Compound glycyrrhizin lyophilized powder injection and preparation method thereof

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...

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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

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