Multilayer coextrusion-lamination softly bagged inosine sodium chloride injection composition and preparation method thereof

Abstract

The invention provides a multilayer coextrusion-lamination softly bagged inosine sodium chloride injection composition. Each 100ml of inosine sodium chloride injection composition comprises the following components by weight: 0.6+ / -0.05g of inosine and 0.9+ / -0.05g of sodium chloride, or 0.6+ / -0.05g of inosine, 0.9+ / -0.05g of sodium chloride and 0.1+ / -0.02g of D-gluconic acid-thita-lactone; and the multilayer coextrusion-lamination softly bagged inosine sodium chloride injection composition can be obtained by performing heat-seal of a multilayer co-extrusion-lamination composite membrane and a plastic infusion container interface, then filling inosine sodium chloride injection composition and performing heat-seal together with a ring type seal cap of the plastic infusion container in a class-100 clean room. A preparation method comprises the following steps: adding water for injection into inosine or a mixture of inosine and D-gluconic acid-thita-lactone, stirring evenly and then adding sodium chloride, stirring and dissolving, and filtering through a microporous filtering membrane to obtain the inosine sodium chloride injection composition; and performing heat-seal of a multilayer co-extrusion-lamination composite membrane and a plastic infusion container interface, then filling inosine sodium chloride injection composition and performing heat-seal together with a ring type seal cap of the plastic infusion container, and sterilizing to obtain the composition.

Description

technical field [0001] The invention relates to a multi-layer co-extruded composite film soft bag inosine sodium chloride injection composition and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Inosine is an inosine compound, white crystalline powder. Melting point 218 ° C (decomposition). Slightly soluble in water, insoluble in chloroform or ethanol. Odorless, slightly bitter taste. [0003] Inosine is a normal component of the human body and participates in nucleic acid metabolism, protein synthesis and energy metabolism in the body. It can improve the activities of coenzyme A and pyruvate oxidase, so that cells can carry out normal metabolism under hypoxia, which is helpful for damaged liver cells. Recovery, can stimulate the production of antibodies in the body and promote the absorption of iron in the intestine; used for adjuvant treatment of leukopenia and thrombocytopenia caused by various reasons, heart f...

AI Technical Summary

Problems solved by technology

Since the glass bottle or hard plastic bottle injection must be introduced into the air, and there are many patients in the hospital, there are many pathogenic microorganisms, and the air pollution is serious, the introduction of air during the infusion is likely to cause infusion reactions or cross-infection to the patient. In addition, the glass bottle or Hard plastic bottles have a certain shape and large volume, are easily broken during transportation, and occupy a large area for storage, etc.

There are also some problems in plastic PVC soft bags. For example, there are dozens of formula components, some of which are even small molecular additives, and the amount of plasticizer is as high as about 50%. Trace components will be partially separated and enter the liquid medicine. When the liquid medicine is injected into the human body, side effects are likely to occur, and even cause serious harm to the human body; PVC soft bags have poor heat resistance and are inconvenient to disinfect. The storage period is short, it is difficult to meet the use requirements

In addition, PVC soft bags are not easy to degrade and recycle, which is easy to cause environmental pollution