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Powder injection of compound glycyrrhizic acid glycosides and preparation method thereof

A technology for glycyrrhizin and injection for injection, which is applied in the field of compound glycyrrhizin freeze-dried powder injection and its preparation, and can solve the problems of inability to fully meet, opalescence, strict requirements on storage conditions, etc.

Active Publication Date: 2008-12-10
TIBET WEIXINKANG MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The disadvantages of compound glycyrrhizin powder for injection in the prior art are strict requirements on storage conditions and high cost of storage conditions. For example, the drug standard YBH09612006 of the State Food and Drug Administration describes the storage conditions of compound glycyrrhizin for injection as "airtight, Store in a cool and dark place (protected from light and not exceeding 20°C), Instructions for Compound Monoammonium Glycyrrhizinate S for Injection (Guoyao Zhunzi H20050700, date of approval: December 27, 2006, Harbin Sanlian Pharmaceutical Co., Ltd.) storage conditions Described as "closed, stored in a cool and dark place (protected from light and not exceeding 20°C)", the existing marketed products often have problems in the process of storage, transportation, and use that cannot be fully satisfied. not exceeding 20°C), especially in summer and southern China, due to the high temperature, there may be different degrees of product quality problems caused by careless storage and transportation, such as precipitation after drug reconstitution, and after reconstitution Occurrence of different degrees of opalescence, a serious threat to the safety of clinical medication

Method used

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  • Powder injection of compound glycyrrhizic acid glycosides and preparation method thereof
  • Powder injection of compound glycyrrhizic acid glycosides and preparation method thereof
  • Powder injection of compound glycyrrhizic acid glycosides and preparation method thereof

Examples

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Effect test

Embodiment 1

[0074] 1. Preparation of process samples of each recipe

[0075] 1.1 Prescription process 1

[0076] Prescription: monoammonium glycyrrhizinate S (calculated as glycyrrhizin) 400g, cysteine ​​hydrochloride 200g, glycine 4000g, anhydrous sodium sulfite 160g, dextran 40500g.

[0077] Preparation method: Weigh dextran 40, add 10-15 times of water for injection, heat and stir to dissolve; add 0.2% (m / v) medicinal charcoal, stir for 20-30 minutes, decarbonize to obtain dextran 40 solution, take and prepare Measure 20% to 50% water for injection and dextran 40 solution, add it into the liquid mixing tank (barrel) and stir evenly; add glycine into the liquid mixing tank (barrel), stir to dissolve; dissolve anhydrous sodium sulfite with appropriate amount of water for injection, add the Stir in the liquid tank (barrel); add monoammonium glycyrrhizinate S into the liquid mixing tank (barrel), and stir until dissolved; dissolve the prescribed amount of cysteine ​​hydrochloride with an ...

Embodiment 2

[0184] Prescription: monoammonium glycyrrhizinate S (calculated as glycyrrhizin) 400g, cysteine ​​hydrochloride 200g, glycine 4000g, anhydrous sodium sulfite 160g, dextran 40430g, sodium chloride 75g.

[0185] Preparation method: Weigh dextran 40, add 10 to 15 times of water for injection, heat and stir to dissolve; add 0.2% (m / v) medicinal charcoal, stir for 20 to 30 minutes, decarbonize to obtain dextran 40 solution, take and prepare Measure 20% to 50% of water for injection and dextran 40 solution, add it into the liquid mixing tank (barrel) and stir evenly; add glycine into the liquid mixing tank (barrel), stir and dissolve; add anhydrous sodium sulfite and sodium chloride with appropriate amount of water for injection Dissolve, add to the liquid mixing tank (barrel), and stir; add monoammonium glycyrrhizinate S into the liquid mixing tank (barrel), and stir until dissolved; mix the prescribed amount of cysteine ​​hydrochloride with an appropriate amount of water for inject...

Embodiment 3

[0187] Prescription: monoammonium glycyrrhizinate S 400g, cysteine ​​hydrochloride 300g, glycine 4000g, anhydrous sodium sulfite 240g, dextran 40430g, sodium chloride 75g.

[0188] Preparation method: prepared with the same method as in Example 2.

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Abstract

The present invention relates to compound glycyrrhizin type powder injection and the preparation method thereof, in particular to compound glycyrrhizin for injection, compound glycyrrhizic acid mono-ammonium S powder injection and the preparation method thereof, which are characterized in that the powder injection consisting of glycyrrhizin (or mono-ammonium glycyrrhizinate), glycine and cysteine hydrochloride that are taken as the active ingredient and the bearer acceptable in medicine and the preparation method are included in the prescription; wherein, the bearer acceptable in medicine contains dextran. The compound glycyrrhizin type powder injection of the present invention can be preserved at room temperature, thus remarkably improving the stability of the medicine, better guaranteeing safety and significance of the medicine and effectively decreasing the storage and transportation cost in production and transportation processes of the medicine.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a compound glycyrrhizic acid glycoside freeze-dried powder injection and a preparation method thereof. Background technique [0002] Compound glycyrrhizin injection is composed of three main components: glycyrrhizin (or monoammonium glycyrrhizinate), glycine, and cysteine ​​hydrochloride. Glycyrrhizin (C 42 h 62 o 16 ) is insoluble in water, so it is generally made into a salt form to increase its water solubility, such as making ammonium glycyrrhizinate salt, domestic raw materials such as monoammonium glycyrrhizinate S (C 42 h 65 NO 16 2H 2 O), glycyrrhizin and its medically acceptable salts have significant anti-inflammatory effects, immunomodulatory effects, inhibition of experimental liver cell damage, inhibition of virus proliferation and inactivation of viruses and other pharmacological effects. [0003] Glycyrrhizin and its medically acceptable salts have allergies such as i...

Claims

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Application Information

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IPC IPC(8): A61K31/704A61K31/197A61K9/08A61K9/19A61P1/16A61P35/00A61P37/08
Inventor 胡军岳元婷刘烽张勇
Owner TIBET WEIXINKANG MEDICINE CO LTD
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