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Decoloring method and decoloring agent for quinolone injection

A quinolone and decolorizing agent technology, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., and can solve the problems of decreased content of main drugs, unqualified, dark solution color and other problems

Active Publication Date: 2009-07-29
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, the decolorization method of quinolone injection preparation process usually has two kinds of traditional processes, one uses charcoal powder as a decolorizer, the consequences of doing so will reduce the content of the main drug, or even unqualified; the other does not use charcoal powder As a decolorizing agent, this can ensure that the content of the main drug is qualified, but the color of the solution is still very dark, which is not easy for patients to accept

Method used

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  • Decoloring method and decoloring agent for quinolone injection
  • Decoloring method and decoloring agent for quinolone injection
  • Decoloring method and decoloring agent for quinolone injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1: Pazufloxacin mesylate (Hua Na Da Pharmaceutical Factory) sodium chloride injection

[0020] formula:

[0021]

[0022] Preparation Process:

[0023] 1) Place the sodium chloride of the formulated amount in 3 / 4 volume of water for injection, and stir to dissolve it.

[0024] 2) Add Pazufloxacin and stir continuously to dissolve it.

[0025] 3) Adjust the pH to 2.5-4.0 with methanesulfonic acid. ℃

[0026] Decolorization process:

[0027] 1) Warm up the prepared medicinal solution to 35°C, add 2g of charcoal powder (Liyang Zhuxi Activated Carbon Co., Ltd., ZX-767 activated carbon for needles) to it while stirring, and then continuously add 10g of talcum powder (Shanghai Shuo Si Talc Co., Ltd., 2500 mesh).

[0028] 2) Keep warm at 35°C and stir for 30 minutes at a stirring speed of 100 rpm.

[0029] 3) Use a diatomite sand filter rod (Suzhou Jiangnan Filter Factory, medium size) for primary filtration, and then use a 0.22 μm fin for fine filtration ...

Embodiment 2

[0035] Embodiment 2: ofloxacin (Zhejiang Xinchang Pharmaceutical Factory) sodium chloride injection

[0036] formula:

[0037]

[0038] Preparation Process:

[0039] 1) The sodium chloride of formula quantity is placed in the water for injection of 3 / 4 volume, stirs to make it dissolve.

[0040] 2) Ofloxacin was added and stirred continuously to dissolve it.

[0041] 3) Adjust the pH to 6.0-7.0 with hydrochloric acid.

[0042] Decolorization process:

[0043] 1) Warm up the prepared medicinal solution to 37°C, continuously add 1 g of talc powder (Shanghai Shuosi Talc Powder Co., Ltd., 2000 mesh) into it while stirring, and then continuously add 0.5 g of charcoal powder (Liyang Zhuxi Activated Carbon Co., Ltd., ZX-766 activated carbon for needles).

[0044] 2) Keep warm at 37°C and stir for 60 minutes at a stirring speed of 90 rpm.

[0045] 3) After primary filtration with diatomite sand filter rod (Suzhou Jiangnan Filter Factory, fine size), then fine filtration with ...

Embodiment 3

[0051] Embodiment 3: Levofloxacin Chloride (Jingxin Pharmaceutical Co., Ltd.) Sodium Chloride Injection

[0052] formula:

[0053]

[0054] Preparation Process:

[0055] 1) The sodium chloride of formula quantity is placed in the water for injection of 3 / 4 volume, stirs to make it dissolve.

[0056] 2) Ofloxacin was added and stirred continuously to dissolve it.

[0057] 3) Adjust the pH to 6.0-7.0 with hydrochloric acid.

[0058] Decolorization process:

[0059] 1) Warm up the prepared medicinal solution to 40°C, and continuously add 5g of charcoal powder (Liyang Zhuxi Activated Carbon Co., Ltd., ZX-768 activated carbon for needles) and 30g of talcum powder (Shanghai Shuosi Talcum Powder Co., Ltd.) into it while stirring. company, 300 mesh) homogeneous mixture.

[0060] 2) Keep warm at 40°C and stir for 35 minutes at a stirring speed of 110 rpm.

[0061] 3) After primary filtration with diatomite sand filter rod (Suzhou Jiangnan Filter Factory, fine size), then fine fi...

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Abstract

The invention relates to a decolorizing agent for quinolone injection, which comprises carbon powder and talcum powder, and the weight ratio of carbon powder to talc powder is 1:2 to 1:6. The present invention also relates to a method for decolorizing quinolone injection, the steps of which include: heating the liquid to be decolorized to 30-40°C; at this temperature, adding the decolorizing agent described in claim 1 or 2 while stirring; Add 0.05-1g of charcoal powder and 0.1-5g of talcum powder to the decolorizing solution; keep warm at 30-40°C and continue stirring for 15-60min; filter to remove the decolorizing agent.

Description

technical field [0001] The invention relates to a decolorization process for injections. More specifically, the present invention relates to the decolorizing method and decolorizing agent of quinolone injection. Background technique [0002] At present, the decolorization method of quinolone injection preparation process usually has two traditional processes, one uses charcoal powder as a decolorizer, the consequences of doing so will reduce the content of the main drug, or even unqualified; the other does not use charcoal powder As a depigmentation agent, this can ensure that the content of the main drug is qualified, but the color of the solution is still very dark, which is difficult for patients to accept. See: "Research on Decolorization Performance of Activated Carbon", Chang Yu, Xing Jinlong, Bai Yingbin, Yang Huilan, Journal of Taiyuan University of Technology, Issue 02, 1995; "Research on Adsorption and Decolorization of Amino Acid Mixture by Activated Carbon", Sun...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/04A61K9/08A61K31/496A61K31/5383A61P31/04
Inventor 陈佩丽朱正鸣王颖彦乌旭琼史建国夏凌云
Owner SHANGHAI SINE PHARMA LAB