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Phloroglucinol and trimethylphloroglucinol injection and preparation method of injection

A technology of trimethylphloroglucinol and phloroglucinol, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, which can solve problems such as low quality and residual ethanol, Achieve the effect of less impurities, reduce the content, and solve the unqualified content

Active Publication Date: 2020-10-30
武汉人福药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at problems such as low product quality of phloroglucinol and trimethylphloroglucinol injection and ethanol residue, a kind of phloroglucinol and trimethylphloroglucinol injection and its preparation method should be found, and then prepared An injection with less impurity content and higher quality

Method used

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  • Phloroglucinol and trimethylphloroglucinol injection and preparation method of injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] An injection of phloroglucinol and trimethylphloroglucinol, comprising: 0.1 part of phloroglucinol, 0.0001 part of trimethylphloroglucinol, 0.06 part of sodium chloride and L - Cysteine ​​0.0001 part.

[0031] The preparation method of above-mentioned injection comprises the following steps:

[0032] (1) After heating the water for injection to 53°C, add trimethylphloroglucinol, stir and disperse evenly;

[0033] (2) After cooling down to 25°C, fill with carbon dioxide, wherein the time for filling with carbon dioxide is 20min, the flow rate of carbon dioxide is 35L / min, add phloroglucinol, sodium chloride and L-cysteine, and stir until The solution is clear;

[0034] (3) After the solution is sterilized and filtered with a 0.45 μm and a 0.22 μm PVDF microporous filter element, it is sealed and sterilized in a water bath, wherein the condition of the water bath sterilization is 121° C. for 8 minutes.

[0035] In addition, the amount of water for injection needs to me...

Embodiment 2

[0037] An injection of phloroglucinol and trimethylphloroglucinol, comprising: 10 parts of phloroglucinol, 0.01 part of trimethylphloroglucinol, 7 parts of sodium chloride and L - Cysteine ​​0.02 parts.

[0038] The preparation method of above-mentioned injection comprises the following steps:

[0039] (1) After heating the water for injection to 59°C, add trimethylphloroglucinol, stir and disperse evenly;

[0040] (2) After cooling down to 30°C, fill with carbon dioxide, wherein the time for filling with carbon dioxide is 60min, the flow rate of carbon dioxide is 15L / min, add phloroglucinol, sodium chloride and L-cysteine, and stir until The solution is clear;

[0041] (3) After the solution is sterilized and filtered with a 0.45 μm and a 0.22 μm PVDF microporous filter element, it is sealed and sterilized in a water bath, wherein the condition of the water bath sterilization is 121° C. for 18 minutes.

[0042] In addition, the amount of water for injection needs to meet t...

Embodiment 3

[0044] An injection of phloroglucinol and trimethylphloroglucinol, in parts by weight, comprising: 1 part of phloroglucinol, 0.001 part of trimethylphloroglucinol, 2 parts of sodium chloride, L - Cysteine ​​0.08 parts.

[0045] The preparation method of above-mentioned injection comprises the following steps:

[0046] (1) After heating the water for injection to 55°C, add trimethylphloroglucinol, stir and disperse evenly;

[0047] (2) After cooling down to 28°C, fill with carbon dioxide, wherein the time for filling with carbon dioxide is 30min, the flow rate of carbon dioxide is 25L / min, add phloroglucinol, sodium chloride and L-cysteine, and stir until The solution is clear;

[0048] (3) After the solution is sterilized and filtered with a 0.45 μm and a 0.22 μm PVDF microporous filter element, it is sealed and sterilized in a water bath, wherein the condition of the water bath sterilization is 121° C. for 15 minutes.

[0049] In addition, the amount of water for injection...

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Abstract

The invention provides a phloroglucinol and trimethylphloroglucinol injection and a preparation method thereof, and relates to the field of pharmaceutical preparations. The injection comprises phloroglucinol, trimethylphloroglucinol, sodium chloride and L-cysteine. The preparation method comprises the following steps: (1) heating water for injection, adding trimethylphloroglucinol, and uniformly stirring and dispersing; (2) after cooling, introducing carbon dioxide, adding phloroglucinol, sodium chloride and L-cysteine, and stirring until the solution is clear; and (3) sterilizing the solutionin a water bath after sterilizing and filtering the solution. The finally obtained injection is less in impurity quantity, the effect of the injection is consistent with that of an original product,and meanwhile, the problems that trimethylphloroglucinol is extremely difficult to dissolve and the content of trimethylphloroglucinol is unqualified due to adsorption in the preparation process are solved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an injection of phloroglucinol and trimethylphloroglucinol and a preparation method thereof. Background technique [0002] Phloroglucinol is a non-atropine, non-papaverine pure smooth muscle antispasmodic, which can directly act on spasmodic smooth muscle and has little effect on normal smooth muscle. Phloroglucinol was first developed by the French Laboratoires L.Lafon company, and phloroglucinol oral freeze-dried tablets, injections, suppositories and coated tablets were successively launched in the 1990s, with trade names of Spasfon. Among them, there are many imitation varieties of injection dosage forms in China, but there are more or less differences in the quality of the medicines and the original research products, such as inconsistent prescription composition and a large number of impurities. After analysis, the original Spasfon injection is a compound injecti...

Claims

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Application Information

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IPC IPC(8): A61K31/09A61K9/08A61K47/02A61K47/18A61P21/02A61K31/05
CPCA61K9/0019A61K9/08A61K31/05A61K31/09A61K47/02A61K47/183A61P21/02A61K2300/00
Inventor 李长浩陈良立陈莹唐维郭芬陈诗邓霞飞郑虎潘越
Owner 武汉人福药业有限责任公司
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