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Compound ammonium glycyrrhetate 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 side effects, poor stability, single effect and curative effect, etc., and achieve the effect of improving stability, good stability and remarkable curative effect

Inactive Publication Date: 2018-10-16
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; at the same time, the main active ingredients of compound monoammonium glycyrrhizinate preparations are mainly monoammonium glycyrrhizinate As an active ingredient, the effect and curative effect are relatively single. During treatment, it needs to be used in combination with other drugs, which increases the dosage and risk of medication for patients. The development of compound ammonium glycyrrhizinate monoammonium preparations combined with other drugs can meet the clinical needs of patients. To meet the needs of patients, reduce the risk and dosage of medication, and help to enhance its curative effect and scope of application, so as to better serve the majority of patients

Method used

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  • Compound ammonium glycyrrhetate S injection pharmaceutical composition as well as preparation method and application thereof
  • Compound ammonium glycyrrhetate S injection pharmaceutical composition as well as preparation method and application thereof
  • Compound ammonium glycyrrhetate S injection pharmaceutical composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A compound monoammonium glycyrrhizinate S injection pharmaceutical composition, comprising the following raw materials in parts by weight:

[0030] 400g monoammonium glycyrrhizinate S, 320g cysteine ​​hydrochloride, 4.0kg glycine, 400g anhydrous sodium sulfite, 45g disodium edetate, 1.0kg sodium chloride, 30g sodium citrate, 21g citric acid, 280ml capillary Extract, Radix Bupleurum extract, Curcuma turmeric extract, Radix Radix Radix and Phellodendron Phellodendron extract by reflux extraction, and finally dilute to 200L with water for injection.

[0031] The preparation method of this compound monoammonium glycyrrhizinate S injection pharmaceutical composition comprises the following steps:

[0032] S1. Weigh glycyrrhizinate monoammonium salt S, cysteine ​​hydrochloride, glycine, sodium citrate, anhydrous sodium sulfite, disodium edetate, citric acid, sodium chloride and Chinese medicinal materials; Weighing and dissolving charcoal in the charcoal storage and weighing...

Embodiment 2

[0039] A compound monoammonium glycyrrhizinate S injection pharmaceutical composition, comprising the following raw materials in parts by weight:

[0040] 430g monoammonium glycyrrhizinate S, 300g cysteine ​​hydrochloride, 4.2kg glycine, 450g anhydrous sodium sulfite, 40g disodium edetate, 1.2kg sodium chloride, 40g sodium citrate, 25g citric acid, 300ml capillary extract, Radix Bupleuri extract, Curcuma extract, Radix Radix Radix and Phellodendron Phellodendron extract by reflux extraction, and finally dilute to 210L with water for injection.

[0041] A preparation method of compound monoammonium glycyrrhizinate S injection pharmaceutical composition, is characterized in that, comprises the following steps:

[0042] S1. Weigh glycyrrhizinate monoammonium salt S, cysteine ​​hydrochloride, glycine, sodium citrate, anhydrous sodium sulfite, disodium edetate, citric acid, sodium chloride and Chinese medicinal materials; Weighing and dissolving charcoal in the charcoal storage an...

Embodiment 3

[0049] A compound monoammonium glycyrrhizinate S injection pharmaceutical composition, comprising the following raw materials in parts by weight:

[0050] 500g monoammonium glycyrrhizinate S, 400g cysteine ​​hydrochloride, 4.5kg glycine, 500g anhydrous sodium sulfite, 50g disodium edetate, 1.5kg sodium chloride, 60g sodium citrate, 50g citric acid, 350ml capillary Extract, Radix Bupleurum Extract, Curcuma Radix Extract, Radix Isatidis Extract and Phellodendron Phellodendron Extract by reflux extraction, and finally dilute to 280L with water for injection.

[0051] A preparation method of compound monoammonium glycyrrhizinate S injection pharmaceutical composition, is characterized in that, comprises the following steps:

[0052] S1. Weigh glycyrrhizinate monoammonium salt S, cysteine ​​hydrochloride, glycine, sodium citrate, anhydrous sodium sulfite, disodium edetate, citric acid, sodium chloride and Chinese medicinal materials; Weighing and dissolving charcoal in the charcoa...

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Abstract

The invention relates to the technical field of medicines and specifically relates to a compound ammonium glycyrrhetate S injection pharmaceutical composition as well as a preparation method and application thereof. The pharmaceutical composition is prepared from monoammonium glycyrrhizinate S, cysteine hydrochloride, glycine, anhydrous sodium sulfite, edetate disodium, sodium chloride, sodium citrate, citric acid and traditional Chinese medicine extract; finally, the volume is fixed at 180-450L with injection water; the pharmaceutical composition is prepared by the following steps: weighing and grinding, reflux extraction, mixing and dosing, sterilization and filtration and filling and sealing; the pharmaceutical composition can be applied to the treatment of abnormal liver function caused by acute and chronic persistent hepatitis; according to the compound ammonium glycyrrhetate S injection pharmaceutical composition provided by the invention, the treatment effect and stability of the drug are enhanced while the solubility of particles in the drug is higher; thus, the injection pharmaceutical composition has higher safety and better effect, the dosage is reduced, and the medication safety is improved for the patients.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a compound monoammonium glycyrrhizinate S injection pharmaceutical composition and a preparation method and application thereof. 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 real...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61K36/282A61K36/233A61K36/195A61K36/315A61K36/756A61K31/704A61K9/08A61K47/18A61K47/12A61K47/02A61K47/04A61P1/16A61P31/14A61P31/20A61P39/02
CPCA61K36/9066A61K9/0019A61K9/08A61K31/704A61K36/195A61K36/233A61K36/282A61K36/315A61K36/756A61K47/02A61K47/12A61K47/183A61K2236/331A61K2236/39A61K2236/51A61P1/16A61P31/14A61P31/20A61P39/02A61K2300/00
Inventor 费青张丹张恒张戈
Owner JILIN BAINIAN HANKE PHARM CO LTD
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