Compound monoammonium glycyrrhizinate S pharmaceutical composition and method for preparing frozen powder injection

A technology of monoammonium glycyrrhizate and freeze-dried powder injection, which is applied in the preparation of compound monoammonium glycyrrhizate S pharmaceutical composition and freeze-dried powder injection, and the field of compound monoammonium glycyrrhizate S freeze-dried powder injection, which can solve the problem of compound glycyrrhizic acid Problems such as poor stability of monoammonium, embolism, serious harm of insoluble particles, etc.

Active Publication Date: 2010-08-04
九瑞健康股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The compound monoammonium glycyrrhizinate is not stable, so the existing injection preparations generally add ingredients to improve its stability. Although the addition of these ingredients delays the degradation of the active ingredients in the preparation, it is found in the study that the addition of these ingredients is easy to cause injection. The increase of insoluble particles in the liquid, especially after a long time of storage, the insoluble particles change greatly, and the insoluble particles have potential side effects. A large number of studies have proved that insoluble particles will cause potential serious harm that is difficult to find for a while, and it is also the current clinical allergy

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1 Compound monoammonium glycyrrhizinate S freeze-dried powder injection

[0050] composition

[0051] Monoammonium Glycyrrhizinate S(C42H65NO16·2H2O) 40g

[0052] Glycine (C2H5NO2) 400g

[0053] Cysteine ​​Hydrochloride (C3H7NO2S·HCl·H2O) 30g

[0054] Anhydrous sodium sulfite 40g

[0055] Sodium citrate 4g

[0056] Sodium chloride 16g

[0057] Appropriate amount of sodium hydroxide

[0058] Add water for injection to 2000ml

[0059]

[0060] Made 1000 pieces

[0061] Preparation:

[0062] (1) Take the anhydrous sodium sulfite and monoammonium glycyrrhizinate S of the prescription amount in the liquid mixing tank, add 80% of the prescription amount of sterile water for injection, stir and dissolve;

[0063] (2) Add the prescribed amount of glycine, cysteine ​​hydrochloride, edetate disodium, and sodium chloride one by one, stir and dissolve one by one, adjust the pH value to 6.0-6.5 with 1mol / L NaOH solutio...

Embodiment 2

[0066] Example 2 Compound monoammonium glycyrrhizinate S freeze-dried powder injection

[0067] composition

[0068] Monoammonium Glycyrrhizinate S (C42H65NO16 2H2O) 80g

[0069] Glycine (C2H5NO2) 800g

[0070] Cysteine ​​Hydrochloride (C3H7NO2S·HCl·H2O) 60g

[0071] Anhydrous sodium sulfite 80g

[0072] Sodium citrate 8g

[0073] Sodium chloride 32g

[0074] Appropriate amount of sodium hydroxide

[0075] Add water for injection to 4000ml

[0076]

[0077] Made 1000 pieces

[0078] Preparation:

[0079] (1) Take the anhydrous sodium sulfite and monoammonium glycyrrhizinate S of the prescription amount in the liquid mixing tank, add 80% of the prescription amount of sterile water for injection, stir and dissolve;

[0080] (2) Add the prescribed amount of glycine, cysteine ​​hydrochloride, edetate disodium, and sodium chloride one by one, stir and dissolve one by one, adjust the pH value to 6.0-6.5 with 1mol / L N...

Embodiment 3

[0083] Example 3 Compound monoammonium glycyrrhizinate S freeze-dried powder injection

[0084] composition

[0085] Monoammonium Glycyrrhizinate S (C42H65NO16 2H2O) 120g

[0086] Glycine (C2H5NO2) 1200g

[0087] Cysteine ​​Hydrochloride (C3H7NO2S·HCl·H2O) 90g

[0088] Anhydrous sodium sulfite 120g

[0089] Sodium citrate 12g

[0090] Sodium chloride 48g

[0091] Appropriate amount of sodium hydroxide

[0092] Add water for injection to 6000ml

[0093]

[0094] Made 1000 pieces

[0095] Preparation:

[0096] (1) Take the anhydrous sodium sulfite and monoammonium glycyrrhizinate S of the prescription amount in the liquid mixing tank, add 80% of the prescription amount of sterile water for injection, stir and dissolve;

[0097] (2) Add the prescribed amount of glycine, cysteine ​​hydrochloride, edetate disodium, and sodium chloride one by one, stir and dissolve one by one, adjust the pH value to 6.0-6.5 with ...

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PUM

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, in particular to a compound monoammonium glycyrrhizinate S pharmaceutical composition and a method for preparing a frozen powder injection. The composition is the monoammonium glycyrrhizinate S frozen powder injection and comprises the following components: monoammonium glycyrrhizinate S, cysteine hydrochloride, glycine, anhydrous sodium sulphite, sodium citrate, sodium chloride, sodium hydroxide and water for injection. The frozen powder injection is more stable and safer.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a compound monoammonium glycyrrhizinate S pharmaceutical composition and a method for preparing a freeze-dried powder injection thereof. The composition is a compound monoammonium glycyrrhizinate S freeze-dried powder injection. Background technique [0002] Compound monoammonium glycyrrhizinate is used for abnormal liver function caused by acute, chronic and persistent hepatitis; it has certain adjuvant therapeutic effect on toxic hepatitis, traumatic hepatitis and cancer. It can also be used for food poisoning, drug poisoning, drug allergy, etc. [0003] At present, the compound monoammonium glycyrrhizinate preparations for clinical application include injection, freeze-dried powder and the like. The compound monoammonium glycyrrhizinate is not stable, so the existing injection preparations generally add ingredients to improve its stability. Although the addition...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/704A61K47/20A61P1/16A61P35/00A61P39/02A61P37/08
Inventor 王保明
Owner 九瑞健康股份有限公司
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