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Phloroglucinol freeze-drying composition for injection and preparation method thereof

A technology of phloroglucinol and its composition, which is applied in the field of phloroglucinol freeze-dried composition for injection and its preparation, can solve the problems of visible foreign matter, etc., and achieve low product impurity content, reduced dissolution time, and stable product quality Effect

Active Publication Date: 2015-04-08
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the problem of visible foreign matter often appearing after reconstitution of freeze-dried powder injections, the present invention adopts a new composition and its preparation method to obtain a high-quality and stable phloroglucinol freeze-dried composition for injection

Method used

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  • Phloroglucinol freeze-drying composition for injection and preparation method thereof
  • Phloroglucinol freeze-drying composition for injection and preparation method thereof
  • Phloroglucinol freeze-drying composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013]

[0014] Dissolve phloroglucinol and Tween 80 in water for injection, and use a high-pressure homogenizer until it is completely dissolved; add lactose, stir and dissolve until uniform, and adjust the pH value to 4.0 with 0.1moL / L hydrochloric acid; then add activated carbon for needles, and stir 30 minutes; fine filter the above solution with a 0.22um microporous membrane; fill it into 7mL vials, the filling volume of each bottle is 3mL, half stoppered with rubber, and freeze-dry through the following freeze-drying steps to obtain the freeze-drying curve. Dry composition: After the packaged products are put into the box, cool down to -38°C for pre-freezing and keep for 3 hours; turn on the vacuum, raise the temperature of the partition to -10°C, and keep it warm for 8 hours; raise the temperature of the partition to 0°C , keep it for 1 hour; raise the temperature of the separator to 10°C, keep it for 1 hour; raise the temperature of the separator to 25°C, keep it for...

Embodiment 2

[0016]

[0017] Dissolve phloroglucinol and Tween 80 in water for injection, and use a high-pressure homogenizer until it is completely dissolved; add lactose, stir and dissolve until uniform, and adjust the pH value to 5.1 with 0.1moL / L hydrochloric acid; then add activated carbon for needles, and stir 30 minutes; fine filter the above solution with a 0.22um microporous membrane; fill it into 7mL vials, the filling volume of each bottle is 3mL, half stoppered with rubber, and freeze-dry through the following freeze-drying steps to obtain the freeze-drying curve. Dry composition: After the packaged products are put into the box, cool down to -40°C for pre-freezing and keep for 1 hour; turn on the vacuum, raise the temperature of the partition to -8°C, and keep it warm for 8 hours; raise the temperature of the partition to 0°C , keep it for 2 hours; raise the temperature of the separator to 8°C, keep it for 1 hour; raise the temperature of the separator to 30°C, keep it for 6...

Embodiment 3

[0019]

[0020] Dissolve phloroglucinol and Tween 80 in water for injection, and use a high-pressure homogenizer until it is completely dissolved; add lactose, stir and dissolve until uniform, and adjust the pH value to 5.9 with 0.1moL / L hydrochloric acid; then add activated carbon for needles, and stir 30 minutes; fine filter the above solution with a 0.22um microporous membrane; fill it into 7mL vials, the filling volume of each bottle is 3mL, half stoppered with rubber, and freeze-dry through the following freeze-drying steps to obtain the freeze-drying curve. Dry composition: After the packaged products are put into the box, cool down to -40°C for pre-freezing and keep for 2 hours; turn on the vacuum, raise the temperature of the partition to -8°C, and keep it warm for 10 hours; raise the temperature of the partition to 0°C , keep for 2 hours; raise the temperature of the separator to 9°C, keep for 2 hours; raise the temperature of the separator to 28°C, keep for 7 hours...

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Abstract

The invention belongs to the field of medicines and provides a phloroglucinol freeze-drying composition for injection and a preparation method thereof. The preparation method of the phloroglucinol freeze-drying composition for injection comprises the following steps: dissolving phloroglucinol and tween-80 in water for injection, dissolving by a high pressure homogenizer, adding mannitol, and stirring and dissolving till the mixture is uniform; adjusting the pH value to 4.0-6.0 by 0.1moL / L hydrochloric acid; replenishing water for injection to full dose; then adding active carbon for a needle and stirring for 20 minutes; precisely filtering the solution by using a 0.22 micron microfiltration membrane; and packing the precise filtrate in penicillin bottles and freezing and drying to obtain the freeze-drying composition. The phloroglucinol composition provided by the invention is good in quality and high in stability.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a preparation method of phloroglucinol, more specifically to a freeze-dried composition of phloroglucinol for injection and a preparation method thereof. Background technique [0002] Phloroglucinol is a new antispasmodic drug newly developed abroad and used clinically. It has been widely used in the treatment of diseases caused by smooth muscle spasm in Europe. 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. , has no effect on cardiovascular function. Another pharmacological...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/05A61P21/02A61P29/02A61K47/26
Inventor 张贵民寻明金秦士慧
Owner SHANDONG NEWTIME PHARMA