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Compound monoammonium glycyrrhizate S injection pharmaceutical composition as well as preparation method and application thereof

A technology of monoammonium glycyrrhizinate and monoammonium glycyrrhizinate, which is applied in the field of medicine, can solve the problems of difficult discovery of insoluble particles in medicines, affect human health, and poor stability, and achieve significant curative effect, improved stability, and good stability Effect

Inactive Publication Date: 2018-09-21
JILIN BAINIAN HANKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing compound monoammonium glycyrrhizinate is mainly used in two forms of injection and freeze-dried powder in clinical application, but the preparations of compound monoammonium glycyrrhizinate currently in use are uneven, and most of them generally have the problem of poor stability , in order to enhance the stability of the drug, most of the current drugs are realized by adding a stabilizer to it. Although the addition of a stabilizer improves the stability of the drug, it will also lead to the generation of insoluble particles that are not easy to find in the drug , these particles have potential side effects and seriously affect human health, so it is urgent to develop new stable and safe compound monoammonium glycyrrhizinate preparations

Method used

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  • Compound monoammonium glycyrrhizate S injection pharmaceutical composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A compound monoammonium glycyrrhizinate S injection pharmaceutical composition, comprising the following raw materials in parts by weight:

[0029] Monoammonium glycyrrhizinate S 520g, cysteine ​​hydrochloride 390g, glycine 5.2kg, anhydrous sodium sulfite 520g, edetate disodium 52g, sodium chloride 2.08kg, activated carbon 130g, and finally dilute to 260L with water for injection.

[0030] The preparation method of this compound monoammonium glycyrrhizinate S injection pharmaceutical composition comprises the following steps:

[0031] S1. Weighing: Transfer monoammonium glycyrrhizinate S, cysteine ​​hydrochloride, glycine, anhydrous sodium sulfite, disodium edetate and sodium chloride from the material temporary storage room to the weighing room for weighing ingredients; activated carbon It is necessary to carry out the carbon weighing and carbon dissolving treatment in the carbon storage and weighing chamber first, that is, weigh the medicinal charcoal with a weighing ...

Embodiment 2

[0037] A compound monoammonium glycyrrhizinate S injection pharmaceutical composition, comprising the following raw materials in parts by weight:

[0038] Monoammonium glycyrrhizinate S 400g, cysteine ​​hydrochloride 300g, glycine 4.0kg, anhydrous sodium sulfite 400g, edetate disodium 40g, sodium chloride 1.0kg, activated carbon 100g, and finally dilute to 180L with water for injection.

[0039] The preparation method of this compound monoammonium glycyrrhizinate S injection pharmaceutical composition is the same as in Example 1.

Embodiment 3

[0041] A compound monoammonium glycyrrhizinate S injection pharmaceutical composition, comprising the following raw materials in parts by weight:

[0042] Monoammonium glycyrrhizinate S 600g, cysteine ​​hydrochloride 500g, glycine 6.0kg, anhydrous sodium sulfite 650g, edetate disodium 60g, sodium chloride 3.0kg, activated carbon 200g, and finally dilute to 450L with water for injection.

[0043] The preparation method of this compound monoammonium glycyrrhizinate S injection pharmaceutical composition is the same as in Example 1.

[0044] Drug efficacy verification:

[0045] In order to further illustrate the application value of the compound monoammonium glycyrrhizinate S injection pharmaceutical composition of the present invention, the stability and drug efficacy of the medicament in each embodiment of the present invention are verified, and the verification results are as follows:

[0046] 1. Stability experiment:

[0047] The medicaments prepared according to the formul...

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Abstract

The invention relates to the technical field of medicines, in particular to a compound monoammonium glycyrrhizate S injection pharmaceutical composition as well as a preparation method and applicationthereof. The pharmaceutical composition is prepared from 400-600g of monoammonium glycyrrhizinate S, 300-500g of cysteine hydrochloride, 4.0-6.0kg of glycine, 400-650g of anhydrous sodium sulfite, 40-60g of disodium edetate, 1.0-3.0kg of sodium chloride and 100-200g of activated carbon; finally, fixing the volume to 180-450L by using water for injection. The preparation method of the pharmaceutical composition comprises the steps of weighing, concentrating, diluting, carrying out sterile filtration, filling and sealing. The compound monoammonium glycyrrhizate S injection pharmaceutical composition can be used for treatment of abnormal liver function caused by acute and chronic and persistent hepatitis, not only improves medicament stability, but also can avoid insoluble particles from generating in medicament, and is good in safety, better in efficacy and more remarkable in curative effect.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a compound monoammonium glycyrrhizinate S injection pharmaceutical composition, its preparation method and application. Background technique [0002] The monoammonium glycyrrhizinate in the compound monoammonium glycyrrhizinate has a strong protective effect on liver cells. The compound monoammonium glycyrrhizinate is widely used in the treatment of abnormal liver function caused by acute, chronic and persistent hepatitis. In the adjuvant therapy of toxic hepatitis, traumatic hepatitis and cancer. The existing compound monoammonium glycyrrhizinate is mainly used in two forms of injection and freeze-dried powder in clinical application, but the preparations of compound monoammonium glycyrrhizinate currently in use are uneven, and most of them generally have the problem of poor stability , in order to enhance the stability of the drug, most of the current drugs are realized by a...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/18A61K31/704A61P1/16
CPCA61K9/0019A61K9/08A61K31/704A61K47/183A61P1/16
Inventor 费青张丹张恒张戈
Owner JILIN BAINIAN HANKE PHARM CO LTD
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