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Tribenoside lidocaine suppository and preparation method thereof

A technology of tribenzyl glycoside lidocaine and lidocaine, which is applied in the directions of pharmaceutical formulations, suppository delivery, medical preparations of inactive ingredients, etc., and can solve the problems of instability, large amount of related substances in suppositories, poor stability of tribenzyl glycosides, etc. , to achieve the effect of small related substances, small voids in the tail, and moderate hardness

Active Publication Date: 2022-07-29
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the preparation process needs to be heated to a high temperature of 130°C. Tribenzyloside has poor stability and is unstable under strong acid, light and high temperature conditions, and can be decomposed to produce various unknown impurities.
Therefore, the related substances of the suppository prepared in this way are larger

Method used

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  • Tribenoside lidocaine suppository and preparation method thereof
  • Tribenoside lidocaine suppository and preparation method thereof
  • Tribenoside lidocaine suppository and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027] Preparation Process:

[0028] Completely melt SUPPOCIRE A and SUPPOCIRE NB at 60°C in advance, add lanolin, stir and mix to dissolve, after complete dissolution, continue to stir while cooling to 50°C, add lidocaine, and start stirring until lidocaine is completely dissolved. . Continue to cool down to 40°C while stirring, add the tribenzyl glucoside raw material, stir evenly, start filling into the double aluminum blister, and perform gradient cooling in the freezer, that is, first cool down to 15-25°C, cool for 10- After 15 minutes, the temperature is lowered to 0 to 5°C, cooled for 15 to 20 minutes, and then sealed.

Embodiment 2

[0030]

[0031] Preparation Process:

[0032] Completely melt SUPPOCIRE A and SUPPOCIRE NB at 60°C in advance, add lanolin, stir and mix to dissolve, after complete dissolution, continue to stir while cooling to 50°C, add lidocaine, and start stirring until lidocaine is completely dissolved. . Continue to cool down to 40°C while stirring, add the tribenzyl glucoside raw material, stir evenly, start filling into the double aluminum blister, and perform gradient cooling in the freezer, that is, first cool down to 15-25°C, cool for 10- After 15 minutes, the temperature is lowered to 0 to 5°C, cooled for 15 to 20 minutes, and then sealed.

Embodiment 3

[0034]

[0035]

[0036] Preparation Process:

[0037] Completely melt SUPPOCIRE A and SUPPOCIRE NB at 60°C in advance, add lanolin, stir and mix to dissolve, after complete dissolution, continue to stir while cooling to 50°C, add lidocaine, and start stirring until lidocaine is completely dissolved. . Continue to cool down to 40°C while stirring, add the tribenzyl glucoside raw material, stir evenly, start filling into the double aluminum blister, and perform gradient cooling in the freezer, that is, first cool down to 15-25°C, cool for 10- After 15 minutes, the temperature is lowered to 0 to 5°C, cooled for 15 to 20 minutes, and then sealed.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and relates to a rectal administration preparation, in particular to a tribenoside lidocaine suppository and a preparation method thereof. The tribenoside and lidocaine suppository is mainly prepared from active ingredients including tribenoside and lidocaine, a matrix stearin and a water absorbent lanonol. The tribenoside lidocaine suppository prepared by the invention has the advantages of moderate hardness, smooth and complete surface, smaller voids at the tail of the suppository particle, smaller related substances and the like. The preparation process is simple, the preparation temperature is low, the influence on the stability of the tribenoside raw material is small, the requirement of industrial mass production is met, meanwhile, the accelerated stability inspection shows that indexes are superior to those in the prior art, and the quality and safety of a preparation product are improved.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. Specifically, it relates to a rectal administration preparation, and in particular to a tribenzylglucoside lidocaine suppository and a preparation method thereof. Background technique [0002] Tribenzyl glycoside is composed of two optical isomers, α-isomer (α-ethyl-3,5,6-tribenzyloxy-D-glucofuranoside) and β-isomer (β-ethyl-3,5,6 - Tribenzyloxy-D-glucofuranoside), which has anti-inflammatory, anti-toxin, enhance capillary toughness, protect wound tissue and promote its healing and weak analgesic effects, and sphingosine Combined use can prevent Gram-negative and Gram-positive bacteria. This drug was discovered and synthesized in the 1950s, and was first marketed in Japan in 1978 as an oral drug for the treatment of hemorrhoids. Because it is highly fat-soluble, easily absorbed by the small intestine, and has a high drug utilization rate, its clinical efficacy is relatively l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K31/7034A61K47/14A61P9/14A61K31/167
CPCA61K31/167A61K31/7034A61K9/02A61K9/0031A61K47/14A61P9/14A61K2300/00
Inventor 李娜韩乃巍陈小伟刘忠
Owner SHANDONG NEWTIME PHARMA
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