Compound glycyrrhizin lyophilized powder injection and preparation method thereof

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

Inactive Publication Date: 2014-06-18
北京藏卫信康医药研发有限公司
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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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  • Compound glycyrrhizin lyophilized powder injection and preparation method thereof
  • Compound glycyrrhizin lyophilized powder injection and preparation method thereof
  • Compound glycyrrhizin lyophilized powder injection and preparation method thereof

Examples

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Embodiment 1

[0073] Prescription: monoammonium glycyrrhizinate S (calculated as glycyrrhizin) 400g, cysteine ​​hydrochloride 200g, glycine 4000g.

[0074] Preparation method: Take an appropriate amount of water for injection and add it to the liquid mixing tank (barrel), add glycine to the liquid mixing tank (barrel), stir to dissolve; add glycyrrhizic acid monoammonium salt to the liquid mixing tank (barrel), stir until dissolved, add hydrochloric acid Dissolve cysteine ​​with an appropriate amount of water for injection, add it into the liquid preparation tank (barrel) while stirring, adjust the pH value of the liquid medicine to the range of 5.5-7.5 with ammonia water, add 0.1% (g / ml) activated carbon for needles, and stir After 20-30 minutes, filter to remove charcoal, and rinse with appropriate amount of water. Calculate the dilute constant volume according to the batch size and prescription quantity, add water for injection to the constant volume (25000mL), stir for more than 10 minu...

Embodiment 2

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

[0077] Preparation method: Take an appropriate amount of water for injection and add it to the liquid mixing tank (barrel), add glycine to the liquid mixing tank (barrel), stir and dissolve; add monoammonium glycyrrhizinate and anhydrous sodium sulfite to the liquid mixing tank (barrel), and stir until Dissolve, dissolve cysteine ​​hydrochloride with an appropriate amount of water for injection, add it to the liquid preparation tank (barrel) while stirring, adjust the pH value of the liquid medicine to the range of 5.5 to 7.5 with ammonia water, add 0.1% (g / ml) needle Use activated carbon, stir for 20-30 minutes, filter to remove carbon, and rinse with appropriate amount of water. Calculate the dilute constant volume according to the batch size and prescription quantity, add water for injection to the constant vol...

Embodiment 3

[0079] Prescription: monoammonium glycyrrhizinate S (calculated as glycyrrhizin) 400g, cysteine ​​hydrochloride 200g, glycine 4000g, disodium hydrogen phosphate 24.36g, sodium dihydrogen phosphate 13.73g.

[0080] Preparation method: Take an appropriate amount of water for injection and add it to the liquid mixing tank (barrel), add glycine to the liquid mixing tank (barrel), stir to dissolve; add glycyrrhizic acid monoammonium salt to the liquid mixing tank (barrel), stir until dissolved, add hydrochloric acid Dissolve cysteine ​​with an appropriate amount of water for injection, add it to the liquid preparation tank (barrel) while stirring, add disodium hydrogen phosphate-sodium dihydrogen phosphate pH buffer, and adjust the pH value of the liquid to within the range of 5.5 to 7.5 with ammonia water , add 0.1% (g / ml) activated carbon for needles, stir for 20-30 minutes, filter to remove carbon, and rinse with appropriate amount of water. Calculate the dilute constant volume ...

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Abstract

The present invention relates to a compound glycyrrhizin lyophilized powder injection and a preparation method thereof, particularly to compound glycyrrhizin for injection, a compound monoammonium glycyrrhizinate S lyophilized powder injection for injection, and a preparation method thereof. According to the present invention, the prescription contains a lyophilized powder injection comprising glycyrrhizin (monoammonium glycyrrhizinate) adopted as an active component, glycine, cysteine hydrochloride and a disodium hydrogen phosphate-sodium dihydrogen phosphate or dipotassium hydrogen phosphate-potassium dihydrogen phosphate pH buffer, and a preparation method of the lyophilized powder injection; and the drug liquid content is stable during the compound glycyrrhizin lyophilized powder injection preparation process, the finished product can be stored at a room temperature, the injection stability is significantly improved, the safety and the effectiveness of the injection are well ensured, and the warehousing transportation cost during the injection production storage and transportation process is effectively reduced.

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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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/704A61K47/02A61K47/18A61P1/16A61P17/00A61P37/08A61P39/02A61K31/198
Inventor 谷景斌胡军刘烽张勇
Owner 北京藏卫信康医药研发有限公司
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