloric acid buffer solution

[0022] (2) Weigh 0.05 g of Tween 80, add it into the solution obtained in step (1), and mix well to obtain a mixed solvent;

[0023] (3) Take by weighing 100g pyrithione hydrochloride, join in the mixed solvent, adjust PH4.0 with above-mentioned glycine-hydrochloric acid buffer solution;

[0024] (4) ultrafiltration is carried out to the solution obtained in step (3), and activated carbon adsorption;

[0025] (5) The solution obtained in step (4) is filtered through a microporous membrane, and aseptically packaged to obtain the obtained solution.

Embodiment 2

[0027] Pyritinol Hydrochloride 100g

[0028] Macrogol 300 100ml

[0029] PH 5 Glycine-HCl Buffer 400ml

[0030] Tween 80 0.08g

[0031] Total 500ml

[0032] Preparation:

[0033] (1) Measure 100ml of polyethylene glycol 300 and add it to 400ml of glycine-hydrochloric acid buffer solution

[0034] (2) Weigh Tween 80 0.08g, add it to the solution obtained in step (1), and mix well to obtain a mixed solvent;

[0035] (3) Take by weighing 100g pyrithione hydrochloride, join in the mixed solvent, adjust PH4.0 with glycine-hydrochloric acid buffer solution;

[0036] (4) ultrafiltration is carried out to the solution obtained in step (3), and activated carbon adsorption;

[0037] (5) The solution obtained in step (4) is filtered through a microporous membrane, and aseptically packaged to obtain the obtained solution.

Embodiment 3

[0039] Pyritinol Hydrochloride 100g

[0040] Macrogol 400 120ml

[0041] PH 5 Glycine-HCl Buffer 380ml

[0042] Tween 80 0.05g

[0043] Total 500ml

[0044] Preparation:

[0045] (1) Measure 120ml of polyethylene glycol 300 and add it to 380ml of glycine-hydrochloric acid buffer solution

[0046] (2) Weigh 0.05 g of Tween 80, add it into the solution obtained in step (1), and mix well to obtain a mixed solvent;

[0047] (3) Take by weighing 100g pyrithione hydrochloride, join in the mixed solvent, adjust PH4.0 with amino acid-hydrochloric acid buffer solution;

[0048] (4) ultrafiltration is carried out to the solution obtained in step (3), and activated carbon adsorption;

[0049] (5) The solution obtained in step (4) is filtered through a microporous membrane, and aseptically packaged to obtain the obtained solution.

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PUM

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Abstract

The invention discloses a new pyritinol hydrochloride injection. The injection comprises pyritinol hydrochloride and mixed solvent, wherein the mixed solvent consists of polyethylene glycol, tween 80 and amino acid-hydrochloric acid buffer solution. The pyritinol hydrochloride injection provided by the invention has pH of 3.5 to 4.5, which is obviously greater than that of a normal pyritinol hydrochloride preparation, so stimulation on a blood vessel in clinical use caused by acidity of liquid medicament is obviously reduced.

Description

technical field [0001] The invention relates to a new drug for improving brain metabolism, in particular to a new pyrithione hydrochloride injection and a preparation method thereof. Background technique [0002] Pyritinol Hydrochloride as Vitamin B 6 Derivatives are clinically used as drugs for improving brain metabolism. At present, there are frequent reports of severe phlebitis during the clinical use of pyrithione hydrochloride preparations, and severe side effects limit its clinical application. Among them, acidity is one of the important factors causing severe irritation. As a hydrochloride, pyrithione hydrochloride is strongly acidic and easily soluble in an acidic environment. The pH of the aqueous solution is ≤ 2.8, but the solubility is poor in a neutral or alkaline environment. Because the normal pH of human plasma is 7.35~ 7.45, weakly alkaline, after intravenous injection of pyrithione hydrochloride preparations, its acidity seriously interferes with the norm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/444A61K47/34A61P25/00A61K47/10A61K47/26
Inventor 张春丽许晓关晶华吉春张坤黄俊
Owner BEIJING KAWIN TECH SHARE HLDG