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...

Examples

Embodiment 1

[0015] Example 1: According to the ratio of 0.6 g of inosine and 0.9 g of sodium chloride per 100 ml of inosine and sodium chloride injection composition, weigh inosine, add about 80% water for injection in full, stir evenly, and then add Sodium chloride, stir to dissolve, add water for injection to nearly the full amount, stir well, add 0.03wt% activated carbon for needles, stir well, filter to remove activated carbon after standing, add water for injection to the full amount, adjust the pH value to 10% NaOH solution 7.5. After passing the inspection of the semi-finished products, filter them with 0.45μm and 0.22μm microporous membranes in turn to obtain the inosine and sodium chloride injection composition; in the 100-level clean area, use modified ethylene propylene polymerization from the inside to the outside. The multi-layer co-extrusion composite film composed of material layer, polyethylene layer, polyethylene layer, ethylene methacrylate polymer layer and polyester cop...

Embodiment 2

[0016] Example 2: According to the ratio of inosine 0.6g, sodium chloride 0.9g, D-glucono-delta-lactone 0.1g per 100ml of inosine sodium chloride injection composition, inosine and D-glucose were weighed acid-delta-lactone and mix to obtain a mixture, then add about 80% of the total water for injection, heat to 52 ° C, stir until the mixture of inosine and D-glucono-delta-lactone is completely dissolved, cool to room temperature, and then add Sodium chloride, stir to dissolve, add water for injection to 90% of the total amount, stir well, add 0.03wt% of activated carbon for injection, stir well, filter to remove activated carbon after standing, add water for injection to the full amount, use D-gluconic acid- The pH value of δ-lactone was adjusted to 6.5, and the inosine sodium chloride injection composition was filtered by microporous membrane; After the container interface is heat-sealed, the inosine-sodium chloride injection composition is filled, the air is drawn out, then ...

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...

Examples

Embodiment 1

[0015] Example 1: According to the ratio of 0.6 g of inosine and 0.9 g of sodium chloride per 100 ml of inosine and sodium chloride injection composition, weigh inosine, add about 80% water for injection in full, stir evenly, and then add Sodium chloride, stir to dissolve, add water for injection to nearly the full amount, stir well, add 0.03wt% activated carbon for needles, stir well, filter to remove activated carbon after standing, add water for injection to the full amount, adjust the pH value to 10% NaOH solution 7.5. After passing the inspection of the semi-finished products, filter them with 0.45μm and 0.22μm microporous membranes in turn to obtain the inosine and sodium chloride injection composition; in the 100-level clean area, use modified ethylene propylene polymerization from the inside to the outside. The multi-layer co-extrusion composite film composed of material layer, polyethylene layer, polyethylene layer, ethylene methacrylate polymer layer and polyester cop...

Embodiment 2

[0016] Example 2: According to the ratio of inosine 0.6g, sodium chloride 0.9g, D-glucono-delta-lactone 0.1g per 100ml of inosine sodium chloride injection composition, inosine and D-glucose were weighed acid-delta-lactone and mix to obtain a mixture, then add about 80% of the total water for injection, heat to 52 ° C, stir until the mixture of inosine and D-glucono-delta-lactone is completely dissolved, cool to room temperature, and then add Sodium chloride, stir to dissolve, add water for injection to 90% of the total amount, stir well, add 0.03wt% of activated carbon for injection, stir well, filter to remove activated carbon after standing, add water for injection to the full amount, use D-gluconic acid- The pH value of δ-lactone was adjusted to 6.5, and the inosine sodium chloride injection composition was filtered by microporous membrane; After the container interface is heat-sealed, the inosine-sodium chloride injection composition is filled, the air is drawn out, then ...