Method for preparing phloroglucinol injection

A technology of phloroglucinol injection and phloroglucinol, which is applied in the fields of pharmaceutical formula, drug delivery, digestive system, etc., can solve the problems such as the decrease of trimethylphloroglucinol content, and achieve the assurance level of sterility Effect

Active Publication Date: 2010-10-13
NANJING LIFENERGY R & D +1
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to provide a preparation method of phloroglucinol injection for the problem that the content of trimethylphloroglucinol decreases in the preparation process of phloroglucinol injection

Method used

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  • Method for preparing phloroglucinol injection
  • Method for preparing phloroglucinol injection
  • Method for preparing phloroglucinol injection

Examples

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Effect test

Embodiment 1

[0019] Example 1 Study on the decrease of trimethylphloroglucinol content during the filtration process of phloroglucinol injection 1.1 Whether the decrease of trimethylphloroglucinol content during the filtration process is related to its low solubility in water.

[0020] The comparative experiment is as follows: Weigh 7 g of sodium chloride, 1 g of sodium bisulfite, 0.35 g of citric acid, and 1.025 g of disodium hydrogen phosphate dodecahydrate, add a small amount of water for injection to dissolve; add 10 g of phloroglucinol, and make up water for injection When the volume of the solution is 1000mL, stir to dissolve to obtain solution A; prepare two parts of solution A, dissolve 10 mg and 20 mg of trimethylphloroglucinol with 2 ml of ethanol respectively, add to solution A, stir evenly, and take samples to check the trimethyl phloroglucinol Phloroglucinol content; at the same time, 0.22 μm polyethersulfone filter membrane sterilization filtration while hot, check the trimeth...

Embodiment 2

[0042] Weigh 7g of sodium chloride, 1g of sodium bisulfite, 0.35g of citric acid and 1.025g of disodium hydrogen phosphate dodecahydrate, add a small amount of water for injection to dissolve; add 10g of phloroglucinol, and make up water for injection until the volume of the solution is 1000mL, stir to make it dissolve, add 1g of activated carbon and stir evenly, decarbonize with 1μm filter membrane to obtain the filtrate; dissolve 10mg of trimethylphloroglucinol with 20ml of 75% ethanol aqueous solution, filter through a 0.22μm filter membrane, add Add to the above filtrate, stir evenly, to obtain the intermediate product solution, check the phloroglucinol content, trimethylphloroglucinol content and pH of the intermediate product solution; reduce the temperature of the intermediate product solution to 5 ° C, filter 0.45 μm polyethersulfone Membrane sterilization filtration, check filtrate (finished solution) phloroglucinol content, trimethyl phloroglucinol content and pH. Af...

Embodiment 3

[0046] Weigh 7g of sodium chloride, 1g of sodium bisulfite, 0.35g of citric acid and 1.025g of disodium hydrogen phosphate dodecahydrate, add a small amount of water for injection to dissolve; add 10g of phloroglucinol, and make up water for injection until the volume of the solution is 1000mL, stir to dissolve, add 1g of activated carbon and stir evenly, decarbonize with 1μm filter membrane to obtain filtrate; dissolve 10mg of trimethylphloroglucinol with 10ml of ethanol, filter through 0.22μm filter membrane, add to the above filtrate, stir Evenly, get the intermediate product solution, check the intermediate product solution phloroglucinol content, trimethylphloroglucinol content and pH, reduce the temperature of the filtered solution to 10 ° C, 0.22 μm polyethersulfone sterile filtration, check the filtrate (finished product solution ) phloroglucinol content, trimethylphloroglucinol content and pH. After passing the test, potting and steam sterilization at 121°C for 20 min...

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Abstract

The invention belongs to the field of medicinal preparations, and discloses a method for preparing phloroglucinol injection. The method for preparing the phloroglucinol injection comprises the following steps of: (1) preparing solution containing phloroglucinol and trimethyl phloroglucinol; (2) stirring the solution uniformly and then filtering the solution for sterilization; (3) encapsulating the filtered solution by a conventional method and sterilizing the encapsulated solution, wherein the temperature for the sterilizing filtration in the step (2) is 5 to 40 DEG C, and preferably 10 to 35 DEG C. The technical scheme can ensure stable content of the trimethyl phloroglucinol during the preparation of the phloroglucinol injection. Meanwhile, the method for preparing the phloroglucinol injection ensures the sterility assurance level of the injection by using the sterilization process with over sterilization effect.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and relates to a preparation method of phloroglucinol injection. Background technique [0002] Phloroglucinol is a new type of antispasmodic analgesic widely used in clinic at present, and is widely used in the treatment of diseases caused by smooth muscle spasm. It can directly act on the smooth muscle of gastrointestinal tract and genitourinary tract spasm, and is a muscle-tropic, non-atropine, non-opavine smooth muscle antispasmodic. Compared with other antispasmodics for smooth muscle, it is characterized by no anticholinergic effect. While relieving smooth muscle spasm, it will not produce a series of anticholinergic side effects, and will not cause symptoms such as hypotension, increased heart rate, and arrhythmia. , had no effect on cardiovascular function. Another pharmacological property of it is that it only acts on spastic smooth muscle and has little effect on normal smooth...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/05A61P1/06A61P13/06
Inventor 方文胡俊熊守军杨洁
Owner NANJING LIFENERGY R & D
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