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Phloroglucinol injection and preparation method thereof

A phloroglucinol injection and phloroglucinol technology, which is applied in the fields of pharmaceutical formula, drug delivery, digestive system, etc., can solve problems such as inconvenient use, and achieve the effect of ensuring the level of sterility assurance

Inactive Publication Date: 2015-02-04
NANJING CHANGAO PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to provide a new phloroglucinol injection and its preparation method for the problems that phloroglucinol injection is easy to degrade to generate impurities and long-term low-temperature (below 10°C) storage is easy to precipitate crystals and cause inconvenience in use.

Method used

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  • Phloroglucinol injection and preparation method thereof
  • Phloroglucinol injection and preparation method thereof
  • Phloroglucinol injection and preparation method thereof

Examples

Experimental program
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Effect test

reference example 1

[0020] Reference example 1 without antioxidant

[0021]

[0022] Preparation Process

[0023] Weigh the prescribed amount of excipients propylene glycol, sodium citrate, and citric acid and dissolve them in the prescribed amount of water for injection successively, add the prescribed amount of phloroglucinol dihydrate to dissolve; add 0.1% (mass volume ratio) powdered medicinal Activated carbon, stirred and adsorbed for 15 minutes; decarburized by filtration with a 0.45 μm microporous membrane, and then sterilized and filtered with a 0.22 μm microporous membrane; part of the filtrate was taken for intermediate content inspection; filling and sealing in ampoules, 121 ℃ × 15min sterilization, that is.

reference example 2

[0024] Reference example 2 antioxidant is sodium sulfite

[0025]

[0026] Preparation Process

[0027] Weigh the prescribed amount of excipients sodium sulfite, propylene glycol, sodium citrate, and citric acid and dissolve them in the prescribed amount of water for injection, add the prescribed amount of phloroglucinol dihydrate to dissolve; add 0.1% (mass volume ratio) powder Activated carbon for medicinal use, stirred and adsorbed for 15 minutes; decarburized by filtration with a 0.45 μm microporous membrane, and then sterilized and filtered with a 0.22 μm microporous membrane; take part of the filtrate to check the content of intermediates; fill and melt seal in ampoules , sterilized at 121°C for 15 minutes, ready to serve.

reference example 3

[0028] Reference example 3 without propylene glycol

[0029]

[0030] Preparation Process

[0031] The excipients sodium pyrosulfite, sodium citrate, and citric acid of the prescribed amount were weighed and dissolved in the prescribed amount of water for injection successively, and the prescribed amount of phloroglucinol dihydrate was added to dissolve; 0.1% (mass volume ratio) powdered drug Use activated carbon, stir and adsorb for 15 minutes; decarburize with a 0.45 μm microporous membrane first, and then sterilize and filter with a 0.22 μm microporous membrane; take part of the filtrate to check the content of intermediates; fill and melt seal in ampoules, Sterilize at 121°C for 15 minutes to obtain the product.

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Abstract

The invention belongs to the field of medicine preparations, and provides a phloroglucinol injection. The phloroglucinol injection is composed of an active composition phloroglucinol, an anti-oxidant sodium metabisulfite, propylene glycol, a pH conditioning agent selected from citric acid and sodium citrate, and injection water. The invention also provides a preparation method of the above injection. The prepared phloroglucinol injection solves the problems that a phloroglucinol injection in a conventional dosage form is easy to degrade and bad in stability, and has usage inconvenience because the crystal is easy to precipitate after the phloroglucinol injection is stored at a low temperature for a long time.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a phloroglucinol injection and a preparation method thereof. Background technique [0002] Phloroglucinol is also known as phlorizinol and garcinol, and its chemical name is 1,3,5-trihydroxybenzene. It is widely used clinically to treat diseases caused by smooth muscle spasm, such as acute spasmodic pain caused by digestive system and biliary tract dysfunction, acute spasmodic urethra, bladder, renal colic, etc. Phloroglucinol belongs to myotropic, non-atropine, non-papaverine pure smooth muscle antispasmodics, which can directly act on the smooth muscles of the gastrointestinal tract and genitourinary tract. Compared with other smooth muscle antispasmodics, phloroglucinol does not have anticholinergic effect, and will not produce a series of anticholinergic side effects such as increased heart rate and arrhythmia while relieving smooth muscle spasm. Anima...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/05A61K47/12A61P21/02A61P1/06A61P13/02A61P13/10A61P13/12
Inventor 霍立茹李新杰钟雪彬丁南南汪礼权黄海燕杨晓兵
Owner NANJING CHANGAO PHARMA SCI & TECH CO LTD
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