Phloroglucinol injection and preparation method thereof

A phloroglucinol injection, phloroglucinol technology, applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, drug delivery, etc., can solve the problems of rapid growth of substances, easy oxidation and instability of phloroglucinol

Active Publication Date: 2021-03-19
ZHEJIANG WANBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to solve the problem that phloroglucinol is easily oxidized and unstable in the existing preparation process, and the related substances are placed for a long time to increase rapidly, the purpose

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
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1 prepares phloroglucinol injection (contrasting the impact of feeding gas as carbon dioxide or nitrogen on the stability of the preparation)

[0039] Single bottle dose: total volume: 4mL / bottle, phloroglucinol hydrate: 40mg / bottle, the prescription is as follows:

[0040] Phloroglucinol Hydrate 40mg

[0041] Trimethylphloroglucinol 0.04mg

[0042] Sodium chloride 28mg

[0043] Hydrochloric acid amount

[0044] Appropriate amount of water for injection

[0045] Gas Carbon Dioxide / Nitrogen

[0046] Example 1 Preparation process: add 80% of the prescribed amount of water for injection at 80°C, and simultaneously feed carbon dioxide / nitrogen to make it saturated in water. Add the prescribed amount of trimethylphloroglucinol, phloroglucinol hydrate and sodium chloride and stir for 5 minutes, adjust the pH to 4.00 with hydrochloric acid, add water for injection to a sufficient amount and stir for 10 minutes, pass the solution through a 0.22 μm filter membran...

Embodiment 2

[0057] Example 2 Preparation of Phloroglucinol Injection (Contrast the Effect of Deoxygenation on Preparation Stability)

[0058] Single bottle dose: total volume: 4mL / bottle, phloroglucinol hydrate: 40mg / bottle, the prescription is as follows:

[0059] Phloroglucinol Hydrate 40mg

[0060] Trimethylphloroglucinol 0.04mg

[0061] Sodium chloride 28mg

[0062] Hydrochloric acid amount

[0063] Appropriate amount of water for injection

[0064] Gas CO2 / None

[0065] Example 2 Preparation process: add 80% of the prescribed amount of water for injection at 80°C, and simultaneously feed carbon dioxide or not feed gas. Add the prescribed amount of trimethylphloroglucinol, phloroglucinol hydrate, and sodium chloride, stir for 5 minutes, stir to dissolve completely, adjust the pH of the solution to 4.00 with hydrochloric acid, supplement water for injection to a sufficient amount, and add 0.22 Filter with μm filter membrane and potting.

[0066] Investigate the related substances ...

Embodiment 3

[0070] Example 3 Preparation of Phloroglucinol Injection (Contrasting the Impact of Antioxidants on Preparation Stability)

[0071] Single bottle dose: total volume: 4mL / bottle, phloroglucinol hydrate: 40mg / bottle, the prescription is as follows:

[0072] Phloroglucinol Hydrate 40mg

[0073] Trimethylphloroglucinol 0.04mg

[0074] Sodium chloride 28mg

[0075] Antioxidant (sodium bisulfite / sodium metabisulfite) 8mg

[0076] Hydrochloric acid amount

[0077] Appropriate amount of water for injection

[0078] gas nitrogen

[0079] Example 3 Preparation process: add 80% of the prescription water for injection at 80° C., and feed nitrogen at the same time. Add the prescribed amount of antioxidant (sodium bisulfite / sodium pyrosulfite), trimethylphloroglucinol, phloroglucinol hydrate, and sodium chloride, stir for 5 minutes, stir to dissolve completely, and adjust the solution with hydrochloric acid pH to 4.00, supplemented with water for injection to a sufficient amount, fil...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and relates to a phloroglucinol injection and a preparation method thereof. The phloroglucinol injection comprises the following mainactive pharmaceutical ingredients: phloroglucinol, trimethylphloroglucinol, an osmotic pressure regulator sodium chloride and water for injection. The preparation method is mainly characterized in that carbon dioxide is used as a stabilizer, so that the use of an antioxidant is avoided, the pH value of the solution is reduced, the stability of the solution is improved, the prescription process issimplified, and the phloroglucinol injection with stable content, slow impurity growth and long validity period is obtained.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a phloroglucinol injection and a preparation method thereof. Background technique [0002] Phloroglucinol is widely used in clinical antispasmodic pain relief, for the treatment of diseases caused by smooth muscle spasm. By directly acting on the smooth muscles of the gastrointestinal tract and genitourinary tract spasm, it will not produce anticholinergic side effects while relieving the spasm of the smooth muscles, and will not cause symptoms such as hypotension, increased heart rate, and arrhythmia. [0003] Phloroglucinol was first discovered by Laboratoires Lafon, whose trade name is SPASFON (Spasfon), and related dosage forms such as oral freeze-dried tablets / sugar-coated tablets / suppositories / injections have been developed. Laboratoire L.Lafon was acquired by Cephalon on December 28, 2001, and TEVA acquired Cephalon in 2011, so the current French sales manufacture...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/04A61K31/05A61P1/06A61P21/02
CPCA61K9/08A61K9/0019A61K47/02A61K31/05A61P1/06A61P21/02
Inventor 尹莉芳严真李菁菁肖丽蒙余波陈安
Owner ZHEJIANG WANBANG PHARMA
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